Bio-Tek Synergy H1 User manual

Synergy™ H1
Hybrid Multi-Mode Microplate Reader
Instructions for Use
For In Vitro Diagnostic Use
June 2012
© 2012
Part Number 8041005
Revision B
BioTek®Instruments, Inc.

ii | Preface
Notices
BioTek® Instruments, Inc.
Highland Park, P.O. Box 998
Winooski, Vermont 05404-0998 USA
All Rights Reserved
© 2012, 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 , Gen5™, BioStack™, and Take3™ and
Take3Trio™ Micro-Volume Plates are trademarks of BioTek Instruments, Inc. Harta™
is a trademark of Harta Instruments. Glowell™ is a trademark of LUX Biotechnology,
Ltd.
Microsoft®, Windows®and Excel®are either registered trademarks or trademarks of
Microsoft Corporation in the United States and/or other countries.
Kalrez®is a registered trademark of DuPont Performance Elastomers, L.L.C. (DPE).
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.
BioTek Instruments, Inc.

Contact Information | iii
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: [email protected]
Service/TAC
Phone: [phone] (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: [phone]
E-Mail: [email protected]
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: [email protected]
Synergy H1

iv | Preface
Instructions for Use Requirements
This document fulfills the basic needs of persons operating this device, according to the
requirements of the In Vitro Diagnostic Directive for “Instructions for Use.” Some of the
device’s higher-level functions and features, as well as certain detailed maintenance and
qualification routines, are described in the Synergy H1 Operator’s Manual.
Intended Use Statement
•The Synergy H1 is a hybrid multi-mode microplate reader. The performance
characteristics of the data reduction software have not been established with any
laboratory diagnostic assay. The user must evaluate this instrument and PC-based
software in conjunction with their specific assay(s). This evaluation must include
the confirmation that performance characteristics for the specific assay(s) are met.
•This product may be used for In Vitro Diagnostic, research and development, or
other 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.
BioTek Instruments, Inc.

Warnings | v
Warnings
Operate the instrument on a level, stable surface away from excessive humidity.
Bright 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 hazard warnings are provided to help avoid injury:
Warning! Internal Voltage. Always turn off the power switch and unplug the
power supply before cleaning the outer surface of the instrument or removing its
top case.
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! Instrument Weight. The instrument with all available modules
weighs up to 55 pounds (24.95 kg). Use two people when lifting and carrying the
instrument.
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.
Synergy H1

vi | Preface
Warning! Potential Biohazards. Some assays or specimens may pose a
biohazard. Adequate safety precautions should be taken as outlined in the assay’s
package insert. Always wear safety glasses and appropriate protective equipment,
such as chemical-resistant rubber gloves and apron.
Warning! Unspecified Use. Failure to operate this 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
absorbance data. All information 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
personnel.
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: Power Supply. Use only the power supply shipped with the
instrument 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.
BioTek Instruments, Inc.

Precautions | vii
Caution: Shipping Hardware. The carrier shipping screw and filter reader
shipping bracket must be removed before operating the instrument. They must be
reinstalled before shipping the instrument.
Caution: Electromagnetic Environment. Per EN 61326-2-6 it is the user’s
responsibility to ensure that a compatible electromagnetic environment for this
instrument is provided and maintained in order that the device will perform as
intended.
Caution: Electromagnetic Compatibility. Do not use this device in close
proximity to sources of strong electromagnetic radiation (e.g., unshielded
intentional RF sources), because these may interfere with the proper operation.
Synergy H1

viii | Preface
CE Mark
Based on the testing described below and information contained
herein, this instrument bears the CE mark
See the Declaration of Conformity for more 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 61000-4-11, Voltage Dips, Short Interruptions and Variations
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.”
EN 61010-2-81, “Requirements for automatic and semi-automatic laboratory
equipment for analysis and other purposes.”
BioTek Instruments, Inc.

Electromagnetic Interference and Susceptibility | ix
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)
•Product registration with competent authorities
•Traceability 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
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. Like all
similar equipment, 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 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 cable must be
used with this equipment. Operation with non-approved equipment or unshielded
cables is likely to result in interference to radio and television reception.
Canadian Department of Communications Class A
This digital apparatus does not exceed Class A limits for radio emissions from
digital apparatus set out in the Radio Interference Regulations of the 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.
Synergy H1

x | Preface
User Safety
This device has been type-tested by an independent laboratory and found to meet the
requirements of the following:
•Underwriters Laboratories UL 61010-1
“Safety requirements for electrical equipment for measurement, control and
laboratory use; Part 1: general requirements”
•Canadian Standards Association CAN/CSA C22.2 No. 61010-1
“Safety requirements for electrical equipment for measurement, control and
laboratory use; Part 1: general requirements”
•EN 61010 standards: see CE Mark on page viii
BioTek Instruments, Inc.

