illumina Infinium LiHa User manual

Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
Operating Manual
Infinium LiHa and Infinium RoMa

© 2020, Illumina, Inc. All rights reserved.
All trademarks are the property of Illumina, Inc. or their respective owners.
I

0 - Preface
Manufacturer
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 0 - 1
0 Preface
For Your Safety Before performing any work on or with the Infinium LiHa and Infinium RoMa,
first read the Operating Manual - Document # 1000000110155 v00 carefully,
in particular chapter 2 “Safety”.
0.1 Manufacturer
Address of
Manufacturer
0.2 Use of the Product
0.2.1 Intended Use
Intended Use The Infinium LIHA/ROMA is an automated robotic solution for sample preparation.
Note: This product is intended for research use only (RUO) and will not be for
clinical use.
0.2.2 Improper Use
Improper Use The Infinium LiHa and Infinium RoMa must not be used with options or
components which are not approved by Illumina.
WARNING
The use of non approved options may impair the safety concept of the Infinium
LiHa and Infinium RoMa.
This means that the safety and compliance to national and international
standards, as required for UL/CSA certification, by EC directives, etc. cannot be
ensured any more.
Illumina Inc.
5200 Illumina Way
San Diego, CA 92122
United States

0 - 2 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
0 - Preface
CE Conformity
0.3 CE Conformity
Declaration of
Conformity
The Infinium LiHa and Infinium RoMa is designed and built in compliance with the
basic safety and health requirements of applicable EC Directives. With the
declaration of conformity the manufacturer declares conformity with the provisions
of the Directives.
CE Label
0.4 CSA Certification
The Infinium LiHa and Infinium RoMa is tested and certified by the Canadian
Standards Association (CSA).
CSA Marking The CSA marking is affixed to the Infinium LiHa and Infinium RoMa.
Canada IC Compliance
This Class A digital apparatus meets all requirements of the Canadian
Interference - Causing Equipment Regulations.
This device complies with Industry Canada license - exempt RSS standards.
Operation is subject to the following 2 conditions:
1 This device may not cause interference.
2 This device must accept any interference, including interference that may
cause undesired operation of the device.
The CE label is affixed to the Infinium LiHa and Infinium RoMa.

0 - Preface
FCC Rules
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 0 - 3
0.5 FCC Rules
FCC
Compliance
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following 2 conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that
may cause undesired operation.
CAUTION
Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
Note: This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to Part 15 of the FCC rules. These limits are
designed to provide reasonable protection against harmful interference when the
equipment is operated in a commercial environment. This equipment generates,
uses, and can radiate radio frequency energy and, if not installed and used in
accordance with the instrumentation manual, may cause harmful interference to
radio communications. Operation of this equipment in a residential area is likely to
cause harmful interference in which case users will be required to correct the
interference at their own expense.

0 - 4 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
0 - Preface
FCC Rules

-
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 1 - 1
Table of Contents
0Preface
0.1 Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-1
0.2 Use of the Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-1
0.2.1 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-1
0.2.2 Improper Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-1
0.3 CE Conformity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-2
0.4 CSA Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-2
0.5 FCC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-3
1 About This Manual
1.1 Reference Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Trademarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
2Safety
2.1 Safety Message Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1.1 Signal Words . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1.2 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.3 Operating Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.4 User Qualification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.4.1 Operator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.4.2 Key Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.5 Safety Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
2.6 Product Safety Signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
2.7 Laser Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
2.8 Decontamination Declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

1 - 2 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
-
3 Technical Data
3.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.1.1 Infinium LiHa and Infinium RoMa Overview . . . . . . . . . . . . . . . . . . . . . 3-1
3.1.2 Product Identification and Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.2 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.2.1 Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.2.2 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.2.3 Status Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3.2.4 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
3.2.5 Emissions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
3.2.6 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
3.2.7 I/O Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
3.3 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
3.3.1 Computer Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
3.3.2 Software Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
3.3.3 System Liquid Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
3.3.4 Sample Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
3.4 System Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
3.4.1 Liquid Handling Arm (LiHa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
3.4.2 Robotic Manipulator Arm Standard (RoMa) . . . . . . . . . . . . . . . . . . . . . 3-12
3.4.3 Positive Identification (PosID) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
3.5 Chemical Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
3.5.1 Standard Materials Resistance Table . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
4 Description of Function
4.1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Structure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2.1 Mechanical Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.2.2 The Infinium LiHa and Infinium RoMa Worktable. . . . . . . . . . . . . . . . . 4-3
4.2.3 Liquid System Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.3 Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.3.1 Liquid Handling Arm (LiHa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.3.2 Robotic Manipulator Arm Standard (RoMa Standard) . . . . . . . . . . . . . 4-6
4.3.3 Barcode Scanner on RoMa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
4.3.4 Safety Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
4.4 Positive Identification (PosID) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
4.5 Liquid System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14
4.5.1 Tubing Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
5 Putting into Operation
5.1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1.1 Initial Installation of the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

