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1. 3 3 1 Installation of internal ancillary reagents Standard A ISE IDS iSYS Trigger A Immunoassay IDS iSYS Trigger B Immunoassay WARNING OPENING CLOSING THE LID The lid must be opened for this operation Always handle the lid carefully during opening and closing and is fully open to ensure it is stable When the lid is not fully open there is a risk of it falling Take care not to knock the lid during any analyser intervention e Open the lid fully Remove the cap from the new ancillary reagent container If necessary take out the bung and remove the empty container e Scan the ancillary with the barcode reader Install the new bottle in its position identified by colour code e Install the supply line into the bottle Standard A is automatically primed when newly installed IDS iSYS Trigger A and B are not automatically primed and therefore a manual priming request is required If the barcode is not read by the barcode reader click on the ancillary reagent then use the keyboard to enter the identifier Close the lid Refer to the catalogue for the product references of the ancillary reagents to be ordered IDS iSYS User Manual Rev C1 Use 3 3 40 Software version V4 XX Use 3 3 Installation of Ancillary Reagents continued 3 3 2 Installation of external ancillary reagents Desenin Colonel IDS iSYS System Liquid White All 5 litres IDS iSYS Wash 10 litres Blue
2. tds Isys User Manual jnas iraan Software version V4 XX For further assistance please contact IDS Technical Support Tel 0191 519 6153 Fax 0191 519 0760 Email techsupport uk idsplc com C l IDS FRANCE S A 42 rue St phane Mazeau 21320 POUILLY EN AUXOIS FRANCE IDS Ltd 10 Didcot Way Boldon Business Park Boldon Tyne and Wear NE35 9PD Tel 0191 519 0660 Revisions a 02 21 2008 10 21 2008 IDS iSYS User Manual Rev C1 08 07 2009 Software version V4 XX Revision A V 3 03 SECTION 1 OPERATING PRINCIPLE SECTION 2 USE SECTION SECTION 3 MESSAGES SECTION 4 MAINTENANCE SECTION 5 PROBLEMS AND CORRECTIVE ACTION APPENDIX I WASTE DISPOSAL APPENDIX II DISINFECTING THE DEVICE APPENDIX III DISPOSAL OF THE MEDICAL DEVICE Attached document Connection Protocol revision C Revision B V312 Replacement of 3x3 with IDS iSYS Replacement of BIOCODE HYCEL by IDS SECTION 1 OPERATING PRINCIPLE SECTION 2 USE SECTION 3 MESSAGES SECTION 4 MAINTENANCE SECTION 5 PROBLEMS AND CORRECTIVE ACTION APPENDIX WASTE DISPOSAL APPENDIX II DISINFECTING THE DEVICE APPENDIX III DISPOSAL OF THE MEDICAL DEVICE Attached document Connection Protocol revision D Revisions Continued a a 02 26 2009 Revision C V 4 03 SECTION 1 OPERATING PRINCIPLE SECTION 2 USER INTERFACE SOFTWARE SECTION 3 USE SECTION 4 MESSAGES SECTION 5 MAINTENANCE SECTION 6 PROBLEMS AND CORRECTIVE ACTION APPENDIX WAST
3. Immunoassay e Bone and Growth Infectious Diseases e Hypertension e Autoimmunity Biochemistry Substrates Enzymes Electrolytes e Specific Proteins Coagulation e Chronometric tests e Chromogenic substrates Immunoassays The tOS isys must only be used by trained personnel working in compliance with the safety precautions set out in tnis manual see Section 1 6 1 page 16 and good laboratory practice GLP 1 Coagulation version available during 2010 IDS iISYS User Manual Rev C1 Operating Principle 1 1 2 Software version V4 XX Operating Principle 1 2 General Overview LOS isys is an in vitro diagnostic analyser It enables Immunoassays Biochemistry and Coagulation assays to pe carriea out on a single analytical platform Individual assays are carried out in disposable cuvettes which are automatically loaded onto a carousel Asynchronous management allows each cuvette to be processed individually and transferred to the relevant reaction modules positioned around the carousel The cuvette is able to ensure compatibility in all three fields The measurements specific to each discipline are carried out directly in the reaction cuvette Luminescence measurements carried out in the luminometer Immunoassay Absorbancy measurements carried out continuously by the spectrophotometer Biochemistry Optical measurements for detection of a clot in the chronometer Coagulation Designed for
4. In this case click on the If the reason for validation failure has been clearly identified and deemed to have no impact on results the calibration may be forced at the discretion of the operator IDS iSYS User Manual Rev C1 Use 3 10 60 Software version V4 XX Use 3 10 Results continued 3 10 2 Results of controls e Click on the position occupied by the control The results obtained for this control are displayed along with the programmed limits of acceptance A result outside the limits is displayed in red The results of the controls are automatically stored and recorded in Levey Jennings charts and inspected using the Westgard rules if selected The results of the control can be printed out from its position Ifa control is outside the acceptable limits the status of the calibration is displayed as Invalid In this case request a new calibration Westgard Rules Inspection If WESTGARD rules are selected for the test the rules defined in the analytical configuration will be tested in the following order Control dota In control gt Accept run Out of control gt reject run The violation of certain rules will generate automatic requests In this event the M J icon flashes in the WARNING button The violation of 2 2S 4 1S 10 X rules will automatically generate a request of calibration e Click on the WARNING button to open the window e Click on ve to req
5. 1 FILE menu Save Restore Exit Allows the user to save the database in addition to the automatic save performed each week The saved database contains Analytical configuration Personal library e Calibrations and the quality controls Reagent and ancillaries traceability Stored results The database is saved under the format used in the application Rector Allows the user to restore all or part of the saved database as desired including Analytical configuration Personal library e Calibrations and the quality controls Stored results Allows the user to exit the software Exit IDS iSYS User Manual Rev C1 User Interface Software 2 3 25 Software version V4 XX User Interface Software 2 3 Menus continued 2 3 2 SESSIONS menu Sessions Shark jor i et ee E Shut down Work List Stark Run Cycle cron Wom rs a Run cycle Monitoring Volumes monitoring Qualification contrals Automatic identification of the sample tray positions Access Allows the user to start up the analyser All modules will be initialised and ZAL automatically primed The reading modules are automatically controlled Once start up is complete the option becomes inactive grey Allows the user to put the analyser into standby mode In standby mode the reagents are stored between 8 and 10 C For an analyser equipped with the selective electrodes module ISE the Stan
6. A luminometer measuring luminescence in Immunoassay reactions Immunoassay version Two or four washers depending on configuration for washing magnetic particles Immunoassay version Two barcode readers one located on the front face of the analyser the other integrated into the reagent compartment identify samples ancillary reagents and reagent cartridges supplied by IDS IDS iISYS User Manual Rev C1 Operating Principle 1 2 Software version V4 XX Operating Principle 1 2 General Overview continued The reagent cartridges are stored in the refrigerated reagent compartment between 12 and 15 C while the analyser is operating and between 8 and 10 C in standby mode Depending on the configuration of the analyser up to 15 Immunoassay parameters can be programmed simultaneously or up to 36 Biochemistry parameters or a combination of both up to the maximum number of positions available For Immunoassays the analyser only uses reagents supplied by IDS and its partners For Biochemistry it is possible to use reagents available from suppliers other than IDS however these reagents will not be managed using the barcode system and the information required for traceability must be manually programmed by the operator If reagents other than those marketed by IDS and its partners are used IDS takes no responsibility for the validity of results obtained It is the responsibility of the operator to ensure any non IDS reagents are
7. Memorized Profiles Settings Contains a list of all the tests developed for the analyser Selecting one from the list displays the set up of the test steps of the assay calibrators and controls handling volumes incubation time etc Some elements can be modified by the Supervisor such as units or controls others can only be viewed Analytical configuration Contains a list of tests that can be run on the analyser Personal library Allows access to the list of all products and suppliers stored in the system Suppliers and Products Allows the user to create an unlimited number of profiles which can be used for Memorized Profiles programming Allows the operator to personalise the system e System selection of printing options automatic validation of results automatic transfers to the LIS activation of sound alarms programming of automatic start up and shut down Languages selection of user language Operators programming of access level and user authorisation name and access code Settings System Languages Operators IDS iSYS User Manual Rev C1 User Interface Software 2 3 29 Software version V4 XX User Interface Software 2 3 Menus continued 2 3 6 MANAGEMENT OF LOTS menu Management of Lots Reagents Calibrators Control Ancilaries k Personal library Preventive alert thresholds Reagents Trace On board volumes Displays reagents used
8. 1 4 Installation 9 1 4 1 Environment 9 1 4 2 Electricity suppl 9 1 4 3 Connections 10 1 5 Operating Principles 11 1 5 1 Absorbency measurements 11 1 5 2 Potentiometry measurements 13 1 5 3 Luminescence measurements 15 1 6 Safety Precautions 16 1 6 1 General precautions 16 1 6 2 Special precautions 16 Section 2 User Interface Software I7 2 1 Structure of the Software _ S i8 2 2 Main Screen YD 2 3 Menus _ gt O 2 3 1 FILE menu 2 3 2 SESSIONS menu 2 3 3 DATA Menu 2 3 4 MAINTENANCE menu 2 3 9 SET UP menu FD 2 3 6 MANAGEMENT OF LOTS menu 30 2 3 HELP menu 30 2 4 Function Keys 31 IDS iSYS User Manual Rev C1 Table of Contents i Software version V4 XX Table of Contents a Section 3 Use 32 3 1 Start u 33 3 1 1 Initial Start u 33 3 1 2 Start up from standby mode 33 3 2 Installation of Reagents 34 3 2 1 Colour codes associated with reagent positions in the reagent compartment 38 3 3 Installation of Ancillary Reagents 39 3 3 1 Installation of internal ancillary reagents 40 3 3 2 Installation of external ancillary reagents 41 3 3 3 Installation of IDS iSYS cuvettes 42 3 4 System Performance Checks Immunoassay only 43 3 4 1 Programming the qualification profile 43 3 4 2 Programming the automatic qualification profile 44 3 4 3 Management of results 44 3 5 Programming Calibrations and Controls 45 3 6 Loading of Calibrators Controls or Samples in the Sample Tray 48 3 6 1 Installation using
9. 3 10 2 Results of controls 61 3 10 3 Sample results 62 3 10 4 Work list results 62 3 11 Messages Associated with Results 64 3 12 Results Storage 67 3 13 Quality Control Management 68 3 13 1 Cumulative analysis 68 3 13 2 Westgard rules 70 3 14 Switching the Analyser Off 72 3 15 Switching the Analyser Off Completely 73 IDS iSYS User Manual Rev C1 Use 32 Software version V4 XX Use 3 1 Start up Aitial Start up he analyser on a pressing the switch located on the left hand side to position 1 Secs Data Maintenance Set up Management of Lots Window Help Shuk dawn Work List Start Run Cycle Stop Run yc e Run cwele f Janitor volumes monitoring Qualification controls Automatic identification of the sample tray positions Access All modules are initialised and the ancillary reagents are automatically primed If a new version of the software is detected on the analyser after opening a message about downloading this new version to the analyser will appear 3 1 2 Start up from standby mode Enter your access code to open a session The analyser can be programmed to start up automatically ata selected wake up time Use 3 2 Installation of Reagents IDS iSYS User Manual Rev C1 Use 3 1 33 Software version V4 XX Take care when opening and closing the reagent compartment rough handling when opening and closing the drawer may cause the internal reagents to spill C Access
10. 5 4 5 Replacement of IDS iSYS Wash Solution pump Immunoassay Switch the analyser off Remove the cover from the right hand side of the analyser Press on the two pins at each side of the pump to be changed and remove the pump body from its shaft Disconnect the pipes from the connectors and plug into the new pump Clean the shaft of the pump with absorbent paper soaked in alcohol e Put the pump back in place on its shaft Replace the cover of the analyser e Switch the analyser back on again and perform the start up procedure e Carry out partial priming of the washers in order to prime the tubing circuit again 5 4 6 Replacement of IDS iSYS System Liquid pump Switch the analyser off Remove the cover from the right hand side of the analyser Press on the two pins at each side of the pump to be changed and remove the pump body from its shaft Disconnect the pipes from the connectors and plug into the new pump Clean the shaft of the pump with absorbent paper soaked in alcohol e Put the pump back in place on its shaft Replace the cover of the analyser e Switch the analyser back on again and perform the start up procedure e Carry out partial priming of the arm in order to prime the circuit again 5 4 7 Replacement of liquid waste pump WARNING RISK OF BIOLOGICAL CONTAMINATION As this part of the analyser is in contact with biological samples it must be considered to pose a potential risk of infection Wear dis
11. Identifier and name of the reagent e Lot number Number of the container in the lot Type of container Expiry date Status of the reagent e Available volume or number of cuvettes This menu allows the user to manually enter a barcode identifier in the event of misreading by the integrated barcode reader Clicking on the liquid or solid wastes allows the user to confirm emptying IDS iSYS User Manual Rev C1 User Interface Software 2 2 29 Software version V4 XX User Interface Software 2 2 Main Screen continued Sample tray t og iT Oo x3 g i o O re O 9 9 Te kore 19 de Dais 24 ag Te de Te O 9 Te a 2 gt ae 2 Te O O O Q 9 O aq 20 O 9 D Q g a aa T O 4Q 9 a O Te 9 O Q a Te gt The illustration above shows the samples tray with the positions occupied by Calibrators e Controls e Samples Each position is equipped with a detection sensor The samples are identified by the barcode reader on the front face prior to loading the sample Alternatively barcode identifiers can be entered manually after sample loading Any position of the sample compartment may be used to load a calibrator a control or a sample An icon identifies the type of reagent installed see Section 3 page 48 For each occupied position the following options are available Entry of the identifier and the
12. Violation refused appe eee ee Ed ST O s cmt me oe Select the test and the time period of interest For each run the software displays the control measurement the result of the selected Westgard rules examination INCONTROL OUT OF CONTROL or WARNING and the violated rules The chart can be display by clicking the tab Graphs IDS iSYS User Manual Rev C1 Use 3 13 70 Software version V4 XX Use 3 13 Quality Control Management continued 3 13 2 Westgard rules continued 1 95 One control measurement exceeds the limits of x 2s This rule provides a WARNING and an additional inspection with the other rules 1 35 One control measurement exceeds the limits of x 3s This rule is sensitive to random errors The run is judged to be OUT OF CONTROL 2 2s Two consecutive measurements within the run exceed the same limit either x 2s or x 2s This rule is sensitive to systematic errors This rule is applied to the same control lot or on different control lots one measurement of each control exceeds the same limit The run is judged to be OUT OF CONTROL R as The range between the high and low control measurements within a run exceeds 4s This rule is sensitive to random errors This rule is applied on the same control lot and on different control lots one measurement exceeds the 2s limit and the other exceeds the 2s limit The run is judged to be OUT OF CONTROL 44s 4 consecutive control
