Human Elisys Quattro User Manual
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Human Elisys Quattro User Manual

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Elisys Quattro
| User Manual
HUMAN -
ELISYS QUATTRO
User Manual
|
Cat.No. 16300/1

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Summary of Contents for Human Elisys Quattro

  • Page 1 Elisys Quattro | User Manual HUMAN - ELISYS QUATTRO User Manual Cat.No. 16300/1...
  • Page 2 Intellectual property rights shall remain with HUMAN GmbH You are entitled to use the ELISYS QUATTRO software and the printed accompany- ing material at your place of work only. Any violations of property rights or copyright or trademark may be subject to legal action.

  • Page 3: Table Of Contents

    Performing a Test Run ......4-1 ELISYS QUATTRO - User Manual HUMAN TOC-1...
  • Page 4 Putting System Out of Action ......6-8 TOC-2 ELISYS QUATTRO - User Manual HUMAN...
  • Page 5 Technical Data ........8-1 ELISYS QUATTRO - User Manual HUMAN...
  • Page 6 TOC-4 ELISYS QUATTRO - User Manual HUMAN...

  • Page 7: Intended Use

    For in Vitro Diagnostics only! Prior the use of the ELISYS QUATTRO system for IVDs, any test methods (assays) and kits must be validated by the user in combination with the system according to common clinical laboratory practice, local legislation, and the state of the art.

  • Page 8: Notes

    In Vitro Diagnostic Medical Device Lot Number Expiration Date Storage Temperature CE Mark Catalogue Number Serial Number 1.1.4 Special Types LEDs LEDs (light emitting diode) are printed in spe- cial type. Example: PWR LED, ERR LED ELISYS QUATTRO - User Manual HUMAN...

  • Page 9: Safety Instructions

    ELISYS QUATTRO is designed and manufactured in accordance with the safety re- quirements for electronically and IVD measuring devices. If the local law lays down regulations on the installation and/or operation of microplate analyzers, then it is the operators responsibility to adhere to them.

  • Page 10: Electrical Safety

    The use of a multi plug is not allowed! Do not allow anything to rest on the power cord. If you can see that the instrument has become unsafe to use, switch it off and disconnect it from the mains supply. ELISYS QUATTRO - User Manual HUMAN...

  • Page 11: Laser Safety

    1.2.4 Mechanical Safety Do not place the instrument on a unstable table, cart, or similar. The instrument may fall, causing serious damage to the system or injure the user. ELISYS QUATTRO - User Manual HUMAN...

  • Page 12: Biological Safety

    For this reason, do not use any organic solvents unless such solvents are expressly authorised. It is not possible to autoclave the containers for liquids and waste! 1.2.6 Cleaning the System Switch the instrument off and disconnect it from the mains supply before cleaning, disinfection or decontamination. ELISYS QUATTRO - User Manual HUMAN...

  • Page 13: Disposal

    General waring labels are positioned on: • Patient sample and rack unit flap 1.3.2 Biological Hazard Labels Biological hazard labels are positioned on: • Waste bag cover • Waste container • Waste bottles (positioned in the drawer) ELISYS QUATTRO - User Manual HUMAN...

  • Page 14: Electrical Hazard Labels

    Test plate compartment (near the bar code scanner on the left side at the front). 1.3.5 Type Label The type label in positioned on: • Rear side of the instrument (near the mains switch) ELISYS QUATTRO - User Manual HUMAN...

  • Page 15: System Basics

    System Basics System Basics Overview The ELISYS QUATTRO is a fully automated microtiter plate analyzer performing the complete sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measure- ment and evaluation. The instrument is controlled via the Windows PC software Phoenix.

