900 TS Operators Manual - 1561000 Rev C
900 TS Operators Manual - 1561000 Rev C
900 TS Operators Manual - 1561000 Rev C
Operator’s Manual
800™ TS
Absorbance Reader
Operator's Manual
Notices
BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
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.
Contents
Notices ii
Contents iii
Contact Information vi
Revision History vii
Document Conventions viii
Intended Use Statement ix
Quality Control ix
Warranty and Product Registration ix
Warnings ix
Hazards x
Precautions xi
CE Mark xiii
Electromagnetic Interference and Susceptibility xiv
User Safety xv
Safety Symbols xvi
Introduction 1
Product Description 2
Package Contents 3
Optional Accessories 3
Product Support and Service 5
Installation 7
Product Registration 8
Important Information 8
1. Unpack and Inspect the Reader 8
2. Remove the Shipping Hardware 9
3. Install the Optional Door in Top Cover 10
4. Verify the Filter Wheel Contents 11
5. Select an Appropriate Location 14
IQ/OQ/PQ Description 62
Recommended Qualification Schedule 64
System Test 64
Absorbance Plate Test 66
Absorbance Liquid Tests 68
Specifications 75
General Specifications 76
Absorbance Specifications 77
Error Codes 81
Error Codes Overview 82
Error Codes 82
Sample Reports 89
Sample System Report 90
Sample Absorbance Test Plate Report 91
Sample Assay Results 92
Contact Information
BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
Internet: www.biotek.de
Phone: +49 (0) 7136 9680
Fax: +49 (0) 7136 968 111
Email: info@biotek.de
Revision History
Rev Date Changes
A 5/2017 Release to production
B 8/2017 Preface and Installation chapter: Deleted the word “ambient” when describing
specified temperature ranges; corrected Fahrenheit value of the low end of the specified
temperature range.
Getting Started: Added note about the included blank USB stick.
Specifications:Added the Fahrenheit temperature values.
C 10/2017 Preface: Updated wording of Reader Data Reduction Protocol Hazard to read “All information
displayed on the screen, sent to an attached printer, or exported via computer
control...”
Introduction: Fixed a typo in the PN for the Tungsten replacement lamp kit for
800TS and 800TSI.
Document Conventions
A Warning indicates the potential for bodily harm and tells you how to avoid the
Warning!
problem.
A Caution indicates potential damage to the instrument and tells you how to avoid the
Caution
problem.
Note Bold text is primarily used for emphasis.
Topics that apply only to specific 800 TS models are preceded by a notice in italic, for
italic
example, Applies only to 800 TS models with incubation.
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.
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 displayed on the screen, sent to an
attached printer, or exported via computer control must be thoroughly
analyzed by the operator.
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, the temperature near the instrument should
remain within the range listed in Appendix A, Specifications. 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 (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.
CE Mark
Based on the testing described below and information
contained herein, this instrument bears the CE mark
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
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.
User Safety
This device has been type-tested by an independent laboratory and found to meet the
requirements of the following:
l Underwriters Laboratories UL 61010-1, “Safety requirements for electrical equipment
for measurement, control and laboratory use; Part 1: General requirements.”
l 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.”
l EN 61010 Standards, see CE Mark starting on page xiii.
Safety Symbols
Some of the following symbols may appear on the instrument or accessories:
Alternating current Warning, risk of crushing or pinching
Courant alternatif Attention, risque d'écrasement et pincement
Wechselstrom Warnen, Gefahr des Zerquetschens und
Corriente alterna Klemmen
Corrente alternata Precaución, riesgo del machacamiento y
sejeción
Attenzione, rischio di schiacciare ed
intrappolarsi
Direct current Warning, hot surface
Courant continu Attention, surface chaude
Gleichstrom Vorsicht, heiße Oberfläche
Corriente continua Precaución, superficie caliente
Corrente continua Attenzione, superfice calda
Both direct and alternating Laser radiation: Do not stare into beam
current Rayonnement laser: Ne pas regarder dans le
Courant continu et courant faisceau
alternatif Laserstrahlung: nicht in den strahl blicken
Gleich - und Wechselstrom Radiación de laser: No mire fijamente al rayo
Corriente continua y Radiazione di laser: Non stare nel fascio
corriente alterna
Corrente continua e
corrente alternata
Earth ground terminal Warning, potential biohazards
Borne de terre Attention, risques biologiques potentiels
Erde (Betriebserde) Warnung! Moegliche biologische Giftsoffe
Borne de tierra Atención, riesgos biológicos
Terra (di funzionamento) Attenziones, rischio biologico
Protective conductor Caution (refer to accompanying documents)
terminal Attention (voir documents
Borne de terre de d'accompanement)
protection Achtung siehe Begleitpapiere
Schultzleiteranschluss Atención (vease los documentos incluidos)
Borne de tierra de Attenzione, consultare la doc annessa
protección
Terra di protezione
Introduction
This chapter introduces the 800 TS and provides contact information for
technical assistance.
Product Description 2
Package Contents 3
Optional Accessories 3
Product Support and Service 5
2 | Chapter 1: Introduction
Product Description
The 800 TS is a compact, filter-based, single-channel absorbance microplate reader. All
models are equipped with a touchscreen interface and support endpoint dual-wavelength
reads from 400-750 nm on standard 6- to 96-well plates. The narrow beam (NB) model
supports 384-well plates. UV models support a measurement range from 340-750 nm.
Some models offer incubation to 50˚C and/or linear plate shaking.
Basic data analysis, reporting, and exporting are provided via the touchscreen. With
optional Gen5 software, kinetic and well area scanning read modes are supported, along
with BioCell and 60-, 72-, and 96-well Terasaki plates. Gen5 also offers extensive data
analysis and reporting and exporting capabilities. The reader is available in five models.
Model Measurement Range Default Filters (in nm) Plate Types Shaking Incubation
800TS 400-750 nm 405, 450, 490, 630 6- to 96-well yes no
800TSI 400-750 nm 405, 450, 490, 630 6- to 96-well yes yes
800TSNB 400-750 nm 405, 450, 490, 630 6- to 384-well no no
800TSUV 340-750 nm 340, 405, 450, 490, 630 6- to 96-well yes no
800TSUVI 340-750 nm 340, 405, 450, 490, 630 6- to 96-well yes yes
The filter wheel contains up to five filters and is user accessible. For models with fewer
than five filters, removable plugs are installed in the empty wheel locations.
The 800TS and 800TSI models use a tungsten bulb as their light source. The other models,
800TSUV, 800TSUVI, and 800TSNB, use a halogen bulb.
Use of labware other than those described here can result in positioning errors during program
execution.
Models with incubation capability are equipped with a door. This door is also available
for purchase as an accessory for non-incubation-capable models. If you order a door
separately, you must install it yourself.
Package Contents
Package contents and part numbers are subject to change. Please contact BioTek Customer
Care with any questions.
Item Part #
800 TS Operator's Manual on USB flash drive 1561000
Non-incubation models: 01281
Power supply
Incubation models: 02395
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
Optional Accessories
Accessory availability and part numbers are subject to change. Please contact BioTek
Customer Care if you have any questions or visit www.biotek.com and use the
Accessories search tool.
Item Part #
Item Part #
See page vi for contact information for BioTek Global Service and Support.
Running a system test when a problem occurs provides valuable information for TAC.
When the test is complete, save it from the touchscreen to a USB flash drive or, in
Gen5, click Save As to save a text file of the system test report, which can be emailed
to TAC.
If you need to return an instrument to BioTek for service or repair, please contact the TAC
for a Service Call Notice (SCN) number and the shipping address. Repackage the
instrument according to the instructions at the end of Chapter 2, Installation.
Installation
This chapter includes instructions for unpacking and setting up the 800 TS.
Instructions are also included for preparing the reader for shipment.