13. Immunoassay IDS iSYS D Sorb 1 litre Black All Remove the lid and level sensor from the container to be replaced Scan the new ancillary reagent with the barcode reader Put the level sensor in position within the new ancillary reagent for the IDS iISYS D Sorb and IDS iSYS Wash solutions Priming of the IDS iSYS System Liquid takes place automatically For other ancillaries request partial priming from the menu Fle Sessions data Maintenance Setup Management ofLots Window Help Initialization l Self checking 5 User maintenance d Factory maintenance Technical support a 3 status of analyser Fo Ifthe ancillary barcode is not read by the barcode reader click on the ancillary reagent then use the keyboard to enter the identifier Refer to the catalogue for the product references of the ancillary reagents to be ordered For Biochemistry use only the IDS iSYS System Liquid reference R5H135A IDS iSYS User Manual Rev C1 Use 3 3 41 Software version V4 XX Use 3 3 Installation of Ancillary Reagents continued 3 3 3 Installation of IDS iSYS cuvettes WARNING RISK OF INJURY Do not place your hand or fingers into the loader If necessary remove the empty IDS iSYS Cuvettes box Scan the replacement box with the barcode reader e Within 10 seconds of the barcode reading install the IDS iSYS Cuvettes cube into the loader with the window to the front Remov
14. V4 XX Use 3 2 Installation of Reagents continued 3 2 1 Colour codes associated with reagent positions in the reagent compartment Rail free Reagent correct Presence of a rack or reagent detected but not identified A calibration will be requested in the next 24 hours Preventive alarm threshold reached Reagent volume inadequate or reagent expired Information associated with the reagent not available IDS iSYS User Manual Rev C1 Use 3 2 38 Software version V4 XX Use 3 3 Installation of Ancillary Reagents On board levels and expiry dates of ancillary reagents are managed by the analyser The ancillary reagents comprise IDS iISYS Cuvettes e Internal ancillary reagents External ancillary reagents e Click on jE Selle pradu to display the level of ancillary reagents available For each solution the current volume is displayed The number of IDS iSYS Cuvettes present in the loader is displayed If an ancillary reagent is displayed as missing or volume is inadequate colour code red install a new ancillary reagent If the analyser is carrying out an assay only the IDS iSYS Cuvettes cube and the IDS iSYS System Liquid can be replaced The other ancillary reagents cannot be replaced until the analyser has completed the cycle Only use IDS products IDS iSYS User Manual Rev C1 Use 3 3 39 Software version V4 XX Use 3 3 Installation of Ancillary Reagents continued
15. a barcode 48 3 6 2 Installation without barcode 50 3 6 3 Colour codes associated with sample positions 51 3 7 Programming Samples 52 3 8 Assays 53 3 8 1 Performing assays 53 3 8 2 Adding samples during an assay 54 3 8 3 Adding or replacing a reagent during an assay 54 3 8 4 Releasing an alarm during an assay 55 3 9 Adding an Emergency STAT Sample 56 3 10 Results 57 3 10 1 Result of a calibration 58 3 10 2 Results of controls 61 3 10 3 Sample results 62 3 10 4 Work list results 62 3 11 Messages Associated with Results 64 3 12 Results Storage 67 3 13 Quality Control Management 68 3 13 1 Cumulative analysis 68 3 13 2 Westgard rules 70 3 14 Switching the Analyser Off 72 3 15 Switching the Analyser Off Completely 73 Section 4 Messages 74 4 1 Messages Associated with Calibrations 75 4 2 Messages Associated with Calibration Controls 77 4 3 Messages Associated with Results 78 4 4 Warning Messages 81 4 5 Error Messages 82 IDS iSYS User Manual Rev C1 Table of Contents ii Software version V4 XX Table of Contents i Section 5 Maintenance 83 5 1 Daily Maintenance 84 5 1 1 General Maintenance 85 5 1 1 1 Cleaning the reagent compartment and Plexiglas 85 5 1 1 2 Cleaning the sample tray and Plexiglas 85 5 1 1 3 External cleaning of the probe 86 5 1 1 4 Decontamination of the probe 86 5 1 2 Biochemistry ISE Maintenance 86 5 1 2 1 Cleaning cycle for selective electrodes 86 5 2 Weekly Maintenan
16. authorised Drawer unlocked P i i I O Sampling in progress Access denied Drawer locked Flashing between red and green Sampling in less than 2 minutes IDS iSYS User Manual Rev C1 Use 3 2 34 Software version V4 XX Use 3 2 Installation of Reagents continued During the run cycle if a reagent is to be aspirated within 2 minutes the drawer light flashes red and green When opening the reagent compartment during the run cycle assays which are under way may be stopped if a reagent was scheduled to be added when the compartment was open In the event of this the rescheduled assays are automatically added to the end of the work list The reagent racks are loaded in the refrigerated compartment The reagent cartridges are placed on racks specific to each field An Immunoassay reagent rack is designed to hold a cartridge containing all the reagents needed for the test Biochemistry reagents are supplied in the form of individual reagent bottles Biochemistry reagent racks are designed to contain either 3 x 50 mL bottles or 6 x 20 mL bottles Rack IDS1 Rack IDS2 3 x 50 mL 6 x 20 mL mwj m N f 1 Te Wl Ml mu vi A i T TW Nh LLN WON NN POULIN If the reagents have been stored on board and the analyser has been put into standby mode the identification of these reagents will be restored upon start up Reagent cartrid
17. contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures Switch off the analyser e Open the lid Push the pipetting arm to the left until it is above the reagent compartment Carefully remove the Plexiglas over the sample tray e Clean the solid waste chute with a cotton bud soaked in alcohol e Without dismantling clean the upper section of the drainage area by using a cotton bud soaked in alcohol on the interior and the exterior Replace the Plexiglas Close the lid e Switch the analyser back on again and start it up When maintenance is complete return to the weekly maintenance menu click on the corresponding Faena hena h then confirm the maintenance by clicking on YES 5 2 2 Biochemistry ISE Maintenance 5 2 2 1 Cleaning the selective electrodes injection well WARNING RISK OF BIOLOGICAL CONTAMINATION This part of the analyser is in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures e Open the lid Clean the injection well with a cotton bud soaked in the daily cleaning solution Close the lid e When maintenance is complete click on the corresponding then confirm the maintenance by clicking on YES Execute the maintenance IDS iSYS User Manual Rev C1 Maintenance 5 2 90 Software version V4 XX Maintenance 5 2 We
18. continuous loading the analyser works on a smaple by sample basis There are several configurations available Immunoassay and Biochemistry Biochemistry and Coagulation Immunoassay Biochemistry and Coagulation For Biochemistry as an option the analyser can be fitted with a module using selective electrodes ISE to determine Sodium Potassium and Chloride levels IDS iISYS User Manual Rev C1 Operating Principle 1 2 3 Software version V4 XX Operating Principle 1 2 General Overview continued With all modules fitted the analyser comprises the following key components O eS A refrigerated reagent compartment consisting of 15 rails containing the Immunoassay Biochemistry or Coagulation racks as well as a specialised rack for chronometric reagents A sample tray with 64 positions for samples calibrators and controls A pipetting arm that pipettes both reagents and samples For Biochemistry configurations an optional ISE module with selective electrodes for the simultaneous determination of Sodium Potassium and Chloride levels A thermo regulated carousel set at 37 C with 90 positions for disposable cuvettes Incorporated into the carousel is the spectrophotometer used for measuring absorbancy from certain Immunoassay Biochemistry and Turbidimetry reactions An automatic cuvette loader taking 960 cuvettes at a time pre formed as a cube Two modules for chronometric measurements Coagulation version
19. fields The calibration used for calculating the result was forced OMR All fields It has not been possible to calculate the result because the calibration is not valid OMR All fields The result calculated is below the lower limit of the field of measurement OMR All fields The result calculated is above the upper limit of the field of measurement The sample will be automatically diluted If the message OMR accompanies the message RED the result is still higher than the upper limit of the field of measurement after dilution In this case the sample must be re diluted to a level higher than that programmed in the analytical configuration then tested again MA All fields The assay is no longer being requested by analyser MES All fields Error when recovering the measurements MRE Immunoassay The calibration used for calculating the result was obtained with at least one relative light unit RLU measurement excluded LOW All fields Result lower than the lower normal value IDS iSYS User Manual Rev C1 Use 3 11 65 Software version V4 XX Use 3 11 Messages Associated With Results continued HIGH All fields Result higher than the higher normal value ORA Immunoassay The result cannot be calculated as the measurement is lower than the scope of the measurements defined by the master curve ORA Immunoassay The result cannot be calculated as the measurement is higher than the scope of the measure
20. mains plug located on the left hand side of the analyser e Switch the analyser off and unplug the power cable Using a screwdriver remove the fuse holder from its housing e Replace the faulty fuse ensuring it is of the same value Return the fuse holder to its housing e Switch the analyser back on and perform the start up procedure IDS iSYS User Manual Rev C1 Maintenance 5 4 99 Software version V4 XX Maintenance 5 4 Analyser Interventions continued 5 4 4 Replacement of secondary fuses WARNING RISK OF ELECTRIC SHOCK It is essential for the mains connection to be unplugged when replacing fuses Turn off the analyser and unplug the power cable Remove the screws from the secondary fuse protection plate located on the right hand side of the analyser and gently prise the plate away using a flat head screwdriver see picture 1 Picture 7 Picture 2 Insert a flat head screwdriver into the fuse holder and turn anti clockwise to unscrew see picture 2 Take out the fuse holder and replace the faulty fuse with one of the same value see picture 3 Picture 3 e Return fuse holder to its housing and screw firmly into place taking care not to over tighten Replace the fuse protection plate e Switch the analyser back on again and perform the start up procedure IDS iSYS User Manual Rev C1 Maintenance 5 4 100 Software version V4 XX Maintenance 5 4 Analyser Interventions continued
21. on the system e Personal library data storage for different reagent lots for the tests in the personal library for each cartridge the identifier the lot number the expiry date and the remaining number of tests can be displayed Preventive alert thresholds allows programming of the minimum available number of tests for each assay When this level is reached a preventive alarm is generated Trace traceability of calibrations controls and results obtained with each reagent cartridge e On board volumes displays volumes and number of tests for all on board reagents and ancillaries Lists calibrators used on the system Allows users to manually input the values for Calkar each lot of calibrator Allows activation of the calibrator lots used for a specific assay Lists controls used on the system Allows users to enter manually the values of each lot of control Allows activation of the control lots used for a specific assay Ancillaries 2 3 HELP Menu Displays data for the lots of ancillaries used with the system For each ancillary the identifier the lot number and the expiry date can be displayed Displays information concerning software for example specific version Help r I Melp IDS Ltd IDS iSYS User Manual Rev C1 Software version V4 XX User Interface Software 2 3 30 User Interface Software 2 4 Function Keys The function keys can be used as a shortcut to access the follo
22. optimised and validated for use on the analyser Samples and reagents are aspirated using a probe equipped to detect liquid level using capacitance The sample and reagents are pipetted in accordance with the validated parameters for each assay and transferred into a cuvette where the reaction takes place Between each sample the probe is rinsed internally and externally in order to eliminate any risk of contamination immunoassays The cuvettes are transferred to the washer module where magnets hold the solid phase magnetic particles whilst washing takes place The cuvette is then transferred to the luminometer where trigger reagents are added to produce luminescence When measurement is complete cuvettes are automatically ejected into a re usable solid waste tray Biochemistry assays Photometric changes taking place in the reaction are measured continuously by the spectrophotometer The analyser is connected to a computer via an Ethernet link The software is able to programme the analyser workload and carry out the following functions Management of lots of reagents calibrators and controls e Quality controls Levey Jennings and Westgard Management of ancillary reagents Operator traceability Transfer of results to a centralised computer system Printing storing and traceability of results IDS iISYS User Manual Rev C1 Operating Principle 1 2 5 Software version V4 XX Operating Principle 1 3 Characte
23. peripheral computer equipment external printer and computer is earthed IDS iISYS User Manual Rev C1 Operating Principle 1 4 Software version V4 XX 9 Operating Principle 1 4 Installation continued In the event of prolonged storage the analyser performance must be checked The unpacking installation and initial qualification of the analyser must only be carried out by a qualified IDS representative 1 4 3 Connections Fluidic connections The fluidic connections are located on the right hand side of the analyser The tubing is identified by a colour code Description Colour code Field IDS ISYS System Liquid White All IDS iISYS Wash Solution Blue Immunoassay Liquid Waste Red All IDS iSYS D Sorb Black All Connect the tubing corresponding to the colour code to the right hand side of the analyser by applying a quarter turn to the screw Install the tubing into each of the respective containers Connect the volume detection devices for IDS iISYS Wash IDS iSYS D Sorb Solution and Liquid Waste For the Biochemistry or Coagulation analyser configurations the IDS iSYS Wash solution is not used Do not connect any tube to the blue connector trical connections For the Biochemistry analyser configurations use only the IDS iSYS System Liquid reference R5H135A The electrical connections are located on the left hand side of the analyser Connect the analyser to the PC via the Ethernet cable
24. replicates absorbances is outside the limits specified in the analytical configuration for the test Blank out of range Biochemistry The reagent blank is outside the limits specified in the analytical configuration of the test Fail of calibration All fields calculation The calibration could not be calculated Sensitivity out of range Biochemistry The sensitivity calculated is lower than the value specified in the analytical configuration Determination coefficient Biochemistry too low The determination coefficient calculated for the calibration curve is lower than the value specified in the analytical configuration Monotony Problem Biochemistry Immunoassay The calibration has not been calculated as the curve is not strictly increasing or decreasing Tolerance out of range Immunoassay The deviation between the relative light unit RLU obtained for one of the calibrators and the measurement of the last calibration is higher than the percentage specified in the analytical configuration IDS iSYS User Manual Rev C Messages 4 1 75 Software version V4 XX Messages 4 1 Messages Associated with Calibrations continued Control out of range All fields The control carried out with the calibration has not been calculated or is outside the limits of acceptability Determination coefficient Biochemistry too low for one assay The slope of the kinetics calculated for one of the calibrators was calculated on a non linear s
25. type of reagent installed without a barcode e Programming of the analyses to be carried out Results display for controls or samples Colour coded analysis status see Section 3 page 57 IDS iSYS User Manual Rev C1 Software version V4 XX User Interface Software 2 2 29 User Interface Software 2 2 Main screen continued Status bar Analyser initialized Pending profiles 2 Complete profiles 0 Incomplete profiles 1 Automatic actions 0 Displays the analyser status work list and the connection status of the analyser com flashes blue in normal activity or red when there is a break in communication anen Status of the analyser Number of profiles without associated positions These profiles will never be Pending profiles 2 _ performed The profiles will be started only when a position is assigned Number of completed profiles in the work list Complete profiles 0 Number of incomplete profiles in the work list with at least one assay programmed Incomplete profiles 1 but not completed re Number of automatic requests generated by the system The list can be accessed via Automatic actions 0 the WARNING window IDS iSYS User Manual Rev C1 User Interface Software 2 2 24 Software version V4 XX User Interface Software 2 3 Menus Other functions are accessed by using the pull down menus on the interface File Sessions Data Maintenance Set up Management of Lots Window Help
