EUROIMMUN Medizinische Labordiagnostika AG Sprinter XL Instructions For Use Manual
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EUROIMMUN Medizinische Labordiagnostika AG Sprinter XL Instructions For Use Manual

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

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Summary of Contents for EUROIMMUN Medizinische Labordiagnostika AG Sprinter XL

  • Page 1 L a b o r d i a g n o s t i k a Instructions for use Sprinter XL EUROIMMUN Medizinische Labordiagnostika AG · D-23560 Lübeck · Seekamp 31 · Tel. 0 45 1/58 55-0 · Fax 58 55-591...
  • Page 2 Violation will entail an obligation to pay compensation. All rights reserved in the event of granting of patents or registration of a utility model. Publisher: EUROIMMUN Medizinische Labordiagnostika AG Seekamp 31 23560 Luebeck, Germany Phone: +49 (0) 451 5855 0...

  • Page 3: Table Of Contents

    Editing a worklist - 35 -  7.4  Running a test - 37 -  7.4.1  Loading the Sprinter XL for immunofluorescence - 38 -  7.4.2  Optional: Reading of slide ID (2DBarcode) - 45 -  7.4.3  Loading the Sprinter XL for ELISA - 49 - ...
  • Page 4 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a 8  RESULT REPORTS - 59 -  9  CLEANING AND MAINTENANCE - 64 -  9.1 ...

  • Page 5: Warning, Safety And Other Notices

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Warning, safety and other notices The symbols described here are used in this manual, on individual instrument parts and the packaging.
  • Page 6 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a  S YMBOLS Produced by Completed by In vitro diagnostic medical device Order Number CE label Fuse...

  • Page 7: Introduction

    The instrument should only be used by trained personnel. For IVD compliant use of the Sprinter XL, all test methods and kits must be validated by the user in conjunction with the device. Here the usual clinical laboratory practice, locally applicable laws and the current state of the art are to be observed.

  • Page 8: Safety Notes

    Applicable laws must be followed for the safe electrical operation of the instrument. The Sprinter XL may only be operated with the voltage source which is noted on the nameplate. If you are unsure whether the voltage is suitable, please contact an authorised seller or your local energy utility.
  • Page 9 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a The instrument must be connected to the power supply with the included connection cable.
  • Page 10 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a  M ECHANICAL SAFETY Never place the instrument on an instable table, carriage or similar item. The instrument can fall and suffer considerable damage as a result or injure the user.
  • Page 11  S AFETY MEASURES It is important that the work area of the Sprinter XL is constructed as described in the manual. Ensure that there are no unnecessary items in the work area. The liquid waste container should be emptied on a daily basis to avoid an overflow of the washing station when rinsing the needles.

  • Page 12: Instrument Safety And Emc

    EN 61010-1. The system has left the factory in flawless condition in terms of safety. The Sprinter XL meets the requirements of the IVD directive 98/79/EC “In vitro diagnostics directive” of the European Union. Conformity with the above EC directive is documented by the CE label.

  • Page 13: Maintenance

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a The nameplate is located on the left side panel of the instrument next to the integrated barcode scanner.

  • Page 14: Warranty Notes

    L a b o r d i a g n o s t i k a Warranty notes The Sprinter XL, including its original accessories, may only be used for the analytical methods described in this manual. Please observe the following...

  • Page 15: General Information On The Instrument

    L a b o r d i a g n o s t i k a General information on the instrument The Sprinter XL is a system with a modular structure which allows the automatic processing of IFA microscope slides and ELISA microplates, from sample preparation to the final washing or measuring step.
  • Page 16 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Wash method Flooding the microscope slides in a 5-slide tray/strip-by-strip washing of ELISA plates Washer head 8-channel washer head Reader...
  • Page 17 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Physical External dimensions 112 cm (B) x 85 cm (T) x 55 cm (H) Weight Approx.

  • Page 18: Instrument Description

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Instrument description The moveable robotic arm guides four washable pipetting needles, which pipette the samples and reagents.
  • Page 19 L a b o r d i a g n o s t i k a  F IMMUNOFLUORESCENCE RONT VIEW Figure 5-1: Sprinter XL – Standard configuration IFA Integrated barcode scanner Sample racks 8x Reagent racks 2x Control racks 4x...
  • Page 20 L a b o r d i a g n o s t i k a  F ELISA RONT VIEW Figure 5-2: Sprinter XL – Standard configuration ELISA Integrated barcode scanner Sample racks 8x Reagent racks 2x Standard/Control rack 4x...
  • Page 21 L a b o r d i a g n o s t i k a  F ELISA/IFA RONT VIEW COMBINATION Figure 5-3: Sprinter XL – Standard configuration ELISA/IFA Integrated barcode scanner Sample racks 8x Reagent racks 2x Standard/Control racks 4x...
  • Page 22 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a  N AMEPLATE Figure 5-4: Nameplate - 20 - 5 General information on the instrument...

  • Page 23: Installation Process

    Please observe the following safety notes when unpacking, transporting and storing the Sprinter XL: o The Sprinter XL is supplied in a wooden case on a pallet. Check the container for damage before opening. o When unpacking, use the delivery note to ensure that all system components are present.

