Bio-Tek Synergy H1 User manual

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Synergy H1
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Operator’s Manual

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Synergy H1
Multi-Mode Reader
Operator's Manual
BioTek®Instruments, Inc.
Part Number 8041000
Revision K
May 2016
© 2016

Notices
BioTek®Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2016, BioTek®Instruments, Incorporated. No part of this publication may be
reproduced, transcribed, or transmitted in any form, or by any means electronic or
mechanical, including photocopying and recording, for any purpose other than the
purchaser’s use without written permission of BioTek Instruments, Inc.
Trademarks
BioTek®is a registered trademark and Synergy™, Gen5™, BioStack™, BioCell™, and
Take3™ are trademarks of BioTek Instruments, Inc. Harta™ is a trademark of Harta
Instruments.
Microsoft®, Windows®, Windows 7, Windows 8, and Excel®are either registered
trademarks or trademarks of Microsoft Corporation in the United States and/or other
countries.
All other trademarks are the property of their respective holders.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a commitment by
BioTek Instruments, Inc. Changes made to the information in this document will be
incorporated in new editions of the publication. No responsibility is assumed by BioTek for
the use or reliability of software or equipment that is not supplied by BioTek or its affiliated
dealers.
BioTek Instruments, Inc.
ii | Preface

Contents
Notices ii
Trademarks ii
Restrictions and Liabilities ii
Contents iii
Contact Information x
Global Service and Support x
Customer Service and Sales x
Service/Technical Assistance Center (TAC) x
European Coordination Center/Authorized European Representative x
Revision History xi
Document Conventions xiv
Intended Use Statement xiv
Quality Control xv
Warranty and Product Registration xv
Repackaging and Shipping xv
Warnings xvi
Hazards xvi
Precautions xvii
CE Mark xix
Directive 2014/30/EU: Electromagnetic Compatibility xix
Emissions—Class A xix
Immunity xix
Directive 2014/35/EU Low Voltage (Safety) xix
Directive 2012/19/EU: Waste Electrical and Electronic Equipment xx
Directive 98/79/EC: In Vitro Diagnostics (if labeled for this use) xx
Electromagnetic Interference and Susceptibility xx
USA FCC CLASS A xx
Canadian Department of Communications Class A xx
User Safety xxi
Safety Symbols xxii
Introduction 1
Product Description 2
Package Contents &Accessories 3
Optional Accessories 4
Materials for Conducting Liquid Tests 5
Synergy H1 Operator's Manual
Contents | iii

Product Support & Service 6
Technical Assistance Center (TAC) 6
Applications Support 6
Installation 7
Product Registration 8
Important Information 8
1: Unpack and Inspect the Synergy H1 9
2: Select an Appropriate Location 9
3: Remove the Shipping Hardware 10
4: Install the Power Supply 11
5: Install the Gas Controller 11
6: Unpack and Inspect the Dispense Module 12
7: Install the Dispense Module 13
8: Connect the Host Computer 16
9: Install Gen5 Software 17
10: Turn on the Reader 17
11: Establish Communication 17
12: Verify/Set Dispenser Calibration Values 18
13: Run a System Test 19
14: Test the Injection System 20
Operational/Performance Qualification 21
Repackaging and Shipping Instructions 22
Prepare the Dispense Module for Shipment 25
Getting Started 29
Modular Design 30
External Components 31
Internal Components 31
Filter Cube 32
Injection System 33
Dispense Module 33
Priming the Injection System 34
Gen5 Software 35
Define the Filter Cube in Gen5 and on the Reader 35
Protocols and Experiments 36
Dispense Module Control 37
Prime 37
Purge 37
Plate Shaking Options 38
BioTek Instruments, Inc.
iv | Preface