  • Page 16: Top Level Instrument Modules

    System Basics Top Level Instrument Modules Figure 2-2: ELISYS QUATTRO - View on top level Dilution plates (see chapter 2.2.1 on page 2-3)selftest Tip racks (see chapter 2.2.1 on page 2-3) Patient sample and reagent unit (see chapter 2.2.2 on page 2-4) Tip ejection station and waste bag (see chapter 2.2.3 on page 2-4)

  • Page 17: Tray For Tip Racks And Pre-Dilution

    Move the tip rack from above straight into the specific position, the groove must fit into the pin (see figure 2-3: and see chapter 5.1 on page 5-1). The clamp shall fix the tip rack. Figure 2-3: Placement of tip racks: A1 is on the top left ELISYS QUATTRO - User Manual HUMAN...

  • Page 18: Patient Sample And Reagents Unit With Bar Code Reader

    With the cover plate removed, the waste bag can be taken out of the holding device and replaced (Disposal see chapter 5.3 on page 5-7). Pipettor wash station (see figure 2-2: position 3b) The pipettor wash station is located next to the tip ejection station. ELISYS QUATTRO - User Manual HUMAN...

  • Page 19: Test Plate Compartment With Bar Code Scanner

    (Loading/Unload- ing see chapter 5 on page 5-1). Drawer Instrument Modules The drawer is automatically locked during a run. The green LED INSTR goes off. ELISYS QUATTRO - User Manual HUMAN...

  • Page 20: Wash Buffer Container And Waste Bottles

    System Basics Figure 2-5: ELISYS QUATTRO - Bottom drawer pulled out Test plate compartment with plate transport unit (see chapter 2.2.4 on page 2-5) Wash buffer container (square) and waste bottles (round) (see chapter 2.3.1 on page 2-6) Wash unit for test plates (see chapter 2.3.2 on page 2-6) Incubators (see chapter 2.3.3 on page 2-6)

  • Page 21: Photometer (Back Of Bottom Drawer)

    The photometer is moved out with the bottom drawer. Other Instrument Modules 2.4.1 Guide Rail for Pipettor (See figure 2-1: position 8) It is used to move the pipettor in the X- and Y-direction. ELISYS QUATTRO - User Manual HUMAN...

  • Page 22: Pipettor (Z-Direction)

    The system will stop immediately when the instrument cover or the lockable flap is opened during a run! Connections Figure 2-6: ELISYS QUATTRO - Instrument rear panel with connections ELISYS QUATTRO - User Manual HUMAN...

  • Page 23: Led Displays

    Power Green, when turned on, otherwise off. Ready Green, when ready for a run, otherwise off (e.g. in case of Error or during initiali- sation) Error Yellow, when instrument error has occurred, otherwise off. ELISYS QUATTRO - User Manual HUMAN...
  • Page 24 Right Load Green, when plate compartment can be opened, otherwise off. Instrument Green, when instrument drawer (bottom drawer, see figure 2-1: position 5 can be opened. 2-10 ELISYS QUATTRO - User Manual HUMAN...

  • Page 25: Principles Of Methods

    The photometer consists of a poly- chromatic or monochromatic light source. In the case of the ELISYS QUATTRO, this is a halogen lamp which emits a spectrum. The desired wavelength is filtered out us- ing a wavelength selector (i.
  • Page 26 System Basics 2-12 ELISYS QUATTRO - User Manual HUMAN...

  • Page 27: Software Structure And Operation

    To define assay process steps (pipetting, washing, incubating, measurement, etc.). • Panel Definition / Set-up Panel To combine assays and samples on test plates to create a worklist for routine. • Worklist To check the conditions for a certain worklist. ELISYS QUATTRO User Manual HUMAN...

  • Page 28: Menu Guidance

    S y s t e m S e t u p . . . Definition of instrument parameters. S e l f t e s t Performance of a selftest (initialisation). V e r i f y Checks the photometer ELISYS QUATTRO User Manual HUMAN...
  • Page 29 H e l p T o p i c s Calls on-line help. A b o u t Ph o e n i x . . . Shows the version number of the Phoenix soft- ware. Table 3-1: General menu guidance ELISYS QUATTRO User Manual HUMAN...

