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1-2

ELISYS QUATTRO

- User Manual HUMAN

Intended Use

1.1.2

Notes

Notes are indicated with a symbol and printed in special types. For special situations
were used the following symbols.

Consult instructions for use!

Notes are indicated by this symbol and printed in special types.

Disconnect mains power connector before servicing!

1.1.3

Symbol Keys

1.1.4

Special Types

Manufactured by

In Vitro Diagnostic Medical Device

Lot Number

Expiration Date

Storage Temperature

CE Mark

Catalogue Number

Serial Number

LEDs

LEDs (light emitting diode) are printed in spe-
cial type.
Example: PWR LED, ERR LED

Содержание Elisys Quattro

Страница 1: ...HUMAN ELISYS QUATTRO User Manual Elisys Quattro User Manual Cat No 16300 1...

Страница 2: ...ompany ing material at your place of work only Any violations of property rights or copyright or trademark may be subject to legal action Rev DATE REVISION DESCRIPTION 01 2004 12 First edition 02 2011...

Страница 3: ...p Racks and Pre dilution 2 3 2 2 2 Patient Sample and Reagents Unit with Bar Code Reader 2 4 2 2 3 Tip Ejection Station Pipettor Wash Station Pipetting Station 2 4 2 2 4 Test Plate Compartment with Ba...

Страница 4: ...Dilution Plates 5 1 5 1 4 Load Tip Racks 5 1 5 1 5 Load Sample and Reagent Racks 5 2 5 1 6 Load Test Plates 5 5 5 2 Unloading 5 6 5 2 1 Remove Dilution Tubes Take Tip Racks off 5 6 5 2 2 Remove Racks...

Страница 5: ...ELISYS QUATTRO User Manual HUMAN TOC 3 7 Error Messages 7 1 7 1 General Error Messages 7 1 7 2 Error Messages of Components 7 6 8 Technical Data 8 1...

Страница 6: ...TOC 4 ELISYS QUATTRO User Manual HUMAN...

Страница 7: ...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 legislati...

Страница 8: ...tructions for use Notes are indicated by this symbol and printed in special types Disconnect mains power connector before servicing 1 1 3 Symbol Keys 1 1 4 Special Types Manufactured by In Vitro Diagn...

Страница 9: ...ent works safely both electrically and mechanically The systems are tested by the man ufacturer and supplied in a condition that allows safe and reliable operation The user has to observe the informat...

Страница 10: ...vice personnel only 1 2 2 Electrical Safety Country specific regulations regarding safe electrical operation of the in stalled system have to be observed Check that the operating voltage is set correc...

Страница 11: ...sockets etc can be electrically live Even after the device has been switched off components e g capacitors can be under voltage as the result of an electrical charge All current carrying parts are so...

Страница 12: ...e reliable operation of the instrument and to protect from overheating these openings must not be blocked or covered 1 2 5 Biological Safety Risk of infection Handling of samples and reagents Avoid co...

Страница 13: ...ntial infectious material and all parts that may come in contact with poten tial infectious material must be disposed according to national legislation All parts which have been replaced must be dispo...

Страница 14: ...ent near the mains switch 1 3 4 Laser Hazard Labels Laser hazard labels are positioned on Patient sample and reagent unit bar code scanner on the right side at the front Test plate compartment near th...

Страница 15: ...ess the pre defined assays as well as assays programmed by the user The clear structure with intuitive user guidance allows simple and quick operation of daily routine jobs as well as programming of u...

Страница 16: ...3 selftest 1b Tip racks see chapter 2 2 1 on page 2 3 2 Patient sample and reagent unit see chapter 2 2 2 on page 2 4 3a Tip ejection station and waste bag see chapter 2 2 3 on page 2 4 3b Pipettor w...

Страница 17: ...ns for tip racks 300 l or 1100 l tips see figure 2 2 position 1b as well as a position for the dilution rack see figure 2 2 position 1a 6 additional reagent positions are also available Move the tip r...

Страница 18: ...racks is possible when the instrument is in the in cubation mode Keep the flap of this unit closed during a run It may be opened only for re loading see chapter 5 2 on page 5 6 Opening the flap while...

Страница 19: ...ompart ment The test plate compartment can be opened only on request by the software The LED indicator LD lights up green Open the door and place the respective bar coded test plate with the holding f...

