2 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2003-12
WARNING
CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED IN
Notice
Every effort has been made to avoid errors in text and diagrams; however, Tecan
Austria GmbH assumes no responsibility for any errors, which may appear in this
publication.
It is the policy of Tecan Austria GmbH to improve products as new techniques
and components become available. Tecan Austria GmbH therefore reserves the
right to change specifications at any time.
We would appreciate any comments on this publication.
Manufacturer
Tecan Austria GmbH
Untersbergstraße 1A
A-5082 Grödig/Salzburg
AUSTRIA / EUROPE
Telephone: 0043 (0)6246/8933
FAX: 0043 (0) 6246/72770
E-mail: office.austria@tecan.com
THIS PUBLICATION BEFORE OPERATING THE INSTRUMENT.
Copyright Information
The contents of this publication are the property of Tecan Austria GmbH and are
not to be copied, reproduced or transferred to another person or persons without
prior written permission.
Copyright Tecan Austria GmbH
All rights reserved.
Printed in Austria.
Declaration for EU Certificate
See the back of this publication.
SUNRISE Absorbance Reader Intended Use
See chapter 2.2.1 Sunrise Intended Use.
About the Instructions For Use
This publication is intended as Instructions For Use for the SUNRISE
Absorbance Reader, which is designed to measure the light absorbance (optical
density) of samples in 96 well microplates. It is intended as reference and
instruction for the user.
This document instructs how to:
• Install the instrument
• Clean and maintain the instrument
Warranty
3 Year Warranty
As an expert for microplate instrumentation Tecan proves its commitment to
quality and offers a unique 3 year warranty for your SUNRISE Absorbance
Reader as a standard. Warranty invalid if instrument is opened or modified.
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 3
Warnings, Cautions and Notes
There are various types of notices used in this publication. These notices
highlight important information or warn the user of a potentially dangerous
situation. The notices used in this publication appear below:
Note:
Gives helpful information.
Caution
Indicates a possibility of instrument damage or data loss if instructions
are not followed.
WARNING
INDICATES THE POSSIBILITY OF SEVERE PERSONAL INJURY, LOSS
OF LIFE OR EQUIPMENT DAMAGE IF THE INSTRUCTIONS ARE NOT
FOLLOWED.
WARNING
INDICATES THE POSSIBLE PRESENCE OF BIOLOGICALLY
HAZARDOUS MATERIAL. PROPER LABORATORY SAFETY
PRECAUTIONS MUST BE OBSERVED.
WARNING
INDICATES LASER. DO NOT STARE INTO THE BEAM!
4 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2003-12
Symbols
Manufactured by
Date of manufacture
Communauté Européenne
IVD
In vitro diagnostic medical device
Laser
Biohazardous
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 5
Abbreviations
Abbreviation
A Ampere
Abs Absorbance
C Celsius
CE Communauté Européenne
cm Centimeter
F Fahrenheit
Hz Hertz
IVD In vitro diagnostics
IVD-D In vitro diagnostics Directive
kg Kilogram
l; L Liter
MB Megabyte
µL Microliter
mL Milliliter
nm Nanometer
REF Reference Number/ Order Number
SN Serial Number
TYPE Name and type of instrument
V Volts
VA Volt ampere
VOLTAGE Voltage
6 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2003-12
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 9
1. Safety
1. Safety
1.1 Instrument Safety
1. Always follow basic safety precautions when using this product to reduce
the risk of injury, fire or electrical shock.
2. Read and understand all information in this document. Failure to read,
understand and follow the instructions in this publication may result in
damage to the product, injury to operating personnel or poor instrument
performance.
3. Observe all WARNINGS and CAUTION statements in this publication.
4. Never open SUNRISE while the instrument is plugged into a power source.
5. Observe proper laboratory safety precautions, such as wearing protective
clothing and using approved laboratory safety procedures.