-
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 1 - 3
6 Operation
6.1 Operating and Display Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1.1 Operating Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Operating Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.3 Operating in Routine Operation Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.3.1 Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.3.2 Enclosed Work Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.3.3 Switching the Instrument On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.3.4 Instrument Preparation and Checks . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.3.5 Checks and Terminating Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
6.3.6 Switching the Instrument Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
6.3.7 When a Crash Occurred . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
6.4 Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
7 Preventive Maintenance and Repairs
7.1 Tools and Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1.1 Cleaning Agents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Maintenance Schedule. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
7.2.1 Maintenance: Immediate Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 7-5
7.2.2 Maintenance Table: Daily Maintenance. . . . . . . . . . . . . . . . . . . . . . . . 7-6
7.2.3 Maintenance Table: Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . 7-8
7.2.4 Maintenance Table: Yearly Maintenance. . . . . . . . . . . . . . . . . . . . . . . 7-8
7.3 Maintenance Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
7.3.1 Liquid System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
7.3.2 Syringe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
7.3.3 Fixed Tips of LiHa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
7.3.4 Wash Station . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
7.3.5 Worktable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
7.3.6 Safety Panels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
7.3.7 Liquid Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
7.3.8 Carriers and Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18
7.3.9 Positive Identification (PosID) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
7.3.10 Arm Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21
7.4 Precision and Function Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
7.4.1 Liquid Handling Performance Verification Testing . . . . . . . . . . . . . . . . 7-22
7.5 Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22
8 Troubleshooting
8.1 Troubleshooting Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
9 Shutdown, Transport and Storage
9.1 Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1.1 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.1.2 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
9.2 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.2.1 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.2.2 Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
9.3 Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5

1 - 4 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
-
10 Disposal
10.0.1 Local Requirements European Union . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
10.0.2 Local Requirements People’s Republic of China . . . . . . . . . . . . . . . . . 10-1
11 Spare Parts and Accessories
11.1 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.2 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.3 Infinium LiHa and Infinium RoMa Basic Accessories Kit . . . . . . . . . . . . . . 11-1
11.4 Carriers, Racks, Troughs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.4.1 Carriers for Microplates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
11.4.2 Carriers for Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
11.4.3 Wash Stations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
11.5 Tips and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
12 Customer Support
12.1 Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1

1 - About This Manual
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 1 - 1
1 About This Manual
Purpose of This
Chapter
This chapter points out the purpose of the manual, specifies the product the
manual deals with and who the manual is intended for. Furthermore, it explains
the symbols, conventions and abbreviations used and offers other general
information.
Purpose of This
Manual
This manual describes the Infinium LiHa and Infinium RoMa and provides all
information required for its safe operation and to maintain it in good working order.
Product
Pictures
The delivered instrument may not exactly match the product pictures shown in this
operating manual.
Target Group This manual is intended for everyone who wants to learn about the safe operation
of the Infinium LiHa and Infinium RoMa and how to maintain its perfect working
condition. In particular, laboratory personnel and operators are addressed.
Laboratory personnel operating Infinium LiHa and Infinium RoMa instruments
require also thorough knowledge of applications, instrument functions and
software programs as well as all applicable safety rules and regulations.
Scope This manual is applicable for
Illumina Infinium LIHA; P/N 20040483
Illumina Infinium ROMA; P/N 20040482
Symbols and
Conventions
Cross-references appear as follows: e.g. “Refer to section “1.1.1 1-2“
– 1.1.1 refers to the corresponding chapter number
– The symbol denotes “page number”
– 1-2 refers to the page number, whereas the first number stands for the
chapter number (chapter 1 page 2)
Note: The symbols pertaining to safety (WARNINGS and ATTENTIONS) are
explained in chapter 2 “Safety”,
 2-1.