26. wipe solution suitable for medical devices e Close the drawer e Open the lid and clean the Plexiglas over the reagent compartment with absorbent paper soaked in de ionised water Then use a disinfectant wipe solution suitable for medical devices Close the lid e When maintenance is complete click on the corresponding Execute the maintenance then confirm the maintenance by clicking on YES 5 2 1 2 Cleaning the sample tray and Plexiglas WARNING RISK OF BIOLOGICAL CONTAMINATION This part of the analyser is in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures Do not use any spray products on the analyser WARNING RISK OF INJURY If a position has to be cleaned take care not to push the wipe into the position with your finger risk of cuts from the detection sensors e Open the lid and clean the Plexiglas over the tray with absorbent paper soaked in de ionised water Then use a disinfectant wipe solution suitable for medical devices Close the lid e When maintenance is complete click on the corresponding then confirm the maintenance by clicking on YES Esecute the maintenance IDS iSYS User Manual Rev C1 Maintenance 5 2 88 Software version V4 XX Maintenance 5 2 Weekly Maintenance continued 5 2 1 General Maintenance continued 5 2 1 3 Cleaning the rinsing well WARNING RISK OF BIOLOGICAL CONTAMINATIO
27. A O lt 0 0 5 1 31 Q 47 ag G S 8 46 re Analyser initialized Pending profiles 0 Complete profiles 1 Incomplete profiles 0 Aufomatic actions 99 30 04 2009 12 13 42 nen a eee Start aca eee eae _k WOE Reagent Compartment Function buttons Sample Tray Status bar The Standard B position for ISE is present only with 80 positions drawer diameter 13 mm With the 64 positions drawer diameter 16 mm this position has been removed Menu bar Provides access to the different pull down menus File Sessions Data Maintenance Set up Management of Lots Window Help IDS iSYS User Manual Rev C1 User Interface Software 2 2 19 Software version V4 XX User Interface Software 2 2 Main Screen continued Reagent Compartment 1 z ISE ches ii 0 QO m a7 O m The illustration above shows the reagent compartment with reagents on board The racks are automatically identified by the integrated barcode reader when the rack is inserted in the rail For each occupied position the following information is displayed Test name e Lot number Status of the reagent indicated by a colour code see Section 3 page 38 Detailed information for each analyte may be accessed by clicking on the cartridge in the case of Immunology or individual Biochemistry reagents Information includes Test name Reagent type e Lot number e Container number Type of container Expir
28. Analyser Interventions continued 5 4 10 Replacement of Standard A or Waste pumps e Open the lid Remove the cover located at the rear Release the pump body from its shaft by pinching the two clips at either side and gently pulling Disconnect the pipes from the connectors and plug into the new pump Clean the pump shaft with absorbent paper soaked in alcohol e Return the pump body to its shaft Put the cover back in place and close the lid If the body for the Standard A pump has been replaced carry out one or several priming procedures of the ISE module to prime the circuit again IDS iSYS User Manual Rev C1 Maintenance 5 4 103 Software version V4 XX SECTION 6 Problems amp Corrective Action 6 1 Resolving Errors in Cartridge Check System CCS 105 6 2 Resolving Errors in Selective Electrodes 107 IDS iSYS User Manual Rev C Problems amp Corrective Action 104 Software version V4 XX Problems amp Corrective Action 6 1 Resolving Errors in Cartridge Check System CCS Possible cause amp corrective action CCS1 CV outside limits 1 Check for air bubbles in the tubing circuit Carry out a full priming of the arm 2 Check for the presence of bubbles in the reagents there should be none 3 Check that the probe is not blocked or bent Carry out a decontamination of the probe see Section 5 1 1 4 page 86 If the probe is bent replace it and check the XY reference position s
29. Connect the mains supply cable IDS iISYS User Manual Rev C1 Operating Principle 1 4 10 Software version V4 XX Operating Principle 1 5 Operating Principles Depending on the type of analysis the LCS isys Jses the following measurement principles Luminescence measurements carried out in the luminometer Immunoassay Absorbancy measurements carried out continuously by the spectrophotometer Potentiometry measurements made by the selective electrodes ISE Optic detection of clot by chronometer 1 5 1 Absorbancy measurements Samples and reagents are aspirated in accordance with the validated parameters for each assay and are transferred into a cuvette where the changes in absorbancy or optical density will be monitored in the course of the reaction taking place Photometric measurements are carried out in the reaction cuvette maximum interval between two consecutive measurements is 25 seconds These measurements are carried out at the wavelength specific to the analysis defined in the parameters by automatic selection of the appropriate interferential filter In monochromatic light and at constant temperature the relationship between absorbancy or optical density OD and the concentration of the analyte is provided by the BEER LAMBERT law OD ec 1C with OD Log 0 Where l Light flow at cuvette entrance Light flow at cuvette exit Molar extinction coefficient of the analyte in L mo
30. Declaration 112 A 3 Disposal Of the Analyser 113 A 4 IDS iSYS Cuvettes 114 A4 1 List of C symbols used on the IDS iSYS Cuvettes cube 114 A4 2 Storage of the IDS iSYS Cuvette cubes 114 IDS iSYS User Manual Rev C Appendices 109 Software version V4 XX Appendices A 1 Waste Disposal WARNING RISK OF BIOLOGICAL CONTAMINATION Waste which contains or which has been in contact with biological specimens must be considered to be a potential risk of infection Always wear disposable gloves for all handling procedures Waste must be disposed of in accordance with current local regulations Liquid waste Liquid waste is collected in a 10 litre container Liquid waste should be considered potentially infectious and must therefore be processed prior to disposal in accordance with current local regulations Dilute commercial bleach with water to obtain a 9 solution of active chloride e Put 250 mL of freshly prepared bleach into an empty container 10 litres e When the container is 3 4 full add 125 mL of freshly prepared bleach Eliminate the processed waste in accordance with current local procedures Do not use bleach in tablet form Solid waste Probes Electrodes IDS iISYS Cuvettes Solid waste should be considered potentially infectious and must therefore be disposed of in accordance with current local regulations IDS iSYS User Manual Rev C Appendices 110 Software version V4 XX Appendices
31. E DISPOSAL APPENDIX II DISINFECTING THE DEVICE APPENDIX III DISPOSAL OF THE MEDICAL DEVICE APPENDIX IV IDS iSYS CUVETTES Attached document Connection Protocol revision E 08 07 2009 Revision C1 V 4 03 a U General review of the terminology in all sections w and appendices of revision C SECTION 1 OPERATING PRINCIPLE SECTION 2 USER INTERFACE SOFTWARE SECTION 3 USE SECTION 4 MESSAGES SECTION 5 MAINTENANCE SECTION 6 PROBLEMS AND CORRECTIVE ACTION APPENDIX I WASTE DISPOSAL APPENDIX II DECONTAMINATING iale ANALYSER APPENDIX III DISPOSAL OF THE ANALYSER APPENDIX IV IDS iISYS CUVETTES Attached document Connection Protocol revision E IDS iSYS User Manual Rev C1 08 07 2009 Software version V4 XX Preface Special precautions The safety precautions specific to certain handling procedures described throughout the user manual are indicated in the following form Important notice Precaution which MUST be respected Presence of a potential risk Special Precautions IDS iSYS User Manual Rev C1 08 07 2009 Software version V4 XX Preface This instruction manual is to be used in conjunction with the tdssys in vitro diagnostic analyser and must be read before installing or using the analyser The tds isys in vitro diagnostic analyser must only be used by personnel trained by approved IDS staff The purpose of the user manual is to explain The way the analyser works How to use it in routi
32. E venes The probe will be placed over the reference position located to the left of the rinsing well If the probe is correctly centred on the reference position click on The pipetting arm will move to the rinsing well A message confirming cancellation of the procedure is displayed Click on OK to validate this message If the probe is off centre readjust its position using the movement arrows and click The pipetting arm will move to the rinsing well before returning to a point above the reference position e Click e When the check on the reference position is completed exit this menu Amessage confirming completion of the procedure is displayed Click on OK to IDS iSYS User Manual Rev C1 Maintenance 5 4 98 Software version V4 XX Maintenance 5 4 Analyser Interventions continued 5 4 2 Replacement of probe continued Prime the analyser as follows File Sessions data Maintenance Set up Management of Lots Window Help Initialization O o i Self checking y User maintenance Factor maintenance Technical support e all P Status of analyser Fa e Select ARM Mixed Partial Priming then click on B Pinna The analyser will prime the tubing circuit and rinse the probe 5 4 3 Replacement of primary fuses WARNING RISK OF ELECTRIC SHOCK lt is essential for the mains connection to be unplugged during replacement of fuses The primary fuses are located in the
33. N This part of the analyser is in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures e Open the lid e Pour alcohol into the rinsing well Use a cotton bud soaked in alcohol to clean the well e When maintenance is complete click on the corresponding Execute the maintenance then confirm the maintenance by clicking on YES 5 2 1 4 Cleaning the reagent barcode reader mirror Do not spray any product onto the medical device Open the reagent drawer e Clean the mirror with absorbent paper soaked in alcohol Close the reagent drawer again e When maintenance is complete click on the corresponding m ee A EE AEE AA then confirm the maintenance by clicking on YES 5 2 1 5 Checking dilutors and IDS iSYS System Liquid pumps Remove the cover from the right hand hand side of the analyser e Check for any leaks on the tubing connections at the outlet of each dilutor e Check for any leaks on the IDS iSYS System Liquid pumps Replace the cover e When maintenance is complete click on the corresponding then confirm the maintenance by clicking on YES IDS iSYS User Manual Rev C1 Maintenance 5 2 89 Software version V4 XX Maintenance 5 2 Weekly Maintenance continued 5 2 1 General Maintenance continued 5 2 1 6 Cleaning the solid waste chute WARNING RISK OF BIOLOGICAL CONTAMINATION This part of the analyser is in
34. Potential of the electrode in the sample e Ey Potential developed under standard conditions gt RT NF Constant dependent on temperature referred to as slope log Decimal logarithm function ea Activity coefficient of the ion measured in the solution eC Concentration of the ion measured in the solution A comparison method is used Firstly the module measures the potentials developed by the sample passing in front of the electrodes A measurement is then taken on Calibrator A The difference between the two potentials is a logarithmic function of the concentration of the ions measured in the sample divided by their respective concentration in the Calibrator As the differences of potentials and concentrations in sodium potassium and chloride ions of the Calibrator are known the ionic concentrations of the sample can be calculated using the NERNST equation Or E Eo S log C E Eo S Cy Cs x 10 Where E Potential of the electrode in the sample e Ey Potential developed by the electrode in the solution of Calibrator e S Slope of the electrode calculated during calibration Q Concentration of the ion in the sample e Cs Concentration of the ion in the solution of Calibrator The slope S is determined during calibration with the solutions of Calibrators A and B whose concentrations are known When a calibration is carried out the slope is calculated from the difference between the second measu
35. Resolving Errors Cartridge Check System CCS continued Problem Possible cause amp corrective action i CCS4 Value outside limits 1 Replace the IDS iSYS Triggers and the IDS iSYS Cuvettes cube in use Carry out a full priming of luminometer then repeat the CCS4 test 2 If the problem persists contact IDS Service amp Support personnel CCSB CV outside limits 1 The magnetic particles of the CCS cartridge are not correctly mixed manually mix the magnetic particles vial by gentle repeated inversion 2 Check that the probe is not blocked or bent Carry out a decontamination of the probe see Section 5 1 1 4 page 86 If the probe is bent replace it and check the XY reference position see Section 5 4 2 page 98 3 Check for air bubbles in the IDS iSYS Wash Solution tubing Carry out a full priming of all washers 4 Repeat the CCSB test 5 If the problem persists contact IDS Service amp Support personnel CCS1 CCS2 Ratio outside 1 Check for air bubbles in the tubing circuit Carry out a full priming of the limits arm 2 Check for the presence of bubbles in the reagents there should be none 3 Check that the probe is not blocked or bent Carry out a decontamination of the probe see Section 5 1 1 4 page 86 If the probe is bent replace it and check the XY reference position see Section 5 4 2 page 98 4 Check for air bubbles in the IDS iSYS Triggers A and B tubing 5 Repeat the CCS1 amp 2
36. STEM SETTINGS menu the profile is stored as soon as the profile is completed As soon as the position occupied by this sample is released the profile is automatically transferred to storage All stored results can be viewed via the DATA menu under RESULTS STORAGE The results can be stored individually or in multiples Click on work List then click 272 Store Transter Select the relevant profile option to be stored all profiles selection profiles without message then click Validate I The stored profiles change to a yellow colour code As soon as a position for which the profile has been stored is released the profile will be available in results storage e It is also possible to delete all the stored profiles from the work list To do this click on B veee nen select Profiles stored and BA vas All the stored profiles are deleted from the work list and transferred to analyser software s database It is possible to request repeat analyses for a stored profile as long as the tube is still in the sample rack IDS iSYS User Manual Rev C1 Use 3 12 67 Software version V4 XX Use 3 13 Quality Control Management The results calculated for the controls are automatically stored for each reagent lot The results are recorded for each test and for each lot of reagent for cumulative analysis Levey Jennings and depending on the analytical configuration with Westgard rules for one or two levels o
37. User Manual Rev C1 User Interface Software 2 3 26 Software version V4 XX User Interface Software 2 3 Menus continued 2 3 3 DATA menu Calibrations FS Results storage F4 Quality Controls Records Working panel Master Curves Counters Allows access to all the calibrations currently valid for each test in the personal library Displays the active calibration of a reagent lot for each test of the personal library Allows access to the stored results When opened the results are displayed Various filters can be applied to display results for a single date between two dates or for the Results storage entire storage period Analysis of quality controls results e LEVEY JENNINGS cumulative analysis of the results obtained by test or by a control lot for a programmable period of time e WESTGARD inspection of the control results with selected rules e History by product record of the results obtained for each reagent and for all tests using this reagent Printouts global printouts of Levey Jennings data LEVEY JENNINGS FF WESTGARD History by Product Quality Contrals Printings d Records events for System Database e Access e Analytical e Laboratory Information System LIS transfers e Maintenance Positive identification For use in fail mode failure to detect samples and reagents Allows user to memorise configurations of the reagent compartment with the positions
