User Manual: Catalog # 001000

IH-1000
User Manual
Catalog # 001000
Identification
Identification
Document
IH-1000 User Manual
Version 1.5 - 07/2017
SAP: H009142
REF 001000
IVD 
Manufacturer
a DiaMed GmbH
Pra Rond 23
1785 Cressier FR
Switzerland
Tel. +41 (0)26 67 45 111

Fax +41 (0)26 67 45 145
Copyright ©
The reproduction, even partially, of this document is forbidden. No part may be copied in
any form, and it may not be used, edited nor transmitted by any electronic means
(photocopy, photography, magnetic supports or other recording processes), without the
written authorization of Bio-Rad. All rights and particularly reproduction, translation, edition,
distribution and also industrial property and recording are reserved.
2 | IH-1000
Identification
Version History
Document Software
Date Modification
Version Version
1.0 07/2010 First edition
1.1 V3.0 03/2011 V3.0 Soft updates
1.2 V4.0 11/2012 V4.0 Soft and troubleshooting updates
1.3 11/2013 Compliance 61010-1 2010, User level and minor updates
1.4 V04.04 03/2015 V04.04 Soft updates and minor updates
1.5 V04.07 07/2017 New layout

Content update according to the software version
Revised:
• the Glossary on page 12;
• the procedures of Managing Liquids and Wastes on
page 109;
• the description of the Options on page 143;
• the Maintenance Operations on page 167;
• the list of Examples of Test Execution on page 208
• Barcode Exception Mask Filter Option on page 149;
Added:
• a glossary of abbreviations;
• a procedure for Removing Sample Racks on page 104
IH-1000 | 3
Identification
PAGE INTENTIONALLY LEFT BLANK
4 | IH-1000
TABLE OF CONTENTS
Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Chapter 1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

1.1 Appropriate Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
1.2 Warranty Limitation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.3 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
1.3.1 Persons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
1.3.2 Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
1.3.3 Sample Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
1.4 Typographical Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.4.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.4.2 Command . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.4.3 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
1.4.4 Procedure Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.4.5 Cross Reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.4.6 List of Items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.4.7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.4.8 Images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
1.4.9 Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.4.9.1 Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.4.9.2 Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Chapter 2 Safety and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

2.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.1.1 Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.1.2 Importance of the Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.1.3 Disregarding the Safety Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.2 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.3 General Safety Instructions and Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.3.1 Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.3.2 Packaging Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Chapter 3 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
3.2 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
IH-1000 | 5
3.3 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.3.1 Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.3.2 Pipetting Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3.3.3 Rear View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
3.3.4 Computer Connecting Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
3.4 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.4.1 Performances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.4.2 Commercial Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.4.3 Dimensions of Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.4.4 Electrical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
3.4.5 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
3.4.6 Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
3.4.7 Identification Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
3.5 Theory of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3.5.1 Reaction Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3.5.2 Test, Interpretation and Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
3.6 Process Flow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
3.7 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.7.1 Full Positive Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.7.2 Liquid Level Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.7.3 Clot Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
3.7.4 Priming and washing the Fluid Circuit . . . . . . . . . . . . . . . . . . . . . . . . . 41
Chapter 4 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

4.1 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
4.2 IH-1000 Software Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.2.1 Header strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.2.1.1 Last Screen or Main Screen Button . . . . . . . . . . . . . . . . . . . 45
4.2.1.2 Menu Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.2.1.3 Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.2.1.4 Miscellaneous Information Area . . . . . . . . . . . . . . . . . . . . . . . 45
4.2.2 Interactive Instrument Image . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.2.3 Search Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.2.4 Traceability Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.2.5 Samples and Reagents Loading Area . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.2.6 Footer Strip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.2.6.1 Resources Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.2.6.2 Tests Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.2.6.3 Other Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.3 Warning Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
4.4 Authentication Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.5 Maintenance Reminder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
4.6 Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Chapter 5 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53

5.1 Starting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.1.1 Preliminary Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.1.2 Starting Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.2 Exiting the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.3 Stop All of the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
5.4 Shutdown of the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.5 Rescue Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
5.6 Step by Step Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6 | IH-1000
Chapter 6 Managing Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67
6.1 Managing Gel Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.1.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
6.1.2 Gel Cards Storage Drawer Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6.1.2.1 Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6.1.2.2 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
6.1.3 Opening / Closing the Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
6.1.4 Loading Gel Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
6.2 Managing Samples and Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
6.2.1 Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
6.2.1.1 Using Standard Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.2.1.2 Using Low Volume Tubes (for Red Cells Only) . . . . . . . . . . . . . 76
6.2.1.3 Using Plunger Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
6.2.1.4 Using Low Volume Segment Blood . . . . . . . . . . . . . . . . . . . . 77
6.2.1.5 Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
6.2.1.6 Emergency Sample Rack . . . . . . . . . . . . . . . . . . . . . . . . . . 80
6.2.1.7 Using a New Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
6.2.1.8 Specifications for Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
6.2.1.9 Specifications for Barcodes . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.2.1.10 Sample Tubes Dead Volume . . . . . . . . . . . . . . . . . . . . . . . . 82
6.2.1.11 IH-1000 Centrifuged Sample Tubes Minimum Plasma Height . . . . . 82
6.2.1.12 Red Blood Cells Minimal Height . . . . . . . . . . . . . . . . . . . . . . 83
6.2.2 Diluent Rack and Diluent Product . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.2.2.1 Diluent 1 Rack Product Instructions . . . . . . . . . . . . . . . . . . . . 85
6.2.2.2 Inserting a Diluent Rack Product . . . . . . . . . . . . . . . . . . . . . 85
6.2.3 Reagent Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
6.2.3.1 Use of the Cleaning Solution SETUP CLEAN . . . . . . . . . . . . . . 88
6.2.3.2 Preparation of 15ml of SETUP CLEAN . . . . . . . . . . . . . . . . . . 89
6.2.4 Samples / Reagents Area Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
6.2.4.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
6.2.4.2 Rack Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
6.2.4.3 Sample Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
6.2.4.4 Diluent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
6.2.4.5 Reagent Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
6.2.4.6 Details Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
6.2.4.7 Sample Barcode Manual Input . . . . . . . . . . . . . . . . . . . . . . . 98
6.2.4.8 No Cap confirmation . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
6.2.5 Loading Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
6.2.6 Removing Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
6.2.6.1 Removing Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . 104
6.2.6.2 Removing Reagent or Diluent Racks . . . . . . . . . . . . . . . . . . 106
6.2.6.3 Remove all Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
6.2.6.4 Removing Diluent and Sample Rack manually . . . . . . . . . . . . . 107
6.2.6.5 Removing Reagent Racks manually . . . . . . . . . . . . . . . . . . . 108
6.3 Managing Liquids and Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
6.3.1 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
6.3.2 Checking Liquids and Wastes Status . . . . . . . . . . . . . . . . . . . . . . . . 111
6.3.3 Refilling a System Liquid Container . . . . . . . . . . . . . . . . . . . . . . . . . 112
6.3.4 Cleaning Liquid Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
6.3.5 Cleaning of the Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
6.3.6 Replacing a Liquid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . 116
6.3.7 Priming Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
6.3.8 Cleaning Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
6.3.9 Replacing the Gel Cards Waste Bin . . . . . . . . . . . . . . . . . . . . . . . . . 118
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6.4 Checking Resources Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
6.4.1 Missing Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
6.4.2 Resources on Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
6.4.2.1 Gel Cards Storage Drawer Area . . . . . . . . . . . . . . . . . . . . . 121
6.4.2.2 Reagent / Diluent Area . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Chapter 7 Managing Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

7.1 Performing a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
7.2 Performing an Urgent Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
7.3 TESTS Buttons of the Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
7.4 Tests in Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
7.4.1 Details of a Test in Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
7.5 Tests ready to start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
7.5.1 Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
7.6 Tests without Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
7.7 Tests to Repeat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
7.7.1 Repeat Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134
7.8 Samples without Request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
7.8.1 Associate a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
7.9 Checking Pipetting Area Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
7.9.1 Opening the Pipetting Area Window . . . . . . . . . . . . . . . . . . . . . . . . . 139
7.9.2 Clot Detection Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
7.9.2.1 Clot Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Chapter 8 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143

8.1 Options Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
8.2 General Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
8.2.1 Barcode Exception Mask Filter Option . . . . . . . . . . . . . . . . . . . . . . . 149
8.3 Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.4 Controls Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
8.4.1 Return of the Cards in Drawer for Second Reading Option . . . . . . . . . . . 155
8.4.1.1 Remaining Cards Locations in the Drawer . . . . . . . . . . . . . . . 155
8.5 Disabled Mode Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
8.6 Cap Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
8.6.1 Type of Reagent Vials with Detected Cap . . . . . . . . . . . . . . . . . . . . . 158
8.6.2 Type of Standard Tubes with Detected Cap . . . . . . . . . . . . . . . . . . . . 159
8.6.2.1 Type of Cylindrical Tubes Caps not Detected . . . . . . . . . . . . . 160
8.6.3 Low Volume Tube (for Red Cells only) Cap Detection . . . . . . . . . . . . . . 160
8.6.4 Plunger Cap Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
Chapter 9 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161

9.1 Checking Components Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
9.2 Maintenance Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
9.3 User Level Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
9.4 Maintenance Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
9.4.1 Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
9.4.2 Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
9.4.2.1 Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
9.4.2.2 Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
9.4.2.3 6 and 12 Months Maintenance . . . . . . . . . . . . . . . . . . . . . 178
9.4.2.4 Total Estimated Times and Liquid Volumes for Weekly Maintenance 178
9.4.3 QC Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
9.4.4 Removing the ID-Cards Piercing Array Equipped . . . . . . . . . . . . . . . . . 179
9.5 Needle Cleaning Right/left Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
9.6 Needle Change Right/left Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
8 | IH-1000
9.7 Rinse Right/Left Pipettor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
9.8 Reading Station Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
9.9 General Initialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
9.10 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
9.10.1 Short Term Storage in Laboratory Conditions . . . . . . . . . . . . . . . . . . . 188
9.10.2 Other Storage Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Chapter 10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189

10.1 Alarms and Error Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
10.2 Software Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
10.2.1 All Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
10.2.2 Transport Arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190
10.2.3 Identification Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
10.2.4 Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
10.2.5 Reading Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
10.2.6 Pipettors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194
10.2.7 Hydraulic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
10.2.8 Reagent Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
10.2.9 Gel Cards Piercing Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
10.2.10 All Cameras . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197
10.2.11 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Chapter 11 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201

11.1 Equipment and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
11.1.1 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
11.1.2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
11.2 CE Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
11.3 Documents / Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
11.3.1 Decontamination Certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
11.3.2 Maintenance Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
11.4 Spare Parts Ordering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
11.5 Device Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
11.5.1 General Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
11.5.2 Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206
11.6 List of Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
11.6.1 User Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
11.6.2 Service Manuals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
11.6.3 Spare Parts Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
11.7 Examples of Test Execution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .219
IH-1000 | 9
10 | IH-1000
1 GENERALITIES
Chapter Overview
This chapter contains basic information on the instrument and the document structure.
1.1 Appropriate Use

Exclusively use the IH-1000 as an in vitro diagnostic instrument.
The IH-1000 may only be used by trained and authorized personnel in a medical
laboratory. It may not be used in the patient’s direct environment.
Using the IH-1000 is only permitted in conjunction with the corresponding software or in
a configuration which is authorized by Bio-Rad.
The use of any material other than the one specified in the User Manual (e.g. non-
authorized substances) is forbidden.
The instructions contained in the current User Manual must be adhered to with particular
reference to the safety instructions.
IH-1000 | 11
Generalities
1.2 Warranty Limitation

Although the instrument and its software have been tested, it is highly recommended to
perform a backup of the computer before any installation and use of the software.
Bio-Rad denies any responsibility in case of:
• wrong use of the instrument;
• unauthorized modification (willingly or unwillingly);
• not complying to the instructions contained in the manuals provided with the instru-
ments and software;
• not complying to the safety instructions contained in the manuals;
• damages linked with the use of the instrument, in particular any data loss or any finan-
cial loss which could possibly be attached to the use of the software;
• if the instrument is used in a manner not specified by the manufacturer, the protection
provided by the instrument may be impaired.
When the instrument is connected to a host, the user takes the entire responsibility for an
error-less transmission of the results (hardware, software, firmware, etc...) to this system.
Any warranty will be deemed void if fault is found to have been caused by
maltreatment, misuse, unauthorized maintenance of service or negligence of regular
maintenance and service, accidental damage, incorrect storage or use of the
products for operations outside their specified limitations, outside their
specifications, contrary to the instructions given in this manual.
Each Bio-Rad’s IH-1000 is tested by the manufacturer before shipping.
1.3 Glossary
The following terms, among others, are used in this manual.
GUI Graphical User Interface
ID-Card Term which designates the gel card
LAN Local-Area Network
QC Quality Control
UDI Unique Device Identifier
UPS Uninterruptible Power Supply
USB Universal Serial Bus
12 | IH-1000
Glossary
1.3.1 Persons
Manufacturer
The manufacturer of the IH-1000 is:
DiaMed GmbH
Pra Rond 23
1785 Cressier FR
Switzerland
Operator
The operator is the owner of a IH-1000 when using it as its owner and when transferring
it to a third-party.
Personnel
The term “personnel” includes any person who performs any kind of operation with the
IH-1000. These individuals should be qualified in accordance with the manufacturer’s
requirement.
Technical personnel
The term «technical personnel» designates the duly trained persons, who are allowed to
perform specific tasks on the IH-1000.
For instance, an electrician is designated as technical personnel for the activities linked to
wiring the IH-1000 to the electrical network.
Personnel qualifications
The personnel qualifications define the minimum requirements which must be met by the
authorized personnel.
IH-1000 | 13
Generalities
Minor Injury
A Reversible injury that does not require medical treatment.
Moderate Injury
A Reversible injury that does require medical treatment.
Major Injury
The damage that is irreversible, causes handicap or death.
1.3.2 Product
Instrument
This is the IH-1000 distributed by the manufacturer.
Bio-Rad authorized Gel Card

Gel card based on column agglutination technique including a microtube system
consumable where the antigen-antibody binding is fixed in the gel matrix.
Only gel cards manufactured by Bio-Rad may be used in the instrument.
Sample
Content of any sample tube.
Bio-Rad authorized Reagent

A consumable substance or compound that is added to a system in order to bring about
a chemical reaction, or is added to see if a reaction occurs. Such a reaction is used to
confirm the presence of another substance.
Only reagents manufactured by Bio-Rad may be used in the instrument.
14 | IH-1000
Glossary
1.3.3 Sample Material

ABO/Rh Testing
Centrifuged blood samples are required for tests which involves red cells EDTA is
considered an acceptable anticoagulant for patient and donor samples.
Clotted samples (no anti coagulant in the sample) cannot be used when red cell testing is
being performed.
Clotted, grossly hemolyzed, grossly lipemic or grossly icteric samples may result in
inaccurate typing or increased “not interpretable” results.
Anti-coagulated blood samples can be tested for up to 48 hours after collection. If the
samples are not tested within 24 hours of collection, samples should be stored at 2-8 °C.
The samples must return to room temperature prior to analysis. The use of cold samples
may cause dispensing errors or non-specific reactions.
Prior testing, samples must be centrifuged according to the local Good Laboratory
Practices, e.g. 10 minutes at 1500g, to obtain a distinct separation between cells and
plasma/serum.
Antibody Screen Testing

Plasma or serum can be used for the antibody screening, antibody identification and
crossmatch test on the IH-1000. The serum must be in a separate tube without the
presence of red cells in the same tube.
IH-1000 | 15
Generalities
1.4 Typographical Conventions

The following styles are used in this manual.
1.4.1 Description
This style, used in conjunction with illustration numbers, is preceded with the
corresponding numbers:
Example
1 First element.
2 Second element.
3 Etc...
1.4.2 Command
Any software command, button, function key, window, icon, option, tab, checkbox,
selection box, article, menu, tool bar, field and section used in this document is
represented by a bold italic font.
Example
The EXIT command allows to quit the software.
1.4.3 Procedure
Each procedure step to be carried out step-by-step by the user is preceded by a letter.
Example
A Open the drawer.
B Put the gel card into position as shown.
C Close the drawer.
16 | IH-1000
Typographical Conventions
1.4.4 Procedure Result

A procedure result is shown by the following symbol .
Example
A Click on the Parameters button.

 The parameter screen is displayed.
1.4.5 Cross Reference

This style helps the user to find complementary information linked to the current subject.
Example
See chapter Cross Reference on page 17.
1.4.6 List of Items

This style is used in order to display a list of elements.
Example:
• item 1;
• item 2;
• item 3.
1.4.7 Troubleshooting
The complete description along with the error code, the description and the corrective
actions as follows:
Error code Error description Corrective actions
1.4.8 Images
Versions on screen shots do not necessarily correspond with the current version of
software.
IH-1000 | 17
Generalities
1.4.9 Warning
The following styles are used in this manual.
Content of software screens and buttons remain in English printed in bold italic type and
are followed by their translation in brackets (e.g. click the VALIDATE button to confirm).
1.4.9.1 Warning
To designate:
an imminent and dangerous situation which, if not avoided, may lead to major injury
of the user;
or a potentially dangerous situation which, if not avoided, may lead to:
• moderate injury of user or in the tests being false;
• injury of user or in important delay in delivery of the test results.
1.4.9.2 Note
Indicates:
• a preferred procedure or recommended use,
• a general or informative remark.
18 | IH-1000
2 SAFETY AND HANDLING
Chapter contents
This chapter sets out safety instructions to ensure safe and trouble-free operation of the
IH-1000 and its associated softwares. It also describes the handling and storage
conditions.
IH-1000 | 19
Safety and Handling
2.1 Introduction
2.1.1 Principles
Before carrying out any operation whatsoever on the IH-1000, it is imperative to read
this chapter and fully understand it.
In case of any doubt, consult your Bio-Rad representative.
2.1.2 Importance of the Safety Instructions
All the safety instructions in this User Manual and on the instrument must be
complied with in order to prevent accidents to persons, damage to equipment or
pollution of the environment.
In a similar manner, the legal bylaws and the recognized technical rules which apply in the
country of use of the IH-1000 must be adhered to.
2.1.3 Disregarding the Safety Rules

Disregarding the safety rules, as well as existing legal and technical regulations, may lead
to accidents, property damages or environmental pollution.
Disregarding the instructions for use given by the manufacturer may reduce the level
of protection offered by the instrument.
20 | IH-1000
Environmental Conditions
2.2 Environmental Conditions
The IH-1000 may only be used indoors and never in the immediate vicinity of patients.
The electrical safety of the IH-1000 is guaranteed only if the electrical installation of
the building complies with national regulations applicable to buildings for medical
purposes or laboratories and if this installation is functioning perfectly.
The IH-1000 may not be used in premises subject to risks of fire or explosion.
As for any other electrical device, the IH-1000 may not be located near a water tap.
Do not allow any liquid to penetrate inside the housing of any instrument. In case of
major spillages of liquid inside any instrument, proceed immediately as follows:
A. Switch off the IH-1000 at the power switch.
B. Disconnect the plug.
C. Dry the instrument.
D. Clean and decontaminate the instrument.
E. Check all electrical functions.
See chapter Decontamination on page 167.
For more information, contact your representative.
The IH-1000 must be kept away from potential sources of interference.

