EUROIMMUN Medizinische Labordiagnostika AG Sprinter XL Instructions For Use Manual Download Page 6

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2 Warning, safety and other notices

M e d i z i n i s c h e
L a b o r d i a g n o s t i k a
A G

EUROIMMUN



YMBOLS

Produced by

Completed by

In vitro diagnostic medical device

Order Number

CE label

Fuse

Serial number

The instrument should not be placed in
ordinary domestic waste.



PECIAL WRITING CONVENTIONS

Menu items

Menu items are printed in bold.
Example:

Main menu

Keys/buttons

Keys and buttons are printed in italics or
are shown as a symbol.
Example: Press

Enter



BBREVIATIONS

Abbreviation

°C

Celsius

Hertz

IVD

In vitro diagnostic medical device

Kilogramme

l Litre

Millilitre

Serial

number

Summary of Contents for Sprinter XL

Page 1: ...ROIMMUN Medizinische Labordiagnostika AG D 23560 L beck Seekamp 31 Tel 0 45 1 58 55 0 Fax 58 55 591 M e d i z i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN Instructions for use Sprinter...

Page 2: ...ject to change the manual is not covered by an update service Unless expressly authorised forwarding and duplication of this document and the utilisation and communication of its contents are not perm...

Page 3: ...21 6 2 Unpacking transport storage 21 6 3 Ambient conditions 22 6 4 Installation and commissioning 22 7 OPERATING INSTRUCTIONS 24 7 1 The Sprinter XL software 24 7 2 Before and after each worklist 27...

Page 4: ...Weekly maintenance work 64 9 1 3 Monthly cleaning 65 9 2 Service plan for service technicians 67 9 3 Instrument disinfection 67 9 4 Decommissioning the system 67 10 ERROR REMEDIES 68 10 1 Error messa...

Page 5: ...g buttons keys NOTES Notes are indicated with a symbol and printed in bold and italics The symbols are as follows Read the manual before use Information is identified with this symbol It contains usef...

Page 6: ...Serial number The instrument should not be placed in ordinary domestic waste SPECIAL WRITING CONVENTIONS Menu items Menu items are printed in bold Example Main menu Keys buttons Keys and buttons are...

Page 7: ...in diagnostic institutions The results should always be checked for correctness by medically qualified personnel For diagnosis the clinical symptoms of the patient should always be taken into account...

Page 8: ...may only be performed by trained qualified and authorised service personnel The system was developed and tested according to the provisions of the IVD directive Unauthorised procedures invalidate all...

Page 9: ...liquids and for the system Replacement fuses must meet the specifications nominal voltage nominal current strength type of the manufacturer Always replace burnt out fuses never repair Never short cir...

Page 10: ...crushed or pinched while the robotic arm is in motion There is also a potential risk of injury from the pipette tip Only reach into the instrument when it is paused and a dialogue window prompts you...

Page 11: ...n into the waste tank pointing downward without loops and kinks Always ensure that all other tubes are free of kinks and links Always ensure that the system liquid container is adequately filled with...

Page 12: ...nal a 2D Barcode reader for reading the Slide ID can be ordered The 2D barcode reader works with a LED The LED is assigned to class exempt risk group according to EN 62471 The light emitted from this...

Page 13: ...shaken nor sprayed into the instrument Use a cloth dipped into a detergent for cleaning or disinfection Only use approved detergents or disinfectants The applicable regulations are to be followed for...

Page 14: ...of any defects immediately and do everything possible to minimise the damage If EUROIMMUN AG is informed of such a defect it is obligated to remove it it is EUROIMMUN s decision whether it does this...

Page 15: ...guration 64 49 standards controls depending on device configuration 20 12 secondary reagents depending on device configuration 6 9 sample buffer depending on device configuration 4 wash buffer Accesso...

Page 16: ...iguration Dilutions 13 freely definable dilutions per test Processing steps Dilution and transfer Incubation shaking heating Washing Dispensing Measuring step Miscellaneous Barcode scanner CCD camera...

