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2021-07

Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9

Symbols

Manufacturer

Date of manufacture

CE conformity marking

United Kingdom Conformity Assessed

marking shows that the labeled product is following the applicable regulation in
Great Britain.

Consult instructions for use

Catalogue number

Serial Number

Unique Device Identification

The UDI symbol identifies the data carrier on the label.

WEEE symbol

China RoHS symbol

TÜV SÜD MARK

Biological risks

Laser

Содержание sunrise

Страница 1: ...TECAN Instructions for Use for SUNRISE Microplate Absorbance Reader Document Part No 30086638 2021 07 Document Revision No 2 9...

Страница 2: ...ormation Prior to contacting Tecan for product support prepare the following information for the best possible technical support see name plate Model name of your product Serial number SN of your prod...

Страница 3: ...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 Certifi...

Страница 4: ...UCTIONS 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...

Страница 5: ...Kingdom Conformity Assessed marking shows that the labeled product is following the applicable regulation in Great Britain Consult instructions for use Catalogue number Serial Number Unique Device Id...

Страница 6: ...sius CE CE conformity marking cm Centimeter F Fahrenheit Hz Hertz IVD In vitro diagnostics kg Kilogram l L Liter LED Light emitting diode LIS Laboratory Information System MB Megabyte ml Milliliter nm...

Страница 7: ...Instrument Features 27 2 6 1 Measurement Modes 27 2 6 2 Microplate Shaking 28 2 7 Instrument Spare Parts and Tools 28 2 8 Software for the SUNRISE Microplate Absorbance Reader 29 3 Installation Proce...

Страница 8: ...lutions 47 5 6 2 Disinfection Procedure 47 5 7 Disinfection Declaration 49 5 8 Disposal of Instrument 50 5 8 1 Introduction 50 5 8 2 Disposal of Packing Material 50 5 8 3 Disposal of Operating Materia...

Страница 9: ...e application of approved laboratory safety procedures CAUTION IF THE INSTRUCTIONS GIVEN IN THIS PUBLICATION ARE NOT CORRECTLY FOLLOWED THE INSTRUMENT MAY BECOME DAMAGED OR PROCEDURES MAY NOT BE CORRE...

Страница 10: ...GNETIC ENVIRONMENT FOR THE INSTRUMENT IS MAINTAINED SO THAT THE INSTRUMENT PERFORMS AS INTENDED DO NOT OPERATE THE INSTRUMENT IN CLOSE PROXIMITY TO SOURCES OF STRONG ELECTROMAGNETIC RADIATION E G UNSH...

Страница 11: ...e 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...

Страница 12: ...lso be established Make sure the instrument and the software are suitable for use with the reagents chemicals and microplates that are being used see 6 2 Optimizing for Maximum Performance and 6 3 Ope...

Страница 13: ...ed 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 a...

Страница 14: ...oduct is used as intended the person is able to recognize and avoid dangers Computer application skills and good language skills for the respective national language at the installation site and Engli...

Страница 15: ...handheld barcode scanner plus ASTM export This option is not used for clinical diagnostics in China Barcode BCR option for SUNRISE with remote control RC This option is not used for clinical diagnosti...

Страница 16: ...A Fuse rating 2 x F 2 0 A 250 V Fast Blow Outside dimensions Width 28 5 cm 11 22 inch Depth 34 0 cm 13 39 inch Height 14 5 cm 5 71 inch Weight Max incl all options 8 6 kg Ambient temperature Operation...

Страница 17: ...000 2 000 OD 400 750 nm 2 000 3 000 OD R 0 999 R 0 999 R 0 999 better than x of measurement value plus corresponding OD value Note All deviations from the measurement value are meant in positive and n...

Страница 18: ...nearity 492 nm 0 000 2 500 OD 2 R 0 999 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 fi...

Страница 19: ...nts 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...

Страница 20: ...roplates Only 96 well format microplates without lid v shaped flat and round including strip wells with transparent bottom can be used with the SUNRISE Microplate Absorbance Reader PARAMETERS CHARACTE...

Страница 21: ...y 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 ed...

Страница 22: ...e 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 no...

Страница 23: ...Conformity on the last page of this document 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 approve...

Страница 24: ...cal Tecan representative for replacement labels 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...

Страница 25: ...on of the new and customized Filterslides see 3 8 Defining the Instrument Settings 2 5 2 Gradient Filter Carriage SUNRISE gradient filters can only be used with the SUNRISE tuneable wavelength option...

Страница 26: ...s 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 t...

Страница 27: ...ion 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...

Страница 28: ...TE 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 Frequ...

Страница 29: ...or 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 for service engineer...

Страница 30: ...g 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 Inst...

Страница 31: ...eport 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...

Страница 32: ...NG 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 betwee...

Страница 33: ...ired 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 install...

Страница 34: ...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 rat...

Страница 35: ...er 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...

Страница 36: ...te measurement mode Click Next and the following dialog box appears These settings are not available for the SUNRISE Microplate Absorbance Reader Click Finish and the following dialog box appears The...

Страница 37: ...le 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 Er...

Страница 38: ...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 Wrong Transport Paramet...

Страница 39: ...mber 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 adjust...

Страница 40: ...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 mu...

Страница 41: ...cal 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 flus...

Страница 42: ...ocedure outlined in the appropriate software Instructions for Use Note The SUNRISE specifications are different if the instrument is equipped with the 4filter option 6filter option or tuneable wavelen...

Страница 43: ...nstrument 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 Rem...

Страница 44: ...ord 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...

Страница 45: ...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 5 4 2 Liquid Spills If any liquid is spilled on the instrument...

Страница 46: ...Weekly Clean the cover and the plate transport with a mild detergent CAUTION NEVER USE ACETONE AS IT WILL DAMAGE THE COVERS 5 5 3 Every Six Months Clean the filters using an optical cleaning solution...

Страница 47: ...t 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 5 6 1...

Страница 48: ...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 press...

Страница 49: ...e distributor or service center Disinfection Declaration I declare that the outer surfaces and the plate transport of the instrument in this package have been disinfected to remove or inactivate any b...

Страница 50: ...OLLECTED SEPARATELY 5 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 P...

Страница 51: ...f 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 SUNR...

Страница 52: ...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 6 2 1 Instrument...

Страница 53: ...e 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 ob...

Страница 54: ...lignment 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...

Страница 55: ...6 Quality Control 2021 07 Instructions for Use for SUNRISE No 30086638 Rev No 2 9 55 Acceptable Microplate Unacceptable Microplate...

Страница 56: ...ument 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...

Страница 57: ...ddle 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...

Страница 58: ...0 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 6 3 5 Instrument Linearity with Liquid Samples The linearity for the in...

Страница 59: ...lication used Note The limits of the instrument s linearity will be measured with the QC plate Example for a tuneable wavelength instrument Readings 0 100 to 2 500 OD Dilution Factor Absorbance 1 2 62...

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Страница 61: ...er Carriages 41 6 Filter 43 Fuse Replacement 44 H handheld barcode scanner 15 22 High Meniscus Liquids 56 I Installation 32 Instrument cleaning 45 Description 22 disinfection 47 Linearity 58 Location...

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