Biotek Epoch Operator's Manual

Operator’s Manual
Microplate Spectrophotometer
Epoch
Epoch™ Microplate Spectrophotometer
Operator's Manual
August 2009 © 2009 Part Number 7201000 Revision A BioTek® Instruments, Inc.
ii | Preface

Notices

BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2009, 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 Epoch™, Gen5™, and Take3™ are trademarks of BioTek Instruments, Inc. BioCell™ is a trademark of BioTek Instruments and is patented under U.S. patent number 5,963,318.
Microsoft 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.
®
, Windows®, Windows XP, Windows 2000, and Windows Vista™ are
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 | iii

Contents

Notices ................................................................................................ ii
Contents ..............................................................................................iii
Contacting BioTek Instruments, Inc.......................................................... v
Revision History ................................................................................... vi
Document Conventions..........................................................................vii
Intended Use Statement....................................................................... viii
Quality Control.................................................................................... viii
Warranty and Product Registration ......................................................... viii
Warnings............................................................................................ viii
Hazards and Precautions........................................................................ ix
CE Mark .............................................................................................. xi
Electromagnetic Interference and Susceptibility ........................................xii
User Safety ........................................................................................ xiii
Safety Symbols ................................................................................... xiv
Introduction ...................................................................1
Product Description................................................................................ 2
Package Contents .................................................................................. 2
Optional Accessories .............................................................................. 3
Product Support & Service ...................................................................... 4
Installation.....................................................................5
Product Registration............................................................................... 6
1: Unpack and Inspect the Instrument...................................................... 6
2: Remove the Carrier Shipping Hardware................................................ 7
3: Select an Appropriate Location ........................................................... 8
4: Connect the Power Supply ................................................................. 9
5: Connect the Host Computer ............................................................... 9
6: Install the Software on the Host Computer ........................................... 9
7: Turn on the Reader ........................................................................... 9
Operational/Performance Qualification .................................................... 11
Repackaging and Shipping .................................................................... 11
Controlling Epoch Using Gen5 ......................................15
Overview............................................................................................ 16
Controlling the Reader with Gen5........................................................... 16
Instrument Qualification ..............................................19
Recommendations for Achieving Optimum Performance ............................ 20
Recommended Qualification Schedule..................................................... 21
Installation and Performance Qualification Procedures............................... 22
Absorbance Plate Test .......................................................................... 25
Liquid Testing ..................................................................................... 33
Epoch Operator’s Manual
iv | Preface
Preventive Maintenance ...............................................43
Overview............................................................................................ 44
Required Materials ............................................................................... 44
Warnings & Precautions ........................................................................ 45
Routine Cleaning Procedure .................................................................. 45
Decontamination ................................................................................. 46
Specifications ...............................................................49
General Specifications .......................................................................... 50
Read Specifications .............................................................................. 50
Optical Performance............................................................................. 52
Error Codes ..................................................................55
Overview............................................................................................ 56
General Errors..................................................................................... 57
Fatal Errors......................................................................................... 65
BioTek
®
Instruments, Inc.
Contacting BioTek Instruments, Inc. | v

Contacting BioTek Instruments, Inc.

BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA

Customer Service and Sales

Internet: www.biotek.com
Phone: 888-451-5171 (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: 802-655-7941
E-Mail: customercare@biotek.com

Service/TAC

Phone: 800-242-4685 (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: 802-654-0638
E-Mail: tac@biotek.com

European Coordination Center/Authorized European Representative

BioTek® Instruments GmbH
Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany
Internet: www.biotek.de
Phone: +49 (0) 7136 9680
Fax: +49 (0) 7136 968 111
E-Mail: info@biotek.de
Epoch Operator’s Manual
vi | Preface

Revision History

Revision Date Changes
A 8/2009 Initial release to Production
BioTek® Instruments, Inc.

Document Conventions

This manual uses the following typographic conventions:
Example Description
Document Conventions | vii
This icon calls attention to important
Warning!
Caution
Note
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.
text is primarily used for emphasis.
Bold
This icon calls attention to important information.
safety notes.
Epoch Operator’s Manual
viii | Preface

Intended Use Statement

The Epoch is a single-channel, automated, benchtop, general-purpose microplate monochromator that performs optical density measurements of samples in a microplate format. The user must evaluate this instrument with PC-based software in conjunction with the specific assay. This evaluation must include the confirmation that performance characteristics for the specific assay are met.
This system is designed for use with PC-based software only. BioTek Gen5 software will provide the user with instrument control and data reduction.
The intended use of this instrument is dependent on the instrument’s labeling. If there is an IVD label, then the instrument may be used for clinical, research and development, or other nonclinical purposes. If there is no such label, then the instrument may only be used for research and development, or for other nonclinical purposes.

