Biotek Epoch 2 Instructions For Use Manual

Epoch 2

Microplate Spectrophotometer

INSTRUCTIONS FOR USE

BioTek Instruments, Inc.

1771011 Revision A

Preface Page 2 of 42

Contents

Installation ............................................................................................................ 12

Getting Started ..................................................................................................... 17

Maintenance ........................................................................................................ 33

Qualification ......................................................

Specifications........................................................................................................ 43

....................................................39

Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Preface Page 3 of 42

Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Preface

Notices

BioTek® Instruments, Inc.

100 Tigan Street

Highland Park, P.O. Box 998

Winooski, Vermont 05404-0998 USA

All Rights Reserved

© 2018, 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™, Take3™, BioStack™, and Gen5™ 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®, Windows®, 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.

Preface Page 4 of 42

Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Contact Information

Global Service and Support

Instrument service and repair is available worldwide

www.biotek.com/service_support

U.S. Headquarters

BioTek® Instruments, Inc.
100 Tigan Street
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
www.biotek.com

Customer Service/Sales: 802-655-4740 or [e-mail]
Technical Assistance Center (TAC): 802-655-4740 or [e-mail]

European Coordination Center/Authorized European Representative

BioTek® Instruments GmbH
Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany

www.biotek.de

Phone: [phone]

Fax: [phone]

Email: [e-mail]

Instructions for Use Requirements

This document fulfills the basic needs of persons operating this device, according to
the requirements of the In Vitro Diagnostic Directive (98/79/EC) for “Instructions for
Use.” Some of the device's higher-level functions and features, as well as certain
detailed maintenance and qualification routines, are described in the operator’s
manual.

Intended Use Statement

This instrument is intended for IVD use. The performance characteristics of the data
reduction software have not been established with any laboratory diagnostic assay.
Users 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.

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

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.

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 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 model. See Hazards
and Precautions.

Hazards

The following hazard warnings are provided to help avoid injury:

Warning! Internal Voltage. Always turn off the power switch and unplug the
power supply before cleaning the outer surface of the instrument.

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.

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Warning! Lubricants. Do not apply lubricants to the microplate carrier or
carrier track. Lubricant on the carrier mechanism or components in the carrier
compartment will attract dust and other particles, which may obstruct the
carrier path and cause the instrument to produce an error.

Warning! Liquids. Avoid spilling liquids on the instrument; fluid seepage into
internal components creates a potential for shock hazard. 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. Contact BioTek Technical Assistance Center for
assistance.

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 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 displayed on the screen, sent to an
attached printer, or exported via computer control must be thoroughly
analyzed by the operator.

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 chemical­resistant rubber gloves and apron.

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 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.

Caution: Environmental Conditions. Do not expose the system to temperature
extremes. For proper operation, the temperature near the instrument should
remain within the range listed in Specifications. Performance may be
adversely affected if temperatures fluctuate above or below this range.

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Caution: Sodium Hypochlorite. Do not expose any part of the instrument to
the recommended diluted sodium hypochlorite solution 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. Operate this power supply within the range of line voltages listed
on it.

Caution: Shipping Hardware. The shipping hardware must be removed before
operating the instrument and reinstalled before repackaging the instrument
for shipment.

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 maintenance protocols may void the
warranty. See Maintenance.

Caution: Electromagnetic Environment. Per IEC 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.

Caution: Touchscreen. Do not use sharp implements to operate the
touchscreen.

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

CE Mark

Directive 2014/30/EU: 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.

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 Radio Frequency (RF) Immunity
EN 61000-4-4, Electrical Fast Transient/Burst Immunity
EN 61000-4-5, Surge Immunity
EN 61000-4-6, Conducted RF Disturbance Immunity
EN 61000-4-11, Voltage Dips, Interruptions and Short Variations

Directive 2014/35/EU 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 61010-2-010. "Particular requirements for laboratory equipment for the heating of

materials."

Directive 2012/19/EU: Waste Electrical and Electronic Equipment

Disposal Notice: Dispose of the instrument according to Directive 2012/19/EU, “on

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

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Electromagnetic Interference and Susceptibility

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 Canada Department of Communications.

User Safety

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

• 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.”

• EN 61010 Standards, see CE Mark starting on page 8.

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Safety Symbols

Some of these symbols appear on the instrument or accessories:

Alternating current

Both direct and alternating current

Direct current

Earth ground terminal

Protective conductor terminal
On (Supply)

Off (Supply)

Caution (refer to accompanying documents)

Warning, risk of electric shock
Warning, risk of crushing or pinching

Warning, potential biohazards

Warning, hot surface

Laser radiation: Do not stare into beam

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Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Laser energy: Exposure near aperture may cause burns. Do not
stare directly at the laser during operation.

In vitro diagnostic medical device

Separate collection for electrical and electronic equipment

Consult instructions for use

Installation Page 12 of 42

Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Installation

Models

Model

Touchscreen

Cuvette Port

EPOCH2NS

EPOCH2NSC •

EPOCH2TS •

EPOCH2TSC • •

Package Contents

Item

Notes

A specific model of an Epoch 2 instrument
per sales order

All required accessories to power the
instrument

Interface cables, if required

User manual and/or instructions

Optional accessories per sales order,
unless shipped separately

Installation Page 13 of 42

Epoch 2 Instructions for Use 1771011 Revision A BioTek Instruments, Inc.

Unpack the Box