  • Page 30: Worklist Menu Guidance

    Graphical display of the processing of a work- list (plate-specific) U t i l i t i e s S y s t e m U t i l i t i e s Manual plate control. Table 3-2: Worklist menu guidance ELISYS QUATTRO User Manual HUMAN...

  • Page 31: Result Menu Guidance

    U t i l i t i e s E x p o r t R e s u l t s Shows a dialogue to start the export of the results to a file and/or to LIMS. Table 3-3: Result menu guidance ELISYS QUATTRO User Manual HUMAN...

  • Page 32: File Types

    Assay protocol files *.asy C:\Phoenix\Assays Files documenting daily data communication between PC *.log C:\Phoenix\Eventlogs and ELISYS QUATTRO instrument as well as error mes- sages. Coordinate files for e.g. pre-dilution plates *.mpc C:\Phoenix Coordinate files for the racks *.rac C:\Phoenix Result files *.res...

  • Page 33: Performing A Test Run

    Performing a Test Run Performing a Test Run System Start 1. Start the ELISYS QUATTRO instrument. 2. Start the computer. 3. Start the Phoenix software by clicking on the respective icon on the desktop or choosing S t a r t | P h o e n i x .

  • Page 34: Input Of Patient Data

    The patient editor only accepts letters and numbers as patient ID. The use of any spe-cial characters such as "%", "-", "$", "€","'", "|", "/", "\", ";", "," or "." when creating a patient ID or receiving from the host computer is forbidden. ELISYS QUATTRO User Manual HUMAN...
  • Page 35 To do this, select the patients and then the assay(s). 8. Click on the O K button. You will find further information to the tests in the manual of the respective test. ELISYS QUATTRO User Manual HUMAN...

  • Page 36: Input Of Bar Coded Patient Samples

    Performing a Test Run 4.2.2 Input of Bar Coded Patient Samples 1. Insert samples into the ELISYS QUATTRO with the worklist closed. The patient bar codes are read. The dialogue box depicted to the right appears on the screen, showing the identified bar codes.

  • Page 37: Worklist Definition

    S a v e P a n e l button to save the defined plate panel. The assigned patients are not stored. 3. Click on the A d d Pl a t e . . . button. Plate 1 is entered in the Explorer tree. ELISYS QUATTRO User Manual HUMAN...
  • Page 38 To run the same patient with the same assay on more then one plate the op- tion must be selected. A l l o w m u l t i p l e d e t e r m i n a t i o n s ELISYS QUATTRO User Manual HUMAN...

  • Page 39: Defining Several Assays Per Plate

    Only possible with identical incubation parameters! The item must always be enabled! S t a r t a s s a y w i t h a n e w s t r i p ELISYS QUATTRO User Manual HUMAN...

  • Page 40: Defining Several Plates

    The first assay of the next plate is displayed. This and possibly following assays and plates have to be treated as described above. After the last plate the W o r k l i s t window is dis- played (see next chapter). ELISYS QUATTRO User Manual HUMAN...

  • Page 41: Start A Worklist

    (see figure) or as Pl a t e S c h e d u l e . The selection is made via the View menu. The individual plates and process steps are dis- played in different colors. ELISYS QUATTRO User Manual HUMAN...
  • Page 42 The Re a g e n t r e q u i r e m e n t s shows the required reagents (Example). Make sure the required reagents are available and there is sufficient space in the liquid waste container. 4-10 ELISYS QUATTRO User Manual HUMAN...

  • Page 43: System Status

    • Reactions by the user on these actions are dis- played in green. • User actions such as manual definition of rea- gents are also displayed in red. ELISYS QUATTRO User Manual HUMAN 4-11...