  • Page 24: Ambient Conditions

    10% to 85% at 30°C, no condensing moisture Installation and commissioning Commissioning and installation of the Sprinter XL may only be performed by an authorised service technician of EUROIMMUN AG. o Place the instrument on the work surface in such a way that the main switch and the emergency stop are easily accessible.
  • Page 25 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a o Connect the mains cable to the mains power supply and connect it to the mains outlet of the instrument.

  • Page 26: Operating Instructions

    You can receive supplemental information from our service. The Sprinter XL is a precision instrument which may be impaired in its performance or damaged if handled improperly. The system may only be operated by competent persons instructed in its use which have the experience required to handle diagnostic tests.
  • Page 27 EUROIMMUN L a b o r d i a g n o s t i k a Programming of the Sprinter XL may only be performed by an authorised service technician of EUROIMMUN AG. You can exit the programming window with the Worklist button and the window to create the worklist opens.
  • Page 28 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Service The daily service is performed with this menu. Return With this menu you can return to the programming window (the button is sometimes not active) Remove Samples To remove selected sample(s)

  • Page 29: Before And After Each Worklist

    7.2.1 Flushing with the system liquid The Sprinter XL uses system liquid to clean the pipetting needles and to fill the 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.
  • Page 30 If necessary, repeat the process. To start the service, press the Continue button. The Sprinter XL flushes the needle washing station with system liquid. - 28 -...
  • Page 31 L a b o r d i a g n o s t i k a 7.2.2 Decontamination of the pipetting needles The Sprinter XL requires an alcoholic solution (ethanol 70%) to decontaminate the pipetting needle. For decontamination place the alcoholic solution into the position described in the Description window.

  • Page 32: Rinsing The Washer Head

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a 7.2.3 Rinsing the washer head Place all 4 supplied wash buffer tubes into a vessel with distilled or deionised water.

  • Page 33: Completing A Worklist

    Creating a worklist A worklist can be manually created by the user or automatically sent and imported via 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.

  • Page 34: Importing A Worklist From Lab Software

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-11: Manually defining samples The next steps are performed as described in chapter 7.3.4. 7.3.2 Importing a worklist from lab software If the instrument is connected to lab software, proceed as follows: Click on Import to import the worklist.
  • Page 35 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Keep the instrument cover closed until the initialisation of the arm is complete and the prompt appears instructing you to load the sample rack.
  • Page 36 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Special aspects If you work with an imported worklist, the samples which were not found are marked with a “?”.

  • Page 37: Editing A Worklist

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a If necessary, press the arrow button to display the position numbers (tube) in ascending order.
  • Page 38 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-19: Sample Selection De-selecting To de-select samples, hold down the control key (Control on the keyboard) and samples left-click into the field to be de-selected.

  • Page 39: Running A Test

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-21: Selection of titer dilutions Select the desired dilutions by left-clicking on the desired field. The selected fields turn yellow.

  • Page 40: Loading The Sprinter Xl For Immunofluorescence

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a 7.4.1 Loading the Sprinter XL for immunofluorescence Proceed as follows: Was daily maintenance performed? If not, follow the steps described in chapter 7.2.
  • Page 41 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a If the required cavities (wells) are available, confirm with Yes. If the memory function is active and you would like to start with new dilution plates, click on No.
  • Page 42 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-26: Cavities for predilution and serial dilution insufficient Confirm the message with OK and place unused predilution plates/ tubes and serial dilution plates in the device.
  • Page 43 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-28: Dilution area The Plates tab is not required in immunofluorescence. Plates Microscope In order to display the number and position of the microscope slides required...
  • Page 44 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Place the microscope slides into the microscope slide racks in the order shown in the figure.
  • Page 45 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Reagent The configuration of the reagent rack in the instrument is as follows: configuration Conjugate Controls...
  • Page 46 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Reagents The Reagents tab shows which reagents must be loaded. In the left part of the window there is a graphic display of the rack for the secondary reagents and its position for the impending test run.

  • Page 47: Optional: Reading Of Slide Id (2Dbarcode)

    Press the Back button to close the Info window 7.4.2 Optional: Reading of slide ID (2DBarcode) Slide ID reading is an optional feature in the Sprinter XL software. To enable Option Slide ID the Slide ID reading option, special settings in the software and hardware are required, which need to be made by an EUROIMMUN service technician.
  • Page 48 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a In the slide info box of the tab “Slides” a predefined ID (YYYYMMDD- number_of_run-plate+slidenumber) is displayed.
  • Page 49 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a As soon as the reading process of the slide rack is finished, the proceeding slide rack can be selected.
  • Page 50 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a The same Slide ID cannot be assigned twice. If during manual reading process Twice assigned the Slide ID is assigned twice, the following error message appears: Slide ID...