Safety Symbols | xi
Safety Symbols
Some of the following symbols may appear on the instrument or dispense module:
Alternating current
Courant alternatif
Wechselstrom
Corriente alterna
Corrente alternata
Both direct and alternating current
Courant continu et courant alternatif
Gleich - und Wechselstrom
Corriente continua y corriente alterna
Corrente continua e corrente alternata
Direct current
Courant continu
Gleichstrom
Corriente continua
Corrente continua
Earth ground terminal
Borne de terre
Erde (Betriebserde)
Borne de tierra
Terra (di funzionamento)
On (Supply)
Marche (alimentation)
Ein (Verbindung mit dem
Netz)
Conectado
Chiuso
Protective conductor terminal
Borne de terre de protection
Schutzleiteranschluss
Borne de tierra de protección
Terra di protezione
Off (Supply)
Arrêt (alimentation)
Aus (Trennung vom Netz)
Desconectado
Aperto (sconnessione dalla rete
di alimentazione)
Caution (refer to accompanying
documents)
Attention (voir documents
d’accompanement)
Achtung siehe Begleitpapiere
Atención (vease los documentos incluidos)
Attenzione, consultare la doc annessa
Warning, risk of electric shock
Attention, risque de choc
électrique
Gefährliche elektrische schlag
Precaución, riesgo de sacudida
eléctrica
Attenzione, rischio di scossa
elettrica
Warning, risk of crushing or pinching
Attention, risque d’écrasement et
pincement
Warnen, Gefahr des Zerquetschens und
Klemmen
Precaución, riesgo del machacamiento y
sejeción
Attenzione, rischio di schiacciare ed
intrappolarsi
Warning, hot surface
Attention, surface chaude
Warnen, heiße Oberfläche
Precaución, superficie caliente
Attenzione, superficie calda
Warning, potential biohazards
Attention, risques biologiques potentiels
Warnung! Moegliche biologische Giftstoffe
Atención, riesgos biológicos
Attenzione, rischio biologico
Synergy H1

xii | Preface
BioTek Instruments, Inc.
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 vitro
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
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

Installation

2 | Installation
Package Contents
Item Part #
Synergy H1 Operator’s Manual 8041000
Power supply 76061
Power cord set (specific to installation environment):
Europe (Schuko)
USA/International
United Kingdom
Australia/New Zealand
75010
75011
75012
75013
RS-232 serial cable 75034
USB cable with USB Driver Software 75108
7090204
Phillips screwdriver 01188
Models with injectors (“D” dispenser models), an external dispense
module (packed separately), with the following accessories:
Injector
Inlet tubes (2) from supply bottles to syringe drives
250-µL syringes (2)
Syringe thumbscrews (2)
Priming plate
Injector tip priming trough
Dispense module communication cable
Dispense module front cover
Dispense module box
Supply bottles (2, 30 mL)
Supply bottle holders (2)
Injector tip cleaning stylus and plastic storage bag
Strap reagent racks (6)
8040541
7082121
7083000
19511
8042202
8042068
75107
8042197
8040534
7122609
8042193
2872304
7212035
Models with the gas controller (“G” models) (packed separately):
Gas controller unit, CO2/O2 control
Shipping accessories, CO2/O2 control
Gas controller unit, CO2 only
Shipping accessories, CO2 only
1210500
1210009
1210504
1210010
BioTek Instruments, Inc.

1: Unpack and Inspect the Reader | 3
1: Unpack and Inspect the Reader
The instrument should be removed from the box by two people. It
weighs up to 55 pounds (24.95 kg).
Save all packaging materials. If you need to ship the instrument to
BioTek for repair or replacement, you must use the original
materials. Using other forms of commercially available packaging,
or failing to follow the repackaging instructions, may void your
warranty.
During the unpacking process, inspect the packaging, instrument,
and accessories for shipping damage. If the instrument is damaged,
notify the carrier and your BioTek representative. Keep the
shipping boxes and the packaging materials for the carrier’s
inspection. BioTek will arrange for repair or replacement
immediately.
1. Open the shipping box, remove the instrument from the box, and place it on a
level, stable surface.
2. Place the packaging materials back into the shipping boxes for reuse if the
reader needs to be shipped again.
2: Unpack and Inspect the Dispense Module
If applicable:
1. Open the shipping box. Remove the accessories box and foam insert that
contains the injector tubing and bottle holders.
2. Lift out the module and place it on a level surface.
3. Open the accessories box and removes its contents. The accessories should
include the dispense module–related items.
4. Place all packaging materials into the shipping box for reuse if the dispense
module needs to be shipped again.
Synergy H1