Страница 20: ...nit One waste bottle contains the liquid waste which is pumped to the waste container which is positioned below the instru ment The second bottle serves as overflow protection 2 3 2 Wash Unit for Test...

Страница 21: ...accommodating four plates for room temperature incubation It is located below the incubators in front of the photometer 2 3 4 Photometer Back of Bottom Drawer See figure 2 5 position 7 The photometer...

Страница 22: ...ng area The closed position of this flap is monitored by a contact switch The ELISYS QUATTRO cannot be operated without this cover or flap in order to avoid getting in contact with the working area du...

Страница 23: ...lays The LED displays on the instrument front panel next to the left and right door have the following meaning 10 Tubing connection for system liquid 11 Electrical connection for system liquid level s...

Страница 24: ...hen left drawer has been cleared for loading and unloading of pre dilution plates and tips otherwise off Right Load Green when plate compartment can be opened otherwise off Instrument Green when instr...

Страница 25: ...ly clear solution A part of the light is absorbed in the sample The intensity of the light coming out of the sam ple is measured with a measuring cell detector The light striking the detector is conve...

Страница 26: ...2 12 ELISYS QUATTRO User Manual HUMAN System Basics...

Страница 27: ...explorer tree on the left hand side and the selected item on the right hand side Clicking on the plus sign of a folder on the explorer tree opens the respective options clicking on the minus sign clo...

Страница 28: ...worklist report Save As Saves active file e g worklist report under a new name Print Prints the active document Print Preview Shows the active document as print preview Print Setup Defines the printer...

Страница 29: ...ions Definition of software parameters Window New Window Opens a new window Cascade Cascades the active windows Tile Tiles the active windows Arrange Icons The icons can be re arranged Shows the names...

Страница 30: ...ot specific information and the required reagents for the displayed worklist Start Starts the loading dialogue once the loading dialogue has been completed a run using the current worklist can be star...

Страница 31: ...Assays Shows the Change Assay Protocol dialogue This dialogue shows the used assay Change of these assays are marked in the result report Retest Shows the Retest dialogue This dialogue shows all teste...

Страница 32: ...strument as well as error mes sages log C Phoenix Eventlogs Coordinate files for e g pre dilution plates mpc C Phoenix Coordinate files for the racks rac C Phoenix Result files res C Phoenix Results S...

Страница 33: ...t the ELISYS QUATTRO instrument 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 Start Phoenix 4 Cl...

Страница 34: ...t Utilities Patient Details or click on the icon on the tool bar and define the patients and the associated tests in the Patient Edi tor 2 Click on the Add Patient s button to open the Add Patient s d...

Страница 35: ...he software returns to the Patient Editor and shows the patients that were entered new Repeat this step if necessary for further patient IDs 6 Click on the Add Test s button in the Patient Editor 7 In...

Страница 36: ...see chapter 4 3 1 on page 4 5 You will find further information to the tests in the manual of the respective test 1 Insert samples into the ELISYS QUATTRO with the worklist closed The patient bar code...

Страница 37: ...using one assay per plate Click on the OK button to accept this proposal and proceed with defining several plates see chapter 4 3 3 on page 4 8 or with input of reagent data see chapter 4 3 4 on page...

Страница 38: ...able assay files asy in the selected subdirectory 5 Select the desired assay file 6 Click on the Open button The plate panel pre defined in the selected assay protocol is entered into the plate depict...

Страница 39: ...e enabled The selected patients are listed in the Set Up Panel dialogue box as contents of the assay folder 1 The respective plate must be active If not click on the plate name in the Explorer tree 2...

Страница 40: ...ign of an assay folder to view the respective patient IDs in the Explorer tree Change the order of plates via the Move Up and Move Down buttons 1 After all required plates have been defined in the Set...

Страница 41: ...ded not loaded error the selected assays and the number of patients are displayed In the Explorer tree click the plus sign of the work list folder and then the respective item Click on the Start butto...

Страница 42: ...layout All plate layouts defined in the current worklist are displayed one below the other The view can be switched between Layout Label e g T1 T2 and Patient IDs e g 318261 513255 The Reagent requir...

