IFU Sunrise AR TSC English V1 6

TECAN
Instructions for Use for

sunrise Absorbance Reader
+ Option Touchscreen Color

Document Part No.: 30041769
2010-05
Document Revision No.: 1.6

2 Instructions for Use for sunrise Absorbance Reader No. 30041769 Rev. No. 1.6 2010-05
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2010-05 Instructions for Use for sunrise Absorbance Reader No. 30041769 Rev. No. 1.6 3

WARNING
CAREFULLY READ AND FOLLOW THE INSTRUCTIONS PROVIDED
IN THIS PUBLICATION BEFORE OPERATING THE INSTRUMENT.
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 with appropriate verification, validation,
and approvals.

We would appreciate any comments on this publication.
Manufacturer
Tecan Austria GmbH
Untersbergstrae 1A
A-5082 Grdig/Salzburg
AUSTRIA / EUROPE
Telephone: 0043 (0)6246/8933
FAX: 0043 (0) 6246/72770
E-mail: office.austria@tecan.com
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
Provided upon request
sunrise Absorbance Reader Intended Use
See chapter 2.2.1 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 will be invalid if the instrument is opened or modified.

Warnings, Cautions and Notes
The following types of notices are used throughout this publication to highlight
important information or to warn the user of potentially dangerous situations:

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 INJ URY,
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!

ATTENTION
Negative environmental impacts associated with the treatment of WEEE
Do not treat electrical and electronic equipment as unsorted municipal
waste.
Waste of electrical and electronic equipment must be collected
separately.

Symbols

Manufactured by

Date of manufacture

Conformit Europenne
I VD
In vitro diagnostic medical device

Laser

Bio-hazardous

Abbreviations

Abbreviation
A Ampere
Abs. Absorbance
ADC Analog digital converter
ASCII American Standard Code for Information
Interchange
ASTM American Society for Testing and Material
C Celsius
CE Conformit Europenne
cm Centimeter
F Fahrenheit
Hz Hertz
IVD In vitro diagnostics
IVD-D In vitro diagnostics Directive
kg Kilogram
l; L Liter
LED Light emitting diode
LIS Laboratory Information System
MB Megabyte
ml Milliliter
nm Nanometer
OD Optical Density
REF Reference Number/ Order Number
SN Serial Number
TYPE Name and type of instrument
USB Universal serial bus
V Volts
VA Volt ampere
VGA Video graphics array
VOLTAGE Voltage

Table of Contents
1. Safety .......................................................................................... 11
1.1 Instrument Safety .......................................................................... 11
2. General ........................................................................................ 13
2.1 Introduction ................................................................................... 13
2.2 Area of Application ........................................................................ 15
2.2.1 Intended Use ................................................................................... 15
2.2.2 Variations of sunrise ......................................................................... 16
2.2.3 Available Options for sunrise ............................................................ 17
2.3 Specifications ................................................................................ 18
2.3.1 General ........................................................................................... 18
2.3.2 Standard Instrument (Standard Filter Carriage) ............................... 19
2.3.3 Touchscreen Color Instrument ........................................................ 20
2.3.4 Tuneable Wavelength Instrument (Gradient Filter Carriage) ............ 21
2.3.5 6 Filter Instrument (6 Filter Carriage) ............................................... 21
2.3.6 Temperature Control ....................................................................... 22
2.3.7 Barcode Laser Scanner (Integrated for Plate IDs) ........................ 23
2.3.8 Microplates ...................................................................................... 23
2.3.9 Barcode Labels ............................................................................... 24
2.3.10 USB Stick for Data Storage (Magellan System Stick) ...................... 25
2.3.11 USB Stick for Data Export (Magellan Export Stick
Part of LIS Option for sunrise Touchscreen Color) ............................ 26
2.4 Instrument Description ................................................................. 26
2.4.1 Back Panel Connections ................................................................. 27
2.4.2 Handling the Microplate ................................................................... 28
2.5 Filter Carriage Description ............................................................ 29
2.5.1 Standard Filter Carriage .................................................................. 29
2.5.2 Gradient Filter Carriage ................................................................... 29
2.5.3 6 Filter Carriage ............................................................................... 30
2.6 Instrument Features ...................................................................... 31
2.6.1 Measurement Modes ....................................................................... 31
2.6.2 Microplate Shaking .......................................................................... 32
2.7 Instrument Accessories ................................................................ 32
2.8 Software for the sunrise Absorbance Reader ................................ 33
3. Installation Procedure ............................................................... 35
3.1 Introduction ................................................................................... 35
3.2 Unpacking and Inspection ............................................................ 35
3.3 Unpacking Procedure ................................................................... 36
3.4 Power Requirements ..................................................................... 36
3.5 Environmental Requirements ....................................................... 36
3.6 Instrument Installation Procedure ................................................ 37
3.7 Installation of Instrument Control Software ................................ 37

3.8 Defining the Instrument Settings .................................................. 38
3.8.1 Installation of Sunrise Instrument Settings Software ...................... 38
3.8.2 Starting the Sunrise Instrument Settings ........................................ 39
3.8.3 Define Instrument Mode ................................................................... 39
3.8.4 Define Filter ..................................................................................... 40
3.8.5 Define Measurement Mode .............................................................. 41
4. The sunrise Touchscreen ........................................................... 43
4.1 Introduction .................................................................................... 43
4.2 Area of Application for the Touchscreen Option ......................... 44
4.3 Specifications ................................................................................. 44
4.4 Instrument Description .................................................................. 45
4.4.1 Touchscreen Back Panel Connections ............................................. 45
4.4.2 Data Handling .................................................................................. 46
4.4.3 Data Handling with LIS Option ASTM Export ................................ 46
4.4.4 Printer Compatibility ......................................................................... 47
4.4.5 Handling the USB Stick .................................................................... 48
4.4.6 USB Stick Data Management ........................................................... 49
4.4.7 LIS Option (for sunrise Touchscreen Color only) ............................... 49
4.5 Operating the Touchscreen ........................................................... 52
4.5.1 Introduction ...................................................................................... 52
4.5.2 Starting the Software ........................................................................ 52
4.5.3 Special Features of MagellanCE ...................................................... 53
4.6 Change Instrument Control Mode ................................................. 55
4.6.1 Set Instrument in Remote Mode ....................................................... 55
4.6.2 Set Instrument in Local Mode ........................................................... 56
5. Error Messages and Trouble Shooting .................................... 57
5.1 Introduction .................................................................................... 57
5.1.1 Table of Error Messages and Trouble Shooting for sunrise Mode ..... 57
5.1.2 Table of Error Messages and Trouble Shooting
for SPECTRA Mode ......................................................................... 60
5.1.3 Table of Error Messages and Trouble Shooting for Touchscreen ..... 61
5.1.4 Error Message and Trouble Shooting for Handheld
Barcode Scanner ............................................................................. 62
5.2 Definition of Overflow .................................................................. 62
6. Maintenance & Cleaning ........................................................... 63
6.1 Introduction .................................................................................... 63
6.2 Filter Replacement ......................................................................... 64
6.2.1 Standard Filter Carriages ................................................................. 64
6.2.2 Gradient Filter Carriages .................................................................. 65
6.2.3 6 Filter Carriages ............................................................................. 66
6.3 Fuse Replacement ......................................................................... 67
6.4 Cleaning the Instrument ................................................................ 68
6.4.1 Cleaning the Device ......................................................................... 68

6.4.2 Cleaning the Touchscreen ............................................................... 68
6.4.3 Liquid Spills ..................................................................................... 68
6.5 Preventive Maintenance Plan for sunrise ...................................... 69
6.5.1 Daily ................................................................................................ 69
6.5.2 Weekly ............................................................................................ 69
6.5.3 Every Six Months ............................................................................ 69
6.5.4 Yearly (Customer or Service Technician) ........................................ 69
6.5.5 Every Four Years (Service Technician Required) ............................ 69
6.6 Instrument Disinfection................................................................. 70
6.6.1 Disinfection Solutions ...................................................................... 70
6.6.2 Disinfection Procedure .................................................................... 70
6.7 Disinfection Declaration ................................................................ 72
6.8 Disposal of Instrument .................................................................. 73
6.8.1 Introduction ..................................................................................... 73
6.8.2 Disposal of Packing Material ........................................................... 73
6.8.3 Disposal of Operating Material ........................................................ 73
6.8.4 Disposal of the Instrument ............................................................... 74
7. Quality Control ........................................................................... 75
7.1 Introduction ................................................................................... 75
7.2 Optimizing for Maximum Performance ........................................ 76
7.2.1 Instrument Location ......................................................................... 76
7.2.2 Operating Procedure ....................................................................... 76
7.2.3 Self Check Procedure ...................................................................... 77
7.3 Operational Qualification (OQ) ..................................................... 78
7.3.1 QC PAC 2 ....................................................................................... 78
7.3.2 Microplate Test ................................................................................ 78
7.3.3 High Meniscus Liquids ..................................................................... 80
7.3.4 Instrument Precision with Liquid Samples ....................................... 82
7.3.5 Instrument Linearity with Liquid Samples ......................................... 83
Index .................................................................................................. 85

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. Not reading,
understanding or not observing the instructions may result in damage to the
product, injury to operating personnel or poor instrument performance.
Tecan is not responsible for damage or injuries resulting from incorrect
handling of the device.
3. Observe all WARNING and CAUTION statements in this
publication.
4. Always disconnect the device from the main power supply prior to
maintenance, cleaning, and disinfection.
5. Never open the sunrise while the instrument is plugged into a power source.
6. Observe suitable safety precautions for laboratories such as wearing of
protective clothing and the application of appropriate and tested laboratory
safety procedures.

WARNING
IF THE sunrise ABSORBANCE READER OR THE MAGELLAN
SOFTWARE ARE MODIFIED IN ANY WAY, THE PERFORMANCE OF
THE READER MAY BE NEGATIVELY AFFECTED,
THE WARRANTY WILL NO LONGER BE VALID AND THE
INSTRUMENT WILL NOT BE CE CONFORM.

2. General
2. General
2.1 Introduction

Note
sunrise Absorbance Reader is intended for use with external software only.

Caution
Before starting measurements, make sure that the microplate
position A1 is inserted correctly.
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.

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, for storage and for 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:
o I
I
T on Transmissi =
Io =incident light
I =detected light (after the sample)
The absorption (Optical Density) is the logarithm of the reciprocal transmission.
T
1
Log OD=
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 integrated 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.
2. General
The sunrise Absorbance Reader is available with Touchscreen, tuneable
wavelength, temperature control and barcode scanner options.
Magellan is a reader control and data reduction software package, and also can
be 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 regulatory compliance . A range
of policies and standard operating procedures according to local
regulations must also be established.

Make sure the instrument and the software are suitable for use with the reagents,
chemicals and microplates that are being used (see 7.2 Optimizing for Maximum
Performance and 7.3 Operational Qualification).