The IH-1000 may not be exposed to direct sunlight, heat, dust or excessive humidity
(use only in a clean laboratory environment).
The instrument must not be located near sources of high electromagnetic radiation
which may interfere with proper operation.
The use of the instrument in a dry environment especially if synthetic materials are
present (clothes, synthetic carpets, etc.) may cause electrostatic discharges and
lead to false results.
Assess the electromagnetic environment of the site in which the IH-1000 is located
before switching it on.
IH-1000 | 21
Safety and Handling
This instrument has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This instrument generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instruction, may cause harmful
interference to radio communications. There is no guarantee that interference will
not occur in a particular installation. If this instrument does cause harmful
interference to radio or television reception which can be determined by tuning the
instrument off and on, the user is encouraged to try to correct interference by one or
more of the following measures:
A. Reorient or relocate the receiving antenna.
B. Increase the separation between the instrument and receiver.
C. Connect the instrument into an outlet on circuit different from that to which the
receiver is connected.
D. Consult the dealer or an experienced radio/TV technician for help.
This class (B) digital apparatus complies with Canadian ICES-003.
Changes or modifications not expressly approved by the party responsible for

compliance could void the user's authority to operate the instrument.
22 | IH-1000
General Safety Instructions and Signs
2.3 General Safety Instructions and Signs
EXPLOSION
The IH-1000 is not explosion resistant. Sparks may cause a fire or an explosion.
Do not install the IH-1000 in the vicinity of inflammable or explosive products.
Do not use flammable, explosive or chemically reactive materials during the
centrifugation with sufficient force to cause a danger.
INFECTION
Each well on each gel card can contain up to 125 µl of blood sample solution.
There is a risk of infection from skin contact with blood. Always wear protective
gloves when working, in accordance with laboratory safety regulations.
CONTACT WITH WATER

The IH-1000 is not protected against water penetrations. Water penetrating the
instrument may cause an electrical discharge.
Do not install the IH-1000 in the vicinity of water or in any place where a risk of water
penetration is possible.
Repair and service operations must only be performed by a qualified service

engineer appointed by the manufacturer.
Take into account all the warnings and follow all instructions provided on the IH-1000
and in the documentation.
The IH-1000 may only be connected to the electrical power sources specified.
It is imperative to use the liquids specified in the manual to clean the IH-1000. To use
a different liquid, consult the manufacturer and ask for his approval.
The use of materials other than those defined in the user’s manual (unauthorized
hazardous substances such as inflammable, explosive or chemically unstable
substances) is forbidden. Any infringement of this rule will be considered by the
manufacturer as guilty negligence.
Never attempt to use spare parts other than those supplied by the manufacturer.
IH-1000 | 23
Safety and Handling
The instrument may only be placed on a flat surface capable of bearing its weight.
Do not place anything above the IH-1000 as this may hamper the use of the
instrument. This also avoids any object falling on the instrument.
The IH-1000 must be located nearby a mural electrical socket to avoid using an
extension power cord.
The IH-1000 must be located in such a manner that operating their disconnecting
devices (the ON/OFF switch and the separable plug of the power supply cord) is
possible at all times. In the latter case, the socket outlet must be placed near the
instrument and must be easily accessible by the operator.
Ensure that the ventilation around the IH-1000 is sufficient to avoid any excessive
heating which may cause malfunctions and/or failure of the instrument. A space of
300mm all around the instrument must be left clear of any obstacle.
If the instrument needs to be moved, please contact your service engineer.
Always stop the IH-1000 with the SHUTDOWN function. Never use the general power
switch, except in case of an emergency.
The IH-1000 may only be operated with the software supplied and with the
accessories approved by the manufacturer (example: external barcode reader).
Never connect a USB device (USB key, camera…) to IH-1000 without previously
scanning it with an updated antivirus.
The IH-1000 is delivered without an antivirus. The use of an antivirus is
recommended and should regularly be updated. This installation should be done on
both PCs. Ask your local distributor.
Make sure that the LIS is equipped with the necessary protection to ensure no virus
nor access is transmitted to the IH-1000.
Make sure that no automatic software update is activated on the instrument
computer.
It is imperative to obtain the manufacturer approval before using the IH-1000 in

combination with other devices.
24 | IH-1000
2.3.1 Signs
The following signs can be found on the IH-1000. Associated dangers are explained in
the table.
Appropriate safety instructions for specific situations are described along this manual. For
each specific procedure, read carefully the complete chapter.
In case of malfunction or any other technical incident for which a remedy has not been
described in the User Manual, please contact the manufacturer immediately.
Sign Description Explanation
Caution, consult -
accompanying
documents
Biological hazard INFECTION

All blood samples should be considered potentially infectious. Contact
with skin/mucous membranes must be avoided.
Always wear protective gloves when working with gel cards, sample
tubes, waste bin and with any instrument, in accordance with
laboratory safety regulations.
All biological waste must be handled and treated by the user before
disposal in accordance with local procedures and directives.
High voltage ELECTROCUTION

danger During maintenance work, use extreme caution at all times when the
IH-1000 is powered and uncovered; the instrument must not be left
unmonitored.
Avoid using non-isolated metallic parts to work inside the instrument
such as screwdrivers.
Laser beam CLASS 2 LASER - PERMANENT EYESIGHT INJURY

danger • Never look directly into the barcode reader laser beam.
• Never modify, open or remove any protections of the laser beam.
• Never interrupt the laser beam with a reflecting object.
Most metals reflect the laser beam.
Pinching danger PINCH POINT HAZARD

Keep hands clear during operation.
IH-1000 | 25
Safety and Handling
Sign Description Explanation
Burning danger HOT SURFACE

Contact may cause burns. Do not touch.
Electrostatic -
shock
danger
Irritant product IRRITATING

Avoid contact with skin and eyes.
Corrosive product CORROSIVE

Causes severe burns.
Avoid contact with skin and eyes.
Main switch Power ON
Main switch Power OFF
Protective earthing -
26 | IH-1000
2.3.2 Packaging Signs

Symbol Description
Fragile, handle with care.
Keep dry.
Keep upright.
Maximum and minimum humidity rate.
Maximum and minimum temperature.
Do not stock another IH-1000 on top of the first one.
IH-1000 | 27
Safety and Handling
28 | IH-1000
3 INSTRUMENT OVERVIEW
Chapter Overview
This chapter is a general presentation of the instrument.
3.1 Introduction
The IH-1000 automated analyzer allows to launch different kinds of tests within seconds.
A large number of tests can be processed simultaneously. Multiple tests can be performed
without any special interaction from the operator.
Several high-definition cameras allow to get clear pictures and precise tracing of
information during the whole process.
The IH-1000 software allows to monitor on-going tests and resources status.
An external Data Management software (IH-Com) is required to create test request and to
analyze results.
Read carefully the User Manual of the IH-Com Data Management Software.
IH-1000 | 29
Instrument Overview
3.2 Intended Use

IH-1000 is a fully automated system for immunohematology diagnostics.
IH-1000 is able to handle all kinds of immunohematological gel card technologies including
ABO blood grouping, reverse testing, phenotype, Rh-subgroups, antibody screening,
antibody identification, single antigens, direct AHG testing (DAT) and crossmatch.
The main functions of IH-1000 are:
• preparation of a sample cell suspension;
• distribution of sample cell suspensions, sample plasma, test cells into gel cards;
• incubation;
• centrifugation;
• gel card reading;
• single well reaction interpretation.
IH-1000 is only allowed to use gel cards and reagents from the ID-System authorized by
Bio-Rad.
30 | IH-1000
Instrument Overview
3.3 Instrument Overview

3.3.1 Front View
5
10
6 9
4
11
2 12
1
Figure 1. IH-1000 - Front view opened
1 Right front door: gel cards waste 7 Instrument Power Switch

2 Left front door: Liquids containers 8 Touch-screen
3 Gel cards storage drawer 9 Keyboard
4 Samples and reagents loading area 10 Barcode reader
5 Pipetting area, protected by a window 11 Samples preparation table
6 Computer power button 12 UPS and batteries
IH-1000 | 31
Instrument Overview
3.3.2 Pipetting Area
1
2
3 4
5
Figure 2. IH-1000 - Front view - Pipetting area
1 Flux compensator
2 Left pipettor
3 Transport arm
4 Right pipettor
5 Washing module
6 Localization module
32 | IH-1000
Instrument Overview
3.3.3 Rear View
Only a service engineer is allowed to open the back doors.
1 8
6
4 5
Figure 3. IH-1000 - Rear view opened
1 Gel cards piercing module

2 Centrifuges (12 gel cards)
3 Automate computer
4 Master computer
5 Connecting panel
6 Power supply
7 Reading module
8 Incubator at 37°C
IH-1000 | 33
Instrument Overview
3.3.4 Computer Connecting Panel
Only a service engineer is allowed to open the back doors.
On all other connection (USB, RS232, screen, LAN), connect only safety Extra Low
Voltage devices.
AUTOMATE Connections
1 WIRELESS (USB connection): To connect an external Wi-Fi device on the computer

(Automate)
2 KEYBOARD (USB connection): To connect an additional keyboard to manage the
computer (Automate)
3 MOUSE (USB connection): To connect an additional mouse to manage the computer
(Automate)
4 UPS (USB connection): To connect the UPS
5 OPTION (USB connection): To connect optional USB devices on the computer (Automate)
6 SCREEN: To connect another screen on the computer (Automate)
Do not touch or change the connections on the automated PC.
MASTER Connections
7 WIRELESS (USB connection): To connect an external Wi-Fi device on the computer

(Master)
8 PRINTER (USB connection): To connect a printer to the computer (Master)
9 LAN (Ethernet cable): To connect the LAN network cable
10 RS232 (Serial port): To connect the RS232 communication cable
The IP address used by the IH-1000 to transmit between the R2 Master PC and the D2
Automate are defined as follows:
• R2 Master PC IP address: 192.168.0.1
• D2 Automate IP address: 192.168.0.2
34 | IH-1000
Instrument Overview
1 2 3 4
5 6
7 8 9 10
Figure 4. Computer connecting panel
IH-1000 | 35
Instrument Overview
3.4 Technical Data

3.4.1 Performances
Throughput Depending on the profile up to 120 gel cards per hour
Load capacity • Up to 180 sample tubes;

• up to 28 reagent vials;
• up to 240 gel cards;
• 2x5L container for system liquid;
• 2x5L container for liquid waste;
• 1x5L container for cleaning liquid;
• 320 gel cards capacity waste bin
Identification Full positive identification (by barcode) of primary sample tubes, reagent vials,
diluent products and gel cards including lot number and expiry date control
3.4.2 Commercial Information

Order number 001000
3.4.3 Dimensions of Instrument

Width 1 1229mm (without screen holder)
Width 2 1730mm (with screen holder)
Height 1691mm
Depth 823mm
Weight 540Kg
3.4.4 Electrical Data

Power supply Connection on a standard system (presence of normal overvoltage)
Voltage 100/240VAC
Frequency 50/60Hz
Power 1350VA
Heat emission 720W
The IH-1000 earthing protection is via the power cord therefore the mains supply used
must be connected to a protective earth.
The instrument must be powered by an earthed mains power supply.
The power cord must be replaced by a power cord which is in accordance with local
regulations. Voltage/Current specifications are: 250V/10A or 110V/15A.
36 | IH-1000
Technical Data
3.4.5 Environmental Conditions

Operating temperature +15°C to 27°C
Storage & transport temperature -20°C to +55°C
Relative humidity, no condensing 5 to 80% rh (storage, transport and operating)
Maximum relative humidity 80% for temperature up to 31°C, decreasing linearly

to 50% at 40°C.
Power fluctuation +/-10%
Transient overvoltage Category II
Altitude max 2000m
3.4.6 Emissions
Noise 75dB(A) max
Pollution level 2
IH-1000 | 37
Instrument Overview
3.4.7 Identification Plate

Please copy the following information from
the identification plate in the fields below. IH-1000
Type (instrument)
100-240 VAC
REF 001000 50/60 Hz
SN XXXXXXXX Max. 1350 VA
DiaMed GmbH
Pra Rond 23, 1785 Cressier FR
Switzerland
Serial number (SN) --
Made in France
IVD
(01)03610520514184
(11)000000
RO00005 A
(21)XXXXXXXX
This class (B) digital apparatus complies with Canadian ICES-003
Figure 5. Identification plate
Sign Description
Manufacturer reference (order number)

REF
Serial number
SN
Manufacturer
a
Date of manufacture (yyyy-mm)
CE Mark
See chapter CE Compliance on page 203.
In Vitro Diagnostic medical device

IVD
See documentation
WEEE mark
See chapter CE Compliance on page 203.
Curtis-Straus marking - Canadian & US
2D barcode (SN + UDI-DI)

UDI = Unique Device Identification (GTIN-14)
38 | IH-1000
Theory of Operations
3.5 Theory of Operations

3.5.1 Reaction Process
The ID-System is based on a process concerned with the determination of antigen-
antibody complexes. The agglomerated particles are separated from non-agglomerated
particles by the means of an inner gel. The gel cards used contain 6 microtubes.
The reaction occurs on the gel-filled microtubes. The gel contains specific antibodies or
reactives in accordance with the desired reaction.
After adding the sample to test, it is possible to visually observe in the gel column the
separation between the agglomerated and non-agglomerated hematies after a
centrifugation. Depending on the intensity of the reaction, hematies penetrate the gel to a
different extend. It is thus possible to classify the reaction into 5 steps: ++++, +++, ++,
+, -.
3.5.2 Test, Interpretation and Result

The camera interprets the result of the reaction in the corresponding gel card. The camera
image is divided into search windows. The search windows are then analyzed.
Search windows are divided into 5 zones: the lower part for a negative result, the upper
part for the positive ++++ results and three intermediate zones for the +, ++, and +++
results.
A computer algorithm then analyses the image and determines the reaction result for each
microtube (refer to the IH-Com User Manual for detailed information on reaction results):
Reaction result Description
+, ++, +++, ++++ Positive (in 4 steps)
- Negative
? No result interpretation possible

Check result manually during validation
Liq Liquid distribution problem
dp Double population
wF Doubtful result / Gel not clear.

Please check manually for foreign particles
wR Nonhomogeneous area above the pellet (red cells or foreign bodies)

Please check manually
wP Check surface of the pellet
wD No clear cell pellet. Please check manually
[] Well not used for the test
L No liquid distribution detected in the well
W Well not found for interpretation
E No reaction available in the well
E No liquid above the gel
IH-1000 | 39
Instrument Overview
A test result is based on the results of the corresponding microtubes. That result must
then be validated by the user on the basis of the digital image provided. Manual
corrections are marked with an asterisk “*”.
3.6 Process Flow

Depending on the process, the pipettor will take suitable quantities of sample, diluent and
reagent. It will then supply them to the appropriate gel cards. The sampling needle is then
automatically sent to the washing module.
1 As soon as the drawer is closed, the transport arm detects the kind of gel card loaded
in each tray.
2 The samples, diluents and reagents are identified by the identification module as soon as
the racks are loaded. The transport arm carries them into the pipetting area after
identification.
3 The transport arm brings the gel cards to the piercing module, then to the pipetting area.
4 The pipettor aspirates the sample, the diluent and the reagent, and then supplies it in the
appropriate gel card.
5 If necessary, the transport arm brings the gel card to the 37°C incubator.
6 The transport arm puts the gel card into an available centrifuge. If necessary,
counterweighting gel cards are loaded; the number of gel cards in the centrifuge must be
even.
7 The transport arm takes the centrifuged gel card into the reading module.
8 The camera reads the result.
9 The gel card is put in the gel cards waste bin.
40 | IH-1000
Features
3.7 Features
3.7.1 Full Positive Identification
The IH-1000 automatically identifies the resources required by reading the barcodes of the
elements inside the instrument and compares them with the ones needed by the selected
test program.
It also checks the lot number and the expiry date of the devices used in the system.
3.7.2 Liquid Level Detection

The IH-1000 is designed to permanently check the availability of reagent, diluent and
solutions in order to avoid any failure.
Level detection is disabled for any tube with Low volume segment blood (racks of
type 4 - Barcode 04 or 14).
See chapter Using Low Volume Segment Blood on page 77.
It also checks and prompts the user when the waste container is full.
3.7.3 Clot Detection

To prevent any obstruction of the fluid circuit by red cells or serum during the pipetting
process, the IH-1000 is able to detect the presence of a blood or serum clot by means
of a sensor.
There is no clot detection available with small dilutions <1%.
This detection is also performed in case of using whole blood and not only concentrated
red cells.
We strongly recommend to only use anticoagulated samples and to not use samples
that are older than 48 hours.
See chapter Clot Detection on page 141.
3.7.4 Priming and washing the Fluid Circuit

The IH-1000 allows several operations on liquids. The wash function enables to clean
internally and externally the dispensing needles and to prime the fluid circuit.
IH-1000 | 41
Instrument Overview
42 | IH-1000
4 SOFTWARE OVERVIEW
Chapter Overview
This chapter introduces the IH-1000 control software.
4.1 Software Overview

The IH-1000 software allows to monitor on-going tests and resources status in the
instrument.
External Data Management software is required to analyze results.
Read carefully the User Manual of the IH-Com Data Management software.
IH-1000 | 43
Software Overview
4.2 IH-1000 Software Main Screen

The main screen allows to access most of the instrument functions.
2 6
Figure 6. Main screen
1 Header strip on page 45

2 Current operation area
3 Interactive Instrument Image on page 46
4 Footer Strip on page 49
5 Search Area on page 47
6 Traceability Area on page 47
7 Samples and Reagents Loading Area on page 48
The header and footer strips (1) and (3) are always visible and give access to the options
available, depending on the current operation.
The current operation area (2) will display the detailed information.
44 | IH-1000
IH-1000 Software Main Screen
4.2.1 Header strip

The header strip has three buttons and displays miscellaneous information. It is identical
on all software screens.
Figure 7. Header strip
4.2.1.1 Last Screen or Main Screen Button
On any screen, MAIN SCREEN button allows to go back to the main screen.
On the main screen, LAST SCREEN button is displayed instead. It allows to go back to
the last screen consulted.
4.2.1.2 Menu Button
The MENU button gives access to the MENU screen with the following functions:
• OPTIONS (See chapter Options on page 143.)
• MAINTENANCE (See chapter Maintenance Screen on page 164.)
• AUTHORIZED MAINTENANCE See chapter User Level Screen on page 165.)
• EXIT (See chapter Exiting the Software on page 56.)
• STOP ALL (See chapter Stop All of the Instrument on page 57.)
• SHUTDOWN (See chapter Shutdown of the Instrument on page 58.)
4.2.1.3 Data Management
Button to switch to Data Management software (IH-Com).

See IH-Com Data Management User Manual.
4.2.1.4 Miscellaneous Information Area
Status screen showing system date and time, system status, software
version and logged in user.
IH-1000 | 45
Software Overview
4.2.2 Interactive Instrument Image

The instrument image is divided into 5 areas. Clicking on each area gives access to
specific functionalities and information.
Areas become red in case of errors. See chapter Errors on page 52.
3
1
4
Figure 8. Interactive instrument image
1 COMPONENTS AREA
See chapter Checking Components Status on page 162.
2 LIQUIDS / WASTE AREA
See chapter Managing Liquids and Wastes on page 109.
3 PIPETTING AREA
See chapter Checking Pipetting Area Status on page 138.
4 SAMPLE / REAGENT AREA
See chapter Managing Samples and Reagents on page 74.
5 GEL CARDS STORAGE DRAWER
See chapter Managing Gel Cards on page 68.
46 | IH-1000
4.2.3 Search Area

Specific test related to a sample can be found by inputting sample
barcode.
Sample barcode can be typed with the keyboard or scanned with the
barcode reader.
Only functional for loaded samples.
4.2.4 Traceability Area
A Click INFORMATIONS from the main screen to access the LOG LIST
screen.
This screen allows to:
• display the traces in detail;
• filter by Level;
• to print the last 2 pages of traces.
B Click ARCHIVE to archive one or several number of trace files within a

range of time.
 The following screen is displayed.
Figure 9. Dates selection screen
C Select the Start and End date.
D Click OK.
 All traces available are compressed to the desktop in a new folder
named with the date of log files “LogFiles dd mm yyyy”.
IH-1000 | 47
Software Overview
Figure 10. Log list screen
4.2.5 Samples and Reagents Loading Area
Figure 11. SAMPLES / REAGENT area
This area shows the current status of each rack loaded into the instrument.
Clicking on this image will open the SAMPLE REAGENT AREA screen, which gives more
information.
The green bar indicates the preferential side (left or right) in the instrument to load
additional samples (faster processing).
See chapter Samples / Reagents Area Screen on page 90.
48 | IH-1000
4.2.6 Footer Strip

The footer strip displays the available options and information according to the current
operation.
For the main screen, the following buttons are available:
1 2
Figure 12. Footer strip on the main screen
1 Resources buttons 2 Tests buttons
4.2.6.1 Resources Buttons

The resources buttons give access to the RESOURCES management screens.
See chapter Managing Resources on page 67.
Resources to be charged and Resources on board are accessible from this menu.
Resources missing for one test in particular and Resources missing for all the tests are
accessible only from the TESTS WITHOUT RESOURCES screen.
4.2.6.2 Tests Buttons

These buttons give access to the TESTS management screens.
See chapter Managing Tests on page 123.
The TESTS buttons allows to access the screens that list tests according to their state.
The tests screens are accessible only if the corresponding button displays a non-nil
number of tests (otherwise, the button is disabled).
IH-1000 | 49
Software Overview
4.2.6.3 Other Buttons

Depending on the current operation, the following buttons appear on the footer strip.
BACK Button
The BACK button is available on all the software screens (except main screen). It allows
to go back to the previously consulted screen.
PRINT Button
When displayed, the PRINT button allows to print out the displayed datas.
Navigation keys
On some screens the navigation keys are available. It allows to scroll vertically and/or
horizontally in the current screen.
4.3 Warning Screen

This screen has a red triangular sign and is displayed when:
• an error on a test is detected;
• an authentication has failed;
• an acknowledgment or an out of service of a component is required by the user, an
acknowledgment of an empty container, of a full liquid waste container or of the full gel
cards waste bin is required by the user;
• the gel cards storage drawer is open;
• in some cases a confirmation by inputting the word «yes» is required.
 An appropriate message informs the user in each case.
Figure 13. Warning screen
50 | IH-1000
Authentication Screen
4.4 Authentication Screen

This screen has a yellow padlock and allows special logging:
• to access screens with protected access;
• to carry out specific actions on the automated analyzer.
Figure 14. Authentication required
4.5 Maintenance Reminder
The weekly maintenance has to be done once a week (after 7 days).

