RX Modena Operator Manual

Operator Manual | RX9003
Amendment Record
RX modena Operator Manual

Amendment Record
Page Rev. Done by:

Page(s) Description Date
No. Initials
1.0 ALL NEW MANUAL RELEASED RANDOX November 2016
1.0.1 xiv Amendment to product label RANDOX December 2016
Appendices Addition of Operator Maintenance

1.0 RANDOX December 2016
11 Table
Manual Updated to Version 2.00

RANDOX February 2017
Upgrade to Manual Language Style,
2.0 ALL
Images and Standards
Corrected error in auto page

2.0.1 Appendices RANDOX March 2017
numbering and margins
2.0.1 xxviii Corrected typo and punctuation RANDOX March 2017
Manual Updated to Version 3.00
Update of RX series logo

Update of Randox font style RANDOX January 2018
3.0 ALL Update Cross Contamination table
Addition of section 9.5.9 (Cuvette C1
Solution Soak)
Update to
3.10 xiii - xliv Cross Contamination table (pg xx) RANDOX March 2018
and Carryover table (pg. xxi)
Update to TOC to account for change

3.01 i - xii RANDOX March 2018
to Cross Contamination table
Amendment Record
Page Ver. Done by:

Page(s) Description Date
No. Initials
Foreword
Information for Operators
FOREWORD
INFORMATION FOR OPERATORS
This section provides details on how to use this manual and

fundamental information relating to the RX modena analyser.
Document No. RX9003 RX modena — Operator Manual

Rev 3.01 — March 2018 Page i
Foreword
Document type: Document status:

Operator Manual Version 3.0
Randox Laboratories Ltd
55 Diamond Road Supplementary title: Document number:
Crumlin RX9003
County Antrim
RX modena Date of issue Language
BT29 4QY
United Kingdom. January 2018 ENGLISH
technical.services@randox.com Original
Instructions
2017: All rights reserved.
With the exclusion of documents or part(s) thereof, issued by Randox Laboratories Ltd or one of its authorized agents, directly
to (and for the sole use of) the end user: No part of this publication may be reproduced, stored in a retrieval system, or
transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording or otherwise
without the written permission of the publisher.
Information correct at time of print. Randox Laboratories Ltd is a subsidiary of Randox Holdings Ltd a company registered
within Northern Ireland with company number N.I. 614690.
VAT Registered Number: GB 151 6827 08. Product availability may vary from country to country. Please contact your local
Randox representative for information.
RX modena — Operator Manual Document No. RX9003

Page ii Rev 3.01 — March 2018
Foreword
RX modena Operator Manual Contents

Foreword Information for Operators ........................................................................................ i
Foreword .................................................................................................................................. xiii
Intended Use........................................................................................................................... xiii
Target User............................................................................................................................. xiii
Disclaimer ............................................................................................................................... xiii
Trademarks..............................................................................................................................xiv
About Manuals ..........................................................................................................................xv
Composition of Separate Volumes ............................................................................................................. xv
Warning Symbols ....................................................................................................................xvi
Symbols Representing the Types of Hazards .......................................................................xvi
Precautions for Safe Use ............................................................................................................................. xvi
Precautions for Installation ......................................................................................................................... xvii
Prevention of Damage, Fire, Electric Shock and Injury ........................................................................... xvii
Performance Assurance ............................................................................................................................ xvii
Precautions for Operation ........................................................................................................................ xviii
Prevention of General Damage and Injuries ........................................................................................... xviii
Prevention of Electric Shock.................................................................................................................... xviii
Prevention of Infection ............................................................................................................................ xviii
Handling of Samples ................................................................................................................................. xviii
Handling of Reagent and Other Solutions ............................................................................................... xix
Prevention of Cross Contamination of Assays ..................................................................... xx
Rx Modena Carryover Avoidance: ........................................................................................ xxi
Catalogue number:................................................................................................................. xxi
Performance Assurance ............................................................................................................................ xxii
Data Management ..................................................................................................................................... xxii
Precautions for Maintenance..................................................................................................................... xxiii
Prevention of Injury.................................................................................................................................. xxiii
Prevention of Electric Shock.................................................................................................................... xxiii
Prevention of Infection ............................................................................................................................ xxiii
Performance Assurance ........................................................................................................................... xxiv
Data Management .................................................................................................................................... xxiv
Water Quality Requirements (Reference) ......................................................................... xxv
Precautions for Handling Wastewater ......................................................................................................xxv
Warning Labels..................................................................................................................... xxvi
Types of Labels .......................................................................................................................................... xxvi
Location of Labels ...................................................................................................................................... xxvi
External View ........................................................................................................................................... xxvi
Inside of Top Cover ................................................................................................................................ xxvii
Installation/Operation Environment ................................................................................ xxviii
Installation/Operation Conditions ......................................................................................................... xxviii
Temperature/Humidity Conditions ....................................................................................................... xxviii
Installation Space .......................................................................................................................................xxix
Power Supply ............................................................................................................................................. xxx
Water Supply and Drainage ......................................................................................................................xxxi
Water Supply System ............................................................................................................................. xxxii
Drainage System ..................................................................................................................................... xxxii
Components ....................................................................................................................... xxxiii
Operating Software............................................................................................................ xxxiii
System Requirements .............................................................................................................................. xxxiii
Software List ............................................................................................................................................ xxxiv
Software Version Check.......................................................................................................................... xxxiv
Specifications ....................................................................................................................... xxxv
Analyser Specifications .............................................................................................................................xxxv
Rev 3.01 — March 2018 Page iii
Foreword
Analysis Specifications ..................................................................................................... xxxviii

Sample/Reagent Barcode Reader Specifications .................................................................................. xxxix
Sample/Reagent Barcode Label Specifications ........................................................................................... xl
Sample Barcode Type .................................................................................................................................xli
Sample Identification Code (Sample ID) ............................................................................. xlii
EMC Compliance ................................................................................................................... xliii
WEEE Directives ................................................................................................................... xliii
For Business Users in the European Union: .............................................................................................. xliii
Disposal in Countries outside the European Union.................................................................................. xliii
Contact Randox ...................................................................................................................... xliv
Section 1 Overview ................................................................................................................1—1
1 Overview .........................................................................................................................1—3
1.1 Features and Major Functions....................................................................................1—3
1.2 Part Names and Function ...........................................................................................1—4
1.2.1 External View ............................................................................................................................... 1—4
1.2.2 Inside of Top Cover..................................................................................................................... 1—5
1.2.3 Inside the Front Door.................................................................................................................. 1—6
1.3 Operation Flow ............................................................................................................1—7
1.4 Assay Settings ..............................................................................................................1—8
1.4.1 Measurement Principles and Assay Methods ............................................................................. 1—8
1.4.1.1 Principles ................................................................................................................................. 1—8
1.4.1.2 Operation Sequence............................................................................................................... 1—9
1.4.1.3 Special Assay Procedure....................................................................................................... 1—10
1.4.1.4 Dilution Measurement of a Routine Sample........................................................................ 1—10
1.4.1.5 Reagent Blank Measurement ................................................................................................ 1—11
1.4.1.6 Reagent Blank Measurement using Purified Water ............................................................. 1—12
1.4.2 Assay Specifications of this Analyser ......................................................................................... 1—13
1.4.2.1 Wavelength ........................................................................................................................... 1—13
1.4.2.2 Incubation Time .................................................................................................................... 1—13
1.4.2.3 Volumes of Sample and Reagent Used ................................................................................ 1—13
1.4.2.4 Minimum and Maximum Volume of Reaction Solution ...................................................... 1—13
1.4.2.5 Dummy Volumes .................................................................................................................. 1—14
1.4.2.6 Dead Volume ........................................................................................................................ 1—14
1.4.3 Assay Types Classification ......................................................................................................... 1—14
1.4.3.1 1 Point End Method .............................................................................................................. 1—14
1.4.3.2 2 Point End Method .............................................................................................................. 1—15
1.4.3.3 Liquid Volume Offset ............................................................................................................ 1—15
1.4.3.4 1 Point Rate Method (Single Kinetic Method) ..................................................................... 1—16
1.4.3.5 2 Point Rate Method (Double Kinetic Method) .................................................................. 1—16
1.4.3.6 Liquid Volume Offset ............................................................................................................ 1—17
1.4.4 Blank Measurement ................................................................................................................... 1—17
1.4.4.1 Water Blank Measurement .................................................................................................. 1—17
1.4.4.2 Reagent Blank Measurement ................................................................................................ 1—17
Section 2 Basic Operations ...................................................................................................2—1
2 Basic Operations .............................................................................................................2—3
2.1 Handling of Samples....................................................................................................2—3
2.1.1 Available Sample Tubes and Cups .............................................................................................. 2—3
2.1.1.1 Location of Barcode Labels on Sample Tubes ...................................................................... 2—4
2.1.2 Sample Preparation...................................................................................................................... 2—4
2.1.2.1 Arrangement of Samples ........................................................................................................ 2—4
2.1.2.2 Placing Sample Cups ............................................................................................................... 2—5
2.1.2.3 Placing Sample Tubes ............................................................................................................. 2—7
2.1.2.4 Adding Samples during the Measurement Procedure........................................................... 2—9
2.2 Handling of Reagents ................................................................................................2—12

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Foreword
2.2.1 Reagent Carousel ...................................................................................................................... 2—12

2.2.2 Reagent Preparation .................................................................................................................. 2—12
2.2.2.1 Placing Reagents.................................................................................................................... 2—13
2.3 Operation Software ..................................................................................................2—15
2.3.1 Screen Configuration ................................................................................................................. 2—15
2.3.1.1 Status Display Area............................................................................................................... 2—16
2.3.1.2 Status Display ........................................................................................................................ 2—16
2.3.1.3 Operation Area .................................................................................................................... 2—17
2.3.2 Operations ................................................................................................................................. 2—18
2.3.2.1 Switching Screens ................................................................................................................. 2—18
2.3.2.2 Menu Icons - Main Hierarchies and Sub-Hierarchies .......................................................... 2—18
2.3.2.3 Menu Icons - Sub-Hierarchy View by Category.................................................................. 2—18
2.3.2.4 Menu Icons List ..................................................................................................................... 2—19
2.3.2.5 Function Key Operations ..................................................................................................... 2—20
2.3.2.6 Keyboard Shortcuts .............................................................................................................. 2—20
2.3.2.7 On-Screen Keyboard ........................................................................................................... 2—21
2.3.2.8 Touch Screen Operation ..................................................................................................... 2—21
2.3.3 Rounds ....................................................................................................................................... 2—22
2.4 Online and Offline Operations ................................................................................. 2—23
2.4.1 Online Operations ..................................................................................................................... 2—23
2.4.1.1 Online Real Time .................................................................................................................. 2—23
2.4.1.2 Online Batch ......................................................................................................................... 2—23
2.4.2 Offline Operations ..................................................................................................................... 2—23
2.5 Startup and Shutdown .............................................................................................. 2—24
2.5.1 Startup Procedure ..................................................................................................................... 2—24
2.5.1.1 Login Rights ........................................................................................................................... 2—24
2.5.2 Shutdown Procedure ................................................................................................................. 2—25
2.6 Sleep Feature.............................................................................................................2—26
2.6.1 Sleep and Wakeup Settings ....................................................................................................... 2—26
2.6.1.1 Sleep and Wakeup Screen ................................................................................................... 2—26
2.6.1.2 Edit the Sleep and Wakeup Time ........................................................................................ 2—27
2.6.2 Switch into Sleep Mode ............................................................................................................. 2—27
2.6.3 Return from Sleep Mode ........................................................................................................... 2—27
2.7 Operation Emergency .............................................................................................. 2—28
2.7.1 What to Do in Case of an Alarm.............................................................................................. 2—28
2.7.2 Emergency Stop ......................................................................................................................... 2—28
Section 3 Accessory Functions ............................................................................................. 3—1
3 Accessory Functions.......................................................................................................3—3
3.1 Parameter Settings .....................................................................................................3—3
3.1.1 Setup Screen ................................................................................................................................ 3—3
3.1.1.1 Parameter 1 Screen ................................................................................................................ 3—3
3.1.1.2 Parameter 2 Screen ................................................................................................................ 3—7
3.1.2 Register a Parameter ................................................................................................................... 3—8
3.1.3 Editing a Parameter ...................................................................................................................... 3—9
3.1.4 Copying a Parameter ................................................................................................................. 3—10
3.1.5 Importing Parameters ................................................................................................................ 3—11
3.1.6 Export a Parameter ................................................................................................................... 3—12
3.1.7 Delete a Parameter ................................................................................................................... 3—13
3.1.8 Print a Parameter ....................................................................................................................... 3—13
3.1.9 Various Range Settings .............................................................................................................. 3—14
3.1.9.1 Normal Range ....................................................................................................................... 3—14
3.1.9.2 Technical Range .................................................................................................................... 3—15
3.1.9.3 Comparison Check (%) ........................................................................................................ 3—15
3.1.9.4 Abnormal Range ................................................................................................................... 3—15
3.1.9.5 Panic Range ........................................................................................................................... 3—15

Rev 3.01 — March 2018 Page v
Foreword
3.2 Limit Check Settings.................................................................................................3—16

3.2.1 Linearity Limit ............................................................................................................................. 3—16
3.2.2 Prozone Limit ............................................................................................................................. 3—17
3.2.2.1 Absorbance Limit.................................................................................................................. 3—18
3.2.3 Range Shift Function .................................................................................................................. 3—19
3.3 Reagent Blank and C1 Blank ....................................................................................3—20
3.3.1 Measuring Conditions ................................................................................................................ 3—20
3.3.2 Reagent Blank Timing ................................................................................................................ 3—20
3.3.3 Reagent Blank Method............................................................................................................... 3—21
3.3.4 Replication .................................................................................................................................. 3—21
3.3.5 Reagent Blank Deviation Limit .................................................................................................. 3—21
3.4 Normal Range Name Settings .................................................................................3—22
3.4.1 Normal Range Screen................................................................................................................ 3—22
3.4.2 Registered a Normal Range Name ........................................................................................... 3—23
3.4.2.1 Editing a Normal Name Range............................................................................................. 3—24
3.4.2.2 Deleting a Normal Range Name.......................................................................................... 3—25
3.5 Setting Measurements of Serum Indices ................................................................3—26
3.5.1 Serum Indices Screen ................................................................................................................. 3—26
3.5.2 Serum Indices ............................................................................................................................. 3—27
3.5.3 Settings Related to Measurements of Serum Indices ............................................................... 3—28
3.5.4 Settings Related to Measurements of Serum Indices ............................................................... 3—29
3.5.4.1 Edit Defined Settings for Serum Indices Measurements ..................................................... 3—30
3.5.4.2 Print Defined Settings for Serum Indices Measurement ..................................................... 3—30
3.5.5 Running Order ........................................................................................................................... 3—31
3.5.5.1 Running Order Screen .......................................................................................................... 3—31
3.5.5.2 Run Order Settings ............................................................................................................... 3—32
3.6 Contamination Prevention Settings ........................................................................3—33
3.6.1 Contamination Prevention Screen ............................................................................................ 3—33
3.6.2 Registering a Contamination Prevention Setting ...................................................................... 3—34
3.6.3 Edit a Contamination Prevention Setting .................................................................................. 3—35
3.6.4 Delete a Contamination Prevention Setting ............................................................................. 3—36
3.6.5 Printing a Contamination Prevention Setting............................................................................ 3—36
Section 4 Preparation for Measurement .............................................................................4—1
4 Preparation for Measurement ......................................................................................4—3
4.1 Check Consumables ....................................................................................................4—3
4.1.1 Check Detergent ......................................................................................................................... 4—3
4.1.2 Check the Halogen Lamp Operating Time ................................................................................ 4—3
4.2 Check Reagents ...........................................................................................................4—4
4.2.1 Check Reagent Bottles ................................................................................................................ 4—4
4.2.1.1 Register a Reagent Bottle with a Barcode ............................................................................. 4—5
4.2.1.2 Enter Information on the Inventory Screen to Register a Reagent Bottle ........................... 4—6
4.2.1.3 Delete Registration Information of an Unnecessary Reagent Bottle.................................... 4—7
4.2.1.4 Print Registration Information of a Reagent Bottle ............................................................... 4—8
4.2.2 Inventory Screen .......................................................................................................................... 4—9
4.3 Register Patient Information ...................................................................................4—11
4.3.1 Register and Edit Patient Information ....................................................................................... 4—11
4.3.1.1 Register Patient Information................................................................................................. 4—11
4.3.1.2 Edit Patient Information........................................................................................................ 4—12
4.3.1.3 Import Patient Information................................................................................................... 4—13
4.3.1.4 Export Patient Information................................................................................................... 4—14
4.3.1.5 Delete Unnecessary Patient Information............................................................................. 4—15
4.3.2 Patient Registration Screen ....................................................................................................... 4—16
4.4 Check the Analyser Status .......................................................................................4—18
Section 5 Calibration .............................................................................................................5—1

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Foreword
5 Calibration.......................................................................................................................5—3
5.1 Overview ......................................................................................................................5—3
5.1.1 Flow of Calibration Measurement .............................................................................................. 5—4
5.2 Preparation ..................................................................................................................5—5
5.2.1 Register Orders with Manual Entry ............................................................................................ 5—5
5.2.1.1 Normal Calibration ................................................................................................................ 5—5
5.2.1.2 Worklist Screen (Calibration) ................................................................................................ 5—7
5.2.1.3 Multi-Calibration ..................................................................................................................... 5—8
5.2.1.4 Worklist Screen > Multi-Calibration ................................................................................... 5—10
5.2.1.5 Diluted Calibration ............................................................................................................... 5—11
5.2.1.6 C1 Blank ................................................................................................................................ 5—13
5.2.1.7 Worklist Screen > Diluted Calibration/C1 Blank Measurement ...................................... 5—14
5.2.2 Register Orders with Sample Barcodes.................................................................................... 5—15
5.2.3 Copying and Deleting Orders ................................................................................................... 5—15
5.3 Execute Calibration ..................................................................................................5—16
5.4 Check Results ............................................................................................................5—16
5.5 Multi-Calibration Settings ........................................................................................ 5—17
5.5.1 Multi-Calibration Screen............................................................................................................ 5—17
5.5.2 Register the Multi-Calibrator .................................................................................................... 5—18
5.5.3 Edit the Multi-Calibrator............................................................................................................ 5—19
5.5.4 Delete the Multi-Calibrator....................................................................................................... 5—20
5.5.5 Print the Multi-Calibrator .......................................................................................................... 5—21
5.6 Diluted Calibration Settings..................................................................................... 5—22
5.6.1 Register the Diluted Calibration Settings.................................................................................. 5—23
5.6.2 Edit the Diluted Calibration Settings ......................................................................................... 5—24
5.6.3 Delete the Diluted Calibration Settings .................................................................................... 5—25
Section 6 QC Measurement .................................................................................................6—1
6 Preparation for Measurement ...................................................................................... 6—3
6.1 Overview ......................................................................................................................6—3
6.1.1 Flow of QC Measurement .......................................................................................................... 6—3
6.2 Preparation ..................................................................................................................6—4
6.2.1 Registering Orders with Manual Entry ........................................................................................ 6—4
6.2.1.1 Worklist Screen (QC Measurement) .................................................................................... 6—5
6.2.2 Register Orders with Samples Barcodes .................................................................................... 6—6
6.2.3 Copying and Deleting Orders ..................................................................................................... 6—6
6.3 Execute QC Measurement ......................................................................................... 6—7
6.4 Check Results in the QC Chart.................................................................................. 6—7
6.4.1 Check the QC Results for 1 Day ................................................................................................ 6—7
6.4.2 Check the Cumulative Results for 30 Days in the Past.............................................................. 6—9
6.4.3 QC Chart Screen ....................................................................................................................... 6—11
6.5 Check Results in the QC Results List ...................................................................... 6—13
6.5.1 Search and Filter QC Measurement Results ............................................................................ 6—13
6.5.1.1 Check the QC Results for 1 Day ......................................................................................... 6—13
6.5.1.2 Check the QC Results for a Specified Period ..................................................................... 6—15
6.5.1.3 Check the QC Results for an Item ...................................................................................... 6—17
6.5.2 Delete or Output the QC Table Screen .................................................................................. 6—19
6.5.2.1 Delete Unnecessary QC Measurement Results ................................................................. 6—19
6.5.2.2 Print QC Measurement Results ........................................................................................... 6—20
6.5.2.3 Output QC Measurement Results to a File ........................................................................ 6—21
6.5.3 QC Table Screen ....................................................................................................................... 6—22
6.5.3.1 Search Function Area ........................................................................................................... 6—22
6.5.3.2 QC Table Screen (Daily) ...................................................................................................... 6—24
6.5.3.3 QC Table Screen (Cumulative) ........................................................................................... 6—26
6.5.3.4 QC Table Screen (Detail) .................................................................................................... 6—28

Rev 3.01 — March 2018 Page vii
Foreword
6.6 Register QC Samples ................................................................................................6—29

6.6.1 QC Sample Registration Screen................................................................................................ 6—29
6.6.2 Register Samples ........................................................................................................................ 6—30
6.6.3 Edit QC Samples ........................................................................................................................ 6—31
6.6.4 Delete QC Samples ................................................................................................................... 6—32
6.7 Set the Conditions for QC ........................................................................................6—33
6.7.1 QC Range Screen ...................................................................................................................... 6—33
6.7.1.1 Replication............................................................................................................................. 6—35
6.7.1.2 Judgement Conditions .......................................................................................................... 6—35
6.7.1.3 Set the QC Range ................................................................................................................. 6—36
6.7.1.4 Edit the QC Range................................................................................................................ 6—37
6.7.1.5 Delete the QC Range ........................................................................................................... 6—38
6.7.1.6 Print the QC Range .............................................................................................................. 6—38
Section 7 Sample Measurement...........................................................................................7—1
7 Sample Measurement ....................................................................................................7—5
7.1 Overview ......................................................................................................................7—5
7.1.1 Flow of Sample Measurement ..................................................................................................... 7—5
7.2 Register Orders ...........................................................................................................7—6
7.2.1 Register Orders Online ............................................................................................................... 7—6
7.2.1.1 When Barcodes are Used Online in Real Time Mode ......................................................... 7—6
7.2.1.2 When Barcodes are NOT Used Online in Real Time Mode ............................................... 7—6
7.2.1.3 When Barcodes are used in Online Batch Mode.................................................................. 7—7
7.2.1.4 When Barcodes are NOT used in Online Batch Mode ....................................................... 7—8
7.2.2 Register Orders Offline ............................................................................................................... 7—9
7.2.2.1 Register Orders Using Manual Entry ..................................................................................... 7—9
7.2.2.2 Register Orders through Barcodes ...................................................................................... 7—11
7.2.3 Copying Order........................................................................................................................... 7—12
7.2.4 Delete Unnecessary Orders ..................................................................................................... 7—13
7.2.4.1 Delete an Individual Order................................................................................................... 7—13
7.2.4.2 Delete Multiple Orders ........................................................................................................ 7—13
7.2.4.3 To Batch-Delete Orders ...................................................................................................... 7—14
7.2.5 Worklist Screen ......................................................................................................................... 7—15
7.3 Execute Measurement ..............................................................................................7—18
7.4 Orderless Test ...........................................................................................................7—18
7.4.1 Set the Orderless Items ............................................................................................................ 7—19
7.4.2 Change Orderless Settings ........................................................................................................ 7—20
7.5 Monitor Measurement Progress ..............................................................................7—21
7.5.1 Monitor the Sample and Reagent Status................................................................................... 7—21
7.5.1.1 Carousel Monitor Screen ..................................................................................................... 7—22
7.5.1.2 Display of Sample Categories .............................................................................................. 7—22
7.5.1.3 Display of Measurement Status............................................................................................ 7—23
7.5.1.4 Display of Reagent Placement Status ................................................................................... 7—23
7.5.2 Monitor Detailed Measurement Progress ................................................................................ 7—24
7.5.2.1 Round Monitor Screen ......................................................................................................... 7—24
7.6 Set the Panel Test .....................................................................................................7—26
7.6.1 Panel Test Screen ...................................................................................................................... 7—26
7.6.2 Register the Panel Test .............................................................................................................. 7—27
7.6.3 Edit the Panel Test ..................................................................................................................... 7—28
7.6.4 Delete the Panel Test ................................................................................................................ 7—29
7.6.5 Print the Panel Test ................................................................................................................... 7—30
7.7 Set Templates............................................................................................................7—31
7.7.1 Template Screen ........................................................................................................................ 7—31
7.7.2 Register a Template ................................................................................................................... 7—32
7.7.3 Edit a Template .......................................................................................................................... 7—33
7.7.4 Delete a Template ..................................................................................................................... 7—34

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7.7.5 Print a Template ........................................................................................................................ 7—35

7.7.6 Import a Template ..................................................................................................................... 7—35
7.7.7 Execute an Auto Template ....................................................................................................... 7—35
7.8 Set the Calculated Testing ....................................................................................... 7—36
7.8.1 Calculated Test Screen .............................................................................................................. 7—36
7.8.2 Register a Calculated Test ......................................................................................................... 7—38
7.8.3 Edit a Calculated Test ................................................................................................................ 7—39
7.8.4 Delete a Calculated Test ........................................................................................................... 7—40
7.8.5 Print a Calculated Test .............................................................................................................. 7—41
7.9 Set the Mask Function .............................................................................................. 7—42
7.9.1 Worklist Screen ......................................................................................................................... 7—42
7.10 Set the Orderless Items ........................................................................................... 7—43
7.10.1 Orderless Test Screen ............................................................................................................... 7—43
7.11 Add Samples during the Measurement Procedure ............................................... 7—44
7.11.1 Add Samples through Barcode ................................................................................................. 7—44
7.11.1.1 Add Samples to 1 Holder..................................................................................................... 7—44
7.11.1.2 Add Samples to Multiple Holders ........................................................................................ 7—48
7.11.2 Add Samples using Manual Input............................................................................................... 7—53
7.11.2.1 Add Samples to 1 Holder..................................................................................................... 7—53
7.11.2.2 Add Samples to Multiple Holders ........................................................................................ 7—57
7.12 Finish Measurements ................................................................................................7—62
7.12.1 Automatically Delete or Preserve Orders ............................................................................... 7—62
7.12.2 Tasks to be done when Measurements are finished ................................................................ 7—62
Section 8 Measurement Results ........................................................................................... 8—1
8 Preparation for Measurement ...................................................................................... 8—3
8.1 Review Measurement Results .................................................................................... 8—3
8.1.1 Review Measurement Results ..................................................................................................... 8—3
8.1.1.1 Execute a Search ..................................................................................................................... 8—3
8.1.1.2 Delete Search Results............................................................................................................. 8—4
8.1.1.3 Delete Individual Measurement Results ................................................................................ 8—5
8.1.2 Review Time Course ................................................................................................................... 8—6
8.1.3 Results Screen .............................................................................................................................. 8—8
8.1.3.1 If ‘All’, ‘Routine Sample’ or ‘STAT’ is Selected in Sample Category .................................... 8—9
8.1.3.2 Measurement Results Display Area ..................................................................................... 8—11
8.1.3.3 If Calibrator is Selected in Sample Category ....................................................................... 8—12
8.1.3.4 If QC Sample is Selected in Sample Category ..................................................................... 8—15
8.1.3.5 If Reagent Blank is Selected from Sample Category ........................................................... 8—18
8.1.3.6 If Number of Tests is Selected in Sample Category ........................................................... 8—21
8.1.3.7 Time Course Output Settings Area ..................................................................................... 8—23
8.1.3.8 Pop-up Window Showing Time Course ............................................................................. 8—23
8.2 Print Measurement Results ...................................................................................... 8—24
8.2.1 Set the Report Format .............................................................................................................. 8—24
8.2.1.1 Report Format Screen .......................................................................................................... 8—24
8.2.2 Register a Report Format .......................................................................................................... 8—26
8.2.3 Edit a Report Format ................................................................................................................. 8—27
8.2.4 Delete a Report Format ............................................................................................................ 8—27
8.2.5 Print a Report Format ............................................................................................................... 8—28
8.2.6 Print Measurement Results with Normal Print Format ........................................................... 8—29
8.2.7 Print Measurement Results with Report Print Format ............................................................ 8—30
8.2.8 Printing Measurement Results with History Print Format ....................................................... 8—31
8.2.9 Print Time Course ..................................................................................................................... 8—32
8.3 Output Measurement Results as a File ................................................................... 8—34
8.3.1 Output Measurement Results as a CSV File ............................................................................. 8—34
8.3.2 Output Time Course as a CSV File .......................................................................................... 8—35
Section 9 Maintenance ..........................................................................................................9—1
Rev 3.01 — March 2018 Page ix
Foreword
9 Maintenance ....................................................................................................................9—3
9.1 Overview ......................................................................................................................9—3
9.2 Unit Maintenance Screen ...........................................................................................9—4
9.3 Work Hour Counter Screen ......................................................................................9—6
9.4 Daily Inspection and Cleaning ....................................................................................9—7
9.4.1 Management of Reagent Bottles ................................................................................................. 9—7
9.4.2 Sample Disposal ........................................................................................................................... 9—7
9.4.3 Replenish Detergents .................................................................................................................. 9—7
9.4.3.1 Check and Replace Detergent Bottles .................................................................................. 9—7
9.4.3.2 Check of Detergents .............................................................................................................. 9—9
9.4.4 Lamp Operation Time - Check ................................................................................................. 9—10
9.4.4.1 Water Blank Absorbance Check ......................................................................................... 9—10
9.4.4.2 Maintenance > System Monitor > Water Blank Absorbance............................................ 9—10
9.4.5 Sample Pipette Unit - Inspection and Cleaning ........................................................................ 9—12
9.4.5.1 Internal Pipette Cleaning ...................................................................................................... 9—14
9.4.6 Reagent Pipette Units - Inspection and Cleaning ..................................................................... 9—15
9.4.6.1 Inspection .............................................................................................................................. 9—15
9.4.6.2 Exterior Cleaning .................................................................................................................. 9—15
9.4.6.3 Internal Pipette Cleaning ...................................................................................................... 9—17
9.4.7 Washing Unit - Inspection and Cleaning................................................................................... 9—17
9.4.8 Mix Units - Inspection and Cleaning ......................................................................................... 9—19
9.5 Weekly Inspection and Cleaning .............................................................................9—21
9.5.1 Troughs - Inspection and Cleaning ........................................................................................... 9—21
9.5.2 Sample Carousel - Inspection and Cleaning ............................................................................. 9—21
9.5.3 Reagent Carousel - Inspection and Cleaning ............................................................................ 9—24
9.5.4 Work Table - Inspection and Cleaning ..................................................................................... 9—27
9.5.5 Water Blank Absorbance Check 1 ........................................................................................... 9—27
9.5.6 Water Blank Absorbance Check 2 ........................................................................................... 9—28
9.5.7 Wash Cuvettes .......................................................................................................................... 9—29
9.5.8 Perform a Cuvette C1 Solution Soak ....................................................................................... 9—31
9.6 Maintenance Work Performed by the Administrator ..........................................9—32
9.6.1 Replace the Halogen Lamp ....................................................................................................... 9—32
9.6.1.1 Lamp Post-replacement Check ............................................................................................ 9—35
9.6.2 Fluidic Wash ............................................................................................................................... 9—36
9.6.2.1 Wash Procedure ................................................................................................................... 9—37
9.6.3 Remove Pipette Blockages ........................................................................................................ 9—40
9.7 Maintenance by Service Engineers ..........................................................................9—42
Section 10 Miscellaneous Settings......................................................................................10—1
10 Miscellaneous Settings .................................................................................................10—3
10.1 Change Device Settings ............................................................................................10—4
10.1.1 Host Communication Settings .................................................................................................. 10—5
10.1.2 Sample ID Settings ..................................................................................................................... 10—6
10.1.3 Automatic Print Settings ............................................................................................................ 10—7
10.1.4 Notification Sound Settings ....................................................................................................... 10—8
10.1.5 Other Device Settings ............................................................................................................... 10—9
10.2 Operation Settings ..................................................................................................10—10
10.2.1 Operation Settings Screen....................................................................................................... 10—10
10.2.1.1 Change Operation Settings ................................................................................................ 10—11
10.3 User Accounts .........................................................................................................10—12
10.3.1 Administer User Accounts ...................................................................................................... 10—12
10.3.1.1 User Accounts Screen ........................................................................................................ 10—12
10.3.1.2 Add a User Account ........................................................................................................... 10—13
10.3.1.3 Change the Password/User Level ..................................................................................... 10—14
10.3.1.4 Delete a User ...................................................................................................................... 10—16
10.3.2 List of Available Screens by User Level .................................................................................. 10—17
Page x Rev 3.01 — March 2018
Foreword
10.4 Backup ......................................................................................................................10—18

10.4.1 Backup Screen .......................................................................................................................... 10—18
10.4.2 Data Backup ............................................................................................................................. 10—19
10.4.2.1 Save the Database .............................................................................................................. 10—19
10.4.2.2 Load a Backup the Database.............................................................................................. 10—20
10.4.2.3 System Parameters Backup ................................................................................................ 10—21
10.4.2.4 Load System Parameters .................................................................................................... 10—22
10.4.3 Automatic Backup ................................................................................................................... 10—23
10.4.3.1 Set the Automatic Backup Function .................................................................................. 10—23
10.4.3.2 Load Automatic Backup Data ............................................................................................ 10—24
Section 11 Troubleshooting ................................................................................................11—1
11 Troubleshooting ...........................................................................................................11—3
11.1 About Troubleshooting ............................................................................................ 11—3
11.1.1 Check the Operating Environment ........................................................................................... 11—3
11.1.2 Items to Communicate to your Randox Representative ......................................................... 11—3
11.1.2.1 When Contacting About Assay Problems .......................................................................... 11—3
11.1.2.2 When Contacting About Analyser Problems ..................................................................... 11—3
11.2 Measurement Result Problems ............................................................................... 11—4
11.2.1 Check of Reagent, Calibrator and QC Sample Preparation.................................................... 11—4
11.2.1.1 About Reagent Preparation ................................................................................................. 11—4
11.2.1.2 About QC Sample Preparation ........................................................................................... 11—4
11.2.1.3 About Calibrator Preparation .............................................................................................. 11—4
11.2.2 Case-by-Case Check Descriptions ........................................................................................... 11—5
11.2.2.1 Measurement Results for a Specific Assay Item in all Samples (High or Low) .................. 11—5
11.2.2.2 Abnormal Measurement Results Occur at Random ........................................................... 11—6
11.2.2.3 Measurement Results for Multiple Assay Items in an Abnormal Specific Sample ............. 11—6
11.3 Analyser Problems ....................................................................................................11—7
11.3.1 Analyser Power Source Does Not Turn On ........................................................................... 11—7
11.3.2 Alarms and Recovery Actions ................................................................................................... 11—7
11.3.2.1 What to Do in Case of an Alarm ........................................................................................ 11—7
11.3.2.2 Save Alarms........................................................................................................................... 11—8
11.3.3 Alarm History Screen ................................................................................................................ 11—9
11.4 Flag Information ......................................................................................................11—10
11.4.1 Evaluation Flag.......................................................................................................................... 11—10
11.4.2 Error Flag.................................................................................................................................. 11—10
Section 12 RX modena - ISE Module ................................................................................. 12—1
12 ISE Module ....................................................................................................................12—3
12.1 Precautions for Operation and Measurement ....................................................... 12—3
12.1.1 Precautions for the use of Samples ........................................................................................... 12—3
12.1.2 Precautions for the use of Solution........................................................................................... 12—3
12.1.3 Precautions before Measurement ............................................................................................. 12—3
12.1.4 Precautions for the Test Parameter ......................................................................................... 12—4
12.2 Precautions for Preventive Maintenance................................................................ 12—5
12.2.1 Precautions for Samples ............................................................................................................ 12—5
12.2.2 Precautions for the Seal Replacement ...................................................................................... 12—5
12.2.3 Precautions for the Storage of the Cl Electrode ...................................................................... 12—5
12.2.4 Precautions for the Storage of the Ref Electrode .................................................................... 12—5
12.2.5 Precautions for Washing the Wash Bottle ............................................................................... 12—5
12.2.6 Precautions for the Aging of the Electrode .............................................................................. 12—5
12.3 Overview ....................................................................................................................12—6
12.3.1 Features and Major Functions ................................................................................................... 12—6
12.3.1.1 System Diagram of the ISE Unit ........................................................................................... 12—6
12.3.1.2 Measurement Flow ............................................................................................................... 12—6
12.4 Specifications .............................................................................................................12—7

Rev 3.01 — March 2018 Page xi
Foreword
12.5 Consumables and Periodical Replacement Parts ..................................................12—8

12.5.1 Consumables.............................................................................................................................. 12—8
12.6 Operation Procedures ..............................................................................................12—9
12.6.1 Works required at installation .................................................................................................. 12—9
12.6.1.1 Removing the protection tape ............................................................................................. 12—9
12.6.1.2 Aging of the ISE Electrode .................................................................................................... 12—9
12.6.1.3 Placement of ISE Electrodes ............................................................................................... 12—10
12.6.1.4 Placement of the Buffer Bottle and the Internal Standard Solution Bottle....................... 12—10
12.6.2 Checks Prior to Use ................................................................................................................ 12—11
12.6.2.1 Check the Buffer Bottle and Internal Standard Solution Bottle ........................................ 12—11
12.6.3 Calibration ................................................................................................................................ 12—11
12.6.4 Procedures ............................................................................................................................... 12—12
12.6.4.1 Calibration Ranges .............................................................................................................. 12—12
12.6.5 Patient Sample Measurement .................................................................................................. 12—12
12.6.6 Check and Output of Measurement Results .......................................................................... 12—12
12.7 ISE Parameter Screen ............................................................................................12—13
12.7.1 Normal Range Setting .............................................................................................................. 12—14
12.7.2 Instrument Factor Setting ........................................................................................................ 12—14
12.7.3 ISE Rerun Setting ...................................................................................................................... 12—15
12.8 Maintenance .............................................................................................................12—16
12.8.1 Daily.......................................................................................................................................... 12—16
12.8.1.1 Replacement of the standard solution ~ ISE Calibration ................................................... 12—16
12.8.1.2 Checks Prior to Use ........................................................................................................... 12—16
12.8.1.3 Maintenances after the Daily Routine Tests ...................................................................... 12—16
12.8.2 Weekly ..................................................................................................................................... 12—16
12.8.2.1 Electrode Line Wash .......................................................................................................... 12—16
NOTE: Screen images shown in this manual are representative of those displayed by the analyser system.
Due to continuous improvements in the analyser software and differences in equipment implementation,
images may not be exactly the same as those displayed by the analyser.

Page xii Rev 3.01 — March 2018
Foreword
FOREWORD
Intended Use
The analyser is designed to analyse human samples such as serum, plasma, urine and whole blood.
• Never use the analyser for any purpose other than sample analysis.
Target User
This manual is written for clinical laboratory technologists.
• Before using this product, please read the instructions described in this manual carefully, and make
sure to keep this manual for future reference.
Disclaimer
Randox Laboratories Ltd. shall not be responsible for any failure or damage of the analyser or any damage
caused by direct or indirect use of the analyser under the following conditions.
• Failures or damages caused by not following the instructions, precautions and intended use described
in this manual.
• Failures or damages caused by repair or alteration performed by any company other than those
designated by our company.
• Failures or damages caused by the use of the analyser in conjunction with any instrument other than
those designated by our company.
• Failures or damages caused by not using the analyser under the operating environment specified in
this manual such as power supply conditions and installation environment.
• Failures or damages caused by earthquake, flood or other natural disasters.
• Failures or damages caused by relocation or transportation of the analyser after the installation, which
our company is not informed of.
For the warranty period, repairs and after sales service, contact the local Randox Representative or
distributor or contact the relevant Randox business unit listed at the end of this section.
• The warranty may become void if the analyser is not used in accordance with the instructions
described in this manual.

Rev 3.10 — March 2018 Page xiii
Foreword
Trademarks
• Randox is a trademark of Randox Laboratories Ltd.
• Windows® 8.1 Pro is either a registered trademark or trademark of Microsoft Corporation in the
United States and/or other countries.
• Intel is either a registered trademark or trademark of Intel Corporation in the United States and/or
other countries.
• All brand and product names are registered trademarks, trademarks or service marks of their
respective holders.
Randox Laboratories Ltd are the legal manufacturer

of the RX modena brand of analyser.
Randox Laboratories Ltd are registered in Randox Teoranta are registered in the
the United Kingdom at: Republic of Ireland at:
55 Diamond Road Meenmore
Crumlin County Donegal
County Antrim F94 TV06
BT29 4QY Republic of Ireland.
United Kingdom.
Typical product label/rating plate.
NOTE: Exact design and details may vary. Always refer to the label attached the analyser.

Page xiv Rev 3.10 — March 2018
Foreword
About Manuals
Composition of Separate Volumes
The manuals for the analyser include the following separate volumes.
Document name Document No. Description
Rx modena RX9003 This volume is prepared for CLINICAL LABORATORY

Operator Manual TECHNOLOGISTS engaged in analyses in order to
enable them to perform daily routine tasks.
The main topic of this volume is the flow of routine
tasks. It also describes maintenance procedures to be
performed by the user.
Rx modena RX9004 This volume is prepared for SERVICE ENGINEERS

Service Manual responsible for installation, in-depth maintenance, repair
and management of the analyser.
It enables the advanced configuration of settings and
management of operations. It describes various types of
settings that can only be configured with high level
access rights, periodic maintenance and tasks requiring
specialist technical knowledge.
NOTE: The content of this manual is subject to change without notice.

Please contact your Randox Representative for the latest revision.

Rev 3.10 — March 2018 Page xv
Foreword
Warning Symbols
The following symbols are used in this manual to indicate hazards and associated warnings.
Symbols Representing the Types of Hazards

General precautions required for the correct use of the analyser and the
CAUTION
prevention of injury or damage.
ELECTRICAL
Precautions required for the prevention of electric shock.
HAZARD
HOT
SURFACE Precautions required for the prevention of burns to the skin.
HAZARD
BIOLOGICAL
Precautions required for the prevention of infection.
HAZARD
DO NOT Prohibited actions regarding the contact with the analyser that may lead to
TOUCH injury, damage or skin burn.
Precautions for Safe Use

Read this section carefully before using the analyser.
• Always follow the precautions indicated by the labels attached to the analyser and described in this
manual.
• If there is any indication of defect, STOP the operation immediately and contact a Randox
Representative support. Do NOT attempt to resolve the problem without advice or assistance from
an authorised Randox Engineer or Randox Representative.

Page xvi Rev 3.10 — March 2018
Foreword
Precautions for Installation

Prevention of Damage, Fire, Electric Shock and Injury
• Install the analyser in accordance with the installation environment and conditions
described in this manual.
• Never relocate the analyser by yourself. Contact your Randox Representative for
assistance.
• For precautions relating to the installation of external devices, refer to this operator
manual.
Performance Assurance
• Do not install the analyser close to any device that may generate abnormal noise.
• Do not install the analyser close to any device that may generate electromagnetic waves.
• Install the analyser in a location where the temperature range is between 15 and 30 °C
and where the variation is less than ± 2 °C per hour.
• Install the analyser in a location where the humidity range is between 45 and 85 %.
• Purified water must meet the NCCLS C3-A3 Type ll Guideline or higher (such as
NCCLS C3-A3 Type l or LSI C3-A4).
• Make sure purified water is free from air bubbles and foreign substances.
• Keep the temperature of purified water between 5 and 25 °C. Water outside this range
may affect the measurement results.
• Make sure that fluid tubes connected to the supply and waste ports have no severe
bends, deflections or deformity. Conditions such as these may lead to restricted fluid
flow that may affect measurement results, disconnection or leakage during operation.
• Make sure that external storage devices such as USB memory sticks are virus checked
(and not infected with a computer virus) before use. An infected PC or storage device
may lead to abnormal operation of the analyser.
• Do not install any software that is not specified on the analyser PC. Unspecified software
• Make sure that the software versions are correct. Contact your Randox representative
for the latest (or most appropriate) software for your specific equipment. Incorrect
software versions may lead to abnormal operation of the analyser.