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, INJ URY TO OPERATING PERSONNEL OR POOR
INSTRUMENT PERFORMANCE.

2. General
2.2 Area of Application
2.2.1 Intended Use
The Sunrise instrument is a 96-well absorbance reader for the measurement of
light absorbance (optical density) of liquid media. The instrument is intended to
be used primarily in in-vitro diagnostic analysis of samples from the human body
to obtain information on physiological and pathological states.
For applications in human medicine, only the Magellan Tracker software is
intended for the use with the instrument. Software and instrument have been
validated for measurement and for the evaluation of qualitative and quantitative
Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled
diagnostic parameters and instrument specifications; they are therefore intended
for professional use in in-vitro diagnostics.
A list of testkits which have been validated for this instrument is available at the
manufacturer:
E-mail: expertline-at@tecan.com

Note
If the Surni se absorbance reader or the Magellan software is modifi ed in
any way, the warranty wil l no longer be val id and the instrument will lose
regulatory conformity.

Note
The operating authority must use only CE-l abeled test kits for clini cal
diagnostic appli cations. The operating authority must assure that the
combination of a particul ar CE-label ed test kit used with the CE-label ed
Sunrise absorbance reader and its options have been validated to meet
the IVD di recti ve 98/79/EC or other rel evant national or local regulations.

If the Sunrise absorbance reader is used differently from the Intended Use
mentioned above or if it is used with other software than Magellan Tracker, the
instrument is no longer IVD conform and the user is responsible for the respective
use and the necessary validation.

Note
Results obtained using the Sunri se are influenced by the proper use of
the instrument and microplates, according to the i nstructions given in
this document, as well as the liquid compounds used (reagents,
chemistry). The instructions for use, storage, and applications involving
samples or reagents must be followed strictl y. Results must therefore be
interpreted carefully.

2. General
2.2.2 Variations of sunrise
All variations of the sunrise Absorbance Reader and its options are designed to
meet the IVD directive 98/79/EC of European Union.
sunrise Hardware Variations
The following table shows the compatibility of the filter slides with each sunrise
hardware variation:
sunrise Variations 4 Filterslide 6 Filterslide
Gradient
filterslide
Standard X
6 Filter X X
Tuneable wavelength X X X
sunrise Options
The sunrise options work with all hardware variations and accessories and can
be used in any combination:
sunrise Options
Temperature Control
Touchscreen
Barcode (integrated)
LIS (handheld barcode scanner plus ASTM export)
sunrise Accessories
The sunrise accessories work with all hardware variations and options and can
be used in any combination:
sunrise
Accessories
IVD compliant for Europe
Research Use
Only

Included in CE1 Separate CE2
None/
Unrelated3
4 Filterslide

X
6 Filterslide X
Gradient Filter X
sunrise Instrument
Settings
X
XFluor 4 X
Magellan X
Magellan TS X
QC Pac 1 X
QC Pac 2 X

1 IVD compliant for Europe. Included in the CE declaration for the instrument.
2 IVD compliant for Europe. 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. 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 an integrated barcode scanner can be added
onto the basic system which is dedicated to remote controlled computer
operation.
The LIS option is an additional option for Sunrise Touchscreen instruments and
allows reading sample IDs from compatible barcodes by using a handheld
barcode scanner which is part of the LIS Option.
Factory Installed Options Upgrade in Field Possible
Touchscreen
100373302
Barcode Scanner 10037304
integrated, for plate IDs

Barcode Upgrade Kit 30000322
LIS Option (handheld
barcode scanner) for sample IDs; 30036611

Tuneable Wavelength from
400 700 nm; 10037306

Temperature Control
10037303

6 Filter
30004221

2. General
2.3 Specifications
The tables below list the specifications for the instruments.
2.3.1 General
For all instrument options:

PARAMETERS CHARACTERISTICS
Main power input 100 - 120 & 220 - 240 V 10% 50/60 Hz
(Auto sensing)
Consumption Stand by mode: approx. 50 VA
Operational mode: max. 110 VA
Fuse rating 2 x F 2.0 A / 250 V (Fast Blow)
Outside dimensions Width: 25.5 cm (11.22 inch)
Depth: 34.0 cm (13.39 inch)
Height: 14.5 cm (5.71 inch)
Height with touchscreen 21.0 cm (8.27 inch)
Weight 6 kg
Min. (Standard RC) 6.2 kg
Max. (incl. all options) 8.6 kg
Ambient temperature:
Operation 15C to 35C (59F to 95F)
Storage -20C to 60C (-4F to 140F)
Relative humidity:
Operation 20 % to 90 %
Storage 5 % to 95 %
Over voltage category II
Pollution degree 2
Method of disposal Contaminated waste
Environment See 3.5 Environmental Requirements for more
information.
Stability:
Normal measurements
After 15 minutes warm up time
max. +/- 0.001 OD

2. General
2.3.2 Standard Instrument (Standard Filter Carriage)
Measurement time:
dual wavelength
single wavelength

8 seconds
6 seconds
Wavelength range:
Standard

340 - 750 nm
Measurement range:
340 - 399 nm
400 - 750 nm

0 - 3.000 OD
0 - 4.000 OD
Resolution: 0.001 OD
Accuracy:
(492 nm) 0.000 - 2.000 OD
(492 nm) 2.000 - 3.000 OD

Better than +/- (1.0 % +0.010 OD)
Better than +/- (1.5 % +0.010 OD)
Precision:
(492 nm) 0.000 - 2.000 OD
(492 nm) 2.000 - 3.000 OD

Better than +/- (0.5 % +0.005 OD)
Better than +/- (1.0 % +0.005 OD)
Linearity:
(340 - 399 nm) 0.000 - 2.000 OD
(400 - 750 nm) 0.000 - 2.000 OD
2.000 - 3.000 OD

Better than +/- 2 %
Better than +/- 1 %
Better than +/- 1.5 %
Wavelength selection:
Standard filter

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.
Filter wavelength accuracy Central wavelength +/- 2 nm
Filter bandwidth
At 50% transmission:

10 +/- 2 nm
Light source: Halogen lamp 20 W
All connected devices must be approved and listed as per IEC 60950-1
Information Technology Equipment Safety and equivalent local standards.
Computer interface:
Serial RS 232 C
Printer

300 - 38,400 baud
Only with the Touchscreen option.
2. General
2.3.3 Touchscreen Color Instrument
Screen size 640 x 480 pixel, app. 19 cm (7.5) diagonal
Color VGA
Operating system WindowsCE
Operating software MagellanCE
Memory 64 MB (RAM)
Storage >=32 MB (USB stick)
Computer interface:
Serial RS 232 C Printer 300 - 38,400 baud; parallel connection to the printer.
USB stick labeled
magellan System Stick
Port for USB stick.
USB master Printer USB connection to the printer.
USB slave ACS Only for service.
USB stick labeled
magellan Export Stick
For data export (LIS option; see chapter 4.4.7 LIS
Option (for sunrise Touchscreen Color only) for
more information
MagellanCE software See Magellan Manual
Personal computer:
Interface
Operating system
For USB stick data exchange and/or backup.
USB port
Windows 98/98SE, ME, 2000, XP

2. General
2.3.4 Tuneable Wavelength Instrument (Gradient Filter
Carriage)
Measurement time:
Dual wavelength
Single wavelength

16 seconds
8 seconds
Wavelength range:
Gradient filter
Standard filter

400 - 700 nm
340 - 399 nm & 700 - 750 nm
Measurement range:
340 - 399 nm
400 - 750 nm

0 - 3.000 OD
0 - 4.000 OD

Resolution: 0.001 OD
Accuracy:
(492 nm) 0.000 - 2.000 OD

Better than +/- (1.5 % +0.010 OD)
Precision:
(492 nm) 0.000 - 2.500 OD

Better than +/- (1.0 % +0.005 OD)
Linearity:
(492 nm) 0.000 - 2.500 OD

Better than +/- 2 %
Wavelength selection:
Gradient filter

Special gradient filter any wavelength
between 400 and 700 nm in 1 nm steps.
The instrument can use up to eight
different filter carriages
Filter wavelength accuracy Central wavelength +/- 2 nm
Filter bandwidth
At 50% transmission:
450 nm
550 nm
650 nm

10 - 16 nm
10 - 14 nm
10 - 18 nm
Light source: Halogen lamp 20 W
Computer interface:
Serial RS 232 C
Printer

300 - 38,400 baud
Only with the Touchscreen option.
2.3.5 6 Filter Instrument (6 Filter Carriage)
See 2.3.2 Standard Instrument (Standard Filter Carriage).

2. General
2.3.6 Temperature Control
Peltier-based temperature control.

Temperature range: Room temperature up to 42C increments of 0.1C
Accuracy typical +/- 0.2C
Preheating time 30 min.
The sunrise specification of the temperature control unit (typical accuracy +/-
0.2C) applies if everything (reader, microplate, reagents, samples) has already
target temperature.
There is no specification for the heating up period and we are aware that within
this period not all wells are heated up equally. This effect will be seen especially
when reagents are not preheated.
During preheating the plate transport with a 96 well microplate loaded has to be
inside of the instrument. Only in this way a homogenous temperature is received
in the instrument. The microplate must not be the same as the one used for
measurement but should be clean to keep influences on the following
measurement low.
Every time the plate transport is moved it will take up to 1 min to reach again a
homogenous temperature inside of the instrument.
Bear in mind that if non-preheated microplate and/or reagents are added,
temperature control will take a certain time depending on the temperature
difference between microplates.
We recommend a longer measurement interval (e.g. 1 min) to increase
homogenous temperature distribution. Keep the difference between target
temperature and the temperature of microplate with reagents and samples lower
than 20 C (68 F).
2. General
2.3.7 Barcode Laser Scanner (Integrated for Plate IDs)

WARNING
LASER RADIATION DO NOT STARE INTO THE BEAM!
CLASS II / 2 LASER PRODUCT.
The Class II / 2 Laser Scanner corresponds to the following norms:
DIN EN 60825-1 : 2001
CDRH 21 CFR 1040.10
Classification Class II / 2 Laser Product
Input power 5 V DC +/- 10%
Emission duration >0.25 s
Scan rate 42 +/- 3 Scans / second (bi-directional)
Laser power <1 mW
Definition of depth Max. 40 cm
Resolution 0.15 mm
Min. print contrast 25% at 675 nm
Ambient light Sun light: 40000 Lux
Halogen light: 1500 Lux
2.3.8 Microplates
Only 96-well format microplates (v-shaped, flat and round including strip-wells)
with transparent bottom can be used with the sunrise Absorbance Reader.
Max. overall plate height 14.35 mm +/- 0.76 mm
(0.5650 inches +/- 0.0299 inches)
Diameter of wells 7.0 mm (0.276 inches)
Pitch size (center to center) 9.0 mm (0.3543 inches)
Bottom shape V-shaped, Flat and Round bottom
The barcode sticker has to be positioned on the right hand side of the plate,
7 mm from the front-right edge. The barcode may be up to 48 mm long.
2. General
2.3.9 Barcode Labels
Barcode Scanner (Integrated) for Plate IDs
Only the following barcode types are suitable for processing:
Code 128
Code 39
Interleaved 2 of 5
Barcode labels must fulfill the following norms:
ISO/IEC 15416 Automatic identification and data capture techniques
Bar code print quality test specifications
Linear symbols (e.g. EN 1635).
ANSI X3.182-1990 (R1995): Guideline for Bar Code Print Quality

Note
The barcode must have the quality Class A, B or C / ANSI/CEN/ISO
standard. Dirty, folded, wet or damaged barcode labels must not be
used. The adhesive labels must be flat and not peeling off at the edges.