Otherwise an orange maintenance reminder (WEEKLY MAINTENANCE
NECESSARY) will appear.
See chapter Maintenance on page 161.
IH-1000 | 51
Software Overview
4.6 Errors
When a fault occurs in the instrument, the concerned area is highlighted in red on the
interactive image and a red informative area shows up on the screen (the SAMPLE /
REAGENT area is always visible, it is colored in red in case of error).
Detailed information on errors are given by clicking either on the red area of the interactive
image or on the red message.
3
2
2
1
4 3 4
5
5
Figure 15. Main screen - Faults
1 Error in the SAMPLE / REAGENT area

The green bar with the logo indicates on which side a sample rack has to be loaded to
ensure a faster processing.
2 Error in the COMPONENTS area

See chapter Checking Components Status on page 162.
3 Error in the PIPETTING area
4 Error in the GEL CARDS STORAGE DRAWER area
5 Error in the LIQUIDS / WASTES area
52 | IH-1000
5 GETTING STARTED
Chapter Overview
This chapter explains how to start using the instrument, including how to shutdown the
instrument.
It is necessary to be logged in the Data Management software to be able to perform

any operation on the IH-1000.
IH-1000 | 53
Getting Started
5.1 Starting the Instrument

5.1.1 Preliminary Checks
Before starting a working day, the following checks and actions must be performed.
A Check that the room temperature is between 15°C and 27°C.
B Empty the gel cards waste bin (4).

See chapter Replacing the Gel Cards Waste Bin on page 118.
Make sure to have an empty waste bin during the system start up.
C Empty the liquid waste containers (3).

See chapter Replacing a Liquid Waste Container on page 116.
D Fill the system liquid containers (2) with system liquid.

See chapter Refilling a System Liquid Container on page 112.
E Check that the window (1) of the pipetting area is completely closed.
See chapter Remove all Racks on page 106.
At start up if racks are detected in the pipetting area, they are listed as being
in error (in order to check their validity).
Before starting a working day remove ALL RACKS from the instrument.
2 3
Figure 16. Starting the instrument
54 | IH-1000
Starting the Instrument
5.1.2 Starting Procedure
A Start the instrument by positioning the On / Off switch to “I” (1).
2
1
B Press and hold the power button (2) for a few seconds.
 The computer starts.
A green light around the power button (2) indicates that the
computer is powered on.
C Double-click on the icon to start the IH-Com Data Management Software.

 The IH-Com Data Management interface is displayed.
D Login to IH-Com with your User ID and Password.
E Start the IH-1000 Software: click on the IH-1000 button in the IH-Com Data
Management interface.
 The instrument scans and identifies all gel cards present in the
drawer during the initialization.
The IH-1000 Software can also be started by double-clicking the IHM1000

icon on the desktop.
IH-1000 | 55
Getting Started
F The IH-1000 software checks if there were errors during the initialization
process.
If an error is detected: the Alert screen next is displayed showing
the list of initialization errors.
Click OK to close the IH-1000 software.
Figure 18. Alert screen
5.2 Exiting the Software

This function shuts down the user interface; the master computer remains started.
A From any screen, click on MENU.
B Click on EXIT.
The IH-1000 user interface will be closed immediately but the instrument will keep on
working.
C To restart the software, double click the corresponding icon on the desktop
or in the Data Management software.
56 | IH-1000
Stop All of the Instrument
5.3 Stop All of the Instrument

This button stops as soon as possible all the tests in progress on the instrument.
B Click on STOP ALL.

 The authentication screen appears.
Figure 19. Stop All instrument - Authentication
By clicking on STOP ALL, all tests in progress are lost and it is not possible to
continue. The only solution is to shut down the instrument with the SHUTDOWN
button.
C Confirm the STOP ALL procedure:

• Enter your login and password;
• Click on OK.
D SHUTDOWN the instrument.

See chapter Shutdown of the Instrument on page 58.
IH-1000 | 57
Getting Started
5.4 Shutdown of the Instrument

This function allows to completely shutdown the instrument.
Always switch off the IH-1000 with the SHUTDOWN function. Never use the general
power switch, except in case of an emergency.
If the instrument is blocked, shutdown with the Rescue Shutdown button (refer to
chapter Rescue Shutdown on page 59).
B Click on SHUTDOWN.
The shutdown command is not possible if any test is on-going in the IH-1000. Use
STOP ALL function first.
See chapter Stop All of the Instrument on page 57.
Do not remove diluent racks manually before shutdown. The system will remove
automatically all racks. In case of manual remove of the diluent racks before shutdown,
there is a risk of losing data.
C Confirm or not the shutting down procedure:

 If YES: the instrument shuts down if no tests are on-going;
If NO: the procedure is canceled.
Figure 20. Shutdown of the instrument - Confirmation
58 | IH-1000
Rescue Shutdown
5.5 Rescue Shutdown
Only use the Rescue shutdown button if it is not possible to shutdown the instrument
through the IH-1000 software (according explanations in chapter Shutdown of the
Instrument on page 58).
A Double-click on the Rescue Shutdown icon on the desktop.

 The IH-1000 Rescue Shutdown screen appears.
Figure 21. Rescue Shutdown - Confirmation
If the icon is not on the desktop, ask your service engineer to install it.
B Confirm the Rescue Shutdown procedure:

• Type the password: Shutdown
• Click on OK.
 The Automate computer shuts down.
The progress is displayed in the bar.
 Wait until it has shut down completely (less than 5 minutes).
C If IH-Com is running, quit the software.

D Shut down the Master PC.
IH-1000 | 59
Getting Started
5.6 Step by Step Procedure

A Start the instrument by positioning the On / Off switch to “I”.
2
1
B Press and hold the power button (2) for a few seconds.
 The computer starts.
A green light around the power button (2) indicates that the
computer is powered on.
When starting the IH-1000 software, no gel card appears as loaded in the drawer. The
drawer must be opened and closed so that the instrument scans all gel cards.
C Double-click on the icon to start the IH-Com Data Management software.

For detailed information refer to the IH-Com Data Management
User Manual.
 The IH-Com Data Management interface is displayed.
D Login to IH-Com with your User ID and Password.
E Start the IH-1000 Software: click on the IH-1000 button in the IH-Com Data
Management interface.
User Manual.
 The instrument initializes automatically. It scans and identifies all gel
cards present in the drawer during the initialization.
The IH-1000 Software can also be started by double-clicking the IHM1000

icon on the desktop.
60 | IH-1000
Step by Step Procedure
F Wait until the System status displays Ready (top right of the main screen).
Figure 23. information area - System status
G Make sure that no area on the interactive image is highlighted in red. (red =
error in the specific area).
 If one of the areas is red, see Errors on page 52.
H Click on the DATA MANAGEMENT button to switch back to the IH-Com

Data Management Software.
I In the IH-Com, go to the Work list screen area.

 In this screen all the samples with an open order (sent by LIS or
manually created in IH-Com) are displayed.
User Manual.
Figure 24. IH-Com - Work List screen area
J Click on the IH-1000 button to switch back to the IH-1000 Software.
IH-1000 | 61
Getting Started
K Place the sample tubes correctly on the foreseen sample rack.

Make sure that the caps are removed.
For more detailed information, see Sample Racks on page 74.
Figure 25. Sample rack
L Load the racks.

See chapter Loading Racks on page 102.
1
1
Figure 26. Loading racks
A green light (1) indicates that the slot is available.

A blinking red light indicates that a rack is moving: loading or unloading.
A red light indicates that the slot is not available. A rack is already loaded. Sample and
diluent racks can be loaded in positions 1 to 18. Reagent racks can be loaded in
positions R1 to R4.
Engage the rack in the slot and push it slowly until it locks automatically. (2) Shows a
well-placed rack.
At any time, the rack must lay on the bottom of the slot in order to be locked at the
correct position.
If the rack is pushed too far, a collision with the transport arm could occur.
62 | IH-1000
M If the button TESTS WITHOUT RESOURCES is active, one or more

resources are missing to start the test.
For more info, see chapter Tests without Resources on page 132.
N Click on MISSING RESOURCES to see which resources are needed to start

the test.
For more info, see chapter Checking Resources Status on
page 119.
O Load the required resources.

See chapter Diluent Rack and Diluent Product on page 84.
See chapter Reagent Racks on page 86.
Figure 27. Resources
P As soon as all resources needed for a specific test are on board, the test is
displayed on the TESTS READY TO START list.
For more info, see chapter Tests ready to start on page 130.
Q After a few seconds the tests switches to TESTS IN PROGRESS and the
instrument starts the run.
For more info, see chapter See chapter Tests in Progress on
page 126.
R If the test process has finished without any error, the test disappears from
the TESTS IN PROGRESS list.
S If the test process has finished with an error, the test is displayed on the
TESTS TO REPEAT list.
In that case, see chapter Tests to Repeat on page 133.
IH-1000 | 63
Getting Started
T If the specific test has been processed without any error, click on the DATA
MANAGEMENT button to get to the IH-Com Data Management Software
and to see the results.
U In the IH-Com, go to the Results screen area to be able to validate the

result.
User Manual.
Figure 28. IH-Com - Results screen area
V When all the tests are processed, shut down the instrument from the
IH-1000 software.
For more detailed info, see Shutdown of the Instrument on
page 58.
Always switch off the IH-1000 with the SHUTDOWN function.

Never use the general power switch, except in case of an emergency.
The shutdown command is not possible if any test is on-going in the IH-1000. Use
STOP ALL function first.
64 | IH-1000
W Confirm or not the shutting down procedure:

 If YES: the instrument shuts down if no tests are on-going;
If NO: the procedure is canceled.
Figure 29. Shutdown of the instrument - Confirmation
IH-1000 | 65
Getting Started
66 | IH-1000
6 MANAGING RESOURCES
Chapter Overview
This chapter presents the resources needed to perform the tests.
IH-1000 | 67
Managing Resources
6.1 Managing Gel Cards

6.1.1 Description
Figure 30. Loading gel cards
1 Gel card
2 Protection foil
3 Gel cards tray
4 Gel cards storage drawer
Gel cards are stored in trays, each tray can contain up to 12 Gel cards.
The gel cards trays are stored in the instrument drawer, the gel cards storage drawer can
contain up to 20 trays.
Take care that the gel cards are protected from dust during the storage.
68 | IH-1000
Managing Gel Cards
6.1.2 Gel Cards Storage Drawer Screen

This screen displays a detailed status of the gel cards loaded into the gel cards storage
drawer of the instrument.
6.1.2.1 Access
It can be accessed by the following ways:
• From the main screen, click on the GEL CARDS STORAGE DRAWER of the interactive
image.
• From any screen where the GEL CARDS STORAGE DRAWER button appears.
6.1.2.2 Description
Figure 31. Gel cards storage drawer screen
Symbol Description
Normal gel card tray

Example:
It contains 12 gel cards out of a possible 12
The type is “Liss/Coombs”
The barcode is 5053
The tray is in location #11 in the drawer
Empty tray location
IH-1000 | 69
Managing Resources
Symbol Description
Tray with an error

When clicking on the tray with an error, a message appears to explain the error.
Tray disabled
Total quantity of each type of gel card
Unlocks the drawer latch
6.1.3 Opening / Closing the Drawer
A Click on OPEN DRAWER to request the opening of the drawer.

 The instrument will finish all on-going actions with gel cards before
the drawer can be opened. It takes a few seconds!
When possible, the drawer latch is unlocked and the drawer can be
opened manually.
When opening the drawer, take care that gel cards and trays do not move during the
operation.
 A message appears indicating that it is required to close the gel

cards storage drawer area as soon as possible.
Figure 32. Wait for drawer unlocking
To load gel cards, the drawer must be completely pulled out.
70 | IH-1000
Managing Gel Cards
B Load the gel cards.

See Loading Gel Cards on page 72 for detailed information.
C Close the drawer by pushing it manually until it is completely closed.

 The instrument scans and identifies all loaded gel cards.
When closing the drawer, take care that gel cards and trays do not move during the
operation.
D Click on OK.
If the gel cards storage drawer is

in error, the OPEN DRAWER
button is in red.
A Warning screen with the error is
displayed.
IH-1000 | 71
Managing Resources
6.1.4 Loading Gel Cards
A Prepare trays with gel cards.
Check that the protection foil (1) of each gel card is not damaged.
Do not load opened or partially used gel cards. The right free end of the protection foil
must be horizontal or lower, not folded or upstanding.
Check that the barcode of each gel card is clean and not scratched. If necessary,
clean the barcode with a lint free rag.
Make sure that:

• each tray only contains one type of gel cards;
• the barcodes (2) are correctly oriented (the barcode must be visible with the free end
of the protection foil (1) showing to the right of instrument);
• the gel of the gel card is in good condition;
• there are no air bubbles present;
• the expiry date of the gel card is valid (checked by the instrument as well).
B Open the drawer.

See chapter Opening / Closing the Drawer on page 70.
When opening the drawer, take care that gel cards and trays do not move during the
operation.
If there are unsealed gel cards in the drawer:
INFECTION
Each well on each gel card can contain up to 125 µl of blood sample solution.
There is a risk of infection from skin contact with blood. Always wear protective
gloves when working, in accordance with good laboratory practices.
C Put the trays in the drawer.

Trays can be placed in any available place in the drawer.
To be able to close the drawer, all gel card trays must be correctly inserted.
If the option RETURN OF THE CARDS IN DRAWER FOR SECOND READING is set to
ALWAYS or CUSTOMIZED, the gel cards will be put back to the positions 4, 5, 9, 10,
13, 14, 15, 18, 19, 20.
If ONLY IF UNSPECIFIED RESULT is set, the gel cards will be put back to positions
15 and 20.
Make sure that these positions are available.
72 | IH-1000
Managing Gel Cards
To ensure a proper identification of the empty trays, use the white trays (REF 009888)
for the cards returned to the drawer.
D Close the drawer: manually push it until it is completely closed.

 The instrument will automatically scan the first gel cards of each gel
card tray.
All the gel cards of one tray are assumed to be identical to the first
one.
Each gel card type is double checked when used. If the type is
different than the one expected, a warning message appears in the
GEL CARDS STORAGE DRAWER screen; the remaining gel cards
are assumed to be of the same type as the last gel card.
When closing the drawer, take care that gel cards and trays do not move during the
operation.
Sealed gel cards should not stay longer than 7 days in the IH-1000.
Figure 33. Put the trays in the drawer
IH-1000 | 73
Managing Resources
6.2 Managing Samples and Reagents

Three types of rack can be loaded in the IH-1000: sample, diluent and reagent racks.
• Racks containing samples or diluents can be loaded in positions 1 to 18 of the rack
area.
• Racks containing reagents can be loaded in positions R1 to R4.
• Racks are identified with barcodes.
6.2.1 Sample Racks
5
3
4
3
Figure 34. Sample rack - Description
1 Sample tube
2 Sample barcode
3 Rack identification number and barcode
4 Sample tube numbering
5 Handle
A sample rack can contain up to 10 sample tubes.

Sample racks can be introduced from position 1 to 18 in the racks area.
The barcode of the tube (1) has to be visible on the left side. If the barcode of a sample
can not be read, the instrument shows an alarm of an unreadable or non detected
barcode. See chapter Sample Status on page 92.
74 | IH-1000
Managing Samples and Reagents
Racks processing order does neither depend on the position of the racks nor on the
racks identification number; the first rack in will be processed first.
The position of the sample in the rack defines which sample will be processed first; the
sample in position 1 will be processed before the sample in position 2.
Use only centrifuged samples.
The reliability of the results depends on correct compliance to the Good Laboratory
Practices for reagents and samples.
The best performance will be obtained when using anticoagulated samples within 48
hours of collection, however older samples may be used. When testing with donor
segments, the samples can be used up to the expiration of the donor unit.
The racks and tubes must be clean.

The barcodes of the rack and tubes must be clean and not scratched.
If necessary, clean the barcodes with a lint free cloth.
Never try to load a sample rack in position R1 to R4 of the loading area.
To prevent quantity detection errors, no foam or

bubble must be present at the surface of the liquid.
Remove sample tubes caps before loading the rack 13 mm
into the IH-1000. min.
To prevent overflow when pipetting, take care of

the maximum filling level of the sample tube.
The tubes must be inserted correctly into their

places.
The tubes must be vertical; check the correct
functioning of the guiding springs.
9
Unload all the samples at the end of the testing.
IH-1000 | 75
Managing Resources
6.2.1.1 Using Standard Tubes
Standard tubes must be used only with racks of type 1 (Barcode 01 or 11) and racks
of type 4 (Barcode 04 or 14). See chapter Labeling on page 79.
See chapter Cap Detection on page 158.
6.2.1.2 Using Low Volume Tubes (for Red Cells Only)

Low volume tubes (for red cells only) must be used for small quantity sample.
Use SARSTEDT products:
1 Micro tube 1.5mL ref. 72.703

2 Rounded end tube 5mL ref. 55.475.005
The micro tube must be completely inserted into the tube.
Low volume tubes (for red cells only) must be used only with racks of type 2 (Barcode
02 or 12). See chapter Labeling on page 79.
9
2
Figure 35. Low volume tubes (for red cells only)
6.2.1.3 Using Plunger Tubes
Plunger tubes must be used only with racks of type 3 (Barcode 03 or 13). See chapter
Labeling on page 79.
If these conditions are not respected, there is a risk to crash the needle.
76 | IH-1000
6.2.1.4 Using Low Volume Segment Blood
Low volume segment blood must be used with Standard tubes and racks of type 4
(Barcode 04 or 14). See chapter Labeling on page 79.
Segment blood is the blood contained in the pipe linked to the blood bag. This blood is
used to check the blood bag.
A Cut segments of this pipe to get the blood inside.
Figure 36. Segment bloods
The volume of segment blood in the tube is 200 µl ±15% (170 - 230µl). It corresponds
to a length of segment between 7 to 9 centimeters.
To avoid to crash the needle, always use the same type of tubes.
Make sure to load the samples shortly after mixing/homogenizing.
The 2nd cell suspension is not allowed for the samples in racks of type 4.
When using rack type 4 for segments of blood bags on the IH-1000, an adequate
amount of red blood cells is required to prepare a correct red blood cell suspension.
IH-1000 | 77
Managing Resources
Specificities for Tests

• Tests not allowed for segment blood are not processed by IH-1000.
• Only one aspiration or one dilution is allowed per sample tube. If a test requires several
aspirations or dilutions, only the first one is processed.
• If resources are missing: Only the tests with enough resources are done, the other
tests are deleted.
• Samples centrifuged and/or with plasma required for the test have to be loaded on
another type of rack.
Otherwise an error message is displayed in the log. Eg: Test/Profile not
allowed for segment blood sample [several aspirations].
See chapter Traceability Area on page 47.
If a default profile is configured, it is ignored for this racks type. The samples are
displayed in the SAMPLES WITHOUT REQUEST list. See chapter Profile Options on
page 151.
Level detection is disabled for any sample tube with Low volume segment blood on rack
of type 4. See chapter Liquid Level Detection on page 41.
Make sure that all resources are on board before loading a rack of type 4. As only
one aspiration can be done per sample tube, the test could be canceled or only
partially processed.
78 | IH-1000
6.2.1.5 Labeling
Figure 37. Description - Labeling
1 The first character defines emergency levels of rack:

• 0: Not urgent;
• 1: Urgent.
2 The second character defines the type of rack:
• 1: Standard Spherical bottom tube;
• 2: Low volume tubes (for red cells only);
• 3: Plunger tube;
• 4: Segment blood (in Standard Spherical bottom tube);
• 5 and 6: Not defined.
3 Example:
• 12 = Urgent, Low volume tube (for red cells only);
• 03 = Not urgent, Plunger tube.
IH-1000 | 79
Managing Resources
6.2.1.6 Emergency Sample Rack

The emergency sample rack is similar to a standard sample rack except that it has a
special barcode that confers a top level priority. If the required resources are available, all
the samples of the emergency rack will be processed before the samples of a standard
rack. A message on the GUI indicates the expected time to start the test.
The emergency rack is identified with a red label.
Standard samples racks instructions apply for this rack.
See chapter Sample Racks on page 74.
To get results faster, try to load all the emergency samples in the same rack (if
possible).
6.2.1.7 Using a New Rack

Stickers with barcodes must be put on a new rack so that it can be used in the
instrument.
Figure 38. Stickers on samples racks
6.2.1.8 Specifications for Tubes
Shape Cylindrical with spherical, flat or conical bottom
Outer diameter Between 10 and 17mm
Inner diameter Between 8 and 15mm
Height Between 66 and 100mm
Material Glass, Plastic or polyethylene
80 | IH-1000
6.2.1.9 Specifications for Barcodes

Types of barcodes read by the instrument:
• Code 39, 93, 128
• Interleaved 2 of 5 t
• EAN-8
• CODABAR with control character suppressed
• UCC-EAN 128 with control character suppressed l L
e
• ISBT 128 with specific characters
• EAN13 (equal to UPC-A 13) H
b
Figure 39. Barcode dimensions
It is recommended to use secured barcode types.