Rev 3.10 — March 2018 Page xvii
Foreword
Precautions for Operation

Prevention of General Damage and Injuries
• Do not open the front cover, the rear cover, the side covers or the top cover during
operation. It may lead to injury.
• Do not touch moving parts or put your fingers or hands in the openings. It may lead to injury.
• Be careful not to injure your hands when opening or closing the top cover.
• Do not look directly into the light from the halogen lamp or the laser beam emitted by
barcode reader(s), it may lead to eye injury.
• Do not apply excessive pressure to the body of the analyser.
• Do not apply excessive pressure to the sample tray or the reagent tray.
• Do not touch the analyser or associated equipment with wet hands. It may cause damage.
Prevention of Electric Shock

• Make sure that electrical tasks are only performed in the presence of another member of
staff (safety person). Improper handling may lead to electric shock.
operation. Touching the parts inside may lead to electric shock.
• Always remove electrical power to the analyser before correcting/cleaning a fluid spill or
leakage inside the equipment.
• Do not touch the analyser or associated equipment with wet hands. It may lead to electric
shock.
• Contact your Randox Representative for corrective action if required.
Prevention of Infection
• Make sure protective gloves, masks and goggles (PPE) are worn to prevent infection when
handling samples and other materials/equipment.
• Do not directly touch potentially infectious samples, reagents or waste water.
• Do not touch the analyser or associated equipment with wet hands. It may transmit infection.
• If samples or reagents contact your skin, eyes or mouth, immediately flush with clean water
then, if required, seek medical attention.
• If sample or reagent fluids are found on the analyser, immediately wipe them off.
Clean/sterilise the affected area as required.
Handling of Samples
The analyser is designed to analyse human samples such as serum, plasma, urine and whole blood.
There may be some assay items (reagents) that are not measureable on the analyser. For details,
contact your Randox Representative.
• Use samples that are free from foreign substances. Such substances may block the sample
pipette and may affect the measurement results.
• Some chemical substances found in samples such as medical agents, anticoagulants, or
preservatives may have clinically significant effect on the result.
• Some assay items (reagents) may require special handling. Refer to the documentation that
accompanies the item(s) or contact your Randox Representative.
• Medical agent or metabolic products of haemolysed, turbid, or high-bilirubin serum may
affect the measurement results. For details, contact your Randox Representative.
• Store samples in appropriate environment. Improper storage of samples may lead to
deterioration of their components.
• To prevent evaporation or contamination of samples, do not leave them unsealed for an
extended period of time. It may lead to incorrect measurement results.

Page xviii Rev 3.10 — March 2018
Foreword
Handling of Reagent and Other Solutions

For details of storage, handling and usage of reagents, calibrators or QC samples, contact
Randox Technical Services or the distributor of the solutions.
• Improper storage of reagents, calibrators or QC samples may lead to incorrect
measurement results even when they are within the specified expiry dates. For details,
refer to the instructions written on the packages, vials or package inserts.
• Some reagents are highly acidic or alkaline. If reagents contact your skin, eyes or mouth,
immediately provide first aid such as flushing with water and seek medical attention if
necessary.
For the stability of opened reagents, calibrators or QC samples, contact the manufacturer or
distributor of these solutions.
• Proper calibration is required for acquiring correct measurement results. For details
about calibration, contact Randox Technical Services or the distributor of the reagents.
• Cross contamination between reagents during the measuring process may affect the
measurement results. Refer to the table on page XX for details. For further information
about how reagents affect each other, contact Randox Technical Services or the
distributor of the reagents.

Rev 3.10 — March 2018 Page xix
Foreword
Prevention of Cross Contamination of Assays

To minimise the risk of cross-contamination between assays it is recommended that the following assays
are not tested in sequence. Methods in Column 1 should NOT be directly followed by the method
shown in Column 2:
I.e. As shown in the table below, an Iron test should not follow an Albumin test.
Column 1 Column 2
Albumin Iron
Glucose GODPAP Phosphate
Uric acid Phosphate
ALT Phosphate
AST Phosphate
LD Phosphate
CK Phosphate
ALP (AMP) Magnesium
ALP (DEA) Magnesium
Glucose Hexokinase Magnesium
CKMB Magnesium
Triglycerides Magnesium
Cholesterol Magnesium
Uric Acid Magnesium
Potassium Sodium
Direct Bilirubin Sodium
Transferrin Sodium
Total Protein Sodium
Total Protein Potassium
Total Protein Copper
Transferrin Chloride
Direct Bilirubin Chloride
Cholesterol Lipase
Triglycerides Lipase
Potassium LDH
Potassium GLDH
Urea GLDH
Creatinine* CRP
Fructosamine Bile acids
Amylase Magnesium
Pancreatic amylase Magnesium
Liquid CO2 Magnesium
Direct LDL Lipase
Cholesterol Calcium
TIBC Iron
Myoglobin HFABP
Cystatin C HFABP
Adiponectin HFABP
Micro-albumin Calcium

Page xx Rev 3.10 — March 2018
Foreword
*When testing Creatinine and CRP in the same run on the Rx Imola, Randox recommend using the Full
Range CRP kit, Catalogue numbers CP3847 or CP3849.
The use of CRP kit CP3826 is not recommended.
*Randox HFABP should be run in isolation or separated from other IT assays in the measurement order.
* Bile acids and Lipase should not be tested in the same run.
* NEFA and Triglycerides should not be tested in the same run.
*Lipase and Triglycerides should be the last two chemistries in the testing running order.
(All other Chemistries) / (Lipase) / (Triglycerides).
Rx Modena Carryover Avoidance:

If Method 1 is directly followed by Method 2, the indicated wash should be applied to prevent
contamination. If a wash solution is not sufficient, method 2 should NOT follow method 1 in the running
order, alternatively this can be tested separately.
Catalogue number:
• C1 wash – RX8143
• Acid Wash – WS8397
Method 1 Method 2 Reagent Pipette Wash solution

Albumin Iron R1>R1 C1 Wash
Glucose Oxidase Inorganic phosphorus R1>R1 C1 Wash
Uric Acid Inorganic phosphorus R1>R1 C1 Wash
R2>R2
Cholesterol Calcium R1>R1 Acid Wash
Albumin Calcium R1>R1 C1 Wash
TIBC Iron N/A Amend running
order/ test
separately
CKMB Magnesium R1>R1 C1 Wash
Triglycerides Magnesium R1>R1 C1 Wash
CK Magnesium R1>R1 Acid Wash
ALP AMP Magnesium R1>R1 Acid Wash
ALP DEA Magnesium R1>R1 Acid Wash
Glucose Hexokinase Magnesium R1>R1 Acid Wash
Amylase Magnesium R1>R1 Acid Wash
LCO2 Magnesium R1>R1 Acid Wash
Micro-albumin Calcium R1>R1 Acid Wash
If you require any further information about this, please contact your local Randox Representative or
Technical Support.

Rev 3.10 — March 2018 Page xxi
Foreword
• Only use the analyser in a location where the temperature range is between 15°C and
30°C and where the temperature variation is less than ±2°C per hour.
• Only use the analyser in a location where the humidity is between 45% and 85%.
• Make sure that the temperature of purified water is between 5°C and 25°C. Out of
range temperatures may affect the measurement of results.
• To minimise interference from external light or other environmental factors, do NOT
open the front cover, the rear cover, the side covers or the top cover during operation.
NOTE: Operation will stop and the analyser will not generate correct measurement results
when the lid of the reagent carousel or the sample carousel is opened during operation.
• Perform QC measurements to verify that the analyser performance is as expected.
• Make sure that there is sufficient volume of reagent(s) and wash solution(s) before
measurement.
• Make sure that there are valid calibration curves before measurement.
• Perform fresh calibration when the lot number of reagent has been changed.
• Make sure that there is sufficient volumes of sample before measurement.
• Make sure that there are no fluid leaks from the sample pipette and/or the reagent
pipettes.
• Make sure that the purified water is free from air bubbles and foreign substances.
• Do NOT use portable radios or cellular phones in the area where the analyser is
installed. These equipment types may generate electromagnetic waves or other
interference which may lead to abnormal operation of the analyser.
Data Management
• Make sure that external storage devices such as USB memory sticks are virus checked
(and virus free) before use. An infected PC or storage device may lead to abnormal
operation of the analyser.
• Be careful not to enter erroneous patient information. In order to avoid such errors, it is
recommended to prepare patient information on the host computer before starting
analysis.
• Do NOT shutdown the analyser and the analyser PC during operation. Sudden
shutdown may lead to database corruption.
• When shutting down the analyser and the analyser PC, make sure to follow the correct
shutdown procedures as written in this manual.
• Create regular backup copies of the database stored in the analyser PC. If backup copies
are not created, the database cannot not be recovered in the event of a problem such as
a malfunction of the analyser.

Page xxii Rev 3.10 — March 2018
Foreword
Precautions for Maintenance

Prevention of Injury
• For maintenance and periodic parts replacement, make sure to follow the instructions
describe in this manual.
• When performing maintenance work, make sure to pay extra attention to safety.
• When performing maintenance work, make sure that moving parts are not in motion.
Where possible, turn the analyser off and remove electrical power.
• When the halogen lamp is being replaced, wait 30 minutes minimum after use to
allow the lamp to cool.
• Do not look directly into the light from the halogen lamp or the laser beam emitted by
barcode reader(s), it may lead to eye injury.
• Be careful not to puncture skin with the tips of pipettes.
• When manually moving a pipette horizontally or vertically, make sure to hold the arm
close to the shaft. Do NOT hold the arm at the end.
• Be aware, alcohol used for cleaning is a flammable liquid.
• Be careful not to injure your hands when opening or closing the top cover.
Prevention of Electric Shock

operation. Touching the parts inside may lead to electric shock.
• Always remove electrical power to the analyser before correcting/cleaning a fluid spill or
leakage inside the equipment. Make sure the task is supervised by another member of
staff. Contact your Randox Representative for corrective action if required. Improper
handling may lead to electric shock.
• Do not touch the analyser or associated equipment with wet hands. It may lead to
electric shock.
Prevention of Infection
• Any part removed from the analyser for replacement may be contaminated and MUST
be cleaned/sterilised before repair or disposal. For disposal of waste, contact your
Randox Representative.
• Where appropriate Personal Protective Equipment (PPE) such as gloves, masks and
goggles to prevent direct skin contact with sample and reagent fluids.
 If samples or reagents contact your skin, eyes or mouth, immediately provide first
aid such as flushing with water and seek medical attention if necessary.
 If samples or reagents are found on the analyser or associated equipment,
immediately wipe them off. Clean/sterilize the affected area as required.
• Work surfaces, work equipment or other similar material must be cleaned and sterilised
using laboratory grade cleaning products. Cleaning solution residues should be removed
with laboratory grade water to prevent accidental contamination of samples.
• Do not directly touch potentially infectious equipment, samples, reagents or wastewater.
Make sure to wear appropriate PPE to prevent transfer of infection.

Rev 3.10 — March 2018 Page xxiii
Foreword
• Use only genuine consumables and Randox parts.
 For the purchase of parts, contact your Randox Representative or your distributor.
Any use of non-genuine parts may affect the performance and safety of the analyser.
• Only perform user maintenance as described in this manual to maintain the performance
of the analyser.
 Randox Laboratories Ltd shall not be responsible for any damage caused by
maintenance work performed by any service engineer not trained by Randox.
• After any replacement of parts, make sure that the measurement results are correct.
Data Management
• Periodically create backup copies of the database to secure against unexpected loss of
data.
• Create regular backup copies of the database stored in the analyser PC. If backup copies
are not created, the database cannot not be recovered in the event of a problem such as
a malfunction of the analyser.

Page xxiv Rev 3.10 — March 2018
Foreword
Water Quality Requirements (Reference)

Water Quality Specified in NCCLS C3-A3 Third Edition
Type I Type II
Minimum resistivity 10 1
(MΩ • cm @ 25 °C)
Microbial content (CFU/ml) 10 1,000
Silicate (mg/l) 0.05 0.1
pH Not specified Not specified
Particulate matter 0.22 µm filter Not specified
Organic contaminants Activated carbon, distillation or Not specified
reverse osmosis
Water Quality Specified in CLSI C3-A4
Specification for Clinical Laboratory Applications

Conductivity < 0.1 µS/cm @25 °C (> 10 MΩ • cm @25 °C)
Total organic carbon (TOC) < 500 µg/L (ppb)
Microbial content < 10 cfu/ml
Particulates and colloid Use of 0.22 µm or smaller membrane filter
Precautions for Handling Wastewater

Disposal of wastewater and used samples may require special treatment.
The analyser discharges low-concentration wastewater and high-concentration wastewater separately.
Please follow the precautions below for the handling of wastewater.
• Reagents, QC samples, calibrators or wash solutions may contain substances that are
regulated under the local/national regulations or effluent standards. Contact the
manufacturer or distributor of these solutions and dispose of them accordingly.

Rev 3.10 — March 2018 Page xxv
Foreword
Warning Labels
Types of Labels
The following types of labels are attached on the areas that are considered dangerous.
Label Meaning Location
CAUTION Top cover
ELECTRIC SHOCK Power breaker
HOT SURFACE HAZARD Lamp case
Pipette covers, mixing unit covers, washing unit cover,

BIOLOGICAL HAZARD
supply and waste ports, lid of sample carousel
Location of Labels
External View

Page xxvi Rev 3.10 — March 2018
Foreword
Inside of Top Cover
* This label is attached to the lamp case inside of the lamp cover.

Rev 3.10 — March 2018 Page xxvii
Foreword
Installation/Operation Environment
This section describes the installation/operation environment required for correct operation of the
analyser and standard accessories. Installation (unpacking, installation and operation check) must only be
performed by service engineers designated by Randox or a Randox distributor with Randox trained service
personnel.
Never relocated the analyser by yourself. To relocate the analyser, contact the Randox
Technical Services or your Randox distributor.
Installation/Operation Conditions
Install and operate the analyser in a place…
• that is indoors.
• that is not subject to direct sunlight.
• that is not subject to direct wind, rain or any form of water. (Keep the analyser indoors.)
• where amounts of dust are small.
• that is not subject to vibration or noise.
• where the floor is flat and has virtually no inclination.
• where the floor is capable of supporting the weight of the analyser (approximately 300 kg) and any
associated equipment.
• where the voltage variation Less than ± 10 %.
• where there is no strong noise sources (facility or instrument) around the analyser.
• where there is no fluorescent light directly above the analyser.
• at an altitude of 2000 meters or less above the sea level.
• where the analyser will not be adversely affected by environmental factors such as atmospheric
pressure, temperature, humidity, ventilation, sunlight, dust, salt, sulphur.
• that is not near to where chemicals are stored, and where no gas is generated.
• where the power cord of the analyser can be safely connected to the power source so that the failure
of the analyser may not adversely affect the facility or important medical devices in the facility such as
power supply systems for operation.
Temperature/Humidity Conditions
• Room temperature of 15 to 30°C and temperature variation of less than 2°C per hour.
• Room humidity of 45 to 85% (no condensation).
• Install the analyser in a place that is well ventilated or equipped with a ventilation system.
• Install the analyser in a place where the analyser is not subject to direct drafts from the ventilation
system.

Page xxviii Rev 3.10 — March 2018
Foreword
Installation Space
Make sure sufficient space is maintained around the analyser to allow access for maintenance and allow
ventilation of heat from the analyser.
• Keep a space of at least 500 mm behind the analyser for ventilation, maintenance and
emergency shutdown. Do not leave things around the power supply unit.
• Keep a space of at least 1000 mm on the right side of the analyser for ventilation,
maintenance and operation of the PC.
• Keep a space of at least 1000 mm in front of the analyser for operation and maintenance.
Water Supply
Space for
Power Outlet ventilation
Drainage 500 mm or
more
Supply Port
Drainage
Ports
PC
850 mm
Analyser
1000 mm or more
1300 mm 1000 mm or more
FRONT

Rev 3.10 — March 2018 Page xxix
Foreword
Power Supply
Connect the power cord from the power inlet of the analyser (approx. 5 m) to a 3-core power outlet with
a ground terminal (A-Type, S-Type or O-Type).
Make sure that the ground resistance is less than 100 Ω.
• Grounding of the power outlet must only be performed by suitably qualified person.
• Use the power breaker on the back of the analyser (as shown below) to turn the power
OFF in cases where there has been a system or electrical malfunction.
 Remove the power cable from the building power outlet to guarantee that power to
the analyser cannot be restored (switched back on).

Page xxx Rev 3.10 — March 2018
Foreword
Water Supply and Drainage

The analyser has 7 ports for water supply and drainage as described below.
• Check the water supply system and drainage system before instalment.
• For the disposal of high concentration wastewater, prepare a dedicated tank or dispose
of it according to the local/national regulations or effluent standards.
• For the disposal of low concentration wastewater, dispose of it according to the
local/national regulations or effluent standards.
No. Type Purpose Tube Location

Low Silicon tube Analyser to
Wastewater from
1 concentration • Internal diameter: 15 mm drainage
washing unit
drainage 1 • External diameter: 22 mm (low conc.)

Wastewater from
troughs

Wastewater from
troughs
High Silicon tube Analyser to

Wastewater from
washing unit
drainage • External diameter: 22 mm (high conc.)
High
Silicon tube Analyser to
concentration Wastewater from
5 • Internal diameter: 3 mm drainage
drainage for ISE module
• External diameter: 7 mm (high conc.)
ISE*1

Rev 3.10 — March 2018 Page xxxi
Foreword
Pressure-resistant hose
Purified water (accessory) Water supply to
6 Water supply supply analyser
• Internal diameter: 12 mm
• External diameter: 18 mm
Maintenance C-1 solution Wash solution to

7 Dedicated tube (accessory)
supply supply analyser
Water Supply System

Water pressure 0.10 to 0.34 MPa
Capacity 20 litres per hour or higher
Tube Pressure resistant hose (Internal diameter: 12 mm, external diameter: 18 mm)
Water quality Required: NCCLS C3-A3 Type ll
Recommended: NCCLS C3-A3 Type I, CLSI C3-A4
Drainage System
Drainage capacity 20 litres per hour
Height Higher than 300 mm between the drainage system and drain ports
Tubing condition Arrange tubing so that the wastewater is discharged by gravity.
The tips of drain tubes are kept in the air and not in contact with the surface of
wastewater in the drainage system.

Page xxxii Rev 3.10 — March 2018
Foreword
Components
No. Name Qty. Remarks
1 RX modena 1 Analyser
2 Accessory set 1 Refer to the accessory list for details.
3 User manual 1 ―
4 Accessory list 1 ―
5 Package insert 1 ―
Operating Software
To operate the analyser, the software must be installed on a specified PC (sold separately).
System Requirements
Item Minimum Requirements Recommended Specifications

OS Windows® 8.1 Pro 64 bit As shown on the left column
CPU Intel® Core™ i3 or higher Intel® Core™ i5 or higher
HDD More than 10 GB free space More than 50 GB free space
Memory 8 GB DDR3 or more 16 GB DDR3 or more
VGA Intel® HD Graphics 4600 or higher As shown on the left column
Resolution* 1920 × 1080 pixel only As shown on the left column
Screen Size 27 inch (59.66 cm × 33.60 cm) or larger As shown on the left column
Sound (optional) On-board sound or Sound card and If required, capable of emitting PC
external speakers system sounds/alarms (as a minimum).
NOTE: The analyser’s graphical interface is designed for use with a touch screen monitor. A standard
keyboard and mouse may be used as an alternative or at the same time.
NOTE: Scaling of the resolution by Windows® is not supported.
When using an external storage devices, such as USB memory sticks, always run a virus check
before use.
If the PC or the external storage device is infected with computer viruses, it may lead to
abnormal operation of the analyser.
Do not install any software on the PC that is not specified by Randox. Unspecified software

Rev 3.10 — March 2018 Page xxxiii
Foreword
Software List
The software for the analyser PC (sold separately) is as follows:
Name Version* Purpose

User Interface 2550XXXXXX Operation of the analyser
NOTE: XXX varies with the software version.
The software(s) for the analyser are as follows:
Name Version*1 Purpose

Unit Main 2550XXXXXX Moving unit control
Unit LIQ 2550XXXXXX Liquid detection control
Unit DTR 2550XXXXXX Measurement control
Unit ISE 2550XXXXXX ISE unit control*2
Unit SPT 2550XXXXXX Clot detection control
NOTE: XXX varies with the software version.
Software Version Check
1. Click the Alarm History ( ) icon.

The Alarm History screen is
displayed.
2. Check the software version is

correct.
The software versions are displayed
on the right side of the Alarm History
screen.
NOTE: Contact your Randox Representative for the latest software version.

Page xxxiv Rev 3.10 — March 2018
Foreword
Specifications
Analyser Specifications
Model Name RX modena - Clinical Chemistry Analyser
Usage • General chemistry as photometric assay
• Immunology as photometric assay (Latex reagent available)
Assay type • 1 point end • 1 point rate
• 2 point end • 2 point rate
Type of • Factor • Exponential
Calibration • Linear • Spline
• Point to point • Spline 2
• Log-logit
Throughput • Max. 800 tests per hour (general chemistry assay only)
• Max. 1200 tests per hour (general chemistry assay and ISE assay)
Incubation Time • 1 Reagent Assay: 10 minutes (R1)
• 2 Reagents Assay: 5 minutes (R1) + 5 minutes (R2)
• Able to test 1 reagent and 2 reagents assays simultaneously.
Sample Type • Serum • Haemocyte (after centrifugation)
• Plasma • Whole Blood
• Urine
Simultaneous Up to 100 assays + 3 ISE assays (Na, K, Cl)
Assays
Unit Components • Chassis Unit (CHS) • Supply Water Unit (SWU)
• Incubation Reaction Unit (IRU) • Trough Unit (TR)
• Sample Carousel Unit (ASP) • Washing Unit (WU)
• Sample Pipette Unit (SPT) • Subtank Unit (Subtank)
• Reagent Carousel Unit (RCU) • Power Supply Unit (PSU)
• Reagent Pipette Unit 1/2 (RPT1, • Control Unit (CNU)
RPT2) • Sample Barcode Reader (ASP-
• Sample Pump Unit (SPP) BCR)
• Reagent Pump Unit1/2 (RPP1, • Reagent Barcode Reader (RCU-
RPP2) BCR)
• Wash Pump Unit (WPP) • Degassing Unit (DGU)
• Detector Unit (DTR) • Clot Detection Sensor Unit
• Mixing Unit 1/2 (MIX1, MIX2) • ISE Unit
Incubator (IRU) Heating method Direct heating by silicon-rubber heater
Heating range • 37 ± 0.1 °C (Stand-by)
• 37 ± 0.2 °C (During run)
Cuvette Material • Resin
• Glass (optional)
Dimensions W3 × D5 × H30 (mm)
Light path 5 mm
Quantity 153
Minimum reaction 50 µl to 250 µl
volume

Rev 3.10 — March 2018 Page xxxv
Foreword
Sample Carousel Tube • Diameter: 12 mm to 16 mm, length:

• 75 mm to 100 mm (Volume for paediatric: 50 µl
to 100 µl) or sample cup (2 ml)
Holding structure • Outer/Middle: Detachable turn table
• (Outer: 9 positions × 6 holders, Middle: 10
positions × 4 holders)
• Inner: Detachable turn table (10 positions)
Positions • Inner: Up to 10 sample cups
• Middle: Up to 40 sample tubes
• Outer: Up to 54 sample tubes
Drive system Individual drive for inner/middle and outer trays
Sample Pipette Number of pipettes 1
Liquid detection Detection of change in capacitance
Sampling volume 0.5 µl to 25 µl
Reagent Carousel Holding structure Detachable turn table
Positions • Up to 100 reagent bottles
• Outer: Up to 50 bottles (70 ml)
• Inner: Up to 50 bottles (20 ml)
Cooling method Cooling with Peltier elements
Cooling range 8 °C to 15 °C
Drive system Individual drive for inner and outer trays
Reagent Pipette Number of pipettes 2
Liquid detection Detection of change in capacitance
Sampling volume • R1 reagent: 50 µl to 250 µl
• R2 reagent: 5 µl to 180 µl
Sample Pump Pump type Syringe pump
Reagent Pump Pump type Syringe pump
Wash Pump Pump type Syringe pump
Detector Method Spectrophotometry (13 wavelengths simultaneous)
Wavelength 13 wavelengths (340, 380, 415, 450, 478, 510, 546,
570, 600, 660, 700, 750, 800 nm)
Wavelength selection Grating method
Light source Tungsten halogen lamp
Cooling method Air cooled by fan
Mixing Unit Number of units 2
Stirring mechanism Stepping motor (5 step speed control)
Paddle material Stainless steel

Page xxxvi Rev 3.10 — March 2018
Foreword
Supply Water Water supply 1 pump.

Unit
Trough water supply 6 pumps.
Washing unit drain 7 pumps
• (High conc.: WU1, WU2 low conc. WU3 to
WU7).
Trough drain Gravity.
Water consumption 20 litres per hour.
Trough Unit Pipette trough 4 (SPTx2, RPT1, RPT2).
Mixing unit trough 2 (MIX1, MIX2).
Washing Unit Mechanism 7 step washing sequence:
1. Nozzle 1 drainage & detergent supply.
2. Nozzle 2 detergent drainage & water supply.
3. Nozzle 3 water drainage & detergent supply.
4. Nozzle 4 detergent drainage & water supply.
5. Nozzle 5 water drainage & water supply.
6. Nozzle 6 water drainage (only drainage nozzle).
7. Nozzle 7 water drainage (only drainage nozzle).
 Nozzle 7 is installed with a wipe tip.
Subtank Number of tanks 3.
Volume 800 ml.
Power Supply Voltage AC 100 V to 240 V.
Frequency 50 Hz / 60 Hz.
Consumption 2000 VA.
Voltage variation ± 10 %.
Environmental Operating temperature 15 to 30°C (Acceptable range: 2°C per hour).
Requirements Storage temperature -10 to 50°C.
Operating humidity 45 to 85% or lower (No condensation).
Transport/storage 45 to 85% or lower.
humidity
Operating pressure 800 to 1060 hPa.
Transport pressure 500 to 1060 hPa.
Dimensions Outside dimensions W1300 mm × D850 mm × H1150 mm (Excluding
protrusions).
Mass 300 kg or lower.
Noise level 75 dB (1 meter or longer away from the analyser with
its covers closed).
Transient overvoltage Overvoltage category II.
Rated pollution degree Pollution degree 2.

Rev 3.10 — March 2018 Page xxxvii
Foreword
Safety regulations • EN61010-2-081:2002+A1

• IEC61010-2-081:2001+A1
• EN/IEC61010-2-101:2002
• EN/IEC60825-1:2007
EMC regulations EN61326-2-6:2006
Laser regulations Class 1 laser product
Analysis Specifications
Number of Assays • General chemistry: 240 assays.
• ISE: 3 assays (Na, K, Cl)*1.
Normal range 50 ranges (6 prefixed ranges included).
Multi-calibrator 30 calibrators.
QC sample 40 samples.
Panel test 50 sets.
Calculated test 40 sets.
Template 10 sets.
Worklist 1000 samples.
Reagent registration 200 reagents.
Number of reagent bottles 100 bottles.
Measurement results • Results for samples: • Calibration results:
1,000,000 tests. 25,000 tests.
• Time course for sample: • Time course for calibration:
60,000 tests. 6.000 tests.
Calibration curve 240 assays × 2 curves (Old/New).
QC results 50,000 tests.
Number of patients 30,000 patients.
Number of rounds per day*2 99 rounds.
NOTE: This analyser manages cycles of measurements in units of ‘round’.

A round represents a cycle from the start to the end of a measurement. Refer to section 2.3.3.

Page xxxviii Rev 3.10 — March 2018
Foreword
Sample/Reagent Barcode Reader Specifications

The specifications for the Sample Barcode Reader and the Reagent Barcode Reader are as follows.
Type Class 2 laser product

Emitted 660 nm
wavelength
Output 85 µW
• Do not look directly into the laser beam emitted by the barcode readers,
it may lead to eye injury.
• If sample/reagent barcode reader fails, contact Randox Technical Services
or your Randox distributor. Adjustment of the barcode readers must be
performed by a Randox trained service engineer. Do NOT attempt to
adjust the equipment yourself.
During operation, the Reagent Barcode Reader and the Sample Barcode Reader each emit a laser beam in
the direction shown below.

Rev 3.10 — March 2018 Page xxxix
Foreword
Sample/Reagent Barcode Label Specifications

The specifications for sample/reagent barcode labels are as follows:
Sample barcode
Bar module 0.25 mm to 1.00 mm
width
Barcode height 12 mm or higher.
Barcode length 673 mm or shorter, including the quiet zone.
Quiet zone 4 mm or 10 times the length of the minimum module width, whichever is greater.
Print Black on a white background.
Quality standard shall comply with the ANSI MH10.8M standard.
Location

Page xl Rev 3.10 — March 2018
Foreword
Sample Barcode Type

The barcode types available for sample barcodes are as follows.
Type SID Digit Check Digit Effective Characters

UPC-A 10 1 digit, modulus 10 Numbers 0 to 9
UPC-E 6 1 digit, modulus 10 Numbers 0 to 9
JAN-13 12 1 digit, modulus 10 Numbers 0 to 9
JAN-8 7 1 digit, modulus 10 Numbers 0 to 9
ITF 3 to 15 1 digit, modulus 10 Numbers 0 to 9
NW7 3 to 15 1 digit, modulus 16 Numbers 0 to 9
(CODABAR) symbols -$/.+
CODE39 3 to 8 1 digit, modulus 43 Numbers 0 to 9
Alphabets Capital letters
Symbols - . space $ / + %
CODE128 3 to 15 2 digits, modulus 103 Numbers 0 to 9
(Set A) Alphabets Capital letters
Symbols !#$%()+.-/:;<=>?@\]
(Set B) Alphabets Capital/small letters
Symbols !#$%()+.-/:;<=>?@\]{
}~
(Set C)
NOTES:
1. For UPC-A, add "0" to the head of the SID to make it 11 digits.
2. For UPC-E, add "0" to the head of the SID to make it 7 digits.

Rev 3.10 — March 2018 Page xli
Foreword
Sample Identification Code (Sample ID)

A "sample identification code" (sample ID) is a code that identifies a sample, and a "general identification
code" (general ID) is a sample code added with number of repeated tests and replication information. The
structure of a code varies with sample categories.
Sample
Sample ID Digit General ID Details
Category
Routine xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1 x: Sample ID
Routine (Emergency) xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1 y: Reagent code
z: Concentration
Routine (Paediatric) xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1
n: Number of tests*1
Online xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1 m: Replication*2
Online (Paediatric) xxxxxxxxxxxxxxx 3 to 15 xxxxxxxxxxxxxxx-nn1
STAT 99000xxx 8 99000xxx-nn1
STAT (Paediatric) 990009xx 8 990009xx-nn1
Orderless 920000xx 8 920000xx-nn1
QC Sample 970000xx 8 970000xx-nnm
Calibrator 98yyyyyz 8 98yyyyyz-nnm
Multi-Calibrator 950000xz 8 950000xz-nnm
Calibrator (Dilution) 93yyyyyz 8 93yyyyyz-nnm
C1 Blank 9510000x 8 9510000x-nnm
Reagent Blank 91yyyyy1 8 91yyyyy1-nnm
*1 Number of repeated tests for one sample.

*2 Replication number for calibration and QC measurement.

Page xlii Rev 3.10 — March 2018
Foreword
EMC Compliance
This is a group 1, class ‘A’ product in accordance with EN 55011/CISPR 11.
This product does not generate and/or intentionally use radio-frequency energy, in the form of
electromagnetic radiation, inductive and/or capacitive coupling, for the treatment of material or inspection
/ analysis purpose, is suitable for use in all establishments other than those directly connected to a low
voltage power supply network which supply buildings used for domestic purposes.
This is a class ‘A’ product.
There may be potential difficulties in ensuring electromagnetic compatibility in non-industrial environments,
due to conducted as well as radiated disturbances.
Cables used for this product are as follows:
• Power cord (5 m or shorter, non-shielded)
• LAN cable (3 m or shorter, non-shielded)
This equipment complies with the emission and immunity requirements described in this
part of the IEC 61326 series:
• This equipment has been designed and tested to CISPR11 Class A. In a domestic environment it may
cause radio interference, in which case, you may need to take measures to mitigate the interference.
 The electromagnetic environment should be evaluated prior to operation of the device.
 Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these may interfere with the proper operation.
WEEE Directives
Information for Users on Collection and Disposal of Old Equipment and Used
Batteries:
• The symbols on the products, packaging, and/or accompanying documents mean that used electrical
and electronic products and batteries should not be mixed with general household waste.
• For proper treatment, recovery and recycling of old products and used batteries, please take them to
applicable collection points, in accordance with your national legislation and the Directives
2002/96/EC and 2006/66/EC.
• By disposing of this product correctly, you will help to save valuable resources and prevent potential
negative effects on human health and the environment, which could otherwise arise from
inappropriate waste handling.
• For more information about collection and recycling of old products, contact your local municipality,
your waste disposal service or the point of sale where you purchased the items.
• In accordance with national legislation, penalties may be applicable for incorrect disposal of this waste,
For Business Users in the European Union:

To discard electrical and electronic equipment, contact the distributor or your Randox Representative for
further information.
Disposal in Countries outside the European Union

These symbols are only valid in the European Union. If you wish to discard these items, please contact
your local authorities or your Randox Representative and ask for the correct method of disposal.

Rev 3.10 — March 2018 Page xliii
Foreword
Contact Randox
Randox welcomes customer contact and will be happy to discuss your training, service and warranty
requirements. We also welcome feedback on our products and documentation that may be used to bring
future improvements.
If making contact to report an equipment malfunction or similar issues, please supply the equipment type
and specific equipment serial number. Also, where possible, please supply as much detail as possible about
the issue and the circumstances in which it occurred.
• Should the equipment no longer be under warranty or not subject to a Service Contract, before any
work is done, you will be advised of any costs that may be incurred to return your equipment to
operational use.
To help us meet your needs quickly and efficiently, please contact the Randox Representative that is most
relevant to your area of business:
NOTE: Local representatives may be available in some regions.
Refer to the purchase documentation for further details.
Randox Laboratories Ltd

55 Diamond Road
Crumlin
County Antrim
BT29 4QY
United Kingdom
Technical Services
+44 (0) 28 9445 1070
technical.services@randox.com

Page xliv Rev 3.10 — March 2018
Section 1
Overview
SECTION 1
OVERVIEW
This chapter provides an overview of the analyser and describes the

name and function of each main part.
Document No. RX9003 Rx modena — Operator Manual

Rev 3.0 — January 2018 Page 1—1
Section 1
Overview
Section 1 − Contents
Section 1 Overview................................................................................................................1—1
1.1 Features and Major Functions................................................................................ 1—3
1.2 Part Names and Function ....................................................................................... 1—4
1.2.1 External View .............................................................................................................................. 1—4
1.2.2 Inside of Top Cover ................................................................................................................... 1—5
1.2.3 Inside the Front Door ................................................................................................................ 1—6
1.3 Operation Flow ........................................................................................................1—7
1.4 Assay Settings ..........................................................................................................1—8
1.4.1 Measurement Principles and Assay Methods ............................................................................ 1—8
1.4.1.1 Principles ............................................................................................................................. 1—8
1.4.1.2 Operation Sequence .......................................................................................................... 1—9
1.4.1.3 Special Assay Procedure .................................................................................................. 1—10
1.4.1.4 Dilution Measurement of a Routine Sample ................................................................... 1—10
1.4.1.5 Reagent Blank Measurement ........................................................................................... 1—11
1.4.1.6 Reagent Blank Measurement using Purified Water ........................................................ 1—12
1.4.2 Assay Specifications of this Analyser ....................................................................................... 1—13
1.4.2.1 Wavelength....................................................................................................................... 1—13
1.4.2.2 Incubation Time................................................................................................................ 1—13
1.4.2.3 Volumes of Sample and Reagent Used............................................................................ 1—13
1.4.2.4 Minimum and Maximum Volume of Reaction Solution .................................................. 1—13
1.4.2.5 Dummy Volumes.............................................................................................................. 1—14
1.4.2.6 Dead Volume ................................................................................................................... 1—14
1.4.3 Assay Types Classification........................................................................................................ 1—14
1.4.3.1 1 Point End Method ......................................................................................................... 1—14
1.4.3.2 2 Point End Method ......................................................................................................... 1—15
1.4.3.3 Liquid Volume Offset ....................................................................................................... 1—15
1.4.3.4 1 Point Rate Method (Single Kinetic Method) ................................................................ 1—16
1.4.3.5 2 Point Rate Method (Double Kinetic Method) ............................................................. 1—16
1.4.3.6 Liquid Volume Offset ....................................................................................................... 1—17
1.4.4 Blank Measurement .................................................................................................................. 1—17
1.4.4.1 Water Blank Measurement .............................................................................................. 1—17
1.4.4.2 Reagent Blank Measurement ........................................................................................... 1—17
Rx modena — Operator Manual Document No. RX9003

Page 1—2 Rev 3.0 — January 2018
Section 1
Overview
1 Overview
1.1 Features and Major Functions

RX modena is a clinical chemistry analyser that has a throughput of up to 800 tests per hour.
• The analyser is operated from a remote PC through a direct connection via an Ethernet crossover
cable.
• The PC software supports operations on a touch screen but a standard keyboard and mouse may
also be used.
• This analyser provides the measurement result search, print functions and enables a serial
communication with external devices such as a host computer using the ASTM protocol.
• 153 cuvettes are located in the Incubator Reaction Unit (IRU) on the analyser.
• After the reagent and sample are stirred in the cuvette, the absorbance of the reaction solution is
measured. To carry out measurement, up to 2 wavelengths can be selected from a range of 13
specified wavelengths.
• The removable sample tray can contain up to 94 sample tubes and up to 10 sample cups.
• The removable reagent tray can contain up to 100 reagent bottles.
• The reagent carousel temperature is maintained between 8°C and 15°C.

Section 1
Overview
1.2 Part Names and Function

1.2.1 External View
Number Name Function

① Top cover Protects the measurement mechanism, sample carousel and reagent
carousel.
② STAT window Used to access the inside of the top cover to add samples during
measurement.
③ Status LED Indicates the power status or communication status.
④ Power breaker Used to turn the analyser ON or OFF.
Refer to Section 2.5.
⑤ Power cable Connects to the building power supply.
⑥ Cable hole Aperture for general-use cables.
⑦ Front door Used when replenishing detergent or performing analyser
maintenance.

Section 1
Overview
1.2.2 Inside of Top Cover

Keep the top cover closed when performing measurement operations.
• To add samples or reagents, or to clean, open the top cover or STAT window.
① Sample pipette Aspirates a sample from the sample carousel and discharges it into a
cuvette on the incubator.
② Mixing units Used to stir reagent and sample in a cuvette.
③ Incubator Holds cuvettes. The interior is always kept at the specified
temperature.
④ Troughs Used to wash the sample pipette, reagent pipettes and mixing unit.
⑤ Washing unit Washes cuvettes before and after measurement.
⑥ Reagent pipettes Aspirates a reagent from the reagent carousel and discharges it to a
cuvette on the incubator.
⑦ Reagent carousel Used to place reagent bottles. The interior is kept at a low
temperature.
⑧ Lamp cover Open this cover when replacing a halogen lamp.
⑨ Sample carousel Used to hold sample tubes or sample cups.
⑩ Start switch Used to confirm the added samples and restart.
⑪ STAT switch Used to transition to the mode for adding samples.
⑫ STAT LED Indicates whether it is possible to add samples to each tray.
⑬ STAT lids Used to add samples on the outer and middle trays of the sample
carousel respectively.
⑭ ISE cover Open this cover when conducting maintenance on the ISE unit.

Section 1
Overview
1.2.3 Inside the Front Door

Open the front door to access detergent and drainage.
① Detergent bottles Used for the washing unit.

② Maintenance supply Supplies purified water for fluidic washing.
port
③ ISE consumable space Space for placing consumables used by the ISE unit.

Section 1
Overview
1.3 Operation Flow

Return from sleep mode
The analyser automatically returns from sleep mode at a specified time.
Check before starting work

Check the remaining amounts of reagents, detergents and diluents that are
used for measurement.
Calibration
Execute each of the steps below and review the result:
• Partial calibration.
• Full calibration.
QC measurement
Execute the QC measurement and review the result.
Preparation for measurement

Place a routine sample in the sample carousel and register the order.
Start the measurement

Start the measurement procedure.
• The progress and result of the currently executed measurement
can be viewed on the Round Monitor Screen.
Review of results
The results of the completed measurement can be searched on the Results
Screen, results can be displayed and reviewed here.
• Results can also be printed or saved in CSV format.
• If required, results can be sent to a host computer.
Inspection after the completion of work

Inspection and cleaning of the analyser should be carried out before setting
the analyser into sleep mode.

Section 1
Overview
1.4 Assay Settings

1.4.1 Measurement Principles and Assay Methods
1.4.1.1 Principles
Spectrophotometry analyses the concentration of the target substance quantitatively within the reaction
solution, measuring the absorbance of the substance (the degree to which the substance absorbs light).
This assay method is referred to as absorption photometry, which is based on Beer-Lambert Law.
Beer-Lambert Law is a combination of the following 2 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.
The reaction solutions of reagent and sample are put in cuvettes of the same size, so their light paths are
constant. Under those conditions, measuring the absorbance of a sample (calibrator), the concentration of
which is previously known, enables the 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.

Section 1
Overview
1.4.1.2 Operation Sequence

1. Initialize each unit.
2. Prime operation.
3. Water blank measurement of the cuvette initially used.
4. The sample carousel rotates and starts the order sequence.
5. Dispensing the R1 reagent.
• The reagent pipettes aspirate the R1 reagent placed in the reagent carousel then dispense it
into cuvettes on the incubator. Both the incubator and reagent carousel rotate to the
appropriate position to aspirate or dispense the reagent.
6. Dispensing a sample.
• The sample pipette aspirates the sample placed in the sample carousel then dispenses it into
the cuvette on the incubator where the R1 reagent has been dispensed. Both the incubator and
sample carousel turn to the appropriate position to aspirate or dispense the sample.
7. Stirring.
• The mixing unit stirs the R1 reagent and sample in the cuvette.
• The incubator turns to move the cuvette to the appropriate position for stirring.
8. Photometry.
• After the reagent and sample are stirred in a cuvette on the incubator, the detector unit
measures the absorbance of the reaction solution for approximately 5 minutes.
9. Dispensing R2 reagent.
• The reagent pipettes aspirate the R2 reagent placed in the reagent carousel and dispense it into
the cuvettes on the incubator where the R1 reagent and samples have been dispensed.
• Both the incubator and reagent carousel rotate to the appropriate position to aspirate or
dispense the reagent.
10. Stirring.
• The mixing unit stirs the R1 and R2 reagents and sample in the cuvette.
• The incubator rotates to move the cuvette to the appropriate position for stirring.
11. Photometry.
• After the reagent and sample are stirred in a cuvette on the incubator, the detector unit
measures the absorbance of the reaction solution for approximately 5 minutes.
12. Washing.
• The wash unit disposes of the reaction solution in the cuvette for which measurement has
finished, and washes the cuvette with detergent and purified water.
• The washed cuvette will be used for the next measurement.

Section 1
Overview
1.4.1.3 Special Assay Procedure

Depending on the measurement, a special sequence can be performed by using 2 cuvettes.
The following explains measurement processes that differ from the assay sequence described in Section
1.4.1.2.
1.4.1.4 Dilution Measurement of a Routine Sample

When the concentration of a sample is too high and exceeds the measurable range, the sample can be
diluted prior to measurement.
The diluting conditions can be set on the Parameter 1 screen for each assay.
For dilution measurement, 2 cuvettes are used: one for diluting a sample and the other for measuring.
1. Dispensing diluent (diluting cuvette).
2. Dispensing the R1 reagent (measuring
cuvette).
3. Dispensing the sample (diluting cuvette).
4. Stirring (diluting cuvette).
5. Dispensing the diluted sample (measuring
cuvette).
6. Stirring (measuring cuvette).
7. Reaction and photometry.
cuvette).