We recommend to guarantee the quality of the barcode labels by means of local
SOP.
The barcode has to be accurately aligned horizontally and positioned on the right
hand side of the plate, 7 mm from the front-right edge. Position the barcode as
near as possible to the bottom.

7
6
55
A1

Length max 48 mm (3.5 inch)
Bars height min 6 mm (0.24 inch)
Quiet zone min 5 mm (0.2 inch)
Resolution min 0.15 mm (5.905 mil; 0.0059 inch) module width
Length max 29 digits

2. General
Handheld Barcode Scanner Supplied With LIS Option for Sample IDs
Only the following barcode types are suitable for processing:
Codabar
Code 128
Code 39
Interleaved 2 of 5
The maximum barcode length which can be processed by the handheld barcode
scanner supplied with the LIS option is 20 characters.

Note
The barcode label must be of good printing quality with clearly
separated individual barcode lines.
Dirty, folded, wet or damaged barcode labels must not be used. The
adhesive labels must be flat and not peeling off at the edges.
We recommend to ensure the quality of the barcode labels by means of local
SOPs.
Reading field 80 mm typical (3.1496 inch)
Max. resolution 0.13 mm (5.118 mil; 0.00511 inch)

Caution
To guarantee reliable operation it is mandatory to use only the handheld
barcode scanner supplied with the LIS option in combination with the
sunrise Touchscreen Color reader. It is not allowed to change any
predefined scanner settings.

2.3.10 USB Stick for Data Storage (Magellan System Stick)

Please Note
Use always the currently Tecan released and Tecan approved Magellan
System USB stick! Otherwise data leakage may be possible.

Storage
>=32 MB
Data retention min. 2 years
Erase cycles 100,000 times

Do not expose the USB stick to extreme temperatures, fire, water, moisture, dust,
smoke, electrical power and mechanical forces.
2. General
2.3.11 USB Stick for Data Export (Magellan Export Stick Part
of LIS Option for sunrise Touchscreen Color)

Please Note
Use always the currently Tecan released and Tecan approved Magellan
Export USB stick! Otherwise data leakage may be possible.

Do not expose the USB stick to extreme temperatures, fire, water, moisture, dust,
smoke, electrical power and mechanical forces.

2.4 Instrument Description
The illustration below shows the components of the instruments.

Power ON LED
Lamp compartment Filter block compartment
Plate support
2. General
2.4.1 Back Panel Connections
The illustration below shows the connections located in the back panel of the
instrument.

All connected devices must be approved and listed as per EN 60950, UL 1950 or
CSA C22.2 No. 950 for Data Processing Devices.

Barcode Laser Scanner Labels
Label reproductions on the instrument housing and interior:

Note
If any labels become damaged or removed, contact you local Tecan
representative for replacement labels.
Instrument main fuses
ON / OFF switch
Main socket
Printer interface (serial port)
(only available with touchscreen option)
Serial RS232 interface Fuse values
Barcode laser scanner labels
(only available with barcode option)
2. General
2.4.2 Handling the Microplate
Insert or remove the microplate only when the plate support is fully ejected (as
illustrated below) and the plate transport motor is not active .
For details, see the corresponding Instructions for Use of the selected SW
product (Magellan, MagellanCE, etc.).

WARNING
WHEN HANDLING THE MICROPLATE ALWAYS USE DISPOSABLE
GLOVES AND PROTECTIVE CLOTHING.

Power ON LED
Plate support
2. General
2.5 Filter Carriage Description
The sunrise instrument can use the following types of filter carriages:
sunrise Standard, 6 Filter and Gradient Filter (with tuneable wavelength option).
2.5.1 Standard Filter Carriage
The sunrise standard filter carriage has up to four narrow band interference filters
that have a fixed wavelength.
SUNRISE Standard Filter Carriage

When a wavelength is selected, the entered wavelength is compared against the
list of entered filter values for this filter carriage.
If the required filter is fitted in the filter carriage, the filter carriage is moved so that
the required filter is in the light beam.

Note
For more information about the definition of the new and customized
Filterslides, see 3.8 Defining the Instrument Settings.
2.5.2 Gradient Filter Carriage
sunrise gradient filters cannot be used with a standard or 6 Filter instrument.
The sunrise gradient filter carriage is fitted with a gradient filter that allows the
selection of any wavelength from 400 to 700 nm.
Gradient Filter Carriage
Gradient Filter
700 nm 400 nm

The gradient filter carriages are calibrated by the manufacturer and each one is
unique.

Note
When another gradient filter is inserted into the instrument, the instrument
must be re-calibrated. This re-calibration procedure can only be
performed by the manufacturer or by a service engineer.
calibration table. The filter carriage is moved the required distance, so that the
required section of the gradient filter is in the light beam.
Gradient filters can only be used with the sunrise tuneable wavelength
Absorbance Reader.
Filter positions
4 3 2 1
2. General
2.5.3 6 Filter Carriage
The sunrise 6 Filter carriages cannot be used with a standard instrument.
The sunrise 6 Filter carriage has up to six narrow band interference filters that
have a fixed wavelength.

list of defined filter values for this filter carriage.
If the required filter is fitted in the filter carriage, the filter carriage is moved, so
that this specific filter is in the light beam.

Note
For more information about the definition of the new and customized
Filterslides, see 3.8 Defining the Instrument Settings.
6 Filter carriages can only be used with the sunrise 6 Filter and the tuneable
wavelength Absorbance Reader.
1 2 3 4 5 6
Filter positions
2. General
2.6 Instrument Features
Microplates can be measured using the following features:
Various measurement modes
Single or dual wavelength measurements
Microplate shaking
2.6.1 Measurement Modes
The instrument can be set to use the following measurement modes:
Normal The plate transport is moved quickly under the measurement
diodes so that a fast measurement is obtained. Each well is
measured at three points, 8 times for each point.
Accuracy The plate transport is moved very slowly under the measurement
diodes so that a very accurate measurement is obtained. Each well
is measured at three points, 55 times for each point.
Center This option measures the optical density only in the center of each
well. It is recommended for U-bottom wells or for liquids with high
meniscus. Each well is measured at one point, 22 times.
With the Normal and Accuracy measurement modes, the optical density is
measured at three positions across the wells and the average measured optical
density value from the three measurements is used as the optical density of the
well.

Note
The accurate measurement cycle should always be used when measuring
high optical densities.
The Center measurement mode should be used if the liquid in the microplate
produces a high meniscus, as an incorrect optical density could be obtained if the
optical density is measured at three positions. If an agglutination measurement is
performed, up to 40 measurement positions per well are used.

Note
For more information about setting the measurement mode,
see 3.8 Defining the Instrument Settings.
2. General
2.6.2 Microplate Shaking
The sunrise is able to shake the microplate before it is measured. Use external
software (for example: Magellan) to set the shaking modes.
The microplate can also be shaken between each of the kinetic measurement
cycles.

WARNING
WHEN USING A 96 WELL PLATE IN HIGH SHAKE MODE, SPILLAGE
MAY OCCUR IF THE WELLS ARE FILLED WITH MORE THAN 300 L.
The shaking widths and frequencies for the 4 sunrise shake modes are as
follows:

Shake Mode Shake Width Shake Frequency
HIGH
NORMAL
LOW
WIDE
2.8 mm
4.4 mm
4.4 mm
14.2 mm
12.3 Hz
9.2 Hz
7.8 Hz
2 Hz

2.7 Instrument Accessories
The table below contains the order numbers for instrument accessories:
Part Name Article Number
Halogen Lamp. ......................................................................................... 13709008
Reader to External Computer Cable ....................................................... 13350005
QC Pac 1 for sunrise .............................................................................. 10037371
QC Pac 2 for sunrise .............................................................................. 10037372
Additional Filter Slide (Standard 4-Filter) ................................................. 30004215
Additional Filter Slide (6-Filter) ................................................................. 10036319
TS - Pen ................................................................................................... 11106542
Barcode Upgrade Kit ................................................................................ 30000322

Note
Please contact your local distributor for available USB sticks.

2. General
2.8 Software for the sunrise Absorbance Reader
Part of the Software CD:
Software Functionality
Magellan Instrument control and data reduction software
(also available for Clinical laboratory use)
(designed to meet Directive 98/79/EC of the
European Community).
XFluor4 Instrument control and transfer of raw data to
Excel (for research use)
sunrise Instrument Settings Enables settings of the sunrise instrument
(sunrise, SPECTRA, ATC mode, etc.).
Rdr Download Enables download of new firmware from PC to
reader.

Note
The sunrise Absorbance Reader is intended for use with only external
software.

Note
For more information about the software features, see the appropriate
individual Instructions for Use. For example, refer to the Magellan
Reference Instructions for Use.

3. Installation Procedure
3.1 Introduction
This chapter contains the necessary information for installing the instrument.
The installation procedure involves unpacking, environmental requirements,
power requirements and interfacing.
3.2 Unpacking and Inspection
The delivered instrument is shipped in one carton, which includes:
Power cable
Computer connection cable
Instructions for Use for sunrise Absorbance Reader, XFluor4 Instructions for
Use
Spare fuses
A software CD, which also contains the XFluor4 program and Magellan
demo program (30 day working license).

Instrument
Accessory box
Foam packaging
Foam
packaging
3.3 Unpacking Procedure
1. Visually inspect the container for damage, before opening it.
Report any damage immediately.
2. Place the carton in an upright position and open it.
The cartridge, filter block and plate transport compartments are fixed with
adhesive tape. The location of the adhesive tape is indicated with a red
arrow.
3. Lift the instrument out of the carton and place it on a flat surface, free from
dust, vibration and away from direct sunlight.
4. Visually inspect the instrument for loose, bent or broken parts.
Report any damage immediately.
5. Compare the instrument's serial number, attached on the rear panel of the
instrument, against the serial number of the instrument on the delivery
(shipping) note.
6. Check the instrument accessories against the delivery (shipping) note.
7. Open the plate support area cover and remove the foam strip that is used as
the microplate transport lock.
8. Please save all packing materials, as it may be required for storage or later
transportation.
3.4 Power Requirements
The instrument is auto sensing for the supplied voltage, and therefore does not
have to be set for the correct voltage.
Connect the instrument only to an electricity supply system with protective earth.