Product Registration 8
Important Information 8
1. Unpack and Inspect the Reader 8
2. Remove the Shipping Hardware 9
3. Install the Optional Door in Top Cover 10
4. Verify the Filter Wheel Contents 11
5. Select an Appropriate Location 14
6. Install the Power Supply 15
7. (Optional) Install the Printer 15
8. (Optional) Install Gen5 on the Host Computer 16
9. (Optional) Install the USB Driver 17
10. (Optional) Connect the Host Computer 17
11. Turn on the Reader 17
12. Set Date and Time on Touchscreen 18
13. Verify the Reader's Filter Table 18
14. (Optional) Establish Communication 19
15: Run a System Test 20
Operational/Performance Qualification 23
Repackaging and Shipping Instructions 24
8 | Chapter 2: Installation
Product Registration
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 at (888) 451-5171 or (802) 655-4740.
Important Information
This chapter contains installation tasks for the 800 TS and accessories. Perform
the tasks in the order presented, skipping those that do not apply to your reader’s
configuration.
Remove the shipping hardware before turning on the instrument.
Reinstall the shipping hardware before repackaging the instrument for shipment.
1. Open the shipping box, remove the accessories tray, and then remove the instrument
from the box and place it on a level, stable surface.
2. Place the packaging materials back into the shipping box for reuse if the instrument
needs to be shipped again.
Remove and store all shipping hardware before you turn on the reader.
3. Remove the two screws on each of the shipping brackets, remove the brackets, and
store the screws in the holes on the brackets.
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.
1. If you have not already done so, remove the top cover by carefully turning over the
reader and removing the six screws that attach the top cover to the base.
2. Remove the two hole plugs from the top cover. You do not need to retain these plugs.
3. Using the nuts and washers that ship with the door, attach the door to the top cover as
shown next.
If you have installed the door on an existing reader (i.e., outside of the instrument
installation process), you can reattach the top cover now. Otherwise, leave the top
cover off and continue to 4. Verify the Filter Wheel Contents.
4. Tape the door closed, then carefully turn the reader upside down over its cover, and
reattach the cover to the reader by screwing in the six screws.
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 9 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.
Note: The filters are not held in place and fall out of the wheel easily, so make sure to have a clean, lint-
free 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 (see the table on page 2) or with the
purchase order if different filters were ordered.
Contact BioTek Customer Care if you did not
receive the expected filters/plugs.
Electrical Grounding. Never use a plug adapter to connect primary power to the
instrument. Use of an adapter disconnects the utility ground, creating a severe
shock hazard. Always connect the system power cord directly to an appropriate
receptacle with a functional ground.
1. Open the printer’s shipping box, and remove the top foam tray.
2. Carefully remove the printer and its components from the shipping box.
Note that the printer is shipped with two adapter plates for use with 58 mm paper.
Unless you plan to use that size of paper roll, you do not need to use these adapter
plates.
1. Insert the round end of the power supply cord into the DC power port on the rear of the
printer, then attach one end of the power cord to the power supply box and plug the
other end into a power outlet.
2. Insert one end of the supplied USB cable into the USB printer port on the rear of the
instrument and the other end in the USB port on the printer.
Do not use the USB port on the front of the 800 TS; that port is for USB flash drives
only.
Refer to the instructions that shipped with the Gen5 software to install the necessary
drivers. The driver must be installed on the computer before you connect the
instrument.
1. Locate the power on/off switch on the right side of the instrument, and turn on the
reader. The reader delays any action until the bulb has warmed up: three minutes for
narrow beam and UV models, and 30 seconds otherwise. Then the reader performs a
power-up system test.
If using Gen5, do not attempt to communicate with the reader until the system
test is finished.
2. When the system test is completed, the touchscreen displays its main screen.
If an error occurs during the system test, the reader beeps and the error code is displayed
on the touchscreen. Make note of the error code number, then tap OK to stop the beeping.
See Appendix B, Error Codes, for information about the error code you noted.
2. Tap the hour value, and use the keypad to enter the
correct time for both the hour and minutes, then click OK.
Note: You can change just the minutes value: Tap the
minutes value and enter the correct time.
4. Tap month, day, or year, and use the keypad to set the
current date. Tap OK when done.
Important! The reader’s filter table must exactly match the contents of the installed
filter wheel.
See the values you wrote down in step 2 of "4. Verify the Filter Wheel Contents" on
page 11. If there is a mismatch, correct the Filter Table to match the filters in the filter
wheel. See "Verify or Change the Reader’s Filter Table" on page 33 for instructions.
NOTE: Instrument must be at the Main Menu screen for Gen5 communication to occur.
1. On the host computer, start Gen5 and log in if prompted. The default System
Administrator password is admin.
2. From the Gen5 main screen, select System > Instrument Configuration and click Add.
3. Set the Reader Type to 800 TS.
4. Perform one of the following steps, as applicable:
l Select Plug & Play.
An 800 TS must be connected via USB to the computer and turned on to appear
in the Available Plug & Play Readers list.
l Set the Com Port to the computer's COM port to which the reader is connected.
The information can be found via the Windows Control Panel, under Ports in the
Hardware/Device Manager area of System Properties (e.g., Serial Port (COM5)).
5. To verify that Gen5 can communicate with the instrument, click Test Comm. If the
communication attempt is successful, Gen5 displays a success message. Return to
Gen5’s main screen.
Communication Errors
If the communication attempt is not successful, try the following:
l Is the reader connected to the power supply and turned on?
l Is the communication cable firmly attached to both the reader and the computer?
l Did you select the correct Reader Type in Gen5?
l Try a different COM Port in Gen5 or use Plug & Play.
l Did you install the USB driver software?
l Is the touchscreen at the Main Menu?
If you remain unable to get Gen5 and the reader to communicate with each other,
contact BioTek’s Technical Assistance Center.
b. On the Incubate tab of the Quick Menu screen, turn on the Temperature Control and
enter a setpoint of at least 37°C, then tap Home to return to the Main Menu.
c. Wait for the temperature display to reach the defined setpoint before continuing.
Using Gen5
The reader ran a "power-up" system test, but that test did not include verifying
that the incubator reaches a set temperature. Therefore, you will run another
system test.
Again, select System > Diagnostics > Run System Test. If prompted to select a reader, select 800
TS and click OK.
4. When the test is completed, a dialog requesting additional information appears. Enter
the information and click OK.
5. The results report appears and should contain the text "SYSTEM TEST PASS."
l If required, print the report and store it with your records.
l The Gen5 software stores system test information in its database; you can retrieve
it at any time.
l You can save the system test report as a text file: click Save As in the System Test
Results dialog.
If an error code is returned, refer to Appendix B and look up the code. If the
problem is something you can fix, do so now and run another system test. If the
problem is something you cannot fix, or if the test continues to fail, contact
BioTek’s Technical Assistance Center at (800) 242-4685 or (802) 655-4740.
Operational/Performance Qualification
Your 800 TS was fully tested at BioTek prior to shipment and should operate properly
following the successful completion of the installation and setup procedures described in
this chapter.
If you suspect that problems occurred during shipment, if you received the reader back
from BioTek following service or repair, or if regulatory requirements dictate that
Operational/Performance Qualification is necessary, turn to Chapter 5, Instrument
Qualification now to learn about BioTek’s recommended OQ/PQ procedures for 800 TS.
A Product Qualification & Maintenance (IQ/OQ/PQ) package for the 800 TS is available
for purchase (PN 1560516). Contact your local BioTek dealer for more information.
Contact BioTek’s Technical Assistance Center for a service call notice (SCN)
number and the shipping address before returning equipment for service.
If the reader has been exposed to potentially hazardous material, decontaminate
it to minimize the risk to all who come in contact with the reader during shipping,
handling, and servicing. Decontamination prior to shipping is required by the U.S
Department of Transportation regulations. See the As-Needed Maintenance
chapter for decontamination instructions.
Remove any labware from the carrier before shipment. Spilled fluids can
contaminate the optics and damage the instrument.