Section 1
Overview
1.4.1.5 Reagent Blank Measurement

The reagent blank measurement does not use a sample and therefore its assay sequence is different. Refer
to Section 1.4.4.
2. Stirring.
5. Stirring.
7. Calculating measurement results.

Section 1
Overview
1.4.1.6 Reagent Blank Measurement using Purified Water

Some reagent blank measurements use purified water as a sample. Refer to Section 1.4.4.
When purified water is used, two cuvettes are used: one for aspirating purified water and the other for
measuring.
1. Dispensing purified water (cuvette for
purified water).
cuvette).
3. Dispensing purified water (cuvette for
purified water → measuring cuvette).
cuvette).
9. Calculating measurement results.

Section 1
Overview
1.4.2 Assay Specifications of this Analyser

RX modena performs spectrophotometry based on the following specifications:
1.4.2.1 Wavelength
After the reagent and sample are stirred in a cuvette on the incubator, the detector unit measures the
absorbance of the reaction solution.
The detector unit gathers rays of light from a halogen lamp to pass them through the cuvette, and
measures the light simultaneously using 13 types of wavelengths predetermined by the grating method, i.e.
340, 380, 415, 450, 478, 510, 546, 570, 600, 660, 700, 750, and 800 nm (up to 2 wavelengths can be
selected for each assay).
1.4.2.2 Incubation Time

• The incubation time differs depending on the number of reagents used.
• It takes approximately 10 minutes for 1
reagent assay. For 2 reagent assay, it takes
approximately 5 minutes for the R1 and R2
reagents respectively.
• For a 2 reagent assay, the photometric range
(the number of measuring points) is 66
points.
• For a 2 reagent assay, the photometric range
is 33 points for R1 and R2 reagents
respectively.
1.4.2.3 Volumes of Sample and Reagent Used
Type Volume used for each test

Sample 0.5 to 25.0 µl
R1 reagent 50 to 250 µl
R2 reagent 5 to 180 µl
The reagent is aspirated from the reagent bottle placed in 1-1 to 10-10 in the reagent carousel. To start
the measurement procedure, the total volume of the reagent and sample must be within the correct
volume range of the reaction solution (between the minimum and maximum of the reaction solution
volume).
1.4.2.4 Minimum and Maximum Volume of Reaction Solution
Type Liquid Volume

Minimum volume of reaction solution 50 µl
Maximum volume of reaction solution 250 µl
The volume of the reaction solution is calculated using the following formula:
Volume of reaction solution =
Volume of sample + R1 (reagent) + R1 (purified water) + R2 (reagent) + R2 (purified water).

Section 1
Overview
1.4.2.5 Dummy Volumes

The consumption of a sample or reagent required mechanically for each pipette is called dummy volume.
The sample pipette requires 7 μl of dummy volume, and the reagent pipettes require 15 μl of dummy
volume. The consumption of the reagent or sample in routine measurement is as follows:
Consumption =
Dispensed volume set on the Parameter 1 screen + Dummy volume.
1.4.2.6 Dead Volume

Dead volume is the required sample volume that must be in the sample vessel in addition to the volume of
fluid that will be consumed during analysis. The required dead volume varies depending on the type/size of
vessel used for analysis.
Vessel Dead Volume

Sample cups 100 µl
Paediatric micro sample cups 50 µl
Sample tubes (*) 5 mm
* Height measured from the bottom. This is independent of the vessel diameter.
1.4.3 Assay Types Classification

Spectrophotometies are classified according to the method of calculating data (end method or rate
method) and the number of photometric ranges to be used. Those methods can be set as assay
parameters from the Parameter 1 screen.
1.4.3.1 1 Point End Method

This method uses a specified single photometric
range to measure the total variation in
absorbance after a certain period of time has
elapsed after dispensing.
• If the data collected in the specified
photometric range is a single unit, the
value is handled as absorbance as it is.
• If the data has multiple results, their
median is calculated as the absorbance.
This method dispenses the reagent and
measures absorbance after a set time
period.
A = Absorbance of the photometric range.
B = Reagent blank.
C = Water blank.
S = Dispensing sample volume.
Variation in absorbance ΔABS can be obtained using the following formula:
ΔABS = A - C - B.
NOTE: Whether or not the reagent blank is present can be specified for each assay item. Refer to
Section 1.4.4.

Section 1
Overview
1.4.3.2 2 Point End Method

This method uses 2 specified photometric ranges
to measure the total variation in absorbance after
a certain period of time has elapsed after
dispensing. The discrepancy in absorbance
between photometric ranges 1 and 2 in the
specified photometric ranges is defined as
absorbance.
This method dispenses the reagent and measures
absorbance after a set time period.
A1 and A2 = the absorbance of the photometric
ranges.
C = the water blank.
B = the reagent blank.
d = the liquid volume offset factor.
S = the dispensing sample volume.
Variation in absorbance ΔABS can be obtained using the formula:
ΔABS = A2 - C - B2 - d (A1 - C - B1).
NOTE: Whether or not the reagent blank is present can be specified for each assay item. Refer to
Section 1.4.4.
1.4.3.3 Liquid Volume Offset

When R2 reagent is dispensed, the sample is
diluted with the R2 reagent. As a result of the
dilution, the discrepancy in concentration occurs
between before and after dispensing of the R2
reagent. To confirm only the discrepancy in
concentration from the reaction of the sample,
correct this difference using liquid volume offset
factor d.
Liquid volume offset factor d is calculated using
the following formula:
S + R1
𝐝𝐝 =
S + R1 + R2
However, if the liquid volumes of photometric ranges 1 and 2 are on the same level (both photometric
ranges 1 and 2 of 1 reagent assay item occur after dispensing of the R2 reagent), the liquid volume offset
is not required (d = 1).
Variation in absorbance ΔABS at this time is calculated using the formula:
ΔABS = (A2 - B2 - C) - (A1 - C - B1).

Section 1
Overview
1.4.3.4 1 Point Rate Method (Single Kinetic Method)

This method uses a specified single photometric
range to measure the variation in absorbance per
time unit during reaction of the samples after
dispensing.
From the data in the specified photometric
ranges, the slope of absorbance variation vs. time
is calculated using straight- line approximation by
the method of least squares. This slope is defined
as the absorbance variation per minute.
The rate method measures the range where
absorbance varies linearly, and converts it into
absorbance variation (slope) per minute to
calculate the variation in absorbance.
ΔABSA = the absorbance variation of the samples.

ΔABSB = the reagent blank.
Absorbance variation ΔABS can be calculated using the following formula: ΔABS = ΔABSA - ΔABSB
NOTE: Whether or not the reagent blank is present can be specified for each assay item. If the reagent
blank is not corrected, variation in absorbance ΔABS is the same value as the absorbance variation of
the sample, i.e., ΔABSA.
1.4.3.5 2 Point Rate Method (Double Kinetic Method)

This method measures the absorbance variation
between 2 points per time unit. Measurement is
performed twice by changing photometric ranges
to calculate the slope of absorbance variation vs.
time using straight-line approximation by the
method of least squares. This slope is defined as
the absorbance variation per minute (ΔABS).
ΔABSA1 = the absorbance variation in
photometric range 1.
ΔABSB1 = the reagent blank
ΔABSA2 = the absorbance variation in
photometric range 2.
ΔABSB2 = the reagent blank.

d = the liquid volume offset factor.
Then variation in absorbance ΔABS can be calculated by using the following formula:
ΔABS = (ΔABSA2 – ΔABSB2) – d (ΔABSA1 – ΔABSB1)
NOTE: Whether or not the reagent blank is present can be specified for each assay item; If the reagent
blank is not corrected, variation in absorbance ΔABS can be calculated by using the following formula:
ΔABS = ΔABSA2 – d x ΔABSA1
Refer to Section 1.4.4.

Section 1
Overview
1.4.3.6 Liquid Volume Offset

As is the case with the end method, when 2
photometric ranges are used for measurement,
the discrepancy in concentration caused by
dilution can be corrected by liquid volume offset
factor d. Liquid volume offset factor d is
calculated using the following formula:
S + R1
𝐝𝐝 =
S + R1 + R2
However, if the liquid volumes of photometric
ranges 1 and 2 are on the same level (both
photometric ranges 1 and 2 of 1 reagent assay
item occur after dispensing of the R2 reagent),
the liquid volume offset is not required (d = 1).
Variation in absorbance ΔABS at this time is
calculated using the following formula:
ΔABS = (ΔABSA2 – ΔABSB2) – (ΔABSA1 – ΔABSB1)
1.4.4 Blank Measurement

There are 2 types of blank measurements:
• Water blank measurement.
• Reagent blank measurement.
1.4.4.1 Water Blank Measurement

Dispensing purified water into a cuvette used for measurement and measuring the absorbance is called
water blank measurement.
Water blank measurement corrects the discrepancy in absorbance caused by cuvettes used for
measurement. This method is also used for judging contamination of cuvettes.
1.4.4.2 Reagent Blank Measurement

Measuring the absorbance of a cuvette into which only a reagent has been dispensed is called the reagent
blank measurement. More accurate measurement results can be obtained by correcting the sample
absorbance using the reagent blank value.
There are 4 types of reagent blanks:
• R1 reagent.
• R1 reagent + R2 reagent.
• R1 reagent + purified water.
• R1 reagent + R2 reagent + purified water.
Conditions such as dispensing volume of the reagent, frequency of measurements (select one from Single,
Duplicate, and Triplicate), and whether or not purified water (equivalent to a sample) is used can be set on
the Parameter 2 screen.

Section 1
Overview
Intentionally Blank

Section 2
Basic Operations
SECTION 2
BASIC OPERATIONS
This section describes the basic operations of the analyser.

Section 2
Basic Operations
Section 2 – Contents
Section 2 Basic Operations ...................................................................................................2—1
2.1 Handling of Samples................................................................................................2—3
2.1.1 Available Sample Tubes and Cups ............................................................................................. 2—3
2.1.1.1 Location of Barcode Labels on Sample Tubes .................................................................. 2—4
2.1.2 Sample Preparation .................................................................................................................... 2—4
2.1.2.1 Arrangement of Samples.................................................................................................... 2—4
2.1.2.2 Placing Sample Cups........................................................................................................... 2—5
2.1.2.3 Placing Sample Tubes ......................................................................................................... 2—7
2.1.2.4 Adding Samples during the Measurement Procedure ...................................................... 2—9
2.2 Handling of Reagents ............................................................................................ 2—12
2.2.1 Reagent Carousel ..................................................................................................................... 2—12
2.2.2 Reagent Preparation ................................................................................................................. 2—12
2.2.2.1 Placing Reagents ............................................................................................................... 2—13
2.3 Operation Software............................................................................................... 2—15
2.3.1 Screen Configuration................................................................................................................ 2—15
2.3.1.1 Status Display Area .......................................................................................................... 2—16
2.3.1.2 Status Display ................................................................................................................... 2—16
2.3.1.3 Operation Area ................................................................................................................ 2—17
2.3.2 Operations ................................................................................................................................ 2—18
2.3.2.1 Switching Screens ............................................................................................................. 2—18
2.3.2.2 Menu Icons - Main Hierarchies and Sub-Hierarchies ..................................................... 2—18
2.3.2.3 Menu Icons - Sub-Hierarchy View by Category ............................................................. 2—18
2.3.2.4 Menu Icons List ................................................................................................................. 2—19
2.3.2.5 Function Key Operations ................................................................................................. 2—20
2.3.2.6 Keyboard Shortcuts ......................................................................................................... 2—20
2.3.2.7 On-Screen Keyboard ....................................................................................................... 2—21
2.3.2.8 Touch Screen Operation ................................................................................................. 2—21
2.3.3 Rounds ...................................................................................................................................... 2—22
2.4 Online and Offline Operations ............................................................................. 2—23
2.4.1 Online Operations ................................................................................................................... 2—23
2.4.1.1 Online Real Time.............................................................................................................. 2—23
2.4.1.2 Online Batch ..................................................................................................................... 2—23
2.4.2 Offline Operations.................................................................................................................... 2—23
2.5 Startup and Shutdown .......................................................................................... 2—24
2.5.1 Startup Procedure .................................................................................................................... 2—24
2.5.1.1 Login Rights....................................................................................................................... 2—24
2.5.2 Shutdown Procedure ............................................................................................................... 2—25
2.6 Sleep Feature .........................................................................................................2—26
2.6.1 Sleep and Wakeup Settings...................................................................................................... 2—26
2.6.1.1 Sleep and Wakeup Screen ............................................................................................... 2—26
2.6.1.2 Edit the Sleep and Wakeup Time .................................................................................... 2—27
2.6.2 Switch into Sleep Mode............................................................................................................ 2—27
2.6.3 Return from Sleep Mode ......................................................................................................... 2—27
2.7 Operation Emergency........................................................................................... 2—28
2.7.1 What to Do in Case of an Alarm ............................................................................................ 2—28
2.7.2 Emergency Stop ........................................................................................................................ 2—28

Section 2
Basic Operations
2 Basic Operations
2.1 Handling of Samples

Samples used for measurement are placed in the sample carousel.
The sample carousel consists of three types of tray. Each tray has its own sample tube holders.
Tray Name Holder No. Description
Outer tray 1 to 6 Contains 6 holders, each capable of storing 9 sample tubes.

It is capable of reading barcode labels attached to sample tubes.
Middle tray 7 to 10 Contains 4 holders, each capable of storing 10 sample tubes.

It is capable of reading barcode labels attached to sample tubes.
Inner tray ― Holds calibrators or QC samples. Up to 10 sample cups can be placed.
2.1.1 Available Sample Tubes and Cups

The sample tubes and sample cups that can be used in the analyser are as follows:
Type Description
Sample tubes • 12 to 16 mm diameter

• 75 to 100 mm length
Make sure rubber caps are removed before use.
Sample cups • 17 mm diameter
• 38 mm in height
• 2 ml in capacity
Paediatric sample cups • 14 mm diameter

• 25 mm in height
• 0.5 ml in capacity
Insert them into sample tubes (13 mm in diameter, 85 mm in height)
and place them in the outer and middle trays.

Section 2
Basic Operations
2.1.1.1 Location of Barcode Labels on Sample Tubes

Attach the appropriate barcode label to each sample tube at the location indicated below.
For detailed specifications of available barcodes, refer to Section 10.1.3.
2.1.2 Sample Preparation

• Avoid direct contact with potentially infectious samples, reagents or wastewater.
• Wear appropriate personal protective equipment (PPE) such as gloves, masks and goggles to
prevent infection when handling samples and reagents.
• Follow the instructions on the appropriate reagent package insert (Instructions for Use/IFU) to
correctly prepare samples, including centrifugation.
• Suspended solids in samples, such as fibrins, cause clogging and must be removed before testing is
performed.
• To prevent sample evaporation, do not leave them unsealed for an extended period of time.
o Evaporation of samples may lead to incorrect measurement results.
• Failure to close the sample carousel cover correctly will cause an error when measurement has
started.
NOTE: Follow the instructions on the appropriate package insert (Instructions for Use/IFU) to
correctly prepare and store calibrators and QC samples.
2.1.2.1 Arrangement of Samples

Measurements are performed in the order of the position numbers. However, samples placed in the inner
tray are given priority.
• Whether or not a tray can be placed depends on the sample category.
• When placing calibrators on the middle and outer trays, make sure the calibrators are placed in
positions that have smaller position numbers than the samples.

Section 2
Basic Operations
2.1.2.2 Placing Sample Cups

Place sample cups containing calibrators, QC samples, etc. in the middle tray and outer tray.
Open the top cover.
Lift and remove the sample carousel cover.

Lift the inner tray holder from the sample
carousel.
• There is a pin on the bottom of the
holder that engages the holes on the
bottom of the sample carousel.
• When removing a holder, pull it
vertically upwards.
Place the removed holder on a flat table

and place sample cups in the holder.

Section 2
Basic Operations
Place the holder back into the sample

carousel.
• Lower the holder vertically down into
the sample carousel until the pin
engages the hole in the carousel.
Replace the sample carousel cover.

• After sample cups have been placed,
make sure that the sample carousel
cover is securely closed.
• Collect calibrators and QC samples
after the completion of calibration and
QC measurement.

Section 2
Basic Operations
2.1.2.3 Placing Sample Tubes

Follow the steps below to place sample tubes in the outer or middle tray.
Open the top cover.
Lift and remove the sample carousel cover.
Lift the outer or middle tray holders from

the sample carousel.
• There is a pin on the bottom of each
bottom of the sample carousel. When
removing a holder, lift it vertically
upward.

Section 2
Basic Operations
Place the removed holders on a flat table and

place the sample tubes in the holders.
• Make sure each sample tube is placed
vertically into a holder and inserted as
far as it will go to prevent tube
movement during the measurement
procedure.
• Make sure that the barcode label is
positioned correctly (if used).
• For measurement of less than 5 ml of
sample, use paediatric sample cups
inserted into their own sample tubes on
the tray.
Place the holders back into the sample

carousel.
• Place the holders so that the positions
marked on the holder match the
positions shown on the sample carousel.
• Insert each holder vertically into the
sample carousel until the pin engages the
hole in the carousel.
Put the sample carousel cover back into

place.
• After sample tubes have been placed,
make sure the sample carousel cover is
securely closed.
• After completing the measurement,
make sure the samples are collected.
• Remove the holders by following the
steps above, and then collect the sample
tubes.

Section 2
Basic Operations
2.1.2.4 Adding Samples during the Measurement Procedure
Prepare and register the samples to be added and their measurement orders.
• The procedures for adding an order depend on the operating mode of the analyser.
Press the STAT switch on the analyser.

• When the preparation for adding
samples is completed, the STAT LED
on the middle or outer tray is
illuminated.
• A confirmation dialog box is displayed
on-screen.
• Do NOT open the STAT window
before the STAT LED is illuminated.
Open the STAT window.
Check the STAT LEDs then open the STAT

lid of the corresponding sample carousel
that is illuminated.

Section 2
Basic Operations
Remove the holder from the sample

carousel.
• There is a pin on the bottom of the
• When removing a holder, lift it
vertically.
Place the removed holder on a flat table and

place sample tubes in the holder.
• Make sure each sample tubes is placed
vertically into a holder and inserted as
far as it will go to prevent tube
movement during the measurement
procedure.
• Make sure that the barcode label is
positioned correctly (if used).
• For measurement of less than 5 ml of
sample, use paediatric sample cups
inserted into their own sample tubes on
the tray.
Place the holder back into the sample

carousel.
• Insert the holder vertically into the
sample carousel until the pin engages
the hole in the carousel.

Section 2
Basic Operations
Close the STAT lid.

• After the sample tubes have been
placed, make sure that the STAT lid
and sample carousel cover are securely
closed.
When all samples to be added have been

placed, close the STAT window.
Press the Start button on the analyser.

• The measurement procedure is
restarted.
• After completing measurement, make
sure samples are collected.

Section 2
Basic Operations
2.2 Handling of Reagents

2.2.1 Reagent Carousel
Reagent bottles used for measurement should be placed in the reagent carousel.
The reagent carousel has outer and inner trays, each with its own holders.
It is capable of reading barcode labels attached to reagent bottles.
Tray Name Holder No. Description
Outer tray 1 to 5 Contains five holders, each capable of storing ten 70 ml reagent
bottles.
Inner tray 6 to 10 Contains five holders, each capable of storing ten 20 ml square
reagent bottles. R1 reagents cannot be placed in the inner tray.
2.2.2 Reagent Preparation

• Avoid direct contact with potentially infectious samples, reagents or wastewater.
• Wear suitable PPE such as gloves, masks and goggles to prevent infection when handling samples
and reagents.
• Use and store reagents correctly according to the instructions on the appropriate reagent
package insert.
NOTE: An incorrectly placed reagent carousel cover will cause an error when measurement is started.
• Prepare sufficient quantities of reagents to ensure that no additional reagents have to be added
during the measurement procedure.
• Place R1 reagents on the outer tray (R1 reagents cannot be placed in the inner tray).

Section 2
Basic Operations
2.2.2.1 Placing Reagents
Open the top cover.
Open the reagent carousel cover.
Remove the outer or inner holders from

the reagent carousel.
• When removing a holder, lift it
vertically upward.

Section 2
Basic Operations
Place the removed holders on a flat table

and locate reagent bottles in the holders.
• Insert a reagent bottle vertically (as far
as it will go) into a holder.
Place the holders back into the reagent

carousel.
• Place holders so that holder numbers
match the position number indicated on
the reagent carousel.
Close the reagent carousel cover.

• After reagent bottles have been placed,
make sure that the reagent carousel

Section 2
Basic Operations
2.3 Operation Software

2.3.1 Screen Configuration
With the operation software, set up and operate the analyser by clicking icons on the display. The screen
configuration of the software is shown below.
②
④
No. Item Name Description
① Status display area This area displays status messages, start time of test, estimated end
time of measurement, and other information of the analyser.
② Main area Used to set up or to check views.

Click the menu icon to change the view.
③ Operation area This area has blue operation buttons that are used across multiple
screens.
④ Menu icons These menu icons are used to select features to be displayed or
configured.

Section 2
Basic Operations
2.3.1.1 Status Display Area ③

④
① ⑤
② ⑥
⑦
① Status Display Displays a message indicating the status of the analyser.
② Screen Name Displays the name of the screen being viewed.
③ Emergency Stop Icon Click this icon to bring the analyser to an emergency stop.
④ Current Date and Time Displays the current date and time.
⑤ Displays the start time of the measurement procedure that is

Start Time
currently running.
⑥ Estimated Displays the estimated end time of the measurement procedure that
Measurement End Time is currently running.
⑦ Next Round Start Time Displays the estimated time when the next round can be started.
2.3.1.2 Status Display

The status displays that indicate the operational state of the analyser include the following:
Display Meaning
Waiting for Start-up Communications are not established between the analyser and the
controls, or the analyser is not powered up.
Preparing The analyser is preparing for analysis, including filling cuvettes and
priming.
Standing by The analyser is ready to start the measurement procedure.
Measuring Measurement is in progress.
Ending Measurement The dispensing procedure is stopped to add samples or the dispensing
Processing (ASP Cover Can be procedure is completed.
Open)
Error Dispensing Stopping The dispensing procedure is stopped because an error has occurred.
In Sleep Mode The analyser is in sleep mode.
Maintenance being Performed The maintenance procedure is in progress.
Emergency Stop Executing The analyser was brought to an emergency stop with an error or by a
user operation.

Section 2
Basic Operations
Display Meaning
Ending Measurement An error has occurred that prevented dispensing from being
Processing (ASP Cover Can be continued.
Open)
Dispensing Ending Process Measurement was terminated after an error caused dispensing to be
Executing interrupted.
Maintenance Completed Maintenance is complete.
Emergency Stop Executing Emergency stop is in progress.
Emergency Stop Completion Completing an emergency stop.

Process Executing
2.3.1.3 Operation Area
Button Name Description
Start Starts or restarts the measurement procedure.
Add Add samples during the measurement procedure.
Save Save settings.
Reset settings to the defaults/abandon any unsaved changes and return to

Cancel
the last saved settings.
Print Print measurement results or settings.
Delete Delete a selected item or setting.
All Delete Batch-delete all orders on the Worklist screen.
Keyboard Displays the on-screen keyboard.
Some buttons in the operation area may not be displayed or may not be enabled at that time.
For example, if no settings are changed on the Settings screen, the Save icon ( ) will be inhibited and
cannot be clicked.

Section 2
Basic Operations
2.3.2 Operations
The analyser software (hosted on a standalone PC) is operated using a touch screen monitor or with a
standard keyboard or mouse. This manual explains the operations of the analyser using a mouse and
keyboard, unless otherwise indicated.
2.3.2.1 Switching Screens

Click an appropriate menu icon to switch screens.
2.3.2.2 Menu Icons - Main Hierarchies and Sub-Hierarchies

There are two hierarchies of menu icons, ‘Main’ and ‘Sub’ hierarchies.
When an icon in the Main hierarchy is selected, any icons available in the Sub-hierarchy are displayed to
the left.
2.3.2.3 Menu Icons - Sub-Hierarchy View by Category

For the Settings icons ( ) and Maintenance icons ( ), the Sub-hierarchy is divided into categories.
If a Settings or Maintenance icon is selected, any options that are available to it are displayed as icons
directly below the one that was selected.
Other icons in the Sub-hierarchy may move to make room for the new options but will still be displayed.

Section 2
Basic Operations
2.3.2.4 Menu Icons List

The following list explains the icons in the main hierarchy. You can use these icons on any screen.
No. Icon Name Description
1 Routine Displays the Carousel Monitor screen.

Switches from the icon displayed in the sub hierarchy to another
screen used for measurement.
2 Calibration Displays the Calibration screen.

screen used for calibration.
3 QC Displays the QC Chart screen.

screen used for QC.
4 Settings Displays the Parameter 1 screen.

It is used by administrators to configure measurement settings.
When the Assay Settings 1 icon ( ), Assay Settings 2 icon ( ),
Test Settings icon ( ), or Advanced Settings icon ( ) is
clicked in the sub hierarchy, additional icons are displayed below the
one that was clicked.
5 Maintenance Displays the Unit Maintenance screen.

It is used by administrators to perform maintenance tasks on the
analyser. Some screens need to be checked on a daily basis before
measurement.
When the System Maintenance icon ( ), System Monitor icon
( ), or Backup icon ( ) is clicked in the sub hierarchy, additional
icons are displayed below the one that was clicked.
6 Alarm Displays the Alarm History screen.
7 Sleep Puts the analyser into sleep mode.
8 Shut down Shuts down the software and turns OFF the power to the analyser PC.
For the icons in the sub hierarchy and screen transitions, refer to the Appendices.
NOTE: Depending on the login rights of the user, some menu icons may not be displayed.

Section 2
Basic Operations
2.3.2.5 Function Key Operations
Key Name Description
F1 Start Starts or restarts the measurement procedure.
F2 Pause Interrupts dispensing samples, reagents and displays the Inventory

screen.
F3 STAT Add samples during measurement.
F4 Alarm Displays the Alarm History screen.
F5 Routine Displays the Carousel Monitor screen.
F6 Assay Settings Displays the Parameter 1 screen.
F7 Calibration Displays the Calibration screen.
F8 QC Chart Displays the QC Chart screen.
F10 Maintenance Displays the Unit Maintenance screen.
F11 Tab menu move up Moves one tab menu up.
F12 Tab menu move down Moves one tab menu down.
2.3.2.6 Keyboard Shortcuts

The following lists the functionality of function keys on a keyboard when they are used in combination
with the Shift or Ctrl key.
Key Combination Name Description
Shift + F1 Orderless Test Starts an orderless test.
Shift + Esc Warning sound Stops a warning sound that is emitted when an alarm has
stop occurred.
Ctrl + F2 Emergency Stop Brings the analyser to an emergency stop.
Ctrl + F5 Print screen Prints a screenshot of the screen in focus. It is disabled

during the measurement procedure.

Section 2
Basic Operations
2.3.2.7 On-Screen Keyboard

Click the Keyboard icon ( ) to display the on-screen keyboard.
In addition to the alphanumeric and standard function keys, it has a number of keys with useful features.
Key Description
Opens the Windows Help and Support pop-up.
Opens the Options window to configure the on-screen keyboard.

Text prediction, touch screen configuration and input controls can be changed in this
window.
Changes the on-screen keyboard transparency to aid in viewing the whole screen.
The keyboard returns to its normal appearance when used.
Docks the on-screen keyboard from a pop-up window into the software.
Recommended if keyboard input is frequently required.
2.3.2.8 Touch Screen Operation

On a touch screen monitor, the following operations are used in place of keyboard or mouse operations.
Operation Description
Tap Gently touch and release a finger on the screen.

• Used to select a button or item.
• For an item that requires text or number characters to be entered, an on-
screen keyboard will be displayed.
Swipe Gently touch the screen then slide the finger across the screen to scroll the page.
Pull-down menu When tapped, a list of menu items are displayed from which items can be selected.
List menu For an item for which you can enter characters and select pre-written content from
a pull-down menu, if you tap an entry field and tap Space on the on-screen
keyboard, the available items will be listed.
Check box This is a square box allowing users to tap to select or deselect an option.
A check mark / tick (  ) in the box indicates that the option is enabled.

Section 2
Basic Operations
2.3.3 Rounds
This analyser manages cycles of measurements in units of a ‘round’. A round represents a cycle from the
start to the end of a measurement.
• Rounds are numbered sequentially each day.
• Rounds can be used to identify the number of tests per day or as search conditions for
measurement results.

Section 2
Basic Operations
2.4 Online and Offline Operations

The analyser allows online and offline operations:
• The operation or measurement procedures may vary depending on the operating mode of the
analyser. If required, check the mode with an administrator.
• Administrators can set the operating mode of the analyser via the Device Settings screen
according to the appropriate policy for the operating organization.
2.4.1 Online Operations

This is mode is used to perform the measurement procedure by obtaining order details from a host
computer. There are 2 modes in the online operations, online real tie and online real batch.
2.4.1.1 Online Real Time

Orders are automatically obtained from a host computer. When used with a sample barcode, preparation
for the measurement procedure is completed only by placing samples into empty positions in the sample
carousel.
2.4.1.2 Online Batch

Online Batch is used to manually obtain orders from a host computer and to register them with the
analyser. When used with a sample barcode, orders can be registered with no regard to positions where
samples are placed.
2.4.2 Offline Operations

For offline operations, register orders with samples via an operation on the analyser. When using offline
operations, the sample placement positions MUST match the order details.

Section 2
Basic Operations
2.5 Startup and Shutdown

2.5.1 Startup Procedure
After starting the analyser from a powered off state, QC measurement and calibration must be performed
before starting analysis of samples.
Turn the power breaker ON at the

back of the analyser.
• The status LED will illuminate
‘orange’.
Turn the PC power switch ON.
• For information on Windows
operation, refer to the manual that
accompanied the PC.
When the Windows desktop screen is displayed, double-click the [Analyser] icon.
The Login screen will be displayed.
Enter your login name and password in

the User Name and Password fields and
then click Login.
The usage permissions (User Level)

confirmation screen is displayed.
Click OK.
The Home screen is displayed.
The status LED will illuminate ‘green’ when

communications between the analyser and
software have started.
2.5.1.1 Login Rights

Different usage permissions (access levels) can be set for different users.
• Login rights and user accounts are managed by the Administrator.
• Administrators can set up User Names, Passwords, and usage permissions on the User Account
screen.

Section 2
Basic Operations
2.5.2 Shutdown Procedure

• When the power to the analyser is turned off, the cooling of the reagent carousel is turned off.
• Do NOT turn the power off if any reagents remain in the reagent carousel.
Click the Power icon ( ).
Click the Shutdown button.

• The software shuts down and PC
power is automatically turned off.
o Clicking Cancel returns you to
the control screen.
Turn the power breaker OFF.

• Off = switch pointing down.
• On = switch pointing up.

Section 2
Basic Operations
2.6 Sleep Feature

The analyser can be put in Sleep Mode without turning the power on or off after daily measurement
procedures have been completed.
The sleep feature places the analyser into a standby state and back into an operational state at a specified
time. In the standby state, the cooling feature of the reagent carousel is maintained and when returning
from the standby state, predefined preparation operations are performed.
CAUTION: Do NOT turn the PC power off with the analyser in sleep mode. The automatic wake
from standby will not take place.
2.6.1 Sleep and Wakeup Settings

NOTE: When using detergents for washing pipettes or filling cuvettes, detergents must be placed in the
reagent carousel or sample carousel. The placement position must be registered in the Inventory screen
or Worklist screen.
2.6.1.1 Sleep and Wakeup Screen

Routine > Sleep and Wakeup
② ③

① Wakeup Schedule Set the time to awake from sleep mode each day. Select the operations
to perform at return from OFF Routine 1 and Routine 2 displayed in
Routine under each day.
② Wakeup Routine Set the details of Routine 1 and Routine 2 for the wakeup schedule.
Select the number of prime operations (0 to 5) and the number of
cuvette washes (0 to 5), and select the check box of the washing
method for each unit.
③ Pre-Sleep Routine Set the wash sequence before entering sleep mode. Select the check
box of the washing method for each unit and select the liquid for filling
the cuvettes from System Water, Detergent and OFF.
To perform a soak wash for each unit, specify Detergent in Cuvette
Filling.

Section 2
Basic Operations
2.6.1.2 Edit the Sleep and Wakeup Time

Routine > Sleep and Wakeup
Edit each item for sleep and wakeup.

To reset the edited contents,
click Cancel ( ) on the lower part of the
screen.
Click Save ( ) on the lower part of the
screen.
• The edited content is registered.
2.6.2 Switch into Sleep Mode
Click the Sleep icon ( ).

• A confirmation screen is displayed.
Click OK.
• If the analyser has been programmed to
perform specific functions prior to sleep
mode. These will be executed.
• The analyser will then be switched to
sleep mode.
2.6.3 Return from Sleep Mode

When the analyser is manually returned from sleep mode, it is put in a Standby status. In this case, any
predefined wake up procedures will not be carried out.
Click the Sleep icon ( ).

Click OK.
• The analyser returns from a standby
state.

Section 2
Basic Operations
2.7 Operation Emergency

2.7.1 What to Do in Case of an Alarm
If there is a problem with the analyser’s operation, the colour of the Alarm icon ( ) changes to red
( ) and an audible alarm is sounded. If there is an alarm, follow the steps below.
Click the red Alarm icon ( ).
Resolve the problem following the

instructions in the appropriate message.
2.7.2 Emergency Stop

Follow the steps below to bring the analyser to an emergency stop.
Press the Emergency Stop icon ( ) on

the upper-right corner of the screen.
• Alternatively, use the keyboard
shortcut, Ctrl + F2 to initiate an
emergency stop.
After an emergency stop, the analyser is automatically initialized. If the analyser is brought to an emergency
stop during the measurement procedure, all orders are cancelled.
Any orders for which measurement results have not been output are held in the Worklist screen. When
the next round is started after an emergency stop, measurement can be executed for the held orders.

Section 3
Accessory Functions
SECTION 3
ACCESSORY FUNCTIONS
This chapter explains functions required for analyser operation but

that are not necessarily part of the testing process.

Section 3
Accessory Functions
Section 3 Accessory Functions ............................................................................................. 3—1
3.1 Parameter Settings .................................................................................................3—3
3.1.1 Setup Screen ............................................................................................................................... 3—3
3.1.1.1 Parameter 1 Screen ............................................................................................................ 3—3
3.1.1.2 Parameter 2 Screen ............................................................................................................ 3—7
3.1.2 Register a Parameter .................................................................................................................. 3—8
3.1.3 Editing a Parameter .................................................................................................................... 3—9
3.1.4 Copying a Parameter................................................................................................................ 3—10
3.1.5 Importing Parameters............................................................................................................... 3—11
3.1.6 Export a Parameter .................................................................................................................. 3—12
3.1.7 Delete a Parameter .................................................................................................................. 3—13
3.1.8 Print a Parameter...................................................................................................................... 3—13
3.1.9 Various Range Settings ............................................................................................................. 3—14
3.1.9.1 Normal Range .................................................................................................................. 3—14
3.1.9.2 Technical Range ................................................................................................................ 3—15
3.1.9.3 Comparison Check (%) ................................................................................................... 3—15
3.1.9.4 Abnormal Range ............................................................................................................... 3—15
3.1.9.5 Panic Range ....................................................................................................................... 3—15
3.2 Limit Check Settings ............................................................................................. 3—16
3.2.1 Linearity Limit ........................................................................................................................... 3—16
3.2.2 Prozone Limit ........................................................................................................................... 3—17
3.2.2.1 Absorbance Limit ............................................................................................................. 3—18
3.2.3 Range Shift Function ................................................................................................................. 3—19
3.3 Reagent Blank and C1 Blank ................................................................................ 3—20
3.3.1 Measuring Conditions .............................................................................................................. 3—20
3.3.2 Reagent Blank Timing ............................................................................................................... 3—20
3.3.3 Reagent Blank Method ............................................................................................................. 3—21
3.3.4 Replication ................................................................................................................................ 3—21
3.3.5 Reagent Blank Deviation Limit ................................................................................................. 3—21
3.4 Normal Range Name Settings ............................................................................. 3—22
3.4.1 Normal Range Screen .............................................................................................................. 3—22
3.4.2 Registered a Normal Range Name.......................................................................................... 3—23
3.4.2.1 Editing a Normal Name Range ........................................................................................ 3—24
3.4.2.2 Deleting a Normal Range Name ..................................................................................... 3—25
3.5 Setting Measurements of Serum Indices ............................................................ 3—26
3.5.1 Serum Indices Screen ............................................................................................................... 3—26
3.5.2 Serum Indices............................................................................................................................ 3—27
3.5.3 Settings Related to Measurements of Serum Indices .............................................................. 3—28
3.5.4 Settings Related to Measurements of Serum Indices .............................................................. 3—29
3.5.4.1 Edit Defined Settings for Serum Indices Measurements ................................................. 3—30
3.5.4.2 Print Defined Settings for Serum Indices Measurement ................................................. 3—30
3.5.5 Running Order .......................................................................................................................... 3—31
3.5.5.1 Running Order Screen ..................................................................................................... 3—31
3.5.5.2 Run Order Settings........................................................................................................... 3—32
3.6 Contamination Prevention Settings .................................................................... 3—33
3.6.1 Contamination Prevention Screen........................................................................................... 3—33
3.6.2 Registering a Contamination Prevention Setting..................................................................... 3—34
3.6.3 Edit a Contamination Prevention Setting ................................................................................ 3—35
3.6.4 Delete a Contamination Prevention Setting ........................................................................... 3—36
3.6.5 Printing a Contamination Prevention Setting .......................................................................... 3—36

Section 3
Accessory Functions
3 Accessory Functions
3.1 Parameter Settings

Before starting measurement, the parameter needs to be set.
This section explains the procedure for setting a parameter.
3.1.1 Setup Screen

Set parameters on the Parameter 1 and Parameter 2 screens.
3.1.1.1 Parameter 1 Screen
① ②
⑮
⑯
③
⑰
⑤ ④
⑱
⑥ ⑲
⑦ ⑳
⑫ ⑩ ⑪
⑬
21
22
23 24 25
⑭

① Assay No. Select or enter an assay item number (1 to 240).
• Specifying a registered assay item number automatically displays
the registered information.
② Assay Name Select or enter an assay item name (up to six alphanumeric characters and
symbols).
• Specifying a registered assay item name automatically displays the
registered information.
③ Print Name Enter an assay item name for printing (up to 15 alphanumeric characters and
symbols).
• It is output as Assay Item Name when data is printed or output to a
file. If the print name is not entered, the assay item name set in Assay
Name is printed or output to a file.
④ Colour Select a colour for the assay item from the 240 colours.
⑤ Unit Enter a unit for the assay item (using up to six alphabet characters and
symbols).

Section 3
Accessory Functions

⑥ Assay Type Select an assay method.
• End: Uses the end method.
• Rate: Uses the rate method.
⑦ Measuring Points Select a point number of the photometric range (1 to 66, Disable).
• One point: Select a point number for Start and End in the 1 field, and
select Disable for Start in the 2 field.
• Two points: Select a point number for Start and End of each of the 1
field and the 2 field.
A point number should satisfy the following conditions:
• If End is specified for the assay type:
Start ≦ End.
• If Rate is specified for the assay type:
Start < End.
⑧ Wave Length Select the primary and secondary wavelengths for measurement, from 13
wavelengths in the range of 340 to 800 provided.
• Select Disable when not using the secondary wavelength.
• The secondary wavelength should be different from the primary
wavelength.
⑨ Reagent Name Select the R1 and R2 reagent names to be used from the list of registered
reagent codes.
• Select Disable when not using the R2 reagent.
• If a reagent to be used is not displayed, register the reagent.
• Click ( ) to display the Reagent Code screen.
⑩ Reagent (μl) Enter the volume of reagent to be used
• R1: 20 to 250.
• R2: 5 to 180.
⑪ Water (μl) Enter the dispensing volume of purified water if the reagent is diluted with
purified water (R1: 20 to 250, R2: 5 to 180).
• If purified water is not used for dilution, leave this item blank.
⑫ Diluent Select a diluent name when the sample dilution function is used for assay.
• Select Disable when not using the sample dilution function.
• If a diluent to be used is not displayed, register the diluent.
⑬ Detergent Select a reagent name to be used for washing.
• The selected reagent (250 μl) is used to wash the sample pipette and
stirrer.
• Select Disable when not using a detergent.
• If a detergent to be used is not displayed, register the detergent.

Section 3
Accessory Functions

⑭ Stirring Speed Select a stirring speed for dispensed sample (mixing unit 1) and dispensed R2
reagent (mixing unit 2).
• Select a speed according to the viscosity of the reagent.
The estimation of the speed is as follows:
• Fastest: Extremely high viscosity.
• Very Fast: Particularly high viscosity.
• Fast: High viscosity.
• Middle: Normal.
• Slow: Low viscosity.
• None: No stirring.
⑮ Sample Volume Enter the dispensing volume of the sample (0.5 to 25 μl in increments of 0.1
(Normal) μl).
Three steps, i.e., Decrease, Normal and Increase can be selected for the
dispensing volume.
The relationship of Decrease < Normal < Increase should be satisfied.
• When using the sample dilution function: Tick the Dilution check box,
and enter the aliquot (0.5 to 25 in increments of 0.1 μl) and diluent
volume (02 to 250 in increments of 1 μl).
⑯ Sample Volume Enter the dispensing volume of the rerun sample (high value) (0.5 to 25 μl (in
Rerun increments of 0.1 μl)).
(High/Prozone)
dispensing volume.
The relationship of Decrease < Normal < Increase should be satisfied.
⑰ Sample Volume Enter the dispensing volume of the rerun sample (low value) (0.5 to 25 μl in
Rerun (Low) increments of 0.1 μl).
dispensing volume. The relationship of Decrease < Normal < Increase
should be satisfied.
⑱ QC Enter the dispensing volume of the QC sample (low value) (0.5 to 25 μl in
increments of 0.1 μl).
⑲ Calibration Enter the dispensing volume of the calibration sample (low value) (0.5 to 25
μl in increments of 0.1 μl).

Section 3
Accessory Functions

⑳ Range Settings Enter an evaluation flag to be added to the measurement result, and the
automatic rerun conditions for each range.
There are five types of ranges:
• Normal Range.
• Technical Range.
• Comparison Check.
• Abnormal Range.
• Panic Range.
21 Decimal Point Specify the number of significant decimal places in the measurement result.
22 SI Link Specify whether or not to automatically select the order for serum indices
when this assay name is selected on the Worklist screen.
23 Copy Tick this check box to copy the parameter to another assay number.
24 Import Imports a file containing assay items.
25 Export Export assay items to a file.
NOTE: Depending on the analyser settings, the editing of items in user level L3 may also be unavailable.
For details, contact your Randox Representative.

Section 3
Accessory Functions
3.1.1.2 Parameter 2 Screen
③
①
②
④

① Assay No. Select the assay item number. Assay items registered on Parameter 1
screen can be selected.
② Assay Name Displays the assay item name.
③ Limit Check Configure the limit check setting.
④ Blank Measurement Configure the reagent blank measurement or C1 blank measurement

setting.
⑤ Instrument Factor The discrepancies in measurement results due to using different devices
can be corrected for each assay item number.
Enter a and b values for correction expression:
• Y = aX + b (a (slope): -99.9 to 99.9.
• b (intercept): -999.99 to 999.99).
⑥ Run Trigger Configure the range/parameter trigger.
For further details, contact your Randox Representative.

Section 3
Accessory Functions
3.1.2 Register a Parameter
Enter the assay number of the parameter

to be registered.
• Only assay items registered on the
Parameter 1 screen can be selected
on the Parameter 2 screen.
Edit each item.

• Click the Cancel icon ( ) to reset
the edited contents.
Click the Save icon ( ).