38. aintain the performance of the analyser and to guarantee safe use for the operator Environmental conditions required The analyser must not be exposed to direct light Aclean and ventilated air environment The analyser must be placed on a flat work surface capable of supporting its weight 103 kg without significant vibration The surrounding temperature must be between 15 C and 30 C Temperature fluctuations during analyses must not exceed 2 C Relative humidity must be below 70 non condensing The analyser must not be installed under an air conditioning unit Clearance of at least 15 cm must be provided at the rear front left and right of the analyser to allow evacuation of heat produced by the apparatus The analyser must not be installed near strong sources of electromagnetic radiation and electrical interference e g refrigerators Physical characteristics of the analyser Dimensions of the analyser L105xH 70x W 75 cm e Overall dimensions L124xH110xW 71 cm Weight 103 kg Computer system L 60 x H 40 x W 50 cm 1 4 2 Electricity supply The electricity supply must meet the following conditions Voltage 220 240 V Frequency 50 60 Hz e Maximum power consumed 1000 VA If necessary the installation of a regulated electrical supply may be required In order to protect the analyser s electrical safety in accordance with standards it is essential to check that the associated
39. al Immunology and if appropriate Biochemistry Certain maintenance activities are carried out automatically by the system whilst others must be carried out by the operator In both cases the maintenance activities are recorded WARNING OPENING CLOSING THE LID The lid must be opened for some maintenance procedures Handle the lid carefully during opening and closing as there is a risk of it falling Always open the lid fully before any intervention In the maximum height position the lid is stable and will remain open Take care not to knock the lid with your head Never open the lid partially risk of falling back at an inappropriate time IDS iSYS User Manual Rev C1 Maintenance 5 1 84 Software version V4 XX Maintenance 5 1 Daily Maintenance continued 5 1 1 General Maintenance 5 1 1 1 Checking the reagent compartment and Plexiglas Do not use any spray products on the analyser e Open the reagent compartment drawer e Check that no trace of reagent is present on the base plate of the compartment If traces of reagent are evident use absorbent paper to clean the rails Then use a disinfectant wipe solution suitable for medical devices e Close the drawer e Open the lid and check that there are no traces of liquid on the Plexiglas over the reagent compartment If traces of liquid are evident use absorbent paper to remove them Close the lid When maintenance is complete click on the corresp
40. and the position is displayed in green This information is also contained in the CD supplied with the kits If this information is not available the position of the reagent is displayed in white with red stripes In this case install the CD supplied with the kit and use the keyboard to re enter the barcode identifier IDS iSYS User Manual Rev C1 Use 3 2 36 Software version V4 XX Use 3 2 Installation of Reagents continued To select a Biochemistry rack click on IDS Rack Then select the type of rack e Fora3 x 50 mL rack click on IDS 1 Fora 6 x 20 mL rack click on IDS 2 Then click on the position and use the keyboard to enter the barcode identifier for the bottle and select the reagent installed a E s m gt es ee I l E Ba E i iE i q 3 5 z The information about the bottle type of reagent lot expiry date is automatically associated with the barcode reading This information is also contained in the CD supplied with the reagents If the information is not available the position of the reagent is displayed in white with red stripes In this case install the CD supplied with the kit Wait for 40 minutes after installing reagent cartridges before starting assays as the reagent cartridge temperature must be allowed to equilibrate 20 min for Biochemistry IDS iSYS User Manual Rev C1 Use 3 2 37 Software version
41. aning the liquid waste pump shaft 92 5 3 1 3 Cleaning the IDS iSYS D Sorb pump and level sensor shafts 93 5 3 1 4 Cleaning the liquid waste level sensor 93 5 3 1 5 Checking lamp intensity 94 5 3 2 Biochemistry ISE Maintenance 94 5 3 2 1 Cleaning the Standard A and Waste pump shafts 94 5 3 3 Immunoassay Maintenance 95 5 3 3 1 Cleaning the IDS iSYS Wash pump and level sensor shafts 95 5 4 Analyser Interventions 96 5 4 1 Replacement of lamp 96 5 4 2 Replacement of probe 98 5 4 3 Replacement of primary fuses 99 5 4 4 Replacement of secondary fuses 100 5 4 5 Replacement of IDS iISYS Wash Solution pump Immunoassay 101 5 4 6 Replacement of IDS iISYS System Liquid pump 101 5 4 7 Replacement of liquid waste pump 101 5 4 8 Replacement of IDS iSYS D Sorb pump 102 5 4 9 Removal of the on board IDS iSYS Cuvettes cube 102 5 4 10 Replacement of Standard A or Waste pumps 103 IDS iSYS User Manual Rev C1 Maintenance 83 Software version V4 XX Maintenance 5 1 Daily Maintenance In the MAINTENANCE menu select DAILY MAINTENANCE File Sessions data Maintenance Set up Managemerntoflots Window Help Initialization Priming Sell checking et adjustment Dead volumes settings Daily maintenance Weekly maintenance Factory maintenance Technical support Status of analyser Fe Monthly maintenance Maintenances histor Daily maintenance activities are presented under three tabs Gener
42. are version V4 XX Biochemistry Immunoassay The control was not calculated as the calibration is invalid All fields The value calculated for the control is outside the limits of acceptability These limits of acceptability are calculated from data supplied for the control lot Biochemistry Immunoassay The control value was not calculated due to incomplete data generation Biochemistry ISE The control value for one of the electrodes was not transferred by the selective electrodes module Messages 4 2 TT Messages 4 3 Messages Associated with Results Results calculated for samples are accompanied by a colour coded message displayed in the column STATE If a result does not have a message associated with it OK is displayed in the MSG column green colour code associated If a result is accompanied by one of the following messages an orange colour code is associated AIRA Biochemistry Selective electrodes Air detected during the measurement of the sample AIRS Biochemistry Selective electrodes Air detected during the measurement of the sample RDS Immunoassay Problem with agitation of magnetic particles on the reagent rack BLR Biochemistry Absorbance of blank outside the limits defined in the analytical configuration NOIS Biochemistry Selective electrodes Electrical noise interfering with the measurement KIN Biochemistry The absorbances measured while monitorin
43. asure mV Sample tube Air bubble detector Na Electrode Crown Ether K Electrode Valinomycin CI Electrode Flow through a Reference electrode body pA E4 Eri CA A membrane assembly Ag AgCl Electrode Bubble detector Ma Signal to microprocessor Pump tube Ionic contact through 3 5 M KCl Separating air bubble internal filling solution Standard p Membrane To pump Sodium electrode The fluid circuit from the sodium electrode has a selective PVC tube specially formulated to be specifically permeable to sodium ions Potassium electrode The fluid circuit for the potassium electrode has a plastic tube in which valinomycin is incorporated as the selective element Chloride electrode The fluid circuit for the chlorides electrode has a plastic tube specially designed to recognise chloride ions IDS iSYS User Manual Rev C1 Operating Principle 1 5 13 Software version V4 XX Operating Principle 1 5 Operating Principles continued 1 5 2 Potentiometry measurements continued The potential of each electrode is measured in comparison with a stable voltage established by the reference electrode Ag AgCl A selective electrode develops a voltage which varies according to the concentration of the ion to which it responds The relationship between the voltage developed and the ionic concentration is logarithmic and is expressed by the NERNST equation E Flog aC nF Where e E
44. atically perform the data processing to generate a new curve by defining new values for two of the four parameters considered to be critical In practice the 4 parameters of the reference curve specific to the reagent cartridge lot are loaded in the user s analyser via a CD provided with the kit Calibration of the test must then be requested prior to use The calibration is performed and then verified by assaying one or more controls Subsequent calibrations must be repeated regularly in accordance with each assay s instructions for use or as prompted by the analyser IDS iSYS User Manual Rev C1 Operating Principle 1 5 15 software version V4 XX Operating Principle 1 6 Safety Precautions The Us isys is a multiparameter selective analyser for in vitro assays in clinical biology The analyser must only be used by trained personnel in compliance with the following safety precautions and good laboratory practice GLP 1 6 1 General precautions After start up and installation of reagents cartridges must be left for a period of time before use For biochemistry this should be 20 minutes to allow temperature equilibration For Immunoassay this should be 40 minutes for temperature equilibration and magnetic particle re suspension Do not lift the lid while the analyser is running i e during the run cycle Opening the lid during the run cycle interrupts the movements of the pipetting arm Should this occur analyses under way m
45. ay be interrupted and restarted recycled Do not place bottles of reagent on the surface of the analyser While the analyser is in operation do not touch the analyser stop start button Make sure that the reagent and sample racks are clean at all times The database is automatically backed up once a week Operators should store back ups from the computer onto CD or USB flash drive Keep documentation of the set up programmed on the analyser Only Immunoassay and ancillary reagents supplied by IDS and its partners can be used on the analyser catalogue available on request To ensure that the cuvette loader functions correctly only use full cubes of cuvettes Never install isolated layers in the loader In the event of maintenance or an intervention by IDS Service amp Support Personnel the analyser and its various components must first be cleaned and decontaminated as defined in the Maintenance section see Section 5 page 84 Maintenance operations must be carried out at the frequency stipulated for each type of maintenance activity As some parts of the analyser are in contact with the biological samples they must be considered to pose a potential risk of infection Validation of non IDS biochemistry reagents is the responsibility of the user and IDS takes no responsibility for the validity of results if non IDS products are used In order to guarantee the thermo regulation of the carousel ambient temp
46. calibrations and controls can be programmed on demand or automatically by the analyser Each reagent lot has its own calibration thus allowing multiple reagent lots of the same analyte on board at the same time A request for calibration is automatically accompanied by a request to include QCs in the assay QC1 for Biochemistry or several QCs depending on the configuration QC4 is used only for Immunoassays Requests for controls can be made as soon as a validated calibration is stored Requests for calibrations and controls can be made regardless of calibration status During the run cycle the calibrations and the controls take priority over all other tests requested From the main screen click on 27 Calibration Control Col Stoua of Coktenson Curent Med pabbi Gel Ger O63 Ged opkibrestene Pe Alc 138 Ganon TES Cel N 155 Bihi ata mi IEH Tig Programming a Calibration of a New Reagent Lot e Click on alongside the assay to be calibrated A tick is displayed in the calibration column and in the appropriate QC column s If more than one reagent lot is on board when is clicked on a new window appears see below E m z a e Select the lot to be calibrated and then click on EB vae A tick is displayed in the calibration column and in the appropriate QC column s IDS iSYS User Manual Rev C1 Use 3 5 45 Software version V4 XX Use 3 5 Programming Calibrations and Controls continu
47. carefully during opening and closing as there is a risk of it falling Always open the lid fully before any intervention In the maximum height position the lid is Stable and will remain open Take care not to knock the lid with your head Never open the lid partially risk of falling back at an inappropriate time e Open the lid e Remove the cover located at the rear e Click on the corresponding button in front of this item in the maintenance list Follow the instructions displayed er sereen Release the pump body from its shaft by pinching the two clips at either side and gently pulling ensuring the tubes remain connected e Clean the pump shaft with a cloth soaked in alcohol e Return the pump body to its shaft e Put the cover back in place and close the lid To clean the level sensor use absorbent paper soaked in de ionised water e When maintenance is completed click on The date and time it is carried out are recorded 5 3 1 4 Cleaning the liquid waste level sensor WARNING RISK OF BIOLOGICAL CONTAMINATION This part of the analyser is in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures e Click on the corresponding button in front of this item in this maintenance list Remove the lid from the liquidhwastiedbeteaintenance Clean the level sensor with bleach Commercial preparation Rinse the level senso
48. ce then if necessary weekly and monthly maintenance Empty the liquid waste and solid waste tray if necessary Waste must be disposed of in accordance with current local regulations see APPENDIX Waste disposal page 110 WARNING RISK OF BIOLOGICAL CONTAMINATION Waste which contains or has been in contact with biological specimens must be considered to pose a potential risk of infection Wear disposable gloves when handling waste The waste must be disposed of in accordance with current local regulations AL ALLY AGOAN AL A AVL AA AIA TaO nreoQ A A A AA e Check that the volume of Standard A available for the selective electrodes is adequate for the usage required in standby mode It is essential for an analyser equipped with the selective electrodes module to be put into standby mode in order to ensure that the selective electrodes are kept in optimum working order If the analyser has to be switched off the electrodes must be rinsed in de ionised water before being stored in their original packaging Check the ime and date of wake up programmed in the SY V menu if applicable From the Session menu select SHUT DOWN to put the analyser into standby mode Do not turn off the computer in standby mode IDS iSYS User Manual Rev C1 Use 3 14 72 Software version V4 XX Use 3 15 Switching The Analyser Off Completely This procedure is only applicable to analysers not equipped with a selective el
49. ce 87 5 2 1 General Maintenance 88 5 2 1 1 Cleaning the reagent compartment and Plexiglas 88 5 2 1 2 Cleaning the sample tray and Plexiglas 88 5 2 1 3 Cleaning the rinsing well 89 5 2 1 4 Cleaning the reagent barcode reader mirror 89 5 2 1 5 Checking dilutors and IDS iSYS System Liquid pumps 89 5 2 1 6 Cleaning the solid waste chute 90 5 2 2 Biochemistry ISE Maintenance 90 5 2 2 1 Cleaning the selective electrodes injection well 90 5 2 3 Immunoassay Maintenance 91 5 2 3 1 Flushing the IDS iSYS Triggers and IDS iSYS Wash tubing 91 5 3 Monthly Maintenance 92 5 3 1 General Maintenance 92 5 3 1 1 Cleaning the IDS iSYS System Liquid pump shafts 92 5 3 1 2 Cleaning the liquid waste pump shaft 92 5 3 1 3 Cleaning the IDS iSYS D Sorb pump and level sensor shafts 93 5 3 1 4 Cleaning the liquid waste level sensor 93 5 3 1 5 Checking lamp intensity 94 5 3 2 Biochemistry ISE Maintenance 94 5 3 2 1 Cleaning the Standard A and Waste pump shafts 94 5 3 3 Immunoassay Maintenance 95 5 3 3 1 Cleaning the IDS iSYS Wash pump and level sensor shafts 95 5 4 Analyser Interventions 96 5 4 1 Replacement of lamp 96 5 4 2 Replacement of probe 98 5 4 3 Replacement of primary fuses 99 5 4 4 Replacement of secondary fuses 100 5 4 5 Replacement of IDS iISYS Wash Solution pump Immunoassay 101 5 4 6 Replacement of IDS iISYS System Liquid pump 101 5 4 7 Replacement of liquid waste pump 101 5 4 8 Replacement of IDS iSYS D Sorb pump 102 5 4 9 Removal of the on board IDS