If the packaging materials have been damaged or lost, or if the same set has
been used more than four times, contact BioTek to order replacement part
number 1563000. The shipping box, accessories box, and foam trays are included
as a whole set under this part number and cannot be ordered separately.
The shipping brackets must be reattached before the 800 TS can be shipped.
1. Turn off the reader, and unplug the power supply from the power outlet and from the
power supply port on the back of the reader.
2. Disconnect the USB cable(s) from the reader (if using a computer and/or printer).
3. Carefully turn the reader upside down on a level surface.
4. Remove the six black screws holding the top cover to the base, then lift the base off of
the cover and set it right side up on a level surface.
5. Place the carrier shipping bracket around the carrier rail first, then rotate the bracket
down so that it sits on the base pan.
6. Hold the carrier shipping bracket snug against the front of the carrier, then screw in the
two screws to secure it.
7. Place the shaft shipping bracket over the shaft, and, for non-incubation-capable readers,
secure it with the two screws.
8. For incubation-capable readers, place the top incubation shipping bracket over the shaft
shipping bracket, and secure the brackets with two screws.
1. Place the bottom foam tray into the bottom of the shipping container.
2. If the reader has a door, tape it shut, then place the reader inside the original plastic
bag, and carefully lower the reader into the foam tray in the bottom of the box.
3. Place the accessory tray in the box, and then place the accessories into the tray as
shown in the figure.
4. Close the top of the box, and secure it with shipping tape.
5. Write the service call notice (SCN) number and shipping address in large, clear letters
on the outside of the shipping container, and ship the box to BioTek.
Getting Started
External Components 28
Operate the Reader Using the Touchscreen 31
Operate the Reader Using Gen5 Software 38
Recommendations for Optimum Performance 41
28 | Chapter 3: Getting Started
External Components
1 Microplate carrier
2 Touchscreen
3 Power switch
4 USB flash drive port for USB flash drive
1 Power port
2 USB port
3 DO NOT USE! For BioTek Service only
4 USB port for printer
1 Power port
2 USB port
3 DO NOT USE! For BioTek Service only
4 USB port for printer
Optional Printer
Refer to the manual on CD that ships in the printer’s box for more details.
The 800 TS supports outputting the System Test report, the Absorbance Test Plate report,
and measurement results including Raw OD, Delta OD, and blanked data to a thermal
paper printer.
The printer prints on only one side of the paper. Ensure that the paper roll is installed
so that the shiny side of the paper faces up. The printer will not print on the matte side
of the paper.
4. Unroll the paper just enough so that it clears the end of the door, then firmly close the
door until it clicks into place. The printer advances the paper and cuts it.
l To test that the printer is properly installed and communicating with the reader, in
the Main Menu, tap Instrument, then on the Option tab, tap Start to begin the
Printer Test. A short test result prints. If the results did not print, check that the power
cable and USB cable are securely connected and run the test again.
l To print the results of a read (both a Quick Read and a defined protocol read), tap
Output in the top-right corner of the results screen displayed when the read finishes.
l To print System Test results, tap Print in the screen that appears when the system
test finishes.
l To cleanly tear the paper from the printer, pull upward from left to right.
l To advance the paper, press Feed on the front of the printer.
l To turn off the printer, press and hold the ON/OFF button for at least three seconds.
General Information
Do not use a sharp stylus or pencil on the touchscreen. Doing so can damage the
touchscreen's surface. You can use a stylus designed for capacitive touchscreens.
When you turn on the 800 TS, the touchscreen turns on automatically and opens to the
Main Menu after the start-up system test and bulb warm-up. The length of the bulb warm-
up process varies from three minutes for narrow beam and UV models, and 30 seconds
otherwise. See Turn on the Reader in Chapter 2.
l To select a button or check box or to activate a tab, tap the item once.
l To return to the Main Menu from any other screen, tap Home in the top-left corner.
l For instructions on cleaning the touchscreen, see page 46.
l To preserve the life of the bulb, turn it off when not needed by tapping in the
Instrument or Quick Menu. Note that if you turn off the bulb, the reader will go
through the bulb warm-up process when you turn the bulb back on (three minutes for
narrow beam and UV models, and 30 seconds otherwise).
Main Menu
800TSI and 800TSUVI models: When the incubator is turned on, the reader’s internal
temperature is displayed at the top of the screen, as shown above. When the incubator
is off, dashes are displayed.
The left side of the Main Menu screen lists the assay protocols defined on the reader. As
shipped, the reader contains no protocols and the list is empty. Up to 40 uniquely named
protocols can be programmed and stored. Tap Next to scroll through the list.
On the right side of the Main Menu are the following options:
l Quick: Define and run a simple single- or dual-wavelength protocol. You can select
the primary and secondary wavelength values and the plate type. If applicable to your
reader model, shake and/or incubate options are available.
l Protocol: Edit, create (and save), delete, and copy protocols. You can define the
protocol name; select the primary and secondary wavelength values, read speed, and
plate type; and define blank well(s). If applicable to your reader mode, shake options
are available.
The reader automatically performs delta OD and blank subtraction. To select the
dataset(s) for print or export, tap Instrument and then the Output tab.
l Results: View and optionally print/export measurement data stored on the reader
(for the 12 most recently run protocols).
l Instrument: Configure the reader, printer, and USB flash drive settings; define results
output criteria; run an Absorbance Plate Test; and more.
2. Tap the hour value, and use the keypad to enter the
correct time for both the hour and minutes, then click OK.
Note: You can change just the minutes value: Tap the
minutes value and enter the correct time.
4. Tap month, day, or year, and use the keypad to set the
current date. Tap OK when done.
Important! The reader’s filter table must exactly match the contents of the installed
filter wheel.
The maximum number of uniquely named protocols that can be saved on the
touchscreen at the same time is 40.
Create a Protocol
1. From the home screen, tap Protocol, then tap Create.
6. Toggle to set the plate type: 6-, 12-, 24-, 48-, 96, or 384*-well microplates.
7. Note: Only full plate reads are supported on the touchscreen. To read a partial plate, you must
use Gen5.
9. If the reader is equipped with shake capability, tap Options and define a shake step, if
desired. Set the shake’s duration using the keypad and intensity by toggling through the
options.
10. Tap Save. The protocol now appears in the protocol list.
Start a Protocol
The onboard storage for the touchscreen can accommodate data for up to 12
microplate reads. The data is stored by date and time, not by filename. If 12 results are
already in onboard storage, the next read data saved will overwrite the oldest of the
saved results.
Note that only plate read results are saved. System Test and Absorbance Plate Test
results are not saved; they can only be exported to USB flash drive or printed.
1. From the Main Menu, tap Instrument, then tap the Options tab.
2. In the Protocol display order field, select Alphabetically or Last accessed first.
Delete a Protocol
Copy a Protocol
Copying an existing protocol and then editing it is a quick way to create a new protocol.
1. In the Main Menu, select the protocol you want to copy, then tap Copy.
2. You are prompted to enter a name for the copied protocol.
3. Make any desired changes, then tap Save.
BioTek supplies a blank USB flash drive with the instrument if you choose to output the
system test or assay results.
1. In the Main Menu, tap Results, then select the date/time of the read for which you
want to view or output results. The results are displayed on the touchscreen.
2. Tap Output. The results are printed and/or saved to the USB flash drive, depending
on the output format you selected (see page 34).
Gen5 RC (Reader Control) software is supplied with the 800 TS. This edition supports
only instrument control and data reporting/exporting. To perform kinetic reads, data
reduction, and custom exports, a software upgrade is required; contact BioTek
Customer Care.
BioTek Gen5 software supports all 800 TS reader models. Use Gen5 to control the reader;
perform data reduction and analysis on the measurement values; print or export results;
and more. This section provides brief instructions for working with Gen5 to create
protocols and experiments and read plates. Refer to the Gen5 Help system for more
information.