  • Page 44: Loading Samples And Reagents

    The use of primary tubes with gel separator requires a careful check of the sample volume above the gel to avoid any possible errors in dispensing. When refilling a reagent bottle never exceed the bottle shoulder. An over-fill- ing may lead to an incorrect dispensing. 4-12 ELISYS QUATTRO User Manual HUMAN...
  • Page 45 Unallocated but required resources are displayed as circles in differ- ent colours in the top right corner of the screen. You can view the respective name by moving the cursor over these circles. ELISYS QUATTRO User Manual HUMAN 4-13...
  • Page 46 IDs in the rack. This type of verification is also recommended when working with a job list manually created for sample tubes without barcodes. 4-14 ELISYS QUATTRO User Manual HUMAN...

  • Page 47: Loading Other Required Resources

    Please carefully check the tip racks allocation, following the specific color code and type in the software. A tip misplaced can not be recog- nized by the instrument and may cause mechanical damage! ELISYS QUATTRO User Manual HUMAN 4-15...

  • Page 48: Reagent Volume Check

    The I g n o r e button skips the reagent check for this specific reagent (the insufficient volumne is logged) and continues with the reagent check for the next one. Do not change any reagent positions! 4-16 ELISYS QUATTRO User Manual HUMAN...

  • Page 49: Plate Loading

    L o a d P l a t e dia- logue box requests the 2nd plate. 3. Repeat procedure until all plates of the worklist have been inserted. At this point the system does only recognise if a holding frame has been load- ELISYS QUATTRO User Manual HUMAN 4-17...

  • Page 50: Starting And Processing A Run

    C o n t i n u e: • The sample is pipetted into the appropriate well of the micro plate. • The result file flags all samples with “Clot detected” where a clot was detected. 4-18 ELISYS QUATTRO User Manual HUMAN...
  • Page 51 At the end of the pipetting step, a message comes up and shows you all samples which were not pipetted or were a clot was detected. • The result file flags all samples with “MP” where a clot was detected. ELISYS QUATTRO User Manual HUMAN 4-19...

  • Page 52: Pausing Or Cancelling A Run

    Pausing or Cancelling a Run Click the S t o p button to stop the current run. The ELISYS QUATTRO system stops and shows the S y s t e m P a u s e d dialogue box. •...

  • Page 53: Results Report

    The window Q u a n t i t a t i v e R e s u l t s shows the graph which is created with the standards defined in the assay. ELISYS QUATTRO User Manual HUMAN 4-21...
  • Page 54 • Reactions by the user on these actions are dis- played in green. • User actions such as manual definition of rea- gents are also displayed in red. 4-22 ELISYS QUATTRO User Manual HUMAN...

  • Page 55: Re-Loading

    When the specified time is over, select the item E d i t | P a n e l D e f i n i t i o n once more. The L o a d dialogue box appears. ELISYS QUATTRO User Manual HUMAN 4-23...
  • Page 56 (see chapter 4.4.4 on page 4-16). After the volume check the worklist is calculated new (interlacing or adding new plates/assays to be proc- essed). Further processing is then carried out in accordance with the new worklist. 4-24 ELISYS QUATTRO User Manual HUMAN...

  • Page 57: Quality Control Analysis Report (Levey Jennings Plot)

    ID and the last ID in the two boxes. 4. Select up to five assays. 5. Select the period of time in the boxes D a t e f r o m and D a t e t o . ELISYS QUATTRO User Manual HUMAN 4-25...
  • Page 58 8. Select V i e w | D e t a i l to show a detailed list, including the B a t c h N u m b e r of the Kit (if entered, see chapter 4.3.4 on page 4-8). 4-26 ELISYS QUATTRO User Manual HUMAN...

  • Page 59: Loading - Unloading - Disposal

    Push in drawer up to the limit stop (audible click), overcoming a slight resist- ance. Please carefully check the tip racks allocation following the specific colour code and type in the software. A tip misplaced can not be recognized by the instrument and may cause mechanical damage! ELISYS QUATTRO User Manual HUMAN...