Recommendations for Optimum Performance 39
General 39
Luminescence Measurements 40
Monochromator-Based Fluorescence Systems 40
Models with Injectors 40
Incubation and Partial Plates 40
Kinetic Assays Using the Continuous Shake Feature 41
Filters and Mirrors 43
Filter Cube Overview 44
Removing a Filter Cube 46
Installing a Filter Cube 46
Configuring the System for Luminescence Measurements 47
About the Gen5 Optics Library 47
Adding a Filter Cube to the Gen5 Optics Library 47
Handling Filters and Mirrors 49
Change a Filter or Mirror 49
Clean the Filters and Mirrors 52
Filters and Mirrors Available from BioTek 52
Preventive Maintenance 53
Overview 54
Daily Cleaning for the Dispense Module 54
Recommended Maintenance Schedule 55
Warnings and Precautions 56
Clean Exposed Surfaces 57
Inspect/Clean Excitation and Emission Filters 58
Inspect/Clean Mirrors 59
Materials 59
Procedure 60
Flush/Purge Fluid Path 61
Run a Dispense Protocol (Optional) 62
Empty/Clean the Tip Priming Trough 63
Clean the Priming Plate 63
Clean the Dispense Tubes and Injectors 63
Required Materials 63
Remove the Dispense Tubes and Injector Tip Holder 64
Clean the Dispense Tubes and Injectors 64
As-Needed Maintenance 65
Decontamination 66
Synergy H1 Operator's Manual
Contents | v

Required Materials 66
Procedure for Models without the Dispense Module 67
Procedure for Models with the Dispense Module 68
Routine Procedure 68
Clean Exposed Surfaces 68
Decontaminate the Fluid Lines 69
Rinse the Fluid Lines 69
Clean the Tubing and Injectors 70
Decontaminate the Tip Priming Trough and Priming Plate 70
Alternate Procedure 70
Dispense Module, Syringe Replacement 71
Syringe Maintenance Position 71
Replace the Syringe 72
Instrument Qualification Process 73
Instrument System Test 74
Plate Shaker Test 74
Absorbance Testing 75
BioTek Absorbance Test Plates 75
Test Methods 75
Sample Test Report 76
Troubleshooting 76
Peak Absorbance Test 76
Alignment Test 77
Accuracy Test 77
Repeatability Test 77
Absorbance Liquid Tests 77
Test Methods 77
Gen5 Protocol Parameters 78
Results Analysis 80
Absorbance Liquid Test 1 80
Absorbance Liquid Test 2 80
Absorbance Liquid Test 3 81
Troubleshooting 82
Luminescence Testing 83
Test Method 83
Gen5 Protocol Parameters 83
Results Analysis 85
Pass/Fail Criteria 86
BioTek Instruments, Inc.
vi | Preface

Troubleshooting 86
Fluorescence Testing 87
BioTek Fluorescence Test Plate 87
Results Analysis 87
Fluorescence Liquid Tests 88
Test Methods 88
Gen5 Protocol Parameters 88
Results Analysis 98
Corners Test 98
Sensitivity Test 98
Linearity Test 99
Fluorescence Polarization (FP) Test 99
Time-Resolved Fluorescence (TRF) Test 100
Troubleshooting 101
Injection System Testing 102
Test Method 102
Gen5 Parameters 102
Results Analysis 105
Instrument Qualification Procedures 107
Overview 108
IQ/OQ/PQ Description 109
Recommended Qualification Schedule 110
System Test 111
Setup 111
Test Procedure 111
Absorbance Plate Tests 112
Requirements 112
Setup 112
Test Procedure 113
Absorbance Liquid Tests 114
Absorbance Liquid Test 1 114
Materials 114
Solution A 114
Solution B 115
Test Procedure 115
Absorbance Liquid Test 2 116
Materials 116
Test Procedure 116
Synergy H1 Operator's Manual
Contents | vii