For non-secured types (Codabar, Code 39, Code 93, Interleaved 2 of 5), the barcode
must have at least 4 characters in order to prevent confusions. The label must be
completely stuck around the tube.
If these conditions are not respected, there is a risk not to detect the cap and to
crash the needle.
Designation Ref. Description Comments
Color Black with white background
Number of max. 20
characters
Grade B min. recommended Print quality
Module 0.2 to 0.35mm Width of single bars
Ratio from 2.2 to 3 Relation between small and

wide bars
Blank space e Min. 5x Module size x Ratio e.g.: 4.5mm for a Module of
For code 128 only: 0.3mm with a Ratio of 3
7mm with a «Module» of 0.35 (0.35x4x5)
(Code incl. Up to 4 different bar widths)
Height of code H min. 5mm
Length of code L min. 35mm
Total length l max. 70mm
Barcode position: b min. 10mm for rounded end tubes

bottom min. 13mm for flat end tubes (plunger
tubes)
Barcode position: t min. 15mm

top
IH-1000 | 81
Managing Resources
6.2.1.10 Sample Tubes Dead Volume

• Dead volume standard tube 13*75 Terumo: 350µl
• Dead volume plunger tube 11*66 Sarstedt: 500µl
• Dead volume low volume tubes (for red cells only) 1,5ml Sarstedt: 50µl
6.2.1.11 IH-1000 Centrifuged Sample Tubes Minimum Plasma Height
Necessary plasma height Tube diameter (mm)

(mm)
11 12 13 14 15 16 17
25 7 6 6 6 6 6 6
50 7 7 6 6 6 6 6
75 7 7 7 6 6 6 6
100 8 7 7 7 6 6 6
125 8 8 7 7 7 6 6
150 8 8 7 7 7 7 6
175 9 8 8 7 7 7 7
200 9 8 8 7 7 7 7
225 9 9 8 8 7 7 7
250 10 9 8 8 7 7 7
275 10 9 8 8 8 7 7
Distributed
volume (µl) 300 10 9 9 8 8 7 7
325 11 10 9 8 8 8 7
350 11 10 9 9 8 8 7
375 11 10 9 9 8 8 8
400 12 10 10 9 8 8 8
425 12 11 10 9 9 8 8
450 12 11 10 9 9 8 8
475 12 11 10 9 9 8 8
500 13 11 10 10 9 9 8
525 13 12 11 10 9 9 8
550 13 12 11 10 9 9 8
Example: When using 11 mm diameter tubes and when 400 µl of plasma is needed, the
height must be at least 12 mm.
82 | IH-1000
6.2.1.12 Red Blood Cells Minimal Height
low volume
Dimension (mm) Standard tube Plunger tubes tubes (for red
cells only)
Diameter 13 16 11 13 15 16 -
Red Blood cells 6 6 9 10 9 9 5

height
The values are valid for the tubes of type:

• BD diagnosis;
• Terumo and Greiner for standard tubes;
• Sarstedt for plunger tubes;
• Sarstedt ref: 72.703 for low volume tubes (for red cells only).
IH-1000 | 83
Managing Resources
6.2.2 Diluent Rack and Diluent Product
4
3
6
1
Figure 40. Diluent rack - Description
1 Diluent rack
2 Rack guiding block
3 Diluent rack product
4 Identification sticker
5 Protection foil
6 Handle
The diluent rack can hold diluent 1 or diluent 2 products.

The barcode has to be visible in the left side.
The protective foil of the diluent rack product must not be damaged before loading; each
unit will be pierced when necessary.
It is allowed to read sample barcodes manually, but not diluent barcodes.
Check that the barcodes of the rack and of the diluent rack product are clean and not
scratched. If necessary, clean the barcodes with a lint free rag.
Never try to load a diluent rack in position R1 to R4 of the loading area.
When closed, the diluent rack products must not stay more than 7 days in the IH-1000.
84 | IH-1000
6.2.2.1 Diluent 1 Rack Product Instructions
When using the diluent 1 rack product, respect carefully the following instructions.
• The diluent 1 rack product must be stored upright, protection foil on top, never up-
side down.
• The diluent 1 rack product must be stored between +4°C/8°C when not used.
The diluent must be stored at room temperature for at least 35 minutes before it is
used in the instrument.
• Before using the product, apply a little shock against a table to make sure that there
is no air bubble trapped in the wells.
• The SETUP CLEAN product (ref. 009902, dilution 1 to 5) is required when using the
diluent 1 rack product. It must be loaded in a reagent vial, on reagent rack.
6.2.2.2 Inserting a Diluent Rack Product

The diluent rack product sticker must be on the same side as the rack guiding block.
The diluent rack product must be completely inserted into the rack.
Check that the diluent rack product seats properly in the rack, with no obstacle.
If the diluent rack product is not correctly inserted, there will be a collision with the
pipettor.
Figure 41. CAUTION - Height of rack
IH-1000 | 85
Managing Resources
6.2.3 Reagent Racks
6
5
4
Figure 42. Reagents rack - Description
1 Reagent vial
2 Reagent barcode
3 Rotating reagent place
4 Rack identification barcode
5 Reagent vial numbering
6 Handle
A reagent rack can contain up to 7 reagent vials.

The reagent vial barcode has to be visible through the aperture of the reagent place.
Reagent racks can be loaded in position R1 to R4.-
It is allowed to read sample barcodes manually, but not reagent barcodes.

If a reagent vial of a reagent set is replaced by a new one, make sure to have the
same lot number.
The barcode stickers of the rack and vials must not be scratched (e.g. by turning the
vial in the holder) in order to be identified correctly by the instrument.
Follow the instructions of use from the reagent manufacturer.
86 | IH-1000
In order to prevent quantity detection errors, no

foam or bubble must be present at the surface of
the liquid.
The cells of the reagents must be in suspension
before the vial is loaded on the rack.
The cap of the reagent vials must be removed
before loading the rack into the IH-1000.
The vials must fit correctly into their places; there

must be no angle play.
9
The reagent racks can be stored in the fridge with its reagent vials. The vials have to be
taken out of the fridge at least 30 minutes before they are used on the instrument in
order that they reach room temperature.
On-board stability is:

• 2 days (48 hours) for red blood cell reagents;
• 7 days (168 hours) for antisera reagents (ID-Anti M, N, S, s, Fya, Fyb).
The on-board stability does not include the time when the vial is stored in the fridge.
It includes only the time when the vial is in the instrument.
After that time, the reagents must be removed and disposed.
IH-1000 | 87
Managing Resources
6.2.3.1 Use of the Cleaning Solution SETUP CLEAN
Exclusively use the cleaning solution SETUP CLEAN with REF 009902 as
decontamination liquid.
Material required:
• SETUP CLEAN with REF 009902;
• SETUP CLEAN empty vials of 15 ml (REF with barcode);
• Demineralized water.
When using demineralized water, make sure that the water quality corresponds at
least to Grad 2 (ISO 3696) or Type II (ASTM D1193-91).
Solution SETUP CLEAN is dangerous. Please refer to the label of the vial with
reference 009902.
• R35: Causes severe burns.
• S24: Avoid contact with skin.
• S25: Avoid contact with eyes.
• S26: In case of contact with eyes, rinse immediately with plenty of water and
seek medical advice.
• S28: After contact with skin, wash immediately with plenty of water.
The cleaning solution REF 009902 should only be filled into its foreseen 15 ml empty vials
with the REF 009310.
009310 SETUP CLEAN vials 15 ml (x12)
The SETUP CLEAN solution has to be changed daily. The same vial should not be used
longer than 1 month. Therefore REF 009310 contains 12 vials (one vial for every month of
the year).
If a used vial containing SETUP CLEAN solution is outside of the IH-1000, it must be
closed with the foreseen cap delivered with the package.
88 | IH-1000
6.2.3.2 Preparation of 15ml of SETUP CLEAN
A Add 3 ml of SETUP CLEAN REF 009902 in a vial.
B Add 12 ml of demineralized water.
Do not fill more than 15ml of the SETUP CLEAN solution in one vial REF 009310.
The final concentration of this SETUP CLEAN REF 009902 is 20% and can be filled in the
empty vial REF 009310 to be used on the system.
This once prepared solution has to be preserved at ambient temperature.

If SETUP CLEAN solution is stored in a dark, light-protected bottle, it must be replaced
once a month. If SETUP CLEAN solution is not light-protected (if it is in a transparent
bottle), it must be replaced every day.
IH-1000 | 89
Managing Resources
6.2.4 Samples / Reagents Area Screen

This screen displays a detailed status of the samples, diluents and reagents loaded in the
IH-1000.
Access
A From the main screen, click on the SAMPLE / REAGENTS AREA of the
interactive image
From any screen where the REAGENT / DILUENT AREA button appears.
6.2.4.1 Description
4 3 2
5 6 7
Figure 43. Sample / Reagent area screen
1 Rack Status (see page 91)

2 Sample Status (see page 92)
3 Diluent Status (see page 93)
4 Reagent Status (see page 93)
90 | IH-1000
5 Details Button (see page 94)

6 Remove Rack Button
7 Remove All Button (see page 104)
6.2.4.2 Rack Status
Symbol Description What to do ?
The rack is surplus. A rack is already loaded at this place in the

pipetting area.
Remove the supernumerary rack from the
loading area.
The rack is not identified, Remove the rack and check that the
or the barcode of the rack is not valid, barcode sticker is not damaged.
or one of the tubes is not identified, For a diluent rack, check the validity date.
or the diluent rack is out of date.
A sample tube or a reagent vial is in error or Check the samples tubes or reagents vials
an un-loadable rack is detected (not fully errors then remove the rack.
pushed in the instrument). Push the rack deeper in the IH-1000.
The reagent rack has a stirring fault. Remove and replace the rack.
The rack is in the restitution position (only for Remove the rack from the instrument.
particular cases).
The restitution is in progress or the restitution Wait for process completion.

request is memorized.
Rack background color: gray Can be selected for further information/

The rack is in the pipetting position. actions.
Rack background color: orange Click DETAIL or REMOVE button

The rack is selected in order to view details
or to remove it.
Rack background color: yellow Remove the rack

The rack is out of service.
IH-1000 | 91
Managing Resources
6.2.4.3 Sample Status
Symbol Description What to do?
No tube is detected at this position of the -

rack.
The sample is correctly detected. -
Sample correctly detected (donor). -
Sample correctly detected (receiver). -
A tube is detected with a barcode reading If manual input option is enabled, remove the
error or duplication. rack and check the barcode of the defective
tube.
A tube is detected with a cap. See chapter No Cap confirmation on

page 100.
Lack of receiver for sample tube. Check the loaded crossmatch receivers.
Lack of donor for sample tube. Check the loaded crossmatch donors.
Click on the error of a sample rack to display a warning screen describing the nature of
the error.
If the sample rack grid is in error, it is possible to display the error details by clicking on
the representative error icon.
See chapter Disabled Mode Option on page 156.
For particular cases with Low volume segment blood (rack type 4), error messages are
displayed in the log list.
See chapter Traceability Area on page 47.
92 | IH-1000
6.2.4.4 Diluent Status
Symbol Description What to do?
The diluent rack is correctly detected. -
The diluent rack is detected with an error. Remove the rack and replace the diluent
product.
Click on the error of a diluent rack to display a warning screen describing the nature of
the error.
If the diluent rack grid is in error, it is possible to display the error details by clicking on
the representative error icon.
6.2.4.5 Reagent Status
Symbol Description What to do ?
The vial is correctly detected. -
The vial is detected with an error. Remove the rack and check that the vial is
correctly inserted.
The vial is detected and is reserved. -
The vial is detected with a cap error. Remove the rack and remove the cap.
The vial is detected with a barcode reading Remove the rack and check the barcode of
error. the vial: orientation, validity date, barcode.
The vial is detected with a stirring error. Remove and replace the rack.
Click on the error of a reagent rack to display a warning screen describing the nature of
the error.
Remove or reload the rack to initialize it.
If the rack grid is still in error, it is possible to disable it by clicking on the error icon (with
sufficient rights).
IH-1000 | 93
Managing Resources
6.2.4.6 Details Button

This button gives access to precise information about the selected rack.
A Click on the rack image to select it (orange background).
B Click on DETAILS.
 The details screen differ whether a sample, reagent or diluent racks
is selected.
This button is activated only when the rack is in the pipetting position.
94 | IH-1000
Sample / Details Screen
1 2 3
6
4 5
7 8 9 10
Figure 44. Sample details screen
1 Position of the rack

2 Name (barcode) of the rack
3 Remarks/Errors (if any)
4 Position of the sample
5 Barcode of the sample
6 Remarks/Errors of the sample (if any)
7 MANUAL INPUT button (see page 98)
8 REMOVE RACK button (see page 104)
9 SWITCH ON / SWITCH OFF button
10 CAP CORRECTION button (see page 100)
IH-1000 | 95
Managing Resources
Reagent / Details Screen
1 2 3
4 7
5 6
8 9 10
11 12 13
Figure 45. Reagent details screen

4 Position of the content in the rack
5 Barcode of the content
6 Reagent name
7 Reagent usable volume (ml)
Usable volume = measured volume - dead volume
8 Reagent lot number
9 Expiry date
10 Remarks/Errors of the content (if any)
12 SWITCH ON / SWITCH OFF button
13 CAP CORRECTION button (see page 100)
96 | IH-1000
Diluent / Details Screen
2 3 4
1
Figure 46. Diluent details screen

3 Diluent type
5 Lot number
6 Expiry date
The contents of diluent racks are not displayed.
IH-1000 | 97
Managing Resources
6.2.4.7 Sample Barcode Manual Input

The MANUAL INPUT allows to enter manually a barcode for the samples detected with a
barcode error.
This button is activated only when a sample is detected with a barcode error.
If the barcode is read manually, make sure to put the sample back to the original
position.
A From the main screen, click on the SAMPLE / REAGENTS AREA.
B Select the rack with the sample barcode error.
C Click on DETAILS.
D Click on MANUAL INPUT.

 The following screen appears:
1 2
Figure 47. Sample manual input
E Click on REMOVE RACK.
98 | IH-1000
F Scan or type the sample barcode in the Barcode (1) column.
G Scan or type the sample barcode in the Confirm Barcode (2) column.
Copy and Paste functionalities are disabled during this operation.
H Click on OK to validate the input.
Do not click OK on the Authentication screen.
I If the positions of some samples have been switched, an alert screen is

displayed.
 Procedure will have to be repeated.
J Place the sample rack back in the instrument (same position). Wait until the
instrument has inserted the rack completely.
K Enter your login and password.
Figure 48. Authentication Required screen
L Click on the OK button of the AUTHENTICATION REQUIRED screen.
IH-1000 | 99
Managing Resources
6.2.4.8 No Cap confirmation

The NO CAP CONFIRMATION screen allows to confirm the absence of caps when
necessary.
A From the SAMPLE or REAGENT / DETAILS screen, click on the CAP

CORRECTION button.
See chapter Sample / Details Screen on page 95.
 The following screen appears.
This button is activated only when a cap is detected.
1 2
3 4
Figure 49. No Cap confirmation screen
1 Symbol: Tube is detected with a cap

2 Check box activated
3 OK button
4 CANCEL button (see page 98)
100 | IH-1000
To confirm the absence of a cap after checking visually:
A Click the check box (2) next to the symbol; Tube is detected with a cap (1).
Only tubes with a cap are active. When a check box is unchecked, the tube returns to
its initial state.
B Click OK to confirm.
 The following screen appears:
Figure 50. No Cap confirmation warning screen
C Click YES to confirm.

The corresponding state of the tube is updated.
IH-1000 | 101
Managing Resources
6.2.5 Loading Racks

The loading procedure is identical for all kinds of racks.
A rack can be loaded at any time in a free position, even when the instrument is
performing tests.
A Prepare a rack with samples, diluents or reagents.
Figure 51. Racks preparation
Read carefully the instructions given for each type of rack. See:
• Sample Racks on page 74;
• Diluent Rack and Diluent Product on page 84;
• Reagent Racks on page 86.
B Check where to load the rack:

• A green light (1) indicates that the slot is available.
• A blinking red light indicates that a rack is moving: loading or unloading.
• A red light (3) indicates that the slot is not available. A rack is already
loaded.
• Sample and diluent racks can be loaded in positions 1 to 18.
• Reagent racks can be loaded in positions R1 to R4.
1
1
Figure 52. Loading racks
102 | IH-1000
C Engage the rack in the slot and push it slowly until it locks automatically.
(2) shows a well placed rack.
 A camera will automatically identify the new rack and the transport
arm will take it into the instrument for pipetting operations.
At any time, the rack must lay on the bottom of the slot in order to be locked at the
correct position.
If the rack is pushed too far, a collision with the transport arm could occur.
Never put anything else than a rack inside a slot.

The camera would automatically try to identify it and a collision would occur.
Figure 53. DANGER - Racks area
D If the identification fails, the loading area becomes red.
E The rack can be unloaded and identified manually using the manual barcode
reader.
See chapter Sample Barcode Manual Input on page 98.
IH-1000 | 103
Managing Resources
6.2.6 Removing Racks
Wait until the light (1) is green to remove the rack.
The racks completely performed come out of the IH-1000 automatically (2). Be aware
to not hit them accidentally.
6.2.6.1 Removing Sample Racks
A Select the SAMPLE / REAGENT AREA screen or the SAMPLE / DETAILS

screen.
See:
• Samples / Reagents Area Screen on page 90;
• Sample / Details Screen on page 95.
B Select the rack or search the sample tube barcode to remove.
Figure 54. Search function

If necessary in the SAMPLE / REAGENT AREA screen.
Any found sample tube is highlighted in purple.
C Press REMOVE RACK.

 If no sample is processed, the transport arm pushes the rack out.
If one or more samples are processed, a message prompts the
user to confirm the removal.
Figure 55.
104 | IH-1000
D Confirm the rack removal.

 The instrument finishes the pipetting operation on the current
sample. The other samples are not pipetted.
The sample rack is pushed out.
A message displays the remaining time for the user to re-insert the
sample rack on the same position to proceed the tests (see
remarks below).
Figure 56.
Remarks:
If the unloaded sample rack is reloaded in the same position within 60 seconds:
• for samples already identified, the pipetting operation restarts;
• for missing samples, the tests which were scheduled are placed in TESTS TO
REPEAT screen. See Tests to Repeat on page 133.
If the unloaded sample rack is reloaded in the same position after 60 seconds or in
other position, the rack is considered as new rack.
For any missing samples, the status of the scheduled tests is managed as follows:
Test Status Description
TESTS IN PROGRESS No impact.

Sample completely pipetted The test will be completed.
(Sample tube no more
needed)
TESTS IN PROGRESS The status of the test is set to TEST TO REPEAT.

Sample not completely Reason: Missing resources (samples).
pipetted (Sample tube still
needed)
TESTS READY TO START The test is canceled.
TESTS WITHOUT The test is canceled.