• The parameter is saved.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions
then continue operation.

Section 3
Accessory Functions
3.1.3 Editing a Parameter
Select the assay number of the parameter

to be registered.
• The registration information of the
parameter is displayed.
Edit each item.


• The changes are saved.

Section 3
Accessory Functions
3.1.4 Copying a Parameter
Select the assay number for the source

parameter to display the setting details.
Tick the Copy check box.
Enter a destination assay number.

• The copied parameter is saved.

Section 3
Accessory Functions
3.1.5 Importing Parameters
Click ( …).
• The folder select dialog box is
displayed.
Specify (in the folder select dialog box)

the folder where the parameters will be
saved.
Click Import.
• Parameters are imported.
• All the parameter setting files
contained in the folder are imported.
• The imported parameters can be
selected from assay numbers.

Section 3
Accessory Functions
3.1.6 Export a Parameter
Configure the source parameter or select

the assay number for the parameter.
Click ( …).
• The folder selection screen is
displayed.
Specify (in the folder select dialog box)

the folder where the parameters will be
saved.
Click the Export button.

• The parameter is saved in the
specified folder.
• If a parameter with the same name
already exists in the specified folder,
it is overwritten.

Section 3
Accessory Functions
3.1.7 Delete a Parameter
Select the assay number for the

parameter to be deleted.
Click the Delete icon ( ).

Click the OK button.

• The parameter is deleted.
3.1.8 Print a Parameter
Select the assay number for the

parameter to be printed.
Click the Print icon ( ).

• The parameter is printed.
• For information on print settings,
refer to your printer manual(s).

Section 3
Accessory Functions
3.1.9 Various Range Settings

Set various ranges on the Parameter 1 screen.
The following 5 types of ranges can be set in this screen:
• Normal Range.
• Technical Range.
• Comparison Check.
• Abnormal Range.
• Panic Range.
3.1.9.1 Normal Range

This type of range sets a reference range for each assay. Up to 50 types of normal ranges can be
registered.
Enter the upper and lower limits of normal ranges on the Normal Range screen.
Available values are 0 to 9,999,999. (The applied number of digits after the decimal point is that specified
for Decimal Point in the Parameter 1 screen).
Min: When a result is lower than this value, an evaluation flag (L) is attached.
Max: When a result is higher than this value, an evaluation flag (H) is attached.
• If Min - Max is 0 - 0, the normal range judgment is not executed.
• Normal range names must be registered on the Normal Range screen.
• The age range setting for each registered generation can be changed on the Operation Settings
screen.

Section 3
Accessory Functions
3.1.9.2 Technical Range

Sets the effective range of measurement values to indicate reliability of measurement results.
If a result is outside the upper or lower limit value, an evaluation flag (>) or (<) is added to the
measurement result.
The values are displayed as the upper and lower limits of the set concentration and absorbance. The
measurement will be automatically rerun when the automatic rerun function has been enabled.
Conc.
Specify the lower and upper limits of
concentration.
• The available concentration values are 0
to 999,999.
mAbs/10
Specify the lower and upper limits of absorbance.
• The available absorbance values are -999,999 to 999,999.
3.1.9.3 Comparison Check (%)

The range of measurement values that can be
determined to be normal compared with results
within the past 90 days measurement for the same
patient ID.
When the automatic rerun function has been enabled, an automatic rerun is performed if a
measurement result exceeds the set range.
Set the range by specifying the absorbance value from 0 to 9,999,999 (mAbs/10) and the threshold in
percentage form (%). The applied number of digits after the decimal point is that specified for Decimal
Point in the Parameter 1 screen.
3.1.9.4 Abnormal Range

The range of measurement results to be defined
as abnormal values. If a result is outside the
upper or lower limit value, an evaluation flag ($)
is added to the measurement result.
Set the concentration (Conc.) range to 0 to 9,999,999 (the applied number of digits after the decimal
point is that specified for Decimal Point in the Parameter 1 screen).
3.1.9.5 Panic Range

The range of measurement results to be defined as
a panic range. If a result is outside the upper or
lower limit value, an evaluation flag (!) is added to
the measurement result.
Set the concentration (Conc.) range to 0 to 9,999,999 (the applied number of digits after the decimal
point is that specified for Decimal Point in the Parameter 1 screen).

Section 3
Accessory Functions
3.2 Limit Check Settings

There are 4 types of limit checks as shown in the following.
3.2.1 Linearity Limit

Performs a linearity check. This type of check
applies to the rate method, and not to
measurements of calibrators and QC samples.
To specify the threshold for the variation in absorbance from 1 to 99,999 (mAbs/10)/per min.) and the
threshold in percentage form from 0.1 to 99.9 (%).
• Linearity is checked based on the slope ratio between the first and second halves of the
photometric range. The gradient ratio of photometric range 2 is used for the 2 point rate
method.
• If the linearity ratio is greater than the set value, a linearity error occurs and an error flag [LIN] is
shown on the measurement results.
The linearity ratio is calculated using the following formula:
However, a linearity check is not performed in the following cases:

• ΔABSslope ≦ the threshold for the variation in absorbance.
• ΔABSfirst - ΔABSlast ≦ the threshold for the variation in absorbance.
• Less than 4 measuring points in the photometric range.
• Another error with higher priority occurs.

Section 3
Accessory Functions
3.2.2 Prozone Limit

Performs a Prozone check. This type of check does not apply to measurements of calibrators.
Specify the threshold in percentage form

(0.00001 to 99.99999).
Select the direction of judgment (upper limit
or lower limit).
Set the first and last measuring points for
slope 1.
Set the first and last measuring points for
slope 2.
Set the sensitivity limit (1 to 999,999).
• If ΔABS1 is less than the sensitivity limit, a Prozone check is not performed.
• If a measurement value exceeds the allowable limit of the Prozone check value, an error flag
PRO is added to the measurement results and automatic rerun (high) will be applied.

Section 3
Accessory Functions
3.2.2.1 Absorbance Limit

Performs an allowable limit check of
spectrophotometry. This type of check only
applies to the rate method.
Set the Reaction Trend (increase or reduce) and the Limit value (1 to 999,999).
Set the Limit absorbance as the upper limit for increased reaction, or set it as the lower limit for
reduced reaction, and perform the allowable limit check of absorbance.
• The absorbance is calculated in the range of the formula: (Absorbance of primary wavelength -
Water blank of primary wavelength) < Limit value.
• The inside of the photometric range is checked for 1 point rate reaction, while the reaction on
the part of photometric range 2 is checked for 2 point rate reaction.
• When 2 or more starting measuring points are within the absorbance limit, ΔABS is calculated
using the absorbance of measuring points within the range. If the value exceeds the absorbance
limit set on the Parameter 2 screen, an error flag (AB2) is displayed on the measurement results.
• When 8 or more continuous measuring points are within the absorbance limit or when all
measuring points are within the limit, error flag (AB2) is not displayed.
• When there is 1 or less measuring point within the limit, error flag (AB1) is displayed. The
measurement results are not displayed in this case.

Section 3
Accessory Functions
3.2.3 Range Shift Function

When the value set for the absorbance limit is
exceeded, this function enables absorbance to be
calculated by shifting the photometric range.
Select the Range Shift check box.

Set the Start and End points for the Photometric Range.
• When the Range Shift check box is selected:
o Error flags (AB1) and (AB2) are not displayed, but the SFT flag is displayed.
o An automatic rerun is not performed.

Section 3
Accessory Functions
3.3 Reagent Blank and C1 Blank

3.3.1 Measuring Conditions
Select the measuring conditions for reagent blank and C1 blank from the drop-down menu.
Item Name Description

Disable Reagent Blank and C1 Blank Does not measure reagent blank, not execute a partial
calibration using C1 blank.
Use C1 Blank for Calibration (*1) Executes a partial calibration using C1 blank.
(C1 blank is used to correct an intercept only without
changing the slope of the calibration curve; correct b of
Y = aX + b).
Offset Time Course with Reagent Blank Calculates the absorbance of the R1/R2 reagents in
advance to correct the time course by using the value.
Use Reagent Blank as C1 for Calibration (*2) Uses reagent blank as C1 (zero-concentration
calibrator) to execute a full calibration.
*1 If the calibration type is Factor or Linear.
*2 If the calibration type is Linear.
For information on the calibration curve and calibration, refer to Section 5.
3.3.2 Reagent Blank Timing

Select the Reagent Blank Timing measurement from the drop-down menu.
Select either Offset Time Course with Reagent Blank or Use Reagent Blank as C1 for
Calibration.
Configure the following settings:
①
②
③

① Daily Performs a reagent blank measurement every time measurement of
an assay item on which a reagent blank measurement has not been
performed is carried out at the time and rest of day of calibration.
② Every Run Performs a reagent blank measurement for each round.
③ None Does not perform a reagent blank measurement. The last reagent
blank absorbance is used for the measurement.

Section 3
Accessory Functions
3.3.3 Reagent Blank Method

Select the reagent blank measuring conditions from the drop-down menu.

① Measure Reagent Only Measures reagent blank only with a reagent without using
a sample.
② Use System Water as Sample Measures reagent blank using purified water instead of
sample.
3.3.4 Replication
Select the frequency of reagent blank measurement from the drop-down menu.
①
②
③

① Single Determines the reagent blank value from the result of a single
measurement
② Duplicate Sets the reagent blank value to the average obtained from the results
of 2 measurements.
③ Triplicate Sets the reagent blank value to the median obtained from the results
of 3 measurements.
3.3.5 Reagent Blank Deviation Limit

This limit setting is enabled by selecting the Deviation Limit check box.
Specify the allowable range for absorbance discrepancies when measuring reagent blank
(1 to 99,999).

Section 3
Accessory Functions
3.4 Normal Range Name Settings

Set normal range names used to determine the measurement results.
• Up to 50 normal range names can be registered.
3.4.1 Normal Range Screen

① Normal range list Lists the normal ranges registered.
To add or edit a normal range, click the desired row in the
Normal Range Name column.
NOTE: The initial values are registered in No. 01 to 06 as shown in the following.
Normal Range No. Normal Range Name

01 Male-G1
02 Male-G2
03 Male-G3
04 Female-G1
05 Female-G2
06 Female-G3

Section 3
Accessory Functions
3.4.2 Registered a Normal Range Name
From Normal Range No. select a row

in which to register a normal range name.
• An input window is displayed.
Enter a normal range name.

• To reset the edited contents, click
the Cancel icon ( ).

• The normal range name is saved.

Section 3
Accessory Functions
3.4.2.1 Editing a Normal Name Range
Select a row to be edited from the

Normal Range No. column.
• An input window is displayed.
Enter a new normal range name.

• To abandon any changes click the
Cancel icon ( ).

• The changes are stored on the
system.

Section 3
Accessory Functions
3.4.2.2 Deleting a Normal Range Name
From Normal Range No, select a row to be deleted.


• The normal range name is deleted.

Section 3
Accessory Functions
3.5 Setting Measurements of Serum Indices

Set the conditions for measuring serum.
• About qualitative and semi quantitative markers:
At high concentrations of turbidity, Haemolysis or bilirubin in serum, a medical agent and its
metabolic products may affect measurement results depending on the assay method. This
analyser shows the degrees of Haemolysis (H), lipids (L) and icterus (I) in serum in numerical
form by measuring the absorbance of the diluted samples, and displays the qualitative
determination based on these numeric values.
CAUTION: The numeric values may not match the actual concentrations of lipids,
Haemolytic haemoglobin and bilirubin under the influence of medical agents or other factors.
Do not use serum indices as the basis for diagnosis.
3.5.1 Serum Indices Screen
⑥ ⑦
①
② ⑧
③
④
⑤
⑨

① SI Mode Select SI Mode:
• Disable: Uses the reagent selected on the Serum Indices screen.
• Enable: Uses the reagent of the assay item where Enable is selected
for SI Link on the Parameter 1 screen.
② Reagent Type Select R1 or Diluent as the reagent type.
③ Reagent Name Select a reagent name to be used.
④ Reagent Volume Enter dispensing volume of the reagent (50 to 250).
⑤ Sample Volume Enter a sample volume.
⑥ Factor A to F Enter each factor (0 to 999,999).

Section 3
Accessory Functions
⑦ Instrument Factor The discrepancies in measurement results due to using different devices
can be corrected for each assay item.
Assay items that can be corrected are Haemolytic, Lipid, and Icteric.
Enter a and b values for correction expression Y = aX + b. (a (slope):
-99.9 to 99.9, b (intercept): -999.99 to 999.99).
⑧ Haemolytic Specify a display format for qualitative determination.
⑨ Lipid Left column: Enter qualitative determination characters. (Using up to 5

alphanumeric characters and symbols).
⑩ Icteric
Right column: Enter the threshold for qualitative determination. (0 to
999,999).
For details, contact your Randox Representative.
3.5.2 Serum Indices

The serum indices can be calculated using the following calculation formulae:
A to F indicate factors set in 5 and α to ε indicate absorbance of the following wavelengths:

α: 600 nm, β: 700 nm, γ: 570 nm, δ: 415 nm, ε: 510 nm.
Although we recommend that you use the following factors, relevant factors can be set as necessary.
A: 1271, B: 42189, C: 320, D: 4350, E: 889020, F: 223968.
NOTE: Set the qualitative determination character for each index and threshold values as indicated
below.
If the measurement results are H=20, L=200, I=30, results of qualitative determination of serum
indices are displayed as H1 L++ I---.

Section 3
Accessory Functions
3.5.3 Settings Related to Measurements of Serum Indices

The following explains the procedure for setting serum indices by using the reagent set on the Parameter 1
screen.
If you order the assay item for which you selected the SI Link check box in the Parameter 1 screen, the
reagents for that assay item will be used to measure the serum indices.
Select Assay-Linked in SI Mode.
Set each index.

• To abandon any changes, click the
Cancel icon ( ).

• The serum index measurement
settings are stored to the system.

Section 3
Accessory Functions
3.5.4 Settings Related to Measurements of Serum Indices

(When Specifying Reagents to Use)
Select Disable in SI Mode.
Enter information for the reagent to be

used.
Set each index.

Cancel icon ( ).

• The serum index measurement
settings are stored to the system.

Section 3
Accessory Functions
3.5.4.1 Edit Defined Settings for Serum Indices Measurements
Edit each item.

Cancel icon ( ).

• The changes are stored to the
system.
3.5.4.2 Print Defined Settings for Serum Indices Measurement

• The serum indices are printed.
• For more information on print
settings, refer to your printer
manual(s).

Section 3
Accessory Functions
3.5.5 Running Order

The order of measurements and printing results can be specified.
3.5.5.1 Running Order Screen
① ②

① Running Order
Specify the order of measurements.
Sort the rows (assay names) in the order of measurement.
Select a row (assay name) of which you want to change priority and
drag it to a desired row.
② Print
Specify the order of printing.
Sort the rows (assay names) in the order of printing.
Select a row (assay name) of which you want to change the priority of,
and drag it to a desired row (assay name).
• When the Common check box is selected, the order of printing
becomes the same as that of measurement.
③ Common
Select the check box to specify the same order for measurement and
printing.

Section 3
Accessory Functions
3.5.5.2 Run Order Settings

1. Specify the order of measurement and
printing.
• Click the Cancel icon ( ) to
reset the edited contents.
2. Click the Save icon ( ).

• The running order is saved.

Section 3
Accessory Functions
3.6 Contamination Prevention Settings

Contamination of reagent pipettes or cuvettes commonly used for assay items may adversely affect
measurement results. Affects can be minimised by washing reagent pipettes during the intervals between
measurements, or by avoiding using the same cuvette to measure two specific assay items.
3.6.1 Contamination Prevention Screen

① Assay 1 + 2 Select the number of assay items to wash reagent pipettes
between the measurements.
• When a specific number is selected in each of Assay
1 + 2, reagent pipettes are washed during the interval
between the 2 selected assay items.
• Selecting an assay item number automatically displays
the registered assay item name.
• If you want to select all assay items, select the All
check box.
② Pipette Wash Select the Reagent Type and reagent name to be used for
deep washing of the pipette.
• Reagent Type: Select a reagent type from R1, R2,
Detergent, and Disable. When Disable is selected,
pipettes will not be washed.
Reagent Name: Select a Reagent Name.
③ Cuvette Skip Specify whether or not to skip cuvettes in the interval between
the specified assay items (Assay 1 and Assay 2). Select Enable
to replace cuvettes, otherwise select Disable.
④ Contamination prevention Displays the combinations of registered assay items.
settings list

Section 3
Accessory Functions
3.6.2 Registering a Contamination Prevention Setting
Select a row to be configured from the

contamination prevention settings list.
Edit each item.
Cancel icon ( ).

Section 3
Accessory Functions
3.6.3 Edit a Contamination Prevention Setting
Select the row to be edited from the

contamination prevention setting is
displayed.
Edit each item.


• The changes are stored to the
system.

Section 3
Accessory Functions
3.6.4 Delete a Contamination Prevention Setting
Select a row to be deleted from the

contamination prevention setting is
displayed.


• The contamination prevention setting
is deleted.
3.6.5 Printing a Contamination Prevention Setting
Select a row to print the combination of

contamination prevention.

• The contamination prevention
setting is printed.
refer to the manuals that
accompanied the printer.

Section 4
Preparation for Measurement
SECTION 4
PREPARATION FOR MEASUREMENT
This chapter explains the preparation required for measurement.

Section 4
Section 4 Preparation for Measurement............................................................................. 4—1
4.1 Check Consumables ................................................................................................4—3
4.1.1 Check Detergent ........................................................................................................................ 4—3
4.1.2 Check the Halogen Lamp Operating Time ............................................................................... 4—3
4.2 Check Reagents .......................................................................................................4—4
4.2.1 Check Reagent Bottles ............................................................................................................... 4—4
4.2.1.1 Register a Reagent Bottle with a Barcode......................................................................... 4—5
4.2.1.2 Enter Information on the Inventory Screen to Register a Reagent Bottle....................... 4—6
4.2.1.3 Delete Registration Information of an Unnecessary Reagent Bottle ............................... 4—7
4.2.1.4 Print Registration Information of a Reagent Bottle........................................................... 4—8
4.2.2 Inventory Screen......................................................................................................................... 4—9
4.3 Register Patient Information ............................................................................... 4—11
4.3.1 Register and Edit Patient Information ...................................................................................... 4—11
4.3.1.1 Register Patient Information ............................................................................................ 4—11
4.3.1.2 Edit Patient Information ................................................................................................... 4—12
4.3.1.3 Import Patient Information .............................................................................................. 4—13
4.3.1.4 Export Patient Information .............................................................................................. 4—14
4.3.1.5 Delete Unnecessary Patient Information ........................................................................ 4—15
4.3.2 Patient Registration Screen ...................................................................................................... 4—16
4.4 Check the Analyser Status ................................................................................... 4—18

Section 4
4 Preparation for Measurement
4.1 Check Consumables

Before starting the measurement procedure, make sure there is sufficient detergent and operational life
remaining for all consumables.
4.1.1 Check Detergent
Open the door on the front of the

analyser to check the detergent bottle.
Replenish detergent if the remaining
volume of detergent is not sufficient.
For details on replenishment, refer to Section
9.4.3.
4.1.2 Check the Halogen Lamp Operating Time

Click the Maintenance ( ), System Monitor ( ), and Work Hour Counter ( ) icons.
• The Work Hour Counter screen is displayed.
In the Halogen Lamp field, check that the operating time is within the operation life range.
NOTE: If it is not within the available range, replace the halogen lamp. See Section 9.7.1.

Section 4
4.2 Check Reagents

Check the reagent bottle placement status.
4.2.1 Check Reagent Bottles

The remaining amount of the reagent must be checked for each round.
Click the Routine icon ( ) then Inventory icon ( ).

• The Inventory screen is displayed.
In the reagent bottle list on the left-hand

pane of the screen, check that all the
reagent bottles required for
measurement are registered and the
remaining amount is sufficient.
If the remaining volume of reagent is insufficient, register a new reagent bottle.

• When registering a reagent bottle using a barcode, proceed to the next step.
• When manually registering a reagent bottle, refer to Section 4.2.1.2.

Section 4
4.2.1.1 Register a Reagent Bottle with a Barcode

When reagent bottles are managed using barcodes, conduct reagent scanning to update reagent
information when placing reagent bottles.
Reagent scanning automatically recognises information included in each barcode (reagent type. the number
of reagents, full bottle amount, etc.).
NOTE:
• If the previously registered barcode information remains on the Inventory screen, it is
overwritten by the information of a new reagent bottle that is placed at the same position.
When the existing and new reagent bottles are set at different positions, the existing
barcode information is maintained.
• If barcode reading fails, the reagent information previously registered for the target
placement position is maintained without being overwritten.
If the remaining volume of reagent is insufficient, place a new reagent bottle in the reagent
carousel. Refer to Section 2.2.2.
On the Inventory screen, click Reagent

Scan.
• The barcode of the reagent bottle is
read and reagent information is
registered automatically.

Section 4
4.2.1.2 Enter Information on the Inventory Screen to Register a Reagent Bottle

If reagent bottles are not managed using barcodes, information about each reagent bottle must be entered
manually on the Inventory screen.
If the remaining amount of reagent is insufficient, place a new reagent bottle into the reagent
carousel.
• Write down the position at which a new reagent bottle has been placed.
On the Inventory screen, from the

reagent bottle list, select the position at
which a reagent bottle is placed.
• This displays the currently
registered reagent bottle
information.
In the Reagent Name field, change the

reagent name to be registered.
Edit reagent information depending on

the reagent bottle to be replenished.
• Refer to Section 4.2.1.2.

• The reagent bottle is registered.

Section 4
4.2.1.3 Delete Registration Information of an Unnecessary Reagent Bottle

The registration information of a reagent bottle can be deleted if it is no longer required using the following
procedure.

Select the reagent bottle for which

registration information will be deleted,
from the reagent bottle list.
• This displays the registration
information of the selected reagent
bottle.

• The confirmation screen is
displayed.
Click OK.
• This deletes the registration
information of the reagent bottle.

Section 4
4.2.1.4 Print Registration Information of a Reagent Bottle

All the registered information of the reagent bottles can be printed at the same time.


• The Windows Print dialog box is
displayed.
Check the print settings, then click OK.

• For information on print settings, refer to your printer manuals.
This prints summarises the registration information of the reagent bottles.

Section 4
4.2.2 Inventory Screen

The Inventory screen enables information to be checked such as the type and remaining amount of the
bottles (reagent bottles, detergent bottles, and diluent bottles) placed in the reagent carousel.
②
③
④
⑦ ⑤ ⑥
⑧
⑨
⑩
⑪
⑫
⑬
⑭ ⑮
⑯
① Reagent Bottle List Displays a list of reagent bottles placed in the reagent carousel. To
register a reagent bottle, select the desired position from this list.
② Position Select a position to place a reagent bottle in the reagent carousel.
③ Reagent Name*1 Displays the name of the reagent that is contained in the bottle at the
selected position.
• If registered, click Reagent Selection to select the
registered reagent name.
④ Reagent Type Select the type (R1/R2 reagent, detergent, or diluent) of the reagent
that is contained in the bottle at the selected position.
⑤ Lot No. Enter the lot number of the reagent that is contained in the bottle at
the selected position (001 to 999).
• If reagent lot number is skipped, this item will be blank.
⑥ Bottle Size Select the capacity of the bottle at the selected position.
• All the capacities can be selected at positions 1-1 to 5-10.
• The capacity is limited to 20 ml at positions 6-1 to 10-10.
⑦ Volume (ml) Enter the remaining amount of the reagent that is contained in the
bottle at the selected position.
• When a reagent is first registered, its remaining amount is
set to the maximum volume of the bottle.
• The default volume is indicated by the value that is obtained
by subtracting the dead volume from the maximum volume.

Section 4
⑧ Number of Tests Displays the number of tests that are able to be measured with the
bottle at the selected position.
⑨ Assay Name Displays the assay item name that is set to the reagent of the bottle at
the selected position.
⑩ Total Number of Tests*2 Displays the number of tests that can be measured with all the bottles
placed in the reagent carousel for each assay item.
⑪ Expiry Date Double-click the item field, then select the expiry date of the reagent
of the bottle at the selected position.
• If the expiry date is skipped, this item will be blank.
⑫ Onboard Stability Displays the remaining number of days to ensure the stability of the
reagent that is contained in the bottle at the selected position.
• Used to check reagent bottles for which the stability period
check is enabled.
⑬ Barcode Displays the information received from scanning the barcode that is
placed on the bottle at the selected position.
• The information of a barcode can be entered directly from
this item.
⑭ Reagent Scan Starts scanning the barcode of each reagent bottle in the reagent
carousel.
• If item 13 contains the information of the specified barcode,
it is overwritten by the information of the new barcode that
is scanned from the reagent bottle at the same position.
The setting of item 13 is maintained when:
• Reagent scanning is carried out when there are no reagent
bottles set at the same position; and reading of the barcode
at the target position has failed during scanning of the
reagent.
• If necessary, reagent scanning can be performed
automatically when the reagent carousel cover is opened or
closed.
⑮ Reset Volume Returns the setting of item 7 to default.

⑯ Clear Details Deletes the settings of items 6 and 12.
*
1. For information on the reagent names able to be selected, contact your administrator. The
administrator needs to register reagent names and reagent codes in advance, on the Reagent Code screen.
2. The administrator can select whether to calculate the total number of tests by using reagent code units
*
or reagent lot units on the Device Settings screen.

Section 4
4.3 Register Patient Information

Register patient information.
• Patient information can be selected/entered and registered when registering an order.
• For details on how to register an order, refer to Section 6.2.1.
4.3.1 Register and Edit Patient Information

NOTE: Patient information is equivalent to personal information. Sufficient consideration and
precautions are required to handle patient information.
4.3.1.1 Register Patient Information

Register new patient information.
Click the Routine icon ( ) then Patient Registration icon ( ).

• The Patient Registration screen will be displayed.
The Patient Registration screen is

displayed.
• If a registered ID is entered, patient
information of the entered ID is
displayed. To edit the information,
refer to the section below.
Enter the patient ID in the Patient ID

field.
• Click the Cancel
icon ( ), to abandon any unsaved
changes.

• Patient information is registered.

Section 4
4.3.1.2 Edit Patient Information

Edit the registered patient information.

Select the patient sample to edit the

information on the right hand side of the
screen.
• The selected patient information is
displayed.
Edit the required items.

abandon any unsaved changes.

• The selected patient information is
stored to the system.

Section 4
4.3.1.3 Import Patient Information

Import patient information (CSV format) from any folder on the PC.
Click Import.
• The folder selection dialog box is
displayed.
Specify the folder that contains the

patient information.
Click Open.
• Patient information is imported.
• The imported patient information is
added to the patient information list
in the right hand pane of the screen.

• The imported patient information is
saved.

Section 4
4.3.1.4 Export Patient Information

Export all the registered patient information as a CSV format.
The exported patient information file can be saved in any folder on the PC.

Click Export.
displayed.
Specify the folder to save patient

information in.
Click Open.
• The patient information file is saved
in the specified folder.
• If a patient information file with the
same name already exists in the
folder, it is overwritten.

Section 4
4.3.1.5 Delete Unnecessary Patient Information

Delete the registered patient information.

Select the patient ID to be deleted from

the patient information list in the right
hand pane of the screen.
• The selected patient ID is displayed.

Click OK.
• Patient information is deleted.

Section 4
4.3.2 Patient Registration Screen
⑯
① ②
③ ④
⑤
⑥
⑦
⑧
⑨
⑩ ⑪
⑫
⑬
⑭
⑮ ⑰ ⑱ ⑲

① Patient ID Enter the patient ID.
If you select a patient ID from item 14, the registered information is
displayed.
② Patient Name Enter the patient name.
③ Classification*1 Select a classification.
④ Ward*1 Select the name, number, and other items for the target ward.
⑤ Bed No. Enter the bed number (up to 10 alphanumeric characters).
⑥ Blood Type Enter the blood type.
⑦ Medical Chart No. 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.
• To enter the value, select the Enable check box, then enter the
date of birth from the drop down menu.
• Entering the date of birth automatically displays the current age in
the Age field.
⑩ Age Displays the current age of patient.

⑪ Gender Select a gender.
⑫ Race*1 Select a race.
⑬ Remarks Enter a remark regarding the patient (up to 40 alphanumeric characters).
⑭ Additional 1*2 Enter additional information using up to 10 alphanumeric characters.
[ ] • The displayed information may be different depending on the
administrator's setting.
• If it is different, make a note in the left column.

Section 4

⑮ Additional 2*2 Enter additional information using up to 10 alphanumeric characters.
[ ] • The displayed information may be different depending on the
administrator's setting.
• If it is different, make a note in the left column.
⑯ Patient Displays a list of patient information (patient ID, patient name, and social
information list security number).
• The number of registered patient information items is displayed
at the bottom of the list.
⑰ Import Imports the file that has patient information saved.

• Click ( … ) to select the import source folder in advance.
⑱ Export Exports patient information to a file.

• Click ( …) to select the export source folder in advance.
⑲ Open Worklist Moves to the Open Worklist screen.
*
1. For information on the items able to be selected, contact your administrator. The administrator can
configure the setting of this item on the Definition screen.
*
2. The information displayed in Additional 1 and Additional 2 can be changed by the administrator. For
entry information, contact your administrator. The administrator can configure the information to be
displayed regarding this item on the Operation Settings screen.

Section 4
4.4 Check the Analyser Status

Check that the analyser is in the measurable state.
Check that the sample carousel cover,

reagent carousel cover and top cover are
closed.

Check that the value shown in the

Incubator field is between 36.5oC and
37.5oC.
Check that the value (stability waiting

time) of the Lamp field is set to 0 Min.
• When Lamp Power Save Mode is
set to Enable, 2 Min is displayed in
the Lamp field if the analyser is
ready for measurement.
• If stability waiting time is not set to 0
or 2 Min, wait for a few moments.

Section 5
Calibration
SECTION 5
CALIBRATION
This chapter explains how to perform calibration.

Section 5
Calibration
Section 5 Calibration .............................................................................................................5—1
5.1 Overview ..................................................................................................................5—3
5.1.1 Flow of Calibration Measurement ............................................................................................. 5—4
5.2 Preparation ..............................................................................................................5—5
5.2.1 Register Orders with Manual Entry ........................................................................................... 5—5
5.2.1.1 Normal Calibration ............................................................................................................ 5—5
5.2.1.2 Worklist Screen (Calibration) ........................................................................................... 5—7
5.2.1.3 Multi-Calibration................................................................................................................. 5—8
5.2.1.4 Worklist Screen > Multi-Calibration ............................................................................... 5—10
5.2.1.5 Diluted Calibration ........................................................................................................... 5—11
5.2.1.6 C1 Blank............................................................................................................................ 5—13
5.2.1.7 Worklist Screen > Diluted Calibration/C1 Blank Measurement .................................. 5—14
5.2.2 Register Orders with Sample Barcodes .................................................................................. 5—15
5.2.3 Copying and Deleting Orders .................................................................................................. 5—15
5.3 Execute Calibration............................................................................................... 5—16
5.4 Check Results.........................................................................................................5—16
5.5 Multi-Calibration Settings .................................................................................... 5—17
5.5.1 Multi-Calibration Screen .......................................................................................................... 5—17
5.5.2 Register the Multi-Calibrator ................................................................................................... 5—18
5.5.3 Edit the Multi-Calibrator .......................................................................................................... 5—19
5.5.4 Delete the Multi-Calibrator ..................................................................................................... 5—20
5.5.5 Print the Multi-Calibrator ......................................................................................................... 5—21
5.6 Diluted Calibration Settings ................................................................................. 5—22
5.6.1 Register the Diluted Calibration Settings ................................................................................ 5—23
5.6.2 Edit the Diluted Calibration Settings ....................................................................................... 5—24
5.6.3 Delete the Diluted Calibration Settings................................................................................... 5—25

Section 5
Calibration
5 Calibration
5.1 Overview
Calibrations are required to calculate the calibration curve to use as the measurement standard on the
analyser and for correcting the calibration curve. This involves executing the measurement of calibrators
that reproduce the concentration of a specific component.
Calibration is broadly divided by usage as follows:
Type Full Calibration Partial Calibration

Work The calibration curve is registered or re- The calibration curve is corrected
Description registered by measuring calibrators with up to by measuring calibrators with 1 or
7 concentrations. 2 concentrations.
Obtained Master Work

Calibration
Work
Curve
Required Execute at the frequency specified for each Frequency specified for each assay
Frequency*1 assay item, or in the following cases: item.
• When registering a new assay item.

• When changing reagent lots.
NOTE: *1 - For details on the calibration frequency, contact the manufacturer or distributor of the
reagents to be used and the corresponding calibrators.
The types of calibration method are as follows:
Normal This is the normal calibration executed for each assay item.
calibration
Multi-calibration This calibration uses a multi-calibrator that can be applied to multiple assay items.
Diluted This calibration is used instead of using a separate calibrator for each
calibration concentration, by diluting a calibrator with the maximum concentration.
C1 blank This is partial calibration using a C1 blank sample that can be applied to multiple
assay items.
This manual describes the actual work performed for calibration; namely, registering orders for
measurement, the measurement execution and checking methods.
For details about the calibration curve, calibration settings and the execution schedule, check with the
administrator in advance.

Section 5
Calibration
5.1.1 Flow of Calibration Measurement

The flow of calibration measurement is as follows.
Calibrator Preparation
Place calibrators in the sample carousel.
Order Registration
Register the order for calibration measurement.
Measurement Start
Execute calibration measurement.
Results Check
Check the results of calibration measurement.

Section 5
Calibration
5.2 Preparation
5.2.1 Register Orders with Manual Entry
The following explains the method for directly entering the order for calibration measurement from the
Worklist screen.
5.2.1.1 Normal Calibration
Place calibrators in the sample carousel. Refer to Section 2.1.2.
NOTES:
• When placing calibrators in the middle tray or outer tray, check the number label on the tray
and place the calibrators in a position with a smaller number than any routine sample.
• When executing full calibration, check the number label on the tray and be sure to place the
calibrators in the sample carousel in sequence, starting with the calibrator with the lowest
concentration.
• When executing partial calibration, register a separate order for each measuring point of the
calibrators with the required concentration.
Click the Routine icon ( ) then Worklist icon ( ).
• The Worklist screen is displayed.
Select the placed position of the

calibrators from the sample list on the left
of the screen or the Pos. (From) drop-
down menu.
Select Calibrator in Sample Category.
• The display on the Worklist screen

switches to Worklist Screen
(Calibration).

Section 5
Calibration
Place check marks against the assay items

for calibration measurement.
• For the assay items, contact the

administrator.
Select the concentration to execute

calibration in No.
• Select Full to execute full calibration,

and select from C1 to C7 to execute
partial calibration.
Click on the Save ( ) icon.

The order is registered.
• After completing the registration of all

orders for calibration, proceed to
calibration execution. Refer to Section
5.3.
NOTE: In calibration and QC measurement, a template function can be used to register a combination
of sample placement positions and orders in advance, which can be called later. When templates are
registered, the required settings can be called and used from Template on the Worklist screen.
To set up a template, refer to Section 7.7.2.

Section 5
Calibration
5.2.1.2 Worklist Screen (Calibration)
For details on the Worklist screen and the corresponding operations, refer to Section 7.9.1.
When Calibrator is selected in Sample Category on the Worklist screen, the screen switches to the
following display.
① ②
③ ④

① Sample List Lists the samples registered in the sample carousel and their positions.
② Template*1 Calls a template in which a combination of the status of each sample in the
sample carousel and the individual orders has been registered in advance.
③ Pos. (From) Select the position of the samples to use for measurement. To execute full
calibration, specify the position of the lowest concentration calibrator (C1).
④ No. Select the concentration to execute calibration.
• To execute full calibration, select Full.
• To execute partial calibration, select from C1 to C7.
⑤ Assay Items*2 • Select the check box to the left side of an assay item name to order
measurement for the corresponding assay.
• The background colour of the assay item indicates warnings. If both
red and yellow are activated, the red warning display is prioritised.
o Red: Calibration has not been executed or the effective period
has expired.
o Yellow: QC measurement has not been executed, or the
measurement interval for QC has elapsed.
o Grey: The reagent bottles have not been registered.
*1
The administrator can configure the setting of this item on the Template screen.
• *2
The administrator must set the registration contents of this item in advance on the Parameter
1 screen and Parameter 2 screen. Also, the calibration settings must be registered for each assay
item on the Calibration screen.

Section 5
Calibration
5.2.1.3 Multi-Calibration
Place a multi-calibrator in the sample carousel. Refer to Section 2.1.2.
NOTES:
• When placing calibrators in the middle tray or outer tray, check the number label on the tray
• When executing full calibration, check the number label on the tray and be sure to place the
calibrators in the sample carousel in sequence, starting with the calibrator with the lowest
concentration.
• When executing partial calibration, register a separate order for each measuring point of the
calibrators with the required concentration.
Click the Routine icon ( ) then Worklist icon ( ).

The Worklist screen is displayed.
Select the placed position of the samples

from the sample list on the left of the
screen or the Pos. (From) drop-down
menu.
Select Multi-Calibrator in Sample

Category.

switches to the Worklist Screen (Multi-
Calibration).
Select the multi-calibrator name in Multi-

Calibrator Name.
• When the multi-calibrator name is

selected, the assay items that are
registered for calibration are selected
automatically.
• The check mark of assay items can
be deselected as necessary.
• For the multi-calibrator name and
assay item, contact the administrator.

Section 5
Calibration
Select the concentration to execute

calibration in No.
• Select Full to execute full calibration,

or select from C1 to C7 to execute
partial calibration.


5.3.
of sample placement positions and orders in advance, which can be recalled later. When templates are
registered, the required settings can be used from Template on the Worklist screen.

Section 5
Calibration
5.2.1.4 Worklist Screen > Multi-Calibration

When Multi-Calibrator is selected in Sample Category on the Worklist screen, the screen switches to
the following screen.
① ②
③ ④
① Sample List Lists the samples registered in the sample carousel and their positions.
② Template*1 Calls a template in which a combination of the status of each sample in the
sample carousel and the individual orders has been registered in advance.
③ Pos. (From) Select the position of the samples to use for measurement.
• To execute full calibration, specify the position of the lowest

concentration calibrator (C1).
④ No. Select the concentration for which to execute calibration.
• To execute full calibration, select Full.

• To execute partial calibration, select from C1 to C7.
⑤ Multi-Calibrator Select the multi-calibrator name.

Name*2

Section 5
Calibration
⑥ Assay items*3 When the multi-calibrator name is selected, the check boxes to the left side
of the assay item names that are set for calibration are selected automatically.
Deselect check boxes as necessary.
• The background colour of the assay item indicates warnings.

o Red: Calibration has not been executed or the effective period
has expired.
o Yellow: QC measurement has not been executed, or the
o Grey: The reagent bottles have not been registered.
• If both red and yellow are activated, the red warning display is
prioritised.
*1 The administrator can configure the setting of this item on the Template screen.
*2 The administrator must set the registration contents of this item in advance on the Multi-Calibration
screen.
*3 The administrator must set the registration contents of this item in advance on the Parameter 1 screen
and Parameter 2 screen.
Also, the calibration settings must be registered for each assay item on the Calibration screen.
5.2.1.5 Diluted Calibration
Place a calibrator (to use for diluted calibration) in the sample carousel. Refer to Section 2.1.2.
NOTE: When placing calibrators in the middle tray or outer tray, check the number label on the tray
Click the Routine ( ) icon then Worklist ( ) icon.


menu.
Select Calibrator (Dilution) in the

Sample Category.

switches to ‘Worklist Screen (Diluted
Calibration/C1 Blank Measurement)’.

Section 5
Calibration
From the assay list, select the assay that

requires diluted calibration measurement.
Add a check mark to the items.

administrator.


5.3.
of sample placement positions and orders in advance, which can be selected later. When templates are
registered, the required settings can be selected from Template on the Worklist screen.
The administrator can configure the settings of the template from the Template screen.

Section 5
Calibration
5.2.1.6 C1 Blank
Place a calibrator (to use for diluted calibration) in the sample carousel. Refer to Section 2.1.2.
NOTE: When placing calibrators in the middle tray or outer tray, check the number label on the tray
Click the Routine ( ) icon then Worklist ( ) icon.


menu.
Select C1 Blank in Sample Category.

switches to ‘Worklist Screen (Diluted
Calibration/C1 Blank Measurement)’.
• When C1 Blank is selected in Sample
Category, the assay items that are set
for C1 blank measurement are selected
automatically.
• The check mark of assay items can be
deselected as necessary.
administrator.
• The order is registered.

calibration execution.
• Refer to Section 5.3 for more
information.
of sample placement positions and orders in advance, which can be selected later. When templates are
registered, the required settings can be selected from Template on the Worklist screen. The
administrator can configure the settings of the template from the Template screen.

Section 5
Calibration
5.2.1.7 Worklist Screen > Diluted Calibration/C1 Blank Measurement

• When Calibrator (Dilution) or C1 Blank is selected in Sample Category on the Worklist

screen, the screen switches to the following display.
① ②
③
④
⑤
① Sample list Lists the samples registered in the sample carousel and their positions.
② Template*1 A template containing each sample and assay requiring calibration that is
registered in advance.
③ Sample Indicates the screen when Calibrator (Dilution) or C1 Blank is selected

Category in this item. Select according to the calibration usage.
④ Pos. (From) Select the position of the samples to use for measurement.
• When Calibrator (Dilution) is selected in Sample Category, select

the position of the placed calibrator with the maximum
concentration.
• When C1 Blank is selected in Sample Category, select the placed
position of the C1 blank sample.

Section 5
Calibration
⑤ Assay items*2 When Calibrator (Dilution) is selected in Sample Category.
• Select the check box to the left side of an assay item name to order
measurement for the corresponding assay.
When C1 Blank is selected in Sample Category.
• The check boxes to the left side of the assay names set for
calibration are selected automatically. Deselect check boxes as
necessary.
The background colour of the assay item indicates a warning.
• Red: Calibration has not been executed or has expired.

• Yellow: QC measurement has not been executed, or the
• Grey: The reagent bottles have not been registered.
If both red and yellow are activated, the red warning display is prioritised.
• *1 The administrator can configure the setting of this item on the Template screen.
• *2 The administrator must set the registration contents of this item in advance on the Parameter
1 screen and Parameter 2 screen. Also, the calibration settings must be registered for each assay
on the Calibration screen and Diluted Calibration screen.
5.2.2 Register Orders with Sample Barcodes
Place calibrators with attached sample barcodes in the sample carousel.
• Place the same way for multi-calibration, diluted calibration and C1 blank.
Proceed to measurement start. Refer to Section 5.3 for more information.
NOTE: For details on registering orders with sample barcodes, refer to Section 7.2.
5.2.3 Copying and Deleting Orders

For the order copying method and the deletion method for registered orders, refer to Sections 7.2.3 and
7.2.4.

Section 5
Calibration
5.3 Execute Calibration

After order registration is complete, start calibration measurement.
NOTE: Do not add samples during calibration measurement.
Click on the Start ( ) icon.

Calibration measurement starts.
• For checking the measurement

progress and the operations after the
completion of measurement, refer to
Section 7.5 and 7.12.
5.4 Check Results

The calibration results after the completion of measurement can be checked from the Calibration screen.
From the menu icons, click the Calibration ( ) icon.
The Calibration screen is displayed.
Select the assay in Method No.
• The calibration results and calibration

curve of the selected assay item are
displayed.
• If the reagent extend over 2 lots, the
results display can be switched by
selecting New Lot and Old Lot in the
Reagent Lot drop-down menu.
In the calibration curve display, on the

right of the screen, check that the Date
and Time has been updated to the
measurement date and time.
• When calibration measurement is

completed, with no errors, the
calibration curve is updated The Date
and Time is updated to the new
measurement date and time.

