Biotek Synergy H1 Operator's Manual

Operator’s Manual

Hybrid Multi-Mode Microplate Reader

Synergy

™

H1

Synergy H1™

Hybrid Multi-Mode Microplate Reader
Operator’s Manual

March 2014
© 2014
Part Number 8041000
Revision G
BioTek® Instruments, Inc.

ii | Notices

Notices

BioTek® Instruments, Inc.

Highland Park, P.O. Box 998

Winooski, Vermont 05404-0998 USA

All Rights Reserved

© 2014, 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™ H1, Gen5™, BioStack™, and
Take3™ and Take3Trio™ Micro-Volume Plates are trademarks of BioTek Instruments,
Inc. Harta™ is a trademark of Harta Instruments. Glowell™ is a trademark of LUX
Biotechnology, Ltd.

Microsoft

®

, Windows®, and Excel® are either registered trademarks or trademarks of

Microsoft Corporation in the United States and/or other countries.

®

Kalrez

is a registered trademark of DuPont Performance Elastomers, L.L.C. (DPE).

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.

Contents

Global Service and Support ................................................................ v

Revision History ............................................................................. vii

Document Conventions .................................................................... ix

Intended Use Statement .................................................................. ix

Quality Control ................................................................................ x

Warranty and Product Registration ..................................................... x

Repackaging and Shipping ................................................................. x

Warnings ........................................................................................ x

Hazards ......................................................................................... xi

Precautions ................................................................................... xii

CE Mark ....................................................................................... xiii

Electromagnetic Interference and Susceptibility ................................. xiv

User Safety ................................................................................... xv

Safety Symbols ............................................................................. xvi

Introduction ........................................................................................ 1

Product Description ......................................................................... 2

Package Contents & Accessories ........................................................ 3

Optional Accessories ........................................................................ 4

Product Support & Service ................................................................ 6

0BInstallation ......................................................................................... 7

Product Registration ........................................................................ 8

Important Information ..................................................................... 8

1: Unpack and Inspect the Reader ..................................................... 9

2: Unpack and Inspect the Dispense Module ...................................... 10

3: Unpack and Inspect the Gas Controller .......................................... 11

4: Select an Appropriate Location ..................................................... 11

5: Remove the Shipping Hardware .................................................... 12

6: Install the Power Supply .............................................................. 13

7: Connect the Gas Controller .......................................................... 13

8: Install the Dispense Module ......................................................... 13

9: Connect the Host Computer ......................................................... 17

10: Install Gen5 on the Host Computer ............................................. 18

11: Turn on the Reader ................................................................... 18

12: Establish Communication ........................................................... 18

13: Run a System Test ................................................................... 19

14: Test the Injector System ........................................................... 20

Operational/Performance Qualification ............................................... 22

Repackaging and Shipping Instructions ............................................. 22

Getting Started .................................................................................. 29

Modular Design .............................................................................. 30

External Components ...................................................................... 31

Internal Components ...................................................................... 31

Contents | iii

Synergy H1 Operator’s Manual

iv | Contents

Gen5 Software ............................................................................... 36

Recommendations for Optimum Performance ..................................... 39

Filters and Mirrors ............................................................................. 43

Filter Cube Overview ...................................................................... 44

Filters and Mirrors .......................................................................... 48

Preventive Maintenance .................................................................... 53

Preventive Maintenance .................................................................. 54

Warnings and Precautions ............................................................... 55

Clean Exposed Surfaces .................................................................. 56

Inspect/Clean Excitation and Emission Filters ..................................... 57

Inspect/Clean Mirrors ..................................................................... 58

Flush/Purge the Fluid Path ............................................................... 60

Run a Dispense Protocol (Optional) ................................................... 61

Empty/Clean the Tip Priming Trough ................................................. 62

Clean the Priming Plate ................................................................... 62

Clean the Dispense Tubes and Injectors ............................................ 63

As-Needed Maintenance .................................................................... 65

Decontamination ............................................................................ 66

Dispense Module: Syringe Replacement ............................................. 72

0BInstrument Qualification ................................................................... 75

Overview ...................................................................................... 77

IQ/OQ/PQ ..................................................................................... 77

Recommended Qualification Schedule ............................................... 78

System Test .................................................................................. 79

Absorbance Plate Test ..................................................................... 85

Absorbance Liquid Tests .................................................................. 91

Fluorescence Liquid Tests ................................................................ 99

Luminescence Test ....................................................................... 122

Dispense Module Tests .................................................................. 129

Specifications .................................................................................. 141

General Specifications ................................................................... 142

Absorbance Specifications ............................................................. 144

Dispense/Read Specifications ......................................................... 145

Fluorescence Specifications (Mono-Based) ....................................... 145

Fluorescence Specifications (Filter-Based) ........................................ 146

Luminescence Specifications .......................................................... 147

Error Codes ..................................................................................... 149

Overview .................................................................................... 150

Error Codes ................................................................................. 151

Instrument Dimensions for Robotic Interface ................................. 155

BioTek Instruments, Inc.

