Bio-Tek 405 LS User manual

Operator’s Manual
Microplate Washer
405™ LS

405™ Microplate Washer LS
Operator's Manual
BioTek Instruments, Inc.
January 2013
© January 2013
Part Number 1171030
Revision B

ii | 405 LS Operator's Manual
Notices
BioTekInstruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2013, 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 405™ Microplate Washer LSis a
trademark of BioTek Instruments, Inc.
Microsoft®, Internet Explorer®, Windows®, Windows 7, Windows Vista®,
Windows XP, 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.
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Notices| iii
Contents
Notices ii
All Rights Reserved ii
Trademarks ii
Restrictions and Liabilities ii
Contact Information viii
Customer Service and Sales viii
Service/TAC viii
European Coordination Center/Authorized European Representative viii
Document Conventions ix
Document Revision History ix
Intended Use Statement ix
Quality Control x
Warranty and Product Registration x
Repackaging and Shipping x
Warnings x
Hazards and Precautions xi
Hazards xi
Precautions xii
CE Mark xiv
Directive 2004/108/EC: Electromagnetic Compatibility xiv
Directive 2006/95/EC Low Voltage (Safety) xv
Directive 2002/96/EC: Waste Electrical and Electronic Equipment xv
Directive 98/79/EC: In Vitro Diagnostics(if labeled for this use) xv
Electromagnetic Interference and Susceptibility xv
USA FCC CLASS A xv
Canadian Department of Communications Class A xvi
User Safety xvi
Safety Symbols xvii
Introduction 1
Introducing the 405™ Microplate Washer LS 2
Instrument Models 3
BioStack Compatibility 3
Package Contents 5
Waste and Dispense System Accessories 6
Optional Accessories 7
Physical Specifications 9
Performance Specifications 10
BioTek's Customer Resource Center 12
Installation 13
Unpack and Inspect the Instrument 14
Remove the Shipping Hardware 14
Setting Up the 405 LS 18
Install the Microplate Carrier 18
Connect the Vacuum Pump, Tubes, and Bottles 18
Waste System 19
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Install the Vacuum Line Filter 21
Install the Fluid Supply System 22
Final Check 24
Attach the Mist Shield 24
Install Software/Connect to Computer 25
Connect to Host Computer 25
Connect to Power 26
Define Instrument Settings 26
LHC Users Only 26
Standard Vacuum Pump Users 27
Define Startup Preferences (LHC users only) 27
Verify Performance 29
Verify the Washer 30
Run the Verify Test ("Q" Models Only) 30
Repacking the 405 Washer 32
Operation 37
Basic Operation 38
About the 405 LS Wash Step 38
Optimize Performance 39
405 Recommendations for Priming the Washer 39
Optimize protocols to improve evacuation 40
Running Predefined Protocols 41
Creating Protocols: Washing, Aspirating and Dispensing Fluid 41
LHC Users Only: Customize the Predefined Protocols 41
Predefined Protocols Listing 43
Predefined Sample Protocols 44
Introducing the 405 LS Keypad 46
Quick Wash (Keypad only) 47
Quick Prime (Keypad only) 48
Create or Edit a Protocol (Keypad Only) 48
How to name a protocol (Keypad only) 49
Define the Plate Type and Plate Map (or Partial Plate) 50
How to shake the plate 51
How to enter negative numbers (Keypad only) 52
How to copy a protocol 52
How to delete a protocol 52
Using LHC to Control the 405™ Washer 54
Introducing the LHC Workspace 54
Communications Port 55
405 Steps 55
LHC Protocols 56
LHC Protocols Explained 57
Target Instrument Settings 58
How to define a Protocol (LHC only) 59
How to use the Adjust Utility- LHC 60
Upload-Download Protocols (LHC Only) 62
Wash Step Parameters Table 62
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Shake/Soak Step Parameters 66
Pre-Dispense 67
Washer Flow Rates 68
How to define a Final Aspiration step 69
Add a secondary aspiration to a wash cycle 70
Bottom Wash 70
