Biotek 800TSI, 800TS, 800TSNB, 800TSTSUV, 800TSUVI Instructions For Use Manual

800™ TS

Absorbance Reader

Instructions for Use

BioTek® Instruments, Inc.
© 2017
PN 1561011, Rev A

BioTek Instruments, Inc.

ii | Notices

Notices

BioTek® Instruments, Inc.

Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA

All Rights Reserved

© 2017, 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 800™ TS 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.

Contact Information | iii

Contact Information

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

Global Service and Support

BioTek instrument service and repair is available worldwide at one of BioTek's
International Service Centers and in the field at your location. To arrange for service or
repair of your instrument, contact the office nearest you; visit www.biotek.com for up-to­date contact information. For customer service, sales, and technical assistance, refer to the
information below.

Customer Service and Sales

Internet: www.biotek.com

Phone: [phone] (toll-free in the U.S.)

802-655-4740 (outside the U.S.)

Fax: [phone]

Email: [e-mail]

Service/Technical Assistance Center (TAC)

Phone: [phone] (toll-free in the U.S.)

802-655-4740 (outside the U.S.)

Fax: [phone]

Email: [e-mail]

European Coordination Center/Authorized European Representative

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

Internet: www.biotek.de

800 TS

Phone: [phone]

Fax: [phone]

Email: [e-mail]

BioTek Instruments, Inc.

iv | Instructions for Use Requirements

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 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 Synergy Neo Operator's Manual.

Intended Use Statement

The 800 TS is a single-channel, filter-based absorbance reader designed to perform
measurements of samples in a microplate format. 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
charactertistics for the specific assay(s) are met.

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 (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 model. See Hazards and

Precautions.

Hazards

The following hazards are provided to help avoid injury:

Warning! Power Rating. The instrument’s power supply or power cord must
be connected to a power receptacle that provides voltage and current within
the specified rating for the system. Use of an incompatible power receptacle
may produce electrical shock and fire hazards.

Warning! Electrical Grounding. Never use a plug adapter to connect primary
power to the external power supply. Use of an adapter disconnects the utility
ground, creating a severe shock hazard. Always connect the power cord
directly to an appropriate receptacle with a functional ground.

Warning! Service. Only qualified technical personnel should perform service
procedures on internal components.

Warning! Accessories. Only accessories that meet the manufacturer's
specifications shall be used with the instrument.

Warning! 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.

Hazards | v

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 TAC 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 exported via computer control must be
thoroughly analyzed by the operator.

800 TS

BioTek Instruments, Inc.

vi | Precautions

Warning! Hot Surface.The tungsten lamp assembly is hot when the
instrument is turned on. Turn off the reader and allow the lamp to cool for at
least 15 minutes before attempting to replace it.

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

Warning! Potential Biohazards. Some assays or specimens may pose a
biohazard. This hazard is noted by the symbol shown here. Adequate safety
precautions should be taken as outlined in the assay’s package insert. Always
wear safety glasses and appropriate protective equipment, such as 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 Touchscreen. Do not use sharp implements to operate the
touchscreen. Using a sharp stylus or other implement may damage the display.

Caution: Environmental Conditions. Do not expose the system to temperature
extremes. For proper operation, ambient temperatures should 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. Do not expose any part of the instrument to the
recommended diluted sodium hypochlorite solution (bleach) for more than 20
minutes. Prolonged contact may damage the instrument surfaces. Be certain to
rinse and thoroughly wipe all surfaces.

Caution: Power Supply. Use only the power supply shipped with the instrument.
Operate this power supply within the range of line voltages listed on it.

Precautions | vii

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 Chapter 4, 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.

800 TS

BioTek Instruments, Inc.

viii | CE Mark

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 more specific information.

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 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 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 61010-2-081. “Particular 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.“

Electromagnetic Interference and Susceptibility | ix

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.

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

•

Product registration with competent authorities

•

EN 61010-2-101. “Particular requirements for in vitro diagnostic (IVD) medical
equipment.”

•

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

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 Canadians Department of
Communications.

Le present appareil numerique n'emet 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.

800 TS

BioTek Instruments, Inc.

x | User Safety

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
requirements.”