WARNING
TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY
BE REPLACED WITH THE SAME TYPE AND RATING OF FUSES.

3.5 Environmental Requirements
The instrument should be placed on a flat, level surface that is free from dust,
solvents and acidic vapors.
Vibration and direct sunlight must be avoided, to ensure correct results.
Ambient Temperature:
Operation 15C to 35C (59F to 95F)
Storage -20C to 60C (-4F to 140F)
Relative Humidity:
Operation 20 % to 90 %
Storage 5 % to 95 %

3.6 Instrument Installation Procedure
The following procedures detail the necessary steps to be followed when
installing the instrument.

Caution
Before the instrument is installed and switched on, it should be left to
stand for at least three hours, so there is no possibility of condensation
causing a short circuit.
When the requirements above have been met, installation is carried out using the
following procedure:
1. Place the instrument into the required position.
Ensure that the distance between the back panel of the instrument and the
wall is at least 10 cm.
2. Connect the instrument to the external computer with the required interface
cable.
The interface cable is connected into the 9 pin serial interface socket, in the
back panel.
For connection at the external computer with a COM port use the serial
serial interface cable.
For connection at the external computer with an USB port use the serial
USB converter cable.
3. Ensure that the main power switch in the back panel of the instrument is in
the off position.
4. Insert the power cable into the main power socket in the back panel.
5. Switch the instrument on using the main power switch in the back panel and
wait for 15 minutes.
The instrument is now ready to measure microplates.

3.7 Installation of Instrument Control Software

Note
For more information about installing the software, see Magellan or
XFluor4 Instructions for Use, which can be found on the software CD.

3.8 Defining the Instrument Settings
This program enables the user to define the settings of:
Instrument modes
Filter definition
Measurement modes

Caution
If used in the IVD environment, only the authorized person is allowed to
change and define the Sunrise Instrument Settings.
3.8.1 Installation of Sunrise Instrument Settings Software
The Sunrise Instrument Settings software is installed using the following
procedure:
1. Insert Tecan Detection Suite CD into the required CD ROM drive.
2. The setup dialog box is displayed. Click the service and settings button.
Click the setup button for the Sunrise Instrument Settings. The installation
program is started, which installs Sunrise Instrument Settings onto your
computer
3. A series of dialog boxes will appear, read each one, enter any necessary
information and click Next to continue.
4. The files are then installed and the program icon is created.
5. When the Installation Complete dialog box appears, click Finish and the
Sunrise Instrument Settings program is ready to be used.
3.8.2 Starting the Sunrise Instrument Settings
In case an instrument is already connected to one of Tecan's programs, close the
program or disconnect the instrument.
The Sunrise Instrument Settings software is started by clicking the Sunrise
Instrument Settings icon on the desktop if present or go to Start Programs
Tecan and select Sunrise Instrument Settings.
The following dialog box appears:

In the Sunrise Instrument Settings dialog box, select the communication port
and the baud rate. Click Next.
3.8.3 Define Instrument Mode

To use an instrument with software designed for previously manufactured Tecan
readers, select the appropriate instrument mode and baud rate. Click Next.
sunrise mode It is recommended to use the sunrise mode with 9600 baud
Spectra mode Simulates a SPECTRA Reader
Rainbow mode Simulates a Rainbow Reader
ATC mode Simulates an ATC Reader
3.8.4 Define Filter
Before inserting the filter make sure that the slots are free of dust and dirt.

Click the Filter-slide Out button to move the filter out of the instrument.
To insert a Filter-slide, open the filter compartment manually and slot the filter in
so that the filter end of the slide is inserted first. (Do not force the Filter-slide into
the instrument beyond the point of resistance).
Click the Filter-slide In button and the filter is inserted.
Pos 1 - 6 shows the filter values for the currently loaded absorbance filters.

Note
The instrument is able to recognize predefined Filterslides and you must
not attempt to change the filter values. However, if the filters in the Filter-
slide have been changed (by a service engineer) or if a new undefined
customized Filter-slide is to be used, the Filterslides need to be defined.
To define the filter values for a new Filter-slide, enter the required wavelengths in
the text boxes. Click Next.

Note
The wavelength range for the sunrise is 340 - 750 nm.

3.8.5 Define Measurement Mode

Select the appropriate measurement mode.
Click Next and the following dialog box appears:

These settings are not available for the sunrise Absorbance Reader.
Click Finish and the following dialog box appears:

The measurement mode has now been set successfully.
If the filter values for the new Filter-slide have been defined, then the following
dialog box appears at the end of the program.

4. The sunrise Touchscreen
4.1 Introduction
The sunrise Touchscreen option consists of:
A screen that includes a touch panel
A Touchscreen pen
Operating software MagellanCE
Magellan System USB stick
Additional option for data export with sunrise Touchscreen Color:
LIS option
The LIS option is an additional option for sunrise Touchscreen Color instruments
and allows reading sample IDs from compatible barcodes by using a dedicated
handheld barcode scanner, which is part of the LIS option.
The Touchscreen option enables the user to control the reader and evaluates
obtained data, using the onboard software. The WindowsCE
The MagellanCE provides the user with Wizards for all operating procedures and
guides the user through the software program via step-by-step commands.
based software,
MagellanCE, offers the user the possibility for full instrument control, data
reduction and storage. Enhanced curve fitting and screening tools, as well as the
possibility to combine several assays on one plate, makes it an ideal tool for
various laboratory purposes. The Touchscreen offers a clear and easy overview
of all available data.

Disclaimer
Magellan has been carefully revised and checked. With the exception of
negligence or intention, Tecan takes no liability for any damages that
occur as a result of the software.

Caution
If the instructions given in this manual are not correctly performed, the
instrument may be damaged or the procedure may not be correctly
performed and the safety of the instrument cannot be guaranteed.

Caution
Before the instrument is installed and switched on, it should be left to
stand for at least three hours, so there is no possibility of condensation
causing a short circuit.

Caution
Before starting measurements, make sure that the microplate position
A1 is inserted correctly.

Windows is registered trademark of the Microsoft Corporation.
4.2 Area of Application for the Touchscreen Option
See 2.2 Area of Application.
4.3 Specifications
The table below lists the specifications for the Touchscreen.
Screen size 640 x 480 pixel, app. 19 cm (7.5) diagonal
Color VGA
Operating system WindowsCE
Operating software: MagellanCE
Memory 64 MB (RAM)
app 25 kinetic cycles
Storage
>=32 MB (USB stick)
app 1000 endpoint measurements

4.4 Instrument Description
The illustration below shows the components of the instrument.

4.4.1 Touchscreen Back Panel Connections
The illustration below shows the connections located in the back panel of the
Touchscreen.


Power ON LED
Plate support
Touchscreen
USB stick housing
Printer USB interface
or
USB hub interface
or
USB stick for data export
Magellan system stick Service interface

Note
Use only the following recommended types of active USB hubs for the
sunrise TSC reader:
D-Link DU-H4
Manufacturer Model:
D-Link DUB-H4

Note
Please note that an active USB hub is not part of the LIS-option.
4.4.2 Data Handling
The illustration below shows the concept of data handling of the instrument.

The standard storage memory for onboard operation is the USB stick. The USB
stick offers a capacity of >=32 MB to save results and defined methods.
Depending on the size of the files, up to 1000 files can be stored permanently on
the USB stick. Additional USB sticks can be ordered for memory extension. But at
the same time there should never be more than one USB stick in use with the
instrument to prevent mismatches. Data can be transferred to a PC by plugging
the USB stick into a PC.
Additionally, the sunrise can be connected to the personal computer (PC) and
by-pass the onboard software (serial RS232 interface).

Please Note
Only from Tecan approved USB sticks may be used. Otherwise data
leakage may be possible.
4.4.3 Data Handling with LIS Option ASTM Export
Refer to chapter 4.4.7 LIS Option (for sunrise Touchscreen Color only) for further
information. A detailed description of the ASTM export can be found in the
Magellan IFU.
Printer USB interface

USB stick
(data exchange)
Service interface
Printer interface (parallel port)
(only available with touchscreen option)
PRINTER COMPUTER
Serial RS232 interface
(remote control)

Interface for:
USB hub
USB stick for data export

4.4.4 Printer Compatibility
The sunrise Touchscreen supports the following industry standard printer
languages:
Hewlett-Packard PCL3 Compatible devices
Selected Epson printers
Not only Hewlett-Packard printers support PCL3, but also the majority of the laser
printers. Please contact your printer provider or look up the printer specifications
on the Internet homepage of the printer manufacturer for further information.

Note
Printer languages up to PCL5E are compatible with PCL3. PCL6 is not
longer compatible with PCL3.
For further information see the Hewlett-Packard homepage.

For examples of supported printers refer to the sunrise Touchscreen Color
instrument attached list Selection of Compatible Printers.
To connect the printer with the parallel interface at the back panel of the
instrument use a parallel cable of the type IEEE-1284 up to a maximum length of
3 meters.
To connect the printer with the USB interface at the back panel of the
Touchscreen use a USB 2.0 certified A - B cable up to a maximum length of
3 meters.

Note
To receive best printing performance under Magellan, adjust the printing
head. Connect the printer to a personal computer. Then install and
execute the according utility programs which are delivered with the
printer.

4.4.5 Handling the USB Stick
Driver Installation
For Windows 98/98SE a driver is required. If on your PC no USB driver for
storage tools is already installed please contact the local sales person to receive
the driver file. Execute the file and follow the on-screen instructions to complete
driver installation. Plug the USB stick into an available USB port. A new
Removable Disk drive with a newly assigned drive letter appears in the My
Computer window.
For Windows ME, 2000 and XP no driver is required. Simply plug the USB stick
into an available USB port, and Windows will install the files needed. A new
Removable Disk drive with a newly assigned drive letter appears in the My
Computer window.
How to Safely Plug and Unplug the USB Stick
After plugged in wait a minimum of 15 sec before the USB stick is recognized. It
is recognized when the LED lights steadily.

Caution
During operation it is not allowed to plug in more than one USB stick at
the same time. Otherwise data leakage may be possible.
Touchscreen Color option:
The USB stick has to be plugged into the appropriate port in the instrument
housing. The USB stick must not be plugged into the USB printer port.

Caution
Before removing the USB stick makes sure that the LED is steady and
not flashing. If USB stick is removed while the LED is flashing,
unpredictable damage to the files and/or USB stick may occur due to a
write cache issue.

Caution
During a Measurement, Evaluate Data, Create/Edit a Sample List,
Create/Edit a Method, Attach a Signature and Delete Files the USB stick
may not be removed.
To remove the USB stick from the Touchscreen unplug it directly when no data is
transferred, that is, the LED is not flashing. Remember that Magellan is saving
data during certain actions, so a storage medium is needed. Therefore the USB
stick may not be removed.
To remove the USB stick in Windows 98/98SE unplug it directly when no data is
transferred, that is, the LED is not flashing.
To remove the USB stick in Windows ME, 2000 and XP left click on the Unplug
or Ej ect Hardware icon on the system tray. A pop-up menu appears. Click to
continue. The Safe To Remove Hardware dialog appears. Confirm the dialog
with OK. The USB stick is now ready to be unplugged.
Write-Protect Function (Where Appropriate)
When the write protect switch is set to unlocked (open padlock symbol), data
can be written to and read from the USB stick. When the write protect switch is
set to locked (closed padlock symbol), data can be read from the USB stick, but
no data can be written to the USB stick.