Absorbance Liquid Test 3 117
Materials 117
Buffer Solution 117
Test Procedure 118
Luminescence Test 119
Requirements 119
Test Procedure 119
Fluorescence Plate Tests 120
Requirements 120
Test Procedure 120
Fluorescence Liquid Tests 121
Materials 121
All tests: 121
Corners/Sensitivity/Linearity (FI) Tests: 123
Fluorescence Polarization (FP) Test: 123
Time-Resolved Fluorescence (TRF) Test: 124
Test Solutions 124
Corners/Sensitivity/Linearity (FI) Tests: 124
Fluorescence Polarization (FP) Test: 125
Time-Resolved Fluorescence (TRF) Test: 125
Test Procedure 126
Pipette Maps 127
Corners, Sensitivity, and Linearity (FI) Tests: 127
Fluorescence Polarization (FP) Test: 128
Time-Resolved Fluorescence (TRF) Test: 129
Alternate/Supplemental Tests Using Methylumbelliferone (MUB) 130
Materials 130
Test Solutions 131
Test Procedure 132
Pipette Map 133
Injection System Tests 134
Materials 134
Alternate Test Solutions 135
Test Procedure for Models with Absorbance Capability 135
Test Procedure for Models without Absorbance Capability 137
Specifications 139
General Specifications 140
Microplates 140
BioTek Instruments, Inc.
viii | Preface

Hardware and Environmental 140
Absorbance Specifications 141
Optics 141
Performance 141
Accuracy 141
Linearity 141
Repeatability 142
Fluorescence Specifications 142
Monochromator-Based Fluorescence 142
Performance 142
Filter-Based Fluorescence 143
Fluorescence Intensity 143
Time-Resolved Fluorescence 143
Fluorescence Polarization 143
Luminescence Specifications 143
Dispense/Read Specifications 144
Error Codes 145
Overview 146
Error Codes 147
Instrument Dimensions for Robotic Interface 151
Sample Reports 155
Synergy H1 Operator's Manual
Contents | ix

Contact Information
BioTek®Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
Global Service and Support
BioTek product service and repair is available worldwide at one of BioTek's International
Service Centers and in the field at your location. To arrange for service or repair, contact
the office nearest you; visit www.biotek.com for up-to-date contact information. For
customer service, sales, and technical assistance, refer to the information below.
Customer Service and Sales
Internet: www.biotek.com
Phone: [phone] (toll-free in the U.S.) or 802-655-4740 (outside the U.S.)
Fax: [phone]
Email: [e-mail]
Service/Technical Assistance Center (TAC)
Phone: [phone] (toll free in the U.S.) or 802-655-4740 (outside the U.S.)
Fax: [phone]
E-Mail: [e-mail]
European Coordination Center/Authorized European Representative
BioTek®Instruments GmbH
Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany
Internet: www.biotek.de
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
BioTek Instruments, Inc.
x | Preface

Revision History
Rev Date Changes
A 11/2010 First issue
B 8/2011 General: Updated instructions for new Gen5 version 2.x. Updated Absorbance
Plate Test information. Preface: Updated Intended Use Statement.
Chapter 1: Introduction: Updated Package Contents to remove wrench, plugs,
clip, and storage bag; added screwdriver. Added Take3Trio Micro-Volume
plate to list of supported plates and Optional Accessories. Updated Solutions
for Liquid Tests in Optional Accessories.
Chapter 4: Filter and Mirrors: Figure 2, corrected the caption by reversing the
“EM” and “EX” filter designations.
Chapter 7: Instrument Qualification: Updated Absorbance Plate Test
definition instructions to support the Erbium glass filter in location C6.
Updated Fluorescence Liquid Test information to include pre-configured TRF
filter cube.
Appendix A: Specifications: Corrected Incubation specification.
C 11/2011 Chapter 2: Installation: Updated the Carrier Shipping Bracket photo in Figure
1. Updated the BioTek part number for the shipping hardware. Updated the
Dispense Module installation instructions.
Chapter 7: Instrument Qualification: For the Absorbance Plate Test, removed
the restriction on the use of the peak closest to 243 nm for the Erbium glass
(any peak may be used). In the Fluorescence Liquid Tests section, for the
Corners/Sensitivity/Linearity tests, added information on Sodium Fluorescein
Kit, BioTek PN 7160013.
Chapter 9: Specifications: Clarified the test methods used for Absorbance
performance and incubation temperature.
D 5/2012 Preface: Updated the Intended Use Statement and the heading for the In
Vitro Diagnostics directive to refer to the instrument’s IVD label (if one
exists). Added ‘Service’ and ‘Accessories’ hazard warnings. Added ‘Spare
Parts’ precaution. Added warning to have two people lift and carry the
instrument.
Chapter 1, Introduction: Corrected the power supply part number. Added
support for the gas controller.
Chapter 3, Getting Started: Added gas controller modules. Updated the
chemical compatibility table for the dispense module.
Appendix B, Error Codes: Added new information to the “Description and
Possible Remedy” sections for several codes.
E 9/2012 Preface: Added EN 61010-2-010 to Directive 2006/95/EC.
Synergy H1 Operator's Manual
Revision History | xi

