Agilent Technologies BioTek Epoch User manual

Agilent BioTek Epoch
Absorbance Microplate
Spectrophotometer
INSTRUCTIONS FOR USE
ERRATA NOTICE: This document
contains references to BioTek.
Please note that BioTek is now
Agilent. For more information, go to
www.agilent.com/lifesciences/biotek.
Document part number 7201009I
Revision C
Agilent Technologies, Inc.
May 2022
For In Vitro Diagnostic Use

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Agilent BioTek Epoch Instructions for Use Agilent Technologies, Inc.
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Contents
Preface .................................................................................................................................3
Copyright ..........................................................................................................................3
All Rights Reserved................................................................................................... 3
Contact Information.........................................................................................................3
Worldwide Sales and Support..................................................................................3
Technical Support and Service.................................................................................3
Customer Care .........................................................................................................3
European Coordination Center................................................................................3
UK Responsible Person (UKRP) ................................................................................4
Intended Use Statement ..................................................................................................4
Incident Reporting............................................................................................................4
Quality Control .................................................................................................................4
Safety Notices...................................................................................................................4
Warnings and Precautions ...............................................................................................5
Electrical Hazards.....................................................................................................5
Chemical/Environmental .........................................................................................5
Components............................................................................................................. 6
Intended Product Use..............................................................................................6
Symbols ............................................................................................................................7
Conformance to Standards ..............................................................................................9
EMC Information and Technical Description .................................................................10
Ingress Protection Code .................................................................................................10
Disposal .......................................................................................................................... 10
Installation .........................................................................................................................11
Important Information ...................................................................................................11
Package Contents...........................................................................................................11
Models............................................................................................................................11
Unpack the Box ..............................................................................................................12
Remove the Shipping Hardware ....................................................................................13
Select an Appropriate Location......................................................................................14
Install the Power Supply.................................................................................................14
Prepare the Host Computer...........................................................................................14
Connect the Host Computer and Reader....................................................................... 15
Turn on the Reader ........................................................................................................15
Establish Communication...............................................................................................15
Troubleshooting.....................................................................................................15
Verify Performance ........................................................................................................16

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Repackaging and Shipping Instructions .........................................................................17
Install the Shipping Hardware........................................................................................17
Repackage the Instrument and Accessories ..................................................................18
Getting Started...................................................................................................................19
Maintenance......................................................................................................................20
Warnings and Precautions .............................................................................................20
Schedule .........................................................................................................................21
Clean Exposed Surfaces.................................................................................................. 21
Decontamination............................................................................................................21
Required Materials ................................................................................................21
Procedure...............................................................................................................22
Instrument Testing.............................................................................................................23
Schedule .........................................................................................................................23
System Test ....................................................................................................................23
Absorbance Tests ...........................................................................................................23
Description.............................................................................................................23
Test Plate Certificates ............................................................................................23
Define the Absorbance Test Plate Parameters......................................................24
Procedure...............................................................................................................24
Specifications .....................................................................................................................25
General Specifications....................................................................................................25
Read Specifications.........................................................................................................26
Optical Performance ......................................................................................................27

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Agilent BioTek Epoch Instructions for Use Agilent Technologies, Inc.
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Preface
Copyright
All Rights Reserved
© Agilent Technologies, Inc. 2021, 2022. No part of this manual may be reproduced in
any form or by any means (including electronic storage and retrieval or translation into a
foreign language) without prior agreement and written consent from Agilent
Technologies, Inc. as governed by United States and international copyright laws.
Contact Information
Agilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA 95051
Worldwide Sales and Support
www.agilent.com/en/contact-us/page
Technical Support and Service
www.agilent.com/en/support
[email protected]
Instrument service and repair is available worldwide at one of our international service
centers and in the field at your location.
Customer Care
[e-mail]
European Coordination Center
Agilent Technologies Denmark ApS
Produktionsvej 42, 2600 Glostrup, Denmark