Caution
Write protection may not be activated or deactivated when the USB stick
is plugged in.

To lock or unlock the write protection unplug the USB stick. After plugged in, wait
a minimum of 15 sec before continuing operation.
4.4.6 USB Stick Data Management
One unique USB stick should be used per instrument in order to avoid mix up.
Depending on the amount of data resulting from measurements, data backup
from the USB stick to a PC is recommended once a week. Data should be stored
additionally on durable storage media (CD, DVD, floppy).
Available memory space on the USB stick should be verified every time before
usage. Backed up data on different media and no more useful for further
measurements can be deleted from the USB stick if expected data amount
exceeds free memory. Use the Delete function of the MagellanCE software from
the Archive files menu.
4.4.7 LIS Option (for sunrise Touchscreen Color only)
The LIS option is available only for sunrise TSC instruments with image version
V1.2. It consists of:
a dedicated pre-adjusted handheld barcode scanner
USB cable for the scanner
MagellanCE V5.2 or higher software for ASTM export
extra USB stick for data export
The handheld barcode scanner allows reading sample IDs from compatible
barcodes (see 2.3.9 Barcode Labels).
In combination with the data export function of MagellanCE software V5.2 or
higher and the Magellan export stick for data export, it is possible to transfer the
corresponding results in ASTM format to compatible Laboratory Information
Systems (LIS).
A second USB stick labeled magellan Export Sti ck is provided with the LIS
option. It is used to store information exported from the sunrise TSC reader in
ASTM format. The USB export stick serves also as the data-transfer-tool to the
LIS.
For detailed information on the ASTM data export of MagellanCE software please
refer to the Magellan Instructions for Use.
How to Setup the LIS Option in Combination with an Active USB Hub (not part of
the LIS option)

Unpack the LIS option containing the following items:
Connect printer, sunrise TSC and active USB hub to mains
Connect active USB hub to the USB port on the back panel of the TSC
element
Connect printer (using USB cable provided with the printer) to the active
USB hub
Connect USB stick labeled magellan Export Stick to the active USB hub
Connect USB cable for barcode scanner to the handheld barcode scanner
Connect handheld barcode scanner to the active USB hub
First switch on the printer and then switch on the sunrise TSC reader
At the first start of the Magellan software, a verification test of the handheld
barcode scanner has to be performed as described below.
Verification Test for the Handheld Barcode Scanner
At the first start of MagellanCE software on the sunrise TSC with LIS option, the
verification test for the handheld barcode scanner has to be performed. This test
checks if the scanner is working properly using the correct scan speed by
scanning the test barcode supplied with the LIS option.
By default, the verification test has to be repeated every 7 days but it can be
adjusted up to 28 days.
Please refer to Magellan IFU for further description.
Operating the Handheld Barcode Scanner
LED ON means: correct reading of barcode in normal mode
LED OFF means: ready to perform barcode reading
LED blinking means: start-up check in progress

magellan System Stick
magellan Export Stick

USB Hub

The dedicated handheld barcode scanner, which is part of the LIS-option, scans
barcodes on contact. To read a barcode the trigger button on the handheld
barcode scanner must be pressed.
Barcode scanning is performed along an imaginary line passing across the
reading window. This imaginary line must pass through the entire code.
Successful scanning is obtained by keeping the handle of the handheld barcode
scanner parallel to the code surface.

Caution
To guarantee reliable operation it is mandatory to use only the handheld
barcode scanner supplied with the LIS option in combination with the
sunrise TSC reader. It is not allowed to change any predefined scanner
settings.
4.5 Operating the Touchscreen
4.5.1 Introduction
The Touchscreen has to be operated with the Touchscreen pen, which is
included in the package.

Caution
4.5.2 Starting the Software
Make sure that the USB stick is plugged into the Touchscreen.
Switch the instrument on.
The wizard list and a keyboard are displayed on the touch panel. The
keyboard is always displayed. When it is not required, it can be dragged to
the edge of the panel by means of the Touchscreen pen.
The wizard structure guides the user through every step. The starter screen
is displayed:

For further information on how to use MagellanCE please refer to the Magellan
Instructions for Use.
4.5.3 Special Features of MagellanCE
Input Panel
Some Input Panel keys have special functions:

Caps lock key
selected
Click to view the capital character keys.
All letters will be capitalized.

Caps key selected
The first letter typed will be in capitals, the following
letters will be in lowercase.
Caps lock and
Caps key selected
The first letter typed will be in lowercase, the following
letters will be in capitals.
Caps lock and
Caps key not selected
All letters will be in lowercase.

Special characters
key
Click to view the special character keys.
Esc key Click to close the current window.

Set Contrast
The contrast of the Touchscreen can be adjusted, if it is not properly set.
In the Wizard List dialog box under Miscellaneous, select Options.
To set the contrast click on the Touchscreen tab. Select Contrast and follow the
instructions.

Caution
Never set the contrast to a too low or a too high value. It might be
impossible to operate the software! Readjust the contrast.
If you want to confirm the new setting, click Appl y. For setting within a certain
range a confirmation dialog appears; to confirm the new setting click OK.
Otherwise cancel this dialog or wait 10 sec to return automatically to the previous
setting.
Date / Time
In the Wizard List dialog box under Miscellaneous, select Options.
Select the Touchscreen tab to set date and time (see screenshot Options,
Touchscreen tab above.).
Enter the current date and time and click Appl y.
4.6 Change Instrument Control Mode
To control the sunrise Touchscreen instrument with an external computer the
instrument must be set to remote mode.
4.6.1 Set Instrument in Remote Mode
In the Wizard List dialog box under Instrument settings, select Instrument
control.
To change the instrument control mode select PC Remote Control. The program
will be closed and the Config remote serial port... dialog box is opened.

Set the Instrument mode to Remote mode and select the remote mode settings
and baud rate.

Note
Tecan reader control programs like XReadPlus or XFluor4 support only
a maximum baud rate of 9600 bauds with the sunrise reader.
Confirm the dialog with OK.

A dialog appears confirming that the instrument is now in remote mode.
Connect the sunrise instrument to the external computer as described in
3.6 Instrument Installation Procedure.
4.6.2 Set Instrument in Local Mode
Confirm the StartUpCE dialog box with OK.

A dialog appears, asking you to unplug the remote cable from the instrument.
Unplug the interface cable from the serial interface at the rear panel of the
sunrise instrument.

Caution
Never set the sunrise Touchscreen instrument to local mode as long as
the instrument is connected to an external PC via an interface cable.
Otherwise it may not be possible to operate the instrument.

Confirm the dialog with OK.
The Config remote serial port... dialog box is opened.
Set the Instrument mode to Local mode and confirm the dialog with OK.
MagellanCE will be started.

5. Error Messages and Trouble Shooting
5. Error Messages and Trouble
Shooting
5.1 Introduction
The internal microprocessor controls and checks all electronic functions as well
as measurements, operations and results. If the microprocessor detects a fault or
an incorrect operating procedure, an error message is displayed on the computer.
5.1.1 Table of Error Messages and Trouble Shooting for
sunrise Mode
The following table gives a brief description of the error messages and the trouble
shooting actions.

Note
If other error messages appear that are not mentioned in the table below,
contact your local service engineer.

Error Message Description Trouble Shooting
System Error
Out of memory in module Internal firmware error Switch instrument off and then on
again. Contact your local service
engineer, if the error continues.
Not implemented Internal firmware error Switch instrument off and then on
Timer event not active Internal firmware error Switch instrument off and then on

Error Messages Description Trouble Shooting
Wrong Transport Positioning
Transport lost steps due to invalid
shaking section
Transport Check that the microplate is
inserted correctly and nothing is
blocking the transport system.
Contact your local service
Transport lost . steps Wrong detection
of the positioning
switches.
Check that the microplate is
Transport inserted steps Wrong detection
of the positioning
switches.
Transport lost steps during calibration Wrong detection
of the positioning
switches.
Wrong Transport Parameters
Transport frequency too low Software error Wrong combination of selected
measurement parameters.
Transport frequency too high Software error Wrong combination of selected
measurement parameters.
Optical Problems
Transport couldn't find full dark edge
during calibration
Lamp or other
optical defect
Check lamp and if the lamp is
working and positioned correctly,
Lamp low The optical
system is
receiving not
enough light
Timeout waiting for lamp on Lamp or other
optical defect
Timeout waiting for measurement
finished
Lamp or other
optical defect

Filter Errors
Already inserted Filter already inserted Check if the filter is properly inserted.
No filter carriage detected The instrument does not
detect the filter carriage
Insert filter. If a filter has been already
inserted, check the filter carriage for
dirt or damage. Contact your local
service engineer, if the error continues.
No measurement filter
defined
The measurement filter is
not defined
Define filter.
No reference filter defined The reference filter is not
defined
Define filter.
Illegal filter carriage
position
Internal firmware or
electrical error
Check the filter carriage for dirt or
damage. Contact your local service
Wavelength nm not
available
The defined reference or
measurement filter is not
available on the inserted
filter carriage
Change filter carriage or check filter
values for incorrect input.
Filter carriage not defined,
Type.. Number
Wrong, damaged or not
defined filter carriage
inserted
Check the filter carriage to see if it is
correct or check the filter carriage for
dirt and damage.
ADC Electronic Error
Offset 340 not adjusted Electronic error on ADC
board or optical problem
Start Lamp Adjust program in the
Setup program. Contact your local
Offset 400 not adjusted Electronic error on ADC
No wavelength defined Electronic error on ADC
Area 400 not adjusted Electronic error on ADC
Area 340 not adjusted Electronic error on ADC
E2Pot Overflow Electronic error on ADC

SPECTRA Mode

Filter The USB stick has not
reached the required
position or is not defined.
Check that the USB stick is correctly inserted
into the instrument. Contact your local
Transport Microplate transport error Ensure that the microplate is inserted
correctly and that nothing is blocking the
transport system. Contact your local service
Lamp low Optical system error This message is displayed when the
instrument detects that the optical system is
not receiving enough light. Possible causes
could be: defective halogen lamp, halogen
lamp incorrectly positioned, optical system is
not clean, filter alignment out of range.
Contact your local service engineer, if the
error continues.
Lamp high Optical system error This message is displayed when the
instrument detects that the optical system is
receiving too much light. Possible causes
could be: defective halogen lamp, halogen
lamp incorrectly positioned. Contact your
local service engineer, if the error continues.
System Internal firmware or flash
EPROM error
Contact your local service engineer.
Abort Lamp or other optical
defect
Check lamp and if the lamp is working and
positioned correctly, contact your local
service engineer.

