tecan SUNRISE Instructions For Use Manual
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tecan SUNRISE Instructions For Use Manual

Microplate absorbance reader
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TECAN
Instructions for Use for
SUNRISE
Microplate Absorbance Reader
Document Part No.: 30086638
2021-07
Document Revision No.: 2.9

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Summary of Contents for tecan SUNRISE

  • Page 1 TECAN Instructions for Use for SUNRISE Microplate Absorbance Reader Document Part No.: 30086638 2021-07 Document Revision No.: 2.9...
  • Page 2 Tecan Customer Support If you have any questions or need technical support for your Tecan product, contact your local Tecan Customer Support organization. Go to http://www.tecan.com/ for contact information. Prior to contacting Tecan for product support, prepare the following information for the best possible technical support (see name plate): •...
  • Page 3 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.
  • Page 4 THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS SUCH AS LEAD WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. FOR MORE INFORMATION GO TO: WWW.P65WARNINGS.CA.GOV/PRODUCT. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...
  • Page 5 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 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...
  • Page 6 Optical Density Remote control Reference Number/ Order Number Serial Number Standard Tuneable wavelength TYPE Name and type of instrument Universal serial bus Volt Volt ampere Video Graphics Array VOLTAGE Voltage Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 7: Table Of Contents

    Error Messages and Trouble Shooting ..................37 Introduction ............................37 4.1.1 Table of Error Messages and Trouble Shooting for SUNRISE Mode ........37 4.1.2 Table of Error Messages and Trouble Shooting for SPECTRA Mode ........40 Definition of ‘Overflow’ ........................40 Maintenance &...
  • Page 8 Microplate Test ........................54 6.3.3 High Meniscus Liquids ......................56 6.3.4 Instrument Precision with Liquid Samples ................58 6.3.5 Instrument Linearity with Liquid Samples ................58 Index ................................61 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 9: Safety

    DISPOSING OF THE INSTRUMENT, ALWAYS DISINFECT THE INSTRUMENT ACCORDING TO THE INSTRUCTIONS GIVEN IN THIS DOCUMENT. OBSERVE PROPER LABORATORY SAFETY PRECAUTIONS SUCH AS WEARING PROTECTIVE CLOTHING WHEN WORKING WITH POTENTIALLY INFECTIOUS SUBSTANCES. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...
  • Page 10 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. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 11: General

    (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.
  • Page 12 2. General The SUNRISE Microplate Absorbance Reader is available with a range of options such as tuneable wavelength, temperature control and barcode scanner. Magellan is a reader control and data reduction software package, and also can be used for concentration and titer determination.

  • Page 13: Area Of Application

    Note If the SUNRISE or the Magellan software is modified in any way, the warranty will no longer be valid and the instrument will lose regulatory conformity.

  • Page 14: User Profile

    2.2.3 Options of SUNRISE The SUNRISE is a modular system, so you can create your own tailor-made instrument that meets exactly your needs. Options such as free wavelength selection, temperature control and an integrated barcode scanner are available. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...
  • Page 15 This option is not used for clinical diagnostics in China. Optics 4-Filter (ST) 6-Filter (6F) Tuneable wavelength (TW) This option is not used for clinical diagnostics in China. Options Temperature control (TC) 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 16: Specifications

    2. General Specifications The tables below list the specifications for the instruments in SUNRISE mode. 2.3.1 General For all instrument options: PARAMETERS CHARACTERISTICS Main power input 100 - 120 & 220 - 240 V, 50/60 Hz (Auto sensing) Consumption Operational mode: max.

  • Page 17: Sunrise Instrument Configuration With 4Filter Option

    Information Technology Equipment – Safety and equivalent local standards. Computer interface: Serial RS 232 C 300 - 38,400 baud 2.3.3 SUNRISE Instrument Configuration with 6Filter Option See 2.3.2 SUNRISE Instrument Configuration with 4Filter Option . 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 18: Sunrise Instrument Configuration With Tuneable Wavelength Option (Gradient Filter Carriage)

    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 300 - 38,400 baud Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 19: Sunrise Instrument Configuration With Option Temperature Control

    +/- 0.2°C (max. +/- 0.5°C) Preheating time 30 min The SUNRISE specification of the temperature control unit (typical accuracy +/- 0.2°C) 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.

  • Page 20: Integrated Barcode Reader Option (Bcr) (For Sunrise With Remote Control Option Only)

    • DIN EN 60825-1 : 2007 • CDRH 21 CFR 1040.10 2.3.7 Microplates 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 CHARACTERISTICS Max. overall plate height 14.35 mm +/- 0.76 mm...

  • Page 21: Barcode Labels

    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 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 22: Instrument Description

    Max. resolution 0.13 mm (5.118 mil; 0.00511 inch) Instrument Description The illustration below shows the components of the instruments. Power ON LED Plate support Lamp compartment Filter block compartment Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 23: Back Panel Connections

    Serial RS232 interface Fuse values Printer interface (parallel port) All connected devices must be approved and listed as per IEC 60950-1 Information Technology Equipment – Safety and equivalent local standards. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 24: Handling The Microplate

    2. General Barcode Laser Scanner Labels (only available with integrated barcode option) Label reproductions on the instrument housing and interior: Note If any labels become damaged or removed, contact you local 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 motor is not active.