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Agilent BioTek Epoch Instructions for Use Agilent Technologies, Inc.
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UK Responsible Person (UKRP)
Agilent LDA UK Ltd.
5500 Lakeside
Cheadle Royal Business Park
Cheadle, Cheshire SK8 3GR
Intended Use Statement
The Epoch is an absorbance microplate spectrophotometer and intended to be used for
the examination of clinical specimens to analyze their characteristics in relation to a variety
of analytes including in human serum and cells.
Incident Reporting
Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority, or appropriate regulatory body, in the country
or region in which the user is established.
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.
Safety Notices
Pay special attention to the following safety notices in all product documentation.
-WARNING-
A WARNING notice denotes a hazard. It calls attention to an operating
procedure, practice, or the like that, if not correctly performed or adhered
to, could result in personal injury or death. Do not proceed beyond a
WARNING notice until the indicated conditions are fully understood and
met.
-CAUTION-
A CAUTION notice denotes a hazard. It calls attention to an operating
procedure, practice, or the like that, if not correctly performed or adhered
to, could result in damage to the product or loss of important data. Do not
proceed beyond a CAUTION notice until the indicated conditions are fully
understood and met.

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Warnings and Precautions
Electrical Hazards
-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.
-CAUTION-Power Supply. Use only the power supply shipped with the instrument,
and operate it within the range of line voltages listed on it.
Chemical/Environmental
-WARNING-
Potential Biohazards. 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 chemical-resistant rubber gloves and apron.
-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, stop 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.
-CAUTION-Liquids. Do not immerse the instrument, spray it with liquid, or use a
dripping-wet cloth on it. Do not allow water or other cleaning solution to
run into the interior of the instrument. If this happens, contact Technical
Support.
-CAUTION-Environmental Conditions. Do not expose the instrument to temperature
extremes. For proper operation, temperature near the instrument should
remain within the range in the Specifications section of this document.
Performance may be adversely affected if temperatures fluctuate above
or below this range
-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.

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-CAUTION-Lubricants. Do not apply lubricants to moving parts. Lubricant on
components in the carrier compartment will attract dust and other
particles, which may cause the instrument to produce an error.
Components
-WARNING-Accessories. Only accessories that meet the manufacturer's specifications
shall be used with the instrument.
-CAUTION-Shipping Hardware. All shipping hardware must be removed before
operating the instrument and reinstalled before repackaging the
instrument for shipment.
-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-Service. Only qualified technical personnel should perform service
procedures on internal components.
Intended Product Use
-WARNING-Software Quality Control. The operator must follow the manufacturer’s
assay package insert when modifying software parameters and
establishing reading methods. 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.
-WARNING-Data Reduction. No limits are applied to the raw measurement data. Data
exported via computer control must be analyzed by the operator. 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.
-WARNING-Unspecified Use. Failure to operate equipment according to the guidelines
and safeguards specified in the product user documentation could result
in a hazardous condition.
-CAUTION-Use of labware other than described in this document can result in
positioning errors during program execution.

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Symbols
Caution
Warning; Biological hazard
Disposal Notice: Dispose of the instrument according to Directive
2012/19/EU, “on waste electrical and electronic equipment (WEEE)” or
local ordinances
Consult instructions for use or consult electronic instructions for use
In vitro diagnostic medical device
CE Marking — indicates compliance with the requirements of the In Vitro
Diagnostic Regulation (2017/746)
Authorized representative in the European Community/European Union
Manufacturer
Date of manufacture
Catalogue number
Serial number
TÜV SÜD Certification Mark – Type tested; production monitored
IP20 Ingress Protection - Product protected against solid objects up to 12
millimeters. Not protected from liquids.
This product complies with environmental protection use period as
defined in People’s Republic of China Electronic Industry Standard
SJ/T11364-2006. Toxic or hazardous substances will not leak or mutate
under normal operating conditions for 40 years.
UK Conformity Assessed marking is a certification mark that indicates
conformity with the applicable requirements for products sold
within Great Britain.

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Temperature limit
Humidity limitation
Unique device identifier
Model number
Importer

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Conformance to Standards
The Epoch meets the requirements of the following standards:
2014/35/EU – Low Voltage Directive
2014/30/EU – EMC Directive
2017/746 – In Vitro Diagnostic Regulation
2011/65/EU (with exemptions) and (EU) 2015/863 – RoHS Directives
2012/19/EU – WEEE Directive as amended by (EU) 2018/849
2006/42/EC of the European Parliament and of the Council of 17 May 2006 on
machinery
Standard Description
IEC QC 080000 IEC Quality Assessment System for Electronic
Components (IECQ System) - Hazardous Substance
Process Management (HSPM) System Requirements
UL 61010-1 UL Standard for Safety Electrical Equipment For
Measurement, Control, and Laboratory Use; Part 1:
General Requirements
EN 61010-1 Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 1:
General Requirements
EN 61010-2-081 Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-081:
Particular requirements for automatic and semi-
automatic laboratory equipment for analysis and other
purposes
EN 61010-2-101 Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-101:
Particular requirements for in vitro diagnostic (IVD)
medical equipment
CAN/CSA C22.2 No. 61010-1 Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 1:
General Requirements
CAN/CSA C22.2 No. 61010-2-081 Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-081:
Particular requirements for automatic and semi-
automatic laboratory equipment for analysis and other
purposes
CAN/CSA C22.2 No. 61010-2-101 Safety Requirements for Electrical Equipment For
Measurement, Control, and Laboratory Use – Part 2-101:
Particular requirements for in vitro diagnostic (IVD)
medical equipment