Touchscreen

USB stick Errors
USB stick is not
accessible
No USB stick plugged in Plug-in USB stick and wait 15 sec before
continue operation.
Write protection activated Unplug USB stick. Unlock the write protection.
Plug-in USB stick and wait 15 sec before
continuing operation.
USB stick is defect Use a PC to format a new USB stick. Create
the folders mth and copy the needed
methods from the backup directory into this
directory. Create the folder wsp and do the
same for needed workspaces. At the
Touchscreen replace the defect USB stick
with the new one and wait 15 sec. Retry!
No storage medium
found! Storing will
not be possible until
you connect the
USB stick!
No USB stick plugged in See above!
Could not create
workspace directory:
\USB-Disk\!

Please note: Error!
Unable to write on
USB stick. Please
make sure the USB
stick is connected
and not write
protected.
No USB stick plugged in
Write protection activated
See above!
\USB-Disk\
contains an invalid
path.
No USB stick plugged in See above!
Access to \USB-
Disk\ was denied.
Write protection activated See above!
Warning! The
storage medium is
running out of disk
space.
There is not enough space on
the USB stick to save new
data.
Save currently not needed data from the
USB stick to a PC backup directory. Delete
then the saved files on the USB stick to gain
more storage space. Retry saving.
An unknown error
occurred while
accessing...
Write protection activated or
deactivated during plugged in
USB stick.
Restart the instrument.
Note: Unplug USB stick to lock/unlock the
write protection
The method defined, mostly
kinetics, needs too much
program memory so it is
impossible to save.
Cancel the saving and redefine the method
(e.g. reduce number of cycles and/or
transformations/calculations).
Undefined status after having
plugged in the USB stick.
Plug-in the USB stick and wait 15 sec before
continuing operation.
Storage medium
space low
The free space on the USB
stick is too low to save new
data.
Save actually not needed data from the USB
stick to a PC backup directory. Delete the
saved files afterwards from the USB stick to
gain more storage space. Retry the action.
Display Errors
Power LED is on
and Touchscreen is
very bright (nothing
on display visible)
Contrast is set to a too low
value
Power LED is on
and Touchscreen is
turned off (nothing
on display visible)
Touchscreen is defect Contact your local service engineer.
5.1.4 Error Message and Trouble Shooting for Handheld
Barcode Scanner
Error Message Description Trouble Shooting
Configuration read
failed
Verification test failed.
Due to incorrect settings,
scanned barcodes might be
incorrect and automated
ASTM export will not be
performed.
1. Wrong test barcode was used for
verification test.
Retry using the correct one!
2. If the error continues, disconnect the
handheld barcode scanner from the
sunrise TSC reader and enter the sample
IDs manually (see Magellan IFU).

5.2 Definition of Overflow
If the result of the absorbance measurement is outside the instrument
specifications (e.g. >4.0 OD) an overflow may occur and the measured OD value
of the current well will be replaced by OVER. This is done by the controlling
software and not by the instrument itself. Depending on the controlling software
used, OD values outside of the instrument specifications might be shown or
replaced by OVER. Please be aware that OD values which are outside the
instrument specifications are not reliable.

6. Maintenance & Cleaning
6.1 Introduction
This chapter contains the following procedures:
Replace the filter carriages
Replace the main input fuses
Clean the instrument
Disinfect the instrument

WARNING
BEFORE DOING ANY MAINTENANCE REMOVE THE MICROPLATE.

6.2 Filter Replacement

Caution
When handling the filters, be careful that they do not become
scratched or soiled with fingerprints or dust.
The direction of the arrow on the filter glass and the direction of the beam must
be identical. Put in the filter glass accordingly. If you can read the print on the
filter glass when the beam comes from the bottom, it is inserted correctly.
Use only framed or black filters and insert them flush to avoid scattered light.
6.2.1 Standard Filter Carriages
The filters of the standard filter carriages can be replaced using the following
procedure:
1. Remove the filter carriage from the instrument.
2. Place the filter carriage on a clean flat surface.

1 2 3 4

3. Using a wooden or rubber rod (ensure that the ends are rounded so that the
corners do not scratch the filters) carefully push the filter and retaining ring
out of the filter carriage.

4. Turn the filter carriage over and insert the new filter and the retaining ring.
5. Carefully push the filter and retaining ring into the filter carriage, using a
wooden or rubber rod.

Rod
Filters
Retaining Rings
Filter
Positions
6.2.2 Gradient Filter Carriages

Note
The instrument specifications can only be guaranteed if genuine Tecan
parts are used.
Using the option tuneable wavelength selection, the instrument is fitted with a
special gradient filter, which allows the selection of any wavelength of light
between 400 and 700 nm. For measurements in the ranges of 340 - 399 nm and
700 - 750 nm the appropriate Standard filter carriage, containing the required
wavelength filters, must be inserted into the instrument.
The filter carriage can be exchanged for another carriage, which contains other
filters; the instrument can store the data for up to eight filter carriages.
To change the filter carriage, please follow the procedure outlined in the
appropriate software Instructions for Use.

Note
The sunrise specifications are different if a standard filter/ 6 filter or a
gradient filter is used.
If a method is defined using standard filters, specifications for standard filters are
valid. If the same method is performed later using gradient filters, specifications
for gradient filters have to be applied. These specifications are not identical to
those of standard filter. Validation of the system has to be performed with those
filters, which finally are actually used during measurement.

Specifications for sunrise with Standard Filter/ 6 Filter
Accuracy:
(492 nm) 0.000 - 2.000 OD
(492 nm) 2.000 - 3.000 OD

Better than +/- (1.0 % +0.010 OD)
Better than +/- (1.5 % +0.010 OD)
Precision:
(492 nm) 0.000 - 2.000 OD
(492 nm) 2.000 - 3.000 OD

Better than +/- (0.5 % +0.005 OD)
Better than +/- (1.0 % +0.005 OD)
Linearity:
(400-750 nm) 0.000 - 2.000 OD
(400-750 nm) 2.000 - 3.000 OD

Better than +/- 1 %
Better than +/- 1.5 %

Specifications for sunrise with Gradient Filter

Accuracy:
(492 nm) 0.000 - 2.000 OD

Better than +/- (1.5 % +0.010 OD)
Precision:
(492 nm) 0.000 - 2.500 OD

Better than +/- (1.0 % +0.005 OD)
Linearity:
(492 nm) 0.000 - 2.500 OD

Better than +/- 2 %
6.2.3 6 Filter Carriages
The filters of the 6 Filter carriages can be replaced using the following procedure:
1. Remove the filter carriage from the instrument.
2. Place the filter carriage on a clean flat surface, so that the Phillips head
screws are visible.

3. Remove the two screws and then remove the retaining bar that holds the
retaining pins.
4. Remove the filters. Be careful not to scratch the filters or soil them with
fingerprints or dust.

5. Insert the new filters and replace the retaining bar. Replace and tighten the
screws while pressing the retaining bar to the filters.

1 2 3 4 5 6
Filter positions
6.3 Fuse Replacement
The following steps must be performed to replace the fuse, which is located
above the power cable connection, in the rear panel of the instrument.

WARNING
TO PREVENT THE RISK OF FIRE, THE MAIN FUSES SHOULD ONLY
BE REPLACED WITH THE SAME TYPE AND RATING OF FUSES.
1. Switch off the instrument and unplug the power cord.
2. Open the plastic cover of the fuse compartment by inserting a screw driver
into the slot in the top of the cover and pushing the cover out.
3. The fuse holders are located above the on/off switch.

4. Pull the fuse holder(s) out and replace the defective fuse(s) with the spare
fuse(s).
Ensure that the fuse(s) has/have the correct rating.
F 2.0 A / 250 V (Fast Blow)
5. Replace the fuse holder(s), ensure that the arrow points in the correct
direction and close plastic cover of the fuse compartment.
6. Reconnect the power cord and switch the instrument on

WARNING
IF THE FUSE CONTINUES TO BLOW, PLEASE CALL FOR SERVICE.
Fuse holders
6.4 Cleaning the Instrument

WARNING
PRIOR TO CLEANING DISCONNECT THE INSTRUMENT FROM THE
MAIN POWER SUPPLY TO AVOID ANY RISK OF FIRE AND
EXPLOSION.

WARNING
THE CLEANING PROCEDURE SHOULD BE PERFORMED IN A
WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL
WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND
CLOTHING.
6.4.1 Cleaning the Device
Clean the outside of the device and the plate transport only with a dry or moist
cloth. If very dirty, clean it with a cloth moistened with a maximum of 70% ethanol
or mild detergent. Wipe dry with a lint-free cloth.
6.4.2 Cleaning the Touchscreen
The Touchscreen panel is very delicate. Clean and treat it very gently. Clean the
display only with a dry or moist cloth. If very dirty, clean it with a cloth moistened
with a maximum of 70% ethanol or mild detergent solution. Wipe dry with a lint-
free cloth.
6.4.3 Liquid Spills
If any liquid is spilled on the instrument, it should be immediately removed to
prevent liquid running into the optical system causing loss of performance or the
error message Lamp Low due to one or more of the diode lenses not being
clean. Contact your local service representative in order to clean and check the
instrument.

WARNING
IF LIQUID SPILLED ON THE PLATE SUPPORT IS POTENTIALLY
INFECTIOUS IT SHOULD BE DISINFECTED ACCORDING TO THE
RELEVANT NATIONAL LAWS AND REGULATIONS.

Note
For disinfection solutions and procedure see chapter 6.6.1 and 6.6.2.

6.5 Preventive Maintenance Plan for sunrise
This preventive maintenance plan is for standard throughput instruments. For
instruments that are used in high throughput, the maintenance intervals might be
shorter.
6.5.1 Daily
No daily maintenance is required.
6.5.2 Weekly
Clean the cover and the plate transport with a mild detergent.

Caution
Never use Acetone as it will damage the covers.
6.5.3 Every Six Months
Clean the filters using an optical cleaning solution (lens tissue
recommended)
6.5.4 Yearly (Customer or Service Technician)
Either done by customer:
Perform the QC Pac 2 Test (see QC Pac Instructions for Use)
Or done by service technician:
Perform extended operational quality check
6.5.5 Every Four Years (Service Technician Required)
Replace the lamp and the filters
Perform extended operational quality check

6.6 Instrument Disinfection
All parts of the instrument that came into contact with biological samples, patient
samples, positive control samples or hazardous material must be treated as
potentially infectious areas.

WARNING
THE DISINFECTION PROCEDURE AND THE DISINFECTANTS
SHOULD CONFORM TO THE RELEVANT NATIONAL LAWS AND
REGULATIONS.