1 - 2 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
1 - About This Manual
Reference Documents
1.1 Reference Documents
Additional reference documents are listed below but are not enclosed or linked.
What Does the
Doc. ID Tell
You?
The Doc. IDs listed below are root numbers. Therefore, they do not contain
information about the language, document version or the medium (data storage
medium, hardcopy, downloadable file, etc.) of the document.
Check the scope of the corresponding document to make sure that you are in
possession of the correct version.
Note: The Doc. ID does not represent ordering information. For orders refer to the
number on the binder, CD casing, etc.
Manuals
supplied with
Infinium LiHa
and Infinium
RoMa
Instruments
The following manuals are included in the shipment and considered part of a
Infinium LiHa and Infinium RoMa instrument:
Infinium LiHa and Infinium RoMa Operating Manual
(Document # 1000000110155)
Infinium Assay Lab Setup and Procedures Guide (Document # 11322460)
Any individual or separate operating manuals for optional equipment according to
your order configuration can be applicable.
For information about the liquids to use with the Infinium LiHa and Infinium RoMa,
refer to section 3.5 “Chemical Resistance”, 3-17.
1.2 Trademarks
The following product names and any registered and unregistered trademarks
mentioned in this manual are used for identification purposes only and remain the
exclusive property of their respective owners (for simplicity reasons, the symbols
for trademarks, such as ®and ™ are not repeated later in the manual):
Windows®is a registered trademark of Microsoft Corporation
Tygon®is a registered trademark of Saint-Gobain Performance Plastics
Corporation
Bacillol Plus® is a registered trademark of the Bode Chemie Hamburg
Decon90® is a registered trademark of Decon Laboratories Limited
DNAzap® is a registered trademark of Ambion Inc.
All trademarks are the property of Illumina, Inc. or their respective owners. For
specific trademark information, see www.illumina.com/company/legal.html

1 - About This Manual
Abbreviations
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 1 - 3
1.3 Abbreviations
cLLD Capacitive liquid level detection
CV Coefficient of variance or variation
DMSO Dimethyl sulfoxide
EN European Norm
EPDM Ethylene Propylene Diene Monomer
ETFE Ethylene/Tetrafluoroethylene-copolymer
FEP Tetrafluoroethylene/Perfluoropropylene-copolymer
FFPM Perfluoroelastomer
FSE Field service engineer
IAC Illumina Automation Control
ILID Integrated liquid detector
LH Liquid handling
LICOS Liquid container supervisor
LiHa Liquid handling arm
MIO Monitored incubator option
MP Microplate
MPO Monitored pump option
PCTFE Polychlorotrifluoroethylene
PE Polyethylene
PEEK Polyetheretherketone
pLLD Pressure based liquid level detection
PMP Pressure monitored pipetting
POM Polyoxymethylene
PP Polypropylene
PosID Positive identification option, barcode scanner
PS Polystyrene
PTFE Polytetrafluoroethylene
PVC Polyvinylchloride
PVDF Polyvinylidenefluoride
RoMa Robotic manipulator arm
RF Radio frequency

1 - 4 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
1 - About This Manual
Abbreviations
SPO Sensored pump option
USB Universal serial bus
UPS Uninterruptable power supply
WHO World Health Organization

2 - Safety
Safety Message Conventions
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 2 - 1
2 Safety
This chapter describes the safety concept of Infinium LiHa and Infinium RoMa,
provides general rules of correct behavior, and warnings concerning hazards
associated with the use of the Infinium LiHa and Infinium RoMa.
2.1 Safety Message Conventions
2.1.1 Signal Words
WARNING indicates the possibility of personal injury or even loss of life if the
instructions are not followed.
ATTENTION indicates the possibility of equipment damage, malfunctions or
incorrect process results, if instructions are not followed.
2.1.2 Safety Symbols
General warning
Toxi c materia l
Biological hazard
Fire hazard
Electrical danger
Crushing hazard
Laser hazard

2 - 2 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
2 - Safety
Safety Message Conventions
Hot surface hazard
Wear protective gloves
Read this
Disturbance of functions by electromagnetic RF waves.
Do not use a cellular phone.