Section 5
Calibration
5.5 Multi-Calibration Settings

These are the multi-calibration settings to calibrate multiple assay items, using 1 calibrator.
5.5.1 Multi-Calibration Screen

Settings > Assay Settings 2 > Multi-Calibration
The following explains the Multi-Calibration screen:

① Multi-Calibrator No. Select the multi-calibrator number (1 to 10).
② Multi-Calibrator Name Enter the multi-calibrator name (using up to 6 alphanumeric

characters).
③ Assay Select the assay item to calibrate using the multi-calibrator.

Section 5
Calibration
5.5.2 Register the Multi-Calibrator

Select the multi-calibrator number.
Edit each item.
• To reset the edited contents, click the

Cancel icon ( ).

The multi-calibrator is registered.

Section 5
Calibration
5.5.3 Edit the Multi-Calibrator

Select the multi-calibrator number to be

edited.
The registration information for
multi-calibration settings is displayed.
Edit each item.

Cancel icon ( ).

The multi-calibrator is registered.

Section 5
Calibration
5.5.4 Delete the Multi-Calibrator


deleted.

A confirmation screen is displayed.

The multi-calibrator is deleted.

Section 5
Calibration
5.5.5 Print the Multi-Calibrator


printed.

The multi-calibrator is printed.
• For information on print settings, refer

to your printer manuals.

Section 5
Calibration
5.6 Diluted Calibration Settings

Settings > Assay Settings 2 > Diluted-Calibration
Multiple calibrators with different concentrations can be created from a single calibrator. ‘Diluted
calibration’ is calibration measurement using a calibrator created from automatic dilution.
① ③ ④ ⑤

① Assay No. Select or enter an assay item number.
Specifying a registered assay item number automatically displays the
registered assay item name.
② Calibrator Lot No. The calibrator lot number is displayed.

If different lot numbers are used for each concentration, the calibrator lot
number with the highest concentration that is registered on the
Calibration screen will be displayed.
③ Conc. The calibrator concentration registered on the Calibration screen is

displayed.
④ Aliquot (μl) Enter the aliquot and the diluent volume.

Diluent (μl)
⑤ Offset Enter this value to correct the effects of any minute amounts of fluid
remaining in the cuvette.
NOTE: Range in which dispensing can be done:

• The sample volume is from 0.5 μl to 25 μl (in steps of 0.1 μl), and the diluent volume is from 50
μl to 250 μl (in steps of 1.0 μl).
• The total setting for the sample volume and the diluent volume should be from 70 μl to 285 μl.

Section 5
Calibration
5.6.1 Register the Diluted Calibration Settings

Select the assay number for which the

diluted calibration settings will be made.
Edit each item.

Cancel icon ( ).
• The diluted calibration settings are

saved.
• The concentration is updated, based
on the aliquot and diluent volume.

Section 5
Calibration
5.6.2 Edit the Diluted Calibration Settings

Select the assay number of the diluted

calibration settings to be edited.
The registration information for diluted
calibration settings is displayed.
Edit each item.

To reset the edited contents, click the
Cancel icon ( ).
• For details on the settings for the

aliquot and diluent volume, refer to
Section 5.6.4.

The changes are saved.
• The concentration is updated, based

on the aliquot and diluent volume.

Section 5
Calibration
5.6.3 Delete the Diluted Calibration Settings

Select the assay number of the diluted

calibration settings to be edited.
The registration information for diluted
calibration settings is displayed.


The diluted calibration settings are
deleted.

Section 5
Calibration
Set the Aliquot and Diluent Volume
Select the assay number.
• The optimum aliquot and diluent

volume for the concentration that was
set on the Calibration screen will be
displayed when the assay number is
selected.
• If the specified concentration cannot
be diluted, the aliquot and diluent
volume will be automatically adjusted
to match the set concentration as
closely as possible, after which the
concentration will be displayed in red.
Edit each item.

Cancel icon ( ).
• If the concentration that was calculated
from the edited value and the
displayed concentration show
inconsistencies as a result of editing the
aliquot and diluent volume, the aliquot
and diluent amounts will be displayed
in red. Saving in this state will calculate
the concentration based on the aliquot
and diluent volume ratio after editing,
and the display will be updated.


The Diluted Calibration and Calibration
screens are updated.

Section 6
QC Measurement
SECTION 6
QC MEASUREMENT
This chapter explains the method for

quality control measurement.

Section 6
QC Measurement
Section 6 QC Measurement .................................................................................................6—1
6.1 Overview ..................................................................................................................6—3
6.1.1 Flow of QC Measurement ......................................................................................................... 6—3
6.2 Preparation ..............................................................................................................6—4
6.2.1 Registering Orders with Manual Entry ...................................................................................... 6—4
6.2.1.1 Worklist Screen (QC Measurement)................................................................................ 6—5
6.2.2 Register Orders with Samples Barcodes ................................................................................... 6—6
6.2.3 Copying and Deleting Orders .................................................................................................... 6—6
6.3 Execute QC Measurement ..................................................................................... 6—7
6.4 Check Results in the QC Chart .............................................................................. 6—7
6.4.1 Check the QC Results for 1 Day............................................................................................... 6—7
6.4.2 Check the Cumulative Results for 30 Days in the Past ............................................................ 6—9
6.4.3 QC Chart Screen ..................................................................................................................... 6—11
6.5 Check Results in the QC Results List .................................................................. 6—13
6.5.1 Search and Filter QC Measurement Results ........................................................................... 6—13
6.5.1.1 Check the QC Results for 1 Day..................................................................................... 6—13
6.5.1.2 Check the QC Results for a Specified Period ................................................................. 6—15
6.5.1.3 Check the QC Results for an Item .................................................................................. 6—17
6.5.2 Delete or Output the QC Table Screen ................................................................................. 6—19
6.5.2.1 Delete Unnecessary QC Measurement Results ............................................................. 6—19
6.5.2.2 Print QC Measurement Results....................................................................................... 6—20
6.5.2.3 Output QC Measurement Results to a File .................................................................... 6—21
6.5.3 QC Table Screen ...................................................................................................................... 6—22
6.5.3.1 Search Function Area ....................................................................................................... 6—22
6.5.3.2 QC Table Screen (Daily) ................................................................................................. 6—24
6.5.3.3 QC Table Screen (Cumulative) ....................................................................................... 6—26
6.5.3.4 QC Table Screen (Detail) ................................................................................................ 6—28
6.6 Register QC Samples ............................................................................................ 6—29
6.6.1 QC Sample Registration Screen .............................................................................................. 6—29
6.6.2 Register Samples ....................................................................................................................... 6—30
6.6.3 Edit QC Samples ...................................................................................................................... 6—31
6.6.4 Delete QC Samples.................................................................................................................. 6—32
6.7 Set the Conditions for QC .................................................................................... 6—33
6.7.1 QC Range Screen ..................................................................................................................... 6—33
6.7.1.1 Replication ........................................................................................................................ 6—35
6.7.1.2 Judgement Conditions...................................................................................................... 6—35
6.7.1.3 Set the QC Range ............................................................................................................ 6—36
6.7.1.4 Edit the QC Range ........................................................................................................... 6—37
6.7.1.5 Delete the QC Range ...................................................................................................... 6—38
6.7.1.6 Print the QC Range .......................................................................................................... 6—38

Section 6
QC Measurement
6.1 Overview
To guarantee the accuracy of measurement within the analyser, it must clearly show the accuracy level
when routine samples are measured. QC measurement is a function for maintaining and managing
accuracy based on the results of measuring QC samples for which a certain concentration has been
defined.
NOTE: Calibration must be performed before measuring routine samples.
6.1.1 Flow of QC Measurement

The flow of QC measurement is as follows:
1. QC Sample Preparation
Place the QC samples in the inner tray of the sample carousel.
2. Order Registration
Register the order for QC measurement.
3. Measurement Execution
Execute QC measurement.
4. Results Check
Check the results of QC measurement.

Section 6
QC Measurement
6.2 Preparation
6.2.1 Registering Orders with Manual Entry
Entering the order for QC measurement from the Worklist screen:
Place the QC samples in the inner tray of the sample carousel.

• Refer to Section 2.1.2.
Click the Routine icon ( ) then Worklist icons ( ).

• The Worklist screen is displayed.

screen or the position drop-down menu.
Select QC Sample under Sample

Category.
switches to QC Measurement.
Select the QC sample name under

QC Sample Name.
• When the QC sample name is
selected, the assay items that are
registered for QC measurement are
selected automatically.
• The check mark of assay items can be
deselected if required.

orders for QC measurement, proceed
to QC measurement execution.
Proceed to Section 6.3.

Section 6
QC Measurement
In calibration and QC measurement, a template function can be used to register in advance, a combination
of sample placement positions and orders for later selection.
When templates are registered, the required settings can be used from Template on the Worklist
screen.
The administrator can configure the settings of the template from the Template screen.
6.2.1.1 Worklist Screen (QC Measurement)

When QC Sample is selected in Sample Category on the Worklist screen, the screen switches to the
following screen.
① ②
③
④
⑤

① Sample list Lists the samples registered in the sample carousel and their
positions.
② Template Calls a template in which a combination of the status of each sample
in the sample carousel and the individual orders has been registered
in advance.
③ Pos. (From) Select the position of the samples to use for measurement.
④ QC Sample Name Select the QC sample name.

Section 6
QC Measurement
⑤ Assay Items When the QC sample name is selected, the check boxes to the left
side of the assay item names that are set for QC measurement are
selected automatically. Deselect check boxes are necessary.
The background colour of the assay item indicates warnings. If both
Red: Calibration has not been executed or the effective period has
expired.
Yellow: QC measurement has not been executed, or the
Grey: The reagent bottles have not been registered.
*1 The administrator can configure the setting of this item on the Template screen.
*2 The administrator must set the registration contents of this item in advance on the QC Sample
Registration screen.
*3 The administrator must set the registration contents of this item in advance on the Parameter 1
screen and Parameter 2 screen. Also, the accuracy values to be managed must be registered on the QC
Range screen.
6.2.2 Register Orders with Samples Barcodes

Place QC samples (with attached sample barcodes) in the sample carousel.
• Proceed to measurement start. Proceed to Section 6.3.
NOTE: For details on registering orders with sample barcodes, refer to Section 7.2.
6.2.3 Copying and Deleting Orders

For the order method and deletion methods for orders that have been registered, refer to Sections 7.2.3
and 7.2.4.

Section 6
QC Measurement
6.3 Execute QC Measurement

After completing order registration, start QC measurement.
Click the Start icon ( ).

• QC measurement starts.
• For checking the measurement
progress and the operations after
measurement completion, refer to
Section 7.5 and 7.12.
6.4 Check Results in the QC Chart

Check the results of QC measurement by displaying the results in a chart format.
6.4.1 Check the QC Results for 1 Day
Click the QC icon ( ) then QC Chart icon ( ).
Select Assay No.
Specify the date in which QC

measurement was executed in the Date
field.
• The QC results of a specific day in
the past can also be checked.
• Up to 50,000 QC measurement
results are saved in this analyser. QC
measurement results earlier than this
are discarded automatically.
Select Daily from the Display Format

drop-down.

Section 6
QC Measurement
Select the QC Sample Name from the

QC Sample Name drop-down.
Click Execute.
• The QC results of the specified date
are displayed in a chart.
Check the accuracy from the QC results.

• When QC results deviate greatly from the average value, the cause must be identified and
corrected.

Section 6
QC Measurement
6.4.2 Check the Cumulative Results for 30 Days in the Past
Click the QC icon ( ) then QC Chart icon ( ).
Select Assay No.
Specify the date on which QC

measurement was executed.
• Cumulative results going back 30 days
in the past from a specific day can also
be checked.
Select Cumulative from the Display

Format drop-down.
Select the QC Sample Name.

Section 6
QC Measurement
Click Execute.
• The QC results of 30 days in the
past including the specified date are
displayed in a chart.
• If multiple QC measurements was
performed on the same day, the results
are displayed together on the vertical
axis.
Check the QC results that the accuracy has been maintained.

corrected.

Section 6
QC Measurement
6.4.3 QC Chart Screen

⑦
⑥
⑧
①
②
③
⑤ ⑨

① Assay No. Select an assay item number from the drop-down menu.
• The assay item number can also be entered directly.
② Assay Name Displays the assay item name. Entered automatically when Assay
No. is selected.
③ Date Specify the date for starting the graph search.
• Enter the search start date directly on the keyboard, or
specify the date from the calendar screen displayed in
the drop-down menu.
④ Display Format Select the display format of the chart from the drop-down menu.
• Daily: Displays the QC data for 1 day on the date
specified in Date.
• Cumulative: Displays the cumulative QC data going back
30 days in the past from the specified date.
⑤ Execute Executes the search for QC data.
⑥ QC Sample Name Select the name of the QC sample.

• N, X, SD and CV indicate the following information for
each QC sample.
• N: Number of data items
• X: Average value, SD: Standard deviation, CV:
Coefficient of variation.
• QC data judged as an error by the QC judgement are
excluded from the calculation.

Section 6
QC Measurement
⑦ QC Chart This chart displays the QC results.

• The QC judgement display is colour-coded as follows.
Blue: Normal.
Yellow: Warning.
Red: Error.
⑧ QC Table Displays the QC results for the point selected in the chart.
⑨ Navigation buttons Moves the selected position on the QC chart.
I<< Selects the oldest result.
<< Selects the result 10 points before the currently

selected data point.
< Selects the result 1 point before the currently selected

data point.
> Selects the result 1 point after the currently selected

data point.
>> Selects the result 10 points after the currently selected

data point.
>>I Selects the newest result.

Section 6
QC Measurement
6.5 Check Results in the QC Results List

6.5.1 Search and Filter QC Measurement Results
6.5.1.1 Check the QC Results for 1 Day
Click the QC icon ( ) then QC Table icon ( ).

• The QC Table screen is displayed.
Select Daily from the Display Formats

drop-down.
If required, select the Assay No of the

assay item.
Select the QC Sample from the QC

Sample Name drop-down.
Specify the date on which QC

measurement was executed and the
round number in the Date and Round
No. fields.
• The QC results of a specific day in the
past.
• QC measurement results for up to
50000 tests are saved in this analyser.
QC measurement results earlier than
this are discarded automatically.

Section 6
QC Measurement
Click Execute.
• The data calculated from the QC
results of the specified date are listed in
QC Table Screen (Daily).
Check the QC results to see whether the accuracy has been maintained.
corrected.

Section 6
QC Measurement
6.5.1.2 Check the QC Results for a Specified Period

Select Cumulative from the display

formats.
If required, select the assay from the

Assay No. drop-down
Select the QC Sample from the QC

Sample Name drop-down.
Select the From and To check boxes

and set the dates of the search period.
• QC measurement results for up to
50000 tests are saved in this analyser.
QC measurement results earlier than
this are discarded automatically.

Section 6
QC Measurement
Click Execute.
• The data calculated from the QC
results of the specified period are listed
in QC Table Screen
(Cumulative).
Check from the QC results that the
accuracy has been maintained.
• When QC results deviate greatly
from the average value, the cause
must be identified and remedied.

Section 6
QC Measurement
6.5.1.3 Check the QC Results for an Item

Select Detail from the display formats.
Select the assay item from Method No.
Select the From and To check boxes

and set the search period.
Specify the target round number for the

search in Round No.

Section 6
QC Measurement
Click Execute.
Check from the QC results that accuracy
has been maintained.
• When QC results deviate greatly from
the average value, the cause must be
identified and corrected.

Section 6
QC Measurement
6.5.2 Delete or Output the QC Table Screen

6.5.2.1 Delete Unnecessary QC Measurement Results
Execute search on the QC Table

screen.
• Refer to Section 6.5.3.1 for further
information.
While the search results are displayed,

click the Delete icon ( ).
Click OK.
• The displayed QC measurement
results are deleted.
• When there are 1000 or more
deletion targets, a confirmation
screen is displayed to inform you that
deletion is not possible. Click OK
and change the search conditions.

Section 6
QC Measurement
6.5.2.2 Print QC Measurement Results
Specify the search conditions in the QC Table screen.

Select Print from the result output

methods.
Click Execute.
• The print dialog box appears.
Check the print settings and start printing.

• For more information on print settings, refer to the manuals that accompanied the printer.
• The QC measurement results are printed.

Section 6
QC Measurement
6.5.2.3 Output QC Measurement Results to a File
Specify the search conditions in the QC Table screen.

Select File from the result output

methods.
Click Execute.
• The save file dialog box is displayed.
Specify the save location and file name,

and click Save.
• The QC measurement results are
saved in CSV format.

Section 6
QC Measurement
6.5.3 QC Table Screen

6.5.3.1 Search Function Area
The following mainly explains the search function area on the left of the screen. The screen switches when
Display Format is changed. Refer to the following:
• QC Table Screen (Daily)
• QC Table Screen (Cumulative)
• QC Table Screen (Detail)
①
⑦
②
③
④

① Display Format Select the display format from the drop-down menu.
• Daily: Collates the QC results for the specified QC samples on
a daily basis, and displays the results by assay item.
• Cumulative: Collate the QC results for the specified QC
samples within the specified period, and displays the results by
assay item.
• Detail: Displays the QC results for the specified assay item on
a 1-item basis.
② Assay No. Select the number of the assays from the drop- down menu.
The number of the assays can also be entered directly. When the
display format is Detail, the assay number must be specified.
③ Assay Name Displays the assay name. Entered automatically when Assay No. is
selected.
④ Output to Select the output for the search results. The following 3 types are
available for the output method.
• Screen: Displays the search results on the screen.
• Print: Prints the search results with the printer.
• File: Saves the search results in a CSV format file. Click ( …)
and specify the output folder.

Section 6
QC Measurement

⑤ QC Sample Select the target QC sample for the search from the drop-down menu.
Name
• When the display format is Daily or Cumulative: The QC
sample must be specified.
• When the display format is Detail: This item is not displayed.
When an assay number is specified, only corresponding QC samples
are displayed.
⑥ Date or period When Display Format is Daily, select the target date for the QC
results search. When Display Format is Cumulative, the target
period for the search can be specified, and when Display Format is
Detail, the round number can also be specified. To enable the entry of
the period specification, the check box must be selected. Enter the date
directly on the keyboard, or specify the date from the calendar screen
displayed in the drop-down menu.
• When both From and To are enabled, the results in the
specified period are the target.
• When only From is enabled, all the results up to the specified
date and round number are the target.
• When only To is enabled, all the results up to the specified
date and round number are the target.
There is no period specification for Daily. Specify only the date and
round number.
⑦ Result list Displays the search results. The displayed contents vary according to
the display format.

Section 6
QC Measurement
6.5.3.2 QC Table Screen (Daily)
① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩

① Assay Name Displays the assay name.
② N Displays the number of items in the corresponding QC data.
③ Mean (X) Displays the average concentration calculated from the

• Fractions are displayed with the number of digits specified in
Decimal Point on the Parameter 1 screen.
• Data identified as Error by the QC judgement is excluded.
④ -2SD The -2SD value (calculated from the latest measurement result
target that exceeds the -2SD range of standard values) is displayed in
the format of [-999.999].
• The display is Blank when calculation is not possible because
the number of data items is 1 or less.
⑤ 2SD The +2SD value calculated from the latest measurement result
target that exceeds the +2SD range of standard values is displayed in
the format of [999.999].
⑥ SD The SD value calculated from the measurement results is displayed
in the format of [999.999].
⑦ CV The coefficient of variation calculated from the measurement results
is displayed as a percentage.
⑧ Min. Displays the minimum in the QC data of the search results.

Section 6
QC Measurement

⑨ Max. Displays the maximum value in the QC data of the search results.
⑩ WARNING/ERROR When QC data in the search results exceeds the standard set for
WARNING or ERROR, the corresponding concentration is
displayed.
• When the judgment results contain multiple errors, the
error with the highest priority is displayed.
*
1 The administrator must register the judgement standard for WARNING and ERROR in advance on
the QC Sample Registration screen.

Section 6
QC Measurement
6.5.3.3 QC Table Screen (Cumulative)

The displayed items are the same as the QC Table screen (daily).
① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩

① Assay Name Displays the assay name.
② N Displays the number of items in the corresponding QC data.
③ Mean (X) Displays the average concentration calculated from the

• Fractions are displayed with the number of digits
specified in Decimal Point on the Parameter 1 screen.
Data identified as Error by the QC judgement are
excluded.
④ -2SD The -2SD value calculated from the latest measurement result
target that exceeds the -2SD range of standard values is
displayed in the format of [-999.999].
• The display is Blank when calculation is not possible
because the number of data items is 1 or less.
⑤ 2SD The +2SD value calculated from the latest measurement result
target that exceeds the +2SD range of standard values is
displayed in the format of [999.999].
⑥ SD The SD value calculated from the measurement results is
displayed in the format of [999.999].
⑦ CV The coefficient of variation calculated from the measurement
results is displayed as a percentage.

Section 6
QC Measurement

⑧ Min. Displays the minimum in the QC data of the search results.
⑨ Max. Displays the maximum value in the QC data of the search

results.
⑩ WARNING/ERROR*1 When QC data in the search results exceeds the standard set for
displayed.

Section 6
QC Measurement
6.5.3.4 QC Table Screen (Detail)
① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨

① Date Displays the date on which the QC measurement was executed.
② Round No. Displays the round number in a range of 1 to 99.
③ No. When measurement was executed multiple times in the same

round, this displays to which measurement the results
correspond.
④ Assay Name Displays the assay item name.
⑤ QC Sample Name*1 Displays the QC sample names.
⑥ Conc.*1 Displays the concentration measured in QC measurement with

up to 7 digits (0 to 9999999).
⑦ WARNING/ERROR*1*2 When QC data in the search results exceeds the standard set for
displayed.
⑧ Error Flag Displays any error flags added to the measurement results. For
details on error flags, refer to Section 11.4.
*1. Displayed for up to 3 samples for each assay item.
*2. The administrator must register the judgment standard for WARNING and ERROR in advance on
the QC Sample Registration screen.

Section 6
QC Measurement
6.6 Register QC Samples

Up to 40 types of QC samples (Q1 to Q40) can be registered for use in QC.
• The assay items registered to the QC samples that have been registered can also be checked.
6.6.1
① QC Sample Registration Screen
⑤
③
①
②

① QC Sample ID Select the QC sample ID number (1 to 40).
② QC Sample Name Enter the QC sample name (using up to 20 alphanumeric characters).
③ QC Sample Lot No. Enter the QC sample lot number (using up to 6 alphanumeric
characters).
④ Linked Assay Names Displays the assay items linked to the QC sample.
⑤ QC Sample List Displays the registered QC samples.

Section 6
QC Measurement
6.6.2 Register Samples
Select the QC Sample IDs.
Edit each item as appropriate.

• The QC samples are stored to the
system.

Section 6
QC Measurement
6.6.3 Edit QC Samples
Select the QC sample IDs to be edited.

• The registration information for the
QC samples is displayed.

• To rest the edited contents, click the
Cancel icon ( ).

• The changes you have made are saved.

Section 6
QC Measurement
6.6.4 Delete QC Samples
Select the QC sample IDs to be

deleted.
QC samples is displayed.

Section 6
QC Measurement
6.7 Set the Conditions for QC

The following explains how to specify the QC samples to use for each assay item and how to set the rules.
• Up to 3 QC samples can be registered per assay item.
6.7.1 QC Range Screen
①
②
③ ⑤
④
⑥ ⑧ ⑨

① Assay No. Select the number of the assay from the Assay No. drop-down.
• Specifying a registered assay item number automatically displays
the registered assay item name.
② Replication Select how many times to measure (from 1 to 3 times) for one QC
measurement.
• For details on replication, refer to Section 6.7.1.1.
③ Interval (Minutes) Enter the QC expiry time for the QC samples (0 to 999).
• When the expiry date for the QC sample is not specified,
enter 0.
• If the expiry time has elapsed since the previous measurement of
the QC samples, the assay item name will be displayed in yellow
on the Worklist screen and an error flag will be added to the
④ Mode (*1) Select the calculation method for the average concentration.
• Mean-R: Uses the average concentration that was directly
entered.
• X-R: Calculates the average concentration from the specified
⑤ Test without QC Select whether to test without QC, by selecting either Enable or Disable.
• If Disable is selected, routine samples of assay items for which
QC measurement has not been performed cannot be measured.

Section 6
QC Measurement
⑥ Point (*2) Set the range for past measurement results (1 to 99).
• Set how many past measurement results to use, starting from the
latest measurement results.
⑦ QC Sample Name Select the QC samples.
⑧ Mean Value If the Mode is Mean-R, enter the average concentration of the QC
samples.
• If the Mode is X-R, the average concentration calculated from
the measurement results is displayed.
⑨ SD Enter the standard deviation value for the QC samples
(0.001 to 999.999).
⑩ Rules The value is determined based on the SD value of the measurement
results for the QC samples, and the result trend.
• There are 10 types of judgement conditions and a flag can be
added to the judgement results.
For the judgment results, the plot for each measurement result is
displayed on the QC Chart screen in colour.
• Black: Not judgement.
• Yellow: Warning.
• Red: Error.
If multiple judgement results have been added to a single measurement
result, the highest judgement conditions will be displayed.
• For details on the judgement conditions, refer to Section 6.7.1.2.
*1 If Mode is X-R, it is necessary to specify the range for the QC table that will be used.
*2 If Mode is X-R.

Section 6
QC Measurement
6.7.1.1 Replication
Specify the number of QC measurements.
①
②
③

① Single Sets the measurement results as the QC range.
② Duplicate Sets the QC range to the average obtained from the results of 2
measurements.
③ Triplicate Sets the QC range to the median obtained from the results of 3
measurements.
6.7.1.2 Judgement Conditions

10 types of judgement conditions are available for QC measurement.
Rules QC Range Flag

1. Current result exceeds 2SD 1:2S
4. Last 2 results exceeds 2SD 2:2S
5. 2 out of last 3 results exceed 2SD 2/3:2S
6. Both max. and min. exceed 2SD R:4S
7. Any 3 results exceed 1SD 3:1S
8. Any 4 results exceed 1SD 4:1S
9. 10 consecutive results are higher/lower than mean 10:X +, 10:X -
10. 7 consecutive results show upward/downward trend 7:T +, 7:T -

Section 6
QC Measurement
6.7.1.3 Set the QC Range
Select the assay number from the

Assay No. drop-down.
Edit each item.


• The QC range is saved.

Section 6
QC Measurement
6.7.1.4 Edit the QC Range
Select the assay number for the range to

be edited from the Assay No.
drop-down.
QC range is displayed.


• The changes are stored to the system.

Section 6
QC Measurement
6.7.1.5 Delete the QC Range
Select the assay number from the

Assay No. drop-down for which the QC
range to be deleted.


• The QC range is deleted.
6.7.1.6 Print the QC Range
Select the assay number of the settings to

be printed.

The QC range settings is printed.
• For more information on print settings,
refer to your printer manuals.

Section 7
Sample Measurement
SECTION 7
SAMPLE MEASUREMENT
This section explains how to measure routine samples,

how to review measurement progress, and how to
add samples during measurement.

Section 7
Sample Measurement
Section 7 Sample Measurement .......................................................................................... 7—1
7.1 Overview ..................................................................................................................7—5
7.1.1 Flow of Sample Measurement ................................................................................................... 7—5
7.2 Register Orders .......................................................................................................7—6
7.2.1 Register Orders Online .............................................................................................................. 7—6
7.2.1.1 When Barcodes are Used Online in Real Time Mode ..................................................... 7—6
7.2.1.2 When Barcodes are NOT Used Online in Real Time Mode........................................... 7—6
7.2.1.3 When Barcodes are used in Online Batch Mode ............................................................. 7—7
7.2.1.4 When Barcodes are NOT used in Online Batch Mode ................................................... 7—8
7.2.2 Register Orders Offline .............................................................................................................. 7—9
7.2.2.1 Register Orders Using Manual Entry ................................................................................. 7—9
7.2.2.2 Register Orders through Barcodes ................................................................................. 7—11
7.2.3 Copying Order ......................................................................................................................... 7—12
7.2.4 Delete Unnecessary Orders .................................................................................................... 7—13
7.2.4.1 Delete an Individual Order .............................................................................................. 7—13
7.2.4.2 Delete Multiple Orders .................................................................................................... 7—13
7.2.4.3 To Batch-Delete Orders.................................................................................................. 7—14
7.2.5 Worklist Screen ........................................................................................................................ 7—15
7.3 Execute Measurement .......................................................................................... 7—18
7.4 Orderless Test .......................................................................................................7—18
7.4.1 Set the Orderless Items ........................................................................................................... 7—19
7.4.2 Change Orderless Settings ...................................................................................................... 7—20
7.5 Monitor Measurement Progress .......................................................................... 7—21
7.5.1 Monitor the Sample and Reagent Status ................................................................................. 7—21
7.5.1.1 Carousel Monitor Screen................................................................................................. 7—22
7.5.1.2 Display of Sample Categories .......................................................................................... 7—22
7.5.1.3 Display of Measurement Status ....................................................................................... 7—23
7.5.1.4 Display of Reagent Placement Status .............................................................................. 7—23
7.5.2 Monitor Detailed Measurement Progress ............................................................................... 7—24
7.5.2.1 Round Monitor Screen..................................................................................................... 7—24
7.6 Set the Panel Test .................................................................................................7—26
7.6.1 Panel Test Screen ..................................................................................................................... 7—26
7.6.2 Register the Panel Test............................................................................................................. 7—27
7.6.3 Edit the Panel Test.................................................................................................................... 7—28
7.6.4 Delete the Panel Test ............................................................................................................... 7—29
7.6.5 Print the Panel Test .................................................................................................................. 7—30
7.7 Set Templates........................................................................................................7—31
7.7.1 Template Screen....................................................................................................................... 7—31
7.7.2 Register a Template ................................................................................................................. 7—32
7.7.3 Edit a Template......................................................................................................................... 7—33
7.7.4 Delete a Template.................................................................................................................... 7—34
7.7.5 Print a Template ....................................................................................................................... 7—35
7.7.6 Import a Template ................................................................................................................... 7—35
7.7.7 Execute an Auto Template ...................................................................................................... 7—35
7.8 Set the Calculated Testing ................................................................................... 7—36
7.8.1 Calculated Test Screen ............................................................................................................ 7—36
7.8.2 Register a Calculated Test ....................................................................................................... 7—38
7.8.3 Edit a Calculated Test............................................................................................................... 7—39
7.8.4 Delete a Calculated Test.......................................................................................................... 7—40
7.8.5 Print a Calculated Test ............................................................................................................. 7—41

Section 7
Sample Measurement
7.9 Set the Mask Function .......................................................................................... 7—42

7.9.1 Worklist Screen ........................................................................................................................ 7—42
7.10 Set the Orderless Items ....................................................................................... 7—43
7.10.1 Orderless Test Screen ............................................................................................................. 7—43
7.11 Add Samples during the Measurement Procedure ........................................... 7—44
7.11.1 Add Samples through Barcode ................................................................................................ 7—44
7.11.1.1 Add Samples to 1 Holder ................................................................................................ 7—44
7.11.1.2 Add Samples to Multiple Holders ................................................................................... 7—48
7.11.2 Add Samples using Manual Input ............................................................................................. 7—53
7.11.2.1 Add Samples to 1 Holder ................................................................................................ 7—53
7.11.2.2 Add Samples to Multiple Holders ................................................................................... 7—57
7.12 Finish Measurements ............................................................................................ 7—62
7.12.1 Automatically Delete or Preserve Orders .............................................................................. 7—62
7.12.2 Tasks to be done when Measurements are finished .............................................................. 7—62

Section 7
Sample Measurement
Intentionally Blank

Section 7
Sample Measurement
7 Sample Measurement
7.1 Overview
For measurements of routine samples, the workflow of sample measurements involving the placement of
samples and registration of orders is similar to that of calibration measurement and QC measurement.
This section explains how to measure routine samples, how to review measurement progress, and how to
add samples during measuring.
7.1.1 Flow of Sample Measurement

The flow of sample measurement is as follows:
1. Preparing Samples
Place routine samples in the sample carousel.
2. Registering Orders
Register the order of measurement.
3. Executing Measurement
Execute measurement.
4. Reviewing Measurement Progress

Measurement progress can be reviewed on the Round Monitor screen.
5. Adding Samples
Add samples as needed.
6. Finishing Measurement
Once measuring is finished, the ending procedure starts.
7. Reviewing Measurement Results

For information on how to review the measurement results,
refer to the Section 8.

Section 7
Sample Measurement
7.2 Register Orders

The procedures used for registering sample orders depend on the operating mode of the analyser.
NOTE: To measure routine samples, they must be placed in the middle or outer tray. The positions on
the inner tray cannot be selected.
7.2.1 Register Orders Online

7.2.1.1 When Barcodes are Used Online in Real Time Mode
Place samples with the barcodes attached in the sample carousel. Refer to Section 2.1.2.
Go to Section 7.3. The order information is automatically obtained from the host.
7.2.1.2 When Barcodes are NOT Used Online in Real Time Mode
When barcodes are not used (for example, when barcode reading fails), manually enter sample IDs using
the following steps.
Place samples in the sample carousel. Refer to Section 2.1.2.
Navigate to Routine > Worklist.
Select the positions where the samples

are to be placed from the sample list on
the left screen or the Pos. (From) drop-
down menu.
Enter the Sample ID in the Sample ID

field.


Section 7
Sample Measurement
7.2.1.3 When Barcodes are used in Online Batch Mode
Click Host Query.

• The order information is obtained
from the host.


Section 7
Sample Measurement
7.2.1.4 When Barcodes are NOT used in Online Batch Mode

When barcodes are not used (for example, when barcode reading fails), enter sample IDs using the
following steps.

are placed from the sample list on the left
menu.
Enter the Sample ID in the Sample ID

field.
Click Host Query.

• The order information is obtained
from the host.


Section 7
Sample Measurement
7.2.2 Register Orders Offline

7.2.2.1 Register Orders Using Manual Entry

are placed, from the sample list on the left
menu.
Select the type of sample vessel from the

Vessel.
• Choose Normal for normal
sample tubes.
• Choose Paediatric only when
paediatric sample cups are used.
Select Routine Sample from the

Sample Category.
• Choose STAT for STAT orders.
NOTE: If the Emergency check box is selected, the measurement of that routine samples takes
precedence.
Enter other order information.


Section 7
Sample Measurement


Section 7
Sample Measurement
7.2.2.2 Register Orders through Barcodes
Select Blank from the Pos. (From)

drop-down menu.
Select Routine Sample from Sample

Category.
• Choose STAT for STAT orders.
NOTE: If the Emergency check box is selected, the measurement of that routine samples takes
precedence.
Enter other order information. Refer to

Section 7.2.5.
Click Save ( ).

Section 7
Sample Measurement
7.2.3 Copying Order

Routine > Worklist
Select the Copy/Delete check box.
From Pos. (From), select the position

to copy its order from.
An unregistered order position can be

selected as the position to copy from. In
this case, 1 order is registered for the
position to copy from, and at the same
time, the corresponding content is copied
to the specified range.
From the Pos. (To), select the last

position to copy to.

• The registered order is copied from
the position selected in the [Pos.
(From)] to the position selected in
the [Pos. (To)].
• Sample IDs will be automatically
assigned sequentially from the ID of
[Pos. (From)].
NOTE: It is possible to consecutively copy the registered order of SID (From) to SID (To) by selecting
SID (From) and SID (To).

Section 7
Sample Measurement
7.2.4 Delete Unnecessary Orders

7.2.4.1 Delete an Individual Order
Routine > Worklist
In the SID, enter the Sample ID for the

order to be deleted.

Click OK.
• The order of the selected sample
ID is deleted.
7.2.4.2 Delete Multiple Orders

Specify the first and last positions or sample IDs in the desired range to delete the appropriate orders.
Select the Copy/Delete check box.

Section 7
Sample Measurement
Specify the range of orders to be deleted.

• To delete orders in a range of
positions, select Pos. (From) and
Pos. (To).
• To delete orders in a range of sample
IDs, select SID (From) and SID
(To).

Click OK.
• The order of the selected Sample
ID is deleted.
7.2.4.3 To Batch-Delete Orders

Delete all orders that have been registered.
Click the All Delete ( ) icon.

Click OK.
• All orders that have been registered
are deleted.

Section 7
Sample Measurement
7.2.5 Worklist Screen
② ③
④
⑤ ⑥
⑦ ⑧ ⑨ ⑩
⑪
⑬ ⑭

① Sample list Lists positions and sample IDs of samples placed in the sample
carousel.
② Manual Scan*1 Select this check box to only enter a sample ID by reading a barcode,
instead of entering it through the keyboard.
③ SID*2 Enter the sample ID. It must be 3 to 15 digits long.
• By default, the number assigned to the specified position is
automatically assigned as the sample ID.
• Numbers from 89990000 to 99999999 cannot be used as
sample IDs for routine samples.
④ SID (From)/SID (To) Used to specify the range of sample IDs when selecting a destination
to which an order is copied or orders to be deleted.
⑤ Copy/Delete Select this check box when copying or deleting orders by specifying
the range with 4 or 7.
• Copy: The information registered in the SID (From) or Pos.
(From) is copied to the SID (To) or Pos. (To). Use 7 to
automatically assign sample IDs sequentially from the ID of
Pos. (From).
• Delete: Used to delete orders in the range you specify.
⑥ Emergency Select this check box to preferentially measure a routine sample.

Section 7
Sample Measurement
⑦ Sample Category*2 Select the type of samples to be tested:

• Routine Sample: Select this to test routine samples.
• STAT: Select this to test STAT samples. If STAT is selected,
a part of sample ID will be fixed.
• Calibrator: Refer to Worklist Screen (Calibration)
• Calibrator (Dilution)]/[C1 Blank: Refer to Worklist
Screen (Diluted Calibration/C1 Blank Measurement).
• Multi-Calibrator: Refer to Worklist Screen (Multi-
Calibration).
• QC Sample: Refer to Worklist Screen (QC Measurement).
• Sample Pipette Detergent: Select this to register an
order using detergents placed in the sample carousel for
operations-related purposes before and after the
measurement or maintenance.
⑧ Test Mode*3 Select Decrease, Normal, or Increase for the sample aspiration
volume.
⑨ Pos. (From)/Pos. (To) Used to specify the range of sample tubes by the appropriate positions
in the sample carousel.
⑩ Vessel*2 Select Normal or Paediatric for the sample vessels.
⑪ Each time the button is clicked, the view of item 13 toggles between
the list of assay items and diagnostic information entry area. Refer to
Section 7.2.5.
⑫ Assay Select the check box to the side of an assay item name to order
measurement for the corresponding assay item.
The background colour of the assay item indicates warnings. If both
• Red: Calibration has not been executed or the effective
period has expired.
• Yellow: QC measurement has not been executed, or the
• Grey: The reagent bottles have not been registered.
⑬ Host Query The order is obtained from the host.
⑭ Rotate Carousel Used to rotate the sample carousel until available holders come under
the STAT lid when adding samples to multiple holders during
measurement.
• *1 Selecting the Manual Scan check box allows entry of a sample ID using a barcode scanner
(sold separately) instead of entering it through the keyboard.
• *2 Depending on the combination of Sample Category and Vessel settings, the high-order digits of
sample ID may result in a fixed value. In this case, you can arbitrarily set the numbers in the range
shown below within the sample ID.
• *3 The sample aspiration volume for each of Decrease, Normal, and Increase options has been
preset by the administrator. The administrator can set the sample aspiration volume for each of
the Decrease, Normal, and Increase options for each parameter on the Parameter 1 screen.

Section 7
Sample Measurement
Format of sample ID Maximum number of

Sample
Vessel (maximum number of digits that can be
Category
digits) optionally set
Routine
Paediatric 8999xxxxxxxxxxx Last 11 digits
Sample
STAT Normal 99000xxxxxxxxxx Last 10 digits
STAT Paediatric 990009xxxxxxxxx Last 9 digits
NOTE: Click on the Print icon ( ) to print the registered content of the order.

Section 7
Sample Measurement
7.3 Execute Measurement

After completing the order registration, follow the steps below to start measurement.
Click the Start icon ( ).

• The measurement startup window is
displayed.
• If required, set the operations
before and after measurement.
7.4 Orderless Test

Orderless test is a function that makes it easier for an operator with little understanding of measuring to
start measurement. Place sample cups or tubes on the sample tray in the sample carousel and run tests
only on the assay items preselected by the administrator.
The administrator can set assay items used for orderless test on the Orderless Test screen.
To start an orderless test, the required reagents must be in the reagent carousel and must be registered
with the analyser. If the volume of reagent is insufficient prior to measurement or if the analyser runs out of
reagents during measurement, the assay items cannot be measured.
Press the F1 key while holding down the Shift key on the keyboard.
• The Orderless Test confirmation dialog box is displayed.

Section 7
Sample Measurement
7.4.1 Set the Orderless Items
Navigate to Settings > Test Settings > Orderless Test.
The function that measures all the measurable assay items for all the samples placed in the sample
carousel is called the ‘orderless test’.
• Before performing an orderless test, set the assay items for which measurement is
permitted.
① Assay items Displays the assay item list. Here, select the assay items for permitting
orderless measurement by ticking the check boxes.

Section 7
Sample Measurement
7.4.2 Change Orderless Settings
Navigate to Settings > Test Settings > Automatic Test.
Specify the assays to permit and prohibit

on the Orderless Test screen.
• Selecting the check boxes on the
left side of the assay item names
will order measurement for those
assay items.

• The orderless test settings are
registered.
• If a different order has been
registered on the Worklist screen,
the registered contents on the
Worklist screen will take priority.

Section 7
Sample Measurement
7.5 Monitor Measurement Progress

While measuring, you can check the progress on the Carousel Monitor and Round Monitor screens.
7.5.1 Monitor the Sample and Reagent Status

On the Carousel Monitor screen, visually check the placement of the samples and reagents and
measurement progress in real time.
After measurement has started, navigate to Routine > Carousel Monitor.
Check the remaining reagent volume and

sample status on the screen.
• The current status of the sample
carousel and reagent carousel can
be checked in real-time on the
Carousel Monitor screen.
• The left side of the screen shows
the current status of the sample
carousel and the right side of the
screen shows the current status of Current status of Current status of
the reagent carousel. sample carousel reagent carousel
• The colouring and icon of a
carousel position indicates the
current status.
NOTES:
• Samples can be added during the measurement procedure.
• If anything is wrong in the information displayed on the Carousel Monitor screen, contact the
administrator.

Section 7
Sample Measurement
7.5.1.1 Carousel Monitor Screen
① ②

① Current status of Displays the sample category and measurement status of each sample in
sample carousel the sample carousel.
Press and hold the placement position of a sample to switch to the
Worklist screen registered in the corresponding position.
② Current status of Displays the placement status of each reagent bottle.
reagent carousel
Press and hold the placement position of a reagent bottle to switch to the
Reagent Code screen registered in the corresponding position.
7.5.1.2 Display of Sample Categories

The types of samples and the state of the test in the sample carousel can be confirmed by icons.
Icon Sample Category

C • Calibrator
• Multi-calibrator
• Calibrator (dilution)
• C1 blank
Q QC sample
M • Sample pipette detergent
• Various ISE solutions*1
S STAT*1
N Routine sample
*1. Displayed when STAT is selected from the Sample Category drop-down menu on the Worklist screen
or when the Emergency check box is ticked.

Section 7
Sample Measurement
7.5.1.3 Display of Measurement Status

The measurement status of the samples in the sample carousel can be confirmed from the display colour
of each position.
Display Colour Description

Grey Indicates that no samples are placed.
Red Indicates that an error occurred during measurement of the ordered assay
items.
Purple Indicates that an item satisfying the rerun conditions exists in the ordered
assay items.
Blue Indicates that a measurement result outside the technical range exists in
the ordered assay items.
Light Blue Indicates that measurement of the ordered assay items completed without
any errors.
Green Indicates that dispensing of the ordered assay items is completed.
White Indicates that dispensing of the ordered assay items is not completed.
Yellow Indicates that no orders are registered.
7.5.1.4 Display of Reagent Placement Status

The placement status of the reagent bottles in the reagent carousel can be confirmed from the display
colour and blinking of each position.
Display Colour Description

Display colour of assay Indicates the remaining reagent volume is sufficient and the reagent can be
item (item colour) used.
Red blinking Indicates the remaining reagent volume is insufficient.