WARNING
IT IS VERY IMPORTANT THAT THE INSTRUMENT IS THOROUGHLY
DISINFECTED BEFOR IT IS REMOVED FROM THE LABORATORY OR
BEFORE ANY SERVICE IS PERFORMED ON IT.
Before the instrument is returned to the distributor or to a service center, all outer
surfaces and the plate transport must be disinfected and a disinfection
declaration must be completed by the operating authority. If a disinfection
declaration is not supplied, the instrument may not be accepted by the distributor
or service center or custom authorities may hold it.
6.6.1 Disinfection Solutions
The outer surfaces and the plate transport of the instrument should be disinfected
using a surface disinfection solution such as:
areadesB (Schlke & Mayr GmbH, D-22840 Norderstedt)
dodarcanarapid neu (Schlke & Mayr GmbH, D-22840 Norderstedt)
Bacillocidrasant (Bode Chemie Hamburg, D-22525 Hamburg)

WARNING
PRIOR TO DISINFECTION DISCONNECT THE INSTRUMENT FROM
THE MAIN POWER SUPPLY TO AVOID ANY RISK OF FIRE AND
EXPLOSION.

6.6.2 Disinfection Procedure
If the laboratory has no specific disinfection procedure, the following procedure
should be used to disinfect the outer surfaces and the plate transport of the
instrument.

WARNING
THE DISINFECTION PROCEDURE SHOULD BE PERFORMED IN A
WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL
WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND
CLOTHING.

Caution
The surface disinfectant can negatively influence the performance of
your instrument, if it is applied or accidentally gets inside the
instrument.

Caution
Make sure that the microplate has been removed from the instrument
before starting disinfection.
Observe the following issues during disinfection:
1. Wear protective gloves, protective glasses and protective clothing.
2. Prepare a suitable container for all disposables used during the disinfection
procedure.
3. Move the plate transport into the load position.
4. If applicable, remove the microplate from the plate transport.
5. Disconnect the instrument from the main power supply and let it cool down
to ambient temperature to avoid any risk of fire and explosion.
6. Disconnect the instrument from the computer.
7. Carefully apply the disinfectant solution according to the manufacturers
instructions for use on the plate transport of the instrument.
8. After the required contact time (according to the manufacturers instructions
for use) wipe the plate transport using a soft paper towel moistened with a
mild detergent or distilled water to remove all traces of the disinfectant.
9. Move the plate transport into the instrument by gently pressing the front end
of the plate transport until the plate transport door is completely closed.
10. Carefully apply the disinfectant solution according to the manufacturers
instructions for use on all outer surfaces of the instrument.
11. After the required contact time (according to the manufacturers instructions
for use) wipe the instrument using a soft paper towel moistened with a mild
detergent or distilled water to remove all traces of the disinfectant.
12. Wipe dry the outer surface of the instrument with a soft paper towel.
13. Disinfect your hands and clean them with a mild detergent.
14. Pack the instrument and its accessories.
15. Dispose of the container with the disposables according to the relevant
national laws and regulations.
16. Complete the disinfection declaration and attach it to the outside of the box
so that it is clearly visible.

Caution
The plate transport should only be moved manually if the instrument is
disconnected from the main power supply.
See below for the disinfection declaration, which must be completed before the
instrument is returned to the distributor/ service center.

6.7 Disinfection Declaration
The following Disinfection Declaration MUST be completed by the operating
authority and attached on top of the package in which the instrument is returned,
before sending it to the distributor or service center.

Disinfection Declaration
I declare that the outer surfaces and the pl ate transport of the instrument in
this package have been disinfected to remove or inactivate any biologi cal
material, patient samples, positive control samples or hazardous material,
which could be dangerous to any personnel, or that it has never been
exposed to any hazardous biological material.
Contact person: ......................................................................................................
Company/ institution: ..............................................................................................
Function: .................................................................................................................
Phone/ Fax: ............................................................................................................
E-mail: ....................................................................................................................
Date of disinfection: ................................................................................................
Date, name: ............................................................................................................
Signature: ...............................................................................................................
6.8 Disposal of Instrument
6.8.1 Introduction
Follow laboratory procedures for bio-hazardous waste disposal, according to
national and local regulations.
This chapter gives instructions on how to lawfully dispose of waste material
accumulating in connection with the sunrise.

Caution
Observe all federal, state and local environmental regulations.

ATTENTION
Negative environmental impacts associated with the treatment of WEEE
Do not treat electrical and electronic equipment as unsorted municipal
waste.
Waste of electrical and electronic equipment must be collected
separately.
6.8.2 Disposal of Packing Material
According to Directive 94/62/EC on packaging and packaging waste, the
manufacturer is responsible for the disposal of packing material.
Returning Packing Material
If you do not intend to keep the packing material for future use, e.g. for transport
and storage purposes:
Return the packaging of the product, spare parts and options via the field service
engineer to the manufacturer.
6.8.3 Disposal of Operating Material

WARNING
BIOLOGICAL HAZARDS CAN BE ASSOCIATED WITH THE WASTE
MATERIAL (MICROPLATE) OF THE PROCESS RUN ON THE sunrise
ABSORBANCE READER.
TREAT THE USED MICROPLATE, OTHER DISPOSABLES, AND ALL
SUBSTANCES USED, IN ACCORDANCE WITH GOOD LABORATORY
PRACTICE GUIDELINES.
INQUIRE ABOUT APPROPRIATE COLLECTING POINTS AND
APPROVED METHODS OF DISPOSAL IN YOUR COUNTRY, STATE
OR REGION.

6.8.4 Disposal of the Instrument
Please contact your local Tecan service representative before disposing of the
instrument.

Caution
Always disinfect the instrument before disposal.

Pollution degree 2 (IEC/EN 61010-1)
Method of disposal Contaminated waste

WARNING
DEPENDING ON THE APPLICATIONS, PARTS OF THE sunrise MAY
HAVE BEEN IN CONTACT WITH BIOHAZARDOUS MATERIAL.
MAKE SURE TO TREAT THIS MATERIAL ACCORDING TO
THE APPLICABLE SAFETY STANDARDS AND REGULATIONS.
ALWAYS DECONTAMINATE ALL PARTS BEFORE DISPOSAL.

7. Quality Control
7. Quality Control
7.1 Introduction

Caution
If at any time the analytical performance of the sunrise is questioned the
user should follow the instructions given for quality control or contact
the local service center.

Caution

This chapter gives the instructions on how to obtain the best performance and
accuracy from this instrument.
Also included are instructions on how to easily check the operational quality of
the instrument.
7. Quality Control
76 Instructions for Use for sunrise Absorbance Reader No. 30041769 Rev No. 1.6 2010-05
7.2 Optimizing for Maximum Performance
The instrument has been fully factory tested to ensure that its performance is
within the specified limits.
Experience has shown that operating technique and laboratory conditions cause
the greatest amount of inaccuracy.
The greatest accuracy can be obtained from the instrument by observing the
recommendations below:
7.2.1 Instrument Location
The instrument should be placed on a level, flat surface that is free from dust,
solvents and acidic vapors.
The instrument must be protected from vibrations and direct light, particularly
sunlight.
When performing the measurements, always close the plate support cover to
ensure that the results are not affected by any external light.
7.2.2 Operating Procedure
General
1. The best repeatability is obtained, when the measurement wavelength
corresponds to the maximum absorbance wavelength of the particular
solution.
It is important to use the maximum absorbance wavelength, if the
absorbance curve of the sample is over a narrow wavelength band.
2. After each microplate has been measured, please refer to the test kit
package for information regarding the validation procedure.
3. When very accurate results are required, ensure the Accurate
measurement mode is used.
7. Quality Control
Microplates
1. The instrument can be used with those types of microplates which are
described in the specifications in chapter 2.3.8 Microplates. The best results
are obtained when clear flat-bottom microplates are used.
Depending on the type of microplate being used, the measurement result
may vary.
Take care especially when using round bottom plates or the strip
frames because it is possible that the measurement results might differ
slightly to what is described in the specifications.
Make sure that the type of microplate used with the sunrise Absorbance
Reader is suitable for the respective application.
2. Use only perfectly clean microplates.
3. Do not allow dust to settle onto the solutions or the microplate, if the
microplate is left to stand for a time before the measurement.
It is recommended to use a cover for protection.
4. Inaccuracies in the amount of solution pipetted has a greater effect on the
results obtained, when small amounts of solutions are used.
It is recommended that a minimum of 200 ml is used in each well.
5. The form of the meniscus of the solution can cause inaccuracies in the
results, particularly if small amounts of solution are used (see 7.3.3 High
Meniscus Liquids).

Caution
Make sure the suitability of the microplate used in combination with the
amount of solution, meniscus properties and the measurement mode is
appropriate for the current application.
7.2.3 Self Check Procedure
Before each microplate is measured, the Self Check calibration procedure is
performed to ensure that the instrument is working correctly and to calibrate the
optical system.
When the self check procedure starts, a digital value for each measurement
channel is taken without the lamp and with the lamp on, using each of the
selected measurement filters.
A calibration curve for each measurement channel is calculated.
7. Quality Control
7.3 Operational Qualification (OQ)
The following test can be performed to ensure that the instrument is working
correctly and accurate results are being obtained.
The repeatability and accuracy of the instrument may vary with the type of
solution and microplate used.
To eliminate this effect, the instruments are tested in the factory with a calibration
plate, which removes the influence of the solution and any variation due to the
positioning of the microplate when it is being measured.
7.3.1 QC PAC 2
QC PAC 2 provides an automated check of reader performance including
accuracy, linearity, precision and alignment with NIST traceable standards. It also
detects damaged or mislabeled filters. For more information, see QC PAC 2
Instructions for Use.

Caution
Use only QC PAC 2 for sunrise instruments. The former version of the
QC PAC 2 (for SPECTRA instruments) is not compatible with the
instrument.
7.3.2 Microplate Test
If the optical densities of the wells in the microplate are not consistent, the results
obtained with this type of microplate will be influenced.
This inconsistency can be checked by reading an empty microplate.
The OD values obtained from the measurement of the empty microplate should
be in a narrow range. For example: +/- 0.010 OD.
If the OD values are not within this range this type of microplate should not be
used.
By using dual wavelength measurements, the influence of the difference in OD
values of the microplate is removed or reduced to a level that is within acceptable
limits.