4 | Installation
3: Unpack and Inspect the Gas Controller
1. Open the shipping box.
2. Lift out the accessories (power supply, tubing, and manual) and set them aside.
3. Lift out the module and place it on a level surface.
4. Place all packaging materials into the shipping box for reuse if the gas
controller module needs to be shipped.
4: Select an Appropriate Location
Install the reader on a level, stable surface in an area where ambient temperatures between
18°C (64°F) and 40°C (104°F) can be maintained. Leave at least six inches of space between
the instrument’s rear panel and any other object. This space ensures proper air flow in and
out of the instrument.
The reader is sensitive to extreme environmental conditions. Avoid the following:
•Excessive humidity. Condensation directly on the sensitive electronic circuits
can cause the instrument to fail internal self-checks. The humidity must be in
the range of 10–85%, non-condensing.
•Excessive ambient light. Bright light may affect the reader’s optics and
readings, reducing its linear range.
•Dust. Readings may be affected by extraneous particles (such as dust) in the
microplate wells. A clean work area is necessary to ensure accurate readings.

If you are installing the BioStack for operation with the
Synergy H1, be sure to allow enough room for both
instruments and the host computer. The BioStack and the
reader require a space approximately 42" D x 17" W x 24" H
(for 30-plate stacks) or 34" H (for 50-plate stacks) (106.7 cm D x
43.2 cm W x 61 cm/86.5 cm H). You will also need additional
room around the instruments for cables, power supplies, and
the computer, and above the BioStack for stack removal.
You may wish to seat the instruments in their aligning plates now.
Refer to the BioStack Operator’s Manual for more information.
BioTek Instruments, Inc.

5: Remove the Shipping Hardware | 5
Synergy H1
5: Remove the Shipping Hardware
Remove all shipping hardware before you turn on the
reader.
1. Locate the shipping hardware.
2. Using a screwdriver, remove the carrier shipping bracket.
3. If the instrument is equipped with the filter module, using a screwdriver,
remove the filter reader shipping bracket.
4. Store the shipping hardware with the original packaging for reuse in case you
need to ship the instrument.
Figure 1
6: Install the Power Supply
Power Rating. The instrument 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.
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.
Carrier shipping
bracket Filter reader
shipping
bracket

6 | Installation
1. Locate the power inlet on the back of the reader.
2. Examine the power supply’s plug. It has a small groove that lines up with a tab
inside the power inlet.
3. Insert the plug into the power inlet.
4. Plug the power supply’s cord into as appropriate power receptacle.
7: Connect the Gas Controller
See the Gas Controller User Guide for installation instructions.
8: Install the Dispense Module
1. Place the dispense module on top of the gas controller (if used) or the reader.
Figure 2
2. Open the plastic bag containing the injector tubes and tips (labeled as PN
8040541). Remove the clear plastic shrouds from the tubes.
BioTek Instruments, Inc.

8: Install the Dispense Module | 7
3. Place the nylon screws and the plastic shrouds in the tool storage bag. Use the
supplied fastener strips to attach the bag to the rear panel of the dispense
module.
4. Remove the two inlet tubes from their plastic canisters.
5. Identify the two syringe valves on the dispense module (see Figure 4). Each is
labeled with a left-pointing arrow.
When installing the inlet and outlet tubes, do not use any tools.
Finger-tighten only!
6. Screw the fitting of one inlet tube into the right side of the Syringe 1 valve.
7. Screw one end of one outlet tube into the left side of the Syringe 1 valve.
8. Screw the other end of the outlet tube into the Syringe 1 port in the injector tip
holder.
9. Repeat these steps to attach the inlet and outlet tubing for Syringe 2.
It is critical that the tubing is installed in the correct ports. Otherwise,
injected fluid may miss the intended well.
10. Thread the injector tip holder, with outlet tubing connected to both ports,
through the hole in the top of the reader.
11. Open the door on the front of the reader, and, holding the injector tip holder by
the tab, insert the injector tips into the appropriate holes inside the reader
(Figure 3).
Injector
tip
holder
Figure 3
Synergy H1

8 | Installation
A magnet located between the injector tips helps to guide the tips into
place and secures them in the reader.
12. Place the light shield over the hole in the top of the reader and finger-tighten
the thumbscrews to secure it.
Outlet
tubes
Syringe
valves
Injector
tip
holder
Light
shield
Inlet
tubes
Figure 4
13. Remove the two syringes from their protective boxes. They are identical and
interchangeable. Each syringe should already be assembled in one piece, but if
for some reason there are two separate pieces, assemble them now: Insert the
white tip of the syringe plunger into the barrel of the syringe and gently push it
all the way into the barrel.
14. Install both syringes, referring to Figure 5:
•Hold the syringe vertically with the threaded end at the top.
•Screw the top of the syringe into the bottom of the syringe valve. Finger-
tighten only.
•Carefully pull down the bottom of the syringe until it rests inside the hole
in the bracket.
•Pass a thumbscrew up through this hole and thread it into the bottom of the
syringe. Hold the syringe from rotating while tightening the thumbscrew.
Finger-tighten only.
BioTek Instruments, Inc.