Important! The reader’s filter table must exactly match the contents of the installed
filter wheel.
1. From the Gen5 main screen, select System > Instrument Configuration, highlight the
800 TS, and click View/Modify.
2. Click Setup, and then click the Absorbance tab.
3. Verify that the values match the contents of the filter wheel. See the Installation
chapter for instructions for accessing the filter wheel.
4. To change the setting for a filter wheel position, enter the new value and click Send
Wavelengths.
5. Click Close when you are finished.
Gen5 stores measurements and other characteristics for individual plate types in a
database. It is essential that you select (or define) the plate type to match the assay
plate. Otherwise, results may be invalid. See the "Plate Type Database" topic in the
Gen5 help for instructions.
4. Add steps to the procedure for reading, shaking, or heating the plate and more. Click
Validate to verify that the reader supports the defined steps, and then click OK.
5. Optionally, perform any of these steps to analyze and report the results:
l Open the Plate Layout dialog and assign blanks, samples, controls, and/or
standards to the plate.
l Open the Data Reduction dialog to add data reduction steps. Categories include
Transformation, Well Analysis, Curve Analysis, and Qualitative Analysis.
l Create a report or export template via the Report/Export Builders.
6. Select File > Save and give the file an identifying name.
These instructions briefly describe how to create an experiment and then read a plate in
Gen5. See the Gen5 Help system for complete instructions.
1. In the Gen5 Task Manager, select Experiment > Create using an existing protocol.
2. Select the desired protocol and click OK.
General
l Microplates should be clean and free from dust or bottom scratches. Use new
microplates from sealed packages. Do not allow dust to settle on the surface of the
solution; use microplate covers or seals when not reading the plate. Filter solutions to
remove particulates that could cause erroneous readings.
l Although the 800 TS supports standard flat, U-bottom, and V-bottom microplates, the
reader achieves optimum performance with flat-bottomed wells. See Appendix A,
Specifications for more information on the supported plates.
l Non-uniformity in the optical density of the well bottoms can cause loss of accuracy,
especially with U- and V-bottom polyvinyl microplates. Check for this by reading an
empty microplate. Dual wavelength readings can eliminate this problem, or bring the
variation in density readings to within acceptable limits for most measurements.
l Inaccuracy in pipetting has a large effect on measurements, especially if smaller
volumes of liquid are used. For best results in most cases, use at least 100 µL per well
in a 96-well plate and 25 µL in a 384-well plate.
l Pipetting solution into 384-well plates often traps air bubbles in the wells, which may
result in inaccurate readings. A dual-wavelength reading method usually eliminates
these inaccuracies. For best results, however, remove the air bubbles by degassing
the plate in a vacuum chamber or spinning the plate in a centrifuge before reading.
l The inclination of the meniscus can cause loss of accuracy in some solutions,
especially with small volumes. Shake the microplate before reading to help bring it
within acceptable limits. Use Tween 20, if possible (or some other wetting agent) to
normalize the meniscus for absorbance measurements. Some solutions develop
menisci over a period of several minutes. This effect varies with the brand of
microplate and the solution composition. As the center of the meniscus drops and
shortens the light path, the density readings change. The meniscus shape will stabilize
over time.
l It is the user’s responsibility to understand the volumetric limits of the plate type in
use as it applies to the assay being run.
l Use of liquids with concentrations of acids, corrosives, or solvents of 3% and greater
can begin attacking the materials inside the instrument's chamber. Running multiple
plates with concentrations < 3% in long kinetic experiments may also have a
destructive effect. If the experiment is incubated, it will accelerate the deterioration
of chamber components. When in doubt about the use of acids, corrosives, or
solvents, please contact TAC@biotek.com.
Maintenance
This chapter provides instructions for cleaning and decontaminating the 800
TS.
Maintenance Overview 44
Warnings and Precautions 45
Clean Exposed Surfaces 45
Clean the Touchscreen 46
Decontamination 47
Filter Storage and Handling 49
Replacing and Aligning the Bulb 49
44 | Chapter 4: Maintenance
Maintenance Overview
A general maintenance regimen for all 800 TS models includes periodically cleaning all
exposed surfaces and decontaminating the instrument before storage or shipment. This
chapter includes instructions for the following:
l Routine cleaning procedure, page 45
l Cleaning the touch screen, page 46
l Decontamination, page 47
l Filter storage and handling, page 49
l Replacing and aligning the bulb, page 49
Required Materials
l Mild detergent
l Deionized or distilled water
l Clean, lint-free cotton cloths
l Sodium hypochlorite (NaClO, or bleach) (decontamination only)
l Safety glasses
l Surgical mask
l Protective gloves
l Lab coat
l Biohazard trash bags
l 125-mL beakers
l Cotton swabs or paper towels
Warning! Internal Voltage. Turn off and unplug the instrument for all maintenance
and repair operations.
Important! 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 the BioTek Service Department.
Do not soak the touchscreen! This will cause damage. Moisten a clean cloth with
deionized or distilled water and wipe the touchscreen. Dry immediately with a
clean, dry cloth.
Important! Do not apply lubricants to the microplate carrier or carrier track.
Lubricant attracts dust and other particles, which may obstruct the carrier path and
cause errors.
Warning! Wear protective gloves when handling contaminated instruments. Gloved
hands should be considered contaminated at all times; keep gloved hands away
from eyes, mouth, nose, and ears.
Warning! Mucous membranes are considered prime entry routes for infectious
agents. Wear eye protection and a surgical mask when there is a possibility of
aerosol contamination. Intact skin is generally considered an effective barrier
against infectious organisms; however, small abrasions and cuts may not always be
visible. Wear protective gloves when handling contaminated instruments.
This procedure is for the housing of the 800 TS instrument. See "Clean the Touch
Screen" on page 46 for the cleaning procedure for the touch screen.
A regular cleaning regimen is recommended to keep the instrument free from dust and
particulates that can cause erroneous readings. Exposed surfaces may be cleaned (not
decontaminated) with a cloth moistened (not soaked) with water or water and a mild
detergent.
1. Turn off and unplug the instrument from the power supply.
2. Wet a clean cotton cloth with water, or with water and mild detergent, then thoroughly
wring out the cloth so that liquid does not drip from it.
3. Wipe the plate carrier, the inside of the plate carrier door (if equipped), and all exposed
surfaces of the instrument.
4. If detergent was used, wipe all surfaces with a cloth moistened with water.
5. Use a clean, dry, lint-free cloth to dry all wet surfaces.
If liquid is spilled inside the reader, call BioTek TAC for cleanup instructions.
Materials
Use the following products to safely clean the touchscreen:
l Deionized or distilled water
l Dish soap or other mild cleaner
l Lintfree disposable towels
Procedure
Decontamination
Any laboratory instrument that has been used for research or clinical analysis is considered
a biohazard and requires decontamination prior to handling.
Decontamination minimizes the risk to all who come into contact with the instrument
during shipping, handling, and servicing. Decontamination is required by the U.S.
Department of Transportation regulations.
Persons performing the decontamination process must be familiar with the basic setup and
operation of the instrument.
Turn off and unplug the instrument for the decontamination procedure.
Required Materials
Procedure
1. Turn off and unplug the reader from the power supply.
2. Prepare an aqueous solution of 0.5% sodium hypochlorite (NaClO, or bleach). If the
effects of bleach are a concern, 70% isopropyl alcohol may be used.
Check the percent NaClO of the bleach you are using. Commercial bleach is typically
10.0% NaClO; prepare a 1:20 dilution. Household bleach is typically 5.0% NaClO;
prepare a 1:10 dilution.
3. Moisten a clean, lint-free cloth with the bleach solution, then thoroughly wring it out so
that liquid does not drip from it. Do not soak the cloth.
4. Wipe the plate carrier and all exposed surfaces of the instrument, except the touch
screen (if equipped).
