30041769 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

Tecan Customer Support Office Address Contact Tecan Asia Pte Ltd. 18 Boon Lay Way,

#09-140 TradeHub 21 Singapore 609966 Singapore

T +65 6444 1886 F +65 6444 1836 [email protected]

Tecan Austria GmbH Untersbergstrasse 1a A-5082 Grdig Austria

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Tecan Benelux bvba Vaartdijk 55 B-2800 Mechelen Belgium

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Tecan Benelux bvba Industrieweg 30 NL-4283 GZ Giessen Netherlands


Tecan (Shanghai) Trading Co. Ltd

Unit 621, Tower 1, German Centre 88, Keyuan Road, Zhangjiang Hi-tech Park Pudong New Area, Shanghai, 201203 China


Tecan Deutschland GmbH Theodor-Storm-Strasse 17 D-74564 Crailsheim Germany

T +49 1805 8322 633 or T +49 1805 TECAN DE F +49 7951 9417 92 [email protected]

Tecan France S.A. 26 avenue Tony Garnier F-69007 Lyon France

T +33 820 88 77 36 F +33 4 72 76 04 99 [email protected]

Tecan Ibrica (Spain) Sabino de Arana 32 E-08028 Barcelona Spain


Tecan Ibrica (Spain) N VI - km 23,300, c/ Pollensa, 4 - Oficina 8 E-28230 Las Rozas de Madrid Spain

T +34 91 151 71 07 F +34 91 151 7120 [email protected]

Tecan Ibrica (Portugal) Quinta da Fonte Edificio Pedro I P-2780-730 Pao D'Arcos Portugal

T +35 21 000 8216

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T +39 (02) 92 44 790 F +39 (02) 92 72 90 47 [email protected]

Tecan Japan Co. Ltd Kawasaki Tech Center 580-16, Horikawa-cho, Saiwai-ku Kawasaki, Kanagawa 212-0013 Japan

T +81 44 556 7311 (Kawasaki) F +81 44 556 7312 (Kawasaki) T +81(0) 6305 8511 (Osaka) [email protected]

Tecan Nordic AB Taljegrdsgatan 11B SE-431 53 Mlndal Sweden


Tecan Schweiz AG Seestrasse 103 CH-8708 Mnnedorf Switzerland


Tecan Systems Inc. Technical support for components

2450 Zanker Road San Jose, CA 95131 USA

T +1 408 953 3100 F +1 408 953 3101 Toll Free in the US: T +1 866 798 3226 [email protected]

Tecan UK Theale Court 11-13 High Street Theale UK-Reading RG7 5AH United Kingdom


Tecan US Technical support for Tecan instruments

4022 Stirrup Creek Road, Suite 310 Durham, NC 27703 USA

T +1 919 361 5200 F +1 919 361 5201 Toll Free in the US: T +1 800 TECAN US or T +1 800 832 2687 [email protected]

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: [email protected]

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 INJURY,

LOSS OF LIFE OR EQUIPMENT DAMAGE IF THE INSTRUCTIONS ARE NOT FOLLOWED.

WARNING INDICATES THE POSSIBLE PRESENCE OF BIOLOGICALLY HAZARDOUS MATERIAL. PROPER LABORATORY SAFETY

PRECAUTIONS MUST BE OBSERVED.

WARNING INDICATES LASER. DO NOT STARE INTO THE BEAM!

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

IVD 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:

oII T onTransmissi =

Io = incident light I = detected light (after the sample)

The absorption (Optical Density) is the logarithm of the reciprocal transmission.

T1 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, INJURY 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: [email protected]

Note If the Surnise absorbance reader or the Magellan software is modified in any way, the warranty will no longer be valid and the instrument will lose

regulatory conformity.

Note The operating authority must use only CE-labeled test kits for clinical diagnostic applications. The operating authority must assure that the

combination of a particular CE-labeled test kit used with the CE-labeled Sunrise absorbance reader and its options have been validated to meet the IVD directive 98/79/EC or other relevant 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 Sunrise are influenced by the proper use of the instrument and microplates, according to the instructions given in

this document, as well as the liquid compounds used (reagents, chemistry). The instructions for use, storage, and applications involving samples or reagents must be followed strictly. 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 CE 2None/

Unrelated 34 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.

When a wavelength is selected, the entered wavelength is compared against the 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.

When a wavelength is selected, the entered wavelength is compared against the 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. 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 The following dialog box appears:

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. The following dialog box appears:

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 The following dialog box appears:

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. 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 Eject 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 Stick 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 Before starting measurements, make sure that the microplate position

A1 is inserted correctly.

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 Apply. 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 Apply.



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



5.1 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 again. Contact your local service engineer, if the error continues.

Timer event not active Internal firmware error Switch instrument off and then on again. Contact your local service engineer, if the error continues.



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 engineer, if the error continues.

Transport lost . steps Wrong detection of the positioning switches.

Check that the microplate is inserted correctly and nothing is blocking the transport system. Contact your local service engineer, if the error continues.

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, contact your local service engineer.

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 engineer, if the error continues.

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 service engineer, if the error continues.

Offset 400 not adjusted Electronic error on ADC board or optical problem


No wavelength defined Electronic error on ADC board or optical problem


Area 400 not adjusted Electronic error on ADC board or optical problem


Area 340 not adjusted Electronic error on ADC board or optical problem


E2Pot Overflow Electronic error on ADC board or optical problem




5.1.2 Table of Error Messages and Trouble Shooting for 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 service engineer, if the error continues.

Transport Microplate transport error Ensure that the microplate is inserted correctly and that nothing is blocking the transport system. Contact your local service engineer, if the error continues.

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




5.1.3 Table of Error Messages and Trouble Shooting for 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. Maintenance & Cleaning 6.1 Int

30041769 ifu sunrise ar tsc english v1 6

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