Page 17: ...t 15 M e d i z i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN Physical External dimensions 112 cm B x 85 cm T x 55 cm H Weight Approx 150 kg Temperature 15 C to 30 C Relative humidity 10...

Page 18: ...pipetting station There are generally 6 positions for microplates or microscope slide racks which can be each equipped with up to 5 standard slides or with a 50 well slide A combination of slide racks...

Page 19: ...eagent racks 2x 4 Control racks 4x 5 Buffer rack 1x 6 Initial dilution plate 7 Titer dilution plate 2x 8 Shaker Pipetting station 9 Incubation positions for microscope slide plates 6x 10 Washing modul...

Page 20: ...3 Reagent racks 2x 4 Standard Control rack 4x 5 Sample buffer rack 1x 6 Dilution area 1 7 Dilution area 2 8 Needle washing station 9 Shaker Pipetting station 10 Microplate incubation positions 6x 11...

Page 21: ...ed barcode scanner 2 Sample racks 8x 3 Reagent racks 2x 4 Standard Control racks 4x 5 Sample buffer rack 1x 6 Initial dilution area 7 Serial dilution area 8 Needle washing station 9 Shaker Pipetting s...

Page 22: ...20 5 General information on the instrument M e d i z i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN NAMEPLATE Figure 5 4 Nameplate...

Page 23: ...le If parts are damaged please contact the relevant field service employee or EUROIMMUN AG 6 2 Unpacking transport storage Please observe the following safety notes when unpacking transporting and sto...

Page 24: ...handling of the system for system liquids and the wash buffer container Also enough space is required to flip the instrument cover up o Remove all packaging materials and clean the instrument o Align...

Page 25: ...n o s t i k a A G EUROIMMUN o Connect the mains cable to the mains power supply and connect it to the mains outlet of the instrument o Review the settings on the instrument to ensure that the needle c...

Page 26: ...working procedure is safe and that the system functions without problems the notes and warnings included in the operating manual must be observed 7 1 The Sprinter XL software Most functions of the so...

Page 27: ...reate the worklist opens Figure 7 3 Worklist window The following buttons are available to operate the software Methods Click on here to select the tests which should be performed Barcode To automatic...

Page 28: ...lick on the plus sign Change dilution plate With this button a dilution plate which has been initiated is discarded and a new plate for the initial dilutions is started Print Report With this button y...

Page 29: ...e system tube and as a rinsing solution following contact with the samples and reagents The system liquid consists of distilled or deionised water and the cleaning solution Setup Clean The amount of S...

Page 30: ...nts of the Sprinter XL Figure 7 5 Service Menu1 Select the Maintenance Prime Procedure menu item under Service operations and press Start In the Description field you will get instructions which you m...

Page 31: ...e buffer 6 The liquid is flushed in using the service menu To reach the service menu press the Service button The service menu will offer you a list with different service points of the Sprinter XL Fi...

Page 32: ...u a list with different service points of the Sprinter XL Figure 7 9 Service Menu3 Select the Maintenance Washer Prime Procedure under Service Operations and press Start In the Description field you w...

Page 33: ...a LIMS to the Sprinter XL Before a new worklist can be created the existing worklist must be deleted Delete the existing worklist via the Clear list button 7 3 1 Manual creation of a worklist with non...

Page 34: ...to load the required samples Here the barcode numbers of the imported worklist are compared to the loaded sample barcode numbers To read in the samples proceed as described in the following chapter 7...

Page 35: ...s of the individual samples appear in a table in the software Then you will be shown the rack position corresponding to the scanned sample barcodes If a barcode cannot be read the software indicates t...

Page 36: ...dow with undetected samples appears remove all samples displayed in the window from the corresponding rack positions Then click on Ignore Select the initial sample ID which has a from the worklist and...

Page 37: ...performed The Methods Selection window opens Left click on the appropriate box of the tests which should be performed The tests are automatically added to the worklist after closing the window with O...

Page 38: ...for the next worklist Following activation the colour of the column changes from yellow to green and the test name changes from black to red Only tests which are confirmed in this way are taken into a...