  • Page 60: Load Sample And Reagent Racks

    If a sample rack is removed which is still in use, all samples not already pipetted out of this rack will be flagged with and not cal- R e m o v e d culated. ELISYS QUATTRO User Manual HUMAN...
  • Page 61 The symbols of these reagents can be allocated from the area Un a l l o c a t e d r e s o u r c e s to the respective positions with the mouse. See notes on page 5-2 ELISYS QUATTRO User Manual HUMAN...
  • Page 62 Once you have loaded all racks distribute the unallocated samples displayed on the screen on the individual rack positions with the mouse in accordance with the identified loading. Close the flap again (audible click). See notes on page 5-2 ELISYS QUATTRO User Manual HUMAN...

  • Page 63: Load Test Plates

    The test plate is first transported into the photometer to check for an ade- quate strip filling; then the plate is placed in the pipettor area. Repeat this process to load several plates in succession. ELISYS QUATTRO User Manual HUMAN...

  • Page 64: Unloading

    Open flap. The plate transport unit with the test plate is already in a position directly next to the plate compartment. Remove plate with holding frame and take plate off the holding frame. Close flap again (audible click). Process plate further manually or dispose off plate. ELISYS QUATTRO User Manual HUMAN...

  • Page 65: Disposal

    5.3.4 Disposal of Instrument Disposal of the instrument according to national legislation. 5.3.5 Disposal of Packaging Material Disposal of the packaging material according to national legislation. ELISYS QUATTRO User Manual HUMAN...
  • Page 66 Loading - Unloading - Disposal ELISYS QUATTRO User Manual HUMAN...

  • Page 67: Service And Maintenance

    End of work Close the finished worklist. Close the Phoenix software. Close Windows 95/2000 and shut off computer, monitor and printer. Switch the ELISYS QUATTRO off. Remove reagent and patient racks. Remove all used dilution tubes. 6.1.2 Weekly Maintenance Procedure Procedure Change the system liquid fluid.

  • Page 68: Monthly Maintenance Procedure

    Periodically, during the year, a specific preventive maintenance can be run by the au- thorised technical personnel. A specific procedure will be followed to ensure a good check on all the instrument parts, which are: • Photometer • Washer • Incubator • Plate transport ELISYS QUATTRO User Manual HUMAN...
  • Page 69 Service and Maintenance • Pipettor ELISYS QUATTRO User Manual HUMAN...

  • Page 70: Cleaning And Disinfecting The Instrument

    Service and Maintenance Cleaning and Disinfecting the Instrument Clean or disinfect the following instrument parts of the ELISYS QUATTRO in accord- ance with the maintenance plan: Housing surface Interior of instrument: • magazine for tip racks and dilution tubes (1), •...

  • Page 71: Cleaning And Disinfecting The Housing Surface

    Phoenix software. The 4 containers with wash buffer/distilled water and the complete washer unit (in- cluding manifold, pumps, valve, tubing) are cleaned during the daily and weekly maintenance. ELISYS QUATTRO User Manual HUMAN...

  • Page 72: Cleaning The Wash Head Needles

    4). If the wash function is not longer adequate, you have to clean the needles of the wash head. Open drawer. Using the supplied cleaning needle, clean the 8 dispense and the 8 aspirate needles of the wash head. Figure 6-2: Cleaning the wash head needles ELISYS QUATTRO User Manual HUMAN...

  • Page 73: Replacement Of Mains Fuse

    Pull out the fuse carrier with a screw driver. Figure 6-3: Fuse carrier Change the faulty fuse(s): Fuse: 4 A T, 250 V Figure 6-4: Fuse carrier with fuses Insert the fuse carrier. Connect the main power. Switch on the system. ELISYS QUATTRO User Manual HUMAN...

  • Page 74: Backup Of Result Files

    Select the R e s u l t s folder. Select the result files (.res) to save. Copy them on the desired data drive. Putting System Out of Action To put system out of action for a longer time contact your local service centre. ELISYS QUATTRO User Manual HUMAN...