50. continued A 2 Decontaminating the Analyser WARNING RISK OF BIOLOGICAL CONTAMINATION Certain parts of the analyser are routinely in contact with biological samples there is therefore a potential risk of infection Wear disposable gloves for all handling procedures Waste must be disposed of in accordance with current local regulations The analyser must be decontaminated after carrying out the regular maintenance procedures described in Section 5 of this user manual It is essential that decontamination is carried out e Prior to any intervention by the Technical Services amp Support personnel Prior to any transportation of the system A cleaning decontaminating declaration must be completed by the user The declaration is printed on the following page and should be duplicated and once completed attached to the analyser in a prominent position lt is essential for this declaration to accompany the analyser during any transportation e g return to factory Cleaning decontamination process Decontaminate the probe with a wipe soaked in a decontaminating solution suitable for medical devices Decontaminate the sample tray and reagent compartment with a wipe soaked in a decontaminating solution suitable for medical devices Decontaminate the rinsing well and the liquid waste tubing by pouring bleach commercial preparation into the drainage hole in the rinsing well Empty the solid waste tray and liquid waste c
51. cover located on the right hand side of the analyser e Click on the corresponding Execute the maintenance button in front of each item in this maintenance list No spindle must rotate while_th ane agicarried out Release the pump body from its shaft by mirim the two clips at either side and gently pulling ensuring the tubes remain connected Clean the pump shaft with absorbent paper soaked in alcohol e Return the pump body to its shaft e Carry out this procedure for the other pumps e When maintenance is completed click The date and time it is carried out are recorded 5 3 1 2 Cleaning the liquid waste pump shaft e Click on box located in front of this maintenance No spindle must rotate while this Release the pump body from its shaft by pinching the two clips at either side and gently pulling ensuring the tubes remain connected Clean the pump shaft with absorbent paper soaked in alcohol e Return the pump body to its shaft e Carry out this procedure for the other pump e When maintenance is completed click on Bx The date and time it is carried out are recorded Ok IDS iSYS User Manual Rev C1 Maintenance 5 3 92 Software version V4 XX Maintenance 5 3 Monthly Maintenance continued 5 3 1 General Maintenance continued 5 3 1 3 Cleaning the IDS iISYS D Sorb pump and level sensor shafts WARNING OPENING CLOSING THE LID The lid must be opened for this maintenance procedure Handle the lid
52. d side of IDS iSYS User Manual Rev C1 Maintenance 5 3 95 Software version V4 XX Maintenance 5 4 Analyser Interventions 5 4 1 Replacement of lamp WARNING RISK OF BURNS Before handling allow the lamp to cool for approximately 10 minutes after switching the analyser off e Switch the analyser off and unplug the power cable e Open the lid Remove the bottom partition at the rear of the rinsing well Disconnect the lamp from its supply Unscrew the securing screws located on both sides of the lamp in order to remove the lamp support unit Remove the old lamp WARNING RISK OF BURNS Do not touch the lamp with your fingers Do not touch the lamp with your fingers IDS iSYS User Manual Rev C1 Maintenance 5 4 96 Software version V4 XX Maintenance 5 4 Analyser Interventions continued 5 4 1 Replacement of lamp continued Put the new lamp and its base in place with the guide pin positioned downwards Tighten the securing screws using a screwdriver Connect the lamp to its power supply Replace the partition Close the lid e Switch the analyser back on and start it up Wait for 10 minutes then request a measurement of the intensity values by the following pathway Maintenance File Sessions data Set up Management of Lots Window Help Initialization Priming Self checking IL User maintenance e Factory maintenance Technical
53. dard A is periodically refreshed Shut down Work List Access to the work list see Section 3 10 4 page 62 Allows the user to start the run cycle see Section 3 8 page 53 nce the analyser is in m h ion mes inactive Start Run Cycle Once the analyser is in assay mode the option becomes inactive This option is active when the analyser is in run cycle Stop Run Cycle Allows the user to stop the assay process This option is active when the analyser is in run cycle Displays information concerning the tests in process The software displays the time Run cycle Monitoring of processing and when each assay s results will be available Allows the user to view the available volumes and the number of tests for each on Volumes monitoring board reagent before or during the run cycle Programming and processing of tests for the reagent Cartridge Check System CCS Qualification contrals Simplifies programming of the work list by applying the same profile to Automatic identification of the sample tray positions each occupied position Management of user access when an access code is entered a specific session is opened The user s identifier and the level of authorisation are displayed at the top of the title bar Access codes and identifiers are programmed in the SETTINGS menu Keep a record of your access codes If lost Operator sessions can be opened by using the code HELP Each access will be recorded IDS iSYS
54. de 7 If the problem persists contact IDS Service amp Support personnel Message NOIS ona 1 Deterioration of an electrode carry out a cleaning cycle If the problem parameter persists replace the electrode Message NOIS on the 3 1 Deterioration of the reference electrode replace the electrode parameters 2 Erratic signal coming from the module environment contact IDS Service amp Support personnel Message DRIF ona 1 If the electrode or Standard A has recently been replaced carry out parameter several start up cycles of Standard A before recalibrating 2 Replace Standard A 3 Deterioration of the electrode carry out a cleaning cycle If the problem persists replace the electrode Message DRIF on the 3 1 If the electrode or Standard A has recently been replaced carry out parameters several start up cycles of Standard A before recalibrating 2 Replace Standard A 3 Incorrect alignment of the electrodes remove the 4 electrodes from the module and reinstall them in the following order from bottom to top Reference Chloride Potassium Sodium 4 Deterioration of the reference electrode replace the electrode IDS iSYS User Manual Rev C Problems amp Corrective Action 6 2 107 Software version V4 XX Problems amp Corrective Action 6 2 Resolving Errors in Selective Electrodes continued Problem Possible cause amp corrective action i Message AIRA 1 Ai
55. e installation of the new item using the barcode reader will automatically release the fault Please note that if the error involves one of the other ancillaries for example IDS iSYS Wash Solution the error must be resolved after stopping the run cycle IDS iSYS User Manual Rev C Messages 4 5 82 Software version V4 XX SECTION 5 Maintenance Ei Section 5 i Section 5 Maintenance 83 5 1 Daily Maintenance 84 5 1 1 General Maintenance 85 5 1 1 1 Checking the reagent compartment and Plexiglas 85 85 5 1 1 2 Checking the sample tray and Plexiglas 5 1 1 3 External cleaning of the probe 86 5 1 1 4 Decontamination of the probe 86 5 1 2 Biochemistry ISE Maintenance 86 5 1 2 1 Cleaning cycle for selective electrodes 86 5 2 Weekly Maintenance 87 5 2 1 General Maintenance 88 5 2 9 88 2 1 1 Cleaning the reagent compartment and Plexiglas 88 5 2 1 2 Cleaning the sample tray and Plexiglas 5 2 1 3 Cleaning the rinsing well 89 5 2 1 4 Cleaning the reagent barcode reader mirror 89 5 2 1 5 Checking dilutors and IDS iSYS System Liquid pumps 89 5 2 1 6 Cleaning the solid waste chute 90 5 2 2 Biochemistry ISE Maintenance 90 5 2 2 1 Cleaning the selective electrodes injection well 90 5 2 3 Immunoassay Maintenance 91 5 2 3 1 Flushing the IDS iSYS Triggers and IDS iSYS Wash tubing 91 5 3 Monthly Maintenance 92 5 3 1 General Maintenance 92 5 3 1 1 Cleaning the IDS iSYS System Liquid pump shafts 92 5 3 1 2 Cle
56. e the protective plastic strip pull upwards to break the seal and then forwards to remove the protective strip Place the protective strip over the cube to protect the window from dust If the barcode is not read by the barcode reader click on the ancillary reagent then use the keyboard to enter the barcode identifier Follow the directions for positioning of the cube in the loader Do not remove the protective strip before installing the cube in the loader Install only full cubes Never install individual plates Reassembly of cuvette plates will cause the analyser to jam Correct positioning of the cube of cuvettes in the loader is essential for the automatic cuvette loading module to function correctly The cuvettes are disposable devices Refer to the catalogue for the product references of the ancillary reagents to be ordered IDS iSYS User Manual Rev C1 Use 3 3 42 Software version V4 XX Use 3 4 System Performance Checks Immunoassay only The performance of the analyser must be checked on a daily basis before performing an assay requiring calibration controls or samples To achieve this a reagent cartridge known as Cartridge Check System CCS is used Different protocols are applied to this cartridge in order to determine the functional state of the various analyser modules For daily use and acceptance criteria refer to the CCS cartridge instructions for use IFU 3 4 1 Programming the qualification pr
57. ection of the curve ISE Error Biochemistry ISE The calibration slope of one of the electrodes was not transferred by the selective electrodes module No control for checking All fields The control measurements requested with the calibration have not been performed Calibration is not considered to be valid Out of the activity limits Biochemistry The slope of the kinetics calculated for one of the calibrators is higher than the limit value of activity specified in the analytical configuration or enzymatic hyperactivity was detected IDS iSYS User Manual Rev C Messages 4 1 76 Software version V4 XX Messages 4 2 Messages Associated with Calibration Controls QC 2B2 Cartridge Q C2MB2 Invalid When the controls carried out with the calibration do not meet the criteria for automatic validation the status of each control is represented by a red circle in the appropriate column s e g QC3 and by a red half circle in the calibration column For Biochemistry assays only QC1 is carried out with the calibration In this case the corresponding assays will not be processed by the analyser until a new calibration has been carried out and is correct or until the calibration is forced The messages associated with the calibration control are displayed with the calibration curve in the control section Calibration out of range Out of range Calculation Error ISE Error IDS iSYS User Manual Rev C Softw
58. ectrode module and to the analysers for which reagents must not be stored internally Remove all the reagents installed on the reagent rack e From the File menu click on EXIT the software will close Then turn off the computer following the procedure for shutting down WINDOWS Finally press the switch located on the left hand side of the analyser into position O IDS iSYS User Manual Rev C1 Use 3 15 73 Software version V4 XX SECTION 4 E Messages Section 4 Messages 74 B 4 1 Messages Associated with Calibrations 75 4 2 Messages Associated with Calibration Controls T7 4 3 Messages Associated with Results 78 4 4 Warning Messages 81 4 5 Error Messages 82 IDS iSYS User Manual Rev C Messages 74 Software version V4 XX Messages 4 1 Messages Associated with Calibrations If a calibration fails to meet the criteria for automatic validation the calibration status is represented by a red half circle For Biochemistry the corresponding assays will not be processed by the analyser until a new calibration is carried out and is correct or until the calibration is forced In the case of Immunoassays assays will be processed but values will not be calculated until an new calibration is carried out and is correct or until the calibration is forced Messages associated with the calibrations are displayed with the calibration curve Abs out of range Biochemistry One of the calibrator
59. ed Programming a New Calibration for a Reagent The resulting screen see below shows a list of all tests in the personal library It also includes the date and time of the last calibration for the on board analytes e Click on the box in the column Cal in front of the lot to be calibrated A tick is displayed in the calibration column and in the QC column s E IDS iSYS FACTORY Factory File Sessions Datas Maintenance Set up Management of Lots Window a Management of Calibration Control C Only on board analytes Analyte Lots Cal Status of Calibration Current Next calibration Qc calibration Not loaded Analyser initialized Pendingprofiles 0 Complete profiles 35 Incomplete profiles Automaticactions 0 COM 29 05 2009 11 42 51 te Start 95 IDS iSYS FACTORY Calibrations for several lots of the same reagent can programmed simultaneously IDS iSYS User Manual Rev C1 Use 3 5 46 Software version V4 XX Use 3 5 Programming Calibrations and Controls continued Programming Quality Controls for a Reagent Lot Controls can be performed at any time for the on board reagent lots provided there is a valid calibration To request a QC1 QC2 QC3 or QC4 quality control click on the box corresponding to the test to be performed Load the necessary calibrators and controls onto the analyser lf the value of a calibrator or control is not defined for the active lot a window automatically o
60. ed The signal generated by the labelled analyte in the luminometer is therefore versely proportiora to the concentration of analyte in the sample Two site sandwich method assay This technique uses two antibodies that detect and bind different portions of the analyte molecule Incubation of these antibodies with the sample results in the formation of a sandwich complex where the analyte is specifically bound by both antibodies Incubation with coated magnetic particles allows capture of these complexes The signal generated by detection of the captured complexes is directly proportional to the concentration of analyte in the sample Generating the master curve and calculation of results The results are calculated in comparison to a calibration curve The specific reference curve master curve for a reagent lot is in the file containing all the data for that lot that is provided on the CD accompanying the cartridge This information is registered in the analyser s database when the CD is introduced on the controlling computer If a new reagent lot is used this curve must be registered on the database and then adjusted by a 2 point calibration before sample results can be calculated 2 point calibration Analyser to analyser variation and different reagent lots will require adjustment of the master curve calibration This is done by assaying two calibrators supplied with the reagent cartridge The analyser s software will autom
61. ed in terms of frequency by the analyser A request for calibration is automatically accompanied by a request to perform QC control Requests for calibrations and controls can be made at any time If the analyser is in the process of carrying out the assay the calibrations and controls take place prior to the analyses requested on the samples IDS iSYS User Manual Rev C1 Operating Principle 1 5 12 software version V4 XX Operating Principle 1 5 Operating Principles continued 1 5 2 Potentiometry measurements The electrolytes in blood are traditionally measured using flame photometry In this method the sample diluted with a known concentration of a reference ion usually lithium or caesium is vaporised then passed through a flame which causes excitation of the cations The energy is re emitted in the form of a light with a different frequency with the amplitude of the emission being proportional to the ion concentration in the sample The development of organic compounds selective to sodium potassium chlorides and other electrolytes has led to the development of sensors capable of taking direct measurements in biological fluids The module for measuring sodium potassium and chloride electrolytes in the cls isys employs selective electrode technology as shown in the diagram below e amate a Signal to microprocessor L Na potential measure mV l K potential measure mV p CI potential me