RESOURCES
IH-1000 | 105
Managing Resources
6.2.6.2 Removing Reagent or Diluent Racks
A reagent rack can be removed only if no reagent vial of the rack is in use.
A Select the SAMPLE / REAGENT AREA screen or the REAGENT / DETAILS

or DILUENT DETAILS screen.
See:
• Samples / Reagents Area Screen on page 90;
• Reagent / Details Screen on page 96;
• Diluent / Details Screen on page 97.
B If necessary (in the SAMPLE / REAGENT AREA screen), click on the rack
image to select it (orange background).
C Press REMOVE RACK.

 The transport arm pushes the rack out.
Figure 57. Remove racks - light
6.2.6.3 Remove all Racks
A Click on REMOVE ALL.

 The transport arm pushes all racks out, all the racks are unloaded.
It is only possible to remove racks which are not in use.
106 | IH-1000
6.2.6.4 Removing Diluent and Sample Rack manually

If a rack is blocked inside the loading area in pipetting position, manually remove it
according to the following procedure.
SHUTDOWN the IH-1000 before removing the racks manually.
A SHUTDOWN the IH-1000.

B Take the rack extractor tool (1).

It is located in the right lower part of the instrument, next to the gel
cards waste bin.
C Slide the rack extractor tool under the rack.
D Insert the extremity of the tool in the dedicated hole of the rack (2).
E Lift smoothly the rack and pull it out.
F Put the rack extractor tool back in place.
Figure 58. Remove racks - pull out
IH-1000 | 107
Managing Resources
6.2.6.5 Removing Reagent Racks manually
Be careful not to damage the electrical contacts of the reagent rack.
A Raise the back of the rack about 35 mm.
B Remove the rack about 15 mm.
C Rest the back of the rack.
D Remove completely the rack.
~35mm
Figure 59. Remove racks - Reagent
108 | IH-1000
Managing Liquids and Wastes
6.3 Managing Liquids and Wastes

This chapter explains how to manage cleaning liquid, system liquid, liquid waste and gel
cards waste.
Cleaning and system liquid containers replacement must be done carefully

according to the following procedures in order to avoid pollution of the hydraulic
circuit.
6.3.1 Description
6
7
1 2 3 5
Figure 60. Liquids and wastes - description
1 Cleaning liquid container (black)

2 System liquid containers (blue)
3 Liquid waste containers (red)
4 Containers drawer
5 Gel cards waste bin
6 Gel cards waste slide
7 Gel cards waste bag
IH-1000 | 109
Managing Resources
A Push the door to open it.
B Pull the containers drawer (4) to easily access the liquid containers (1), (2)
and (3).
The cleaning liquid container (1) is not connected during normal operations; it is used
only for maintenance operations.
C After being processed, used gel cards will fall from the slide (6) into the
waste bag (7).
Never put hands in the gel cards waste slide while the instrument is powered on.
If the liquid waste is connected to a laboratory drain, verify the quality of the tubing
and make sure that it is correctly connected.
110 | IH-1000
6.3.2 Checking Liquids and Wastes Status

The SOLUTIONS / WASTES AREA screen allows to check the liquids and wastes status.
Access
A From the main screen, click on the LIQUIDS / WASTES AREA of the
interactive image.
Description
1 3
2 5 4
Figure 61. Solution / wastes area
1 Cleaning liquid container area

2 System liquid container area
3 Liquid waste container area
4 Gel card waste bin area
5 Maximum gel cards waste capacity of the bin
If all items in Solutions / Wastes Area are in order, it is not possible to perform an
action.
IH-1000 | 111
Managing Resources
6.3.3 Refilling a System Liquid Container
Solution Decon 90 is dangerous.

• R36: Irritating to eyes.
• R38: Irritating to skin.
• S24: Avoid contact with skin.
• S25: Avoid contact with eyes.
• S26: In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice.
Use gloves for all operations.
Take care to connect the correct container to the correct hose. Refer to the color
code.
The system liquid has to be renewed weekly.
Do not mix different solutions of system liquid.
A Check that the second system liquid container is connected to the

instrument while it is running.
B Pull the container out of the instrument.
C Remove the front cap (1) of the container.
Figure 62. Refilling system liquid container
112 | IH-1000
D Clean the container with demineralized water.
E Check that the container is empty.
F Shake the Decon 90 bottle to mix the solution.
G Fill the container with system liquid:

5L of demineralized water and 15mL of Decon 90.
H Put the container cap back in place.
I Put the container back in place in the instrument.
J Click CONTINUE to confirm the message, or CANCEL.
Figure 63. Empty container message
If the “Empty container” message appears again after the container has been refilled,
DO NOT acknowledge the message again, the hydraulic circuit would be primed
again and this would result in overflowing the flux compensator. Contact a service
engineer.
IH-1000 | 113
Managing Resources
6.3.4 Cleaning Liquid Preparation
Solution Microcide SQ™ is dangerous.

• R36/38: Irritating to eyes and skin.
• S37: Wear suitable gloves.
• S39: Use personal protective means for protection of eyes and face.
• S45: In case of accident or sickness, contact medical help immediately.
• S59: Refer to the local distributor for information on recovery / recycling.
• S60: This material and its packing must be disposed of as hazardous waste.
A Remove the front cap (1) of the container.
B Fill the container with cleaning liquid:

2L of demineralized water and 8mL of Microcide SQ™.
This solution is stable for 7 days.
Figure 64. Refilling cleaning liquid container
114 | IH-1000
6.3.5 Cleaning of the Containers

The following procedure explains how to clean a container.
It is necessary to clean a container:
• once a month;
• when a container has not been used for a long time.
A Wait until the ongoing process is finished.
B Take the container out and remove caps and hose.
C Empty completely the container.
D Rinse it with about 1L of cleaning liquid.
E Shake the container.
F Remove and dispose the cleaning liquid.
G Rinse 4x or more the container with demineralized water.
H Wipe the caps and aspiration hose with Isopropanol, then rinse with
demineralized water.
Figure 65. Cleaning containers
IH-1000 | 115
Managing Resources
6.3.6 Replacing a Liquid Waste Container
Liquid waste containers contain contaminated liquids. Handling require special care.
To avoid contaminated liquid spills, liquid waste containers must not be
disconnected during use.
It is strongly recommended to use the antifoaming product (recommended by Bio-Rad)

each time the waste container has to be emptied.
For further information, please ask local distributor or service engineer.
The following procedure explains what to do when a liquid waste container is full.
A Check that the second liquid waste container is connected to the instrument
while it is running.
B Take the container.
C Remove the plunger (1).
Figure 66. Liquid waste container
As soon as the aspiration cap is removed, liquid wastes are automatically routed to the
second liquid waste container.
116 | IH-1000
D Dispose the liquid waste in accordance with your local regulations.
E Put the container back in place with the caps.
Take care to connect the correct container to the correct hose. Refer to the color
code.
F Click CONTINUE to confirm the message, or CANCEL.
Figure 67. Waste full message
6.3.7 Priming Cycle

The priming cycle is made automatically or with the general initialization function.
See chapter General Initialization on page 188.
Make sure to have enough liquid.
6.3.8 Cleaning Cycle

See chapter Weekly Maintenance on page 168.
IH-1000 | 117
Managing Resources
6.3.9 Replacing the Gel Cards Waste Bin
The gel cards waste bin contains contaminated products.

Handling requires special care.
A Prepare an empty waste bin with a bag.
B When the instrument is ready or in idle state:

• replace whole waste bin;
• replace plastic bag in bin.
C Close the waste bag.
D Dispose the bag in accordance with your local regulations.
Figure 68. Replace waste bin
118 | IH-1000
Checking Resources Status
6.4 Checking Resources Status

From the main screen, two buttons in the footer strip allow to check the resources status.
MISSING RESOURCES
See chapter Missing Resources on page 119.
RESOURCES ON BOARD
See chapter Resources on Board on page 120.
6.4.1 Missing Resources

The MISSING RESOURCES button gives access to the following screen, showing all the
missing resources.
1 2 3
Figure 69. Missing resources

2 Reagent / Diluent area
When the missing diluent concerns both the right and the left side, the number of the
wells missing is displayed for each side.
3 Liquids / Wastes area
IH-1000 | 119
Managing Resources
6.4.2 Resources on Board

The RESOURCES ON BOARD button gives access to the following screen, showing all
the resources already loaded into the instrument (Gel cards, reagents, diluents) and the
status of the LIQUIDS / WASTES area.
1 2 3
Figure 70. Resources on board screen

See chapter Gel Cards Storage Drawer Area on page 121.
2 Reagent / Diluent area
See chapter Reagent / Diluent Area on page 121.
3 Liquids / Wastes area
Clicking in this area gives access to the LIQUIDS/WASTES AREA screen which
gives detailed information.
120 | IH-1000
Checking Resources Status
6.4.2.1 Gel Cards Storage Drawer Area

Clicking on this area gives access to the GEL CARD STORAGE DRAWER screen which
gives detailed information.
See chapter Gel Cards Storage Drawer Screen on page 69.
1 Number of gel cards

2 Code of the gel card type
3 Gel card type
1 2 3
Figure 71. Gel cards information
6.4.2.2 Reagent / Diluent Area

Clicking on this area gives access to the SAMPLES / REAGENT AREA screen which
contains more detailed information.
4 Reagent usable volume (ml)

Usable volume = measured volume -
dead volume
5 Reagent code
6 Reagent type
7 Number of available diluent wells
8 Diluent code
4 5 6
9 Diluent type, with indication of side and quantity
(left/right or both)
7 8 9
Figure 72. Reagent and Diluent information
IH-1000 | 121
Managing Resources
122 | IH-1000
7 MANAGING TESTS
Chapter Overview
This chapter presents how to manage the tests.
IH-1000 | 123
Managing Tests
7.1 Performing a Test

The following chart shows a standard process flow for performing tests.
A Start the instrument.

See chapter Starting the Instrument on page 54.
B Create a test request in the Data Management software and transfer the request to the IH-1000.
C Load the corresponding sample and the necessary resources into the instrument.
D If the required resources are available in H If some resources are missing, the test
the instrument, the test is queued in the will be queued in the TESTS WITHOUT
TESTS READY TO START list. RESOURCES list.
 The test will be processed See chapter Tests without Resources on
automatically by the instrument page 132.
as soon as possible, depending
on the availability of the
pipettors, incubator and
centrifuges.
See chapter Tests ready to start on
page 130.
E Once the process begins, the test status I Check the missing resources and load it.
changes to In progress. See chapter Managing Resources on
See chapter Tests in Progress on page 67.
page 126.
F If an error occurs during the process, the J Go on to step D.

test is moved to the TESTS TO REPEAT
list.
See chapter Tests to Repeat on
page 133.
G Once the test is completed, the results

Before performing a crossmatch test,
are automatically transferred to the make sure that there are enough gel
verification software in order to be cards loaded on the IH-1000.
checked.
See IH-Com Data Management User
Manual.
124 | IH-1000
Performing an Urgent Test
7.2 Performing an Urgent Test

To perform an urgent test the same process applies. Use urgent racks so that the sample
is processed before all other samples.
See chapter Sample Racks on page 74.
7.3 TESTS Buttons of the Main Screen

From the main screen, the following buttons allow to access to several functions about
tests.
Buttons are disabled if their function does not apply to any test.
TESTS IN PROGRESS
TESTS READY TO START

See chapter Tests ready to start on page 130.
TESTS WITHOUT RESOURCES

See chapter Tests without Resources on page 132.
TESTS TO REPEAT
See chapter Tests to Repeat on page 133.
SAMPLES WITHOUT REQUEST

See chapter Samples without Request on page 136.
IH-1000 | 125
Managing Tests
7.4 Tests in Progress

This screen displays all the on-going tests in the instrument.
A From the main screen, click on TESTS IN PROGRESS.
1
8
5
6
7
3 4
Figure 73. TESTS IN PROGRESS screen
126 | IH-1000
Tests in Progress
1 Samples special statuses
Emergency sample
Quality control sample

2 Sample barcode number
3 Test description
4 Test start and end time
Black: real time when the test started and ended.
Blue: estimated time when the test should start and finish.
5 Grid
Position of the rack in the loading area
6 Position
Position of the sample in the rack
7 State
Pipetting, incubation, centrifugation, reading or completed.
8 Sorting strip
Click on the column name to sort the datas
9 DETAILS button
This button gives access to the details of the selected sample test
See chapter Details of a Test in Progress on page 128.
IH-1000 | 127
Managing Tests
7.4.1 Details of a Test in Progress
A From the TESTS IN PROGRESS screen, click on DETAILS.
The following screen shows all the ongoing tests for one sample.
Each test uses one or more types of gel cards and can be in a different status. A
different color is used for each state.
1 2
3 4
Figure 74. SAMPLE / DETAILS screen
128 | IH-1000
Tests in Progress
1 Samples special statuses
Emergency sample
Quality control sample

2 Test in progress special statuses
To repeat
Without resources
Ready to start
3 BACK button
4 PREVIOUS / NEXT buttons
The buttons PREVIOUS and NEXT allow to navigate between the samples in
progress without having to return to the previous screen as well as to display
the details of the test previous or next to the one selected.
5 Estimated start time for scheduled test
IH-1000 | 129
Managing Tests
7.5 Tests ready to start

This screen displays the tests that are ready to start: all the required resources are
available in the instrument. They will be processed as soon as possible, depending on the
availability of the pipettors, incubator and centrifuges.
If necessary resources are present and if no emergency rack is loaded, the processing
order depends on the loading order. The first sample loaded will be processed first.
A From the main screen, click on TESTS READY TO START.
Figure 75. TESTS READY TO START screen
1 Information field
2 EMERGENCY button
See chapter Emergency on page 131.
130 | IH-1000
Tests ready to start
7.5.1 Emergency
By clicking on the EMERGENCY button, the status of the sample changes (1).
The status can only be changed if there are tests ready to start.
Figure 76. Emergency status
IH-1000 | 131
Managing Tests
7.6 Tests without Resources

This screen displays the tests that can not be performed because of missing resources.
A From the main screen, click on TESTS WITHOUT RESOURCES.
3 2
Figure 77. TESTS WITHOUT RESOURCES screen
1 Information field
2 DETAILS button
This button gives access to the list of missing resources for the selected test.
See chapter Checking Resources Status on page 119.
3 MISSING RESOURCES button
This button gives access to the list of missing resources for all requested tests.
See chapter Missing Resources on page 119.
It is also possible to display the MISSING RESOURCES / DETAILS screen available for
one particular test.
132 | IH-1000
Tests to Repeat
7.7 Tests to Repeat

Tests can encounter errors during process. If so, they are moved to the following TESTS
TO REPEAT list that informs in which step the instrument was when the error occurred.
To be able to repeat failed tests directly from this screen, activate the option “Allow
failed tests to be repeated” in the Option screen.
Refer also to IH-Com Data Management User Manual.
A From the main screen, click on TESTS TO REPEAT.

This screen is split into two main areas: the complete list of tests in
error (1) and the related missing samples (2).
3 4 5
Figure 78. TESTS TO REPEAT screen
1 TESTS TO REPEAT: Information field

2 MISSING SAMPLES, for each missing sample, the lower list provides the sample
barcode.
3 ACTION button with 2 options: DELETE and REPEAT.
IH-1000 | 133
Managing Tests
4 SELECT ALL button

5 UNSELECT ALL button
If the option Allow failed tests to be repeated is set, the REPEAT function is enabled
under the ACTION button, allowing the selected profiles to be executed again, after
confirmation.
See General Options on page 146.
Otherwise only the DELETE button is displayed, to acknowledge the error of all selected
items, after confirmation.
If a test is present on the TESTS TO REPEAT screen, double click on the test to open
a screen displaying explanation of the error.
7.7.1 Repeat Tests
A Select one or several test to be repeated.
B Select ACTION.
If the option Allow failed tests to be repeated is enabled.
Refer to the comment above.
C Select REPEAT to repeat the test.

 A warning message displays if samples are missing for the selected
tests.
Figure 79. Warning message
134 | IH-1000
Tests to Repeat
D Confirm to restart the test.

 A warning displays eventual missing samples.
Figure 80.
E Load the required samples.

 Related tests status turns to ready to start.
F Confirm the loading of the samples.
Unloaded samples stay in the TESTS TO REPEAT area. It is possible to delete them.
IH-1000 | 135
Managing Tests
7.8 Samples without Request

A From the main screen, click on SAMPLES WITHOUT REQUEST.
2 3
4 5 6
Figure 81. SAMPLES WITHOUT REQUEST screen
1 Sample list
2 Available tests list
3 Description of the tests
4 CONFIRM button
5 SELECT ALL button
6 UNSELECT ALL button
136 | IH-1000
Samples without Request
7.8.1 Associate a Test
A Select a sample in the Samples list (1).
B Select a test in the Tests list (2).
C Click CONFIRM.
 A confirmation message appears.
Figure 82. Confirm test assignment
D Click OK to confirm the test.

 The sample is removed from the list.
IH-1000 | 137
Managing Tests
7.9 Checking Pipetting Area Status

This screen allows to monitor the on-going actions in the pipetting area.
A From the main screen, click on the PIPETTING AREA in the interactive
image.
1 2
10
8 9
4
5 6 7
Figure 83. PIPETTING AREA screen
1 37°C Incubator area

2 Balancing gel cards area
3 Information area
4 Pipetting area Left and Right
5 SWITCH ON
6 SWITCH OFF
7 OPEN (pipetting area window)
See Opening the Pipetting Area Window on page 139
8 Status left pipettor
9 Status right pipettor
138 | IH-1000
Checking Pipetting Area Status
10 Door state (displayed in red when open, in main screen the pipetting area is also
displayed in red)
7.9.1 Opening the Pipetting Area Window
Read the following instruction completely before opening the pipetting area window.
On-going tests will be invalid.
In any case, it is forbidden to open the pipetting area window manually.
Be careful when accessing inside the pipetting area, especially with needles, ID-
Cards piercing module, heat of incubator...
Do not hit the needle.
All racks must be removed before opening the pipetting area window, if this condition
is not respected there is a risk of collision with the racks.
Biological risk in case of projection.
During the initialization, if all racks have not been removed there is a risk to damage
the instrument.
A Remove all returned racks or racks in waiting position.

See chapter Remove all Racks on page 106.
B Click on OPEN (pipetting area window).

 When closing the window, the instrument performs an initialization
and scans the worktable again.
Used gel cards are put to the waste bin.
The requests that have been started before opening the pipetting
area window have to be sent again.
When the pipetting area window is in error, the OPEN button is highlighted in red.
All racks removed - Correct! Racks still loaded - Not correct
Figure 84.
IH-1000 | 139
Managing Tests
7.9.2 Clot Detection Errors

The IH-1000 knows three different clot detection errors:
• Clot detected;
Figure 85. Clot detected error message

• Defusing during sampling;
Figure 86. Defusing during sampling error message

• Distribution canceled.
Figure 87. Distribution canceled error message
All the tests with error go back to the TESTS TO REPEAT screen. Go to that list and
click on the single test to display the error message.
140 | IH-1000
Checking Pipetting Area Status
7.9.2.1 Clot Detection

When a clot detection of a needle occurs, the user must loose the needle from its
obstruction.
 An error message is displayed.
The resources present in the pipetting area undergo the following management:
• For the pipettor, which the needle is clotted.
 The tests pass in error.
• For the other pipettor, which the needle is not clotted:
 No new pipetting batch is engaged.
The current pipetting continues until the users action.
A Click on the PIPETTING AREA (1) of the main screen.

 The PIPETTING AREA screen appears.
B Click OPEN.
 The instrument opens the pipetting area window, once the pipetting
area is accessible (pipetting is finished).
See chapter Opening the Pipetting Area Window on page 139.
The screen next is displayed.
Figure 88. Clot detected - information
Be careful when accessing inside the pipetting area, especially with needles, ID-
Cards piercing module, heat of incubator...
In any case, it is forbidden to open the pipetting area window manually.
IH-1000 | 141
Managing Tests
C Wait before opening the door.

Do not move racks, tubes, vials, reagent racks, gel cards.
Be careful not to move the robot in the horizontal direction.
Move the needle support as indicated on the photos, otherwise there is a risk to
cause damages on the IH-1000.
D When the pipetting area window is open: lift slowly the support of the
needle.
E Lift the support to verify if there is a clot present on the needle.
F If there is no clot present, lift the support until the needle is in high position.
If a clot detection message continues to appear even if there is no clot present, call
your local service engineer.
G If there is a clot, lift the support until the needle is in high position and slide
the clot into the tube.
H Close the pipetting area window.