  • Page 51: Loading The Sprinter Xl For Elisa

    The Slide ID of every slide is visible on the top 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.
  • Page 52 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Dilution plates The instrument works with different dilution areas. The dilutions are carried out in 1.2 ml dilution tubes or in a 2 ml predilution plate.
  • Page 53 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-48: Insufficient dilution wells Confirm the message with OK and request a new plate with the New dilution plate button.
  • Page 54 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Samples and Loading information is shown at the bottom of the window based on tabs. The sample racks and dilution plates are visible on the first tab Samples &...
  • Page 55 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Reagent The configuration of the reagent rack in the instrument is as follows: configuration Reagents Controls...
  • Page 56 After the conjugate step the pipetting unit needs to be rinsed with sulfuric acid (0.5 mol/l). This dilution needs to be inserted in the device by the user (Sprinter XL Position D05). The software does not request this dilution. Schedule The Time Schedule tab shows the detailed temporal progression of the worklist.
  • Page 57 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Info option You can find detailed information on the management and arrangement of samples, reagents and plates by pressing on the “Info”...

  • Page 58: During The Test Run (Start, Pause, Stop)

    Start To start the worklist, press the Start button. Following a brief initialisation phase, the Sprinter XL starts processing the worklist. Before you start a worklist, ensure that the instrument cover is closed. Status A bar diagram (Gantt diagram) is shown of the worklist scheduling at the top of the window.
  • Page 59 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Cancel Put the instrument on pause as described above to stop and cancel the worklist.
  • Page 60 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a 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).

  • Page 61: Result Reports

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Result reports After exiting the worklist, the results and test reports are automatically archived.
  • Page 62 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 8-2: Result report IFA You can print out the preview of the result report using the printer symbol.
  • Page 63 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a The pipetting of controls and samples on the 50 well slides is performed in the vertical direction in the contrast to the horizontal field description of a standard slide.
  • Page 64 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Select the desired result file so that it is marked blue. In the right window a list of all tests is displayed.
  • Page 65 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 8-7: „LoLi“ in the printout Search function With the Search tab you can search for a results report by using the Plate ID or Date fields.

  • Page 66: Cleaning And Maintenance

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Cleaning and maintenance As the user, you must perform the maintenance work described in this chapter. Service work which is described in the maintenance plan (see chapter 9.2) or not explained in the manual is only to be performed by authorised service technicians.

  • Page 67: Monthly Cleaning

    EUROIMMUN Setup Clean (e.g. 50 ml Setup Clean + 200 ml distilled water). o Perform the Washer Prime Procedure in the Sprinter XL software to flush in the cleaning solution under o Let the solution soak in for 15 minutes.
  • Page 68 70% alcohol. filter Then repeat the procedure twice with distilled water. Perform the Prime Procedure in the Sprinter XL software under the Service menu item. Then rinse thoroughly with distilled water (5x). - 66 -...

  • Page 69: Service Plan (For Service Technicians)

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Service plan (for service technicians) During the year, the service technicians can periodically perform preventative service on the instrument.

  • Page 70: Error Remedies

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Error remedies 10.1 Error message: No Liquid found If the filling level of a sample or a reagent is not detected when the liquid is drawn up by the needle, the following error message appears with different fault remedy possibilities: Figure 10-1: No liquid found...

  • Page 71: Error Message: Action Not Startable

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a 10.3 Error message: Action not startable If this error message appears when initialising the instrument, there is a connection problem.

  • Page 72: Consumables And Accessories

    M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Consumables and accessories Article Order number Image Test tubes (5 ml, Ø 12 mm, Sarstedt 55.476 h = 75 mm) Press-in plugs for sample...
  • Page 73 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Article Order number Image 8-Kette Verdünnungsröhrchen Ritter (1,2 ml) 45000-0008 Plastic bottle with cap for IFA conjugate EUROIMMUN (6 ml, Ø...
  • Page 74 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Article Order number Image Dako Pen EUROIMMUN Hydrophobic barrier pen ZG 0261-0101 EUROIMMUN Tweezers ZD 9871-0101...

  • Page 75: Appendix

    12.2 Table of figures Figure 5-1: Sprinter XL – Standard configuration IFA ......... - 17 -  Figure 5-2: Sprinter XL – Standard configuration ELISA ......- 18 -  Figure 5-3: Sprinter XL – Standard configuration ELISA/IFA ...... - 19 - ...
  • Page 76 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 7-24: Wells for predilution insufficient ..........- 39 -  Figure 7-25: Wells for serial dilution insufficient .......... - 39 -  Figure 7-26: Cavities for predilution and serial dilution insufficient .....
  • Page 77 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a Figure 8-7: „LoLi“ in the printout ..............- 63 -  Figure 8-8: Search function ................. - 63 -  Figure 10-1: No liquid found ................
  • Page 78 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a - 76 - 12 Appendix...
  • Page 79 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a 12 Appendix - 77 -...
  • Page 80 M e d i z i n i s c h e EUROIMMUN L a b o r d i a g n o s t i k a YG_0033_A_UK_C03.doc Version: 12/12/2014 EUROIMMUN Medizinische Labordiagnostika AG · E-Mail euroimmun@euroimmun.de · Internet www.euroimmun.de...

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