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EMC Information and Technical Description
The Epoch conforms to:
Emissions:
EN55011/CISPR 11, Class A
CFR Title 47 FCC Part 15 Subpart B, Class A
ICES-001, Issue 5, Class A (CAN ICES-001(A)/NMB-001(A))
ACMA AS/NZS CISPR 11, Class A
Immunity:
EN/IEC 61326-1 and 61326-2-6
ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE
PART 2-6: PARTICULAR REQUIREMENTS FOR (IVD) MEDICAL EQUIPMENT
Ingress Protection Code
IP 20. Protected against solid foreign objects of 12.5 mm diameter and greater. No
protection against water.
Disposal
Dispose of the instrument according to Directive 2012/19/EU, “on waste electrical and
electronic equipment (WEEE)” or local ordinances.

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Installation
Important Information
-CAUTION-Shipping Hardware. All shipping hardware must be removed before
operating the instrument and reinstalled before repackaging the
instrument for shipment.
•This chapter contains installation and setup tasks for the Epoch and accessories.
Perform the tasks in the order presented.
•Save all packaging materials. Be sure to use packaging materials supplied by the
manufacturer when shipping the reader. Using other forms of commercially
available packaging, or failing to follow the repackaging instructions, may void your
warranty.
•During the unpacking process, inspect the packaging, reader, and accessories for
shipping damage. If the reader is damaged, notify the carrier and your Agilent
representative. Keep the shipping boxes and the packaging materials for the
carrier's inspection.
Package Contents
•Epoch instrument model per the sales order
•Epoch User Manual on USB flash drive
•Power supply
•Power cord
•USB cable
•Software and optional accessories per the sales order, unless shipped separately
Models
Part Number Features
EPOCH-SI Microplate Spectrophotometer.
EPOCHH-SI Microplate Spectrophotometer for high-altitude sites.
EPOCHR-SI Microplate Spectrophotometer. BioStack and 3rd party compatible.
EPOCHRH-SI Microplate Spectrophotometer for high-altitude sites. BioStack and
3rd party compatible.

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Unpack the Box
Save the packaging, in case you need to ship the instrument for service/repair.
User manual
Take3 plate
USB cable
Power cable
Power supply
Gen5
software

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Remove the Shipping Hardware
-CAUTION-Shipping Hardware. All shipping hardware must be removed before
operating the instrument and reinstalled before repackaging the
instrument for shipment.
1. See Figure 1. Remove the shipping screw, o-ring, and rubber plug.
2. See Figure 2. Install the plug in the hole where the shipping screw was originally
located, and insert the screw and o-ring in the hole where the plug was originally
located. The plug prevents light from entering the reading chamber during
operation.
Figure 1
Figure 2
Shipping screw
and o-ring
Plug
Plug
Shipping screw
and o-ring

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Select an Appropriate Location
Install the reader on a level, stable surface in an area where an operating temperature
between 18°C and 40°C can be maintained.
The reader is sensitive to extreme environmental conditions. Avoid:
•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
described in the Specifications section.
•Excessive ambient light. Bright light may affect the reader’s optics and readings,
reducing its linear range.
•Dust. Readings may be affected by extraneous particles in the microplate wells. A
clean work area is necessary to ensure accurate readings.
Install the Power Supply
-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.
-CAUTION-Power Supply. Use only the power supply shipped with the instrument,
and operate it within the range of line voltages listed on it.
1. Connect the power cord to the external power supply.
2. Locate the power inlet on the rear of the reader.
3. Plug the rounded end of the power supply's cord into the power inlet.
4. Plug the other end of the power cord into an appropriate power receptacle.
Prepare the Host Computer
Follow instructions supplied with Gen5 to install the necessary software.
•Ensure the computer meets the minimum system requirements as described in the
Gen5 Instructions for Use.
•You must have administrator privileges to install Gen5. Log in to Windows as
“Administrator” or consult your IT department for assistance.