Quality Control

It is considered good laboratory practice to run laboratory samples according to instructions and specific recommendations included in the package insert or standard laboratory protocol for the test to be conducted. Failure to conduct Quality Control checks could result in erroneous test data.

Warranty and Product Registration

Please 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 888/451-5171 or 802/655-4740.

Warnings

Operate the instrument on a level 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
BioTek® Instruments, Inc.
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 Precautions.

Hazards and Precautions

Hazards
The following hazards are provided to help avoid injury:
Hazards and Precautions | ix
Warning! Power Rating.
The instrument’s power supply 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 two-prong plug adapter to connect primary power to the external power supply. Use of a two-prong adapter disconnects the utility ground, creating a severe shock hazard. Always connect the power supply directly to an appropriate receptacle with a functional ground.
Warning! Internal Voltage.
the power supply before cleaning the outer surface of the instrument.
Warning! Potential Biohazards.
Always turn off the power switch and unplug
Some assays or specimens may pose a
biohazard. 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! Liquids.
internal components creates a potential for shock hazard or instrument
Avoid spilling liquids on the reader; fluid seepage into
damage. If a spill occurs while a program is running, abort the program and turn off the instrument. Wipe up all spills immediately. Do not operate the instrument if internal components have been exposed to fluid.
Warning! Unspecified Use.
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 methods.
checks could result in erroneous test data.
Warning! Reader Data Reduction Protocol. No limits are applied to the
raw absorbance data. All information exported via computer control must be thoroughly analyzed by the operator.
Epoch Operator’s Manual
Failure to operate this equipment according to
Failure to conduct quality control
x | Preface
Precautions
The following precautions are provided to help avoid damage to the instrument:
Caution: Service.
The instrument should be serviced by BioTek authorized service personnel. Only qualified technical personnel should perform troubleshooting and service procedures on internal components.
Caution: Environmental Conditions.
temperature extremes. For proper operation, ambient temperatures should
Do not expose the system to
remain within the range listed in Appendix A, Specifications. Performance may be adversely affected if temperatures fluctuate above or below this range. Storage temperature limits are broader.
Caution: Sodium Hypochlorite.
to the recommended diluted sodium hypochlorite solution (bleach) for more
Do not expose any part of the instrument
than 20 minutes. Prolonged contact may damage the instrument surfaces. Be certain to rinse and thoroughly wipe all surfaces.
Caution: External Power Supply.
with the instrument. Operate this power supply within the range of line voltages listed on it.
Caution: Carrier Shipping Bracket.
bracket must be removed before operating the instrument and reinstalled
Only use the power supply shipped
The microplate carrier shipping
before repackaging the instrument for shipment.
Caution: Disposal.
wiring with lead solder. Dispose of the instrument according to Directive
This instrument contains printed circuit boards and
2002/96/EC, “on waste electrical and electronic equipment (WEEE)” or local ordinances.
Caution: Warranty.
may
void the warranty. See Chapter 4, Maintenance for preventive
maintenance procedures.
Caution: Electromagnetic Environment.
responsibility to ensure that a compatible electromagnetic environment for
Failure to follow preventive maintenance protocols
Per IEC 61326-2-6 it is the user’s
this instrument is provided and maintained in order that the device will perform as intended.
Caution: Electromagnetic Compatibility.
proximity to sources of strong electromagnetic radiation (e.g., unshielded
Do not use this device in close
intentional RF sources), because these may interfere with the proper operation.
BioTek® Instruments, Inc.

CE Mark

Based on the testing described below and information contained herein, this instrument bears the CE mark.
Refer to the Declaration of Conformity for specific details.

DIRECTIVE 2003/108/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 and EN 61326-2-6: Class A for Radiated Emissions and Line Conducted Emissions.
CE Mark | xi
Verification of compliance was conducted to the limits and methods of EN 55011—CISPR 11). In a domestic environment it may cause radio interference, in which case you may need to mitigate the interference.
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 61326-2­6 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
Epoch Operator’s Manual
xii | Preface

Directive 73/23/EEC Low Voltage (Safety)

The system has been type-tested by an independent testing laboratory and was found to meet the requirements of EC Directive 73/23/EEC for Low Voltage. Verification of compliance was conducted to the limits and methods of the following:
EN 61010-1 (2001) 2
nd
Edition. “Safety requirement for electrical equipment for
measurement, control and laboratory use. Part 1, General requirements.”

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):
Optical density measurements are traceable to NIST.