Pink blinking Indicates the expiry date of the reagent is expired.
Yellow blinking Indicates the stability period of the reagent is expired.
Orange blinking Indicates the remaining reagent volume is less than 10%.
NOTE: The administrator can set the display colour (item colour) of assay items on the Parameter 1
screen.

Section 7
Sample Measurement
7.5.2 Monitor Detailed Measurement Progress

Check detailed measurement progress on the [Round Monitor] screen in real time.
Navigate to Routine > Round Monitor.
Check detailed measurement progress on

this screen.
The Round Monitor screen provides a

tabular display listing ordered assay items
and allows you to check detailed status in
real time.
NOTES:
• Samples can be added during the measurement procedure. For details, refer to Section 7.11
during the Measurement Procedure.
• If you find anything wrong in the information displayed on the Round Monitor screen, contact
your administrator.
7.5.2.1 Round Monitor Screen
① ② ③
④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩ ⑪ ⑫

Section 7
Sample Measurement

① Incubator Displays the current temperature of the incubator.
• The temperature of the incubator must be kept within the
range of 36.5°C to 37.5°C suitable for measurement.
② Lamp Displays the amount of time for light from the halogen lamp to
stabilise and for measurement to become available.
• It must be 0 Min or 2 Min (when the lamp power save mode is
enabled).
③ Round No. Displays the current round number.
④ Pos. Displays the position of the sample tray.
⑤ PID Displays the patient ID.
⑥ SID Displays the sample ID.
⑦ Assay Name Displays the assay name.
⑧ Status Shows the measurement progress with bar graphs. If an error occurs,
‘E‘ is displayed to enable identification of which stage the error
occurred.
R1 The progress bar indicates that the dispensing of R1 reagent is
completed when it has reached 100%.
S The progress bar indicates that the dispensing of samples is completed
when it has reached 100%.
M1 The progress bar indicates that the first stirring is completed when it
has reached 100%.
O1 The progress bar indicates that the first reaction is completed when it
has reached 100%.
R2 The progress bar indicates that the dispensing of R2 reagent is
completed when it has reached 100%.
M2 The progress bar indicates that the second stirring is completed when
it has reached 100%.
O2 The progress bar indicates that the second reaction is completed
when it has reached 100%.
⑨ Results Displays measurement results in terms of numbers.
⑩ Cuvette No. Displays the number assigned to the cuvette used for measurement.
⑪ Error An error flag is displayed (if it is appended to the measurement

results).
⑫ Remaining Time Displays the remaining time (minutes) it takes to measure each item.

Section 7
Sample Measurement
7.6 Set the Panel Test

Multiple assays can be set as a single panel test and up to 50 panel tests can be registered.
7.6.1 Panel Test Screen
③
①
②

① Panel No. Select or enter the panel number (1 to 50).
② Panel Name Select or enter the panel name (Using up to 10 alphanumeric

characters). Specifying a registering panel name automatically displays
③ Assay Select this check box to add the assay item to the panel test.

Section 7
Sample Measurement
7.6.2 Register the Panel Test

The following explains the procedure for registering the panel test.
Select the Panel No.
Edit each item.

Section 7
Sample Measurement
7.6.3 Edit the Panel Test

The following explains the procedure for editing the registered content of the panel test.
Select the Panel No. to be edited.
Edit each item.

Section 7
Sample Measurement
7.6.4 Delete the Panel Test

The following explains the procedure for deleting the panel test.
Select the Panel No. to be deleted.

panel number is displayed.


• The panel test is deleted.

Section 7
Sample Measurement
7.6.5 Print the Panel Test
Select the Panel No. to be printed.

panel number is displayed.

• The panel test is printed. For
information on print settings, refer to
your printer manuals.

Section 7
Sample Measurement
7.7 Set Templates

The template is a function to register a combination of the registration status of samples in the sample tray
and the orders for these samples in advance.
A registered template can be displayed automatically at a specified time.
Templates are used for calibration and QC measurement. They cannot be used for routine samples.
7.7.1 Template Screen

The following explains the Template screen.
① ②
③
④
① Template No. Select or enter the template number (1 to 10).
② Template Name Select or enter the template name (Using up to six alphanumeric
characters and symbols).
③ Schedule (*) Set the schedule for automatically displaying the templates.
• Enable/Disable: Specify whether the Auto Template function
is ON/OFF for each template.
• Date/Day: Specify the day or date when to activate the Auto
Template function. Either dates or days of the week can be set.
• Time/Round No. Specify the timing when to activate the
Auto Template function. Either times or round numbers can be
set.
• Pos. Set the positions in the sample carousel of the calibrators
or QC samples to be set in the template.
④ Worklist registration Specifies the position at which to place the samples, and the assay items
area. for each sample.

Section 7
Sample Measurement
7.7.2 Register a Template

The following explains the procedure for registering a template.
Navigate to Settings > Test Settings > Template.
Select the Template No.
Edit each item.

• Click Cancel ( ) to reset the
edited contents.

• The template is registered.

Section 7
Sample Measurement
7.7.3 Edit a Template

The following explains the procedure for editing the registered content of a template.
Select the Template No. to be edited.

template is displayed.
Edit each item.

• Click Cancel ( ) to reset the
edited contents.
Click Save ( ).

Section 7
Sample Measurement
7.7.4 Delete a Template
Select the Template No. to be deleted.

Click Delete ( ).
• The confirmation dialog box is
displayed.
Click OK.
• The template is deleted.

Section 7
Sample Measurement
7.7.5 Print a Template
Select the Template No. to be printed.


• The template is printed.
7.7.6 Import a Template
Navigate to Routine > Worklist
Select the template number to use from

the Template drop-down.

• The order content of the template is
imported.
7.7.7 Execute an Auto Template
When the specified time or round comes,

a confirmation screen is displayed.

Section 7
Sample Measurement
7.8 Set the Calculated Testing

Set the measuring conditions for the calculated test.
• This combines the measurement results and performs mathematical operations, and then outputs
the results of the operation as the measurement results.
7.8.1 Calculated Test Screen
⑧
① ②
④ ⑤
③

① Calculated Test No. Enter or select the assay item number.
• For calculated tests, use the assay item numbers from 3001 to
3040.
② Calculated Test Name Enter or select the assay item name (Using up to 6 alphanumeric
• Specifying a registered assay item name automatically displays
③ Print Name Enter an assay item name to use for printing (up to 15 alphanumeric
It is output as [Assay Item Name] when data is printed or output to a
file. If the print name is not entered, the assay item name you have set
in Calculated Test Name is printed or output to a file.
④ Unit Enter a unit used for the relevant item (up to 6 alphanumeric
⑤ Decimal Point Specify the number of significant decimal places for the concentration
that will be output as the measurement results (select from 0 to 5
digits).

Section 7
Sample Measurement

⑥ Expression Enter the calculation formula.
• Up to 10 assay items can be used for arithmetical expressions.
• The calculation formula can be entered by selecting and
double-clicking on the assay item name from the list of assay
numbers.
• Check the calculation formula when registering. If there is an
error, registration cannot be performed.
⑦ List of Items Clicking on an arithmetical operation icon (+, -, ×, ( ), /) will enter the
arithmetical expression into the Expression column.
List of item numbers.
The calculation formula can be entered by selecting and double-
clicking on the assay item name.
⑧ Normal Range For each normal range registered on the Normal Range screen, enter
the normal range for the calculated tests.
• Numbers can be edited by selecting and double-clicking on
the numbers to change from the list.
• Enter so that the higher limit numbers are larger than the
lower input numbers.
• If the higher is not checked, enter the lower only. If the lower
is not checked, enter the higher only.
• If the measurement value is less than the lower limit, an
evaluation flag (L) is added to the measurement results; and if
the measurement value is greater than the upper limit, an
evaluation flag (H) is added to the measurement results.

Section 7
Sample Measurement
7.8.2 Register a Calculated Test
Navigate to Settings > Test Settings > Calculated Test.
Select the calculated test number.
Edit each item.


• The calculated test settings are
registered.

Section 7
Sample Measurement
7.8.3 Edit a Calculated Test
Select the calculated test number to be

edited.
calculated test is displayed.
Edit each item.

• Click the Cancel icon ( ).


Section 7
Sample Measurement
7.8.4 Delete a Calculated Test

deleted.


deleted.

Section 7
Sample Measurement
7.8.5 Print a Calculated Test

printed.

printed.

Section 7
Sample Measurement
7.9 Set the Mask Function

This function prohibits measurement for measurable assay items (for which a parameter has been set,
there are calibration curves, and for which the necessary reagents are in the reagent carousel).
7.9.1 Worklist Screen

1. Click the Mask button.
• The Mask Type screen is displayed.
The current mask status is
displayed.
• If the mask function is not being
used, the check boxes for all the
assay items will be selected.
2. Deselect the check boxes for the assay

items for which the mask function will
be enabled.
• To turn the mask function ON for
all assay items, click Mask All.
• To turn the mask function OFF for
all assay items, click Cancel.
• To reset the edited contents, click
the Cancel icon ( ).
3. Click the Save icon ( ).
• The mask settings are registered.
NOTE: Click the Print icon ( ) to print the registered content of the order.

Section 7
Sample Measurement
7.10 Set the Orderless Items

The function that measures all the measurable assay items for all the samples placed in the sample carousel
is called the orderless test.
• Before performing an orderless test, set the assay items for which measurement is permitted.
7.10.1 Orderless Test Screen
Specify the assays to permit and prohibit

on the Orderless Test screen.
• Selecting the check boxes on the
left side of the assay item names will
order measurement for those assay
items.

• The orderless test settings are
registered.
• If a different order has been
registered on the Worklist screen,
the registered contents on the
Worklist screen will take priority.

Section 7
Sample Measurement
7.11 Add Samples during the Measurement Procedure

If STAT samples are added, the measurement of those samples take precedence and you cannot add
samples until dispensing is complete.
7.11.1 Add Samples through Barcode

7.11.1.1 Add Samples to 1 Holder
Up to 10 sample tubes per holder can be placed on the middle tray and up to 9 sample tubes per holder
on the outer tray in the sample carousel. Follow the steps below to add samples to 1 holder.
Prepare the samples to be added.

Alternatively, click the Add icon ( ).
When the preparation for adding samples is

completed, the STAT LED on the middle or
outer tray lights up.
A confirmation message is displayed on the

screen.
Do not open the STAT window before the STAT LED lights up.

Section 7
Sample Measurement
Check the STAT LEDs and open the STAT

lid of the sample carousel where the LED is
lit.

carousel.
NOTE: There is a pin on the bottom of each holder that fits into the holes on the bottom of the
sample carousel. When removing a holder, pull it straight up.


Section 7
Sample Measurement
NOTES:
• Be sure to insert a sample tube straight into a holder as far as it goes to prevent them from
moving during the measurement procedure.
• Ensure that any barcode label, if affixed, is positioned correctly. Refer to the illustration above.
• For measurement involving less than 5 ml of sample, place paediatric sample cups into sample
tubes on the tray.
Put the holder back into the sample

carousel.
NOTE: Insert holder straight into the sample carousel until the pin in its bottom engages the hole in the
carousel.
Close the STAT lid.
NOTE: After sample tubes have been placed, make sure that the STAT lid and sample carousel cover
are securely closed.

Section 7
Sample Measurement

Press the Start switch. Alternatively, click

the Start icon ( ). The barcodes are read
and order is registered.

Section 7
Sample Measurement
7.11.1.2 Add Samples to Multiple Holders

Follow the steps below to add samples to multiple holders (for example, when 10 or more samples need
to be added).

When the preparation for adding samples

is completed, the STAT LED on the middle
or outer tray will illuminate.
A confirmation message is displayed on the

screen.

Section 7
Sample Measurement
Check the STAT LEDs and open the STAT

lid of the sample carousel where the LED is
lit.

carousel.
NOTE: There is a pin on the bottom of each holder that fits into the holes on the bottom of the
sample carousel. When removing a holder, pull it straight up.


Section 7
Sample Measurement
NOTES:
floating during the measurement procedure.
• Ensure that any barcode label, if affixed, is oriented correctly. Refer to the illustration above.
• For measurement involving less than 5 ml of sample, place paediatric micro sample cups inserted
into their own sample tubes on the tray.

carousel.
carousel.
Close the STAT lid.
NOTE: After sample tubes have been placed, make sure that the STAT lid and sample carousel cover is
securely closed.

Section 7
Sample Measurement

Check the status of each STAT LED, and
then open the STAT lid for LED that is
ON. Remove the holders and insert
sample tubes into them.
NOTE:
• Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.
When removing a holder, pull it straight up.
• Make sure a sample tube is straight when placed into the holder and that it is fully seated to
prevent it from floating during the measurement process.
• Make sure that any barcode label, if affixed, is oriented correctly. Refer to step 6.
• When measuring 0.5 ml or less samples, put paediatric micro sample cups inserted into their
own sample tubes on the tray.
Put the holder back into the sample carousel and close the STAT lid.
NOTE:
• Insert the holder straight into the sample carousel until the pin in its bottom engages the hole in
the carousel.
• After inserting sample tubes, make sure that the STAT lid and sample carousel cover are
securely closed.
Repeat steps 9 through 11 to insert all of the necessary samples.
After inserting all samples to be added,

close the STAT window.

Section 7
Sample Measurement
Press the start switch.

Alternatively, click the Start icon ( ).
The barcodes are read, and order is
registered.

Section 7
Sample Measurement
7.11.2 Add Samples using Manual Input

7.11.2.1 Add Samples to 1 Holder
In the sample carousel, up to 10 sample tubes per holder can be placed on the middle tray and up to 9
sample tubes per holder on the outer tray. Follow the steps below to add samples to 1 holder.

The Worklist screen is displayed that

specifies the positions with which you can
register orders.
Select any specified positions and register

the order of added samples.
• Refer to Registering Orders Using
Manual Entry.
• For STAT samples, set Sample
Category to STAT.
• Set sample categories to Routine
for samples to be analysed in worklist
order.

is ready, the STAT LED on the middle or
outer tray will illuminate.

Section 7
Sample Measurement
Check the STAT LEDs and open the

STAT lid of the sample carousel where
the LED is lit.

carousel.
NOTE: Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.

Section 7
Sample Measurement

place sample tubes in the holders.
NOTES:
floating during the measurement procedure.
• For measurement involving less than 5 ml of sample, place paediatric sample cups inserted into
their own sample tubes on the tray.

carousel.
carousel.

Section 7
Sample Measurement
Close the STAT lid.

Press the start switch. Alternatively, click

the Start icon ( ).

Section 7
Sample Measurement
7.11.2.2 Add Samples to Multiple Holders

Follow the steps below to add samples to multiple holders (for example, when 10 or more samples need
to be added).

The Worklist screen is displayed. This

specifies the positions that can register
sample orders.
Register the order of the added samples.

Refer to Section 7.2.2.1.

is ready, the STAT LED on the middle or
outer tray will illuminate.

Section 7
Sample Measurement
Check the STAT LEDs and open the

STAT lid of the sample carousel where
the LED is lit.
Remove the holders from the sample

carousel.
NOTE: Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.

Section 7
Sample Measurement
Place the removed holders on a flat surface

and place sample tubes in the holders.
NOTES:
• Be sure to insert the sample tube into the holder as far as it will go to prevent them from
becoming loose during the measurement procedure.
• For measurement involving less than 5 ml of sample, place paediatric sample cups into sample
tubes on the tray.
Put the holders back into the sample

carousel.
carousel.

Section 7
Sample Measurement
Close the STAT lid.
Click Rotate Carousel on the Worklist

screen.
As the sample carousel rotates, available
holders are automatically selected and
moved under the STAT lid.
Check the STAT LEDs and open the STAT lid of the sample carousel where the LED is lit.
Remove the holders and place sample tubes on them.
NOTE:
• Pins on the bottom of the holder locate in the holes on the bottom of the sample carousel.
• Make sure a sample tube is straight when placed into the holder and that it is fully seated to
prevent it from floating during the measurement process.
• When measuring 0.5 ml or less samples, put paediatric micro sample cups inserted into their
own sample tubes on the tray.
Put the holders back into the sample carousel and close the STAT lid.

Section 7
Sample Measurement
NOTE:
• Insert the holder straight into the sample carousel until the pin in its bottom engages the hole in
the carousel.
• After inserting sample tubes, make sure that the STAT lid and sample carousel cover are
securely closed.
Repeat steps 10 through 12 to place all of the necessary samples.
When all samples have been added, close

the STAT window.
Press the start switch. Alternatively, click

the Start icon ( ).

Section 7
Sample Measurement
7.12 Finish Measurements

When all measurements of the samples are completed, the analyser initiates the ending operation.
The cuvette cleaning is started and the measurements are finished.
NOTE: Once the analyser has initiated the ending operation, samples cannot be added.
7.12.1 Automatically Delete or Preserve Orders

All completed orders are automatically deleted.
The measurement procedure cannot be completed if:
• The analyser runs out of samples or reagents used for measurements.
• An error has occurred.
• The analyser is brought to an emergency stop.
• Measurements cannot be continued for some reason.
If the analyser fails to complete the measurements, take appropriate action (replenishment of reagents
and/or samples, correct the cause of error, etc.) and re-start the measurements as required.
7.12.2 Tasks to be done when Measurements are finished

When the measurement is finished, perform the following steps (as required):
1. Dispose of used samples.
2. Check for remaining reagent volume.
3. Check for detergents.

Section 8
Measurement Results
SECTION 8
MEASUREMENT RESULTS
This chapter explains the procedures for reviewing

and outputting measurement results.

Section 8
Measurement Results
Section 8 Measurement Results ........................................................................................... 8—1
8.1 Review Measurement Results ................................................................................ 8—3
8.1.1 Review Measurement Results .................................................................................................... 8—3
8.1.1.1 Execute a Search ................................................................................................................ 8—3
8.1.1.2 Delete Search Results ........................................................................................................ 8—4
8.1.1.3 Delete Individual Measurement Results ............................................................................ 8—5
8.1.2 Review Time Course.................................................................................................................. 8—6
8.1.3 Results Screen............................................................................................................................. 8—8
8.1.3.1 If ‘All’, ‘Routine Sample’ or ‘STAT’ is Selected in Sample Category................................ 8—9
8.1.3.2 Measurement Results Display Area................................................................................. 8—11
8.1.3.3 If Calibrator is Selected in Sample Category ................................................................... 8—12
8.1.3.4 If QC Sample is Selected in Sample Category ................................................................ 8—15
8.1.3.5 If Reagent Blank is Selected from Sample Category ....................................................... 8—18
8.1.3.6 If Number of Tests is Selected in Sample Category ....................................................... 8—21
8.1.3.7 Time Course Output Settings Area ................................................................................ 8—23
8.1.3.8 Pop-up Window Showing Time Course ......................................................................... 8—23
8.2 Print Measurement Results .................................................................................. 8—24
8.2.1 Set the Report Format ............................................................................................................. 8—24
8.2.1.1 Report Format Screen ..................................................................................................... 8—24
8.2.2 Register a Report Format ........................................................................................................ 8—26
8.2.3 Edit a Report Format................................................................................................................ 8—27
8.2.4 Delete a Report Format........................................................................................................... 8—27
8.2.5 Print a Report Format .............................................................................................................. 8—28
8.2.6 Print Measurement Results with Normal Print Format .......................................................... 8—29
8.2.7 Print Measurement Results with Report Print Format ........................................................... 8—30
8.2.8 Printing Measurement Results with History Print Format ...................................................... 8—31
8.2.9 Print Time Course .................................................................................................................... 8—32
8.3 Output Measurement Results as a File ............................................................... 8—34
8.3.1 Output Measurement Results as a CSV File ........................................................................... 8—34
8.3.2 Output Time Course as a CSV File ......................................................................................... 8—35

Section 8
Measurement Results
8.1 Review Measurement Results

The analyser stores measurement results as shown below. If the number of measurement results exceeds
the maximum record count, the oldest entries are deleted.
Type Maximum Record Count

Measurement results of routine samples and STAT samples 1,000,000 tests
Time course of routine samples and STAT samples 60,000 tests
8.1.1 Review Measurement Results

Search measurement results and review them on the display.
8.1.1.1 Execute a Search

Routine > Results
Specify search condition.

• Refer to Section 8.1.3 and specify the
appropriate search condition.
Click Execute.
• The search for measurement results is
executed with the specified search
condition and a list of search results is
displayed to the right of the screen.
• If the number of search results exceeds
2000, the search is cancelled. Modify
the search condition and search again.
In the list of search results, validate

measurement results that are to be
reviewed.

Section 8
Measurement Results
8.1.1.2 Delete Search Results

Routine > Results

Click Execute.
condition and search results are
Click the Delete ( ) icon.
Click OK.
• All measurement results selected in the
search are deleted.

Section 8
Measurement Results
8.1.1.3 Delete Individual Measurement Results

Routine > Results

Click Execute.
In the list of search results, select the line

containing the measurement results to be
deleted.
In the list of measurement results, select

the measurement result to be deleted.

Section 8
Measurement Results
Click the Delete ( ) icon.

Click OK.
• The measurement results are deleted.
8.1.2 Review Time Course

Routine > Results

Click Execute.
In the search results display area, select a

sample containing the measurement
results to review the time course for.

Section 8
Measurement Results
In the measurement results display area,

select a measurement result to review the
time course for.
• The time course of a calculated test
cannot be output.
Select Graph as the output destination

of the time course.
• The time course of the selected
measurement results is graphically
displayed.
Review the time course.

Section 8
Measurement Results
8.1.3 Results Screen
③ ④
①

① Sample Category Select a sample category to be searched. The view changes
according to what is selected.
• All All samples are searched.
• Routine Sample Only routine samples are searched.
• STAT Only STAT samples are searched.
• Calibrator The measurement results of calibration, diluted calibration,
multi-calibration and C1 blank measurements are searched.
• QC Sample Only QC measurements are searched.
• Number of Tests The number of tests is specified for the search condition.
Only calibration charts are searched.
• Calibration Chart
② Search Area Specify a search condition and execute a search of
measurement results. The view depends on the Sample
Category for the samples to be searched.
③ List of Results Displays all results from the specified search
④ Search Results Display Area Displays the search results. The view depends on the Sample
Category for the samples to be searched.
⑤ Measurement Results Display Displays the measurement results selected from the search
Area results. The view depends on the Sample Category for the
samples to be searched.
⑥ Time Course Output Settings Used for setting time course output.
Area

Section 8
Measurement Results
8.1.3.1 If ‘All’, ‘Routine Sample’ or ‘STAT’ is Selected in Sample Category

Search Area
This area is used to specify search conditions and to search measurement results.
⑦ ⑧

① ID Select Select Sample ID or Patient ID for the target for search.
② From/To Specify the range of IDs to be searched.

• The setting for To is enabled only when the check box
is selected.
• Up to 15 digits of an ID can be entered.
• Specify a value greater than the finishing number for the
starting number.
• An asterisk (*) can be used as a wildcard character.
③ Date and Time Set the date and time the test was run.
• Start Date It is enabled only when the check box is selected. Set the start
date to be searched. If the check box is deselected, all results
that are obtained on or before the search end date can be
searched.
• End Date It is enabled only when the check box is selected. Enter the
end date to be searched. If the To check box is deselected,
the results that are obtained during a period of time from the
start date of search to the present can be searched.

Section 8
Measurement Results
④ Round No. Enter the round number to be searched within the range of 1 to
99.
• Enter an asterisk (*) if the round number is not
specified.
• Immediately after measuring, the number assigned to
the round that was performed immediately up to that
point will be automatically set.
⑤ Host Transfer Status Specify the state of transfer to the host computer in online
mode.
All: The host transfer status is not used as the search condition.
Transferred: The measurement results for which transfer to
the host was successful are to be searched.
Non-Transferred: The measurement results for which
transfer to the host failed are to be searched.
⑥ Output to Select a search result output destination. Refer to Sections 8.2
and 8.3.
⑦ Selected Assay Click to show the selection list of assays.
• From the list, select the assay item to be searched.
• The selected assays are shown in light blue.
⑧ Select Output ---
⑨ Execute A search of measurement results is executed based on the
specified condition.
1 Not displayed if Sample Category is set to All.
*
Search Results Display Area

The list of the search results based on the specified condition is displayed. The measurement results display
details of results selected in this area. The results of measurements just completed can be viewed on this
screen. If there are many searches or display items, hidden information can be viewed by moving the scroll
bar.
① ② ③ ④

① ID Displays the patient ID. When Sample Category is All and QC
samples are included in the search results, the QC sample
names are displayed.
② Date Displays the measurement date.
③ Round No. Displays the round number.
④ SID Displays the sample ID.

Section 8
Measurement Results
8.1.3.2 Measurement Results Display Area

The measurement results searched from the search results are displayed.

① List of measurement results Lists the measurement results of samples selected from the list
of search results.
② Details of measurement Displays details of the measurement results of samples selected
results from the list of measurement results.
• Result Displays concentration of measurement results.
• Judgement*1 Displays the normal range judgement as [H] or [L].
• Technical Range*1 Displays the technical range judgement as [>] or [<].
• Error Flag*1 Displays an error flag.
• R1 Lot No. Displays the lot number of R1 reagent used for measurement.
Displays the absorbance of measurement results.
• Absorbance
Displays an error code of ISE measurement.
• ISE Error*2
Displays the number of cuvette used for measurement.
• Cuvette No.
1 Refer to Section 11.4.
*
2 The ISE unit is an optional component that can be purchased alongside the equipment.
*

Section 8
Measurement Results
8.1.3.3 If Calibrator is Selected in Sample Category

Search Area
⑥ ⑦

① ID Select Fixed to SID.

is selected.
• Specify a value greater than the finishing number for the
starting number.
• An asterisk (*) can be used as a wildcard character in
searches.
• Start Date This is enabled only when the check box is selected. Set the
start date to be searched. If the check box is deselected, all
results that are obtained on or before the search end date can
be searched.
• End Date This is enabled only when the check box is selected. Enter the

Section 8
Measurement Results
④ Round No. Enter the round number to be searched within the range of 1
to 99.
• Enter an asterisk (*) if the round no. is not specified.
the round that was performed will be automatically set.
⑤ Output to Select the output method for the search results.
Refer to Sections 8.2 and 8.3.
⑥ Select Assay Click to show the selection list of assays.
⑦ Select Output ---
⑧ Execute A search of measurement results is executed based on the


Lists the results of a search, based on the specified condition. The measurement results display area shows
details of results selected. The results of measurements just completed can be viewed on this screen. If
there are many searches or display items, hidden information can be viewed by moving the scroll bar.
① ② ③ ④

① Date Displays the measurement date.
② Round No. Displays the round number.
③ Assay Name Displays assay item names.
④ SID Displays the samples ID.

Section 8
Measurement Results
Measurement Results Display Area

The measurement results selected from the search results are displayed.

② Details of measurement results Displays details of the measurement results of samples

selected from the list of measurement results.
• Results Displays concentration of measurement results.
• Judgement*1 Displays the normal range judgement as [H] or [L].
• Technical Range *1 Displays the technical range lodgement s [>] or [<].
• Error Flag*1 Displays an error flag.
Displays the lot number of the calibrators.
• Lot No.
Displays measured concentration.
• Conc.
Displays the number of cuvette used for measurement.
• Cuvette No.
1 Refer to Section 11.4.
*

Section 8
Measurement Results
8.1.3.4 If QC Sample is Selected in Sample Category

Search Area
⑤
⑥
⑦ ⑧

① ID Select Fixed to SID.

• The setting for To is enabled only when the check
box is selected.
• Specify a value greater than the finishing number for
the starting number.
searches.
• Start Date It is enabled only when the check box is selected. Set the
start date to be searched.
If the check box is deselected, all results that are obtained on
or before the search end date can be searched.
• End Date It is only enabled when the check box is selected. Enter the

Section 8
Measurement Results
④ Round No. Enter the round number to be searched within the range of
1 to 99.
• Enter an asterisk (*) if the round number is not
specified.
• After measuring, the number assigned to the round
that was performed immediately up to that point will
be automatically set.
⑤ Host Transfer Status Fixed to All.
⑥ Output to Select the output method for the search results.

⑦ Select Assay Click to show the selection list of assays.
⑧ Select Output ---
⑨ Execute A search of measurement results is executed based on the


The list of the results of a search, based on the specified condition is displayed.
The measurement results display area shows details of results selected in this area. Results of
measurements just completed can be viewed on this screen. If there are many searches or display items,
hidden information can be viewed by moving the scroll bar.
① ② ③ ④

① ID Displays the QC sample names.
② Date Displays the measurement date.
③ Round No. Displays the round number.
④ SID Displays the sample ID.

Section 8
Measurement Results
Measurement Results Display Area


① List of measurement results Lists the measurement results of samples selected from the list
of search results.
② Details of measurement results Displays details of the measurement results of samples
selected from the list of measurement results.
• Result
• Judgement Displays concentration of measurement results.
• Technical Range Displays the normal range judgement as [H] or [L].
• Error Flag Displays the technical range judgement as [>] or [<].
• R1 Lot No. Displays an error flag.
Displays the lot number of R2 reagent used for measurement.
• Absorbance
Displays the absorbance of measurement results.
• ISE Error
Displays an error code of ISE measurement.
• Cuvette No. Displays the number of cuvette used for measurement.
• QC Flag 1 to 3 Displays the QC flags of measurement results.
• QC Lot No. Displays the lot number of QC samples.
• ToDo
*
1. Refer to Section 11.4.
*
2. *The ISE unit is an optional component that can be purchased alongside the equipment.
*
3. The administrator can configure the information to be displayed regarding this item on the QC Range
screen.

Section 8
Measurement Results
8.1.3.5 If Reagent Blank is Selected from Sample Category

Search Area
This area is used to specify search conditions and retrieve measurement results.
⑥ ⑦

① ID Select Fixed to Sample ID.
② From/To Specify the range of IDs to be retrieved.

is ticked.
• Specify a value greater than the finishing number for
the starting number.
searches.
③ Date and Time Set the date and time when the test was run.
It is only enabled when the check box is ticked. Set the start
date to be retrieved.
If the check box is unticked, all results on or before the
search end date can be retrieved.

Section 8
Measurement Results
④ Round No. Enter the round number to be retrieved within the range of 1
to 99.
• Enter an asterisk (*) when not specifying the round
number.
• Immediately after the completion of measurement, the
number assigned to the round performed immediately
up to that point will be automatically set.
⑤ Output No. Select the output method for the search results.
⑥ Select Assay Click to show the selection list of assays.
• Select the assay item to be retrieved from the list.
⑦ Select Output ---
⑧ Execute Measurement results are retrieved based on the specified

condition.
Search results display area

The list of the results of search performed based on the specified condition is displayed. The measurement
results display area shows details of results selected in this area. If there are many searches or display
items, hidden information can be viewed by moving the scroll bar.
① ② ③

② Round No. Displays the round number.
③ Sample ID Displays the sample ID.
Measurement results display area


Section 8
Measurement Results

① List of measurement results Lists the measurement results of a sample selected from the
list of search results.
② Details of measurement results Displays result details of a sample selected from the list of
measurements.
• Displays concentration of measurement results.
• Displays an error flag.
• Displays the lot number of R1 reagent used for
measurement.
• Displays the lot number of R2 reagent used for
measurement.
• Displays the number of cuvette used for
measurement.

Section 8
Measurement Results
8.1.3.6 If Number of Tests is Selected in Sample Category

Search Area

① Date and Time Set the date and time the test was run.
• Start Date It is enabled only when the check box is selected. Set the
start date to be searched. If the check box is deselected, all
results that are obtained on or before the search end date
can be searched.
• End Date It is enabled only when the check box is selected. Enter the
② Round No. Enter the round number to be searched within the range of 1
to 99.
• Enter an asterisk (*) if you do not specify the round
number.
the round that was performed immediately up to
that point will be automatically set.
③ Output to Select the output method for the search results.
④ Execute A search of measurement results is executed based on the

Section 8
Measurement Results
The list of the results of search performed based on the specified condition is displayed.
The measurement results details area shows details of results you selected in this area. You can view the
results of measurements just completed on this screen. If there are many searches or display items, you
can view hidden information by moving the scroll bar.
①
② ③

① Sample Category Displays the number of tests by sample category and the total
number of tests. Clicking each item toggles the view.
• Routine Sample Displays the number of tests on routine samples.
• STAT Displays the number of tests run on STAT samples.
• Calibrator Displays the number of tests run on calibrators.
• QC Sample Displays the number of tests run on QC samples.
• C1 Blank Displays the number of tests run C1 blank samples.
• ISE Calibrator*1 Displays the number of tests run on ISE calibrators.
• ISE Detergent*1 Displays the number of tests run on ISE detergents.
• Reagent Blank Displays the number of tests run on reagent blank samples.
• Total Displays the total number of all tests.
② Sample Displays the number of samples.
③ Number of Tests Displays the number of tests.
1 The ISE unit is an optional component that can be purchased alongside the equipment.
*

Section 8
Measurement Results
8.1.3.7 Time Course Output Settings Area

Used to output a time course. This area is not displayed if Sample Category is set to Number of Tests in
the search area.
② ③
①

① Graph Displays a graphic of time course on the screen.
② Print Prints a time course.
③ File Outputs a time course as a CSV file.
8.1.3.8 Pop-up Window Showing Time Course

If you click Graph in the time course output settings area, a graphic of time course is displayed on a pop-
up window.
①
②

① Graph Graphically displays time courses.
• Prime Represents the time course of the primary wavelength.
• Sec. Represents the time course of the secondary wavelength.
• Prime-Sec. Represents the time course of primary-secondary wavelengths.
② Changing Scale Changes the scale of a graph.

• Auto Automatically adjusts the scale.
• Max./Min. Specify maximum and minimum values for the scale.

Section 8
Measurement Results
8.2 Print Measurement Results

The following options are available:
• Normal Print1: Prints only measurement results.
• Report Print2: Prints patient information and detailed measurement results.
• History Print: Prints a history of measurement results for each patient ID.
*1 This is available only when Sample Category of the measurement results is set to Routine Sample or
STAT.
8.2.1 Set the Report Format

*2 The administrator can specify Report as the print format and the number of copies on the Report
Format screen. The name for each assay can also be changed.
8.2.1.1 Report Format Screen

Settings > Test Settings > Report Format
① ② ③ ④ ⑤
⑥ ⑦
⑬
⑨
⑩ ⑪

① Print header Sets whether or not the header should be printed.
② Lines per page Enter the maximum number of lines per page.
③ Number of copies Enter the number of copies to be printed.
④ Print start position Specify the print staff position with the following parameters:
• OffsetX: Specify the X coordinate of the print start position (20
to 200).
• OffsetY: Specify the Y coordinate of the print start position (20
to 200).
⑤ Scale Specify the magnification ratio for printing (25 to 200).

Section 8
Measurement Results
⑥ Header Specify the contents and display position of the header (Maximum five
lines).
• Line 1: Maximum 20 characters, font size 20 points.
• Lines 2 to 5: Maximum 50 characters, font size 10 points.
The display position can be moved by dragging and dropping.
⑦ Print date and time The positions for printing the date and time can be moved by dragging
and dropping.
⑧ Patient information The positions for printing the following patient information can be moved
by dragging and dropping.
Double-click the item names to be edited:
• Patient: Patient name (up to eight alphanumeric characters and
symbols).
• ID: Patient ID (up to six alphanumeric characters).
• SID: Sample ID (up to six alphanumeric characters).
• Comment: Comments on each sample (up to 12 alphanumeric
• Physician: Name of physician in charge (up to 12 alphanumeric
• Classification: (up to 16 alphanumeric characters and symbols).
• Bed No.: Bed number (up to 12 alphanumeric characters and
symbols).
• CollectionDate: Date when the samples were taken (up to 20
alphanumeric characters and symbols).
• Date: Date of measurement (up to eight alphanumeric
• Time: Time of measurement (up to eight alphanumeric
• Gender: (up to 10 alphanumeric characters and symbols).
• Age: (up to six numeric characters).
• SSNo.: Social security number (up to 10 alphanumeric
• Race: (up to eight alphanumeric characters and symbols).
• Ward: (up to eight alphanumeric characters and symbols).
• BloodType: (up to 12 alphanumeric characters and symbols).
• Reference1: [1] as defined on Operation Settings screen (up to
10 alphanumeric characters and symbols).
• Reference2: [2] as defined on Operation Settings screen (up to
10 alphanumeric characters and symbols).
⑨ Result display The positions for printing the following measurement results can be
moved by dragging and dropping.
• Method.
• Results.
• Units.
• Flag.
• Normal Range.
• R1 Lot: R1 reagent lot number.
• R2 Lot: R2 reagent lot number.
⑩ Import background Imports a background image for printing.
image
• Only PNG format images can be selected.

Section 8
Measurement Results
⑪ Reset Deletes the edited contents and resets the report format to the default.
⑫ Background image Configure the settings of the image imported by 10 with the following
setting parameters:
• Image OffsetX: Specify the X coordinate of the print start
position for the background image (0 to 200).
• Image OffsetY: Specify the Y coordinate of the print start
position for the background image (0 to 200).
• Image Scale: Specify the magnification ratio for the background
image (25 to 400).
⑬ Recycle Unnecessary items can be deleted by dragging and dropping.
8.2.2 Register a Report Format

Edit each report format item.

• To abandon any unsaved changes and
reset the edited contents, click the
Cancel icon ( ).

• The report format is registered.

Section 8
Measurement Results
8.2.3 Edit a Report Format

Edit each report format item.

Cancel icon ( ).

• The report format is changed.
8.2.4 Delete a Report Format



• The report format is deleted, and
returns to the default settings.

Section 8
Measurement Results
8.2.5 Print a Report Format

Display the report format to be printed.

• Each item can be dragged to change
the print layout.

• The report format is printed.
• For information on print settings, refer
to the manual that accompanied the
printer.
NOTE: If the report format has not been registered, the report format will be printed with the initial
values.

Section 8
Measurement Results
8.2.6 Print Measurement Results with Normal Print Format

Routine > Results
Information of up to 20 characters is output to header text 1. The font size is 20 points.

Select Normal Print in Output to.
Click Execute.
• The search for measurement results
is executed with the specified search
condition and the Windows Print
dialog box is displayed.
Check the print settings and start
printing.
refer to the manual that accompanied
the printer.

Section 8
Measurement Results
8.2.7 Print Measurement Results with Report Print Format

Routine > Results
• Information of up to 20 characters is output to header text 1. The font size is 20 points.
• Information of up to 50 characters is output to header text 2 to 5. The font size is 10 points.
Specify the search condition.

Select Report Print in Output to.
Click Execute.
Check the print settings and start
printing.
refer to your printer manuals. Search
results are printed.

Section 8
Measurement Results
8.2.8 Printing Measurement Results with History Print Format

Routine > Results
• Information of up to 20 characters is output to header text 1. The font size is 20 points.
• Information of up to 50 characters is output to header text 2 to 5. The font size is 10 points.

Select Patient History Print in Output

to.
Click Execute.
refer to your printer manuals. Search
results are printed.

Section 8
Measurement Results
8.2.9 Print Time Course

Routine > Results
Print numerical information of time course.

Click Execute.
• A search of measurement results is
executed based on the specified search
condition.

results to print the time course for.
In the measure results display area, select

a measurement result to print the time
course for.

Section 8
Measurement Results
In the time course output settings area,

click Print.
• The Windows Print dialog box is
displayed.
refer to your printer manuals. The
time course is printed.
The time course parameters are represented as follows:
Parameter Description
M Measuring range. M1 is measuring range 1, and M2 is measuring range 2.
S Absorbance of samples. S2 is the absorbance at the primary wavelength,
and S1 is the absorbance at the secondary wavelength.
W Water blank absorbance. W2 is the water blank absorbance at the primary
wavelength, and W1 is the absorbance at the secondary wavelength.
R Reagent blank absorbance. R2 is the reagent blank absorbance at the
primary wavelength, and R1 is the reagent blank absorbance at the secondary
wavelength.

Section 8
Measurement Results
8.3 Output Measurement Results as a File

• Export the measurement results as a CSV file.
• The exported measurement results can be saved in any folder on the operational PC.
8.3.1 Output Measurement Results as a CSV File

Routine > Results

Select File from the Output to drop-

down.
• The measurement results can be
transferred to the host by setting
Output to Host. This is available only
when Sample Category of the
measurement results is set to Routine
Sample or STAT.
Click ( …).
displayed.
Specify the folder to save measurement

results in.

Section 8
Measurement Results
Click Execute.
saved.
• The name of a CSV file is automatically
determined based on the date and time
of search.
8.3.2 Output Time Course as a CSV File

Routine > Results

Click Execute.
• A search of measurement results is
executed based on the specified search
condition.

results to save the time course for.

Section 8
Measurement Results
In the measurement results display area,

select a measurement result to save the
time course for.
In the time course output settings area,

click File.
• The time course is saved.
• The name of a CSV file is
automatically determined based on
the date and time of search.
The time course parameters are represented as follows:
Parameter Description
M Measuring range. M1 is measuring range 1, and M2 is measuring range 2.
S Absorbance of samples.
• S2 is the absorbance at the primary wavelength.
• S1 is the absorbance at the secondary wavelength.
W Water blank absorbance.
• W2 is the water blank absorbance at the primary wavelength.
• W1 is the absorbance at the secondary wavelength.
R Reagent blank absorbance.
• R2 is the reagent blank absorbance at the primary wavelength.
• R1 is the reagent blank absorbance at the secondary wavelength.

Section 9
Maintenance
SECTION 9
MAINTENANCE
This chapter explains the procedures for maintaining the safety and
performance of the instrument.

Section 9
Maintenance
Section 9 Maintenance ..........................................................................................................9—1
9.1 Overview.....................................................................................................................9—3
9.2 Unit Maintenance Screen ......................................................................................... 9—4
9.3 Work Hour Counter Screen .................................................................................... 9—6
9.4 Daily Inspection and Cleaning .................................................................................. 9—7
9.4.1 Management of Reagent Bottles ................................................................................................ 9—7
9.4.2 Sample Disposal.......................................................................................................................... 9—7
9.4.3 Replenish Detergents ................................................................................................................. 9—7
9.4.3.1 Check and Replace Detergent Bottles .............................................................................. 9—7
9.4.3.2 Check of Detergents .......................................................................................................... 9—9
9.4.4 Lamp Operation Time - Check ............................................................................................... 9—10
9.4.4.1 Water Blank Absorbance Check ..................................................................................... 9—10
9.4.4.2 Maintenance > System Monitor > Water Blank Absorbance ....................................... 9—10
9.4.5 Sample Pipette Unit - Inspection and Cleaning ....................................................................... 9—12
9.4.5.1 Internal Pipette Cleaning .................................................................................................. 9—14
9.4.6 Reagent Pipette Units - Inspection and Cleaning .................................................................... 9—15
9.4.6.1 Inspection ......................................................................................................................... 9—15
9.4.6.2 Exterior Cleaning .............................................................................................................. 9—15
9.4.6.3 Internal Pipette Cleaning .................................................................................................. 9—17
9.4.7 Washing Unit - Inspection and Cleaning ................................................................................. 9—17
9.4.8 Mix Units - Inspection and Cleaning ........................................................................................ 9—19
9.5 Weekly Inspection and Cleaning............................................................................ 9—21
9.5.1 Troughs - Inspection and Cleaning .......................................................................................... 9—21
9.5.2 Sample Carousel - Inspection and Cleaning ............................................................................ 9—21
9.5.3 Reagent Carousel - Inspection and Cleaning .......................................................................... 9—24
9.5.4 Work Table - Inspection and Cleaning ................................................................................... 9—27
9.5.5 Water Blank Absorbance Check 1 .......................................................................................... 9—27
9.5.6 Water Blank Absorbance Check 2 .......................................................................................... 9—28
9.5.7 Wash Cuvettes ......................................................................................................................... 9—29
9.5.8 Perform a Cuvette C1 Solution Soak ...................................................................................... 9—31
9.6 Maintenance Work Performed by the Administrator ......................................... 9—32
9.6.1 Replace the Halogen Lamp ...................................................................................................... 9—32
9.6.1.1 Lamp Post-replacement Check ....................................................................................... 9—35
9.6.2 Fluidic Wash ............................................................................................................................. 9—36
9.6.2.1 Wash Procedure .............................................................................................................. 9—37
9.6.3 Remove Pipette Blockages ....................................................................................................... 9—40
9.7 Maintenance by Service Engineers ........................................................................ 9—42

Section 9
Maintenance
9 Maintenance
9.1 Overview
The items for the inspection after the completion of work are as follows.
Item Frequency
Management of reagent bottles
Sample disposal
Check of detergents
Check of lamp operation time
Daily
Inspection and cleaning of sample pipette
Inspection and cleaning of reagent pipettes
Inspection and cleaning of washing units
Inspection and cleaning of mixing units
Inspection and cleaning of troughs
Inspection and cleaning of sample carousel
Inspection and cleaning of reagent carousel At least once a week
Inspection and cleaning of work table
Check of water blank absorbance

Section 9
Maintenance
9.2 Unit Maintenance Screen

Routine > Unit Maintenance
This is used as the function screen for regular inspections, periodic maintenance and consumable
replacement.
⑪
①
②
③
④
⑤
⑥
⑦
⑧
⑨
⑩

① Initialise Returns each unit to its initial position.
② Prime Fills the tubes with purified water and detergent to

remove any air from inside. Enter the number of times to
fill. (0 to 5 times)
③ Check Water Blank Measures water blank to judge the quality of the cuvettes.
Measurement is performed for all cuvettes in all
wavelengths. Check the measurement results in the
Water Blank Absorbance screen.
④ Wash Cuvettes Washes the cuvettes.
⑤ Fill Cuvettes Fills the cuvettes with purified water or detergent.
⑥ Empty Cuvettes Empties the purified water or detergent inside the

cuvettes.
⑦ Ascend/descend stirrers Ascends or descends the mixing unit.
⑧ Ascend/descend washer Ascends or descends the washing unit.
⑨ Fluidic Wash Performs the fluidic wash.