2 - Safety
General Safety Information
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 2 - 3
2.2 General Safety Information
WARNING
Infinium LiHa and Infinium RoMa are designed and built in accordance with the
present state-of-the-art technology and the recognized technical safety
regulations. Nevertheless, risks to users, property and the environment can arise
if the Infinium LiHa and Infinium RoMa is used without due care and attention.
The safety of all users and personnel depends on the strict observation of these
safety instructions and awareness of the safety-related warnings provided in this
manual.
Please pay great attention to the following general safety information.
This manual must always be available to all persons performing the tasks
described herein.
Legal regulations, such as local, state and federal laws concerning the use or
application, as well as the handling, of dangerous materials in connection with
the Infinium LiHa and Infinium RoMa must be strictly followed.
The operating company is responsible for defining instructions in accordance
with company procedures and local legal requirements. The instructions
provided by the operating company must be strictly observed.
Observe the correct environmental conditions for storage and operation.
Structural changes to the safety devices are forbidden.
Damaged safety devices must be replaced immediately as described in this
manual.
The Infinium LiHa and Infinium RoMa must not be modified in any way without
prior consultation and written approval of Illumina. Authorized modifications to
the system may only be performed by an FSE certified for the repair and
upgrading of the Infinium LiHa and Infinium RoMa.
Illumina will reject any claim resulting from unauthorized modifications.
Fire hazard caused by the improper use of the Infinium LiHa and Infinium
RoMa. The Infinium LiHa and Infinium RoMa should not be installed in
locations where there is a hazard of explosion.
Chemical and biological hazards can be associated with the substances used
or the samples and reagents processed with the Infinium LiHa and Infinium
RoMa (e.g., during loading and unloading). The same applies to waste
disposal.
– Always be aware of possible hazards associated with these substances.
– Use appropriate protective clothing, safety goggles and gloves.
– The handling of substances and the disposal of waste may be subject to
local, state, or federal law, or to regulations with regard to health,
environment, or safety. Strictly observe the corresponding provisions.
Any contamination must be dealt with immediately as described in this
manual.
The user is responsible for ensuring that the Infinium LiHa and Infinium RoMa
is always operated under proper conditions, and that maintenance, service,
and repair tasks are performed with care, on schedule, and only by authorized
personnel.
Risk of incorrect measuring results. After system care or maintenance has
been performed, operation must only be resumed after the correct system
operating conditions have been verified.
Always use recommended consumables and original spare parts for
maintenance and repair to assure good system performance and reliability.

2 - 4 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
2 - Safety
General Safety Information
Lifting or moving the instrument can cause serious injuries
– Injuries to the back due to overload can occur
– Lifting or moving the instrument must be correctly prepared and may only
occur under the direction of a qualified Illumina person
Lifting or moving the instrument can cause damage due to unsecured parts
– Lifting or moving the instrument must be correctly prepared and may only
occur under the direction of a qualified Illumina person
Potentially lethal voltage inside the instrument.
– Equipment is to be connected to a grounded power source using an
approved power cord with grounding (earthing) conductor.
– Do not remove covers and other parts protecting from electricity.
– Always keep the areas of electric parts, such as power supply plug, mains
switch, etc., dry.
Though the safety concept assumes that the safety panel is always closed
during normal operation, it is necessary to have access to the elements in the
working area behind the safety panel for setup, maintenance and
troubleshooting purposes.
Pointed tips and other sharp-edged elements, which might cause injuries
when you reach into the working area with the safety panel open.
– Always be aware of the mechanical hazards.
– Wear laboratory apparel, rubber gloves, safety goggles, etc. as
appropriate.
Unsafe operating condition and wrong measuring results in the process, if the
system is leaking.
– If liquid is dripping from the tips or other parts of the liquid system, the
Infinium LiHa and Infinium RoMa must not be operated any more.
– Operation may only be resumed if the necessary maintenance or repair
work has been performed and the proper condition of the system has
been verified.
ATTENTION
Possible malfunction or functional failure.
Proper operation can be interfered by strong electromagnetic fields.
Evaluate the electromagnetic environment before operating the device.
Do not operate this system in close proximity to sources of strong
electromagnetic fields (for example, unshielded intentional RF sources).
The operating company and the operator is responsible to ensure that a
compatible electromagnetic environment for the system can be maintained in
order that the device will perform as intended.
Electromagnetic RF waves from a cellular phone may affect the function of the
liquid detection.
– Faulty detection of the liquid surface may be the consequence, which
causes the system to produce incorrect results.
– Keep a distance of at least 2 m from the instrument when using a cellular
phone.
Chemical and biological hazards can be associated with the substances used
or the samples processed with the Infinium LiHa and Infinium RoMa.
The same applies to waste disposal.
– Always be aware of possible hazards associated with these substances.