5. Allow the instrument to dry for 20 minutes for thorough decontamination by the bleach.
6. Moisten a cloth with deionized or distilled water and wipe all surfaces of the instrument
that have been cleaned with the bleach solution.
When changing or replacing filters, it is critical that the filters be placed in the
filter wheel in the correct orientation, with the light-direction arrow pointing
downward. Also, the reader or Gen5 software filter table must exactly match the
contents of the filter wheel.
Warning! The bulb will be hot immediately after the reader has been shut down.
Allow the bulb to cool for at least 10 minutes before attempting to replace it.
Warning! The alignment procedure requires you to observe the light path while
the bulb is turned on. To prevent possible vision impairment, avoid looking
directly at the bulb while it is on.
This chapter describes the tests that BioTek Instruments, Inc., has developed
for complete qualification of all models of the 800 TS. This chapter
introduces the various test methods, describes the materials and protocol
parameters used to execute the tests, explains how to analyze test results,
and provides troubleshooting tips in the event of a failure. Instrument
Qualification Procedures, starting on page 61, contains the actual step-by-
step test procedures.
Absorbance Testing
BioTek developed a series of tests for the absorbance system using a combination of solid
state Absorbance Test Plates and liquid plates. The test plates and the materials used for
creating the liquid plates are available for purchase from BioTek.
To qualify the absorbance system for the 800 TS, you should perform:
l Absorbance Liquid Test 1 and Absorbance Plate Test (using BTI #7260522) or
l Absorbance Liquid Test 2
Optionally, to qualify operation in the UV range, you should also perform:
l Absorbance Liquid Test 3 or Absorbance Plate Test at 340 nm (using BTI #7260551)
Check the calibration due date on the test plate's label. If the test plate is overdue for
recalibration, contact BioTek to schedule service.
Test Method
The Absorbance Plate Test is conducted using the 800 TS touchscreen or Gen5 software
(System > Diagnostics > Test Plates) to confirm mechanical alignment and optical density
accuracy, linearity, and repeatability. When complete, a results report displays Pass or Fail
for each individual test.
l Alignment: The test plate has precisely machined holes to confirm mechanical
alignment. The amount of light that shines through these holes is an indication of
whether the microplate carrier is properly aligned with the absorbance optical path.
A reading of more than 0.015 OD for any of the designated alignment holes indicates
that the light is being “clipped” and the reader may be out of alignment.
l Accuracy: The test plate contains NIST-traceable neutral-density glass filters of known
OD values at one or more wavelengths. Actual measurements are compared against
the expected values provided in the test plate’s data sheet. Since there are several
filters with differing OD values, the accuracy across a range of ODs can be
established. Once it is proven that the reader is accurate at these OD values, the
reader is also considered to be linear. To further verify this, you can perform a linear
regression analysis on the test plate OD values in a program such as Microsoft Excel;
an R2 value of at least 0.9900 is expected.
l Repeatability: This test ensures the instrument meets its repeatability specification
by conducting repeated reads of each neutral-density filter on the test plate and
comparing the results.
Troubleshooting
If a test fails, try the troubleshooting tips below. If the test continues to fail, contact BioTek
TAC.
Important! Do not remove filters from the Absorbance Test Plate. Do not use alcohol or
other cleaning agents, and do not touch the filters with your bare fingers.
If a higher-OD well reports "#N/A" for Min/Max Limit and Result, the measured OD is
beyond the specified range for Accuracy or Repeatability used with this test, and
therefore no pass/fail determination is made. It does not indicate a test failure.
Alignment Test
l Ensure that the test plate is properly seated in the microplate carrier.
l Check the four alignment holes (B2, B12, G1, G11) to ensure they are clear of debris.
l Check the microplate carrier to ensure it is clear of debris.
Accuracy Test
l Check the neutral-density filters to ensure they are clean (positions C1, D4, E2, F5, G3,
H6). If needed, clean the filters with lens paper. Do not remove any filters, and do not
use alcohol or other cleaning agents.
l Verify that the wavelength/expected OD values entered for the plate on the reader or
in Gen5 match the information provided on the test plate's data sheet.
Repeatability Test
l Check the neutral-density filters to ensure there is no debris that may have shifted
between readings and caused changes.
l Check the microplate carrier to ensure it is clear of debris.
Test Methods
Absorbance Liquid Test 1 confirms repeatability and alignment of the reader when a
solution is used in the microplate. If these tests pass, then the lens placement and optical
system cleanliness are proven. For the Repeatability portion of this test, two columns
containing a color-absorbing solution are read five times at 405 nm. For each well, an
"allowed deviation" is determined based on its Mean OD and the reader's repeatability
specification. Each well's Standard Deviation must be less than its Allowed Deviation to
pass. To confirm the reader’s mechanical alignment, the plate is rotated 180 degrees in
the carrier (e.g., A1 is now in the H12 position) and the same two columns are read. The
initial and new OD readings are compared, using the reader's accuracy specification. If the
two readings in the same well do not meet specification, the reader may be out of
alignment.
If an Absorbance Test Plate is not available, Absorbance Liquid Test 2 may be conducted
to test the instrument's alignment, repeatability, and accuracy by preparing a series of
solutions of varying OD values as described on page 71.
Absorbance Liquid Test 3 is an optional test offered for those sites that must have proof of
linearity at 340 nm. (Alternatively, the BioTek 340 nm Absorbance Test Plate may be used;
see page 52.) This test is optional since the 800 TS has good “front end” linearity
throughout the specified wavelength range. While the absolute values of the OD cannot be
determined by this test, the results will indicate if there is adequate repeatable absorbance
and a linear slope. This method is dependent upon proper dye dilution and a skilled
pipetting technique. It is expected that the first dilution (mid-level solution) will have an
absorbance value near 75% of that of the stock (high-level) solution, and that the second
dilution (low-level solution) will have an absorbance value near 50% of that of the stock
solution.
The Plate Type setting in each Gen5 protocol should match the actual 96-well plate in
use.
Parameter Setting
Parameter Setting
Parameter Setting
Results Analysis
The Absorbance Liquid Test procedures begin on page 68. All tests are conducted using the
Normal read speed.
Absorbance Liquid Test 1
Accuracy Specification:
± 1.0% ± 0.010 OD from 0.000 to 2.000 OD
Repeatability Specification:
± 0.5% ± 0.005 OD from 0.000 to 2.000 OD
1. The plate is read five times in the “Normal” position at 405 nm. Calculate the Mean OD
and Standard Deviation of those five reads for each well in columns 1 and 2.
2. For each well in columns 1 and 2, calculate the Allowed Deviation using the
Repeatability specification for a 96-well plate (Mean OD x 0.05 + 0.005). For each well,
its Standard Deviation should be less than its Allowed Deviation.
Example: Five readings in well A1 of 0.802, 0.802, 0.799, 0.798, and 0.801 result in a
Mean of 0.8004 and a Standard Deviation of 0.0018. The Mean multiplied by 0.5%
(0.8004 * 0.005) equals 0.004, and when added to 0.005 equals 0.009; this is the Allowed
Deviation for well A1. Since the Standard Deviation for well A1 is less than this value,
the well meets the test criteria.
3. The plate is read five times in the “Turnaround” position at 405 nm. Calculate the Mean
OD of those five reads for each well in columns 11 and 12.
4. Perform a mathematical comparison of the Mean values for each well in its Normal and
Turnaround positions (that is, compare A1 to H12, A2 to H11, B1 to G12,… H2 to A11). To
pass the test, the differences in the compared Mean values must be within the Accuracy
specification for a 96-well microplate.
Example: If the Mean value for well A1 in the Normal position is 1.902 with a specified
accuracy of ±1.0% ±0.010 OD, then the expected range for the Mean of the well in its
Turnaround (H12) position is 1.873 to 1.931 OD. 1.902 x 0.010 + 0.010 = 0.029; 1.902 -
0.029 = 1.873; 1.902 + 0.029 = 1.931.