Verify Performance 72
Handling the Verify Test Plate 73
Verify™ Technology Flowchart Diagram 75
Verify Test Corrective Action 75
About Verify™ Technology 76
Sensitivity: Verify Sensor vs. Absorbance Reader 78
Configure Verify™ Technology Utilities 79
Operating with the BioStack 81
BioStack Alignment Utility 82
Cell Wash 84
Cell Wash Strategies 85
Biomagnetic Separation - Magnetic Bead Assays 89
Perform Magnetic Bead Assays 90
Optimize Magnetic Bead Protocols 90
Flat Magnets 91
Ring Magnets 92
Magnet Height Offset 93
Determine Magnet Height Offset 93
Manifold Stop Screw Adjustment Kit 94
Vacuum Filtration for Filter Plate Assays 97
Install the side bracket 98
Set up the Vacuum Filtration module 99
Enable Vacuum Filtration 101
Create a Vacuum Filtration Protocol 101
Install Vacuum Filtration Plate Carrier 103
Control the Vacuum Level 104
Washer Settings 105
Change the Washer Manifold Setting (Keypad) 107
Change the Plate Carrier Setting (Keypad) 107
Change the Plate Clearance Setting (Keypad) 108
Adjust Utility 108
Run the Adjust Utility (Using the Keypad) 109
Plate Types and Processing Patterns 110
Plate Types Table 111
About Wash Processing Patterns 111
Maintenance 115
Overview 117
Recommended Maintenance Schedule 119
Daily Maintenance 121
Overnight/Multi-Day Maintenance 121
AutoPrime 122
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AutoPrime for Overnight-Weekend Maintenance 123
Turn on AutoPrime for the Washer 123
Removing Protein Residuals and Fungi Growth 124
AutoClean the Washer 125
Quick Clean (Keypad Only) 126
Create an AutoClean protocol 127
Periodic Maintenance 128
Clean the Bottles 128
Clean the Plate Carrier 129
Clean the Vacuum Filtration Carrier 129
Clean the exterior surfaces and mist shield 130
Clean the Buffer Bottle Filter 130
Remove and clean the washer manifold 131
Maintaining the Vacuum Filtration System 133
Clean the Vacuum Filtration Carrier 133
Maintain the Verify™ Technology Components 133
Clean the Verify™ Level Sensor 133
Replacement Procedure for Verify Test Plate 134
Volume coefficients - Slope and Offset 137
Decontamination 138
Tools and Supplies 138
Decontaminate Exterior Surfaces 139
Decontaminate Tubing and Manifold 140
Alternate Decontamination Procedure for Tubing and Manifold 141
Decontaminate the Vacuum Filtration System 142
Long Shutdown Procedure (Prepare for Storage or Shipment) 143
Storing the Instrument 144
Replace Components 144
Remove/Change Wash Manifold 145
Replace the Vacuum Pump Fuse 145
Vacuum Filtration Carrier: Replace the Gasket 146
Qualification 147
Qualification Overview 148
Qualification Schedule 149
System Self-Test, Verify Information 149
Record Basecode 150
Sensor Test: Fluid, Waste, Plate Detection 150
Ultrasonic Cleaner Test 151
Liquid Testing the 405™ Microplate Washer LS 152
Which Tests to Perform? 152
Important Recommendations for All Liquid Tests 153
Washer Liquid Tests 154
Dispense Precision Test 154
Evacuation Efficiency Test 154
Predefined Test Protocols 154
Washer Qualification Test Materials 155
Dispense Precision Test (96) 157
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Evacuation Efficiency Test (96) 158
Evacuation Diagnostic Test 159
Buffer Switching Dispense Test 160
Dispense Precision Test (192) 161
Evacuation Efficiency Test (192) 162
Evacuation Diagnostic Test (192) 163
Vacuum Filtration Evacuation Efficiency Test 165
Qualify the Verify™ Technology Sensor 167
Troubleshooting 179
Troubleshooting 180
General Operation Troubleshooting 182
Washer Problems 183
Communication Errors 188
Error Codes 191
System Error Codes 192
405 LS-LHC Software Error Codes 200
205
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Index .............................................................................................................

