Bio-Tek Synergy H1 Manual de usuario
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: 888-451-5171 (toll-free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: 802-655-7941
Service/TAC
Phone: 800-242-4685 (toll free in the U.S.)
802-655-4740 (outside the U.S.)
Fax: 802-654-0638
European Coordination Center/Authorized European
Representative
BioTek®Instruments GmbH
Kocherwaldstrasse 34
D-74177 Bad Friedrichshall
Germany
Internet: www.biotek.de
Phone: +49 (0) 7136 9680
Fax: +49 (0) 7136 968 111
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.
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