Electromagnetic Interference and Susceptibility

USA FCC CLASS A
Changes or modifications to this unit not expressly approved by the
manufacturer could void the user's authority to operate the equipment.
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. Like all similar equipment, 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 interference, in which case the user will be required to correct the interference at his own expense.
BioTek® Instruments, Inc.
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'met pas du bruits radioelectriques depassant les limites applicables aux appareils numerique de la Class A prescrites dans le Reglement sur le brouillage radioelectrique edicte par le ministere des Communications du Canada.

User Safety

This device has been type-tested by an independent laboratory and found to meet the requirements of the following:
North America
User Safety | xiii
Underwriters Laboratories UL 61010-1, 2001
“Safety requirements for electrical equipment for measurement, control and laboratory use; Part 1: general requirements”
Canadian Standards Association CAN/CSA C22.2 No. 61010-1-04
“Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use; Part 1: General Requirements”
For International User Safety requirements, see CE Mark on page xi.
Epoch Operator’s Manual
xiv | Preface

Safety Symbols

Some of the following symbols may appear on the instrument:
Alternating current
Courant alternatif Wechselstrom Corriente alterna Corrente alternata
Direct current
Courant continu Gleichstrom Corriente continua Corrente continua
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
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)
BioTek® Instruments, Inc.
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, 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, hot surface
Attention, surface chaude Warnen, heiße Oberfläche Precaución, superficie caliente Attenzione, superficie calda
Safety Symbols | xv
Consult instructions for use
Consulter la notice d’emploi Gebrauchsanweisung beachten Consultar las instrucciones de uso Consultare le istruzioni per uso
In vitro diagnostic medical device
Dispositif médical de diagnostic in vitro Medizinisches In-Vitro-Diagnostikum Dispositivo médico de diagnóstico in vitro Dispositivo medico diagnostico in vitro
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
Epoch Operator’s Manual
xvi | Preface
BioTek
®
Instruments, Inc.
Chapter 1
Introduction
This chapter introduces the Epoch and describes its hardware and software features, and technical specifications. Instructions on how to contact BioTek for Product Support & Service are included on page 4.
Product Description.............................................................. 2
Package Contents ................................................................ 2
Optional Accessories ............................................................ 3
Product Support & Service .................................................... 4
Contacting the Technical Assistance Center ........................... 4
Returning Instruments for Service/Repair.............................. 4
2 | Chapter 1: Introduction

Product Description

Powerful, versatile, and compact, the Epoch monochromator offers tunable wavelength selection and wavelength scanning without the need for interference filters. The single-channel reader is completely computer controlled via BioTek’s intuitive and user-friendly Gen5 software. Its key features include the following:
A variety of read modes including endpoint, kinetic, multiwavelength, and spectral scanning.
A monochromator for continuous wavelength selection from 200 to 999 nm in 1-nm increments, and a xenon flash lamp for both UV and visible light absorbance measurements.
Superior optical specifications, with an extended dynamic range of up to
4.000 OD.
Ability to read standard microplates from 6- to 384-wells, Terasaki plates (with adapter), BioTek’s patented BioCell quartz vessel for 1-cm measurements, and the BioTek Take3 Multi-Volume Plate.
Two reading speeds: normal and sweep.

Package Contents

Part numbers are subject to change over time. Please contact BioTek
Customer Care with any questions.
Item Part #
Epoch Operator’s Manual 7201000
Power supply 61062
Power cord
USB cable with Virtual COM Driver Software
to country
varies
according
of use
75108
7090204
BioTek® Instruments, Inc.
Optional Accessories | 3

Optional Accessories

Part numbers are subject to change over time. Please contact BioTek
Customer Care if you have any questions.
Item Part #
7-filter Absorbance Test Plate for absorbance measurement testing 7260522
Epoch Product Qualification (IQ-OQ-PQ) package 7200515
BioCell quartz vessel for 1-cm wavelength fixed pathlength absorbance measurements
BioCell adapter plate for containing up to eight BioCells 7270512
Terasaki plate adapter for 60-, 72-, and 96-well Terasaki plates 7220531
Absorbance Liquid Test Solutions:
BioTek Wetting Agent Solution (PN 7773002)
BioTek QC Check Solution No. 1 (25 ml) or
BioTek QC Check Solution No. 1 (125 ml)
Take3 Multi-Volume Plate TAKE3
7272051
7773002
7120779
7120782
Epoch Operator’s Manual
4 | Chapter 1: Introduction

Product Support & Service

A superior support staff backs all of BioTek’s products. If your instrument(s) or software ever fails to function properly, if you have questions about how to use or maintain it, or if you need to send an instrument to BioTek for service or repair, please contact our Technical Assistance Center (TAC).