62. ee Section 5 4 2 page 98 4 Check for air bubbles on the IDS iSYS Triggers A and B tubing circuits Check for air bubbles in the tubing circuits 5 Repeat the CCS1 test 6 If the problem persists contact IDS Service amp Support personnel CCS2 CV outside limits 1 Check for air bubbles in the tubing circuit Carry out a full priming of the arm 2 Check for the presence of bubbles in the reagents there should be none 3 Check that the probe is not blocked or bent Carry out a decontamination of the probe see Section 5 1 1 4 page 86 If the probe is bent replace it and check the XY reference position see Section 5 4 2 page 98 4 Check for air bubbles in the IDS iSYS Triggers A and B tubing 5 Repeat the CCS2 test 6 If the problem persists contact IDS Service amp Support personnel CCS3x Value outside limits 1 Presence of residual IDS iSYS Wash for the associated washer carry out a full priming of all washers 2 Check for air bubbles in the IDS iSYS Triggers A and B tubing 3 Check IDS iSYS Cuvettes and IDS iSYS Triggers by carrying out a CCS4 test 4 If CCS4 is within the limits replace the IDS iSYS Wash Solution in use Carry out full priming of washers and repeat CCS3 tests 5 If the problem persists contact IDS Service amp Support personnel IDS iSYS User Manual Rev C Problems amp Corrective Action 6 1 105 Software version V4 XX Problems amp Corrective Action 6 1
63. ekly Maintenance continued 5 2 3 Immunoassay Maintenance 5 2 3 1 Flushing the IDS ISYS Triggers and IDS iISYS Wash Solution tubing Prepare a large container at least 10 litres of distilled water and two 500 mL bottles containing distilled water to mimic the IDS iSYS Wash Solution and IDS iSYS Triggers e Click on the corresponding Execute the maintenance button in front of this item in the maintenance list i Ctloris Follow the on screen instru e When maintenance is completed without any error the date and time are recorded IDS iSYS User Manual Rev C1 Maintenance 5 2 91 Software version V4 XX Maintenance 5 3 Monthly Maintenance gt Inthe MAINTENANCE menu select MONTHLY MAINTENANCE Window Help Maintenance Set up Management of Lots File Sessions data Initialization Priming ts Sell checking ev adjustment Factory maintenance Technical support Dead volumes settings Statue of analyser Daily maintenance Weekly maintenance Monthly maintenance Maintenances history e The monthly maintenance activities are presented under 3 tabs General Immunology and if appropriate Biochemistry Certain maintenance activities are carried out automatically by the system whilst others must be carried out by the operator In both cases the maintenance activities are recorded 5 3 1 General Maintenance 5 3 1 1 Cleaning the IDS iSYS System Liquid pump shafts Remove the
64. er The analyser will resume sample aspiration once the drawer is locked 3 8 3 Adding or replacing a reagent during an assay If the light is green open the drawer e When replacing a reagent remove the rack containing the reagent to be replaced Slide the rack containing an Immunoassay reagent cartridge or a Biochemistry cartridge into a rail in the refrigerated compartment until the positioning pin is inserted The reagents are automatically identified by the barcode reader as the rack is inserted in the rail On the interface identified reagents are displayed in green with the corresponding lot number If the reagent barcode is not read identify the reagent manually by using the keyboard see Section 3 2 page 36 Repeat for all racks installed on the analyser then close the drawer The analyser will resume processing samples When the reagent compartment is opened assays which are under way may be cancelled if reagent aspiration was scheduled In this case the assays are automatically rescheduled To optimise analyser function do not leave the reagent compartment open any longer than necessary Do not remove reagent cartridges during the run cycle if in use It is essential for Immunoassay reagent cartridges to remain on the analyser until all the results are obtained IDS iSYS User Manual Rev C1 Use 3 8 54 Software version V4 XX Use 3 8 Assays continued 3 8 4 Releasing an alarm duri
65. erature must be lower than 30 C If necessary provide air conditioning for the site 1 6 2 Special precautions The safety precautions specific to certain handling procedures described throughout the user manual are indicated in the format described in the Preface section IDS iSYS User Manual Rev C1 Operating Principle 1 6 16 software version V4 XX SECTION 2 7 User Interface Software E Section 2 a User Interface Software 17 2 1 Structure of the Software 18 2 2 Main Screen 19 2 3 Menus 25 2 3 1 FILE menu 25 2 3 2 SESSIONS menu 26 2 3 3 DATA menu 27 2 3 4 MAINTENANCE menu 28 2 3 5 SET UP menu 29 2 3 6 MANAGEMENT OF LOTS menu 30 2 3 HELP menu 30 2 4 Function Keys 31 IDS iSYS User Manual Rev C1 User Interface Software 17 Software version V4 XX User Interface Software 2 1 Structure of the Software The software provides access to the options and information required to run the analyser Various options are available via pull down menus at the top of the screen Access to the software requires a password Multiple authorisation levels are managed by the system e Operator and Supervisor levels are for laboratory users while all other levels are reserved for IDS Service and Support personnel Access to items in the menu is dependent on user level Passwords and authorisation levels can be modified later if required The user interface application software is run on an external PC using Microsoft Windo
66. f certain types of message is also indicated with a flashing icon K7 A request for calibration QC1 QC2 or QC3 has been generated automatically These requests are generated in the following cases e No calibration in the memory for the analytes requested e Reagent lot present in the compartment is out of date For Biochemistry if certain Westgard rules have been violated a request for calibration or control is generated depending on the rule in question The calibration and or control s will be carried out after acceptance by the user by clicking YES If the user does not want to accept these actions it is possible to cancel the request by clicking NO This action will be detailed in the Records xa Daily weekly or monthly maintenance has not been carried out Messages are displayed by clicking on the WARNING button If items are missing the installation of the item automatically deletes the message Depending on the nature of the message certain tests may stop In this case the analyser will not be able to complete the entire workload To carry out the entire workload without affecting the deadline for producing the results it is important to act upon the messages as soon as possible Analyser status The temperatures of the carousel and the reagent compartment are continually monitored If during operations one of the temperatures is outside the acceptable limits the analyser will continue to carry
67. f control 3 13 1 Cumulative analysis The results calculated for the controls are stored by reagent lot with the date and time of the assay The results are automatically recorded for cumulative examination The results and the statistical calculations can be displayed for a selected period of time 60 days maximum including mean standard deviation CV and charts control results plotted around the mean value defined for the active lot The control data can be displayed by analyte or active lot By selecting from the control lot the data of the stored lots can be displayed Inthe DATA menu select the following pathway File Sessions Bees Maintenance Set up Management of Lots Window Help Calibrations FS Results storage F4 Quality Controls aoa lcci Per Analyte Records WESTGARD Per Lot Working panel b History by Product Master curves Printings Counters Analyte Product In the pop up menu select the desired analyte The software displays the controls associated with this analyte e Select the control and click on Ba Validate AMYLASE Product LISATROL 1 Lot 231 Period of time last 30 days last 60 days Other dates for display then click on The results of the control are see for the selected time peti IDS iSYS User Manual Rev C1 Use 3 13 68 Software version V4 XX Use 3 13 Quality Control Management continued 3 13 1 Cum
68. g User maintenance Factor maintenance amp Technical support d DO AT adjustment Dead volumes settings F Daily maintenance Status of analyser z Weekly maintenance Monthly maintenance Maintenances histor F The weekly maintenance procedures are presented under 3 tabs General Immunology and if appropriate Biochemistry Certain maintenance activities are carried out automatically by the system whilst others must be carried out by the operator In both cases the maintenance activities are recorded WARNING OPENING CLOSING THE LID The lid must be opened for some maintenance procedures Handle the lid carefully during opening and closing as there is a risk of it falling Always open the lid fully before any intervention In the maximum height position the lid is Stable and will remain open Take care not to knock the lid with your head Never open the lid partially risk of falling back at an inappropriate time IDS iSYS User Manual Rev C1 Maintenance 5 2 87 Software version V4 XX Maintenance 5 2 Weekly Maintenance continued 5 2 1 General Maintenance 5 2 1 1 Cleaning the reagent compartment and Plexiglas Do not use any spray products on the analyser Open the reagent compartment drawer e Clean the upper lid with absorbent paper soaked in de ionised water Clean the compartment base plate with absorbent paper soaked in de ionised water Then use a disinfectant
69. g the reaction are not strictly increasing or decreasing non monotony of the reaction CDE Biochemistry Slope of the kinetics has been calculated on a non linear section of the reaction for KINETIC type of assay The coefficient of determination is lower than the limit value defined in the analytical configuration IDB Biochemistry Selective electrodes Error on one of the bubble detectors DRIF Biochemistry Selective electrodes Deviation relating to the measurement of Calibrator A IDS iSYS User Manual Rev C Messages 4 3 78 Software version V4 XX Messages 4 3 Messages Associated with Results continued ASU CE EDE FOR OMR OMR OMR MA MES MRE LOW IDS iSYS User Manual Rev C Software version V4 XX Biochemistry An absorbance is outside the limits of reaction defined in the analytical configuration The sample will be automatically diluted If the ASU message accompanies the message RED one of the absorbances is still outside the limits of reaction defined after dilution In this case the sample must be re diluted to a level higher than that programmed in the analytical configuration then tested again All fields Error when performing a parameter calculation All fields The calibration used for calculating the result was obtained with at least one calibrator excluded All fields The calibration used for calculating the result was forced All fields It
70. ges can also be installed during the run cycle If access is authorised open the reagent compartment Slide the reagent rack into a rail in the refrigerated reagent compartment until the positioning pin is fully inserted The reagent cartridges are automatically identified by the barcode reader as the rack is inserted in the rail On the interface the reagents are identified and displayed in green with the corresponding lot number Repeat for all the racks to be installed on the analyser IDS iSYS User Manual Rev C1 Use 3 2 35 Software version V4 XX Use 3 2 Installation of Reagents continued If positive identification has failed the reagent cartridge position is displayed in orange with 222 instead of the name and lot number Should identification fail repeat the procedure for putting the reagent rack in position If the position is still not identified click on the position e Select the type of reagent rack installed E 8 8 8 amp 8 43 EEEE I E 2 E r E PELE ELE E 7 O E 2 2 ff o CEOE EOE E T E a x u amp m H a CE E E E E E E E Y 8 g 4 EE E E E E a a A C NA EO 8 Y t 2 2 PRD DD eH i a Tj seer eae Py ws The information relating to the Immunoassay reagent cartridge composition reagent lots expiry date master curve is automatically associated with the barcode reading
71. has not been possible to calculate the result because the calibration is not valid All fields The result calculated is below the lower limit of the field of measurement All fields The result calculated is above the upper limit of the field of measurement The sample will be automatically diluted If the message OMR accompanies the message RED the result is still higher than the upper limit of the field of measurement after dilution In this case the sample must be re diluted to a level higher than that programmed in the analytical configuration then tested again All fields The assay is no longer being requested by analyser All fields Error when recovering the measurements Immunoassay The calibration used for calculating the result was obtained with at least one relative light unit RLU measurement excluded All fields Result lower than the lower normal value Messages 4 3 79 Messages 4 3 Messages Associated with Results continued HIGH ORA ORA RDE RED LS PMS SUB CT RT IDS iSYS User Manual Rev C Software version V4 XX All fields Result higher than the higher normal value Immunoassay The result cannot be calculated as the measurement is lower than the scope of the measurements defined by the master curve Immunoassay The result cannot be calculated as the measurement is higher than the scope of the measurements defined by the master curve Immunoassa
72. he box Run a QC profile on wake up The fields for programming the qualification profile are displayed From the drop down list select the necessary test and programme the required number of replicates see CCS IFU and click haana Repeat the operation for each test required Click on Eo Validate Provided a valid CCS reagent cartridge is present along with sufficient levels of ancillary reagents the analyser will automatically perform the relevant priming and QC profile at the scheduled wake up time 3 4 3 Management of results reve the CCS raw data In the work list choose the individual CCS results you wish to export or select All profiles when prompted This can be done in either the Standard or Tabular views e Click the Extract Results button Choose the location where you would like to save your raw CCS data file name the file and click on Save This will save your raw CCS data in a text file txt Import the data into the EXCEL file provided on the CD Validate the analyser performance using this data as directed by IDS Service and Support Personnel Do not perform immunoassays if the analyser performance level is not satisfactory valid Refer to Section 6 of this manual Troubleshooting see Section 6 page 104 IDS iSYS User Manual Rev C1 Use 3 4 44 Software version V4 XX Use 3 5 Programming Calibrations and Controls The frequency of
73. he lid e Gently clean the probe with absorbent paper soaked in alcohol Close the lid Handle the probe with care Do not twist or bend the probe during cleaning 5 1 1 4 Decontamination of the probe e Check that IDS iSYS D Sorb solution is present on the analyser e Click on the corresponding button in front of this item in the maintenance list The probe will automatically aspirate the IDS iSYS D Sorb solution e Whenlf intenance lis completed without any error the date and time it is carried out are recorded 5 1 2 Biochemistry ISE Maintenance 5 1 2 1 Cleaning cycle for selective electrodes Install an IDS2 rack containing the daily cleaning solution in the reagent compartment position 1 rail 1 e Click on the corresponding Execute the maintenance PUNO in front of this item in the maintenance list BECUIE ME e Then click on to start the maintenance procedure The probe will aspirate the cleaning solution and inject it in Bike s l ctive electrode well The cleaning cycle lasts for approximately two minutes When maintenance is completed without any error the date and time are recorded IDS iSYS User Manual Rev C1 Maintenance 5 1 86 Software version V4 XX Maintenance 5 2 Weekly Maintenance In the MAINTENANCE menu select WEEKLY MAINTENANCE Management of Lots Window Help Maintenance Set up File Sessions data Initialization Priming SelF checkin
74. iSYS Cuvettes cube 102 5 4 10 Replacement of Standard A or Waste pumps 103 Section 6 Problems amp Corrective Action 104 6 1 Resolving Errors in Cartridge Check System CCS 105 6 2 Resolving Errors in Selective Electrodes 107 IDS iSYS User Manual Rev C1 Table of Contents ili Software version V4 XX Table of Contents Appendices 109 A 1 Waste Disposal 110 A 2 Decontaminating the Analyser 111 Cleaning Decontaminating Declaration 112 A 3 Disposal Of the Analyser 113 A 4 IDS iSYS Cuvettes 114 A4 1 List of C symbols used on the IDS iSYS Cuvettes cube 114 A4 2 Storage of the IDS iSYS Cuvettes cube 114 IDS iSYS User Manual Rev C1 Table of Contents iV Software version V4 XX Section 1 Operating Principle E Section oo Operating Principle l 1 1 Field of Use 2 1 2 General Overview 3 1 3 Characteristics 6 1 4 Installation 9 1 4 1 Environment 9 1 4 2 Electricity supply 9 1 4 3 Connections 10 1 5 Operating Principles 11 1 5 1 Absorbancy measurements 11 1 5 2 Potentiometry measurements 13 1 5 3 Luminescence measurements 15 1 6 Safety Precautions 16 1 6 1 General precautions 16 1 6 2 Special precautions 16 IDS iSYS User Manual Rev C1 Operating Principle 1 Software version V4 XX Operating Principle 1 1 Field of Use ws isys is an in vitro diagnostic analyser It enables Immunoassay Biochemistry and Coagulation assays to be carried out on a single analytical platform