WARNING
IF THE SUNRISE ABSORBANCE READER OR THE MAGELLAN
SOFTWARE ARE MODIFIED IN ANY WAY, THE PERFORMANCE OF THE
THE WARRANTY WILL NO LONGER BE VALID AND THE INSTRUMENT
READER MAY BE NEGATIVELY AFFECTED,
WILL NOT BE CE CONFORM.
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 1-1
2. General
2. General
2.1 Introduction
Before starting measurements, make sure that the microplate
The SUNRISE instruments are fully automatic, microprocessor controlled readers
designed for professional use, enabling the user to measure the light absorbance
(optical density) of samples in 96 well microplates according to the specifications
described in this publication for in vitro diagnostics.
Note:
SUNRISE Absorbance Reader is intended for use
with only external software.
Caution
position A1 is inserted correctly.
Note:
Results obtained using the SUNRISE are influenced by the proper use of the
instrument and microplates, according to the instructions given in this
document, as well as the liquid compounds used (reagents, chemistry). The
instructions for use, storage and other manipulations in connection with
samples or reagents must be strictly followed. Taking this fact into
consideration, results must be interpreted carefully.
By reading twelve wells simultaneously, the instrument is able to measure a
microplate in approximately six seconds.
The obtained transmission values are converted into OD values according to the
following formula:
I
T onTransmissi
=
I
o
1
Log OD
=
T
=
o
=
With an innovative range of options, this versatile microplate reader gives
diagnostic and research laboratories all the features for numerous purposes.
Based on a new design concept EPAC, the excellent optical performance and
high quality of the SUNRISE will guarantee fast, reproducible and accurate
measurements.
The SUNRISE is designed to be fitted into Tecan robotic systems.
The SUNRISE Absorbance Reader is an optical 96-well microplate reader for the
measurement of absorbance and turbidimetry of samples from the biological or
non-biological origin according to the specifications described in this document,
intended for professional use only.
light emitted I
light detected I
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2-1
2. General
The SUNRISE Absorbance Reader is available with options Touchscreen,
tuneable wavelength, temperature control and barcode scanner.
The Tecan Sunrise Absorbance Reader when used with the appropriate Magellan
software is declared suitable for in-vitro diagnosis (IVD) purposes (Directive
98/79/EC of the European Community).
Magellan is a reader control and data reduction software package, also used for
concentration and titer determination.
Note:
It is important to note that the proper installation of the instrument and
Magellan software alone will not ensure compliance with the IVD Directive. A
range of policies and standard operating procedures according to local
regulations must also be established.
Make sure that the instrument and the software are suitable for use with the
reagents, chemicals and microplates used (see 7.2 Optimizing for Maximum
Performance and 7.3 Performance Tests).
Caution
If the instructions given in this publication are not correctly followed,
the instrument may become damaged or procedures may not be correctly
performed and the safety of the instrument cannot be guaranteed.
Note:
For more information about the operating instructions,
see Magellan or XFluor4 Instructions for Use.
WARNING
CAREFULLY READ AND UNDERSTAND ALL INFORMATION IN THIS DOCUMENT.
FAILURE TO READ, UNDERSTAND AND FOLLOW THE INSTRUCTIONS IN THIS
PUBLICATION MAY RESULT IN DAMAGE TO THE PRODUCT, INJURY TO OPERATING
PERSONNEL OR POOR INSTRUMENT PERFORMANCE.
2-2 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2003-12
2. General
2.2 Area of Application
2.2.1 Sunrise Intended Use
The Sunrise Absorbance Reader is an optical 96-well microplate reader for the
measurement of absorbance including turbidimetry (optical density) of samples
from biological or non-biological origin according to the specifications described in
this manual intended for professional use in:
in-vitro diagnostic environments with tests like:
• Enzyme Immuno Assays (EIA), e.g. for diagnostic of infectious
diseases, autoimmune diagnostic, allergy screening,
• Agglutination Assays, e.g. for blood typing assays,
• Enzyme Assays, e.g. haemostaseology assays and
• Enzyme Linked Probe Hybridization Assays (ELPHA), e.g. HLA-
typing assays,
which have been validated according to the IVD directive or other
relevant regulations or
pharmaceutical, biotechnological and life science industry, for research
use, for food analysis and veterinary applications.