Global Service and Support | v

Mailing Address:

Winooski, VT 05404

Room 304, Tower D

Phone: [phone]

Phone: [phone]

Email: [e-mail]
Website: www.biotek.com

Email: [e-mail]
Website: www.biotekchina.com.cn

Kocherwaldstrasse 34 D-74177

Germany

50 avenue d'Alsace

France

Phone: [phone]
Fax: [phone]

Phone: [phone]
Fax: [phone]

Email: [e-mail]
Website: www.biotek.de

Email: [e-mail]
Website: www.biotek.fr

BioTek India

BioTek Singapore

Unit 223, Linkway Estate

India

20 Science Park Road #01-08A

Phone: [phone]
Fax: [phone]

Phone: [phone]
Fax: [phone]

Email: [e-mail]
Website: www.biotek.in

Email: [e-mail]
Website: www.biotek.com

Global Service and Support

 See also Product Support & Service on page 6.

BioTek instrument service and repair is available worldwide at one of BioTek's
International Service Centers and in the field at your location. For technical assistance,
contact the Technical Assistance Center (TAC) at BioTek World Headquarters US. To
arrange for service or repair of your instrument, contact the office nearest you.

BioTek World Headquarters US BioTek China

PO Box 998, Highland Park
Winooski, VT 05404-0998
United States
Service Shipping Address:
15 Tigan Street

Outside US: [phone]
Fax: [phone]

BioTek Germany Service Center &
European Coordination Center

Bad Friedrichshall

Ocean International Center
62 Middle 4th East Ring Road
Chaoyang District
Beijing 100025
P.R. China

Fax: [phone]

BioTek Instruments SAS
Bureau de liaison France

68025 Colmar Cedex

New Link Road, Malad West
Mumbai 400064

Synergy H1 Operator’s Manual

Teletech Park
Singapore 117674

vi | Global Service and Support

3F, Gyungnam building, 830-48

Seoul, South Korea (135-936)

Zentrum Fanhöfli 8

Switzerland

Phone: [phone]
Fax: [phone]

Phone: [phone]
Fax: [phone]

Email: [e-mail]
Website: www.biotekinstruments.co.kr

Email: [e-mail]
Website: www.biotek.ch

6 Bull Street

United Kingdom

Phone: [phone]
Fax: [phone]

Email: [e-mail]
Website: www.biotek.uk.com

BioTek South Korea BioTek Switzerland

Yeoksam-dong, Gangnam-gu

BioTek United Kingdom (UK)

Potton, Bedfordshire SG19 2NR

6014 Luzern

BioTek Instruments, Inc.

Revision History | vii

Chapter 1, Introduction: Added information about the incubation

Revision History

Rev Date Changes

A 11/10 Initial release

B 8/11

C 11/11

D 5/12

E 9/12 Preface: Added EN 61010-2-010 to Directive 2006/95/EC.

F 10/13 Preface: Updated contact information to include global information.

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 pre­configured TRF filter cube.

Appendix A: Specifications: Corrected Incubation specification.

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.

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.

Section 1, Introduction: Added information on patent for dual light
path capability.

Appendix A, Specifications: Updated flash lamp specifications.

Synergy H1 Operator’s Manual

viii | Revision History

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.

BioTek Instruments, Inc.

Document Conventions

See also Safety Symbols on page xvi.

This icon calls attention to important safety notes.

Document Conventions | ix

Warning!

Caution

Note:

italic



A Warning indicates the potential for bodily harm and
tells you how to avoid the problem.

A Caution indicates potential damage to the instrument
and tells you how to avoid the problem.

Bold text is primarily used for emphasis.

Topics that apply only to specific Synergy H1 models are
preceded by a notice in italics, for example: Applies only to
Synergy H1 models with injectors.

This icon calls attention to important information.

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 non-clinical
purposes, including research & development. If there is no such label the
instrument may only be used for research and development or other non-clinical
purposes.

Synergy H1 Operator’s Manual

x | Quality Control

Precautions.

Quality Control

It is considered good laboratory practice to run laboratory samples according to
instructions 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. You can register online
through the Customer Resource Center (CRC) at www.biotek.com or by calling 888-451­5171 or 802-655-4740.

Repackaging and Shipping

If you need to ship the instrument to BioTek for service or repair,



contact BioTek for a Return Materials Authorization (RMA)
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.

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 may vary depending on the instrument type. See

Hazards and

BioTek Instruments, Inc.