75. ined in the analytical configuration NOIS Biochemistry Selective electrodes Electrical noise interfering with the measurement KIN Biochemistry The absorbances measured while monitoring the reaction are not strictly increasing or decreasing non monotony of the reaction CDE Biochemistry Slope of the kinetics has been calculated on a non linear section of the reaction for KINETIC type of assay The coefficient of determination is lower than the limit value defined in the analytical configuration IDB Biochemistry Selective electrodes Error on one of the bubble detectors DRIF Biochemistry Selective electrodes Deviation relating to the measurement of Calibrator A IDS iSYS User Manual Rev C1 Use 3 11 64 Software version V4 XX Use 3 11 Messages Associated With Results continued Message Meaning ASU Biochemistry An absorbance is outside the limits of reaction defined in the analytical configuration The sample will be automatically diluted If the ASU message accompanies the message RED one of the absorbances is still outside the limits of reaction defined after dilution In this case the sample must be re diluted to a level higher than that programmed in the analytical configuration then tested again CE All fields Error when calculating a parameter calculated EDE All fields The calibration used for calculating the result was obtained with at least one calibrator excluded FOR All
76. ion QC1 for Biochemistry QC1 to QC4 for Immunoassay is also given If the calibration is validated the message OK is displayed In the event of an invalid calibration a message is displayed at the top of the screen indicating the cause see Section 4 1 page 75 e When it is not possible to automatically validate a calibration the pole ee aan button is displayed IDS iSYS User Manual Rev C1 Use 3 10 58 Software version V4 XX Use 3 10 Results continued 3 10 1 Result of a calibration continued The following tabs display the detailed information relating to the calibration General The general tab shows whether a calibration has passed or not type of curve fit used analyte it refers to and date of calibration It also displays data for the controls including target values mean obtained values CV and status i e pass fail Graph Displays the calibration curve and each calibrator Raw data obtained Target value Value calculated using the mathematic model of the calibration e Calibrator lot Displays value of coefficient of determination r2 Allows calculation of multiple point calibrations after removing a calibrator Reaction Displays the RLU values for Immunoassay or reaction kinetics for Biochemistry for each of the calibrators or controls Traceability Displays traceability data for the modules and ancillary reagents used for each replicate of the calibrators and cont
77. ist of C symbols used on the IDS iSYS Cuvettes cube Manufacturer In vitro diagnostic medical device onal IVD Store hold the box this way up Keep dry bd Fragile pA Single use Catalogue number Lot number LOT J Expiry date Storage temperature Quantity A4 2 Storage of the IDS iSYS Cuvettes cube Always store IDS iSYS Cuvettes cube in their original packaging Never store IDS iSYS Cuvettes cube outside the original packaging Always store the IDS iSYS Cuvettes cube in the upright position as indicated by the arrows on the box e Keep IDS iSYS Cuvettes cube in a clean and dry place sheltered from dust IDS iSYS User Manual Rev C Appendices Software version V4 XX 114
78. l cm Optical pathway cm C Concentration of analyte Mol L 0m Absorbancies are measured with an optical pathway of 0 7 cm and corrected for an optical pathway of 1 cm Depending on the type of assay defined in the analytical configuration for each set up the following absorbancy measurements are used in the calculations Terminal Point Uses the last absorbancy and the first absorbancy Delta Terminal Point Calculation of the difference between the first and the last absorbances Kinetic Calculation of the slope by linear regression over the absorbancies measured Calculation of enzymatic activities using the formula Activity gt Vr Total volum x Ix e gt VE Sample volume e Optical pathway 1 cm Molar extinction coefficient of analyte in L mol cm IDS iSYS User Manual Rev C1 Operating Principle 1 5 11 software version V4 XX Operating Principle 1 5 Operating Principles Comment In the set up the factor entered is equal to e x 100 The results are calculated either in relation to a calibration or multiplied by a factor The function used for the calibration is fixed in the analytical configuration The functions available are Linear regression Linear interpolation Polynomial function degree 2 Polynomial function degree 3 Polynomial function degree 4 e Cubic Spline The calibrations and controls can be programmed on demand or automatically manag
79. lashing F icon will appear Provides access to the alarms generated by the system Alarm Module errors Lack of reagents An error message is indicated in the ALARM button which is displayed in red and contains the number of errors identified IDS iSYS User Manual Rev C1 User Interface Software 2 2 24 Software version V4 XX User Interface Software 2 2 Main Screen continued Function application buttons PIPI start run cycle Starts the run cycle Accesses calibration and quality control requests Displays the current calibration for each on board lot of reagent Calibration Control Ho Provides access to the work list and generated results Contains profiles sent by the Laboratory Information System LIS The work list contains the details of the profiles completed or in progress When the completed profile has been stored the results are displayed in the work list until the associated sample is removed The results are automatically stored provided the tests complete without any errors faults Allows manual entry of a barcode identifier for samples or reagents in the event of a iII Enter Barcode misreading by the integrated barcode readers Allows access to information regarding the ancillary reagents connected to the ETE system and the status of the solid and liquid waste The level of each element is displayed The following detailed information can be displayed by clicking on the reagent button
80. le associated Position occupied by a calibrator calibration programmed oe Position occupied by a control calibration programmed Position occupied by a calibrator no associated request Position occupied by a control no associated request IDS iSYS User Manual Rev C1 Use 3 6 Software version V4 XX 51 Use 3 7 Programming Samples If the analyser is not connected to a centralised computer system the profiles to be carried out must be programmed manually The samples are programmed either directly from their position on the sample tray or from the work list In the latter case the samples are programmed without an associated position e Click on the occupied position or click on Be a in For a sample programmed from the work list enter the identifier SID For a sample programmed on the sample tray the identifier is displayed Select the container PT primary tube cup ST Secondary tube etc Select the type of sample serum urine other Enter the full name optional field Select the analyte s required by checking the box in front of the desired analyte When an analyte is selected a black tick is displayed If an analyte has been selected by mistake uncheck the box to deselect the analyte Proceed in the same way with all analyses to be carried out e When the profile has been programmed in full click on If the patient profile is programmed during the run cycle the sam
81. lly programmed the profile in the memory is automatically associated with the position IDS iSYS User Manual Rev C1 Use 3 6 49 Software version V4 XX Use 3 6 Loading of Calibrators Controls or Samples in the Sample Tray continued 3 6 2 Installation without barcode e If the light is green open the drawer Calibrators and Controls Place the tube s or sample cup s in a free position on the tray e Click on the position which is occupied but not identified The software opens a window which allows the position to be configured Use the keyboard to enter the identifier 1 to 10 alphanumeric characters e Select from the following list e Calibrator Control e Select the name from the list The active lot number is displayed as well as the corresponding expiry date e Select the bottle number and the type of container e Click on Configure Samples Place the sample in a free position on the tray e Click on the position which is occupied but not identified The software opens a window which allows the position to be configured e Use the keyboard to enter the identifier 1 to 10 alphanumeric characters e Select type of product as Sample and click on Configure For samples whose profiles have already been programmed or sent through via a centralised computer the profile in the memory is automatically associated with the sample position e If the profile is not in the memory the profile
82. measurements within or across a run exceeds the same limit either x 1s or x 1s This rule is sensitive to systematic errors This rule is applied on the same control lot or on different control lots 4 consecutive measurements across control lots exceed the same limit either x 1s or x 1s The run is judged to be OUT OF CONTROL 10 10 consecutive control measurements fall on one side of the mean This rule is sensitive to systematic errors This rule is applied on the same control lot or on different control lots The run is judged to be OUT OF CONTROL Rules Inspection The rules defined in the set up test will be tested in the following order IDS iSYS User Manual Rev C1 Use 3 13 71 Software version V4 XX Use 3 14 Switching The Analyser Off The analyser remains in assay mode until the run cycle is stopped Assays must be stopped in order to carry out maintenance procedures Click on al Stop ruin cycle If assays are under way the analyser finishes these before stopping e Check that all the profiles are completed and that there are no unfinished profiles The latter are displayed in purple and their number is indicated on the status bar at the bottom of the screen If all the profiles are completed open the drawer and remove all samples If reagent cartridges are not intended to be stored on board remove reagent racks and store in accordance with IFU recommendations e Carry out daily maintenan
83. ments defined by the master curve RDE Immunoassay The calibration used for calculating the result was obtained with one of the replicates for calibrator excluded RED All fields The result was calculated after a dilution The value given takes into account the dilution factor LS Biochemistry The result was calculated from absorbances measured with an unstable lamp PMS Immunoassay Problem with luminometer stability SUB Biochemistry Detection of enzymatic hyperactivity The change in absorbance per minute AA min calculated between the injection of the sample and the first measurement used in the calculation exceeds the programmed limit The sample will be automatically diluted If the SUB message accompanies the message RED enzymatic hyperactivity is still detected after dilution In this case the sample must be re diluted to a level higher than that programmed in the analytical configuration then tested again CT All fields Temperature of the carousel outside limits during the assay RT All fields Storage temperature of reagents outside limits during the assay W All fields One of the Westgard rules applied for this analyte has been violated IDS iSYS User Manual Rev C1 Use 3 11 66 Software version V4 XX Use 3 12 Results Storage When a sample is completed it must be stored for the results to be archived in the IDS iSYS software built in database If automatic storage has been programmed in the SY
84. mpleted 15 12 2008 11 39 29 940 84 OK Other Completed 15 12 2008 11 35 05 513 50 OK 3 re For each result the display provides the raw RLU measurement __ Raw column and the calculated result cone column For assays performed in replicates REP column the mean of the measurements and of the results are displayed in grey the corresponding CV is displayed in the olumn Click on a to print the table IDS iSYS User Manual Rev C1 Use 3 10 63 Software version V4 XX Use 3 11 Messages Associated with Results The results generated for samples are accompanied by a message displayed in the column MSG associated with a colour code If a result does not have a message attached OK is displayed and the result is associated with a green colour code If one of the messages listed below accompanies a result an orange colour code is associated with the result displayed in STATE column The colour code is also passed on to patient level Green No message accompanies the results Orange At least one result has a message Message AIRA Biochemistry Selective electrodes Air detected during the measurement of Calibrator A AIRS Biochemistry Selective electrodes Air detected during the measurement of the sample RDS Immunoassay Problem with agitation of magnetic particles on the reagent rack BLR Biochemistry Absorbance of blank outside the limits def
85. n 70 uL Urine automatically pre diluted to 1 10 Precision Serum Na CV lt 1 5 100 160 mmol L K CV lt 2 3 0 6 0 mmol L Cl CV lt 2 80 0 120 0 mmol L Cycle time e Serum 30 seconds e Urine 60 seconds Computer system Minimum configuration required Operating system Microprocessor e Windows XP Pro Service Pack 2 e Windows Vista Service Pack 1 English e Type Sempron 3100 or equivalent Live memory 1 Gb Hard disk 80 Gb Ethernet 2 independent Ethernet network adaptors Ports USB ports min 2 one of which at front Input devices Screen Screen resolution Peripherals IDS iSYS User Manual Rev C1 Software version V4 XX Serial port for connection to centralised computer system e Keyboard country specific Mouse Monitor Speakers integrated 1024 x 768 pixels e Reader CD writer Operating Principle 1 3 8 Operating Principle 1 4 Installation 1 4 1 Environment The packaging of the IDS iSYS has been designed to prevent any damage occurring during transportation The analyser can be stored in its original packaging under the following conditions Storage temperature 10 40 C Relative humidity 70 non condensing Duration 2 months A satisfactory installation site is essential for the analyser to function correctly The user must ensure compliance with the conditions required in terms of environment and electricity supply in order to m
86. n of a replicate Immunoassay only e To exclude a calibrator click on Reaction to display calibration Then click on the corresponding red tick The calibration and the control s are calculated with the new curve equation e When points have been excluded the icon HA displayed with the calibration date e Click on EB v save the modification e For Immunoassay individual outlying calibrator or control replicates can be excluded when the CV is above the acceptable limit Click on Reaction to display the RLU measurements To exclude one of the RLU measurements click on the corresponding red tick The calibration and the control s are calculated with the new curve equation e When points have been excluded the icon s displayed with the calibration date e When the recalculated calibration is valid wi control s within acceptable limits the message OK is displayed e Click on to save the modification If the calibration is not validated the button is displayed An invalid calibration can be forced unde operator s responsibility button The control s is are calculated the assays which are already completed are c lCuiatibelcalipatitinoge on standby are resumed Any forcing of a calibratio e journal of events and all the results calculated with this calibration are identified by the message FOR If a calibration is not validated request a new calibration after having replaced failed calibrator control
87. ne working practice The preventive maintenance required L Revision C1 of the ids LSysS User Manual was produced on the 8 July 2009 for the software version V 4 03 The manual comprises the following sections and appendices Section 2 User Interface Software Section 3 Use Section 4 Messages Section 5 Maintenance Section 6 Problems And Corrective Action Appendix Waste Disposal Appendix Il Decontaminating The Analyser Appendix Ill Disposal Of The Analyser Appendix IV IDS iSYS Cuvettes If the analyser is not used in accordance with the recommendations provided in this manual the level of performance offered by the analyser may be impaired and the results generated may be incorrect IDS iSYS User Manual Rev C1 08 07 2009 Software version V4 XX Preface List of C symbols used on the analyser Manufacturer In vitro diagnostic medical device JP Pre V OQ Consult the instructions for use Caution recommended see Safety Precautions Risk of biological contamination Risk of crushing injury Serial number Electrical and electronic waste dispose of in accordance with current country specific laws High temperature Risk of LED radiation Risk of hand injury IDS iSYS User Manual Rev C1 08 07 2009 Software version V4 XX Table of Contents Section Operating Principle 1 1 Field of Use 2 1 2 General Overview 3 1 3 Characteristics 6