Rev Date Changes
Section 1, Introduction: Added information on patent for dual light path
capability.
Appendix A, Specifications: Updated flash lamp specifications.
F 10/2013 Preface: Updated contact information to include global information.
Chapter 1, Introduction: Added information about the incubation gradient.
Chapter 3, Getting Started: Added the workarounds for kinetic assays with
continuous shake.
Chapter 4, Filters and Mirrors: Added a note that the polarizer filters are
keyed to fit in the correct alignment in the filter cube.
Chapter 7, Instrument Qualification: Added “filter-based” to TRF descriptions.
Appendix A, Specifications: Added information about the incubation gradient.
G 3/2014 Chapter 4, Filters and Mirrors: Add photos to procedure for installing the filter
cube; added a table of mirrors with their wavelength ranges.
H 10/2014 General: Updated references to USB drivers to state that they now reside on
the Gen5 software media. Removed statements that the serial numbers must
match between the reader and dispense module. Changed 'RMA' to 'service
authorization number'.
Chapter 2, Installation: Added a new step 13 to verify/set dispenser
calibration values.
Chapter 3, Getting Started: Added a note stating that the workarounds for
kinetic assays with continuous shake apply to Synergy H1 basecode software
versions lower than 2.00 (the issue was addressed in v2.00).
Chapter 7, Instrument Qualification: Corrected the PN for the pre-configured
qualification TRF filter cube (8040555). Under ‘Harta Plate Test’: updated
instructions for checking the test plate’s battery; changed the location of the
buffer wells in the [filter-based] plate layout (from E1-H4 to D1-G4) and
added a note regarding these wells for the monochromator-based test (F1-
G12); updated the attomole conversion and battery check formulas. Under
‘Glowell Test’, revised the radiant flux correction formula.
I 4/2015 Preface, Contact Information: To reduce the risk of providing outdated
contact information for BioTek’s offices worldwide, replaced the former
detailed information for every location with a simpler instruction to visit
www.biotek.com for the most up-to-date information. CE Mark: Updated
Directive headings. Notices: Remove trademark information for Kalrez and
Glowell.
Chapter 3, Getting Started: To ‘Recommendations for Optimum Performance’
added information on the use of acids, corrosives, and solvents.
Chapter 7, Instrument Qualification, Luminescence Test: Removed the
Glowell Test procedure. In the Gen5 [Harta] protocol parameters tables,
changed the Dynamic Range for the Battery Check read steps to Extended.
BioTek Instruments, Inc.
xii | Preface