The fluidic wash must be performed periodically to
prevent bacteria, etc. from forming in the tubes or
subtank.

Section 9
Maintenance

⑩ Wash Sequence Select the check box of the washing method for each unit.
• Trough Wash - Select this check box to wash in
trough.
• Internal Wash - Select this check box to wash
the inside of the pipettes.
• Deep Wash - Select this check box to wash the
sample pipette in a wider range than normal.
• Soak Wash - Select this check box to wash the
outside of the pipettes.
⑪ Pump Test Configure the amount of time and type of pump to test.

Section 9
Maintenance
9.3 Work Hour Counter Screen

Maintenance > System Monitor > Work Hour Counter
①
②
③ ⑤
④ ⑥

① Total Working Hours Displays the total working hours of the analyser.
② Total Number of Tests Displays the number of test.
③ Halogen Lamp Displays the remaining operation time until halogen lamp
replacement.
(Replacement cycle: 1,000 hours)
④ Periodic Maintenance Displays the remaining number of days until periodic maintenance.
• 6 Months - Displays the remaining number of days until
the 6-month periodic maintenance.
• 1 Year - Displays the remaining number of days until the
1-year periodic maintenance.
⑤ Plunger Seal Displays the remaining operation time until plunger seal
replacement.
⑥ Detergent Bottle Displays the remaining operation time until detergent bottle
replacement.
⑦ ISE Displays the remaining operation time until ISE maintenance.
NOTES:
• After replacing consumables, click the Reset button to reset the remaining time.
• The alarm sounds when the remaining hours or number of tests reaches 0 or less.
• Click the Print icon ( ) on the lower part of the screen to print the displayed content.

Section 9
Maintenance
9.4 Daily Inspection and Cleaning

The following explains the inspection and cleaning work to be performed daily.
9.4.1 Management of Reagent Bottles

After use, store the reagent bottles correctly, according to the instructions on the package insert.
9.4.2 Sample Disposal

After use, dispose the samples correctly, according to the rules of your facility.
9.4.3 Replenish Detergents

The detergents used in this analyser are as follows.
Product Name Term Used in this Usage

Manual
Wash Solution #3 Used for cuvette washing by the washing unit.
Wash Solution #3 is an acidic detergent, and
Wash Solution #9 Detergent Wash Solution #9 is an alkaline detergent.
Placed inside the front door.
Wash Solution c-1 Used for special washing, such as the internal
washing of sample pipette, reagent pipettes, and
C-1 Solution fluidic washing.
Must be placed in the sample carousel or reagent
carousel.
Wash Solution #10 Neutral detergent Used for applications such as exterior cleaning.
9.4.3.1 Check and Replace Detergent Bottles
Open the front door on the front of the

analyser to check the detergent bottles.
• Check that the detergent amounts
are sufficient. If the detergent
amounts are insufficient, proceed to
step 2 and replenish detergents.

Section 9
Maintenance
Prepare a new detergent bottle.

Pull out a detergent bottle away from the
analyser.
Remove the cap of the detergent bottle and

remove the tube.
Put the detergent bottle to one side.

• Dispose of the bottle correctly after
this procedure is complete.
Open the new detergent bottle and insert

the tube.

Section 9
Maintenance
Close the cap of the detergent bottle.
Put the detergent bottle back into its

original position.
Close the front door.
9.4.3.2 Check of Detergents

Check that the amount of C-1 solution used for special washing and the amount of neutral detergent used
for exterior cleaning are sufficient. If the remaining volume is low, replenish the detergent bottles.

Section 9
Maintenance
9.4.4 Lamp Operation Time - Check
Navigate to Maintenance > System Monitor > Work Hour Counter.
In the Halogen Lamp field, check that the

operating time is within the operation life
range.
• If it is not within the available
range, replace the halogen lamp.
NOTE: The remaining time (count) in the [Halogen Lamp] field is displayed in yellow when the value is
low and in red when the value reaches zero. If the value is displayed in red, the halogen lamp should be
replaced.
9.4.4.1 Water Blank Absorbance Check
9.4.4.2 Maintenance > System Monitor > Water Blank Absorbance
③
①
④ ⑦ ⑧
⑨ ⑩
⑥
No. Item Description

Name
① Wavelength When the wavelength is selected, the measurement results are displayed.
② Date and When the date and time are selected, the measurement results are displayed.
Time The results for the past 20 measurements can be displayed.
③ Water Blank Displays the water blank measurement results for each cuvette. When this
Absorbance screen is displayed during water blank measurement, the values are updated in
real time.
Cuvettes exceeding the threshold in the selected wavelength are displayed in
red, and cuvettes exceeding the threshold in other wavelengths are displayed
in yellow.
④ Cuvette No. Displays the number of the cuvette selected from the cuvette list.

Section 9
Maintenance
⑤ Period Specify up to how many past measurements to display the water blank
absorbance.
⑥ Threshold Set the threshold for water blank measurement (unit: mAbs/10). (Initial
setting: 5,000)
⑦ Auto Adjust Set the function for automatically adjusting the display range of the water blank
absorbance chart.
⑧ Max./Min. Change the display range of the chart manually.
⑨ Export Saves the saved water blank absorbance in a file. The water blank absorbance
for the past 3 months can be saved. The daily average values are calculated
and saved.
⑩ Replace This function is used by service engineers.
Cuvettes
While the water blank absorbance is being exported, do not remove the storage medium
containing the save location of the data or turn off the power source of the operational PC.
NOTE: Click the Print icon ( ) on the lower part of the screen to print the displayed content.

Section 9
Maintenance
9.4.5 Sample Pipette Unit - Inspection and Cleaning

Inspection:
Inspect the following items:
• Are the samples correctly dispensed during measurement?
• Are the pipette outer walls dirty?
• Is there leakage from the top of the pipette?
• Is the pipette bent?
Exterior Cleaning:
Make sure the exterior of the sample pipette is cleaned daily after the completion of work.
• Make sure that each moving part has
stopped.
• Wear protective gloves to prevent skin
contact with fluids.
• When rotating the sample pipette or
manually moving it up and down, hold the
area near the shaft, not the pipette area or
the end of the arm.
• Protect the top of the incubator during
work to prevent the adherence of foreign
matter such as dirt, fluid or dust to the
cuvettes.
• The alcohol used for cleaning is flammable.
Make sure that there are no flames in the
surrounding area before use.
• Be careful not to cut yourself accidentally on the end of the pipette while cleaning.
• Do not use excessive force when wiping the pipette. For the analyser to function correctly, it is
important that the pipette is vertical. If it is not vertical, it may cause pipette damage or
inaccurate measurement results.
Wipe after cleaning to ensure that no drops of fluid remain.
Check the status display and confirm that all functions have stopped.
Rotate the sample pipette unit and manually

move it up and down to enable cleaning up
to the end of the pipette.

Section 9
Maintenance
Wipe the pipette from the top to the end

using a gauze soaked in alcohol.
Wipe the sample pipette cover with a gauze

soaked in neutral detergent.

Section 9
Maintenance
9.4.5.1 Internal Pipette Cleaning

Make sure to perform internal sample pipette cleaning daily after the completion of work.
• In addition to the following procedure, execution of pipette washing can be set before and after
sleep on the Sleep and Wakeup screen.
Fill a sample cup or sample tube with C-1 solution diluted 100 times and place it on the sample
carousel.
• Refer to Section 2.1.2.
• When using sample barcodes, proceed to step 6.
From the sample list on the left or the

Pos. (From) drop-down menu, select the
placement positions of the detergents.
Select Sample Pipette Detergent

from Sample Category.

• When Sample Pipette Detergent is
selected in Sample Category,
“960000201” is added automatically
as the Sample ID.
• In order registration for sample pipette detergents, a template function can be used to register
a combination of sample placement positions and orders in advance, which can be called later.
When templates are registered, the required settings can be called and used from Template
on the Worklist screen.
• The administrator can configure the settings of the template from the Template screen.
Navigate to Routine > User Maintenance.

Section 9
Maintenance
In the Wash Sequence field, select the

Internal check box in the SPT line.
Click the () button.

• The internal sample pipette cleaning
starts.
9.4.6 Reagent Pipette Units - Inspection and Cleaning

9.4.6.1 Inspection
Inspect the following items.
• Are the reagents correctly dispensed during measurement?
• Is there leakage from the top of the pipettes?
• Are the pipettes bent?
9.4.6.2 Exterior Cleaning

Make sure to clean the exterior of the reagent pipette units daily after the completion of work.
stopped.
• Wear protective gloves to prevent the
fluid from making direct contact with
your skin.
• When rotating the sample pipette or
manually moving it up and down, hold the
area near the shaft, not the pipette area
or the end of the arm.

Section 9
Maintenance
• Protect the top of the incubator during work to prevent the adherence of foreign matter such
as dirt, fluid or dust in the cuvettes.
• The alcohol used for cleaning is flammable. Make sure that there are no flames in the
surrounding area before use.
• Be careful not to cut yourself accidentally on the end of the pipette while cleaning.
• Do not use excessive force when wiping the pipette. For the analyser to function correctly, it is
important that the pipette is vertical. If it is not vertical, it may cause pipette damage or
• Wipe after cleaning to ensure that no drops of fluid remain.
Rotate the reagent pipette units and move

them up and down manually to enable
cleaning up to the end of the pipettes.
Wipe the pipettes from the top to the end

using a gauze soaked in alcohol.
Wipe the reagent pipette covers with a

gauze soaked in neutral detergent.

Section 9
Maintenance
9.4.6.3 Internal Pipette Cleaning

Be sure to perform internal reagent pipette cleaning daily after the completion of work.
• In addition to the following procedure, execution of pipette washing can be set before and after
sleep on the Sleep and Wakeup screen.
Check that reagent bottles containing C-1 solution are placed on the reagent carousel.
In the Wash Sequence field, select the

Internal check box in the RPT1 line or
RPT2 line.
Click the () button.

• The internal reagent pipette cleaning
starts.
9.4.7 Washing Unit - Inspection and Cleaning

Inspection:
Inspect the following items.
• Are the supply and drainage nozzle outer walls dirty?
• Is there leakage from the top of the supply and drainage nozzles?
• Are the supply and drainage nozzles bent?
Cleaning:
Make sure to clean the washing unit daily after the completion of work:
• Make sure that each moving part has stopped.
• Wear protective gloves to prevent the fluid from making direct contact with your skin.
• Protect the top of the incubator during work to prevent the adherence of foreign matter such as
dirt, fluid or dust to the cuvettes.
• The alcohol used for cleaning is flammable. Check that there are no flames in the surrounding area
before use.
• Do not use excessive force when wiping the nozzles. For the analyser to function correctly, it is
important that the nozzles are vertical. If they are not vertical, it may cause nozzle damage or

Section 9
Maintenance
Click Ascend Washer.

• The washing unit ascends from the
operating position to the cleaning
position.
Wipe the supply and drainage nozzles

with a cotton swab soaked in alcohol,
taking care not to bend the nozzles.
Wipe the washing unit cover with a gauze
soaked in neutral detergent.
After the completion of cleaning, click

Descend Washer.
• The washing unit descends from
the cleaning position to the
operating position.

Section 9
Maintenance
9.4.8 Mix Units - Inspection and Cleaning

Inspection:
• Are the reagents correctly dispensed during measurement?
• Is there leakage from the top of the pipettes?
• Are the pipettes bent?
Exterior Cleaning:
Be sure to clean the exterior of the reagent pipette units daily after the completion of work.
• Before cleaning make sure that each moving part has stopped.
• When rotating the reagent pipettes or moving them up and down manually, hold the area near the
shaft, NOT the pipette area or the end of the arm.
• Protect the top of the incubator during work to prevent the adherence of foreign matter such as
dirt, fluid or dust to the cuvettes.
• The alcohol used for cleaning is flammable. Check that there are no flames in the surrounding area
before use.
• Be careful not to cut yourself accidentally on the end of the pipettes while cleaning.
• Do not use excessive force when wiping the pipettes. For the analyser to function correctly, it is
important that the pipettes are vertical. If they are not vertical, it may cause pipette damage or
• Wipe after cleaning to make sure that no drops of fluid remain.
Click Ascend Stirrer.

The stirrers ascend from the operating
position to the cleaning position.

Section 9
Maintenance
Wipe the stirrers with a cotton swab

soaked in alcohol, taking care not to bend
the stirrers.
Wipe the reagent pipette covers with a

gauze soaked in neutral detergent.
After the completion of cleaning, click

Descend Stirrer.
The stirrers descend from the cleaning

position to the operating position.

Section 9
Maintenance
9.5 Weekly Inspection and Cleaning

The following explains the inspection and cleaning work to be performed approximately once a week.
9.5.1 Troughs - Inspection and Cleaning

• Are the troughs dirty?
• Are the troughs deformed?
Cleaning:
Clean the troughs approximately once a week.
• Make sure to check that each moving part has stopped.
1. Clean the troughs with a cotton swab soaked in C-1 solution.
9.5.2 Sample Carousel - Inspection and Cleaning

Inspection:
Inspect the following item:
• Is the inside of the sample carousel dirty?
Cleaning:
Clean the inside of the sample carousel approximately once a week.
stopped.
• Wear protective gloves to prevent fluid
making direct contact with your skin.
• When rotating the reagent pipettes or
moving them up and down manually, hold
the area near the shaft, NOT the pipette
area or the end of the arm.
• Wipe after cleaning to make sure that no
drops of fluid remain.

Section 9
Maintenance
Check that the sample pipette is not on the

sample carousel.
• If the sample pipette is on the sample
carousel, move it slowly by holding
the area near the shaft.
While holding the handle, remove the

sample carousel cover.
Remove all the holders.

• There is a pin on the bottom of each
holder that fits into the holes on the
When removing a holder, pull it
straight up.

Section 9
Maintenance
Wipe the removed holders and sample

carousel cover with a gauze soaked in
neutral detergent.
Wipe the inside of the sample carousel with

a gauze soaked in neutral detergent.
After the completion of cleaning, place all

the holders back into the sample carousel.
• Place the holders in the positions of
the sample carousel labelled with the
same numbers as the holders.
• Insert each holder straight into the
sample carousel until the pin in its
bottom engages the hole in the
carousel.

Section 9
Maintenance
Put the sample carousel cover back into

place.
• Make sure that the sample carousel
9.5.3 Reagent Carousel - Inspection and Cleaning

Inspection
• Is the inside of the reagent carousel dirty?
Cleaning
Clean the inside of the reagent carousel

approximately once a week.
• Ensure that moving parts have stopped.
• Wear protective gloves to prevent fluid
making direct contact with your skin.
• Wipe after cleaning to make sure that no
• When rotating the reagent pipettes or
moving them up and down manually, hold
the area near the shaft, NOT the pipette
area or the end of the arm.
• Wipe after cleaning to ensure that no
Make sure that the reagent pipettes are not on the sample carousel.
• If reagent pipettes are not on reagent carousel, move them slowly by holding the shaft.
Remove the reagent carousel cover.

Section 9
Maintenance
Open the reagent carousel cover.
Remove all the holders.

• When removing a holder, pull it
straight up.
Wipe the removed holders and reagent

carousel cover with a gauze soaked in
neutral detergent.

Section 9
Maintenance
Wipe the inside of the reagent carousel with

a gauze soaked in neutral detergent.
• Completely wipe off any form of
water.
After the completion of cleaning, place the

holders back into the reagent carousel.
• Place the holders in the positions of
the reagent carousel labelled with the
same numbers as the holders.
Put the reagent carousel cover back into

place.
• Make sure that the reagent carousel

Section 9
Maintenance
9.5.4 Work Table - Inspection and Cleaning

Inspection
• Is the work table dirty?
Cleaning
Clean the work table approximately once a week.
• Make sure that each moving part has stopped.
• Wear protective gloves to prevent fluid making direct contact with your skin.
• Wipe after cleaning to make sure that no drops of fluid remain.
1. Wipe the surface and exterior of the

work table with a gauze soaked in
neutral detergent.
9.5.5 Water Blank Absorbance Check 1
Navigate to Maintenance > System Monitor > Water Blank Absorbance.
Check that there is no red or yellow

background colour on the screen.
• If there is red or yellow
background colour, the cuvettes
must be washed or the optical unit
must be inspected. Contact the
administrator.

Section 9
Maintenance
9.5.6 Water Blank Absorbance Check 2
Display the User Maintenance screen.
Click the Check Water Blank button.

The water blank measurement is
performed.
Display the Water Blank Absorbance

screen.
• The absorbance of the water blank
measurement performed in Step 2
is displayed.
• Measurement is performed for all
cuvettes in all wavelengths.
Check that no cuvettes are displayed in

red or yellow.
NOTE: Values exceeding the threshold in the selected wavelength are displayed in red, and values
exceeding the threshold in other wavelengths are displayed in yellow.
• If 51 or more cuvettes exceed the threshold, measurement cannot start.
• When a cuvette is displayed in red or yellow, perform Cuvette Wash.

Section 9
Maintenance
9.5.7 Wash Cuvettes
Display the User Maintenance screen.
Click the Wash Cuvettes button.

The cuvette wash is performed.
Click the Check Water Blank button.

• The water blank measurement is
performed.
The Water Blank Absorbance screen is

displayed.
• The absorbance of the water blank
measurement performed in Step 3 is
displayed.
• Measurement is performed for all
cuvettes in all wavelengths.
Check that no cuvettes are displayed in

red or yellow.

Section 9
Maintenance
NOTES:
• If a cuvette is displayed in red or yellow even after washing the cuvette, the halogen lamp must
be replaced. For the replacement procedure, refer to Section 9.7.1. After replacing the halogen
lamp, check the water blank absorbance again.
• If the water blank absorbance exceeds the threshold even after replacing the halogen lamp,
cuvette replacement may be required. Contact your Randox Representative.

Section 9
Maintenance
9.5.8 Perform a Cuvette C1 Solution Soak
Register C1 Solution as a Detergent as

shown opposite.
Settings>Assay settings 2>Reagent

code>Enable Detergent.
Choose a detergent for cuvettes.
Settings>Advanced
Settings>Operator Settings.
Choose C1 Wash from the drop-down list

as shown opposite.
Click the Save button.
Perform the C1 soak.
Maintenance>System
Maintenance>Unit Maintenance
Choose Wash Solution from the drop

down menu.
Click the Save button.
Click Pour water into cuvette (This will
take 35 minutes).
After a 30 minutes soak, click Waste
water from cuvettes.

Section 9
Maintenance
9.6 Maintenance Work Performed by the Administrator

No. Item Frequency
1 Check of optical unit As appropriate
2 Replacement of halogen lamp Every 1,000 hours of use (*)
3 Fluidic wash Every 2 weeks
4 Pipette clot removal As appropriate
5 Backup creation At least once a week
* 1000 hours is approximately 6 months of use at 8 hrs per day for 20 days per month.
9.6.1 Replace the Halogen Lamp

The halogen lamp must be replaced when the operation time exceeds 1,000 hours.
• A Phillips screwdriver is required for this work.
The lamp case becomes hot. Perform the work after turning off the power source of the
analyser and waiting for at least 30 minutes.
Do not touch the glass surface of the halogen lamp with bare hands. Grease from your
hands may adhere to the glass and cause a malfunction.
Loosen the screw and remove the lamp

cover.
Disconnect the connector of the halogen

lamp.
Loosen the screw of the lamp case (the

screw of the lamp case cannot be
removed).

Section 9
Maintenance
Hold the handle and remove the lamp case.
Remove the 2 screws (M3 x 8), and then

remove the halogen lamp.
Install a new halogen lamp and tighten the 2
screws (M3 x 8).
Hold the handle and install the lamp case in

its original position.
Tighten the screw of the lamp case.
Connect the connector of the halogen lamp.

Section 9
Maintenance
Install the lamp cover in its original position,

and tighten the screw.

Section 9
Maintenance
9.6.1.1 Lamp Post-replacement Check
Navigate to Maintenance > System Monitor > Work Hour Counter.
Click the Reset button of the halogen

lamp.
The operation time is reset.
Navigate to Maintenance > System Maintenance > DTR Adjustment.
Click the Automatic Gain button to

perform gain adjustment.
Check that the gain value of each

wavelength is 10 or higher.
• The alarm sounds when automatic gain fails. Contact your Randox Representative.
• If the gain value of each wavelength is less than 10, contact your Randox Representative.
Click Check Voltage.
Check that there are no items displayed

in red in the Voltage field of each
wavelength.
NOTE: If an item in the Voltage field of each wavelength is displayed in red, contact your Randox
Representative.

Section 9
Maintenance
9.6.2 Fluidic Wash
Prepare 5 litres or more of C-1 solution

diluted 100 times.
Open the front door on the left side.
Insert the accessory fluidic wash tube into

the maintenance supply port.
Insert the fluidic wash tube into the C-1
solution prepared in Step 1.

Section 9
Maintenance
9.6.2.1 Wash Procedure
NOTE: Perform the following Tube Wash procedure every 2 weeks to prevent tubes and sub-tank
from bacteria.
Preparation
No. Name Qty

1 Purified Water 1 litre
2 C1 diluent (wash solution C-1 100 times dilution) 5 litre
3 5 litre tank 1
4 1 litre graduated cylinder 1
5 Paper towel -
Precautions when using Wash Solution C-1

Check the expiry date on the label of wash solution C-1. (6 mouths expiry date after opening).
Prepare wash solution C-1 diluent. (Follow the instructions on the label).
• Use purified water (ion-exchanged water). If tap water is used, brown deposits (iron) or white
deposits (calcium chloride) may be produced after several days.
• If the product expires, sodium hypochlorite contained in the product is decomposed and effective
chlorine is reduced.
• Dispose of an expired product in accordance with local legislation.
Do NOT mix the product with acidic material.
Do NOT allow product contact with metals including zinc, iron, ferric oxide, copper, copper alloy,
etc. They will become corroded.
When re-sampling the product into another container, make sure the container is completely clean
and dry. (Wash and dry as appropriate).
Tube Wash Procedure
Click the Tube Wash button.
Fill a 1 litre container with purified water and 5 litre tank with C-1 diluent.
Remove the tubes from the detergent bottles and insert them into the 1 litre container.

Section 9
Maintenance
Place absorbent paper towel(s) onto SPT

trough 2 to capture excess purified water
produced during the wash process.
The detergent tubes are filled with

purified water. Wait for the designated
time to pass.
After the designated time, insert the maintenance supply tube and detergent tubes into the 5 litre
tank (filled with C-1 diluent).
The tubes are filled with C-1 solution.

Wait for the designated time to pass.
The following dialog appears after 20

minutes to perform a soaking wash with
C-1 diluent. Wait for the designated time
to pass.

minutes.
Insert the maintenance supply tube and
detergent tubes into the container filled
with purified water.

Section 9
Maintenance
The tubes are filled with purified water.

Wait for the designated time to pass.

minutes. Remove the tubes from the
container and wipe with a clean paper
towel.
Install the detergent tubes to the

detergent bottles and close the door.
Perform the prime and wait for the

designated time to pass.
The tube wash is complete.

Section 9
Maintenance
9.6.3 Remove Pipette Blockages

• Wear protective gloves to prevent the fluid from making direct contact with
your skin.
• After turning off the power source of the analyser, remove the pipette blockage.
• When manually rotating up and down, hold the area near the shaft, NOT the end
of the arm.
• Protect the top of the incubator during work to prevent the adherence of foreign
matter such as dirt, fluid or dust to the cuvette.
• Be careful not to cut yourself on the end of the pipette while cleaning.
Turn off the power source of the analyser and the PC.
Hold the shaft, pull up the pipette arm and

move it through the trough.
Loosen the 4 screws (M3 x 8) and remove the pipette cover.

Section 9
Maintenance
NOTE: In the subsequent steps, the clot will fall down from the tip of the pipette. Put a cloth under the
tip of the pipette in advance to receive the clot that will fall down.
Loosen the joint and remove the tube from the

pipette.
Thread the pipette cleaning jig from the joint

area into the pipette.
Push out the clot with the pipette cleaning jig.
Remove the pipette cleaning jig.
Tighten the joint and install the tube onto the

pipette.

Section 9
Maintenance
Install the pipette cover and tighten the 4 screws (M3 x 8).
After turning on the power source of the analyser, clean the inside of the pipettes.
9.7 Maintenance by Service Engineers

To use the analyser correctly and safely, in addition to user maintenance, periodic maintenance and the
replacement of periodic maintenance parts must be performed by a service engineer.
For details on service engineer maintenance, contact your Randox Representative.

Section 10
Miscellaneous Settings
SECTION 10
MISCELLANEOUS SETTINGS
This chapter explains the various settings of

the analyser and operation software.

Section 10
Section 10 Miscellaneous Settings ..................................................................................... 10—1
10.1 Change Device Settings ........................................................................................ 10—4
10.1.1 Host Communication Settings ................................................................................................. 10—5
10.1.2 Sample ID Settings .................................................................................................................... 10—6
10.1.3 Automatic Print Settings........................................................................................................... 10—7
10.1.4 Notification Sound Settings ...................................................................................................... 10—8
10.1.5 Other Device Settings .............................................................................................................. 10—9
10.2 Operation Settings ..............................................................................................10—10
10.2.1 Operation Settings Screen ..................................................................................................... 10—10
10.2.1.1 Change Operation Settings ............................................................................................ 10—11
10.3 User Accounts .....................................................................................................10—12
10.3.1 Administer User Accounts ..................................................................................................... 10—12
10.3.1.1 User Accounts Screen.................................................................................................... 10—12
10.3.1.2 Add a User Account ...................................................................................................... 10—13
10.3.1.3 Change the Password/User Level................................................................................. 10—14
10.3.1.4 Delete a User ................................................................................................................. 10—16
10.3.2 List of Available Screens by User Level ................................................................................. 10—17
10.4 Backup ..................................................................................................................10—18
10.4.1 Backup Screen ........................................................................................................................ 10—18
10.4.2 Data Backup............................................................................................................................ 10—19
10.4.2.1 Save the Database .......................................................................................................... 10—19
10.4.2.2 Load a Backup the Database ......................................................................................... 10—20
10.4.2.3 System Parameters Backup ............................................................................................ 10—21
10.4.2.4 Load System Parameters ............................................................................................... 10—22
10.4.3 Automatic Backup .................................................................................................................. 10—23
10.4.3.1 Set the Automatic Backup Function .............................................................................. 10—23
10.4.3.2 Load Automatic Backup Data........................................................................................ 10—24

Section 10
10 Miscellaneous Settings
Settings > Advanced Settings > Device Settings
① ② ③ ④
⑥
⑤

① Host Communication Set each item for host communication.
② Sample ID Set each item for sample IDs.
③ Remote Maintenance Set each item for the transfer of maintenance data.
④ Others Set various other items.
⑤ Automatic Print Set each item for automatic printing.
⑥ Warning Sound Set each item for the notification sound.

Section 10
10.1 Change Device Settings

Edit each item.
• To reset the edited contents,
click the Cancel icon ( ).
• For details on the host
communication settings, refer to
Section 10.1.1.
• For details on the sample ID settings,
refer to Section 10.1.2.
• For details on the automatic print settings, refer to Section 10.1.3.

• For details on the notification sound settings, refer to Section 10.1.4.
• For details on other settings, refer to Section 10.1.5.

• The changed content is stored in the
system.

Section 10
10.1.1 Host Communication Settings

① Communication Select the host communication mode.
Mode
• Offline - Used to perform measurement according to the
orders set on the operational PC, without communicating with
the host computer. The host computer is not notified of the
• Online Batch - Used to communicate with the host computer
and inquire for orders manually. The retrieved orders are
registered in the software, and then measurement is performed
according to the orders. The host computer is notified
automatically of the measurement results.
• Online Real Time - Used to communicate with the host
computer and perform measurement according to the retrieved
orders. Reading the barcode labels on the sample carousel,
inquiring the host computer for orders and measurement are
performed automatically. The host computer is notified
automatically of the measurement results.
② Rerun Mode Configure the settings of host rerun mode.
Set when Communication Mode is Online Real Time.
• No Requery - Does not re-inquire the host computer for
orders.
• Requery - Re-inquires the host computer for orders, and
performs host rerun only if there is a request.
• Host Rerun - Re-inquires the host computer for orders, and
performs host rerun if there is a response.
③ Baud Rate Select the baud rate from 19200, 9600, 4800, 2400, 1200 and 300.
(initial setting: 9600).

Section 10
④ Data Bit Select the data bit from 7 bit and 8 bit.
(initial setting: 8 bit).
⑤ Stop Bit Select the stop bit from 1 bit and 2 bit.
(initial setting: 1 bit).
⑥ Parity Bit Select the parity bit from None, Even and Odd.
(initial setting: Even).
⑦ Protocol (E1318) Select the protocol from Normal and No Handshake.
(initial setting: Normal).
10.1.2 Sample ID Settings

Settings for various functions of sample IDs can be configured and the information can be checked.
② ③
④
⑤

① Sample ID Select the generation method for sample IDs.
Increment
• Numeric
• Alphanumeric (Uppercase only)
• Alphanumeric
(Initial setting: Numeric)
② Sample ID Prefix Enter the prefix for the sample IDs. The entered prefix is applied to all
sample IDs (up to 14 digits).
③ Total Digits Specify the total number of digits for the sample IDs (up to 15 digits).
The number of digits when the prefix is subtracted from the overall
number of digits is the number of digits in the automatically generated
sample IDs (initial setting: 15).
④ Sample Barcode Switches between enabling and disabling the sample barcodes.
• Enable
• Disable
(Initial setting: Disable)

Section 10
⑤ Barcode Type Up to 4 barcode types can be specified for use as the sample barcodes.
This can only be set when Sample Barcode is Enable.
• UPC (JAN): with check digit
• NW7: with/without check digit
• Code39: with/without check digit
• ITF: with/without check digit
• Code128: with check digit
10.1.3 Automatic Print Settings

Set whether to print automatically when a printer is connected.

① Automatic Print When the check box is selected, the measurement results are printed
automatically after the end of measurement. Select the print format from
Normal and Report (when a printer is connected).
② Automatic QC When the check box is selected, the measurement results are printed
Print automatically at the end of QC measurement (When a printer is
connected).
NOTES:
• When the Automatic Print check box is selected, the print format can be selected.
• For details on report registration, refer to Section 8.2.2.

Section 10
10.1.4 Notification Sound Settings

Various settings can be configured and the information can be checked for the notification sound at the
end of sampling or when an alarm or other alert occurs.
①
②

① Level Set the error level at which to sound the alarm.
• None: The alarm does not sound.
• Emergency Stop: When the analyser performs an emergency
stop (Level 1)
• Sampling Stop: When sampling stops (Level 2) (*1)
• Alarm: When there is a warning from the analyser (Level 3) (*1,
*2)
② Round Complete Select the check box to sound a notification sound at the end of sampling.
Sound (Initial setting: ON)
③ Notification Sound Set the notification time for the notification sound at the end of
at the End of measurement. To disable notification, set OFF.
Measurement
To not set a time, set 0.
(Initial setting: 15)
④ Sound Volume Set the sound volume of the notification sound at the end of sampling and
measurement from 10 levels.
• Mute: The sound volume is 0.
• 1 to 9: The sound volume rises as a higher value is set. (Initial
setting: 3)
*1. The alarm sounds when Level 1 is set.

*2. The alarm sounds when Level 2 is set.
NOTES:
• When the sound volume is set to Mute, the notification sound does not sound regardless of
the level setting.
• When the round complete sound is set to OFF, the notification sound does not sound.

Section 10
10.1.5 Other Device Settings

Various settings can be configured and the information can be checked for the notification sound at the
end of sampling or when an alarm or other alert occurs.
①
②
③
④

① Automatic Reagent When the check box is selected, the reagent barcodes are scanned
Scan automatically when the reagent carousel is closed. (Initial setting: ON)
② Reagent Volume When the check box is selected, the reagent volume is checked at the
Check start of measurement. (Initial setting: ON)
③ Lamp Power Save When the check box is selected, lamp power save mode is enabled.
Mode (Initial setting: OFF)
④ Print Test Sequence When the check box is selected, printing with the general ID is
Number performed. (Initial setting: OFF)
⑤ Result Zero Output When the check box is selected, the result zero output setting is enabled.
(Initial setting: OFF)
⑥ Remaining Test Select the calculation method of Total Number of Tests (how many
Calculation measurements can be performed calculated from all the reagents placed
in the reagent carousel) displayed on the Inventory screen.
• Reagent Code: Calculated from the total remaining volume for
each reagent code.
• Reagent Lot: Calculated from the total remaining volume for
each reagent lot with the same reagent code.
NOTES:
• The lamp power save mode is a function for reducing the power consumption of the halogen
lamp during standby.
• When the lamp power save mode is used, it takes approximately 2 minutes to switch the
voltage.
• If an error is displayed, correct the cause of the error by following the on-screen instructions

Section 10
10.2 Operation Settings

10.2.1 Operation Settings Screen
Settings > Advanced Settings > Operation Settings
① ④
⑤
② ⑥
③ ⑧

① Default Reagent From the reagent bottle sizes, select a maximum of 2 sizes to use as the
Bottle Types initial settings from the following.
• 70: 70 ml bottle
• 20 Sq: 20 ml square bottle
② Additional Fields for Specify the item name for Additional 1 and Additional 2 in the patient
Patient Information information.
③ Normal Range Set the generation to use for the normal range.
Generation
Enter values between G1 and G2, and G2 and G3 to set the age range
for each.
④ Others • Select whether to display NG results from QC measurement.
• When the Initial Result of Rerun check box is selected, automatic
rerun is performed.
(Initial setting: ON)
⑤ Auto Rerun When the check box is selected, automatic rerun is performed.
(Initial setting: OFF)
⑥ Auto Template Set the automatic display function for templates.
⑦ Detergent for Specify the detergent to use for washing reagent pipettes.
Reagent Pipettes
Select 1 of the detergents registered on the Reagent Code screen.
⑧ Detergent for Specify the detergent to use for filling cuvettes. Select 1 of the detergents
Cuvettes registered on the Reagent Code screen.

Section 10
⑨ Popup Control Set the pop-up screen to display automatically during operation.
Set Enable to display the pop-up, and Disable to NOT display the pop-
up.
For L3 users, the ‘Do not do this show again’ check box is displayed
when the pop-up is displayed. When the check box is selected, the
corresponding pop-up is not displayed again.
NOTE: The following 2 types of pop-ups can be set in the initial state.
• Do you want to log out?
• Check remaining volume of detergents.
10.2.1.1 Change Operation Settings
Edit each item.

• To reset the edited contents click the
Cancel icon ( ).

• The changed content is saved.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions then
continue operation.

Section 10
10.3 User Accounts

Administrators can administer user login names, passwords and usage permissions.
10.3.1 Administer User Accounts

10.3.1.1 User Accounts Screen
Settings > Advanced Settings > User Account
①
②
③
④
⑤

① User Name Select an existing user name or enter a new user name.
② User Level Specify the user level.
③ Current Password Enter the old password before changing the password.
④ New Password Enter the new password.
⑤ New Password Re-enter the new password for confirmation.

Check
NOTE: The number of users that can be registered is limited according to the user level. The upper
limit for each level is as follows.
• L1: 20 users
• L2: 10 users
• L3: 5 users

Section 10
10.3.1.2 Add a User Account
Enter the user name.
Select the User Level.
Enter the login password in the New

Password field.
Re-enter the login password in the New

Password Check field.
Cancel icon ( ).

Section 10

• The user is registered.
10.3.1.3 Change the Password/User Level

When changing the user level, the password must also be changed.
When a Level 1 user changes the password of a Level 3 user, then that Level 3 user changes the password
to one of their creation, the new password overwrites the one entered by the Level 1 user.
Select the User Name to be edited

(password and user level).
Select the user level.
Enter the current login password in the

Current Password field.

Section 10
Enter the new login password in the

New Password field.
Re-enter the new login password in the

New Password field.
Cancel icon ( ).
Click the Save icon ( ) on the lower

part of the screen.
• The user is registered.
NOTE: If an error is displayed, correct the cause of the error by following the on-screen instructions then
continue operation.

Section 10
10.3.1.4 Delete a User
Select the User Name to be deleted.

• The registration information for
that user is displayed.


• The user is deleted.

Section 10
10.3.2 List of Available Screens by User Level

The availability of screens on the analyser is managed according to the user level. The following shows the
available screens by user level.
Layer 1 Layer 2 Layer 3 L1 L2 L3 Remarks

Home
Sample/Reagent
Yes Yes Yes
Monitor
Worklist Yes Yes Yes
Inventory Yes() Yes Yes (*1)
Routine Round Monitor Yes Yes Yes
Results Yes() Yes() Yes (*1) (*2)
User Maintenance Yes Yes Yes
Patient Registration Yes() Yes Yes (*1)
Wakeup Schedule No Yes Yes
Calibration Calibration No Yes Yes
QC Graph Yes Yes Yes
QC QC Table Yes() Yes Yes (*1)
QC Range No Yes Yes
Parameter 1 No Yes() Yes() (*3)
Parameter 2 No Yes() Yes() (*3)
Assay Settings 1 Serum Indices No Yes() Yes() (*3)
Running Order No Yes Yes
Wash Program No Yes Yes
Calibration No Yes Yes
Multi-Calibration No Yes Yes
Diluted Calibration No Yes Yes
QC Range No Yes Yes
Settings Assay Settings 2
QC Sample
No Yes Yes
Registration
Reagent Code No Yes() Yes() (*3)
Normal Range No Yes Yes
Panel Test No Yes Yes
Template Yes Yes Yes
Test Settings Calculated Test No Yes Yes
Orderless Test No Yes Yes
Report Format No Yes Yes
Device Settings No Yes() Yes() (*3)
Operation Settings No Yes Yes
Advanced Settings
User Account No No Yes
Definition No Yes() Yes (*4)
Unit Maintenance No No Yes() (*3)
System Maintenance
DTR Adjustment No No Yes
Water Blank
Maintenance No Yes Yes
System Monitor Absorbance
Work Hour Counter No Yes() Yes (*5)
Backup Backup No Yes Yes
Alarm Alarm History Yes() Yes() Yes (*5)
*1. Registered content cannot be deleted in L1.
*2. The number of tests cannot be set as the search condition in L1 and L2.
*3. Depending on the analyser settings, the editing of items in L3 may also be unavailable. For details, contact
your Randox Representative.
*4. Registered content cannot be edited in L2.
*5. The counter cannot be reset in L2.
*6. The alarm history cannot be saved in L1 and L2.

Section 10
10.4 Backup
The state of the analyser can be saved as data.
The backup data can be saved on the HDD or other storage medium (such as a USB memory stick). This
data can be loaded from the operation software to return the analyser to a past state.
10.4.1 Backup Screen

Maintenance > Backup > Backup
①
②

① Enable Automatic Create or load a full backup of the database.
Backup
② Create or Load Set the function that creates a full backup automatically at the end of a
round.
③ Maintenance Create or load a backup of the measuring condition settings.
④ System Parameters This function is used by service engineers.
⑤ Database Recovery Recovers the full backup that was last created by the automatic backup
function.
CAUTION:
Do not remove the storage medium containing the backup data or turn off the power
source of the operational PC while the backup data is being saved or loaded.

Section 10
10.4.2 Data Backup

Backs up all data related to the analyser, such as measuring conditions and measurement result
information.
10.4.2.1 Save the Database
Click the ( …) button on the

database screen.
displayed.
Specify the folder for saving the

backup data in the folder selection
screen.
Click the Save Database button

on the database screen.
• The backup data
(DBBackupsave) is saved in
the specified folder.

Section 10
10.4.2.2 Load a Backup the Database
Click the ( … ) button on the

database screen.
displayed.
Specify the folder containing the

screen.
Click the Load button on the

database screen.
• A confirmation (Warning)
message will be displayed.
Click the OK button on the

message.
• The backup data in the
specified folder is loaded.
NOTE: When the database is loaded, all the current data is overwritten. As a precaution, be sure to
create a backup of the current database before loading.

Section 10
10.4.2.3 System Parameters Backup

Backs up only the data of the setting information related to measurement. Measurement results and order
registration information are not included.
Click the ( …) button on the database

screen.
displayed.
Specify the folder for saving the backup

data in the folder selection screen.
Click the Save Parameters button on

the System Parameters screen.
• The backup data (DBBack) is saved
in the specified folder.

Section 10
10.4.2.4 Load System Parameters
Click the ( …) button on the database

screen.
displayed.
Specify the folder for containing the

screen.
Click the Load Parameters button on

the database screen.
• A confirmation (Warning) message
will be displayed.
Information included in the System Parameters

• Calibration settings • Normal range settings • Panel test
• Calculated test settings • Maintenance settings • Mask settings
• QC settings • Template settings • Sleep and wakeup settings
• Patient information • Reagent code • System settings
• Multi-calibrator registration • Status of reagent • Contamination prevention
registration in settings
• Assay items and parameter • Order information (inner • Settings for operations
• Reagent carousel tray only) before and after
measurement

Section 10
10.4.3 Automatic Backup

The automatic backup function creates a full backup of the database automatically at the end of each
round.
• If a problem such as a software abnormality occurs during measurement, the state after the end of
the last measurement can be recovered.
• Up to 2 backups can be saved, and the oldest backup data is overwritten by the new data at the
end of each round.
10.4.3.1 Set the Automatic Backup Function
Select the Enable Automatic Backup

check box.

• Automatic Backup is enabled.
NOTES:
• The save location of automatic backup files is different from the folder specified with ( …).
• The save location cannot be changed.

Section 10
10.4.3.2 Load Automatic Backup Data
Click the Recover Last Database

button.
• A confirmation message is
displayed.

• The last created automatic backup
of the database is loaded.

Section 11
Troubleshooting
SECTION 11
TROUBLESHOOTING
This chapter explains how to troubleshoot

chemistry and analyser abnormalities.