Hazards

Warning! Internal Voltage. Always turn off the power switch and unplug the

case.

shock and fire hazards.

appropriate receptacle with a functional ground.

procedures on internal components.

shall be used with the instrument.

kg). Use two people when lifting and carrying the instrument.

components have been exposed to fluid. Contact BioTek TAC for assistance.

condition.

data.

analyzed by the operator.

appropriate protective equipment, such as chemical-resistant rubber gloves and apron.

The following hazard warnings are provided to help avoid injury:

power supply before cleaning the outer surface of the instrument or removing its top

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

Hazards | xi

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

Warning! Service. Only qualified technical personnel should perform service

Warning! Accessories. Only accessories that meet the manufacturer’s specifications

Warning! The instrument with all available modules weighs up to 55 pounds (24.95

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

Warning! Unspecified Use. Failure to operate the equipment according to the

guidelines and safeguards specified in this manual could result in a hazardous

Warning! Software Quality Control. The operator must follow the manufacturer’s

assay package insert when modifying software parameters and establishing reading
methods. Failure to conduct quality control checks could result in erroneous test

Warning! Reader Data Reduction Protocol. No limits are applied to the raw

measurement data. All information exported via computer control must be thoroughly

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

Synergy H1 Operator’s Manual

xii | Precautions

operating.

service procedures on internal components.

potentially impair instrument performance or cause damage to the instrument

broader. .

thoroughly wipe all surfaces.

within the range of line voltages listed on it.

electrical and electronic equipment (WEEE)” or local ordinances.

the warranty.

reinstalled before repackaging the instrument for shipment.

intended.

because these may interfere with the proper operation.

Warning! Pinch Hazard. Some areas of the dispense module can present pinch

hazards when the instrument is operating. The module is marked with one of the
symbols shown here. Keep hands/fingers clear of these areas when the instrument is

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

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

Caution: Environmental Conditions. Do not expose the system to temperature

extremes. For proper operation, ambient temperatures should remain within the range
listed in the
temperatures fluctuate above or below this range. Storage temperature limits are

Specifications section. Performance may be adversely affected if

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

Caution: Power Supply. Use only the power supply shipped with the instrument

Caution: Disposal. This instrument contains printed circuit boards and wiring with

lead solder. Dispose of the instrument according to Directive 2002/96/EC, “on waste

Caution: Warranty. Failure to follow preventive maintenance procedures may void

Caution: Shipping Hardware. All shipping hardware (e.g., carrier shipping screw,

filter reader shipping bracket) must be removed before operating the instrument and

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

Caution: Electromagnetic Compatibility. Do not use this device in close proximity

to sources of strong electromagnetic radiation (e.g., unshielded intentional RF sources),

BioTek Instruments, Inc.

CE Mark

Based on the testing described below and information
contained herein, this instrument bears the CE mark.

 See the Declaration of Conformity for more specific information.

Directive 2004/108/EC: Electromagnetic Compatibility

Emissions—CLASS A

The system has been type-tested by an independent, accredited testing laboratory
and found to meet the requirements of EN 61326-1: Class A for Radiated Emissions
and Line Conducted Emissions.

Verification of compliance was conducted to the limits and methods of EN 55011–
(CISPR 11) Class A. In a domestic environment it may cause radio interference, in
which case you may need to mitigate the interference.

CE Mark | xiii

Immunity

The system has been type-tested by an independent, accredited testing laboratory
and found to meet the requirements of EN 61326-1 and EN 61326-2-6 for Immunity.
Verification of compliance was conducted to the limits and methods of the
following:

EN 61000-4-2, Electrostatic Discharge
EN 61000-4-3, Radiated EM Fields
EN 61000-4-4, Electrical Fast Transient/Burst
EN 61000-4-5, Surge Immunity
EN 61000-4-6, Conducted Disturbances from RFI
EN 61000-4-11, Voltage Dips, Short Interruptions and Variations

Directive 2006/95/EC Low Voltage (Safety)

The system has been type-tested by an independent testing laboratory and was found
to meet the requirements of this Directive. Verification of compliance was conducted to
the limits and methods of the following:

EN 61010-1, “Safety requirement for electrical equipment for measurement, control and
laboratory use. Part 1, General requirements.”

EN 61010-2-081, “Requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes.”

EN 61010-2-010, “Particular requirements for laboratory equipment for the heating of
materials.”

Synergy H1 Operator’s Manual

xiv | Electromagnetic Interference and Susceptibility

Directive 2002/96/EC: Waste Electrical and Electronic Equipment

Disposal Notice: This instrument contains printed circuit boards and wiring with lead
solder. Dispose of the instrument according to Directive 2002/96/EC, “on waste
electrical and electronic equipment (WEEE)” or local ordinances.