viii | 405 LS Operator's Manual
Contact Information
BioTekInstruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
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]
E-Mail: [e-mail]
Service/TAC
Phone: [phone] (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: [phone]
E-Mail: [e-mail]
European Coordination Center/Authorized European Representative
BioTekInstruments GmbH
Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany
Internet: www.biotek.de
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]
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Document Conventions| ix
Document Conventions
This manual uses the following typographic conventions:
nThis note format calls attention to important information.
Warnings are presented in this style to call attention to potential hazards and other
safety concerns.
This icon calls attention to important safety information.
Tips and suggestions for improving performance are formatted this way.
Navigation instructions: how to get to the function being described
nWater: Daily maintenance is the key to keeping the liquid handler performing
to specifications. In the maintenance procedures provided in this manual, the
requirement to use distilled (dH2O) or deionized (DI) water can be met by
numerous water purification methods, including MilliQ™. A minimum water
purity of 2mOhm is expected.
Document Revision History
Rev Date Changes
A 5/2012 First issue
B 1/2013 Added content about BioTek's Verify™ Technology, including the Plate
Detection sensor and new shipping hardware. Added instructions for running
the Verify test, analyzing its test results, maintaining the device, replacing
the test plate and qualifying the device. Note: the vacuum filtration plate
carrier was modified to accommodate the Verify device. Pinch hazard
warning label updated. Packing materials modified for all models.
Intended Use Statement
lThe 405™ Microplate Washer LS provides microplate priming, washing, and dispensing
for ELISA™, fluorescence and chemiluminescence immunoassays, cellular and
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agglutination assays.
lIf the instrument has an "IVD" label it may be used for clinical and non-clinical purposes,
including research and development. If there is no such label the instrument may only be
used for research and development and non-clinical purposes.
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.
Warranty and Product Registration
Please take a moment to review the Warranty information that shipped with your
product. Please also register your product with BioTek to ensure that you receive
important information and updates about the product(s) you have purchased.
You can register online through BioTek’s Customer Resource Center (CRC) at
www.biotek.com or by calling 888/451-5171 or 802/655-4740.
Repackaging and Shipping
If you need to ship the instrument to BioTek for service or repair, contact BioTek
for a Return Materials Authorization (RMA) number and use the original packing
materials. Other forms of commercially available packaging are not recommended
and can void the warranty. If the original packing materials have been damaged or
lost, contact BioTek for replacement packing.
Warnings
Operate the instrument on a level, stable surface away from excessive
humidity.
When operated in a safe environment, according to the instructions in this
document, there are no known hazards associated with the 405 LS. However,
the operator should be aware of certain situations that could result in serious
injury; these vary depending on the instrument type. See Hazards and
Precautions.
Strict adherence to instrument maintenance and qualification procedures is
required to ensure accurate dispense volumes and risk-free operation.
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Hazards and Precautions| xi
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 two-prong plug adapter to
connect primary power to the external power supply. Use of a two-prong
adapter disconnects the utility ground, creating a severe shock hazard. Always
connect the power 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 which 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 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 or instrument
damage. If a spill occurs while a program is running, abort the program and
turn the instrument off. Wipe up all spills immediately. Do not operate the
instrument if internal components have been exposed to fluid.
Warning! Unspecified Use. Failure to operate this equipment according to
the guidelines and safeguards specified in this manual could result in a
hazardous condition.
Warning! Direct Drain Waste. If installed, the direct drain waste system
pumps waste fluids from the washer directly into a sink or tank, and, potentially
into public waste water systems. Because the waste may be a biohazard, you
must ensure that you are in compliance with your local or national
government’s laws regarding safe disposal of the waste.
Warning! Ultrasonic Energy. Ultrasonic energy is present in the ultrasonic
cleaner reservoir (if equipped) when AUTOCLEAN/Quick Clean programs are
running. Avoid putting your fingers in the bath. Ultrasonic energy can be
destructive to human tissue.
Warning! Software Quality Control. The operator must follow the
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manufacturer’s assay package insert when modifying software parameters and
establishing washing or dispensing methods. Failure to conduct quality
control checks could result in erroneous test data.