Section 11
Troubleshooting
Section 11 Troubleshooting................................................................................................11—1
11.1 About Troubleshooting......................................................................................... 11—3
11.1.1 Check the Operating Environment ......................................................................................... 11—3
11.1.2 Items to Communicate to your Randox Representative ....................................................... 11—3
11.1.2.1 When Contacting About Assay Problems ...................................................................... 11—3
11.1.2.2 When Contacting About Analyser Problems ................................................................. 11—3
11.2 Measurement Result Problems ............................................................................ 11—4
11.2.1 Check of Reagent, Calibrator and QC Sample Preparation .................................................. 11—4
11.2.1.1 About Reagent Preparation ............................................................................................. 11—4
11.2.1.2 About QC Sample Preparation ....................................................................................... 11—4
11.2.1.3 About Calibrator Preparation ......................................................................................... 11—4
11.2.2 Case-by-Case Check Descriptions .......................................................................................... 11—5
11.2.2.1 Measurement Results for a Specific Assay Item in all Samples (High or Low) .............. 11—5
11.2.2.2 Abnormal Measurement Results Occur at Random ...................................................... 11—6
11.2.2.3 Measurement Results for Multiple Assay Items in an Abnormal Specific Sample ......... 11—6
11.3 Analyser Problems ................................................................................................11—7
11.3.1 Analyser Power Source Does Not Turn On .......................................................................... 11—7
11.3.2 Alarms and Recovery Actions.................................................................................................. 11—7
11.3.2.1 What to Do in Case of an Alarm .................................................................................... 11—7
11.3.2.2 Save Alarms ...................................................................................................................... 11—8
11.3.3 Alarm History Screen ............................................................................................................... 11—9
11.4 Flag Information ..................................................................................................11—10
11.4.1 Evaluation Flag ........................................................................................................................ 11—10
11.4.2 Error Flag ................................................................................................................................ 11—10

Section 11
Troubleshooting
11 Troubleshooting
11.1 About Troubleshooting

11.1.1 Check the Operating Environment
If an abnormality occurs in the analyser, take the following actions:
Inspect the reagent preparation and storage methods.
Inspect the sample preparation and handling methods.
Inspect the analyser operating methods.
Inspect the maintenance work.
WARNING: If an analyser problem is suspected, do not perform internal inspections
yourself. Contact your Randox Representative.
11.1.2 Items to Communicate to your Randox Representative

Before contacting your Randox Representative about problems with measurement results or the analyser,
please prepare the following information:
11.1.2.1 When Contacting About Assay Problems

• Device number.
• Assay item with the problem.
• Description of the status.
• Manufacturing numbers, Catalogue numbers and lot numbers of the reagents, calibrators and QC
samples being used.
• Results of recently performed calibrator measurements.
• Results of recent QC sample measurements.
• Measurement results.
11.1.2.2 When Contacting About Analyser Problems

• Device number.
• Version numbers of software being used.
• Description of the content and status of related alarms.
• Maintenance status of the analyser.

Section 11
Troubleshooting
11.2 Measurement Result Problems

11.2.1 Check of Reagent, Calibrator and QC Sample Preparation
If variation occurs in the measurement results, check the following items.
Be sure to read the package insert and follow the instructions when preparing reagents, calibrators and
QC samples.
11.2.1.1 About Reagent Preparation

• Have the reagents been changed?
• When is the expiry date of the prepared reagents?
• Has preparation been performed with the correct procedure?
• Was preparation performed using deionised water or appropriate diluents that were fresh and
free from bacteria?
11.2.1.2 About QC Sample Preparation

• Was the QC sample prepared using correct amount of deionised water or appropriate diluents?
• Was the QC sample stored as per recommended storage conditions?
• When was the expiry date of the QC samples before preparation?
• Was preparation performed using pipettes whose volume had been calibrated?
• Are the lots of the QC samples within the validity period?
11.2.1.3 About Calibrator Preparation

• Were the lot numbers changed?
• Was calibrator prepared using correct amount of deionised water or appropriate diluents?
• Was calibrator stored as per recommended storage conditions?
• When was the expiry date of the calibrators before preparation?
• Was preparation performed using pipettes whose volume had been calibrated?
• When was the expiry date of the calibrator lot numbers?

Section 11
Troubleshooting
11.2.2 Case-by-Case Check Descriptions

11.2.2.1 Measurement Results for a Specific Assay Item in all Samples (High or Low)
Cause Action
The calibration results are incorrect. Check the calibrator preparation.

Check the calibration settings. If necessary, perform calibration
again.
The calibrators have not been prepared Check the calibrator preparation.
appropriately.
The validity period of the calibrator’s is Refer to the package insert of the calibrators for details on the
expired. stability of the prepared calibrators.
The calibrators have not been stored Refer to the package insert of the calibrators for details on the
appropriately. appropriate storage method.
The reagents have not been prepared Check the reagent preparation.
appropriately.
The reagents are contaminated.
The reagents have deteriorated.
The reagents have not been prepared Refer to the package insert of the reagents for details on the
appropriately. stability of the prepared reagents.
The reagents have not been stored Refer to the package insert of the reagents for details on the
appropriately. appropriate storage method.

Section 11
Troubleshooting
11.2.2.2 Abnormal Measurement Results Occur at Random
Cause Action
The sample pipette or reagent pipettes Clean the sample pipette or reagent pipettes.
are dirty.
Fibrin is occurring in a specific sample • Remove the sample fibrin.

tube or sample cup. • Clean the sample pipette.
There is variation in the dispensing Check whether leakage or dripping is occurring around the
volume of samples or reagents. sample pipette or reagent pipettes. If this is occurring, contact
your Randox Representative.
The stirring is insufficient. • Clean the stirrers.

• Check whether the stirrers are making contact with the
cuvettes while rotating and causing abnormal noise to
occur. If this is occurs, contact your Randox
Representative.
The usage period of the halogen lamp Replace the halogen lamp.
has expired.
The cuvettes are dirty. Clean the washing unit.

Check the water blank absorbance and inspect the optical unit.
A different mechanical problem occurs. Contact your Randox Representative.
11.2.2.3 Measurement Results for Multiple Assay Items in an Abnormal Specific Sample
Cause Action
The sample has not been prepared Check the sample preparation and handling methods.
appropriately.

Section 11
Troubleshooting
11.3 Analyser Problems

When troubleshooting the analyser, only perform operations within the scope described by this manual.
For complex problems, contact your Randox Representative.
11.3.1 Analyser Power Source Does Not Turn On

Check the following items.
• Is the power breaker on the rear panel turned on?
• Has the circuit breaker of the power source system connected to the analyser turned off?
11.3.2 Alarms and Recovery Actions

An alarm is generated if an abnormality occurs in the analyser.
• When an alarm is generated, the colour of the Alarm indicator ( ) changes to red ( ) and an
audible alarm is sounded.
11.3.2.1 What to Do in Case of an Alarm
Click the red Alarm indicator ( ). The

alarm sound stops and the Alarm History
screen is displayed.
Click the most recent alarm in the alarm

history list at the top of the screen.
When the alarm is clicked, the detailed

action to take for the alarm is displayed in
the detailed message field at the bottom
of the screen.
Perform the action displayed in the

detailed message field.
If the problem persists or the action is
unknown, contact your Randox
Representative with the Alarm No. of the
alarm that cannot be resolved.

Section 11
Troubleshooting
11.3.2.2 Save Alarms

If necessary, the history of the alarms that have occurred up to the present can be saved in a CSV file.
Click the Alarm icon ( ).

• The Alarm History screen is
displayed.
…) and specify the save location

Click (
folder.

• The alarms are saved in CSV format.
NOTE:
• Saving the alarm history may not be available, depending on the login rights.
• The administrator should assign rights for user level L3 on the User Account screen to save the
alarm history. For details on the User Account screen, refer to the Service Manual.

Section 11
Troubleshooting
11.3.3 Alarm History Screen

On the Alarm History screen, information about the alarms and the software versions can be checked.
① Alarm History Displays the history of the alarms that have occurred in the analyser in a
list.
Alarm No. Provide the alarm number when contacting your Randox Representative.
Date and Time Displays the date and time of alarm occurrence.
Message Displays the status of the analyser when the alarm occurred in an
abbreviated form.
② Message (Full) Displays detailed information about the alarm, including the action to
take.
③ Software Version Displays version information for the operation software and the software
used for analyser control in a list. Refer to Software List and Software
Version Check in the Foreword.
④ Search Parameters Select the alarm date, time and level for specify results.
⑤ Export Log Saves a log of operations between the analyser and operational PC. The
log is saved in the save location specified with (...). This is not used
under normal circumstances, but we may request a record of operations
for troubleshooting.

Section 11
Troubleshooting
11.4 Flag Information

Flag information may be added to the measurement results according to the status during or after
measurement.
The types of flag information are as follows.
Evaluation flag • Added when measurement results are above or below the normal range.
• Added when measurement results are above or below the technical range.
Error flag • Added when an error occurs during measurement.
Each flag is displayed on the Results screen, and when the measurement results are printed, the flags are
printed together with the measurement results.
The technical range and normal range used as the basis for the evaluation flags are set as parameters for
each assay item by the administrator.
11.4.1 Evaluation Flag

A list of the evaluation flags is shown below.
Evaluation Flag Description
> Indicates a value higher than the technical range.
< Indicates a value lower than the technical range.
H Indicates a value higher than the normal range.
L Indicates a value lower than the normal range.
r Indicates that the result is a rerun measurement result.
11.4.2 Error Flag

A list of the error flags is shown below.
Error Flag Cause Action
AB1 Absorbance limit error 1 The absorbance limit has been exceeded in
measurement using the rate method.
The absorbance limit has been exceeded in all
measurement points, or the 1st point in the
measurable range is within the absorbance limit but
the 2nd and subsequent points exceed the
absorbance limit.
AB2 Absorbance limit error 2 The absorbance limit has been exceeded in
measurement using the rate method.
The first 2 points in the measurable range are within
the absorbance limit, but the 3rd and subsequent
points exceed the absorbance limit.

Section 11
Troubleshooting
CA? An error occurred in Check the following points:

concentration conversion.
• Calibration for the corresponding assay
items is performed correctly.
• The measurement results are outside the
technical range.
CAL Calibration failed. Check the following points:

• The number of calibrators is sufficient.
• An alarm did not occur during
measurement.
CLM No calibration curves have Check the following points:

been registered.
• Calibration for the corresponding assay
items is performed correctly.
• The reagent lots used during measurement
and calibration match.
CLT The reagent lots used in Check the following point:

measurement were different
• The reagent lots used during measurement
from the lots used in
and calibration match.
calibration measurement.
CTO The effective period of Perform calibration then perform measurement

calibration has expired. again.
CXP The measurement interval for Perform QC measurement then perform

QC measurement has elapsed. measurement again.
DB There are no diluent bottles. Register the corresponding diluent bottles on the
Inventory screen.
Check whether the corresponding bottles are filled

with sufficient diluent.
DS There is no remaining volume Register the corresponding diluent bottles on the

for diluents. Inventory screen.

with sufficient diluent.
Diluent shortage. Check the following points.

Outside the detection range of Are there diluents with sufficient volume?
liquid detection for diluents.
Are the reagent pipettes damaged, bent or dirty?
Are there obstructions on the movement lines of
the reagent pipettes?

Section 11
Troubleshooting
DUP Variation limit error The measurements results of double or triple

measurement in calibration measurement exceed
the limit.
EST An abnormality occurred Check the Alarm History screen and take action for
during measurement. the problem.
EXP The validity period of the Use reagents within the validity period.
reagents has expired.
LIN Linearity limit error The limit has been exceeded in measurement using
the rate method, and variation has been found in
the linearity of the time course.
LOT Reagents from different lots Check the following points:

were used in the same round.
• Reagents with different lot numbers have
been placed on the reagent carousel.
• The correct lot numbers were entered for
the reagents when registering the reagent
bottles on the Inventory screen.
OVR Calibrator concentration Check the following points:

conversion error
• There is no error in the registration
contents on the Calibration screen.
• The quality and storage method of
calibrators are appropriate.
PRO Prozone limit error The limit is exceeded, and the prozone
phenomenon has been found in the measured time
course.
R1B There is no R1 reagent bottle. Take the following action.

Register the corresponding reagent bottle on the
Inventory screen.
Check whether the corresponding bottle is filled
with sufficient reagent.
R1S There is no remaining volume Register the corresponding reagent bottle on the
for the R1 reagent. Inventory screen.
R1 reagent shortage Check the following points.

Outside the detection range of Are there reagents with sufficient volume?
liquid detection for the R1
reagent

Section 11
Troubleshooting
R1W Washing the reagent pipettes Check the Alarm History screen and take action for
before R1 reagent dispensing the problem.
failed.
R2B There is no R2 reagent bottle. Register the corresponding reagent bottle on the
Inventory screen.
R2S There is no remaining volume Register the corresponding reagent bottle on the
for the R2 reagent. Inventory screen.
R2 reagent shortage Check the following points.

Outside the detection range of Are there reagents with sufficient volume?
liquid detection for the R2
reagent
R2W Washing the reagent pipettes Check the Alarm History screen and take action for
before R2 reagent dispensing the problem.
failed.
SEN Sensitivity limit error The measurement results exceed the sensitivity
limit.
SFT The range shift function is Indicates the measurement values for which the
being applied. AB1 and AB2 error flags were avoided by shifting
the photometric range of the measurement values.
SI1 Liquid detection cannot be

performed during sample
discharge. Check the following points.
Outside the detection range of Is the sample pipette clotted?
liquid detection during sample
Are there samples with sufficient volume?
discharge
Is the sample pipette damaged, bent or dirty?
SI2 Diluted sample shortage
Outside the detection range of the sample pipette?
liquid detection for diluted
samples

Section 11
Troubleshooting
SPS The sample pipette has been Check the following points:
clotted.
Is the sample pipette blocked?
the sample pipette?
SPW Washing the sample pipette Check the Alarm History screen and take action for
failed. the problem.
SS Sample shortage Check the following points:

Is the sample pipette blocked?
the sample pipette?
STB The onboard stability of Use reagents within the onboard stability period.
reagents has expired.
TE1 The incubator temperature is

extremely low (35oC or
lower).
TE2 The incubator temperature is

Check the Alarm History screen and take action for
extremely high (39oC or
the problem.
higher).
TE3 The reagent carousel

temperature is extremely high
(15oC or higher).
WB There are no detergent Take the following action.

bottles.
Register the corresponding detergent bottles in the
Inventory screen.
with sufficient detergent.
WBE Measurement was not possible Take the following action.

because the cuvettes are dirty.
Perform cuvette washing on the User Maintenance
screen.
Check for dirt on the outer surface of the cuvettes.
Check for damage on the cuvettes. If there is
damage, replace the cuvettes.

Section 11
Troubleshooting
WS There is no remaining volume Take the following action.

for detergents.
Register the corresponding detergent bottles in the
Inventory screen.
with sufficient detergent.
Detergent shortage Check the following points.

Outside the detection range of Are there reagents, diluents and detergents with
liquid detection for detergents sufficient volume?

Section 11
Troubleshooting
Intentionally Blank

Section 12
RX modena - ISE Module
SECTION 12
RX MODENA - ISE MODULE
This section provides information about the ISE Module.

Section 12
Section 12 RX modena - ISE Module ................................................................................. 12—1
12.1 Precautions for Operation and Measurement ........................................................ 12—3
12.1.1 Precautions for the use of Samples ......................................................................................... 12—3
12.1.2 Precautions for the use of Solution ......................................................................................... 12—3
12.1.3 Precautions before Measurement ........................................................................................... 12—3
12.1.4 Precautions for the Test Parameter ........................................................................................ 12—4
12.2 Precautions for Preventive Maintenance ................................................................ 12—5
12.2.1 Precautions for Samples ........................................................................................................... 12—5
12.2.2 Precautions for the Seal Replacement ..................................................................................... 12—5
12.2.3 Precautions for the Storage of the Cl Electrode ..................................................................... 12—5
12.2.4 Precautions for the Storage of the Ref Electrode ................................................................... 12—5
12.2.5 Precautions for Washing the Wash Bottle.............................................................................. 12—5
12.2.6 Precautions for the Aging of the Electrode ............................................................................. 12—5
12.3 Overview .....................................................................................................................12—6
12.3.1 Features and Major Functions .................................................................................................. 12—6
12.3.1.1 System Diagram of the ISE Unit ....................................................................................... 12—6
12.3.1.2 Measurement Flow........................................................................................................... 12—6
12.4 Specifications ..............................................................................................................12—7
12.5 Consumables and Periodical Replacement Parts ................................................... 12—8
12.5.1 Consumables ............................................................................................................................ 12—8
12.6 Operation Procedures ............................................................................................... 12—9
12.6.1 Works required at installation ................................................................................................. 12—9
12.6.1.1 Removing the protection tape ......................................................................................... 12—9
12.6.1.2 Aging of the ISE Electrode................................................................................................ 12—9
12.6.1.3 Placement of ISE Electrodes .......................................................................................... 12—10
12.6.1.4 Placement of the Buffer Bottle and the Internal Standard Solution Bottle .................. 12—10
12.6.2 Checks Prior to Use ............................................................................................................... 12—11
12.6.2.1 Check the Buffer Bottle and Internal Standard Solution Bottle ................................... 12—11
12.6.3 Calibration .............................................................................................................................. 12—11
12.6.4 Procedures .............................................................................................................................. 12—12
12.6.4.1 Calibration Ranges ......................................................................................................... 12—12
12.6.5 Patient Sample Measurement ................................................................................................ 12—12
12.6.6 Check and Output of Measurement Results......................................................................... 12—12
12.7 ISE Parameter Screen .............................................................................................12—13
12.7.1 Normal Range Setting ............................................................................................................ 12—14
12.7.2 Instrument Factor Setting ....................................................................................................... 12—14
12.7.3 ISE Rerun Setting .................................................................................................................... 12—15
12.8 Maintenance .............................................................................................................12—16
12.8.1 Daily ........................................................................................................................................ 12—16
12.8.1.1 Replacement of the standard solution ~ ISE Calibration .............................................. 12—16
12.8.1.2 Checks Prior to Use ....................................................................................................... 12—16
12.8.1.3 Maintenances after the Daily Routine Tests ................................................................. 12—16
12.8.2 Weekly .................................................................................................................................... 12—16
12.8.2.1 Electrode Line Wash ...................................................................................................... 12—16

Section 12
12 ISE Module
12.1 Precautions for Operation and Measurement

CAUTION: This section describes the necessary precautions and warnings for the
safe use of the ISE unit.
Read this section carefully before using the ISE unit.
12.1.1 Precautions for the use of Samples

The ISE unit is designed to measure serum, plasma or urine samples.
It cannot measure a whole blood sample.
Please follow the precautions below:
• In the case that you measure half-coagulated serum or plasma, the measurement result may be
affected by any clog of the nozzle or the fluidics.
• Please refer to the reagent Instructions for Use (IFU) for the necessary precautions for sample
storage after collection. If the sample is stored at room temperature for a long time it may affect
the measurement result.
• It is necessary to prepare the dedicated buffer solution, internal standard solution and standard
solution, to measure the serum, plasma or urine sample with the ISE unit. The use of
undesignated solutions is strongly prohibited as it may cause the corruption of the internal fluidic
system, or significantly shortening of the lifetime of the electrode.
12.1.2 Precautions for the use of Solution

The buffer solution, the internal standard solution and the standard solution must be capped and stored
at room temperature (also after opening). Despite these solutions containing an antiseptic agent, use
them as soon as possible after opening.
• Unsuitable storage (e.g. store solution with open cap) of the buffer solution, the internal
standard solution and the standard solution may cause inaccurate results even if the solution has
not expired.
• Immediately flush with water and consult a doctor if solutions come into contact with your skin,
eyes or mouth.
• Be careful on the concentrating of the standard in case of the use of sample cup. Despite the
concentrating level may be different by conditions such as the type of the sample cup,
temperature or humid, do not use the standard solution which is left more than 20 minutes
inside the sample cup because it affects the accuracy.
• Perform a new calibration when the buffer solution, electrodes and other consumable items are
replaced. It is necessary to perform the calibration once a day to run the ISE unit.
• When the buffer solution is installed inside the analyser, store it on the designated rack.
Incorrect placement of the solution may affect results and cause serious damage on the ISE unit
if there is leakage.
12.1.3 Precautions before Measurement

Before the measurement of patient samples, measure the QC and check if the result is accurate and
within range.

Section 12
12.1.4 Precautions for the Test Parameter

The test parameter for the ISE unit is optimized and validated. Unnecessary change of parameters may affect
test reproducibility, linearity and affect the accuracy of the result.
IMPORTANT
• Correlation offset: There is no offset for the correlation. The setup has to be considered based on
the measurement result of the QC sample.

Section 12
12.2 Precautions for Preventive Maintenance

PPE (personal protective equipment) must be worn as appropriate to the task.
For detailed procedures of the preventive maintenance of the ISE unit, refer to Section
12.1 of this manual. Perform the preventive maintenance correctly, according to the
described procedures.
Undesignated maintenance work may affect measurement results and cause unit
failures.
12.2.1 Precautions for Samples

Wear protective gloves to prevent the risk of infection, when performing preventive maintenance such as
pipette replacement, bottle cleaning or electrode replacement.
12.2.2 Precautions for the Seal Replacement

If the seal is not replaced correctly it may affect reproducibility, linearity and be unable to perform the
calibration.
12.2.3 Precautions for the Storage of the Cl Electrode

Leaving the Cl electrode open may cause inaccurate results due to inactivation caused by drying of the Cl
electrode membrane.
12.2.4 Precautions for the Storage of the Ref Electrode

Leaving the Ref electrode open may cause the inaccurate results due to inactivation caused by drying of
Ref electrode membrane.
12.2.5 Precautions for Washing the Wash Bottle

An unclean wash bottle may affect results due to the carry-over of bacteria into the reaction cell.
12.2.6 Precautions for the Aging of the Electrode

The brand-new electrode may not be very stable until they are ‘aged’ appropriately. Refer to Section
12.6.1.2.

Section 12
12.3 Overview
12.3.1 Features and Major Functions
The ISE unit is an electrolyte measurement module that is installed on the analyser. The ISE unit can
measure Na (Sodium), K (Potassium) and Cl (Chlorine) in serum or urine at the same time, using the
automatic dilution function.
The sample to be tested is dispensed into the ISE unit by the sample pipette of the analyser.
12.3.1.1 System Diagram of the ISE Unit
Sample Pipette
EV1
NC
COM NO
REF Na K CI D.P.
EV3
NC NC NO DG DG
COM
NO COM
EV2
ISEWaste (High Conc.) Internal Buffer

Syringes Standard Solution
Solution
12.3.1.2 Measurement Flow

1. The buffer solution is sent into the dilution pot by the buffer syringe, and then diluted and mixed
with the sample that is dispensed by the sample pipette.
2. The diluted and mixed solution is sent to the electrode by the buffer syringe, and measured for the
difference in potential between each electrode and the Ref (Reference) electrode.
3. The diluted and mixed solution is wasted through the ISE waste port after measurement.
4. The buffer solution and the internal standard solution is sent to clean the flow path, at the
beginning and the end of measurement.

Section 12
12.4 Specifications
Principle Na/K/Cl: Ion Selective Exchange method.
Samples Serum, Plasma and Urine.
Serum measurement: 600 samples/hour.

Throughput
Urine measurement: 400 samples/hour.
Sample Volume 22 μl
Calibration The automatic 2-point calibration by the standard solution (Low and High).
Measurement Serum: Na: 100～200 mmol/l, K: 2.5～10 mmol/l, Cl: 50～200 mmol/l
Range Urine: Na: 10～400 mmol/l, K: 2～300 mmol/l, Cl: 15～400 mmol/l
Operation Operated through the user interface.
Required Power
DC24V 1.5A, DC5V 1A, Supplied from the analyser.
Supply
Dimensions W165 mm × D320 mm ×H240.5 mm
Mass Approximately 5 kg.

Section 12
12.5 Consumables and Periodical Replacement Parts

12.5.1 Consumables
Internal Standard Solution Placed in the designated rack inside the analyser. The 1-point
L (200 ml bag) calibration is automatically performed in each measurement.
Buffer Solution (3L bottle) Placed in the lower part of the analyser.
Standard Solution for Placed in the sample carousel and dispensed into the ISE unit by
Serum (Low/High) the sample pipette.
The standard solution is used by the combination of Low and
High for the 2-point calibration of the ISE unit, and its result is
used for the concentration conversion of the serum test.
Standard Solution for Placed in the sample carousel and dispensed into the ISE unit by
Urine (Low/High) the sample pipette of the analyser.
The standard solution is used by the combination of Low and
High for the 2-point calibration of the ISE unit, and its result is
used for the concentration conversion of the urine test.
Electrode Cleaning Placed in the sample carousel and dispensed into the ISE unit by
Solution the sample pipette of the analyser.
It is also used for the line cleaning.
Selectivity Check Solution Used for the selectivity check of Na and K.

It is measured with the same flow as the patient sample.
ISE Electrode Four types of electrodes (Na, K, Cl and Ref) are used.

Section 12
12.6 Operation Procedures

This chapter described the operation procedures of the ISE unit.
12.6.1 Works required at installation

12.6.1.1 Removing the protection tape
1. Open the work panel of the analyser where the ISE unit is installed.
2. Remove all protection tapes attached to the ISE unit.
12.6.1.2 Aging of the ISE Electrode

Perform the aging procedure of Na, K and CI electrode before beginning to use the ISE unit. The
electrodes may require time to stabilize.
1. Take each ISE electrode out of its package. If the electrode is wet, wipe off any liquid on the
electrode and dry.
2. Remove the sponge inside the case that the ISE electrode is packed in.
3. Put the electrode to be aged into the case.
• Place the electrode cap and be sure not to make contact between the electrode terminal and
liquid.
• In case the aging is performed for Na, K and CI at the same time, put all of them into the same
case.
4. Pour 0.5 ml of serum into the flow path of the ISE electrode.
• Pour serum correctly to treat the flow path evenly.
• Use the pooled serum or the designated quality control sample.
• Use serum that does not have antigenicity to avoid risks of the infection.
• Wear the protective gloves for the handling of the ISE electrode.
5. Add the buffer solution to immerse the whole electrode. (Approx. 25 ml)
6. Leave the electrode for more than 24 hours.
7. Wash the electrode with purified water and wipe it off.
The ISE electrode contains internal liquid. The internal liquid gradually decreases over
time. Shake the electrode before the use and if it is difficult to sense the liquid inside,
weigh the electrode. If the weight of the electrode is less than 9 g, do not use the
electrode as there is not enough internal liquid.

Section 12
12.6.1.3 Placement of ISE Electrodes

1. Place the ISE electrodes in order of Cl, K, Na and Ref from the right side of the ISE unit, to fit each
electrode to the sculpture sign on the tray.
• If the ISE electrodes are placed in the wrong order, data on a specific ISE electrode
may be incorrect.
• Be careful of the handling of the Cl electrode because it is fragile.
2. Tighten the knurled screw while pressing the holding plate.
3. Connect the connector by checking that the colour of each electrode and the cable is same.
• Na: Yellow
• K: Red
• Cl: Blue
• Ref: Black
• Check that the O-ring is attached on the upper contact face of the electrode. In
case the O-ring is missing, use the genuine O-ring that is provided.
• If the ISE unit is used with a missing O-ring, it may cause a leakage and can lead to
unit malfunction.
4. Loosen the knurled screw and press the 4 electrodes (Cl, K, Na and Ref) to until they contact the
upper part of the holder.
5. Tighten the knurled screw in the state of step 4.
6. Hold and twist 4 electrodes together to check that each electrode is connected correctly.
Hold the knurled screw tightly. If the knurled screw is held loose, the electrodes may be
pressed back from the cell during the measurement and cause leakage.
12.6.1.4 Placement of the Buffer Bottle and the Internal Standard Solution Bottle
1. Uncap the buffer solution bottle, and attach the bottle connector.
2. Uncap the internal standard solution bottle, and attach the bottle connector.
3. Perform a prime of the buffer solution and the internal standard solution. During the prime
sequence, remove air bubbles inside the flow path as much as possible. In case air bubbles enter
the flow path, continuously check that there is no leakage or slack especially on the connection
parts.
• Check that liquid flows out smoothly from the dilution cell. If liquid does not flow
out smoothly, there may be a misconnection or blockage in the waste line. In such
cases, stop the sequence on the ISE unit immediately.
• In case the line is blocked, remove Na and K electrode and check if there is
blockage in the flow path. It is impossible to visually check for a blockage in the Cl
electrode, because of its structure.
• In case that liquid does not flow out smoothly despite there is no doubtful point on
the above checks, replace the ISE electrodes.

Section 12
12.6.2 Checks Prior to Use

12.6.2.1 Check the Buffer Bottle and Internal Standard Solution Bottle
Check that the buffer bottle and the internal standard solution bottle have enough volume remaining. If the
volume is low, replace the bottle.
12.6.3 Calibration
The calibration is necessary before measuring patient samples. After each calibration, previous calibration
result will be deleted.
The calibration must be performed separately for serum and urine. It may affect the
precision or accuracy of the result if an undesignated sample is used for the calibration
(e.g. using urine sample for serum calibration etc.).

Section 12
12.6.4 Procedures
1. Place the standard solution of the same sample type with one that requires the calibration (serum
or urine, Low and High for each) on the sample rack of the analyser.
29 µl (sample volume: 22 µl, dummy volume: 7 µl) is required for each sampling.
2. Register the position of the standard solution at Test Selection Screen.

3. Press Serum Calibration or Urine Calibration button at ISE Calibration screen.
12.6.4.1 Calibration Ranges

If the result of the calibration exceeds the range described in the following tables, it is over the acceptable
calibration range.
SERUM Na K Cl
Potential (High) 5 ≦×≦ 35 80 ≦×≦ 110 −40 ≦×≦ −10
Potential (Low) −50 ≦×≦ −20 −50 ≦×≦ −20 5 ≦×≦ 35
Slope 38 ≦×≦ 65 38 ≦×≦ 65 38 ≦×≦ 65
Dilution Ratio 25 ≦×≦ 60 25 ≦×≦ 60 25 ≦×≦ 60
URINE Na K Cl
Potential (High) 50 ≦×≦ 110 725 ≦×≦ 825 −90 ≦×≦ −35
Potential (Low) −280 ≦×≦ −220 170 ≦×≦ 270 40 ≦×≦ 100
Slope 38 ≦×≦ 65 38 ≦×≦ 65 38 ≦×≦ 65
Dilution Ratio 25 ≦×≦ 60 25 ≦×≦ 60 25 ≦×≦ 60
The calibration result may be out of the acceptable range if the analyser is left unused for a long time or the
electrodes are dirty.
• If the calibration result is out of the range, perform electrode cleaning.
• If the result is out of range after electrode cleaning, replace the ISE electrode.
12.6.5 Patient Sample Measurement

Refer to Section 4.3.1.2.
12.6.6 Check and Output of Measurement Results

Section 12
12.7 ISE Parameter Screen

This chapter describes the operation procedures of the ISE unit.
① ISE Type In case that the sample category is Other, select the ISE test type from
ISE and ISE(U).
• If the sample category is Serum or Plasma, only ISE can be
selected.
• If the sample category is Urine, only ISE(U) can be selected.
② Instrument Factor Enter the slope and the intercept to correct the measurement result.
The slope (a) and the intercept (b) is entered to perform the first order
correction using the formula y=ax+b.
③ Normal Range Enter the range of the normal value for the ISE test for each normal
range those are configured at Normal Range screen.

Section 12
12.7.1 Normal Range Setting

1. Move to ISE Parameter screen.
2. Select the normal range to edit.
3. Enter the normal value to set.
Editable Range
Na: 0～999.9.
K: 0～99.99.
Cl: 0～999.9.
Minimum: If the result is lower than this, such results will have ‘L’ flag.
Maximum: If the result is higher than this, such results will have ‘H’ flag.
4. Press the Save icon ( ). The settings for the ISE parameter is saved.
12.7.2 Instrument Factor Setting

1. Move to the ISE Parameter screen.
2. Enter the value to the Instrument Factor field of each ISE method. The value can be entered within
the following range.
Editable Range
A: -99.99 ~ 99.99
B: -999.99 ~ 999.99
3. Press the Save icon ( ). The setting for the ISE parameter is saved.

Section 12
12.7.3 ISE Rerun Setting
① Auto Rerun It performs the ISE automatic rerun when the check-box is ticked.
Move to the Operation Settings screen.

Click ON to perform the automatic rerun for ISE tests. The ISE rerun is performed regardless of
Auto Rerun settings in the same screen.

Section 12
12.8 Maintenance
This chapter describes the procedures of the preventive maintenance of the ISE unit.
12.8.1 Daily
12.8.1.1 Replacement of the standard solution ~ ISE Calibration
ISE calibration must be performed once each day (of operation).
• For each ISE calibration, pour fresh standard solution H and L (that is within the expiry date), into the
sample cup.
12.8.1.2 Checks Prior to Use

Check volumes each day before the start of measurement:
• Buffer solution.
• Internal standard solution.
Make sure that the buffer solution and the internal standard solution are within the expiry
date.
12.8.1.3 Maintenances after the Daily Routine Tests

After the daily routine tests, clean the ISE electrodes:
1. Pour 300 µl of the electrode cleaning solution into a sample cup, and place it on the available
position on the sample rack.
2. Register the position where the electrode cleaning solution is placed
(on the Test Selection screen).
3. Press the ISE Cleaning button on ISE Calibration screen to start the cleaning of the ISE electrodes.
ISE calibration is necessary after the ISE electrode cleaning.
12.8.2 Weekly
12.8.2.1 Electrode Line Wash
Perform the electrode line wash once a week:
1. Remove Na, K, Cl and Ref electrode and replace with the dummy electrode for the line wash.
2. Remove the cap on the dummy electrode.
3. Pour approximately 5 ml of the electrode wash solution using tools such as a pipette.
The electrode cleaning solution contains sodium hypochlorite. In case of skin or eye contact,
wash off with plenty of clean water and consult a doctor immediately.
4. Press ISE line wash button on the ISE Calibration screen to start the electrode line wash.
5. The electrode wash solution may flow over the supply port of the cell pot at the end of the line
wash. In case of the over flow, wipe out the liquid by swab.
6. After the line wash, remove the dummy electrode and replace the Na, K, CI and Ref electrode.
7. Perform ISE prime 10 times using the ISE Calibration screen.
8. Perform ISE calibration.

Appendices
APPENDICES

Rev 3.0 — January 2018 Page A—1
Appendices
Appendices − Contents
Appendices ............................................................................................................................ A—1
Menu List .......................................................................................................................... A—3
Glossary ............................................................................................................................ A—5
Operator Maintenance Schedule ................................................................................... A—9

Page A—2 Rev 3.0 — January 2018
Appendices
A Appendices
Menu List
Routine Menu Calibration Menu
Carousel Monitor Calibration
Worklist ISE Calibration
Inventory
Round Monitor QC Menu
Results QC Chart
User Maintenance QC Table
Patient Registration QC Range
Sleep and Wakeup
Settings Menu
Assay Settings 1 Assay Settings 2
Parameter 1 Calibration
Parameter 2 Multi Calibration
ISE Parameter Diluted Calibration
Serum Indices QC Range

Running Order QC Sample Registration
Contamination Prevention Reagent Code
Normal Range
Test Settings
Panel Test Advanced Settings
Template Device Settings
Calculated Test Operation Settings
Orderless Test User Account
Report Form Definition
Maintenance Menu
System Maintenance System Monitor
Unit Maintenance Water Blank
Absorbance
DTR Adjustment Work Hour Counter

Appendices
Backup Sleep
Backup
Shutdown
Alarm Menu
Alarm History

Appendices
Glossary
Terms that should be understood when using the analyser are listed below. Also refer to the Service
Manual.
Terms Description
Abnormal Range * A range of abnormal values for each assay item.

Absorbance Limit * A function to check if a time course is within the measurable range for
each assay.
Assay Type * A term that shows data calculation methods used for concentration
conversion.
Auto Rerun * A function to automatically perform a re-run when the first result
displays specific flags.
Automatic Backup * A function to automatically save the database after a round.
Automatic Gain * A function to optimize the gain value for each wavelength of the halogen
lamp.
Automatic Print * A function to print out test results during a run.
C1 Blank A function to offset the intercept of a calibration curve based on the
absorbance of the first point of calibration.
Calculated Test A function to calculate multiple results to output specific results.
Calibration Chart A graphical display of actual calibration points compared with ‘ideal’
points.
Calibration Curve A function to extend a calibration curve in order to output estimated test
Extension * results.
Calibration Type * A term that shows the type of calibration curve such as Factor or Linear.
Calibrator (Dilution) A calibrator used for diluted calibration.
Comparison Check * A function to compare the latest and previous results for a same patient
ID.
Contamination A function to minimize cross contamination of reagents between specific
Prevention * combinations of assay items.
Cuvette Skip * A function to minimize cross contamination of cuvettes between specific
combinations of assay items.
Dead Volume * A term that shows the volume of sample required in addition to specified
sampling volume and dummy volume.
Deep Wash A maintenance sequence that washes over a wider range than the
normal wash process by leaving the sample pipette to soak in detergent
inside the sample tubes.
Deviation Limit * A function to set a threshold value against the deviation between
replication test results.
Diluted Calibration A function to create multiple concentration calibrators by diluting the
highest concentration calibrator.

Appendices
Terms Description
Diluted QC * A function to pre-dilute a QC sample at a ratio specified in the

parameter setting of each assay.
Dummy Volume * A term that shows the amount of sample or reagent mechanically
required for each pipette.
Flag Information Complementary information for test results.
Fluidic Wash A maintenance sequence that washes the fluidic tubes inside the analyser
with detergent.
Full Calibration A method of creating a calibration curve by using all calibrators.
History print A print format for the measurement results history that is categorized by
patient ID.
Host Communication * A function to enable order acquisition and result transfer between the
host computer and the operational computer.
Initialize A maintenance sequence that washes the inside of the pipettes by
aspirating and keeping detergent for a certain period of time.
Instrument Factor * A set of coefficients that offset the difference between analysers on a
same assay item.
Internal Wash A maintenance sequence that washes the inside of the pipettes by
aspirating and keeping detergent for a certain period of time.
Lamp Power Save Mode A function to decrease the power consumption of the halogen lamp
during the stand-by mode.
Linearity Limit * A function to specify an acceptable range for linearity against a rate-assay
time course.
Linked Assay * A target assay item whose calibration curve is used instead of the
selected assay item.
MASTER A calibration curve obtained by full calibration.
Measuring Points * A term that shows timings of absorbance measurement during reaction.
Measuring Range A term that shows ranges of measuring points used for concentration
conversion.
Multi-Calibration A function to perform calibration for multiple assay items on a single set
of calibrators.
Multi-Calibrator A calibrator used for multi-calibration.
Normal Print A simple print format that only shows test results.
Normal Range A range of normal values for each assay item.
Normal Range A menu to configure age ranges for generation judgment when the
Generation * normal range is set to ‘Human Auto’.
Orderless A function to run all available assay items on all samples set on the
sample carousel.
Panel Test A function to register multiple assay items as a set.

Appendices
Terms Description
Panic Range * A range of panic values for each assay item.

Parameter * A term that shows analysis conditions for each assay item such as
sampling volume, wavelength and reagents.
Partial Calibration A method of offsetting a calibration curve by using only one or two
calibrators.
Patient Information A set of data that includes patient information such as name, gender and
age.
PID, Patient ID An identification number assigned to a patient.
Primary (Wavelength) A wavelength for each assay item that is primarily used for concentration
conversion.
Prime A maintenance sequence that supplies system water and detergent
through the fluidic system inside the analyser.
Prozone Limit * A function to detect prozone effect in immunoterbimetry assays.
Range Shift A function to output the result for a time course that is over the
absorbance limit by applying alternative measuring points.
Reagent Blank * A function to offset a time course using the absorbance obtained from
measuring reagent only.
Reagent Blank Deviation An allowable range for the absorbance deviation during reagent blank
Limit * measurement.
Reagent Code * An identification number assigned to a reagent.
Reagent Type A term that shows the type of reagent such as R1, R2, diluent or
detergent.
Replication A function to perform QC measurement or calibration multiple times
and apply the optimal value.
Report Print A report type print format that has patient information and detailed test
results.
Round A term that shows how many times measurements have been started.
Sample Category A term that shows the category of a sample such as routine sample,
calibrator and QC sample.
Schedule * A function to automatically load a template at a specified time.
Secondary (Wavelength) A wavelength for each assay item that is used to offset external factors
Sensitivity Limit * A function to check the difference between the lowest concentration and
the highest concentration of calibrators.
Serum Indices * A function to output qualitative assessment of serum by testing the
degree of haemolysis, lipemia and icterus.
SI Mode * A setting method for reagents that is used for the assay of sample serum
indices.
SID, Sample ID An identification number assigned to a sample.

Appendices
Terms Description
Sleep A function that puts the analyser into stand-by mode without shutting
down completely, allowing it to be awoken ready for measurement at a
specified time.
Soak Wash * A maintenance sequence that washes the outside of the pipettes and
stirrers by soaking them in detergent filled cuvettes.
Stability Check A function to check the onboard stability of each reagent.
Technical Range A range of measurable values for each assay item.
Template A function to pre-configure regularly used samples such as calibrators
and QC samples.
Test Mode A function to select a sampling volume from 3 pre-sets.
Test Sequence Number * Supplementary information attached to the end of sample IDs to show
the number of replication tests.
Time Course A set of data that shows changes in absorbance during reaction.
Trough Wash * A maintenance sequence that washes the pipettes and stirrers at the
troughs.
Water Blank * A sequence that dispenses system water into the cuvettes used for
measurement and measures the absorbance of each cuvette.
WORK A calibration curve obtained by partial calibration.
Worklist A term that shows which assays are to be tested.

Appendices
Operator Maintenance Schedule

Appendices
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RX modena Operator Manual

Page Rev. Done by:

1.0 ALL NEW MANUAL RELEASED RANDOX November 2016

1.0.1 xiv Amendment to product label RANDOX December 2016

Appendices Addition of Operator Maintenance

Manual Updated to Version 2.00

Corrected error in auto page

2.0.1 xxviii Corrected typo and punctuation RANDOX March 2017

Manual Updated to Version 3.00

Update of RX series logo

Update to TOC to account for change

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RX modena — Operator Manual Document No. RX9003

RX modena Operator Manual Contents

Analysis Specifications ..................................................................................................... xxxviii

RX modena — Operator Manual Document No. RX9003

2.2.1 Reagent Carousel ...................................................................................................................... 2—12

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3.2 Limit Check Settings.................................................................................................3—16

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6.6 Register QC Samples ................................................................................................6—29

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7.7.5 Print a Template ........................................................................................................................ 7—35

10.4 Backup ......................................................................................................................10—18

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12.5 Consumables and Periodical Replacement Parts ..................................................12—8

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RX modena — Operator Manual Document No. RX9003

Document name Document No. Description

Rx modena RX9003 This volume is prepared for CLINICAL LABORATORY

Rx modena RX9004 This volume is prepared for SERVICE ENGINEERS

NOTE: The content of this manual is subject to change without notice.

Document No. RX9003 RX modena — Operator Manual

Symbols Representing the Types of Hazards

Precautions for Safe Use

RX modena — Operator Manual Document No. RX9003

Precautions for Installation

Document No. RX9003 RX modena — Operator Manual

Precautions for Operation

Prevention of Electric Shock

RX modena — Operator Manual Document No. RX9003

Handling of Reagent and Other Solutions

Document No. RX9003 RX modena — Operator Manual

Prevention of Cross Contamination of Assays

RX modena — Operator Manual Document No. RX9003

Rx Modena Carryover Avoidance:

Method 1 Method 2 Reagent Pipette Wash solution

Document No. RX9003 RX modena — Operator Manual

RX modena — Operator Manual Document No. RX9003

Precautions for Maintenance

Prevention of Electric Shock

Document No. RX9003 RX modena — Operator Manual

RX modena — Operator Manual Document No. RX9003

Water Quality Requirements (Reference)

Water Quality Specified in CLSI C3-A4