Page 39: ...are performed as described in chapter 7 4 7 4 Running a test General instructions to successfully run a test o Ensure that all reagents and microscope slides or microtiter strips have reached room tem...

Page 40: ...fer tube into the filled wash buffer container Start the worklist created according to chapter 7 3 by clicking on the Run button The instrument works with two different dilution areas The initial dilu...

Page 41: ...dilution positions need to be replaced by the user with unused tubes plates In case there are not enough cavities wells available for predilution the following message appears Figure 7 24 Wells for p...

Page 42: ...ation on the temporal progression of the worklist is shown at the top of the window The individual process steps are shown for each plate The image is divided into 10 minute intervals The schedule is...

Page 43: ...sition of the microscope slides required for the next run click on the Slides tab The window will show you in graphic form into which rack position the microscope slides of the individual parameters m...

Page 44: ...e 2 plate 3 etc to display the views for further plates When loading the microscope slide racks ensure that they are correctly positioned Field 1 for standard slides 3 5 or 10 wells must always be in...

Page 45: ...at all covers were removed and no air bubbles can be found in the bottle neck and or the liquid The Stds Ctrls tab shows which standards and controls must be loaded You will be shown the rack area for...

Page 46: ...etailed temporal progression of the worklist Here you can learn the status Running or Done and the scheduling of the individual processing steps of the different tests The times displayed were determi...

Page 47: ...ptional Reading of slide ID 2DBarcode Slide ID reading is an optional feature in the Sprinter XL software To enable the Slide ID reading option special settings in the software and hardware are requir...

Page 48: ...placed on the shaker modul Afterwards the reading process is performed and the rack is returned on its starting position Before starting the reading process the slide racks need to be loaded correctly...

Page 49: ...s for the previous slide rack is finished Unrecognised 2D barcodes can be read in by handscanner or via keyboard after the reading process is finished To do this click on the button Slide ID in the li...

Page 50: ...d the associated position on the slide rack After the message is confirmed the ID assigned in duplicate is automatically replaced by a new predefined ID Afterwards reading process can be repeated In c...

Page 51: ...of the print out Figure 7 45 Print out with Slide ID 7 4 3 Loading the Sprinter XL for ELISA Proceed as follows Was daily maintenance performed If not follow the steps described in chapter 7 2 Check t...

Page 52: ...Figure 7 46 Dilution area ELISA After starting the worklist a window opens with information on the required dilution wells Figure 7 47 Dilution cavities wells query ELISA If the required cavities well...

Page 53: ...he New dilution plate button If the question on dilution capacities was answered with Yes the load window appears Figure 7 49 Load window ELISA Information on the temporal progression of the worklist...

Page 54: ...d wells in olive green Figure 7 50 Predilution plate ELISA To view the number and position of the microtiter strips required for the next run click on the Plates tab Position the strips of the individ...

Page 55: ...e that all covers were removed and no air bubbles can be found in the bottle neck and or the liquid The Stds Ctrls tab shows which standards and controls must be loaded You will be shown the rack area...

Page 56: ...sure that there is enough liquid in the bottles Figure 7 54 ELISA reagents After the conjugate step the pipetting unit needs to be rinsed with sulfuric acid 0 5 mol l This dilution needs to be inserte...

Page 57: ...e top button bar The displayed information depends on the previously selected tab If for example you select the Sample Predilution tab you will obtain information on the sample test assignment and the...

Page 58: ...of the window A red vertical line shows the current time and displays the step that is being performed Figure 7 56 Worklist status To obtain detailed information on the next or previously processed st...

Page 59: ...he window closes and the window automatically appears in which a worklist is created or edited The interrupted tests of the last worklist are shown in red in the main menu Figure 7 58 Cancelled workli...

Page 60: ...UN Press the OK button to go back to the main menu In the main menu you are shown in colour which tests have been processed orange and which are still to be done yellow Figure 7 60 Processed worklist...

Page 61: ...displayed automatically The directory structure is divided into Year Month Day Alternatively another day can be selected in the directory tree Figure 8 1 RepExplorer IFA To select another day double c...