  • Page 25: Filter Carriage Description

    Gradient Filter Carriage SUNRISE gradient filters can only be used with the SUNRISE tuneable wavelength option. 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...

  • Page 26: 6Filter Carriage

    2. General 2.5.3 6Filter Carriage The SUNRISE 6filter carriages can only be used with the SUNRISE 6filter option. The SUNRISE 6filter carriage has up to six narrow band interference filters that have a fixed wavelength. Filter positions When a wavelength is selected, the entered wavelength is compared against the list of defined filter values for this filter carriage.

  • Page 27: Instrument Features

    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. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 28: Microplate Shaking

    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.

  • Page 29: Software For The Sunrise Microplate Absorbance Reader

    Remote Control, is intended for use with external software only. 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. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 30: Installation Procedure

    The delivered instrument is shipped in one carton, which includes: • Power cable • Computer connection cable • Instructions for Use for SUNRISE Microplate 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).

  • Page 31: Unpacking Procedure

    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. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 32: Environmental Requirements

    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. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 33: Installation Of Instrument Control Software

    “SUNRISE Instrument Settings” program is ready to be used. Starting the “SUNRISE Instrument Settings” 3.8.2 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”...

  • Page 34: Define Instrument Mode

    3. Installation Procedure 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.

  • Page 35: Define Filter

    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. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 36: 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 Microplate Absorbance Reader. Click Finish and the following dialog box appears: The measurement mode has now been set successfully.

  • Page 37: Error Messages And Trouble Shooting

    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. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...
  • Page 38 Timeout waiting for measurement Lamp or another optical Check lamp and if the lamp is finished defect working and positioned correctly, contact your local service engineer. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...
  • Page 39 E2Pot Overflow Electronic error on ADC Start Lamp Adjust program in the Setup board or optical problem program. Contact your local service engineer if the error continues. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 40: Table Of Error Messages And Trouble Shooting For Spectra Mode

    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. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 41: Maintenance & Cleaning

    Filters Retaining Rings 4. Turn the filter carriage over and insert the new filter and the retaining ring. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 42: Gradient Filter Carriages For Tuneable Wavelength Option

    To change the filter carriage, please follow the procedure 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 wavelength option. Validation of the system has to be performed with those filters, which finally are actually used during measurement.

  • Page 43: 6Filter Carriages For 6Filter Option

    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. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 44: Fuse Replacement

    6. Reconnect the power cord and switch the instrument on WARNING IF THE FUSE CONTINUES TO BLOW, PLEASE CALL FOR SERVICE. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 45: Cleaning The Instrument

    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 5.6.1 and 5.6.2. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 46: Preventive Maintenance Plan For Sunrise

    • Or done by service technician: • Perform extended operational quality check 5.5.5 Every Four Years (Service Technician Required) • Replace the lamp and the filters • Perform extended operational quality check Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 47: Instrument Disinfection

    WARNING THE DISINFECTION PROCEDURE SHOULD BE PERFORMED IN A WELL-VENTILATED ROOM BY AUTHORIZED TRAINED PERSONNEL WEARING DISPOSABLE GLOVES AND PROTECTIVE GLASSES AND CLOTHING. 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...
  • Page 48 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. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 49: Disinfection Declaration

    Contact person: ...................... Company/ institution: ..................... Function: ........................ Phone/ Fax: ......................E-mail: ........................Date of disinfection: ....................Date, name: ......................Signature: ....................... 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 50: Disposal Of Instrument

    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. Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9 2021-07...

  • Page 51: Disposal Of The Instrument

    5. Maintenance & Cleaning 5.8.4 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.

  • Page 52: Quality Control

    2. After each microplate has been measured, please refer to the test kit package for information regarding the validation procedure. Instructions for Use for SUNRISE No. 30086638 Rev No. 2.9 2021-07...

  • Page 53: Self Check Procedure

    Make sure that the type of microplate used with the SUNRISE Microplate Absorbance Reader is suitable for the respective application. 2. Use only perfectly clean microplates.

  • Page 54: Operational Qualification (Oq)

    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.
  • Page 55 6. Quality Control Acceptable Microplate Unacceptable Microplate 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 56: High Meniscus Liquids

    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 Instructions for Use for SUNRISE No. 30086638 Rev No. 2.9 2021-07...
  • Page 57 Agglutination Method For agglutination measurements, an external software package must be used which is not provided by Tecan. Depending on the software used, the SUNRISE Microplate Absorbance Reader must be set to SUNRISE or SPECTRA mode using the SUNRISE Instrument Settings software. The SUNRISE Microplate Absorbance Reader is able to read up to 40 measurement points per well.

  • Page 58: Instrument Precision With Liquid Samples

    OD values. Determine the unweighted residual square value R of the regression line. Typical residual square values for a standard application are equal or better than = 0.998. Instructions for Use for SUNRISE No. 30086638 Rev No. 2.9 2021-07...
  • Page 59 1.323 OD 0.25 0.679 OD 0.125 0.360 OD 0.0625 0.192 OD 0.03125 0.110 OD 0.025 OD Equation for linear regression: y = 2.5888x + 0.0314 Residual squared value: R 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

  • Page 61: Index

    High Meniscus Liquids ........56 and Inspection ............. 30 Procedure ............31 User Profile ............14 Installation............32 Instrument cleaning ............... 45 Warranty .............3 Description ............22 disinfection ............47 2021-07 Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9...

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