• All the present gel cards on the pipetting area are detected and thrown
to the waste bin.
• All the present resources are identified again.
• The processing procedure can restart.
Figure 89.
142 | IH-1000
8 OPTIONS
Chapter Overview
This chapter presents the available options to configure the instrument.
This configuration is allowed only for specific users; login and password are required.
IH-1000 | 143
Options
8.1 Options Screen

The OPTIONS screen can be accessed from any screen where the MENU button
appears.
A Click on MENU.
B Click on OPTIONS.
Figure 90. Options - Authentication screen
C Type your login and password.
D Click OK.
144 | IH-1000
Options Screen
Figure 91. Options screen
1 GENERAL options
See chapter General Options on page 146.
2 PROFILE options
See chapter Profile Options on page 151.
3 CONTROLS options
See chapter Controls Options on page 153.
4 DISABLED MODE options
IH-1000 | 145
Options
8.2 General Options
Figure 92.
Close window after

This option defines the time (in seconds) before the software automatically comes back to
the main screen. Select Never to disable.
The user can close and open again the software without any effect.
Sound to play on error

This option defines the sound that will be played in case of an error.
Select No Sound to disable.
146 | IH-1000
General Options
Barcode start filter

This option allows to specify the amount of digits to suppress at the beginning of the
samples barcode.
See chapter Barcode Exception Mask Filter Option on page 149.
Barcode end filter

This option allows to specify the amount of digits to suppress at the end of the samples
barcode.
Make sure that the filtering does not remove digits used by IH-Com and/or LIS for a
proper sample identification. Otherwise, IH-Com may detect a discrepancy.
Barcode Exception Mask(s) Filter

To define exceptions for digits suppression in Barcode start filter and Barcode end filter
options.
Show button Data management

To enable or disable the Data management button in the main screen (check to enable).
Use Japanese Barcodes

To inform the instrument that resources are with Japanese barcodes (check to activate).
Cap detection activated

To enable the cap detection function (check to activate).
It is possible to activate the samples cap detection during the racks identification.
Input for samples is always enabled.
If this option is activated the system will detect caps, see Cap Detection on page 158.
If this option is deactivated, no cap will be detected.
IH-1000 | 147
Options
Allow failed tests to be repeated

This option enables the REPEAT button. If all resources are available, failed test can be
repeated directly from the TESTS TO REPEAT screen (check to enable).
2nd cell suspension for ABO testing

This option enforces the pipettors to realize one sample take (and eventually dilution) for
each distribution concerning the ABO tests family (check to enable).
This behavior is legally expected in some countries.

All bloodgroup assays are concerned.
148 | IH-1000
General Options
8.2.1 Barcode Exception Mask Filter Option

This option defines exceptions for barcode filtering set with Barcode start filter and
Barcode end filter. See the examples on the next page.
Make sure that the filtering does not remove digits used by IH-Com and/or LIS for a
proper sample identification. Otherwise, IH-Com may detect a discrepancy.
This option is available only if Barcode start filter and/or Barcode end filter options are
active (value different of 0).
A In Options screen, select Customize to open the Barcode Exception

Mask(s) Filter option.
See Barcode Exception Mask(s) Filter on page 147.
 The following screen appears.
Figure 93. Mask exception list for barcode caesura
B Configure the table of exceptions:

• Maximum number of digit: 3
• Maximum number of rules: 6
• Characters allowed:
a b c d e f g h I j k l m n o p q r s t u v w x y z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
0 1 2 3 4 5 6 7 8 9
Space ! “ # $ % & ’ ( ) * + , - . / : ; < = > ? @ [ \ ] ^ { | } ~
C In Barcode exception pattern area, enter required characters and define if

they should stay At the beginning or At the end.
D Click on the arrow to add the rule to the list.
E Click on OK to validate the exception list.
IH-1000 | 149
Options
Remarks
According to the example of exception table above (Figure 93), the sample barcodes are
filtered, but the system does not suppress digits for the samples barcodes:
• starting with D, R and LAB;
• finishing with QC.
See the examples below.
Filtering criteria
• Barcode start filter = 2
• Barcode end filter = 1
• Exception criteria = see table above
Sample barcodes before filtering Sample barcode after filtering
P00001 P00001
XP0002 XP0002
DP0003 DP0003 (exception, not filtered)
ZP0004 ZP0004
RP0005QC RP0005QC (exception, not filtered)
WP0006 WP0006
LAB0009 LAB0009 (exception, not filtered)
150 | IH-1000
Profile Options
8.3 Profile Options
Figure 94.
It is possible to define and to apply a default profile for not allocated samples and not
allocated emergency samples.
Default profile does not apply to Low volume segment blood (racks of type 4 - Barcode
04 or 14). Samples are displayed in SAMPLES WITHOUT REQUEST screen.
See chapter Using Low Volume Segment Blood on page 77.
For details about how to assign a profile, refer to the Data Management software User
Manual (Test groups).
Apply default profile for not allocated samples

This option allows to choose whether the default profile must apply for not allocated
samples or not.
If the default profile is not applied, a specific profile must be assigned for each one.
IH-1000 | 151
Options
Apply default profile for not allocated emergency samples

This option allows to choose whether the default profile must apply for not allocated
urgent samples or not.
If the default profile is not applied, a specific profile must be assigned for each one.
For details on how to identify a urgent tube, see Emergency Sample Rack on page 80.
If the option “Apply default profile for not allocated samples” is set, a sample loaded
with no specific request for test will be automatically tested with the default profile,
otherwise a specific profile must be assigned for each sample.
Default profile for not allocated samples

This options allows to choose which profile will be assigned to the tubes without test.
This option is active only if the check box Apply default profile for not allocated
samples is checked.
Default profile for not allocated emergency samples

This option allows to choose which profile will be assigned to the not allocated urgent
samples.
This option is active only if the check box Apply default profile for not allocated
samples is checked.
For details on how to identify a urgent tube:
See chapter Emergency Sample Rack on page 80.
152 | IH-1000
Controls Options
8.4 Controls Options
Figure 95.
The Controls area allows to activate:
Gel Control
If this option is activated, the camera checks the gel of the card before the gel card is
used (e.g. presence of air bubbles - Gel card unusable, it is sent to the waste bin).
Return of the cards in drawer for second reading

Choose between:
Never No card is returned for second reading.
Always All cards are returned for second reading.
Only if unspecified result Gel card with unspecified results.

Unspecified results: ?, dp, wF, wR, wP, wD, L, W, E
See chapter Test, Interpretation and Result on page 39.
Customized Only selected results will return the gel cards.

Press the button Customize to define the list (see below).
If the drawer is open or the gel cards trays are full during card reading, the cards will
be thrown away automatically.
IH-1000 | 153
Options
CUSTOMIZE
Choosing a customized return of the
gel cards enables a customization
screen.
• Select available results for given cat-
egories or use All check box to
select or de-select all results.
• Click OK to confirm.
See chapter Return of the
Cards in Drawer for Second
Reading Option on page 155.
Figure 96. Customize screen
Distribution Control (qualitative)
The option is permanently activated.
IH-1000 software records all information on tests processed. If a volume control error
occurs, interpretation code and image of each well used are transferred to IH-Com Data
Management software.
154 | IH-1000
Controls Options
8.4.1 Return of the Cards in Drawer for Second Reading Option

8.4.1.1 Remaining Cards Locations in the Drawer
If the Return of the cards in drawer for second reading option is activated, a counter on
the main screen displays free card places in the drawer (only if less than 12).
Figure 97. Cards locations in the drawer
If only one gel card tray remains empty in the drawer, a warning message is displayed:
Figure 98.
IH-1000 | 155
Options
8.5 Disabled Mode Option

These options allow to disable some of the instrument components.
A module should be disabled if too many errors occur on it.
Figure 99.
A Click on a component button.

Figure 100. Disable component - Authentication screen
A disabled component has a grey button.
B Enter your login and password.
156 | IH-1000
Disabled Mode Option
C Click on OK.
D Enter <YES> and click OK to confirm disabling of component.
Figure 101. Disable component - Confirm screen
Be careful what to disable. If essential parts are disabled, it is not possible to

continue to operate the instrument.
IH-1000 | 157
Options
8.6 Cap Detection
The IH-1000 must not be exposed to direct sunlight.

If this condition is not respected, there is a risk to not read the barcode, to not detect
the cap and to crash the needle.
If the cap detection option is deactivated, no cap will be detected.

If this option is activated, only the valid functions are activated.
8.6.1 Type of Reagent Vials with Detected Cap

All these caps are detected by IH-1000.
A B C D
Figure 102. Reagent cap detection
• Type A-B-C-D on 5 ml vial

• Type E on 10 ml vial (Other caps can not be introduced into the IH-1000)
• Type E on SETUP CLEAN vial
10 ml vials with a dropper can not be loaded.
158 | IH-1000
Cap Detection
8.6.2 Type of Standard Tubes with Detected Cap

These types of tubes must be charged only on rack with code 01 or 11, and in case of
segments samples in rack 04 or 14.
If these conditions are not respected, there is a risk to crash the needle.
All these caps are detected by IH-1000.
BD1 Ter1 Gr1 Gr2 BD2 Ter2 Gr3 Gr4 BD3 Ter3 Gr3
Figure 103. Cylindrical tubes cap detection
Ref Brand Manufacturer Reference (1) Color Size (2)
BD1 BD diagnostic 367704 Opaque blue 13*75
BD2 BD diagnostic 367862 Opaque purple 13*75
BD3 BD diagnostic 367614 Opaque red 13*75
Ter1 Terumo VF-054SBCS Opaque bleu 13*75
Ter2 Terumo VF-054SDK Opaque purple 13*75
Ter3 Terumo VF-054SAS Opaque red 13*75
Gr1 Greiner 454322 Opaque light blue 13*75
Gr2 Greiner 454320 Opaque dark blue 13*75
Gr3 Greiner 454036 Opaque dark purple 13*75
Gr4 Greiner 454021 Opaque light purple 13*75
Gr5 Greiner 454027 Opaque red 13*75
(1) All tubes with the same cap are detectable.

(2) All tubes higher than 100mm with cap, must not be charged on the IH-1000.
IH-1000 | 159
Options
8.6.2.1 Type of Cylindrical Tubes Caps not Detected

The translucent colors: red, blue, purple are not detected.
All the other colors are detected.
Figure 104. Cylindrical tubes cap detection
8.6.3 Low Volume Tube (for Red Cells only) Cap Detection
Not valid function (reliability less than 100%).
Low volume tube (for red cells only) must be used only on rack with code 02 or 12.
If this condition is not respected, there is a risk to crash the needle.
8.6.4 Plunger Cap Detection

Not valid function (reliability less than 100%).
These types of tubes must be loaded only on rack with code 03 or 13.
If this condition is not respected, there is a risk to crash the needle.
160 | IH-1000
9 MAINTENANCE
Chapter Overview
This chapter presents the maintenance operation that can be performed on the
instrument.
IH-1000 | 161
Maintenance
9.1 Checking Components Status

Components status can be checked through the components area screen.
A From the main screen, click on the COMPONENTS AREA of the interactive
image.
3
4 5
Figure 105. Components area screen
1 Instrument temperature
The instrument temperature is measured in the pipetting area.
2 External temperature
The external temperature must be kept between 15°C and 27°C.
3 Back doors status
Only service engineers are allowed to open back doors.
162 | IH-1000
Checking Components Status
4 Components status:
• Grey image:
The component is functioning correctly. No user action is required / possible;
• Red image:
The component is under error status.
Click on the image to show the alert screen and acknowledge the problem.
5 Components images
The color of the instrument depend on the component status explained above.
IH-1000 | 163
Maintenance
9.2 Maintenance Screen

The maintenance screen allows to perform usual maintenance operations required for the
instrument.
The MAINTENANCE screen can be accessed from any screen where the MENU button
appears.
A Click on MENU.
B Click on MAINTENANCE.
C Login with your user name and password to access the maintenance screen.
Figure 106. MAINTENANCE screen
1 See chapter Weekly Maintenance on page 168.

2 See chapter Needle Change Right/left Pipettor on page 184.
3 See chapter Rinse Right/Left Pipettor on page 186.
4 See chapter Reading Station Calibration on page 186.
5 See chapter General Initialization on page 188.
164 | IH-1000
User Level Screen
9.3 User Level Screen

The User level screen allows to define the minimum user level to access the maintenance
actions of the instrument.
Only users with a level higher than 1 can access this screen.
The USER LEVEL screen can be accessed from any screen where the MENU button
appears.
A Click on MENU.
B Click on AUTHORIZED MAINTENANCE.
C Login with your user name and password to access the maintenance screen.
1
2
3
4
5
Figure 107. User Level screen
1 Weekly Maintenance
2 Needle Change Pipettor (right and left)
IH-1000 | 165
Maintenance
3 Rinse Pipettor (right and left)

4 Reading Station Calibration
5 General Initialization
To enable a Level 1 User to perform Weekly Maintenance, General Initialization or any

other maintenance operation, check the corresponding maintenance check box of the
User Level screen.
If checked, users with level 1 will have access to the maintenance action, otherwise only
users with a level higher than 1 will have access to the required maintenance.
If maintenance actions require a user level greater than 1, the buttons of the
MAINTENANCE screen will be grayed for level 1 users.
166 | IH-1000
Maintenance Operations
9.4 Maintenance Operations

Log any maintenance operation in the maintenance record.
See chapter Maintenance Record on page 205.
If any variation of performance of the instrument is observed or suspected even after

maintenance operations, contact your service engineer.
9.4.1 Decontamination
It is user responsibility to do the appropriate decontamination in case of spillage of

hazardous material on or inside of the instrument, with a lint-free cloth soaked in
cleaning solution.
In case of spilling and contamination in the pipetting area or in the drawer:
A Open access to the contaminated area with the user interface software
(pipetting area window or drawer).
See Opening the Pipetting Area Window on page 139 or Opening /
Closing the Drawer on page 70.
B Shut down the instrument.

C Check that there is no damage to the instrument.

If there is any damage, call a service engineer and stop using the
instrument.
D Take out all possible contaminated parts (racks, gel cards, gel cards trays).
E Clean the contaminated areas (on or inside of the instrument), samples racks
and reagents racks with a lint-free cloth soaked in cleaning solution.
Use bactericide, viricide and fungicide disinfectant as cleaning
solution.
IH-1000 | 167
Maintenance
9.4.2 Periodic Maintenance

9.4.2.1 Daily Maintenance
• Check daily the outer surface (is it clean, no blood, no serum...);
• If needed, clean outer surfaces of worktable with any bactericide, viricide and fungicide
disinfectant after switching off the system.
9.4.2.2 Weekly Maintenance
The weekly maintenance must be performed every week even if the instrument is not
used during a long period.
An orange maintenance reminder (WEEKLY MAINTENANCE NECESSARY)

appears on the IH-1000 main screen if the user did not perform the
weekly maintenance within the last seven days.
When a component is disabled, it is not possible to perform the weekly maintenance.

Except if only one pipettor is disabled.
• Check the expiration date of the solutions;

• Prepare a new solution: 2l demineralized water, 8 ml Microcide. This solution is stable
for 7 days;
• Check that there is no leakage around liquid containers.
Before performing the weekly maintenance, make sure that the decontamination liquid is
filled with min. 2 liters.
When starting the instrument: the IH-1000 initializes automatically. It also checks the
modules and the worktable automatically.
Before weekly maintenance, empty the two liquid waste containers and put them
back in place.
168 | IH-1000
B Click on MAINTENANCE.
 The login screen appears.
C Enter your login and password.
D Click on OK.
E Click on the button WEEKLY MAINTENANCE.

 The following screen opens.
Figure 108. Weekly maintenance - Confirm screen
If WEEKLY MAINTENANCE requires a user level greater than 1, this button is grayed
for level 1 users.
F Click on OK to confirm.
 The following screen opens and an audible alarm activates:
Figure 109. Remove ID-Cards piercing array equipped

It is possible to disable the audible alarm with the Stop alarm
button.
The pipetting area window opens automatically.
IH-1000 | 169
Maintenance
G Remove the ID-Cards piercing array equipped.

See chapter Removing the ID-Cards Piercing Array Equipped on
page 179.
H Close the pipetting area window.

 The following screen opens:
Figure 110. Weekly maintenance in progress
I Decontamination of ID-Cards piercing array equipped (2):

• The decontamination support (3) must be put in a tank.
• Microcide SQ™ solution must be filled in the tank to the top of this side
(1).
• Use the prepared solution.
See chapter Weekly Maintenance on page 168.
3 4
Figure 111. ID-Cards piercing array equipped - decontamination support
The solution must not reach the upper surface (4) of the decontamination support.
The Microcide SQ™ solution must not get in contact with the upper mechanical part
of the piercing array.
170 | IH-1000
• The piercing tool must be put on the support.

 After a few minutes, the following screen opens and an audible
alarm activates.
Figure 112. Replace containers
J Open the door of the liquid container compartment (3).
1 2
Figure 113. Replace containers
K Pull out the container drawer (4).
L Remove the two caps of the cleaning liquid container (1).
M Place the two hoses from the system liquid (2) into the cleaning liquid
container (1).
IH-1000 | 171
Maintenance
N Click on OK when containers are changed.

Figure 114. Empty the liquid waste containers
O Empty the two liquid waste containers and put them in place.
See chapter Replacing a Liquid Waste Container on page 116.
P Click OK when done.

Priming of maintenance liquid in progress.
Figure 115. Priming in progress
172 | IH-1000
Q  If both liquid waste containers are full, the following screen opens
and an audible alarm activates:
Figure 116. Both liquid waste containers full

or
 If one liquid waste container is full, the following screen opens:
Figure 117. One liquid waste container full
R Empty the full liquid waste container(s) and put it (them) in place.
IH-1000 | 173
Maintenance
S Click OK.
 After a few minutes, the message changes automatically to
decontamination in progress:
Figure 118. Decontamination in progress

The decontamination time starts to decrease.
During the decontamination, perform the following actions T to V on
page 175.
T Empty the two system liquid containers (2).
1 2
Figure 119. Empty the two system liquid containers
U Rinse the containers with demineralized water, then fill them with system
liquid.
See chapter Refilling a System Liquid Container on page 112.
174 | IH-1000
V Place the containers on the containers drawer.

After the 30 minutes of decontamination, the following screen opens
automatically:
Figure 120. Purge of maintenance liquid in progress

 After a few minutes, the following screen opens and an audible
alarm activates:
Figure 121. Purge of maintenance liquid in progress
W Remove the plungers, clean first with Isopropanol, then with demineralized
water and put them in the system liquid containers.
X Press OK to confirm installation of the plungers.

Figure 122. Priming of system liquid in progress...
IH-1000 | 175
Maintenance
Y Rinse the piercing tool with demineralized water.
Z Dry the piercing tool.

 If one or both liquid waste containers are full, an audible alarm
activates and screen opens as described in Q on page 173.
AA Empty the full liquid waste container(s) and put them in place.
AB Click OK.
The pipetting area window opens automatically.
Figure 123. Install the ID-Cards piercing array
AC Put the ID-Cards piercing array back in position.

See chapter Removing the ID-Cards Piercing Array Equipped on
page 179.
AD Close the pipetting area window.

 If the ID-Cards piercing array is not installed or not locked correctly,
the following screen opens and an audible alarm activates:
Figure 124. ID-Cards piercing array not detected
176 | IH-1000
When the ID-Cards piercing array is correctly installed:

 The following screen opens: Checking in progress.
Figure 125. Checking in progress

 After a few minutes, the following screen opens: Maintenance
succeeded.
Figure 126. Maintenance succeeded
AE Click OK.
At the end of the weekly maintenance, clean the gel cards storage drawer with a lint
free cloth.
AF Click on the DATA MANAGEMENT button to switch to the IH-Com Data

Management software.
AG Perform a QC run.
Refer to the IH-Com Data Management Software for detailed
information.
If the weekly maintenance was interrupted, a warning message displays the error
that occurred.
IH-1000 | 177
Maintenance
AH Click OK to acknowledge the error.