1. The plate is read five times at 450/630 nm ("Normal" position), resulting in five sets of
Delta OD data. Calculate results for Linearity:
l Calculate the mean absorbance for each well, and average the means for each
concentration.
l Perform a regression analysis on the data to determine if there is adequate
linearity. Since it is somewhat difficult to achieve high pipetting accuracy when
conducting linear dilutions, an R2 value of at least 0.9900 is considered adequate.
2. Calculate the results for Repeatability:
l Calculate the Mean and Standard Deviation for the five readings taken at each
concentration. Only one row of data needs to be analyzed.
l For each Mean, calculate the Allowed Deviation using the Repeatability
specification for a 96-well plate of ±0.5% ±0.005 OD.
l The Standard Deviation for each set of readings should be less than the Allowed
Deviation.
Example: Readings of 1.950, 1.948, 1.955, 1.952, and 1.950 will result in a Mean of
1.951, and a Standard Deviation of 0.0026. The Mean (1.951) multiplied by 0.5%
(1.951 x 0.005) = 0.009755, which, when added to the 0.005 (0.009755 + 0.005) =
0.0148 OD, which is the Allowed Deviation. Since the Standard Deviation is less
than this value, the reader meets the test criteria.
3. After gathering data for the Linearity Test, the plate is read five more times with the A1
well in the H12 position ("Turnaround" position). This results in values for the four
corner wells that can be used to assess alignment. Calculate results for the Alignment
Test:
l Calculate the means of the wells A1 and H1 in the Normal plate position (data
from Linearity Test) and in the Turnaround position.
l Compare the mean reading for well A1 to its mean reading when in the H12
position. Next, compare the mean values for the H1 well to the same well in the
A12 position. The difference in the values for any two corresponding wells should
be within the Accuracy specification for 96-well plates. If the four corner wells are
within the accuracy range, the reader is in alignment.
Example: If the mean of well A1 in the normal position is 1.902, where the
specified accuracy is ±1.0% ±0.010 OD, then the expected range for the mean of
the same well in the H12 position is 1.873 to 1.931 OD. (1.902 x 1.0% = 0.019 +
0.010 = 0.029, which is added to and subtracted from 1.902 for the range.)
1. The plate is read five times at 340 nm. For each well, calculate the Mean OD and
Standard Deviation of the five readings.
2. For each Mean calculated in step 1, calculate the Allowed Deviation using the
Repeatability specification for a 96-well plate (Mean OD x 0.015 + 0.005). For each well,
its Standard Deviation should be less than its Allowed Deviation.
Example: Five readings in well A1 of 0.802, 0.802, 0.799, 0.798, and 0.801 result in a
Mean of 0.8004 and a Standard Deviation of 0.0018. The Mean multiplied by 1.5%
(0.8004 * 0.015) equals 0.012, and when added to 0.005 equals 0.017; this is the Allowed
Deviation for well A1. Since the Standard Deviation for well A1 is less than this value,
the well meets the test criteria.
3. Calculate results for Linearity:
l For each of the three test solutions, calculate the average Mean OD for the wells
containing that solution (mean of wells A1 to H2, A3 to H4, and A5 to H6).
l Perform a regression analysis on the data to determine if there is adequate
linearity. The three average Mean OD values are the “Y” values. The solution
concentrations are the “X” values (1.00, 0.75, 0.50). Since it is somewhat difficult
to achieve high pipetting accuracy when conducting linear dilutions, an R2 value of
at least 0.9900 is considered adequate.
Troubleshooting
If an absorbance liquid test fails, try the following. If a test continues to fail, contact BioTek
TAC.
l Check the microwells and plate carrier for debris that may have shifted and caused
changes.
l Ensure the microplate is properly seated in the carrier.
l As applicable, confirm that the plate was properly oriented in the "Normal" and
"Turnaround" positions.
l Liquid Test 1 can fail due to the meniscus effect, which can cause readings to
decrease over time. If you suspect this may be the case, include a shake step between
the read steps in the protocol.
This chapter contains the step-by-step procedures for verifying that the 800
TS and its various subsystems are performing to specification. Instrument
Qualification Process, starting on page 51, introduces the various test
methods, describes the materials and relevant protocol parameters used to
execute the tests, explains how to analyze test results, and provides
troubleshooting tips in the event of a failure.
Overview 62
IQ/OQ/PQ Description 62
Recommended Qualification Schedule 64
System Test 64
Absorbance Plate Test 66
Absorbance Liquid Tests 68
62 | Chapter 6: Instrument Qualification Procedures
Overview
This chapter contains BioTek Instrument's recommended qualification procedures for all
800 TS models.
Every 800 TS reader is fully tested at BioTek prior to shipment and should operate properly
upon initial setup. If you suspect that a problem occurred during shipment, if you have
received the equipment after returning it to the factory for service, and/or if regulatory
requirements dictate that you qualify the equipment on a routine basis, perform the
procedures outlined in this chapter.
See the Recommended Qualification Schedule on page 64 to determine which
qualification tests shall be conducted for your and to meet your site's regulatory
requirements.
A Product Qualification Package (PN 1560516) for the 800 TS is available for purchase.
The package contains complete procedures, Gen5 protocols, checklists, and logbooks
for performing Installation Qualification, Operational Qualification, Performance
Qualification, and Preventive Maintenance. Contact your local BioTek dealer for more
information.
IQ/OQ/PQ Description
Installation Qualification confirms that the reader and its components have been supplied
as ordered and ensures that they are assembled and configured properly for your lab
environment.
l The recommended IQ procedure consists of setting up the instrument and its
components as described in Chapter 2, Installation, and performing the System Test.
l The IQ procedure should be performed initially (before the reader is used for the first
time).
l The successful completion of the IQ procedure verifies that the instrument is installed
correctly. The Operational Qualification procedure should be performed immediately
following the successful IQ.
Operational Qualification confirms that the equipment operates according to
specification initially and over time.
l The recommended OQ procedure consists of performing the system test, absorbance
plate test, and a series of liquid tests.
l The OQ procedure should be performed initially (before first use) and then routinely;
the recommended interval is annually. It should also be performed after any major
repair or upgrade to the hardware or software.
The risk and performance factors associated with your assays may require that the
Operational and Performance Qualification procedures be performed more or less
frequently than shown here.
IQ OQ PQ
Tasks/Tests Initially/
Initially Monthly Quarterly
Annually
All models:
Unpacking, installation, and setup ü
System Test ü ü ü
System Test
Instrument System Test, starting on page 20, describes this test and explains where to
find information on error codes and troubleshooting tips, as well as sample test reports
for 800 TS.
Setup
If your assays use incubation, we recommend enabling temperature control for at least
37°C and allowing the incubator to reach its set point before running the system test. To
access this feature:
l On the touchscreen:
1. Tap the temperature display. Note that until Temperature Control is enabled,
three dashes are displayed.
2. If necessary, turn on Temperature Control and enter a setpoint of at least
37°C, then tap Home to return to the Main Menu.
l In Gen5, select System > Instrument Control, and click the Pre-Heating tab.
1. When the temperature display reaches the defined setpoint, tap Instrument, then tap
Options.
2. Under System test, tap Start.
3. When the test finishes, tap USB Report to save the test results to a USB flash drive,
Print to print the test results, or Exit to close the screen.
1. From the Gen5 main screen, select System > Diagnostics > Run System Test.
If the test fails during execution, a message box appears in the Gen5. Close the box; the
test report contains the error code that was generated by the failure.
2. When the test is complete, a dialog appears, requesting additional information. Enter
any required information and then click OK.
3. The results report appears. it shows either “SYSTEM TEST PASS” or “SYSTEM TEST FAIL
*** ERROR (error code) DETECTED.”
If the test failed, look up the error code in Appendix B, Error Codes, starting on
page 81, to determine its cause. If the cause is something you can fix, turn off the
reader, fix the problem, and then turn the reader back on and retry the test. If
the test continues to fail, or if the cause is not something you can fix, contact
BioTek TAC.