Rev Date Changes
J 10/2015 Preface, CEMark section: Updated Directive headings.
Chapter 2, Installation, removed former step 3 "Unpack and Inspect the Gas
Controller" (the user is now referred to the Gas Controller User Guide).
Chapter 3, Getting Started, clarified that most models ship with a filter cube
installed, and the reader's internal software is configured for that cube. If the
cube is modified or replaced, the software must be updated accordingly. In
the Gen5 Software section, enhanced instructions for updating the Gen5 Filter
Cube table. Added information on the reader's plate shaking capabilities.
Created a new Chapter 7, Instrument Qualification Process to describe the
tests designed to qualify the Synergy H1. Added Gen5 protocol parameters
tables for Absorbance Testing. Renamed the former Chapter 7, Instrument
Qualification as Chapter 8, Instrument Qualification Procedures and moved
the description content to the aforementioned new chapter.
For the Injection System Tests, corrected the volume of water that is
manually pipetted on top of the green test dye solution just prior to the plate
read (changed from 200 µL/well to 150 µL).
Added information for purchasing and using the BioTek 340 nm Absorbance
Test Plate (BTI #7260551).
K 5/2016 Added information on using the BioTek Fluorescence Test Plate to qualify the
Synergy H1 fluorescence system. Updated the Fluorescence Intensity and
TRF liquid tests to utilize a single concentration well and median buffer well
when determining the detection limit.
Synergy H1 Operator's Manual
Revision History | xiii

Document Conventions
This icon identifies information that protects the safety of the operator
and the integrity of data.
Warning! AWarning indicates the potential for bodily harm and tells you how to
avoid the problem.
Caution ACaution indicates the potential for damage to the instrument and tells
you how to avoid the problem.
Note: Bold text is primarily used for emphasis.
This icon calls attention to important information.
This style calls attention to usage instructions and helpful facts. For example, "Refer to
Figure 2-3 when performing these steps" and "Part numbers are subject to change."
Topics that apply only to specific reader models are presented in this style. For
example, "Applies only to models equipped with injectors."
Intended Use Statement
The Synergy H1 is a hybrid multi-mode microplate reader. The performance
characteristics of the data reduction software have not been established with any
laboratory diagnostic assay. The user must evaluate this instrument and PC-based
software in conjunction with their specific assay(s). This evaluation must include the
confirmation that performance characteristics for the specific assay(s) are met.
If the instrument has an “IVD” label it may be used for clinical and nonclinical purposes,
including research and development. If there is no such label the instrument may be
used only for research and development or other nonclinical purposes.
BioTek Instruments, Inc.
xiv | Preface

Quality Control
It is considered good laboratory practice to run laboratory samples according to instruc-
tions and specific recommendations included in the assay package insert for the test to be
conducted. Failure to conduct Quality Control checks could result in erroneous test data.
Warranty and Product Registration
Take a moment to review the Warranty information that shipped with your product. Please
also register your product with BioTek to ensure that you receive important information
and updates about the product(s) you have purchased. Register online through the
Customer Resource Center at www.biotek.com or call [phone] or [phone].
Repackaging and Shipping
If you need to ship the instrument to BioTek for service or repair, contact
BioTek for a Service Call Notice (SCN) number, and be sure to use the
original packing materials. Other forms of commercially available
packaging are not recommended and can void the warranty. If the
original packing materials have been damaged or lost, contact BioTek for
replacement packing.
Synergy H1 Operator's Manual
Quality Control | xv

Warnings
Operate the instrument on a level, stable surface away from excessive
humidity.
Bright sunlight or strong incandescent light can reduce the linear performance
range of the instrument.
Measurement values may be affected by extraneous particles (such as dust) in
the microplate wells. A clean work area is necessary to ensure accurate
readings.
When operated in a safe environment according to the instructions in this
document, there are no known hazards associated with the instrument.
However, the operator should be aware of certain situations that could result
in serious injury; these vary depending on the instrument type. See Hazards
and Precautions.
Hazards
The following hazard warnings are provided to help avoid injury:
Warning! Power Rating. The instrument’s power supply or power cord must
be connected to a power receptacle that provides voltage and current within
the specified rating for the system. Use of an incompatible power receptacle
may produce electrical shock and fire hazards.
Warning! Electrical Grounding. Never use a plug adapter to connect
primary power to the external power supply. Use of an adapter disconnects
the utility ground, creating a severe shock hazard. Always connect the power
cord directly to an appropriate receptacle with a functional ground.
Warning! Service. Only qualified technical personnel should perform service
procedures on internal components.
Warning! Accessories. Only accessories that meet the manufacturer’s
specifications shall be used with the instrument.
Warning! The instrument with all available modules weighs up to 55 pounds
(24.95 kg). Use two people when lifting and carrying the instrument.
BioTek Instruments, Inc.
xvi | Preface