Page 62: ...port is printed by default Here the configuration of one microscope slide is shown per page The microscope slides are listed continuously in Summary mode In the printout of a 50 well slide the well po...

Page 63: ...t to the horizontal field description of a standard slide For microscopy the user needs to observe the pipetting order and the corresponding result print out Figure 8 4 Pipetting order of 50 well slid...

Page 64: ...nt the preview of the result print out is opened Figure 8 6 Result printout ELISA Via the printer symbol the preview of the result print out can be printed By Default the Full Report is printed In the...

Page 65: ...intout With the Search tab you can search for a results report by using the Plate ID or Date fields An expanded search function is available under the History tab Here it is possible to display a cert...

Page 66: ...work The maintenance work to be performed daily is described in chapter 7 2 9 1 2 Weekly maintenance work In addition to daily maintenance the following work must be performed o Empty disinfect e g w...

Page 67: ...ly with a bottle brush and detergent along with the station inserts Then rinse with distilled water o Place the system filter into a vessel with 70 alcohol Perform the Prime Procedure in the Sprinter...

Page 68: ...water a brush and a mild detergent Thoroughly rinse with distilled water Remove the end of the system tube from the station and insert it in a vessel with 70 alcohol Then repeat the procedure twice w...

Page 69: ...chapter 9 1 3 must be performed Never use acetone or alcohol to clean the cover The disinfection process should be carried out by authorised and trained personnel wearing powder free disposable gloves...

Page 70: ...e 10 1 No liquid found Click on Retry to repeat the process Select the Ignore option to switch off the liquid level detection sensor The needle moves until just over the tube bottom and starts aspirat...

Page 71: ...A G EUROIMMUN 10 3 Error message Action not startable If this error message appears when initialising the instrument there is a connection problem In this case you must check all cables and connection...

Page 72: ...Sarstedt 65 809 Sarstedt tubes for IFA 2 ml 10 8 mm Sarstedt 72 609 Screw cap for control tubes Sarstedt 65 716 Sarstedt tubes for IFA sample buffer 120 ml 42 mm Sarstedt 60 597 Dilution plate for sc...

Page 73: ...bottle with cap for IFA conjugate 6 ml 18 5 mm EUROIMMUN ZG 0031 0125 Brown bottle 5 ml EUROIMMUN ZG 0103 0105 Cap for 5 ml bottle EUROIMMUN ZG 0110 0100 Brown bottle 15 ml EUROIMMUN ZG 0105 0115 Cap...

Page 74: ...ako Pen Hydrophobic barrier pen EUROIMMUN ZG 0261 0101 Tweezers EUROIMMUN ZD 9871 0101 Adjustment solution 50 ml EUROIMMUN ZE 1120 1050 6 Setup Clean 500 ml EUROIMMUN ZG 0009 0505 Slide tray white EUR...

Page 75: ...ramming window 24 Figure 7 3 Worklist window 25 Figure 7 4 Container for system liquid and station 27 Figure 7 5 Service Menu1 28 Figure 7 6 Service Menu Description1 28 Figure 7 7 Service Menu2 29 Fi...

Page 76: ...Info Box manual Reading 47 Figure 7 41 Slides Info Box Status Edited 47 Figure 7 42 Twice assigned Slide ID during manual reading in via handscanner 48 Figure 7 43 Twice assigned Slide ID on different...

Page 77: ...i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN Figure 8 7 LoLi in the printout 63 Figure 8 8 Search function 63 Figure 10 1 No liquid found 68 Figure 10 2 Movement blocked 68 Figure 10 3...

Page 78: ...76 12 Appendix M e d i z i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN...

Page 79: ...12 Appendix 77 M e d i z i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN...

Page 80: ...IMMUN Medizinische Labordiagnostika AG E Mail euroimmun euroimmun de Internet www euroimmun de M e d i z i n i s c h e L a b o r d i a g n o s t i k a A G EUROIMMUN YG_0033_A_UK_C03 doc Version 12 12...

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