The Sunrise Absorbance Reader has been validated for use with representative
applications from the above list. The validation shows the general ability of the
Sunrise Absorbance Reader to use the above mentioned methods.
Note
If the Sunrise Absorbance Reader or Magellan software
are modified in any way the instrument loses its guarantee
The operating authority must use only CE-labeled test kits for clinical
diagnostic applications. The operating authority must assure that the
combination of a particular CE-labeled test kit used with the CE-labeled
Sunrise Absorbance Reader as been validated according to the IVD
directive or to other relevant national or local regulations.
If the Sunrise Absorbance Reader is used with any other software other than
Magellan, additional validation must be carried out by the operating authority to
ensure the safety of the results. The operating authority is fully responsible for
any results obtained using software other than Magellan with the Sunrise Absorbance Reader.
and will no longer be IVD compliant.
Note:
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2-3
2. General
2.2.2 Sunrise Variations
All variations of the Sunrise Absorbance Reader and its Options are compliant
with the IVD directive and part of the CE declaration of conformity.
Sunrise Hardware Variations
The following table shows the compatibility of the filter slides with each
Sunrise hardware variation:
Sunrise
Variations
Standard
6 Filter
Tuneable
Wavelength
Sunrise Options
The Sunrise options work with all hardware variations and accessories and can
be used in any combination:
Sunrise Options
Temperature Control
Touch screen
Barcode
Sunrise Accessories
The Sunrise accessories work with all hardware variations and options and can
be used in any combination:
IVD compliant. Included in the CE declaration for the instrument.
2
IVD compliant. CE declaration is separate from that of the instrument.
3
Can be used in an IVD environment. CE declaration does not exist or it is unrelated to IVD compliance.
2-4 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2003-12
2. General
2.2.3 Available Options for SUNRISE
The SUNRISE is a modular system, so you can create your own tailor-made
instrument that meets exactly your needs. Options such as a Touchscreen
combined with a WindowsCE based on-board software, free wavelength
selection, temperature control and a bar code scanner can be added onto the
basic system which is dedicated to remote controlled computer operation.
Factory Installed Options
Touchscreen
B037302
Tuneable wavelength
from 400 – 700 nm
B037306
Temperature Control
SUNRISE Absorbance Reader
B037303
Upgrade in Field Possible
Barcode scanner
B037304
Barcode Upgrade Kit
6 Filter
B03641002
S 039 386
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2-5
2. General
2.3 Specifications
The tables below lists the specifications for the instruments.
All connected devices must
be approved and listed as per
EN 60950, UL 1950 or
CSA C22.2 No. 950 for Data
Processing Devices.
Computer interface:
Serial RS 232 C
Printer
Better than +/- 2 %
Better than +/- 1 %
Better than +/- 1.5 %
Narrow band interference filters. Up to four
filters can be mounted in a filter carriage.
The instrument can use up to eight different
filter carriages.
Halogen lamp 20 W
300 - 38,400 baud
Only functions with the Touchscreen
option.
2003-12 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2-7
2. General
2.3.3 SUNRISE Touchscreen Instrument
PARAMETERS CHARACTERISTICS
Screen Size
Operating System
Operating Software: MagellanCE
Storage
Computer interface:
Serial RS 232 C
Printer
Serial RS 232 C to the Touchscreen
MagellanCE software
240 x 320 pixel
WindowsCE
8 / 32 MB (SUNRISE Memo Card)
300 - 38,400 baud
Only functions with the Touchscreen option.
Only for the XChange program.
See Magellan Manual
2-8 Instructions For Use for SUNRISE Absorbance Reader No. I 137 311 Rev No. 1.0 2003-12