Contacting the Technical Assistance Center

Our Technical Assistance Center is open from 8:30 AM to 5:30 PM (EST), Monday through Friday, excluding standard U.S. holidays. You can send a fax or an e-mail any time.
Phone: 800-242-4685 (in the U.S.) or 802-655-4740 (outside the U.S.)
Fax: 802-654-0638
E-Mail: tac@biotek.com
Please be prepared to provide the following information:
Your name and company information
A daytime phone or fax number, and/or an e-mail address
The product name, model, and serial number
The software part number and basecode version
For troubleshooting assistance or instruments needing repair, the specific
steps that produce your problem, and any error codes displayed (see also Appendix C, Error Codes).

Returning Instruments for Service/Repair

If you need to return an instrument to BioTek for service or repair, please contact the TAC for a Return Materials Authorization (RMA) number before shipping the instrument. Repackage the instrument properly (see Chapter 2, Installation), write the RMA number on the shipping box, and ship to this address:
BioTek Instruments, Inc.
ATTN: RMA# xxxxx 100 Tigan Street Highland Park Winooski, Vermont 05404 USA
BioTek
®
Instruments, Inc.
Chapter 2
Installation
This chapter includes instructions for unpacking and setting up the Epoch, connecting to a PC, and repackaging the instrument.
Product Registration............................................................. 6
1: Unpack and Inspect the Instrument.................................... 6
2: Remove the Carrier Shipping Hardware.............................. 7
3: Select an Appropriate Location ......................................... 8
4: Connect the Power Supply ............................................... 9
5: Connect the Host Computer ............................................. 9
6: Install the Software on the Host Computer ......................... 9
7: Turn on the Reader ......................................................... 9
Operational/Performance Qualification .................................... 11
Repackaging and Shipping .................................................... 11
Before Repackaging the Instrument...................................... 11
Attach the Carrier Shipping Hardware ................................... 11
Repackage the Instrument .................................................. 12
6 | Chapter 2 Installation

Product Registration

If you have not already done so, please register your product(s) with BioTek to ensure that you receive important information and updates about the product(s) you have purchased.
Register online through BioTek’s Customer Resource Center (CRC) at www.biotek.com or by contacting BioTek Customer Care.
Once registered, you can log into the Customer Resource Center and:
Check the status and track your order
Register your product warranty
Manage your equipment inventory
Access documentation on your products
Download user manuals and software
Check the status of your instrument’s service

1: Unpack and Inspect the Instrument

Save all packaging materials! If you need to ship the reader to
BioTek for repair or replacement, it must be carefully repackaged
Inspect the shipping box, packaging, instrument, and accessories for signs of damage.
If the reader is damaged, notify the carrier and your manufacturer’s representative. Keep the shipping cartons and packing material for the carrier’s inspection. The manufacturer will arrange for repair or replacement of your instrument immediately.
See Repackaging and Shipping at the end of this chapter for complete shipping instructions.
according to the instructions, starting on page 11, using the original packing materials. Using other forms of commericially available packaging materials, or failuire to following the repackaging instructions, may void your warranty. If the original packaging materials have been damaged, replacements are available from BioTek.
BioTek® Instruments, Inc.
2: Remove the Carrier Shipping Hardware | 7

2: Remove the Carrier Shipping Hardware

The Epoch is shipped with shipping hardware that must be
1. Using a screwdriver, remove the shipping screw (PN 19502) and o-ring (PN
2. Using your fingers, remove the rubber plug (PN 19610).
3. Install the plug in the hole where the shipping screw was originally located,
The plug prevents light from entering the test chamber during
removed before the reader is used, and saved in case the instrument needs to be repackaged for shipment. See Figure 1.
19608) assembly.
and insert the screw and o-ring in the hole where the plug was originally located. See Figure 2
operation.
Shipping screw and o-ring
Plug
Figure 1: Shipping screw, o-ring, and plug in shipping position
Epoch Operator’s Manual
8 | Chapter 2 Installation
Plug
Figure 2: Shipping screw, o-ring, and plug in usage position

3: Select an Appropriate Location

For optimal operation, install the Epoch on a clean, level surface in an area where ambient temperatures between 18°C (64°F) and 40°C (104°F) can be maintained. The reader is sensitive to extreme environmental conditions. Conditions to avoid are:
Shipping screw and o-ring
Excessive humidity: Condensation directly on the sensitive electronic
circuits can cause the instrument to fail internal self-checks. The humidity must be in the range of 10% to 85%, non-condensing.
Excessive ambient light: Bright sunlight or strong incandescent light can
reduce the linear performance range and affect the instrument’s readings.
Dust: Optical density readings may be affected by extraneous particles (such
as dust) in the microplate wells. A clean work area is necessary to ensure accurate readings.
Excessive vibration: Do not place the reader on a surface that is shared with
machines that cause the surface to vibrate.
BioTek® Instruments, Inc.
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