  • Page 75: Error Messages

    Error Messages Error Messages General Error Messages If the ELISYS QUATTRO does not work, this is often due to minor problems which you can deal with by yourself. This chapter describes error messages and gives instruction on error recovery. '%1' and '%2' are placeholders for a system module or the designation of a plate, a reagent, or an error number.
  • Page 76 Incubator heater %1 Defect in heater foil no. %1. Call service. error Incubator sensor %1 Defect of incubator sensor no. %1. Call service. error ELISYS QUATTRO User Manual HUMAN...
  • Page 77 Electrical or mechanical problems of scanner. Rack scanner not Scanner of reagent and sample Manual allocation of racks or samples detected racks is not connected. and reagents is possible. Call service. ELISYS QUATTRO User Manual HUMAN...
  • Page 78 %1 Unknown incubator Unknown incubator error. Call service. error code %1 Unknown plate trans- Unknown plate transport error. Call service. port error code %1 Unknown washer Unknown washer error. Call service. error code %1 ELISYS QUATTRO User Manual HUMAN...
  • Page 79 Container for washer waste full. Empty container. Washer waste pump Error in washer waste pump. Check connections and container caps error for leaks. If the error persists, call serv- ice. Table 7-1: General Error Messages ELISYS QUATTRO User Manual HUMAN...

  • Page 80: Error Messages Of Components

    Plate load/unload door is open while try- Close the plate load/unload door. Check ing to move. the connectors to the switch. 48 nn Motor not home. nn shows the position. None. The software will reset the plate transport and try again. ELISYS QUATTRO User Manual HUMAN...
  • Page 81 Reading overrun error. Call service. A/D reference voltage error. Call service. 54 nn Faulty optic channel. nn shows the filter Call service. position. EEPROM error. Call service. Table 7-4: Module 43 - Photometer Module 44 Washer ELISYS QUATTRO User Manual HUMAN...
  • Page 82 4B 49 Shake override. Call service. Plate carrier sensor error. Call service. 54 nn Temperature sensor error. nn shows the Call service. sensor number or name. EEPROM error. Call service. Table 7-6: Module 45 - Incubator ELISYS QUATTRO User Manual HUMAN...

  • Page 83: Technical Data

    Dynamic range -0.100 to 3.000 O.D. Accuracy +/- 0.005 or 2.5 % Linearity 0 - 2.000 O.D. +/- 1 % Detection Photo diode Reading time < 15 seconds Read modes Filters Up to 8 positions ELISYS QUATTRO User Manual HUMAN...
  • Page 84 User definable result classes Quantitative Linear to quadratic regression, sigmoidal, and many more Language support Optional; supported via use of Passolo (commer- cially available program) QA analysis Mean, SD, CV, Standard Error and Levey-Jen- nings (basic version) ELISYS QUATTRO User Manual HUMAN...
  • Page 85 (Depth with waste bag and completely opened drawer) Weight Analyzer with cover 130 kg Accessories Approximate 84 kg For electrical details of the PC equipment please refer to the technical documentation of the OEM manufacturer. Noise 67 dB (distance 1 m) ELISYS QUATTRO User Manual HUMAN...
  • Page 86 The following technical tests were carried out: • Safety regulations tests: EN 61010-1 • EMC (Test for electromagnetic compatibility): EN 61326 Values are archived under optimal conditions and can vary depending on en- vironmental conditions, instrumental status and processing conditions! ELISYS QUATTRO User Manual HUMAN...
  • Page 87 Technical Data ELISYS QUATTRO User Manual HUMAN...
  • Page 88 HUMAN Gesellschaft für Biochemica und Diagnostica mbH | Max-Planck-Ring 21 · 65205 Wiesbaden · Germany | Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100 | e-Mail: human@human.de · www.human.de...

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