4. If required, print, sign, and date the report, and store it with your test documentation.
5. If applicable, turn off the incubator.
BioTek Absorbance Test Plate, starting on page 52, describes the test methods and
provides troubleshooting tips in the event of test failure.
Requirement
To perform this test, you will need:
l Absorbance Test Plate, BTI #7260522
l (Optional) 340 nm Absorbance Test Plate, BTI #7260551
l (Optional) 340 nm filter installed in the instrument
l Current Absorbance Test Plate Calibration Certificate(s)
Setup
Before an Absorbance Test Plate can be used for qualification, you must enter information
from its Calibration Certificate into the reader or Gen5. Perform these steps initially, and
then repeat them annually after the test plate is recertified by BioTek.
Using Gen5
4. Select the appropriate Plate Type, and then enter the plate's serial number.
5. Enter the Last Certification and Next Certification dates from the calibration label on
the Test Plate.
6. If the wavelength values in the top row of the grid in Gen5 are appropriate for your
tests, enter the OD Standard values from the Calibration Certificate into the grid. Make
sure you enter the correct value for each well/wavelength combination.
If you need to change the wavelength values, click Wavelength List. Add, change, or
delete the values as needed and click OK.
7. Review all of the values that you entered. When finished, click OK to save the
information.
Test Procedure
1. Place the Absorbance Test Plate on the microplate carrier, with well A1 in the proper
location.
2. From the Main Menu, tap Instrument and then Test Plate.
3. Tap a Wavelength Selection button, then tap Start.
4. When the test is complete, choose an Output option (Print or USB Report), or tap Exit
to return to the Main Menu.
Using Gen5
1. From the Gen5 main screen, click System > Diagnostics > Test Plates > Run. If
prompted, select the desired Test Plate and click OK.
2. When the Absorbance Test Plate Options dialog appears, enter any required
information.
3. Highlight the wavelength(s) to be included in this test.
You need to select only those wavelengths most appropriate for your use of the reader.
Absorbance Liquid Tests, starting on page 54, describes the test methods, lists the
Gen5 protocol parameters, explains how to analyze the test results, and provides
troubleshooting tips in the event of test failure.
Absorbance Liquid Test 1
The tests in this section require specific microplates, solutions, and filters. Your
laboratory may require a deviation from some of these tests. For example, you may
wish to use a different plate or test solution. If deviation from the tests as presented
in this section is required, perform the following steps the first time each test is run:
• Perform the tests exactly as described here.
• Rerun the tests using your particular plates, solutions, and so on.
• If the results are comparable, then the results from these tests will be your
baseline for future tests. Document your new test procedure, and save all test
results.
Materials
Solution A
l BioTek QC Check Solution No. 1 (PN 7120779, 25 mL; or 7120782, 125 mL)
l Deionized water
l 5-mL Class A volumetric pipette
l 100-mL volumetric flask
1. Pipette a 5-mL aliquot of BioTek QC Check Solution No. 1 into a 100-mL volumetric flask.
2. Add 95 mL of DI water; cap and shake well. The solution should measure approximately
2.000 OD when using 200 µL in a flat-bottom microwell.
Solution B
l Deionized water
l FD&C Yellow No. 5 dye powder (typically 90% pure)
l Tween 20 (polyoxyethylene (20) sorbitan monolaurate) or BioTek wetting agent, PN
7773002 (a 10% Tween solution)
l Precision balance with capacity of 100 g minimum and readability of 0.001 g
l 1-liter volumetric flask
l Weigh boat
1. Weigh out 0.092 gram of FD&C No. 5 yellow dye powder into a weigh boat.
2. Rinse the contents into a 1-liter volumetric flask.
3. Add 0.5 mL of Tween 20, or 5 mL of BioTek’s wetting agent.
4. Make up to 1 liter with DI water; cap and shake well.
Test Procedure
1. Using freshly prepared stock solution (Solution A or B), prepare a 1:2 dilution using
deionized water (one part stock, one part deionized water; the resulting solution is a 1:2
dilution). The concentrated stock solution should have an optical density of
approximately 2.000 OD or lower.
2. Pipette 200 µL of the stock solution into column 1.
3. Pipette 200 µL of the diluted solution into column 2.
After pipetting the diluted test solution into the microplate and before reading
the plate, we strongly recommend shaking the plate for four minutes. This will
allow any air bubbles in the solution to settle and the meniscus to stabilize.
Alternatively, wait 20 minutes after pipetting the test solution before reading the
plate.
4. Read the microplate five times at 405 nm using the Normal Read Speed. When
prompted, rotate the plate 180 degrees and continue.
5. Print the five sets of raw data or send it to the USB flash drive for use in another
program.
6. Perform the Results Analysis calculations described in Chapter 5.
If using Gen5:
4. Create a Gen5 experiment based on the 800 TS Abs Test 1 protocol and read the plate.
When prompted, rotate the plate 180 degrees and continue.
5. When the experiment is finished:
l Save the experiment. Refer to the instructions on page 57 to perform calculations
and determine pass/fail.
l Troubleshooting tips are provided on page 59.
l Test descriptions are provided on page 54
The recommended method for testing the instrument’s alignment, repeatability, and
accuracy is to use Absorbance Test Plate BTI #7260522 (see page 52). If the test plate is
not available, however, Liquid Test 2 can be used for these tests.
Materials
Test Procedure
1. Create a percentage dilution series, beginning with 100% of the original concentrated
stock solution (A or B) in the first tube, 90% of the original solution in the second tube,
80% in the third tube, all the way to 10% in the tenth tube. Dilute using the 0.05%
solution of deionized water and Tween 20. This solution can also be made by diluting the
BioTek wetting agent 200:1.
Tube Number 1 2 3 4 5 6 7 8 9 10
The choice of dilutions and the absorbance of the original solution can be varied. Use
this table as a model for calculating the expected absorbances of a series of dilutions,
given a different absorbance of the original solution.
2. Pipette 200 µL of the concentrated solution from Tube 1 into each well of the first
column, A1 to H1, of a new flat-bottom microplate.
3. Pipette 200 µL from each of the remaining tubes into the wells of the corresponding
column of the microplate (Tube 2 into wells A2 to H2, Tube 3 into wells A3 to H3, and so
on).
After pipetting the diluted test solution into the microplate and before reading
the plate, we strongly recommend shaking the plate for four minutes. This will
allow any air bubbles in the solution to settle and the meniscus to stabilize.
Alternatively, wait 20 minutes after pipetting the test solution before reading the
plate.
4. Read the microplate five times at 450 nm (Primary)/630 nm (Secondary) using the
Normal Read Speed.
5. Do not discard the plate. You will use it for the Alignment Test.
6. Print the five sets of raw data or send it to the USB flash drive for use in Excel or other
program.
7. Perform the Linearity and Repeatability calculations described in Chapter 5.
8. (Alignment Test) Rotate the plate 180 degrees in the carrier, and then read the plate
five more times, with the same protocol as described in step 4. This test results in values
for the four corner wells that can be used to determine alignment.
9. Perform the Alignment calculations described in Chapter 5.
If using Gen5:
4. If using Gen5, create an experiment based on the 800 TS Abs Test 2 protocol and read
the plate. When prompted, rotate the plate 180 degrees.
5. When finished:
l Save the experiment. Refer to the instructions on page 57 to perform calculations
and determine pass/fail.
Absorbance Liquid Test 3 is provided for sites requiring proof of linearity at 340 nm.
This test is optional because the 800 TS has good "front end" linearity throughout its
wavelength range. As an alternative, the 340 nm Absorbance Test Plate (BTI #7260551)
may be used for this test.