Warning! Liquids. Avoid spilling liquids on the instrument; fluid seepage into
internal components creates a potential for shock hazard or instrument
damage. If a spill occurs while a program is running, abort the program and
turn the instrument off. Wipe up all spills immediately. Do not operate the
instrument if internal components have been exposed to fluid; contact BioTek
TAC.
Warning! Unspecified Use. Failure to operate the equipment according to
the guidelines and safeguards specified in this manual could result in a
hazardous condition.
Warning! Software Quality Control. The operator must follow the
manufacturer’s assay package insert when modifying software parameters
and establishing reading or dispensing methods. Failure to conduct quality
control checks could result in erroneous test data.
Warning! Reader Data Reduction Protocol. No limits are applied to the
raw measurement data. All information exported via computer control must
be thoroughly analyzed by the operator.
Warning! Internal Voltage. Always turn off the power switch and unplug
the power supply before cleaning the outer surface of the instrument.
Warning! Potential Biohazards. Some assays or specimens may pose a
biohazard. This hazard is noted by the symbol shown here. Adequate safety
precautions should be taken as outlined in the assay’s package insert. Always
wear safety glasses and appropriate protective equipment, such as chemically
resistant rubber gloves and apron.
Warning! Pinch Hazard. Some areas of the dispense module can present
pinch hazards when the instrument is operating. The module is marked with
the symbol shown here. Keep hands and fingers clear of these areas when the
instrument is operating.
Precautions
The following precautions are provided to help avoid damage to the instrument.
Caution: Service. The instrument should be serviced by BioTek-authorized
personnel. Only qualified technical personnel should perform troubleshooting
and service procedures on internal components.
Caution: Spare Parts. Only approved spare parts should be used for
maintenance. The use of unapproved spare parts and accessories may result
in a loss of warranty and potentially impair instrument performance or cause
damage to the instrument.
Synergy H1 Operator's Manual
Precautions | xvii

Caution: Environmental Conditions. Do not expose the instrument to
temperature extremes. For proper operation, ambient temperatures should
remain within the range listed in the Specifications chapter. Performance
may be adversely affected if temperatures fluctuate above or below this
range. Storage temperature limits are broader.
Caution: Sodium Hypochlorite. Do not expose any part of the instrument
to the recommended diluted sodium hypochlorite solution (bleach) for more
than 20 minutes. Prolonged contact may damage the instrument surfaces. Be
certain to rinse and thoroughly wipe all surfaces.
Caution: Power Supply. Use only the power supply shipped with the
instrument, and operate it within the range of line voltages listed on it.
Caution: Disposal. Dispose of the instrument according to Directive
2012/19/EU, “on waste electrical and electronic equipment (WEEE),” or local
ordinances.
Caution: Warranty. Failure to follow preventive maintenance procedures
may void the warranty.
Caution: Shipping Hardware. All shipping hardware (e.g., carrier shipping
screw, filter reader shipping bracket) must be removed before operating the
instrument and reinstalled before repackaging the instrument for shipment.
Caution: Electromagnetic Environment. Per EN 61326-2-6 it is the user’s
responsibility to ensure that a compatible electromagnetic environment for
this instrument is provided and maintained in order that the device will
perform as intended.
Caution: Electromagnetic Compatibility. Do not use this device in close
proximity to sources of strong electromagnetic radiation (e.g., unshielded
intentional RF sources), because these may interfere with the proper
operation.
BioTek Instruments, Inc.
xviii | Preface