Directive 98/79/EC: In Vitro Diagnostics (if labeled for this use)

• Product registration with competent authorities

• Traceability to the U.S. National Institute of Standards and Technology (NIST).

• EN 61010-2-101, “Particular requirements for in vitro diagnostic (IVD) medical

equipment.”

Electromagnetic Interference and Susceptibility

USA FCC CLASS A

RADIO AND TELEVISION INTERFERENCE

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
instruction 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 the user will be required to correct the interference at their own expense.

In order to maintain compliance with FCC regulations shielded cables must be used
with this equipment. Operation with non-approved equipment or unshielded cables is
likely to result in interference to radio and television reception.

Canadian Department of Communications Class A

This digital apparatus does not exceed Class A limits for radio emissions from digital
apparatus set out in the Radio Interference Regulations of the Canadian Department of
Communications.

Le present appareil numerique n'émet pas de bruits radioélectriques depassant les
limites applicables aux appareils numérique de la Class A prescrites dans le Réglement
sur le brouillage radioélectrique édicté par le ministère des Communications du
Canada.

BioTek Instruments, Inc.

User Safety

This device has been type-tested by an independent laboratory and found to meet the
requirements of the following:

• Underwriters Laboratories UL 61010-1, “Safety requirements for electrical

equipment for measurement, control and laboratory use; Part 1: general
requirements.”

• Canadian Standards Association CAN/CSA C22.2 No. 61010-1, “Safety

requirements for electrical equipment for measurement, control and laboratory
use; Part 1: general requirements.”

User Safety | xv

• EN 61010 standards, see

CE Mark starting on page xiii.

Synergy H1 Operator’s Manual

xvi | Safety Symbols

Safety Symbols

Some of these symbols may appear on the instrument or accessories:

Alternating current
Courant alternatif
Wechselstrom
Corriente alterna
Corrente alternata

Direct current
Courant continu
Gleichstrom
Corriente continua
Corrente continua

On (Supply)
Marche (alimentation)
Ein (Verbindung mit dem Netz)
Conectado
Chiuso

Off (Supply)
Arrêt (alimentation)
Aus (Trennung vom Netz)
Desconectado
Aperto (sconnessione dalla

rete di alimentazione)

Both direct and alternating current
Courant continu et courant alternatif
Gleich - und Wechselstrom
Corriente continua y corriente alterna
Corrente continua e corrente alternata

Earth ground terminal
Borne de terre
Erde (Betriebserde)
Borne de tierra
Terra (di funzionamento)

Protective conductor terminal
Borne de terre de protection
Schutzleiteranschluss
Borne de tierra de protección
Terra di protezione

Caution (refer to accompanying documents)
Attention (voir documents

d’accompanement)
Achtung siehe Begleitpapiere
Atención (vease los documentos incluidos)
Attenzione, consultare la doc annessa

Warning, risk of electric shock
Attention, risque de choc

électrique
Gefährliche elektrische schlag
Precaución, riesgo de sacudida

eléctrica
Attenzione, rischio di scossa

elettrica

Warning, hot surface
Attention, surface chaude
Warnen, heiße Oberfläche
Precaución, superficie caliente
Attenzione, superficie calda

Warning, risk of crushing or pinching
Attention, risque d’écrasement et

pincement
Warnen, Gefahr des Zerquetschens und

Klemmen
Precaución, riesgo del machacamiento y

sejeción
Attenzione, rischio di schiacciare ed

intrappolarsi

Warning, potential biohazards
Attention, risques biologiques potentiels
Warnung! Moegliche biologische Giftstoffe
Atención, riesgos biológicos
Attenzione, rischio biologico

BioTek Instruments, Inc.

Safety Symbols | xvii

In vitro diagnostic medical
device

Dispositif médical de
diagnostic in vitro

Medizinisches In-Vitro­Diagnostikum

Dispositivo médico de
diagnóstico in vitro

Dispositivo medico diagnostico
in vitro

Consult instructions for use
Consulter la notice d’emploi
Gebrauchsanweisung beachten
Consultar las instrucciones de

uso
Consultare le istruzioni per uso

Separate collection for electrical and
electronic equipment

Les équipements électriques et
électroniques font l’objet d’une collecte
sélective

Getrennte Sammlung von Elektro- und
Elektronikgeräten

Recogida selectiva de aparatos eléctricos y
electrónicos

Raccolta separata delle apparecchiature
elettriche ed elettroniche

Laser radiation: Do not stare into beam
Rayonnement laser: Ne pas regarder dans

le faisceau
Laserstrahlung: Nicht in den strahl blicken
Radiación de láser: No mire fijamente al

rayo
Radiazione di laser: Non stare nel fascio

Synergy H1 Operator’s Manual