Materials
Buffer Solution
l Deionized water
l Phosphate-Buffered Saline (PBS), pH 7.2–7.6, Sigma tablets, #P4417 (or equivalent)
l β-NADH Powder (β-Nicotinamide Adenine Dinucleotide, Reduced Form) Sigma bulk
catalog number N 8129, or preweighed 10-mg vials, Sigma number N6785-10VL (or
BioTek PN 98233). Store the powder according to the guidelines on its packaging.
Test Procedure
1. Prepare the 75% Test Solution by mixing 15 mL of the 100% Test Solution with 5 mL of
the PBS Solution.
2. Prepare the 50% Test Solution by mixing 10 mL of the 100% Test Solution with 10 mL of
the PBS Solution.
3. Carefully pipette the three solutions into a new 96-well microplate:
l 150 µL of the 100% Test Solution into all wells of columns 1 and 2
l 150 µL of the 75% Test Solution into all wells of columns 3 and 4
l 150 µL of the 50% Test Solution into all wells of column 5 and 6
After pipetting the diluted test solution into the microplate and before reading
the plate, we strongly recommend shaking the plate for four minutes. This will
allow any air bubbles in the solution to settle and the meniscus to stabilize.
Alternatively, wait 20 minutes after pipetting the test solution before reading the
plate.
4. Read the microplate five times at 340 nm using the Normal Read Speed.
5. Print the five sets of raw data or send it to the USB flash drive for use in other program.
6. Perform the Results Analysis calculations described in Chapter 5.
If using Gen5:
4. Create a Gen5 experiment based on the 800 TS Abs Test 3 protocol and read the plate.
l Save the experiment. Refer to the instructions on page 59 to perform calculations
and determine pass/fail.
l Troubleshooting tips are provided on page 59.
Specifications
This appendix contains BioTek's published specifications for the 800 TS.
General Specifications 76
Absorbance Specifications 77
76 | Appendix A: Specifications
General Specifications
Microplates
The 800 TS accommodates standard 6-, 12-, 24-, 48-, 96-, and (with the NB model) 384-well microplates
with 128 x 86 mm geometry and, if using Gen5 software with the NB model, 60-, 75-, and 96-well
Terasaki plates and BioCell vessels.
Incubation: Temperature control for 800TSUVI model: 8°C over ambient to 50°C
Absorbance Specifications
Absorbance Resolution
0.001 OD when operated in standalone mode
0.0001 OD when operated with Gen5
Accuracy
Normal Read Mode: ±1.0% ±0.010 OD from 0.000 to 2.000 OD @ 405 nm
Rapid Read Mode: ±2.0% ±0.020 OD from 0.000 to 2.000 OD @ 405 nm
Sweep Read Mode: ±1.0% ±0.020 OD from 0.000 to 1.000 OD @ 405 nm
Linearity
Normal Read Mode: ±1.0% ±0.010 OD from 0.000 to 2.000 OD @ 405 nm
Repeatability (STD)
Normal Read Mode: ± 0.5% ± 0.005 OD from 0.000 to 2.000 OD @ 405 nm
Rapid Read Mode: ± 1.0% ± 0.010 OD from 0.000 to 2.000 OD @ 405 nm
Throughput
From carrier start to carrier stop:
Absorbance Resolution
0.001 OD when operated in standalone mode
0.0001 OD when operated with Gen5
Throughput
From carrier start to carrier stop:
96-Well, Single Wavelength, Normal Read Mode: 39 seconds
Absorbance Resolution
0.001 OD when operated in standalone mode
0.0001 OD when operated with Gen5
Accuracy
Normal Read Mode (96-well): ±1.0% ±0.010 OD from 0.000 to 2.000 OD @ 405 nm
Rapid Read Mode (96-well) ±2.0% ±0.020 OD from 0.000 to 2.000 OD @ 405 nm
Normal Read Mode (384-well): ±2.0% ±0.020 OD from 0.000 to 2.000 OD @ 405 nm
Rapid Read Mode (384-well): ±2.5% ±0.020 OD from 0.000 to 2.000 OD @ 405 nm
Linearity
Normal Read Mode (96-well): ±1.0% ± 0.010 OD from 0.000 to 2.000 OD at 405 nm
Repeatability (STD)
Normal Read Mode (96-well): ±0.5% ± 0.005 OD from 0.000 to 2.000 OD @ 405 nm
Rapid Read Mode (96-well): ±1.0% ± 0.010 OD from 0.000 to 2.000 OD @ 405 nm
Normal Read Mode (384-well): ±1.5% ± 0.010 OD from 0.000 to 2.000 OD @ 405 nm
Rapid Read Mode (384-well): ±2.0% ± 0.010 OD from 0.000 to 2.000 OD @ 405 nm
Throughput
From carrier start to carrier stop:
96-Well, Single Wavelength, Normal Read Mode: 38 seconds
Error Codes
This appendix lists and describes 800 TS error codes that may appear in
Gen5.
Error codes beginning with “A” (e.g., A100) indicate conditions that require immediate
attention. If this type of code appears, turn the instrument off and on. If the system test
does not conclude successfully, record the error code and contact BioTek’s Technical
Assistance Center.
If an error code appears in Gen5, you should run a system test for diagnostic purposes. In
Gen5, select System > Diagnostics > Run System Test. Having the system test report
before calling the BioTek Technical Assistance Center can speed the resolution of the error.
Error Codes
This table lists the most common and easily resolved error codes that you may encounter.
If an error code appears in Gen5, look for it here. If you find the code, follow the
suggestions provided for solving the problem. If you cannot find the code or if you are
unable to solve the problem, please contact BioTek’s Technical Assistance Center. The
Gen5 Help system also provides troubleshooting tips.
x = motor axis
0 = x axis motor
1 = y axis motor
2 = filter motor
Possible causes:
Dirty axis rail where the bearings are worn and cause too much friction.
Run a self-test.
Note: In cases where a sensor is not functioning, the motor may drive the axis to
its mechanical stop and generate substantial noise but will not cause permanent
damage.
040x Motor failed positional verify.
Motor failed to reach the same position when moved a known number of steps
from the home position and back.
x = motor axis
0 = x axis motor
1 = y axis motor
2 = filter motor
Probable causes:
Troubleshooting:
x = motor axis
0 = x axis motor
1 = y axis motor
2 = filter motor
Run a self-test.
05xy Analog reading saturated.
x = filter position
y = readset
Run self-test.
060x Air reading too low.
x = filter position
Check lamp.
070x Signal to noise too low.
x = filter position
Ensure reader is not too close to another instrument that generates EMI (hot
plate, freezer, PC monitor)
0800 Analog offset out of range.
Hardware error.
Call TAC.
0C0x Power supply failure.
x = failed test
x = readset
Run self-test.
0E0x Attempted read with wavelength that is not present in reader.
x = readset
Run self-test.
0F00 Analog signal error: too low during gain calibration or changed too much
during read.
Run self-test.
1100 Configuration checksum error. Configuration data corrupted.
This error indicates that the stored checksum value from the configuration data
does not match the actual checksum of the current configuration data.
Recreate the assay definition in the correct version of the software and download
it again.
Call TAC.
1200 Carrier corner calibration mission.
x = motor axis
0 = x axis motor
1 = y axis motor
2 = filter motor
Run self-test.
x = motor axis
0 = x axis motor
1 = y axis motor
2 = filter motor
x = failure type
y = thermistor bitfield
Call TAC.
1700 Invalid kinetic interval.
Check assay.
1900 Memory allocation error.
Run a self-test.
2100 Invalid command parameter.
x = motor axis
0 = x axis motor
1 = y axis motor
2 = filter motor
xx = error type
Verify that the blanks are valid for the plate type.
4050 Absorbance test plate certification past due.
1C = No USB output selected
Troubleshooting:
Sample Reports
This appendix contains sample System Test and Absorbance Plate Test
reports for the 800 TS.
90 | Appendix C: Sample Reports