2 - Safety
Operating Company
Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00 2 - 5
– Use appropriate protective clothing, safety goggles, mouth/nose
protection and gloves.
The handling of substances and the disposal of waste may be subject to local,
state or federal law or regulations with regard to health, environment or safety.
Strictly observe the corresponding provisions.
Caustic substances can cause burns and eye injury.
– Always be aware of possible hazards associated with these substances.
– Avoid exposure to caustic substances.
– Use appropriate protective clothing, safety goggles, mouth/nose
protection and gloves.
The instrument is not explosion protected. Not for use in Ex zones.
When using flammable material take the risk of fire into consideration:
– Avoid the formation and accumulation of flammable vapors.
– Avoid the spillage of flammable material.
Regarding all hazards (referring to the listed hazards earlier in this section)
pay attention to the following:
– Prior to using hazardous materials perform a risk assessment.
– Consider specific workplace conditions, such as temperature, air
ventilation, electrostatic discharge.
– Make sure that the risk is acceptable prior to use of the instrument.
Wrong sample results due to disturbances, such as electromagnetic fields or
supply voltage fluctuations, caused by external devices.
– Do not place devices emitting electromagnetic fields close to the
instrument.
– Do not connect devices that may interfere with the supply grid to the same
power line as the instrument.
For California residents only: This product can expose you to chemicals such
as lead which is known to the State of California to cause cancer and birth
defects or other reproductive harm. For more information go to
www.P65Warnings.ca.gov/product.
2.3 Operating Company
The operating company must ensure that the Infinium LiHa and Infinium RoMa, in
particular the safety features, function properly and that all the personnel in
contact with the instrument are adequately trained.
Responsibilities Method and process validation.
Defining the processes in compliance with the Standard Operating
Procedures.
Ensuring that installation and operational qualifications (IQ OQs) have been
completed.
Ensuring that all personnel in contact with the Infinium LiHa and Infinium
RoMa are adequately trained.
Ensuring the availability of appropriate protective clothing and equipment.
Ensuring the maintenance and safe operation of the Infinium LiHa and
Infinium RoMa.
Requiring adherence to laboratory safety regulations and directives.

2 - 6 Infinium LiHa and Infinium RoMa Operating Manual - Document # 1000000110155 v00
2 - Safety
User Qualification
2.4 User Qualification
The laboratory personnel must be fully qualified and trained to operate the
Infinium LiHa and Infinium RoMa. The work described in this Operating Manual
must only be performed by authorized personnel with the qualifications prescribed
below.
Laboratory personnel must:
have suitable technical training,
be familiar with the laboratory safety regulations and directives,
be familiar with the instructions for the safety elements of the instrument,
use protective clothing and equipment,
be familiar with and adhere to good laboratory practices,
and have read and understood the instructions in the Operating Manual.
2.4.1 Operator
The operator (lab technician) works for the operating company.
Required Skills No specific application or system knowledge
Command of local languages
Command of English is preferable
The operator has application software access rights allowing him to run methods
and perform system care.
2.4.2 Key Operator
The key operator (application specialist) supports the operating company or works
for the same company.
Required Skills Extensive application knowledge
Limited system knowledge
Command of local languages
Command of English
In-depth knowledge of the corresponding software manual
Responsibilities Instructing the operator
Writing, running and validating methods
Helping the operator to solve problems with the instrument