•

Canadian Standards Association CAN/CSA C22.2 No. 61010-1, “Safety
requirements
laboratory use; Part 1:

•

EN 61010 Standards, see

for measurement, control and laboratory use; Part 1: General

for electrical equipment for measurement, control and

General requirements.”

CE Mark

starting on page viii.

Safety Symbols

Some of the following 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

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
Schultzleiteranschluss
Borne de tierra de
protección

Terra di protezione

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
Vorsicht, heiße Oberfläche
Precaución, superficie caliente
Attenzione, superfice calda

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

Laserstrahlung: nicht in den strahl blicken
Radiación de laser: No mire fijamente al rayo
Radiazione di laser: Non stare nel fascio

Warning, potential biohazards

Attention, risques biologiques potentiels

Warnung! Moegliche biologische Giftsoffe

Atención, riesgos biológicos

Attenziones, rischio biologico

Caution (refer to accompanying documents)
Attention (voir documents
d'accompanement)

Achtung siehe Begleitpapiere

Atención (vease los documentos incluidos)

Attenzione, consultare la doc annessa

Safety Symbols | xi

800 TS

xvi | Safety Symbols

BioTek Instruments, Inc.

Installation

2 | Package Contents

Package Contents

Item Part #

800 TS Operator's Manual on USB flash drive 1561000

Power supply

Power cord varies according to country of use

USB cable 75108

Blank 4 GB USB flash drive 01087

Dust cover 7332040

Gen5 RC software GEN5RC

Non-incubation models: 01281
Incubation models: 02395

1. Unpack and Inspect the Reader

Save all packaging materials. If you need to ship the reader to BioTek for repair or
replacement, you must use the BioTek-supplied materials. 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 BioTek
representative. Keep the shipping boxes and the packaging materials for the carrier's
inspection. BioTek will arrange for repair or replacement immediately.

1. Place the packaging materials back into the shipping box for reuse if the instrument
needs to be shipped again.

BioTek Instruments, Inc.

Remove the Shipping Hardware | 3

2. Remove the Shipping Hardware

Remove and store all shipping hardware before you turn on the reader.

1. Carefully turn the reader upside down on a level surface.

2. Remove the six black screws holding the cover to the base, then lift the base off the
cover and set it right side up on a level surface.

3. Remove the two screws on each of the shipping brackets, remove the brackets, and
store the screws in the holes on the brackets.

800 TS

4 | Verify the Filter Wheel Contents

4. Store the shipping hardware in a safe place in case it is needed in the future.

5. If applicable (described in the next section), install the door now.

3. Verify the Filter Wheel Contents

The 800 TS ships with up to five preordered filters in the filter wheel. During installation, it
is good practice to verify the filters and their placement, and to confirm that the software
filter table matches the filter wheel’s configuration (discussed later). All five locations in
the wheel must contain either a filter or a plug.

Before continuing, obtain a clean, lint-free cloth.

BioTek Instruments, Inc.

Verify the Filter Wheel Contents | 5

For models with incubation capability: You must first remove the incubation housing to

access the filter wheel.

1. With the top case removed from the reader (see Remove the Shipping Hardware
on page 3 for directions), remove the four thumbscrews from the optic arm, and lift
the optic arm cover off (if equipped).

2. Disconnect the two connectors on the back of the incubation housing, then gently lift
the housing off of the reader.

800 TS

6 | Verify the Filter Wheel Contents

To access the filter wheel:

1. With the top case removed from the reader
(see Remove the Shipping Hardware on page 3
for directions), remove the four thumbscrews
from the filter wheel cover. This cover is directly
under the optics arm.

Note: The filters are not held in place and fall out of the wheel easily, so make sure to have a clean, lint­free cloth in place before turning over the filter wheel.

2. Lift the filter wheel off its pin, then remove
the filters by turning the wheel upside down
over a clean, lint-free cloth. Write down which
filters are installed in the filter wheel and the
location of each filter. You will use this
information later to verify/edit the software
filter table.

Compare the filters with your model’s default
filters or with the purchase order if different
filters were ordered. Contact BioTek Customer
Care if you did not receive the expected
filters/plugs.

Each filter is labeled with a wavelength and an
arrow showing the light direction. The arrows
must point downward when the filter wheel is
installed on the reader.

BioTek Instruments, Inc.