7. Quality Control
Acceptabl e Microplate
1 2 3 4 5 6 7 8 9 10 11 12
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
-------
|
A | 0.042 | 0.039 | 0.045 | 0.041 | 0.039 | 0.037 | 0.043 | 0.043 | 0.040 | 0.039 | 0.043 | 0.041 | A
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
B | 0.042 | 0.042 | 0.040 | 0.040 | 0.042 | 0.040 | 0.045 | 0.043 | 0.039 | 0.038 | 0.043 | 0.039 | B
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
C | 0.043 | 0.040 | 0.040 | 0.043 | 0.041 | 0.041 | 0.042 | 0.042 | 0.041 | 0.046 | 0.043 | 0.039 | C
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
D | 0.043 | 0.043 | 0.047 | 0.038 | 0.039 | 0.040 | 0.040 | 0.041 | 0.042 | 0.039 | 0.039 | 0.049 | D
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
E | 0.041 | 0.044 | 0.046 | 0.043 | 0.039 | 0.040 | 0.040 | 0.042 | 0.043 | 0.041 | 0.045 | 0.044 | E
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
F | 0.046 | 0.042 | 0.041 | 0.043 | 0.042 | 0.052 | 0.043 | 0.047 | 0.045 | 0.044 | 0.041 | 0.040 | F
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
G | 0.041 | 0.043 | 0.041 | 0.040 | 0.042 | 0.042 | 0.041 | 0.040 | 0.043 | 0.043 | 0.041 | 0.041 | G
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
H | 0.042 | 0.040 | 0.040 | 0.044 | 0.045 | 0.039 | 0.041 | 0.046 | 0.045 | 0.044 | 0.040 | 0.045 | H
|
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1 2 3 4 5 6 7 8 9 10 11 12

Unacceptable Microplate
1 2 3 4 5 6 7 8 9 10 11 12
|
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A | 0.104 | 0.105 | 0.110 | 0.134 | 0.136 | 0.168 | 0.147 | 0.140 | 0.163 | 0.154 | 0.167 | 0.188 | A
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
B | 0.119 | 0.107 | 0.110 | 0.151 | 0.133 | 0.168 | 0.153 | 0.138 | 0.165 | 0.167 | 0.167 | 0.178 | B
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
C | 0.111 | 0.117 | 0.121 | 0.141 | 0.146 | 0.136 | 0.156 | 0.150 | 0.158 | 0.173 | 0.170 | 0.182 | C
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
D | 0.112 | 0.101 | 0.113 | 0.153 | 0.146 | 0.127 | 0.139 | 0.143 | 0.152 | 0.165 | 0.163 | 0.170 | D
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
E | 0.105 | 0.109 | 0.114 | 0.135 | 0.120 | 0.131 | 0.142 | 0.138 | 0.143 | 0.161 | 0.163 | 0.163 | E
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
F | 0.096 | 0.106 | 0.110 | 0.138 | 0.132 | 0.128 | 0.128 | 0.149 | 0.158 | 0.155 | 0.161 | 0.172 | F
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
G | 0.097 | 0.110 | 0.112 | 0.125 | 0.133 | 0.125 | 0.120 | 0.132 | 0.145 | 0.155 | 0.168 | 0.156 | G
|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|
H | 0.095 | 0.090 | 0.096 | 0.144 | 0.129 | 0.124 | 0.129 | 0.139 | 0.131 | 0.150 | 0.151 | 0.161 | H
|
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1 2 3 4 5 6 7 8 9 10 11 12

7. Quality Control
7.3.3 High Meniscus Liquids
When measuring liquids that produce a high meniscus, the measured optical
density can be incorrect as the instrument normally measures the optical density
at three positions in the well and uses this average measured optical density as
the optical density for the well.

Normal Mode
3 positions, 8 measurements per position.
Positions are 0.4375 mm apart.
Accuracy Mode
3 positions, 55 measurements per position.
Positions are 0.4375 mm apart.

Normal meniscus High meniscus

Center Mode
1 position, 22 measurements.

Normal meniscus High meniscus
7. Quality Control
Agglutination Method
For agglutination measurements, an external software package must be used.
Depending on the software used, the sunrise Absorbance Reader must be set to
sunrise or SPECTRA mode using the Sunrise Instrument Settings software. The
sunrise Absorbance Reader is able to read up to 40 measurement points per
well.

Note
Instruments with option tuneable wavelength selection must not be used
for agglutination measurements.
After the microplate has been measured, select a well and zoom it so that it is
printed in large scale.
Normal Liquid Liquid with High Meniscus
1 10 20 30 40
0%
50%
100%
0%
50%
100%
R R C C
Measur ement

1 10 20 30 40
0%
50%
100%
0%
50%
100%
R R C C
Measur ement

If the printout has less than sixteen measurement points in the middle of the well,
which are at the same level, use the center measurement.
Manual Method
If the instrument is not able to perform agglutination measurements, measure the
microplate five times.
Then rotate the microplate by 180 and then measure the microplate five times.
For a number of wells, calculate the average optical density value from all the
measurements for these wells.
Compare the average value against the highest and lowest measured values.
Exampl e
Measured Values
0.945, 0.956, 0.937, 0.926, 0.971, 0.936, 0.961, 0.939, 0.942, 0.938 OD
Average =0.945 OD, highest value =0.971 OD, lowest value =0.926 OD
Tolerances for standard instruments: 0.945 +/- (0.5 % +0.005 OD) =
0.945 +/- 0.010 OD
Highest value within tolerance =0.955 OD
Lowest value within tolerance =0.935 OD
Make sure that the values are within the allowed tolerances. If not, use the center
measurement mode.
Repeat the procedure using the center measurement, to ensure that the
measured values are now within the required tolerances.
7. Quality Control
7.3.4 Instrument Precision with Liquid Samples
This procedure can be used to check the precision of the measurements from
one microplate to another.
Fill a new microplate with a freshly prepared Methyl Orange in 0.1 % Tween 20
solution, use different dilutions of the solution in each well so that a range of
optical densities is obtained. Make sure that the wells contain at least 200 ml.
Define a test run using the 492 nm filter and then measure the microplate at least
three times.
For each well calculate the following:
the average OD value
the highest and lowest values
the difference between the average, highest and lowest values

Example for a standard instrument
Readings 0.000 to 2.000 OD
The difference between the average and the highest and lowest values for the
same well should be within +/- (1.0 % +0.010 OD)
e.g. 1.000 +/- 0.020 OD

The difference between the average and the highest and lowest values for the
same well should be within +/- (1.5 % +0.010 OD)
e.g. 2.400 +/- 0.046 OD

Readings above 3.000 OD
Readings above 3.000 OD are only used as an indication and the precision
cannot be guaranteed.
7. Quality Control
7.3.5 Instrument Linearity with Liquid Samples
The linearity for the instrument and application at the wavelength used can be
checked by using a dilution series of a solution.
The result depends on the purity of the dye used and the meniscus of the liquid in
the wells.
As a reference, dilution series of Methyl Orange in 0.1 % Tween 20 solution for
measurements at 492 nm can be used.
The dilution series should be within the range of 0.1 to 3.0 OD for a standard or
6-filter instrument and within the range of 0.1 to 2.5 OD for a tuneable wavelength
instrument.
For other wavelengths, different solutions must be used.
250 ml of each dilution are then pipetted into the microplate, a minimum of at
least two samples should be used for each dilution to reduce the errors caused
by pipetting.
Make sure that the instrument is using the accuracy measurement mode.
The microplate is then measured and a linear regression of OD against
concentration is drawn from the average of the measured OD values.
Determine the unweighted residual square value R
2
of the regression line.
Typical residual square values for a standard application are equal or better than
R
2
=0.998.

Note
Data can vary due to pipetting inaccuracy, meniscus of the liquid and the
application used.

Note
The limits of the instruments linearity will be measured with the QC plate.

Example for a tuneable wavelength instrument
Dilution Factor Absorbance
1 2.621 OD
0.5 1.323 OD
0.25 0.679 OD
0.125 0.360 OD
0.0625 0.192 OD
0.03125 0.110 OD
0 0.025 OD
Equation for linear regression: y =2.5888x +0.0314
Residual squared value: R
2
=1
Index
Index
Numbers refer to pages.

6
6 Filter
Carriage ....................................................... 30
Filter Replacement ....................................... 66
Specifications ............................................... 21
A
Accuracy Mode ................................................ 80
ADC Electronic Error ....................................... 59
Agglutination .................................................... 81
Area of Application .......................................... 15
ASTM export .................................................... 16
B
Back Panel Connections ................................. 27
Barcode Laser Scanner
Specifications ............................................... 23
Barcode Laser Scanner Labels ....................... 27
C
Center Mode .................................................... 80
Cleaning
instrument .................................................... 68
Touchscreen ................................................ 68
D
Date / Time
Touchscreen ................................................ 54
Disinfection
declaration.................................................... 72
instrument .................................................... 70
procedure ..................................................... 70
solution ......................................................... 70
Disinfection Declaration ................................... 72
Disposal
Instrument .................................................... 73
Operating Material ....................................... 73
Packing Material .......................................... 73
E
Environmental requirements ........................... 36
Error Messages ............................................... 57
F
Filter Errors ...................................................... 59
Filter Replacement
6 Filter .......................................................... 66
Standard Filter Carriages............................. 64
Fuse Replacement .......................................... 67
H
handheld barcode scanner ...... 16, 17, 25, 49, 50
High Meniscus Liquids .................................... 80
I
Input Panel
Touchscreen ................................................ 53
Installation ....................................................... 37
Instrument
Accessories ................................................. 32
cleaning........................................................ 68
Description ................................................... 26
disinfection ................................................... 70
Linearity ....................................................... 83
Location ....................................................... 76
Maintenance ................................................ 63
Specifications ............................................... 18
instrument options ........................................... 17
Intended Use ................................................... 15
IVD................................................................... 38
IVD directive .................................................... 14
L
Lamp Low ........................................................ 68
Liquid Spills ..................................................... 68
LIS option ................................ 17, 25, 43, 46, 49
M
Manual Method ................................................ 81
Manufacturer ......................................................3
Measurement Modes....................................... 31
N
Normal Mode ................................................... 80
O
Operating the Handheld Barcode Scanner ..... 50
P
Packing Material
Disposal ....................................................... 73
Index
Returning ...................................................... 73
Performance
Optimizing .................................................... 76
General ..................................................... 76
Microplates ............................................... 77
Procedures ............................................... 76
Self Check Procedure .............................. 77
Power Requirements ....................................... 36
Printer Compatibility ......................................... 47
Printers............................................................. 47
Q
Quality Control ................................................. 75
S
Safety ............................................................... 11
Self Check Procedure ...................................... 77
Setup the LIS Option ....................................... 50
Specifications ................................................... 18
Standard Filter
Filter Replacement ....................................... 64
Sunrise Instrument Settings
Starting ......................................................... 39
Symbols ............................................................. 5
T
Temperature Control
Specifications ............................................... 22
Touchscreen .................................................... 43
cleaning ........................................................ 68
Data Handling .............................................. 46
Date / Time .................................................. 54
Input Panel ................................................... 53
Instrument Description ................................. 45
Instrument Specifications ............................. 44
Operation ..................................................... 52
Trouble Shooting ............................................. 57
Trouble Shooting for Handheld Barcode
Scanner ........................................................ 62
U
Unpacking
and Inspection .............................................. 35
Procedure .................................................... 36
USB driver ....................................................... 48
USB stick ............................................. 46, 48, 49
USB Stick Data Management .......................... 49
V
Verification Test for the Handheld Barcode
Scanner ........................................................ 50
W
Warranty ............................................................ 3

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