Страница 43: ...ion differs Bar coded samples Sample and reagent racks are depicted Non bar coded samples and host connection No racks are depicted yet The Active event log shows the communica tion protocol listing a...

Страница 44: ...culate matter turbity lipaemia foam or erythrocyte de bris may require clarification by filtration or centrifugation before testing The use of primary tubes with gel separator requires a careful check...

Страница 45: ...The bar codes are read and the rack and the available reagents are identified 4 If the rack has been inserted properly up to the limit stop the LED goes off On the screen the loaded resources from th...

Страница 46: ...on the screen by dragging the mouse corresponding to the actual loading to the reagent rack Each dot clearly corresponds to one reagent 4 Insert the required racks one by one into the tracks marked b...

Страница 47: ...dilution plates as well as wash buffer and distilled water as shown on the screen The number and size of the required tips is displayed Observe defaulted positioning Tip racks depicted in dark grey an...

Страница 48: ...agent or to replace it by a new bottle the respective reagent rack has to be moved out reagent has to be refilled or the bottle replaced respectively and the rack has to be inserted again If you press...

Страница 49: ...r Open door and place test plate position A1 on the rear left with the holding frame correctly on the plate transport unit see chapter 5 1 on page 5 1 1 Enter the plate name in the field Plate ID 2 Cl...

Страница 50: ...have been unloaded Dependent on the attitude in the test definition Raise alarm and stop Log and continue or Man ual pipette at end of step the error handling is differ ent at a clot detection Action...

Страница 51: ...flags all samples with Clot detected where a clot was detected Action on error Manual pipette at end of step If a clot is detected the system does not show a message and continues with The pipettor m...

Страница 52: ...ick Resume to continue the run Select a plate and click Abort Plate s to remove the plate Click Abort All Plates to remove all plates Any interruption of a run is documented with the time of its occur...

Страница 53: ...been generated with It provides information on the plate ID and the person responsible for running the test specifies the assay used saves date and time the test has been finished and shows certain de...

Страница 54: ...ontrol well are within the limits specified by the formula in this field the test is con sidered valid and can therefore be evaluated If one of the criterias is failed the test will not be evaluated T...

Страница 55: ...coded patients First enter the additional patients in the Patient Editor see chapter 4 2 1 on page 4 2 2 Select the item Edit Panel Definition The Set up Panel dialog box appears show ing the current...

Страница 56: ...symbols with the mouse to the new sample rack see chapter 4 4 2 on page 4 12 Processed sample racks flashing red LED can be removed 7 Reagents Refill or add additionally required reagents as shown on...

Страница 57: ...he file type QA Analysis Report 3 In the Q A Analysis dialogue box select in the box Controls the respective reagent 4 Select in the box Batch Numbers the respective bach number 5 Select the period of...

Страница 58: ...ming a Test Run 6 Select the Sort Order 7 Click OK to confirm the entries The system shows you the patient result report 8 Select View Detail to show a detailed list including the Batch Number of the...

Страница 59: ...o it clicks into place audible click 5 1 3 Position Dilution Plates 1 Pull very left drawer out The LED DWR must light up green 2 Place dilution plate s in the respective positions as shown in the Loa...

Страница 60: ...h the red LED The bar code labels must face right the bar code reader Samples having particulate matter turbity lipaemia foam or erythrocyte de bris may require clarification by filtration or centrifu...

Страница 61: ...it once more A graphical representation of the correctly inserted rack appears on the screen From the pool of unallocated resources in the right hand side of the screen the loaded reagents are allocat...

Страница 62: ...n accordance with the identified loading Place the mouse pointer on the sample to check the patient ID 3 Insert the next racks as described 4 After loading close the flap again audible click See notes...

Страница 63: ...and push it in overcoming a slight resistance Check if the plate has been inserted correctly and make sure no strip extends beyond the edge of the frame 4 Place holding frame onto the plate transport...

Страница 64: ...tient Samples and Reagents 1 As soon as a LED starts flashing the respective rack can be removed Never remove a rack while still in use Remove it only when the related LED is flashing If a sample rack...

Страница 65: ...ble Tips 1 Pull cover plate next to the plate compartment out horizontally from the front 2 Take waste container off the retaining ring and close it using the supplied lid 3 Place new waste container...

Страница 66: ...5 8 ELISYS QUATTRO User Manual HUMAN Loading Unloading Disposal...