Figure 127. Weekly maintenance interrupted
AI Click OK.
A red maintenance reminder (on the top left of the screen) indicates
that the weekly maintenance must be done again, before a run can be
started. Otherwise it is not possible to start any test.
9.4.2.3 6 and 12 Months Maintenance
The 6 and 12 months maintenance has to be performed by a service engineer.
9.4.2.4 Total Estimated Times and Liquid Volumes for Weekly Maintenance
Estimated time for instrument ~80mn
Estimated system liquid volume 830ml
Estimated decontamination liquid volume 710ml
9.4.3 QC Check
A quality control check must be performed after any maintenance operation.

Refer to the Data Management software for detailed information.
178 | IH-1000
9.4.4 Removing the ID-Cards Piercing Array Equipped
All racks must be removed before opening the pipetting area window. If this
condition is not respected, there is a risk of collision with the racks.
A Open the pipetting area window (from the software).

Figure 128. Pipetting area window
B To unlock the ID-Cards piercing array equipped, turn the lock (4) 90°
towards the back of the instrument.
Figure 129. Remove - ID-Cards piercing array equipped
Take caution to not drop the ID-Cards piercing array equipped, there is a risk to
damage the IH-1000.
In case of shock on piercing pins during the weekly maintenance, visually check for
damage.
IH-1000 | 179
Maintenance
C Lower slightly the ID-Cards piercing array equipped.
D Pull off to the right.
E Remove the ID-Cards piercing array equipped.
When replacing the ID-card piercing array equipped, take care to lock it correctly. (In
contact with the screw, see red circle).
Figure 130. Lock - ID-Cards piercing array equipped
F Perform a QC run.
180 | IH-1000
Needle Cleaning Right/left Pipettor
9.5 Needle Cleaning Right/left Pipettor
The needle cleaning must be performed when the needle is visually soiled.
Follow this procedure for the needle cleaning.
A Click on NEEDLE CHANGE RIGHT PIPETTOR.

 A message appears, asking to open the pipetting area window.
If NEEDLE CHANGE RIGHT PIPETTOR (or left pipettor) requires a user level greater
than 1, this button will be grayed for level 1 users.
B To open the pipetting area window, go back to the main screen.
C Click on the MAIN SCREEN button.
D From the main screen, click on the pipetting area in the interactive image.
E Open the pipetting area window (from the software).

 Follow the procedure below to change the sampling needle for
series.
Make sure that the light inside the instrument is switched off during the process. See
chapter Opening the Pipetting Area Window on page 139.
condition is not respected there is a risk of collision with the racks.
F Bleed the hydraulics.
Always place a tissue under the needle before disconnecting the faradized vein as it
drops.
IH-1000 | 181
Maintenance
G Disconnect the faradized vein for series from the needle using the connector
(3).
3
2
5
2
4
Figure 131.
H Open the 2 locks (2).
I Slide the needle (1) out of its housings (4) (5).
J Verify the needle is purged.
K Clean the needle with a nonwoven wipe and isopropanol solution.

Wipe the needle from the top to the tip of the needle.
It is important to use a soft tissue to avoid damage on the needle coating.
L Dry the needle with a dry nonwoven wipe:

Wipe the needle from the top to the tip of the needle.
It is important to use a soft tissue to avoid damage on the needle coating.
182 | IH-1000
Needle Cleaning Right/left Pipettor
M Locks open (2), needle absent, connector (3) near by.
N Slide the needle (1) in its housings (4) (5).
O With the needle in place, screw the connector (3) on the needle.
P Lock the needle by tilting the two locks (2).

Locks closed, needle is connected and locked in position on its
pipettor Z axis support.
The collar on the needle, when properly inserted, prevents the needle from moving
independent of the mechanism.
Q Clean the needle carefully with a dry nonwoven wipe.
R Close the pipetting area window.

 The message next appears.
S Click OK to validate needle replacement.

 The needle is adjusted automatically.
T Proceed the same way with the left pipettor.
U Perform a QC run.
If the needle cleaning has been interrupted due to a power off, re-start the needle
cleaning procedure.
External light can have an influence on the needle adjustment.
IH-1000 | 183
Maintenance
9.6 Needle Change Right/left Pipettor

A Click on NEEDLE CHANGE RIGHT PIPETTOR.
 A message appears, asking to open the pipetting area window.
If NEEDLE CHANGE RIGHT PIPETTOR (or left pipettor) requires a user level greater
than 1, this button will be grayed for level 1 users.
B To open the pipetting area window, go back to the main screen.
C Click on the MAIN SCREEN button.
D From the main screen, click on the pipetting area in the interactive image.
E Open the pipetting area window (from the software).

condition is not respected, there is a risk of collision with the racks.
F Bleed the hydraulics.
Always place a tissue under the needle before disconnecting the faradized vein as it
drops.
G Disconnect the faradized vein for series (6) from the needle using the
connector (3).
H Open the 2 locks (2).
I Slide the needle (1) out of its housings (4)(5).
J Change the sampling needle for series M17424 (1).
K Locks open (2), needle absent, connector (3) near by.
L Slide the needle (1) in its housings (4) (5).
M With the needle in place, screw the connector (3) on the needle.
N Lock the needle by tilting the two locks (2).

Locks closed, needle is connected and locked in position on its
pipettor Z axis support.
184 | IH-1000
Needle Change Right/left Pipettor
The collar on the needle, when properly inserted, prevents the needle from moving
independent of the mechanism.
O Close the pipetting area window.

P Click OK to validate needle replacement.

 The needle is adjusted automatically.
Q Proceed the same way with the left pipettor.
R Perform a QC run after the replacement.

If the needle replacement has been interrupted by a forced shut down, perform the
needle change procedure again (without changing the needle (Only steps A to E on
page 184 and O to Q on page 185 must be done)) on the next restart of the system.
This is to make sure that the needle is correctly localized.
3
2
5
2
4
Figure 132.
IH-1000 | 185
Maintenance
9.7 Rinse Right/Left Pipettor

The button RINSE RIGHT PIPETTOR or RINSE LEFT PIPETTOR allows to manually
launch a wash cycle of the right or left pipettor, additionally to the automatic rinse during
the runs.
If the buttons RINSE RIGHT PIPETTOR or RINSE LEFT PIPETTOR requires a user
level greater than 1, the button is grayed for level 1 users.
9.8 Reading Station Calibration

After 5000 working hours, the user is asked to do a calibration of the reading module.
A calibration can also be started before the 5000 working hours have passed.
A Put 24 5052 type gel cards (NaCl cards) in the gel cards storage drawer.
Verify that the gel of the gel cards is in good condition and that there are no air
bubbles present. The gel card must be valid, check the expiry date.
B Click on the READING STATION CALIBRATION button to start the

calibration process.
 The following screen is displayed.
Figure 133. Calibration in progress
If the READING STATION CALIBRATION requires a user level greater than 1, the
button is grayed for level 1 users.
The process can take up to 20 minutes. No action on the IH-1000 software can be
performed during the calibration process.
186 | IH-1000
Reading Station Calibration
 When the process is finished, the following message is displayed.
Figure 134. Calibration finished
C Click on OK.
After calibration, the 24 gel cards go back to the drawer and can be used for further
tests.
If launching conditions are not met, an alert screen with the missing items is displayed.
D Perform a QC run.
IH-1000 | 187
Maintenance
9.9 General Initialization
Do not perform an initialization while the instrument is running. The IH-1000 makes all
the initialization automatically.
See Starting the Instrument on page 54 and/or Errors on page 52.
9.10 Storage
When it is planned not to use the instrument during many days, specific operations must
be considered.
9.10.1 Short Term Storage in Laboratory Conditions

If the instrument is not used for few weeks and if it stays in laboratory environment, no
wrapping or packing is required.
Weekly maintenance operations must be performed every week even if the

instrument is not used.
9.10.2 Other Storage Conditions

When the instrument is stored outside laboratory conditions or if it is stored for a long
period, special procedures must be performed by a service engineer.
Refer to a service engineer for handling and storage procedures.
188 | IH-1000
10 TROUBLESHOOTING
Chapter overview
The user must have read and understood this documentation before carrying out any
troubleshooting on the IH-1000. In case of unclear information, please contact the
distributor.
10.1 Alarms and Error Management
When an error message appears on the screen, read it and check whether an
explanation is given in the following list. Then click on the OK button and execute the
required procedure to solve the problem.
IH-1000 | 189
190 | IH-1000
Troubleshooting
10.2 Software Error Messages
For any error messages not listed in the following tables (mainly module and software errors), please contact a service engineer.
10.2.1 All Modules

$2000010D Hardware board communication failure. Restart or contact a service engineer.
$20000309 Hardware board failure. Restart or contact a service engineer.
$2000030D Hardware board communication failure. Restart or contact a service engineer.

$2000030F
$20000403 Robotic movement failure. Try to continue, restart or contact a service engineer.
$0200040A System execution failure. Restart or contact a service engineer.
$2000040C Robotic movement interrupted. Try to continue, restart or contact a service engineer.
$2000040E Robotic movement failure. Restart or contact a service engineer.

$20000414
$2000801B Action impossible due to previous failure. Solve previous failure or contact a service engineer.
$2000FF00 Robotic movement failure. Restart or contact a service engineer.
10.2.2 Transport Arm

$20000404 Robotic movement failure during initialization. Restart or contact a service engineer.
$20000411 Axis drag overshoot. Try to continue or disable the faulty component and contact a
service engineer.
$20000413 Axis positioning error. Try to continue or disable the faulty component and contact a
service engineer.
$20008019 Card presence sensor not working during check. Try to continue, restart the system and contact a service engineer.
$2000820C Gel card transport failure. Try to continue or restart the system.
$20008304 Centrifuge trapdoor failure. Try to continue or disable the centrifuge and contact a service
engineer.
$20008305 Centrifuge trapdoor failure. Try to continue or disable the centrifuge and contact a service
engineer.
10.2.3 Identification Module

service engineer.
service engineer.
$20008402 The rack contains a clogged tube or vial. • Remove the cap on the sample tube or the vial.
This error appears if the option “cap detection” is activated. See No Cap confirmation on page 100 or Removing Racks on
page 104
• If the problem persists, contact a service engineer.
$20008404 The rack barcode is unreadable. Missing or damaged barcode label:

• Verify if the rack is correctly labeled.
Software Error Messages

IH-1000 | 191
192 | IH-1000
Troubleshooting
$20008407 Missing or damaged rack barcode label. Verify if the rack is correctly labeled.
If the problem persists, contact a service engineer.
$20008409 Presence of a rack impossible to process at the starting. The instrument was stopped without using the shutdown function:
• Remove the rack with the software.
See chapter Removing Racks on page 104.
$20008501 The reagent vial barcode is unreadable. Reagent vial incorrectly positioned on the rack:
• Verify if the reagent vial is correctly inserted.
Damaged barcode label or symbology out of specification:
• Verify if the reagent vial is correctly labeled.
$20008503 The reagent vial is out of date at the location requested. • Remove the rack.
• Change the reagent vial.
$20008504 The reagent vial is unusable at the location requested. • Remove the rack.
• Change the reagent vial.
$20008505 Empty barcode on the reagent vial is refused. Incorrect positioning of the vial in the rack:
• Reposition the reagent vial.
$20008601 The diluent wells rack is out of date. Rack out of date. Remove the rack.
$20008602 The barcode of the diluent rack is duplicated. Two diluent rack with the same barcode. Remove all racks.
$20008701 The sample tube barcode is unreadable at the location requested. Sample tube incorrectly positioned on the rack:
• Verify if the sample tube is correctly inserted.
Damaged barcode label or symbology out of specification:
• Verify if the sample tube is correctly labeled.
If the barcode is read manually, make sure to put the sample back
to the original position.
$20008703 The sample tube barcode is duplicated. • Take the rack out again and check the barcodes.
$20008704 The sample tube has an embarked clot. Blood too thick:
• Check that the blood is not over 48 hours old.
10.2.4 Centrifuge
service engineer.
service engineer.
$20008306 Centrifuge balance failure. Insert gel cards in the drawer.
$2000FD04 Speed error. Try to continue, restart and contact a service engineer.

IH-1000 | 193
194 | IH-1000
Troubleshooting
10.2.5 Reading Module
service engineer.
service engineer.
$20008901 Reading module calibration failure. Launch a new calibration or contact a service engineer.
$20008902
$20008903 Expired reading module calibration. Launch a new calibration or contact a service engineer.
$20008905 Reading module calibration failure. Launch a new calibration or contact a service engineer.
$20008909
$2000890A Reading module failure. Launch a new calibration or contact a service engineer.
$2000890B
$2000890C
$2000890D
$20008911 Gel card detected during lighting control. Restart system of contact a service engineer.
$20008913 Lost gel card. Restart system or contact a service engineer.
$20008D05 Reading module failure. Launch a new calibration or contact a service engineer.
$20008D06
$20008D07
10.2.6 Pipettors
service engineer.
service engineer.
$2000801A Shared area conflict. Restart or contact a service engineer.
$20008071 Diluent piercing failure. Verify that the rack is fully inserted in its support.
$20008073
10.2.7 Hydraulic
service engineer.
service engineer.
$20000416 Robotic movement failure. Restart or contact a service engineer.
$20008005 Both pipettors out of order for maintenance. Contact a service engineer.
$20008064 Soiled needle cannot be used. Check washing means or contact a service engineer.
$2000806D Washing failure. Restart or contact a service engineer.
$20008B02 Level detection failure. Try to continue or disable pipettor and contact a service engineer.
$20008B03
$20008B04 Needle external washing volume error. Try to continue or disable pipettor and contact a service engineer.
$20008B05
$20008B0B Incorrect state of the hydraulic management. Check liquid containers and circuits and restart the machine or
contact service engineer.

IH-1000 | 195
196 | IH-1000
Troubleshooting
$20008B12 Clogged needle circuit. Try to continue, follow the needle changing procedure:
$20009201 See chapter Needle Change Right/left Pipettor on page 184.
or disable the pipettor and contact a service engineer.
$20008B15 Both liquid waste containers are full or disconnected. Empty containers and check caps are completely screwed.
$20008B17 Pipettor pressure sensor failure. Try to continue or disable the pipettor and contact a service
engineer.
$20008B18 Washing pump failure. Try to continue or disable the pipettor and contact a service
engineer.
$20008E01 Fluidic calibration failure. Launch a new calibration or contact a service engineer.
$20008E02 Fluidic flow control failure. Try to restart and contact a service engineer.
$20008E03
$20008E04
$20008E05
$20008E06
$20008E07
$20008E08 Fluidic calibration failure. Launch a new calibration or contact a service engineer.
$20008E09
$20008E0A Fluidic software execution failure. Restart or contact a service engineer.
$20008E0C Fluidic calibration failure. Launch a new calibration or contact a service engineer.
$20009211 Clot detected. Execute needle cleaning process.

See chapter Rinse Right/Left Pipettor on page 186.
$2000ED07 Clot detected and solved, sampling cancelled. Try to continue or restart.
$2000ED08 Permanent clot detected, unable to solve automatically. Execute appropriate procedure.
See chapter Clot Detection on page 141.
$2000ED0B Fluidic system failure (pressure sensor). Try to restart and contact a service engineer.
$2000F601 Calibration failure I/O. Launch a new calibration or contact a service engineer.
$2000F608
$2000F609
$2000F60A Software execution failure I/O. Restart or contact a service engineer.
$2000F60C Calibration failure I/O. Launch a new calibration or contact a service engineer.
10.2.8 Reagent Rack

$2000F60D Reagent agitating speed out of range. Use another rack or contact a service engineer.
$2000F60E Reagent agitating failure. Use another rack or contact a service engineer.
10.2.9 Gel Cards Piercing Module

service engineer.
service engineer.
10.2.10 All Cameras

$20000D02 Reading module calibration failure. Launch a new calibration or contact a service engineer.
$2000F007 Camera communication failure. Restart system or contact a service engineer.

IH-1000 | 197
198 | IH-1000
Troubleshooting
$2000F008 Camera calibration failure. Launch a new calibration or contact a service engineer.
$2000F009 Camera failure. Launch a new calibration or contact a service engineer.

$2000F00A
$2000F00B
10.2.11 System
$20000101 Hardware board communication failure. Restart or contact a service engineer.

$20000102
$20000103
$20000104
$20000105
$20000106
$20000107
$20000108
$20000109
$2000010A
$2000010B
$2000010C
$2000010E
$2000010F
$20000110
$20000111
$20000112
$20000113
$20000114
$20000115
$20000901 File access failure. Restart or contact a service engineer.

$20000902
$20000903
$20000904
$20000905
$20000A01 Software execution failure. Restart or contact a service engineer.

$20000A02
$20000A03
$20000A04
$20000A05
$20000A06
$20000E0B File access failure. Restart or contact a service engineer.

$20000E0C
$2000820D Pipetting door not closed. Close the pipetting area window.
$20008706 No message - Pictogram on the GUI (software interface). Check the loaded crossmatch receivers.
$20008707 See chapter Sample Status on page 92.
$20009001 File access failure. Restart or contact a service engineer.

$20009002
$2000910B Inconsistent assay database information. Check input data or contact a service engineer.
$20009112
$20009113
$20009114
$20009115 Missing donor. Check input data. Enter the missing sample.
$2000F702 Hardware board communication failure. Restart or contact a service engineer.

$2000F703
$2000F704
$2000F705
$2000F706

IH-1000 | 199
Troubleshooting
200 | IH-1000
11 APPENDIX
Chapter Overview
This chapter covers non-standard operations on the instrument.
IH-1000 | 201
Appendix
11.1 Equipment and Accessories

11.1.1 Equipment
Description Quantity
IH-1000 1
Reagents rack 4
Diluents rack holder 4
Samples rack 18
Samples rack barcode label set 18
Rack extractor tool 1
Decontamination support 1
Touchscreen 1
Keyboard (language depending on country) 1
Touchscreen arm 1
Power cord 1
Preparation table 1
Containers 5
Gel card waste bin and bag 1
Technical documentation 1
User manual (ref. H009142) 1
11.1.2 Accessories
Description Quantity
Barcode scanner 1
Hub 1
USB key 8Go 1
UPS 1
UPS battery 1
UPS holder 1
202 | IH-1000
CE Compliance
11.2 CE Compliance
This instrument is an in-vitro diagnostic medical device and complies with all applicable
European Community Directives and associated harmonized standards, including but not
limited to the standards pertaining to the electrical safety as well as the emission and
immunity requirements as specified in IEC 61326-2-6.
11.3 Documents / Forms

11.3.1 Decontamination Certificate
Please contact your local distributor for the official electronic document.
The decontamination must be performed by an authorized technician in accordance

with the instructions contained in the corresponding Service Manual.
The IH-1000 and its accessories must be cleaned and decontaminated before any of the
following intervention:
• performing any maintenance;
• revision task;
• before taking the instrument out of service;
• when preparing for transportation;
• before final elimination.
The original certificate must remain in the present manual. When a certificate is
required, make a copy and fill in the latter sample.
Fill in a copy of the decontamination certificate and place it on the instrument, in a
conspicuous place.
The absence of the decontamination certificate may extend the time needed for revision
and maintenance.
Bio-Rad will bill any cleaning and decontamination operation.
IH-1000 | 203
Appendix

Decontamination Certificate
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# $
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& $
K+$
& K+$

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204
| IH-1000 #'9::;<=>:
!" ;:?
# $%&'&%%'* + @%%$J#KK9>
Documents / Forms
11.3.2 Maintenance Record
The original blank maintenance sheet must remain in the present manual. When a
maintenance record is required, make a copy and fill in the latter sample.
Type Page
Serial number
Maintenance / Defect Action Operator Date
IH-1000 | 205
Appendix
11.4 Spare Parts Ordering

Please contact your local service engineer.
11.5 Device Disposal

11.5.1 General Warnings
In order to protect the persons and the environment, any instrument and its
accessories must be disposed of in an appropriate way. Its is mandatory to strictly
apply laws and local bylaws relative to an appropriate disposal procedure.
An instrument may only be dismounted and divided into its basic components by a
qualified technician.
Parts and sub-parts removed from an instrument may not be reused unless after
having been approved in writing by the manufacturer. Any future application has to
be precisely described in the request.
11.5.2 Disposal
The following components can be found in the instrument:
Packing material
• paperboard;
• polyethylene foam;
• anti-static bag;
• class II fireproofed polystyrene.
Instrument
• Plastic materials: PVC, POM, nylon, rubber.
• Electrical components: Motors, copper wires, plastic insulation.
• Electronic components: Epoxy printed boards.
• Optical components: Camera lens, camera body.
• Metals:
Copper: electrical wires;
Aluminum: instrument base, holders, guides for electronics
boards, partitions, covers;
Steel: springs, holders, screws, bolts.
206 | IH-1000
List of Documents
11.6 List of Documents