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Connect the Host Computer and Reader
1. Turn off the computer.
2. Using the supplied USB cable, connect the square end of the cable to the USB port
on the rear of the reader.
3. Connect the other end of the cable to an available USB port on the computer.
4. Turn on the computer.
Turn on the Reader
1. Locate the power on/off switch on the front of the instrument, next to the carrier
eject button. The power on/off switch has a green, internal LED lamp that is
illuminated when the power is on. The carrier eject button, when pressed, ejects
the carrier out of the reader or pulls the carrier back inside the reader to the
carrier home position.
2. Turn on the power. The reader will perform an internal self-test and carrier
homing sequence. The carrier will eject outside the reader, then retract to its
home position inside the reader before it ejects again. Ensure that the reader
performs the carrier homing sequence and that the LED light is illuminated while
the power is on.
If the test is successful, the reader is ready for use. If the test fails, contact
Technical Support.
Establish Communication
On the host computer, start Gen5 and log in if prompted.
1. From the main screen, select System > Instrument Configuration and click Add.
2. Set the Reader Type to Epoch.
3. Perform one of the following steps, as applicable:
•Select Plug & Play.
•Set the Com Port to the computer's COM port to which the reader is
connected.
4. To verify that Gen5 can communicate with the instrument, click Test Comm.
Troubleshooting
If the communication attempt is successful, Gen5 displays a success message. Return to
the main screen. If the communication attempt is not successful, try the following:
•Is the reader connected to the power supply and turned on?
•Is the communication cable firmly attached to both the reader and the
computer?

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•Did you select the correct Reader Type/instrument in Gen5?
•Try a different COM Port or use Plug & Play.
•Did you install the USB driver software?
If you remain unable to get Gen5 and the reader to communicate with each other,
contact Technical Support.
Verify Performance
Refer to the Instrument Testing section for Absorbance Test procedures.

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Repackaging and Shipping Instructions
Please read the information provided below before preparing the Epoch for shipment.
•Contact Technical Support before returning equipment for service.
•Decontamination prior to shipment is required by the U.S. Department of
Transportation regulations.
•If the Epoch has been exposed to potentially hazardous material, decontaminate it
to minimize the risk to all who come in contact with the instrument during
shipping, handling, and servicing. The Maintenance chapter contains
decontamination instructions.
•Ensure the microplate carrier is empty. Spilled fluids can contaminate the optics
and damage the instrument.
•Install the shipping hardware (see next section).
•The instrument’s packaging design is subject to change. If the instructions in this
document do not apply to the packaging materials you are using, contact Technical
Support for guidance.
•Be sure to use packaging materials supplied by the manufacturer. Other forms of
commercially available packaging are not recommended and can void the warranty.
•If the packaging materials have been damaged or lost, or if the same set has been
used more than four times, order replacement part number 7203003.
•The shipping box, accessories box, foam caps, and other items are included as a
whole set under this part number and cannot be ordered separately.
Install the Shipping Hardware
-CAUTION-Shipping Hardware. All shipping hardware must be removed before
operating the instrument and reinstalled before repackaging the
instrument for shipment.
1. If you have not already done so, retract the microplate carrier.
2. Turn off the reader, and unplug the power supply from the power outlet and
from the power supply connector on the back of the reader. Remove the USB
cable from the reader.
3. Using a screwdriver, remove the shipping screw and o-ring from the reader, and,
using your fingers, remove the plug from the reader.
4. Insert the plug in its original hole and use the screwdriver to re-install the
shipping screw and o-ring in its original position.

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Repackage the Instrument and Accessories
Refer to the drawing on page 12.
1. Place the foam cap into the bottom of the shipping container. Note the
orientation of the foam cap in the box.
2. Place the accessories box back into the shipping container.
3. Place the reader inside the original plastic bag and carefully lower the reader into
the two foam caps in the bottom of the box. Note the orientation of the reader
in the box.
4. Place two foam caps over the reader.
5. Bundle the power cord and place it into the accessories box as shown.
6. Place the power supply and USB cable in the accessories box.
7. Close the top of the box and secure it with shipping tape.