Страница 67: ...ps see chapter 5 3 3 on page 5 7 3 Check the waste container liquid level empty and clean if necessary 4 Check the level of washing solution and distilld water in the washer bottle 5 Check the needles...

Страница 68: ...ectants must not be used in the vicinity of circuit boards and light barri ers 1 Clean reagent and patient racks 2 Clean all four washer buffer bottles with distillated water 3 Check the internal wast...

Страница 69: ...Service and Maintenance ELISYS QUATTRO User Manual HUMAN 6 3 Pipettor...

Страница 70: ...s 1 sample and reagent unit 2 test plate area 3 test plate compartment surface 4 incubators 6 drawer with wash unit and wash buffer 5 3 Manifold in washer unit 5 Disinfectants must not come into conta...

Страница 71: ...ation into account guide rails door edg es plate transport unit drawers racks etc The actions listed in the maintenance schedule see chapter 6 1 on page 6 1 have to be performed regularly and have to...

Страница 72: ...safety regulations Always wear gloves The wash head is part of the wash unit located in drawer 5 see figure 6 1 on page 6 4 If the wash function is not longer adequate you have to clean the needles o...

Страница 73: ...back of the analyzer 1 Switch off the system 2 Disconnect the system from the mains power 3 Pull out the fuse carrier with a screw driver Figure 6 3 Fuse carrier 4 Change the faulty fuse s Fuse 4 A T...

Страница 74: ...is backup cannot be carried out directly from the Phoenix software menu Proceed as follows 1 Open the Windows explorer 2 Select the Phoenix folder 3 Select the Results folder 4 Select the result files...

Страница 75: ...attempts fail call service Clot detected in rea gent 1 Clots were detected in reagent 1 Abort the run if necessary and replace reagent Colorimeter 1 not homed The X motor of the photometer is not in t...

Страница 76: ...The system does not recognise the current position of the plate motor in the measuring area The plate motor has to be moved to the home posi tion Select the menu item Utilities Selftest to initialise...

Страница 77: ...ed Plate transport motor cannot find home position Select the menu item Utilities Selftest to initialise the system again If the error persists call service Plate transport car rier error Plate holder...

Страница 78: ...e loaded Suspect tip pickup Pipettor cannot take up pipettor tip correctly does not move deep enough into the tip New teaching of pipettor required Call service System cover closed Message instrument...

Страница 79: ...er head home movement error Error when moving washer head to home position Select the menu item Utilities Selftest to initialise the system again If the error persists call service Washer head motor m...

Страница 80: ...e Table 7 2 Module 41 Virtual module Module 42 Plate transport Module ID Error number Cause Action 41 46 System fluid low Refill the system fluid container 41 57 System waste container is full Empty t...

Страница 81: ...und light levels too high Check position of lamp Check filter posi tions Call service 43 43 A D conversion error Call service 43 46 nn Filter error nn shows the filter position Call service 43 48 nn M...

Страница 82: ...ice 44 53 52 Reagent level is low Refill the reagent bottle Call service 44 52 41 Aspirate pump error Call service 44 52 44 Dispense pump error Call service 44 52 57 Waste pump error Call service 44 5...

Страница 83: ...s Standards Depending on rack configuration Dilution area For up to 152 dilution tubes Number of tips Up to 5 tip racks for 300 l or 1100 l disposable tips Loading Continuous loading of plates samples...

Страница 84: ...300 l Residual volume 2 5 l in U shaped bottom 4 l in flat bottom Fluid alarms Low reagent waste full Features Sweeps soak purge top and bottom wash vari able pump speeds Others Bar code Samples and i...

Страница 85: ...indows 2000 Mains voltage and fuses Universal a c input 100 260 VAC 47 63 Hz Typically max 500 VA Main fuses 4 A T Computer monitor and printer For electrical details of the PC equipment please refer...

Страница 86: ...st under the following conditions indoor use altitude up to 2000 m temperature 5 C to 40 C maximum relative humidity 80 for tempera tures up to 31 C decreasing linearly to 50 relative humidity at 40 C...

Страница 87: ...Technical Data ELISYS QUATTRO User Manual HUMAN 8 5...

Страница 88: ...HUMAN Gesellschaft f r 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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