11.6.1 User Manuals
Language IH-1000 User Manual IH-Com User Manual
English H009142 H009146
German H009156 H009147
French H009159 H009151
Italian H009160 H009149
Spanish H009157 H009148
Portuguese H009158 H009150
Danish H009161 H009153
Swedish H009162 H009154
Norwegian H009163 H009155
Finnish H009166 H009168
Japanese H009167 H009169
Polish H009170 H009171
Hungarian H009190 H009183
Serbian H009191 H009192
Chinese H009195 H009365
Portuguese (Brazil) H009204 H009205
Slovenian H009216 -
Russian H009221 H009222
Czech H009194 H009196
11.6.2 Service Manuals

Language IH-1000 Service Manual IH-Com Service Manual
English only H009144 H009152
11.6.3 Spare Parts Manual

Language IH-1000 Spare parts Manual
English only H009215
IH-1000 | 207
Appendix
11.7 Examples of Test Execution

The table describes some examples of test execution. Refer to the Instructions of Use of
the products for more details.
# Tests Test Procedure
1 Blood groups (human The system will dispense 50µl of “ID-DiaCell A1” to micro tube A1
antibodies) + Reverse and will dispense 50µl of “ID-DiaCell B” to micro tube B.
Grouping with Diluent 1 Afterwards, the system will dispense 50µl of the patient serum or
(E.g. Id-nr. 5008) plasma to both micro tubes A1 and B of the gel card.
5% Preparation of blood The system will dispense 12,5µl of the red cell suspension of
sample (done by the system) patients or donors to the micro tubes (A, B, D (VI-), ctl) of the gel
with Diluent 1 card.
The gel cards will be incubated for 10 minutes at RT in the

system.
The gel card will be centrifuged for 10 minutes in the system.
The reactions will be read by the integrated camera of the system.
The results are interpreted with the Interpretation software.
2 Blood groups (ABO/Rh for The system will dispense 50µl of the red cell suspension to all the
Newborns DVI+) (monoclonal micro tubes (A,B,AB,DVI+,ctl,DAT) of the gel card.
antibodies) with Diluent 2
(E.g. Id-nr. 5096) The gel card will be centrifuged for 10 minutes in the system.
0,8% Preparation of blood The reactions will be read by the integrated camera of the system.
sample (done by the system)
with Diluent 2
3 Blood groups (ABO/Rh for The system will dispense 50µl of the red cell suspension to all the
Newborns) (human micro tubes (A, B, AB, D, ctl, DAT) of the gel card and will add
antibodies) with Diluent 1 & 2 25µl of Diluent 1 to the first 5 micro tubes (A, B, AB, D, ctl).
(E.g. Id-nr. 5006)
0,8% Preparation of blood system.
4 Phenotyping for patients/ The system will dispense 12.5µl of the red cell suspension to all
donors (monoclonal micro tubes of
antibodies) with Diluent 2 the gel card.
(E.g. Id-nr. 5011)
5% Preparation of blood
sample (done by the system) The reactions will be read by the integrated camera of the system.
208 | IH-1000
Examples of Test Execution
5 Phenotyping for patients / The system will dispense 12.5µl of the red cell suspension to all
donors (human antibodies) micro tubes of the gel card.
with Diluent 1
(E.g. Id-nr. 5010) The gel cards will be incubated for 10 minutes at RT in the
system.
sample (done by the system) The gel card will be centrifuged for 10 minutes in the system.
6 Reverse Grouping (A1,A2,B,0) The system will dispense 50µl of “ID-DiaCell A1” to micro tube A1,
(E.g. Id-nr. 5052) 50µl of “ID-DiaCell A2” to micro tube A2, 50µl of “ID-DiaCell B” to
micro tube B and “ID-DiaCell 0" to micro tube 0.
Afterwards, the system will dispense 50µl of the patient serum or
plasma to each micro tube A1, A2, B and 0.

system.
7 Reverse Grouping (A1,A2,B,0) The system will dispense 50µl of “ID-DiaCell” (for reverse grouping
with antibody screening (I, II) and for antibody screening) and the red blood cell suspension for
with Diluent 2 autocontrol to the appropriate microtube depending on the test
(E.g. Id-nr. 5051) combination. Afterwards the system will dispense 50ul of the
patients serum or plasma to each microtube.
0,8% Preparation of blood

sample (done by the system) The gel card will be incubated for 10 minutes at RT in the system.
The reaction will be read by the integrated camera of the system.
The results are interpreted with the interpretation software.
8 Blood groups ABD-Conf. for The system will dispense 12,5µl of the red cell suspension to the
patients / donors (monoclonal appropriate micro tube of the gel card.
antibodies) with Diluent 2
(E.g. Id-nr. 5005, 5105) The gel card will be centrifuged for 10 minutes in the system.
5% Preparation of blood The reactions will be read by the integrated camera of the system.
IH-1000 | 209
Appendix
9 Blood groups ABD-Conf. The system will dispense 12,5µl of the red cell suspension to
(human antibodies) with appropriate micro tubes of the gel card.
Diluent 1
(E.g. Id-nr. 5004) The gel cards will be incubated for 10 minutes at RT in the
system.
sample-(done by the system) The gel card will be centrifuged for 10 minutes in the system.
10 Antibody screening for donors The system will dispense 50µl of the ID-DiaCell Pool to appropriate
with ID-DiaCell Pool micro tubes of gel card. Afterwards, the system will dispense 25µl
(E.g. Id-nr. 5053, 5054) of the donor plasma or serum to appropriate micro tubes of the
gel card.
The gel card will be incubated for 15 minutes at 37°C in the

system.
11 Antibody screening with ID- The system will dispense 50µl of the ID-DiaCell I,II,III and IP,IIP,IIIP
DiaCell I, II, III and IP,IIP and to micro tubes of gel card. Afterwards, the system will dispense
IIIP 25µl of the patient or donor plasma or serum to all micro tubes of
(E.g. Id-nr. 5053, 5054, etc...) the gel card.

system.
12 Liss / Coombs Card for DAT The system will dispense 50µl of the red cell suspension to the
(E.g. Id-nr. 5053 and 5054) appropriate micro tubes.
0,8% Preparation of blood The gel card will be centrifuged for 10 minutes in the system.
with Diluent 2 The reactions will be read by the integrated camera of the system.
210 | IH-1000
13 DAT with ID-DC Screening I The system will dispense 50µl of the red cell suspension to each
(E.g. Id-nr. 5083) micro tube.
14 DAT with ID-DC Screening II The system will dispense 50µl of the red cell suspension to the
(E.g. Id-nr. 5056) appropriate micro tubes.
15 DAT IgG subclasses The system will dispense 50µl of the red cell suspension to the
(E.g. Id-nr. 5089) appropriate micro tubes.
16 Compatibility tests The system will dispense 50µl of the donor red cell suspension to
(crossmatch) by IAT the appropriate micro tubes. Afterwards the system will dispense
(E.g. Id-nr. 5053 and 5054) 25µl of the patient's plasma or serum to the appropriate micro
tubes of the gel card.

sample-(done by the system) The gel card will be incubated for 15 minutes at 37°C in the
with Diluent 2 system.
IH-1000 | 211
Appendix
17 Compatibility tests The system will dispense 50µl of the donor red cell suspension to
(crossmatch) by IAT with auto the appropriate micro tubes. The system will dispense 50µl of the
control suspension of the patient's own red blood cells to the appropriate
(E.g. Id-nr. 5053 and 5054) micro tubes of the gel card. Afterwards the system will dispense
25µl of the patient's plasma or serum to the appropriate micro
tubes of the gel card.
sample-(done by the system)
with Diluent 2 The gel card will be incubated for 15 minutes at 37°C in the
system.
18 Compatibility tests The system will dispense 50µl of the donor red cell suspensions to
(crossmatch) with Autocontrol the appropriate micro tubes. Afterwards will dispense 25µl of the
with the enzyme technique patient's plasma or serum to the appropriate micro tubes of the
(E.g. Id-nr. 5052) gel card.
0,8% Preparation of blood The system will dispense 50µl of the patients own red cell
sample-(done by the system) suspensions to the appropriate micro tubes. Afterwards the system
with Diluent 2 will dispense 25µl of the own patient's plasma or serum to the
appropriate micro tubes.
The system will dispense 25µl ID-Diluent 1 or ID-Papain to the


system.
19 Compatibility tests The system will dispense 50µl of the donor's red cell suspensions
(crossmatch) monoclonal to the appropriate micro tubes.
antibodies
(E.g. Id-nr. 5060) The system will dispense 25µl of the patient's plasma or serum to
appropriate micro tubes of the gel card.
sample (done by the system) The system will dispense 25µl of ID-Diluent 1 to the appropriate
with Diluent 2 micro tubes.

system.
212 | IH-1000
20 Compatibility tests The system will dispense 50µl of the patient's red cell suspension
(crossmatch) human to the appropriate micro tubes (1, 2, 3 and 6 (A,B,D, autocontrol).
antibodies
(E.g. Id-nr. 5059) The system will dispense 50µl of the donor's red cell suspension
to the appropriate micro tubes (1, 2, 3, 4 and 5 (A,B,D/ Enz./
0,8% Preparation of blood AHG).
with Diluent 2 The system will dispense 25µl of the patient's plasma or serum to
the appropriate micro tubes of the gel card.
The system will dispense 25µl of ID-Diluent 1 to the micro tubes

1,2,3 and 4 (A,B,D/ Enz.).

system.
21 Auto control The system will dispense 50µl of the patients own red cell
(E.g. Id-nr. 5053 and 5054) suspensions to the appropriate micro tubes. Afterwards the system
will dispense 25µl of the own patient's plasma or serum to the
system.
22 Indirect antiglobulin test (IAT) The system will dispense 50µl of each test cell reagent to the
procedures with “ID-DiaCells” appropriate micro tubes. Afterwards, the system will dispense 25µl
(E.g. Id-nr. 5053,5054) of the patient's or donor's plasma or serum to the appropriate
micro tubes.

sample (done by the system) The gel card will be incubated for 15 minutes at 37°C in the
with Diluent 2 system.
IH-1000 | 213
Appendix
23 Antibody Identification (IAT) + The system will dispense 50µl of each “ID-DiaPanel” test cell to
Autocontrol with “ID- the appropriate micro tubes (marked 1 to 11). The system will
DiaPanel” dispense 50µl of the patient's own red cell suspension to the 12th
(E.g. Id-nr. 5053, 5054) micro tube for autocontrol.
Afterwards the system will dispense 25µl of the patient's or
donor's plasma or serum to all 12 micro tubes.
(for autocontrol) system.
24 Antibody Identification + The system will dispense 50µl of each "ID-DiaPanel-P" test cell to
Autocontrol with “ID- the appropriate micro tubes (marked 1 to 11). The system will
DiaPanel-P” Papain dispense 50µl of the patient's own red cell suspension to the 12th
(E.g. Id-nr. 5052) micro tube (autocontrol).
Afterwards the system will dispense 25µl of the patient's or
0,8% Preparation of blood donor's plasma or serum to all 12 micro tubes.
with Diluent 2 The system will dispense 25µl "ID-Papain" to the 12th micro tube
(for autocontrol) (autocontrol).

system.
214 | IH-1000
25 Type and Screen (monoclonal The system will dispense 50µl of each “ID-DiaCell” test cell to the
antibodies) appropriate micro tubes. Afterwards, the system will dispense 25µl
(E.g. Id-nr. 5068) of the patient's or donor's plasma or serum to the appropriate
micro tubes.
sample (done by the system) The system will dispense 12,5µl of the red cell suspension to the
with Diluent 2 micro tubes A-B-D (VI-).

system.
26 Type and Screen (human Not yet available on the IH-1000

antibodies)
(E.g. Id-nr. 5067)
with Diluent 1
27 Confirmation of Dweak by IAT The system will dispense 50µl of the patient's or donor's own red
(E. g. Id-nr.: 5054) cell suspension to the appropriate micro tubes. Afterwards, the
system will dispense 50µl of the ID-DiaClon Anti-D weak to the
system.
28 Partial RhD Typing The system will dispense 50µl of the patient's or donor's own red
(E. g. Id-nr.: 4617) cell suspension to the appropriate micro tube (marked 1-6).
Afterwards, the system will dispense 25µl of the ID-DiaClon Anti-D
1-6 to the appropriate micro tubes.
system.
IH-1000 | 215
Appendix
29 Antigen profiles I and II The system will dispense 12, 5µl of the patient's or donor's red
(E. g. Id-nr.: 5037 and 5038) cell suspension to each micro tube.
5% Preparation of blood The gel card will be incubated for 10 minutes at RT in the system.
with Diluent 1 The gel card will be centrifuged for 10 minutes in the system.
30 Antigen profiles III The system will dispense 50µl of the patient's or donor's red cell
(E. g. Id-nr.: 5039) suspension to each micro tube.
0,8% Preparation of blood The gel card will be incubated for 10 minutes at RT in the system.
31 Antigen profiles III with liquid The system will dispense 50µl of the patient's or donor's red cell
antisera suspension to each micro tube.
(E. g. Id-nr.: 4514)
The system will dispense 50µl of the “ID-Test Sera” to the
0,8% Preparation of blood appropriate micro tubes.
with Diluent 2 The gel card will be incubated for 10 minutes at RT in the system.
32 Single antigen testing The system will dispense 12, 5µl of the red cell suspension to the
(E. g. Id-nr.: 5016, etc..) appropriate micro tubes of the gel card.
5% Preparation of blood The gel card will be incubated for 10 minutes at RT in the system.
216 | IH-1000
33 Single antigen testing The system will dispense 12, 5µl of the red cell suspension to the
(E. g. Id-nr.: 5020, etc...) appropriate micro tubes of the gel card.
5% Preparation of blood The gel card will be centrifuged for 10 minutes in the system.
34 Single antigen testing by IAT The system will dispense 50µl of the red cell suspension to the
with liquid antisera appropriate micro tubes of the gel card.
(E. g. Id-nr.: 5033, etc...)
The system will dispense 50µl of the ID-Test Serum to the
0,8% Preparation of blood appropriate micro tubes of the gel card.
system.
IH-1000 | 217
Appendix
218 | IH-1000
Index
A M
Alarm and Error Management Menu button
Behavior 189 Exit (software) 57
Appropriate Use 11 Maintenance screen 164
Authorized Maintenance 165 Daily maintenance 168
General initialization 188
Needle change (right and left pipettor) 184
C Needle cleaning (right and left pipettor) 181
Components area Operations (decontamination) 167
Checking status 162 Pipettors (rinse) 186, 188
Computer connecting panel 34 Reading station calibration 186
Connection panel 35 Weekly maintenance 168
Options screen 144
D Controls options 153
Disabled Mode 156
Definition
Cap detection 158
Major Injury 14
General options 146
Minor Injury 14 Profile options 151
Moderate Injury 14
Stop All (instrument) 57
Device disposal 206 User Level screen 165
Diluent
Rack removal 106 N
Needle change
F Procedure (right and left pipettor) 184
Footer strip Needle cleaning
Resources buttons Procedure (right and left pipettor) 181
Description 119
Norms
Footer strip 119 Safety 18
Resources on board 120
Test buttons
Footer strip 125
P
In progress Pipetting area
Details of a test 128 Clot detection 141
General description 126 Clot detection (errors) 140
Ready to start Interactive instrument image 46
Emergency 131 Pipetting area window (opening) 139
General description 130 Status (screen) 138
Tests to repeat (description) 133
Without resources (description) 132 R
Tests buttons Reagent
Samples without request (description) 136 Rack removal 106
Forms (decontamination certificate) 203 Rescue shutdown 59
Risk
G Classes definition 18
Gel cards area
Interactive instrument image 46 S
Managing ID-Cards 68
Safety
Replacing the ID-Cards waste bin 118
Environmental conditions 21
General instructions 23
L Importance of the instructions 20
List of documents 207 Non-compliance with rules 20
IH-1000 | 219
Index
Safety instructions
Warning 18
Sample / Reagent Area
Cap confirmation 100
Diluent
Diluent rack and general description 84
Inserting a diluent rack product 85
Status (diluent) 93
General rack status 91
Interactive instrument image 46
Loading racks 102
Main screen (description) 90
Reagent
Cleaning solution
Preparation (SETUP CLEAN) 89
Use (SETUP CLEAN) 88
Reagent rack and general description 86
Status (reagent) 93
Sample
Barcode specifications 81
Input (Sample barcode manual input) 98
Material (sample) 15
New (sample rack) 80
Status (sample) 92
Type of sample tubes
Labeling 79
Urgent (sample rack) 80
Volumes (sample) 82
Solutions / Wastes area
Containers (cleaning) 115
General description 109
Interactive instrument image 46
Liquid and wastes status 111
Preparation (cleaning liquid) 114
Priming cycle 117
System liquid container (refilling) 112
Waste liquid container (replacement) 116
Step by step procedure 60
Storage 188
T
Test Execution 208
Troubleshooting
Alarm and Error Management 189
U
Use
Appropriate 11
Introduction 29
User Level 165
W
Warranty
Limitations 12
220 | IH-1000
Notes
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IH-1000 | 221
Bio-Rad
Laboratories
Clinical Web site www.bio-rad.com/diagnostics USA 1 800 224 6723 Australia 61 2 9914 2800 Austria 43 1 877 8901 Belgium 32 03 710 53 00
Brazil 55 31 3689 6600 Canada 1 514 334 4372 China 86 21 61698500 Czech Republic 420 241 430 532 Denmark 45 4452 1000 Finland 358 9 804 22 00
Diagnostics Group France 33 1 47 95 60 00 Germany 49 0 89 318 840 Greece 30 210 7774396 Hong Kong 852 2789 3300 Hungary 36 1 459 6100 India 1800 180 1224
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User Manual H009142 V1.5 © Bio-Rad 07/2017

User Manual: Catalog # 001000

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Copyright:

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User Manual: Catalog # 001000

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IH-1000

Tel. +41 (0)26 67 45 111

1.0 07/2010 First edition

1.1 V3.0 03/2011 V3.0 Soft updates

1.2 V4.0 11/2012 V4.0 Soft and troubleshooting updates

1.4 V04.04 03/2015 V04.04 Soft updates and minor updates

1.5 V04.07 07/2017 New layout

PAGE INTENTIONALLY LEFT BLANK

Chapter 1 Generalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Chapter 2 Safety and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Chapter 3 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Chapter 4 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43

Chapter 5 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53

Chapter 7 Managing Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

Chapter 8 Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143

Chapter 9 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161

Chapter 10 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .189

Chapter 11 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201

1.1 Appropriate Use

1.2 Warranty Limitation

Each Bio-Rad’s IH-1000 is tested by the manufacturer before shipping.

GUI Graphical User Interface

ID-Card Term which designates the gel card

LAN Local-Area Network

UDI Unique Device Identifier

UPS Uninterruptible Power Supply

USB Universal Serial Bus

Bio-Rad authorized Gel Card

Only gel cards manufactured by Bio-Rad may be used in the instrument.

Bio-Rad authorized Reagent

Only reagents manufactured by Bio-Rad may be used in the instrument.

1.3.3 Sample Material

Antibody Screen Testing

1.4 Typographical Conventions

A Open the drawer.

B Put the gel card into position as shown.

C Close the drawer.

1.4.4 Procedure Result

A Click on the Parameters button.

1.4.5 Cross Reference

1.4.6 List of Items

Error code Error description Corrective actions

In case of any doubt, consult your Bio-Rad representative.

2.1.2 Importance of the Safety Instructions

2.1.3 Disregarding the Safety Rules

2.2 Environmental Conditions

For more information, contact your representative.

The IH-1000 must be kept away from potential sources of interference.

This class (B) digital apparatus complies with Canadian ICES-003.

Changes or modifications not expressly approved by the party responsible for

2.3 General Safety Instructions and Signs

CONTACT WITH WATER

Repair and service operations must only be performed by a qualified service

It is imperative to obtain the manufacturer approval before using the IH-1000 in

Sign Description Explanation

Biological hazard INFECTION

High voltage ELECTROCUTION

Laser beam CLASS 2 LASER - PERMANENT EYESIGHT INJURY

Pinching danger PINCH POINT HAZARD

Sign Description Explanation

Burning danger HOT SURFACE

Irritant product IRRITATING

Corrosive product CORROSIVE