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. Adequate safety precautions should be taken as outlined in the
assay’s package insert. This hazard is noted by the symbol shown here. Always
wear safety glasses and appropriate protective equipment, such as chemically
resistant rubber gloves and apron.
Warning! Pinch Hazard. Some areas of the instrument or its components can
present pinch hazards when the instrument is operating. Depending on the
instrument or component, these areas are marked with the symbol shown here.
Keep hands/fingers clear of these areas when the instrument is operating.
Precautions
The following precautions are provided to help avoid damage to the instrument:
Caution: Service. The instrument should be serviced by BioTek authorized
service personnel. Only qualified technical personnel should perform
troubleshooting and service procedures on internal components.
Caution: Spare Parts. Only approved spare parts should be used for
maintenance. The use of unapproved spare parts and accessories may result in
a loss of warranty and potentially impair instrument performance or cause
damage to the instrument.
Caution: Environmental Conditions. Do not expose the instrument to
temperature extremes. For proper operation, ambient temperatures should
remain within the range listed in the Specifications section. 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: Buffer Solution. Although many precautions have been taken to
ensure that the instrument is as corrosion-proof as possible, the instrument is
not sealed and liquids can seep into sensitive components. Make sure that any
spilled buffer solution is wiped off the instrument. Prolonged exposure to salt
solution may corrode parts of the microplate carrier, movement rail, springs,
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Hazards and Precautions| xiii
and other hardware.
Caution: Chemical Compatibility. Some chemicals may cause irreparable
damage to the instrument. The following chemicals have been deemed safe for
use in the instrument: buffer solutions (such as PBS), saline, surfactants,
deionized water, 70% ethyl, isopropyl, or methyl alcohol, 40% formaldehyde,
and 20% sodium hydroxide. Never use acetic acid, DMSO, or other organic
solvents. These chemicals may cause severe damage to the instrument.
Contact BioTek for more information and prior to using other questionable
chemicals.
Caution: Bovine Serum Albumin. Solutions containing proteins, such as
bovine serum albumin (BSA), will compromise the instrument’s performance
over time unless a strict maintenance protocol is adhered to. See
Maintenance procedures regarding BSA.
Caution: Power Supply. Only use the power supply shipped with the
instrument. Operate this power supply within the range of line voltages listed
on it.
Caution: Disposal. This instrument contains printed circuit boards and wiring
with lead solder. Dispose of the instrument according to Directive 2002/96/EC,
“on waste electrical and electronic equipment (WEEE),” or local ordinances.
Caution: Warranty. Failure to follow preventive maintenance protocols may
void the warranty.
Caution: Shipping Hardware. All shipping hardware (e.g., shipping bracket
etc.) must be removed before operating the instrument and reinstalled before
repackaging the instrument for shipment.
Caution: High Flow Pump Installation. DO NOT plug the High Flow vacuum
pump cable into a wall outlet! Use the adapter provided with the pump to
connect the pump to the accessory outlet on the back of the washer. See the
Installation instructions.
Caution: WasteSensorPort on 405 LS. (For customers who have
purchased the BioStack Microplate Stacker.) Although the waste sensor port on
the back of the 405 LS is the same type as the 24-VDC power connector on the
back of the BioStack, if an external 24-VDC power supply is plugged into the
405 LS’s port, it will permanently damage internal components.
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.
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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.
CE Mark
Based on the testing described below and information contained
herein, this instrument bears the CE mark.
nNote: See the Declaration of Conformity for specific information.
Directive 2004/108/EC: Electromagnetic Compatibility
Emissions—Class A
The system has been type-tested by an independent, accredited testing
laboratory and found to meet the requirements of EN 61326-1: 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 61000-4-8 Power Frequency Magnetic Field Immunity Test
EN 61000-4-11, Voltage Dips, Short Interruptions and Variations
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Electromagnetic Interference and Susceptibility| xv
Directive 2006/95/EC 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.”
Directive 2002/96/EC: Waste Electrical and Electronic Equipment
Disposal Notice: This instrument contains printed circuit boards and wiring with
lead solder. Dispose of the instrument according to Directive 2002/96/EC, “on
waste electrical and electronic equipment (WEEE)” or local ordinances.
Directive 98/79/EC: In Vitro Diagnostics (if labeled for this use)
lProduct registration with competent authorities.
lTraceability to the U.S. National Institute of Standards and Technology (NIST).
EN 61010-2-101 Particular requirements for in vitro diagnostic (IVD) medical
equipment.
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
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xvi | 405 LS Operator's Manual
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 Canadian
Department of Communications.
Le present appareil numerique n'émet pas de bruits radioelectriques depassant
les limites applicables aux appareils numerique de la Class A prescrites dans
le Reglement sur le brouillage radioelectrique edicte par le ministere des
Communications du Canada.
User Safety
This device has been type-tested by an independent laboratory and found to meet
the requirements of the following:
lUnderwriters Laboratories UL 61010-1 “Safety requirements for electrical
equipment for measurement, control and laboratory use; Part 1: general
requirements.”
lCanadian Standards Association CAN/CSA C22.2 No. 61010-1 “Safety
requirements for electrical equipment for measurement, control and
laboratory use; Part 1: general requirements.”
lEN 61010 Standards, see CE Mark on page xiv.
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Safety Symbols| xvii
Safety Symbols
Some of these symbols appear on the instrument or accessories:
Alternating current
Courant alternatif
Wechselstrom
Corrientealterna
Correntealternata
Both direct and alternating current
Courant continu et courant alternatif
Gleich - und Wechselstrom
Corriente continua y corrientealterna
Corrente continua e
correntealternata
Direct current
Courant continu
Gleichstrom
Corriente continua
Corrente continua
Earth ground terminal
Borne de terre
Erde (Betriebserde)
Borne de tierra
Terra (difunzionamento)
On (Supply)
Marche (alimentation)
Ein (VerbindungmitdemNetz)
Conectado
Chiuso
Protective conductor terminal
Borne de terre de protection
Schutzleiteranschluss
Borne de tierra de protección
Terra diprotezione
Off (Supply)
Arrêt (alimentation)
Aus (TrennungvomNetz)
Desconectado
Aperto
(scon-
nessionedallaretedialimentazione)
Caution (refer to accompanying
documents)
Attention (voir documents
d’accompanement)
AchtungsieheBegleitpapiere
Atención (vease los
documentosincluidos)
Attenzione, consultare la doc annessa
Warning, risk of electric shock
Attention, risque de choc électrique
Gefährlicheelektrischeschlag
Precaución, riesgo de
sacudidaeléctrica
Attenzione, rischiodiscossaelettrica
Warning, risk of crushing or pinching
Attention, risqued’écrasement et
pincement
Warnen, Gefahr des Zerquetschens
und Klemmen
Precaución, riesgo del
machacamiento y sejeción
Attenzione,
rischiodischiacciareedintrappolarsi
Warning, hot surface
Attention, surface chaude
Warnen, heißeOberfläche
Precaución, superficiecaliente
Attenzione, superficiecalda
Warning, potential biohazards
Attention,
risquesbiologiquespotentiels
Warnung!
MoeglichebiologischeGiftstoffe
Atención, riesgosbiológicos
Attenzione, rischiobiologico
In vitro diagnostic medical device
Dispositif médical de diagnostic in
vitro
Medizinisches In-Vitro-Diagnostikum
Dispositivo médico de diagnóstico in
vitro
Dispositivo medico diagnostico in
Separate collection for electrical and
electronic equipment
Les équipements électriques et
électroniques font l’objet d’une
collecte sélective
Getrennte Sammlung von Elektro-
und Elektronikgeräten
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xviii | 405 LS Operator's Manual
vitro Recogida selectiva de aparatos
eléctricos y electrónicos
Raccolta separata delle
apparecchiature elettriche ed
elettroniche
Consult instructions for use
Consulter la notice d’emploi
Gebrauchsanweisung beachten
Consultar las instrucciones de uso
Consultare le istruzioni per uso
405™ Microplate Washer LS