88. ng an assay On the interface a problem during an assay is indicated by a change in colour of the ALARM button from green to red The number of alarms is indicated in the ALARM button Some faults do not interrupt the run cycle for example lack of reagent or sample and may be resolved in the course of the run cycle Other faults will terminate assays for example lack of IDS iISYS System Liquid fault in a module etc If a module is faulty the analyser will carry out the assays which do not use this module e Click on the ALARM button The software opens the faults window and indicates the fault which has occurred In the case of a lack of ancillaries for example IDS iISYS Cuvettes or IDS iISYS System Liquid installing the new ancillary and ensuring its barcode identifier is read by the barcode reader will automatically release the fault If the fault involves one of the internal ancillary reagents or the IDS iSYS Wash solution the run cycle must be stopped before the fault can be resolved For other faults select the fault then click on EB rese If the fault cannot be resolved during the assay the software displays a message Release this message then either wait for the end of the current workload or request all assays to be stopped IDS iSYS User Manual Rev C1 Use 3 8 55 Software version V4 XX Use 3 9 Adding an Emergency STAT Sample Emergency STAT samples can be programmed for all the sample
89. nter Barcode Use the keyboard to enter the barcode identifier e Select Vial association with samples tray and click OK e Click on Configure The position is configured For the calibrators and controls supplied by IDS enter the 12 figures from the barcode the product the lot number the expiry date as well as the table of corresponding values are automatically entered IDS iSYS User Manual Rev C1 Use 3 6 48 Software version V4 XX Use 3 6 Loading of Calibrators Controls or Samples in the Sample Tray continued Samples e Scan the barcode with the reader located on the front face The analyser will beep when the barcode has been correctly read e Within 5 seconds place the sample in a free position on the rack If the barcode is recognised the analyser will beep a second time On the interface the display will indicate that the position has been identified If no second beep is heard the position is considered to be occupied but not identified In this case re start the barcode reading and installation process If the barcode label is illegible click on MNN Enter Barcode Use the keyboard to enter the barcode identifier e Select Vial association with samples tray and click OK e Select the appropriate Sample e Click on Configure The position is configured For tubes from patients whose profile has already been sent through via a centralised computer or manua
90. of each reagent recorded Working panel Displays the master curve data recorded in the system Immunoassay Displays the number of assays calibrations controls samples Master Curves performed for each test Counters IDS iSYS User Manual Rev C1 User Interface Software 2 3 27 Software version V4 XX User Interface Software 2 3 Menus continued 2 3 4 MAINTENANCE menu Maintenance Initialization Priming Self checking User maintenance Factory maintenance Technical support Status of analyser Initialization Allows selective initialisation of modules Allows selective priming of modules Self checking Allows self checking of measurement modules EEE de User maintenances Deed vokmes settings Daily maintenance 7 Da Weekly maintenance XY adjustment adjustment of the positions of the probe ee x Daily maintenance table of daily maintenance e Weekly maintenance table of weekly maintenance e Monthly maintenance table of monthly maintenance e Maintenance history allows user to display and print the maintenance carried out Reserved for IDS Service and Support Personnel Displays the analyser status see Section 2 2 page 21 Status of analyser IDS iSYS User Manual Rev C1 User Interface Software 2 3 28 Software version V4 XX User Interface Software 2 3 Menus continued 2 3 5 SET UP menu Set up Analytical configuration Personal library Suppliers and Products
91. ofile From the main screen select S Data Maintenance Set up Management of Lots Window Help Start up Shut down Work List Start Run Cycle Stop Run Cycle Run cycle Monitoring volumes monitoring Qualification controls Automatic identification of the sample tray positions Access The qualification profile menu is displayed ERENS FACTORY Pacer Sad fin Sendo atin b gp b of Lots Winds E _ EEE Meanicps 0s Standard Deviatea f se ee ee profiles 33 Moliai aam D pree M 1407 24 If results from a previous profile are present in the list of current results click on Stwecurentpotie renpotie The results are sent to storage and the list is released for a new profile From the drop down list select the necessary test and programme the required number of replicates see CCS IFU then click on Repeat the operation for each test required Start the profile by clicking on DATE Start un cycle IDS iSYS User Manual Rev C1 Use 3 4 43 Software version V4 XX Use 3 4 System Performance Checks Immunoassay only continued 3 4 2 Programming the automatic qualification profile The qualification profile can be programmed as part of the automatic start up of the analyser The automatic Start up is programmed in the set up menu under SYSTEM SETTINGS In the SYSTEM SETTINGS window select the STARTING UP tab e Click on the box Activate wake up Check t
92. onding Execute the maintenance then confirm the maintenance by clicking on YES 5 1 1 2 Checking the sample tray and Plexiglas WARNING RISK OF BIOLOGICAL CONTAMINATION These parts of the analyser are in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures Do not use any spray products on the analyser Open the sample compartment drawer e Check that no trace of liquid is present on the surface of the sample tray If traces of liquid are evident use absorbent paper to clean the surface of the sample tray Then use a disinfectant wipe solution suitable for medical devices e Close the drawer e Open the lid and check that there are no traces of liquid on the Plexiglas over the sample tray If traces of liquid are evident use absorbent paper to remove Close the lid When maintenance is complete click on the corresponding Execute the maintenance then confirm the maintenance by clicking on YES IDS iSYS User Manual Rev C1 Maintenance 5 1 85 Software version V4 XX Maintenance 5 1 Daily Maintenance continued 5 1 1 General Maintenance continued 5 1 1 3 External cleaning of the probe WARNING RISK OF BIOLOGICAL CONTAMINATION This part of the analyser is in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures e Open t
93. ons Serum plasma or urine Primary tubes 5 mL 13 x 75 mm 7 mL 13 x 100 mm 10 mL 16 x 75 mm Secondary tubes 13 x 75 mm Paediatric tubes 500 uL cups ref IS SC105 and 1 5 mL cups ref IS SC115 64 positions for samples calibrators and controls Liquid level detection by capacitance Clot detection Dilutions and automatic pre treatments Reader on front face for barcode identification of samples cuvettes and ancillary reagents Integrated reader for reagents barcode Operating Principle 1 3 6 Operating Principle 1 3 Characteristics continued Reagent compartment Sample volume uL Reagent volume uL Reaction volume uL Pipetting system Spectrophotometer Luminometer Reaction carousel Cuvette loader Common liquid consumables Waste collection Power supply IDS iSYS User Manual Rev C1 Software version V4 XX 15 rails each of which can hold 1x Immunoassay cartridge 3x45 mL Biochemistry Reagent 6 x 20 mL or 5 mL Biochemistry Reagent Storage at 12 15 C whilst operating Internal storage between 8 10 C in standby mode Immunoassay from 4 to 300 uL Biochemistry from 4 to 50 uL Programmable in steps of 0 5 uL Biochemistry from 10 to 400 pL Immunoassay from 10 to 400 uL Programmable in units of 1 uL Immunoassay and Biochemistry from 180 to 550 uL Pipetting reagents and samples by
94. ontainer Decontaminate the solid waste tray with a wipe soaked in a decontaminating solution suitable for medical devices Decontaminate the bodywork the keyboard and the keys of the computer with a wipe soaked ina decontaminating solution suitable for medical devices Do not use any spray products on the analyser IDS iSYS User Manual Rev C Appendices 111 Software version V4 XX Appendices continued Cleaning Decontaminating Declaration NAME OF ANALYSER tds isys SERIAL NUMBER LABORATORY NAME ADDRESS This analyser was cleaned and decontaminated on aiana eee declare that have carried out all stages of cleaning and disinfecting described in the user manual NAME Position optional SIGNATURE LABORATORY SEAL IDS iSYS User Manual Rev C Appendices 112 Software version V4 XX Appendices continued A 3 Disposal Of The Analyser Once the analyser is no longer in use the following precautions must be taken Clean and decontaminate Racks Rinsing wells Selective electrodes injection well Bodywork Liquid waste containers e Solid waste tray Dispose of any solid waste and liquid waste tubing in compliance with current local regulations e Since 13 08 2005 the disposal of electrical and electronic waste has been governed by Directive 2002 96 E C of 27 January 2003 In application of this regulation the corresponding responsibilities are divided up in the foll
95. out assays and the icon will be th in the ANALYSER STATUS button IDS iSYS User Manual Rev C Messages 4 4 81 Software version V4 XX Messages 4 5 Error Messages Error messages appear in the ALARM button which is displayed in red with the number of faults indicated Alarms are classified into two categories Errors in modules These errors indicate that one of the elements of the analyser is no longer operational for example the diluter transfer arm cuvette loader carousel etc The analyser will continue with the workload without using this module or if this is not possible to carry out any new assays the samples being measured will be terminated Release e For resolution select the error then click If the error cannot be resolved during the run cycle the system will display a message Release this message then either wait for the workload under way to complete or ask for the run cycle to be stopped The fault must be released again after stopping the run cycle At the time of release the element concerned is automatically initialised Errors in drawer elements These errors indicate either a lack of an item or that an item loaded on the analyser is unusable The analyser will continue with the workload without using this item or if this is not possible the samples being measured will be terminated In the event of a lack of reagents sample IDS iSYS Cuvettes or IDS iSYS System Liquid th
96. owing way for devices sold by IDS France S A a member of IDS group after this date and used in France Sending the equipment to IDS for disposal is now the CUSTOMER s responsibility Dismantling of the apparatus sorting of the parts and disposal of waste from this equipment is the responsibility of the manufacturer in accordance with current national and local laws In the event of resale to a third party the first CUSTOMER must notify the manufacturer of the name and address of the new owner of the apparatus in order to guarantee traceability of the equipment and for its subsequent disposal and must inform the new owner that it will be its responsibility to send the equipment to the manufacturer for disposal Failing this the first CUSTOMER will have to pay all the costs and all the fines the government may enforce upon the manufacturer for breach of its obligation to ensure the traceability of the disposal of its equipment in accordance with regulations With regard to systems sold before this date failing any specific stipulations disposal of the device is the client s responsibility The manufacturer will be able to arrange for this disposal consult us for a quote For devices sold and used in other countries the CUSTOMER must contact its VENDOR in order to obtain information about its responsibilities IDS iSYS User Manual Rev C Appendices 113 Software version V4 XX Appendices continued A 4 IDS iSYS Cuvettes A4 1 L
97. pens allowing values to be entered The current calibration can be displayed for a reagent lot by double clicking on the lot number or on the display area light green area IDS iSYS User Manual Rev C1 Use 3 5 47 Software version V4 XX Use 3 6 Loading of Calibrators Controls or Samples in the Sample Tray Take care when opening and closing the reagent drawer rough handling when opening and closing the drawer may cause the internal reagents to spill C Access authorised Drawer unlocked O Sampling under way Access denied Drawer locked Any position of the sample tray may be used to install samples calibrators and controls Each of these have an associated icon shown in the table below Calibrator wW i Serum Plasma Other 7 Sample Urine Control 3 6 1 Installation using a barcode If the light is green open the drawer Calibrators and controls e Scan the barcode with the reader located on the front face The analyser will beep when the barcode has been correctly read e Within 5 seconds place in a free position on the rack If the barcode Is recognised the analyser will beep a second time On the interface the display will indicate that the position has been identified If no second beep is heard the position is considered to be occupied but not identified In this case re start the barcode reading and installation process If the barcode label is illegible click on INNI E
98. ple status will immediately be displayed as loaded IDS iSYS User Manual Rev C1 Use 3 7 Software version V4 XX 52 Use 3 8 Assays Do not open the analyser lid during the run cycle as this will cause the moving parts to stop immediately for safety purposes and all assays underway will be lost If all the tems required for carrying out the programmed workload are available the analyser initialises and begins aspirating samples If any of the items required to carry out the programmed workload are missing a window is opened which lists them all Install the missing items then click on ee anean The analyser will begin aspirating samples The run cycle will start even if some items are missing The analyser will then carry out all the assays for which all required items are available The missing items can be installed at any time during the assay by following the procedures described below 3 8 1 Performing assays Assays are carried out in the following order Calibrations Controls Emergency STAT samples Samples Samples are tested in the order of the sample tray positions During a run cycle a test may be terminated by the analyser as a result of certain faults details of which can be viewed by clicking the Warning messages button Faults may include e Calibration fails to comply with the criteria for automatic validation The result of the control violates one of
99. posable gloves for handling procedures e Switch the analyser off Remove the cover from the right hand side of the analyser Press on the two pins at each side of the pump to be changed and remove the pump body from its shaft Disconnect the pipes from the connectors and plug into the new pump Clean the shaft of the pump with absorbent paper soaked in alcohol e Put the pump back in place on its shaft Replace the cover of the analyser e Switch the analyser back on again and perform the start up procedure IDS iSYS User Manual Rev C1 Maintenance 5 4 101 Software version V4 XX Maintenance 5 4 Analyser Interventions continued 5 4 8 Replacement of IDS iSYS D Sorb pump Open the lid Remove the cover located at the rear Press on the two pins at each side of the pump to be changed and remove the pump body from its shaft Disconnect the pipes from the connectors and plug into the new pump Clean the shaft of the pump with absorbent paper soaked in alcohol e Put the pump back in place on its shaft Replace the cover and close the lid e Carry out partial priming of the arm in order to prime the circuit again 5 4 9 Removal of the on board IDS iSYS Cuvettes cube Perform this operation only at the request of IDS Technical Service amp Support personnel Use the special plate provided with the analyser IDS iSYS User Manual Rev C1 Maintenance 5 4 102 Software version V4 XX Maintenance 5 4
100. probe Liquid level detection by capacitance Preheating of reagents samples Internal and external rinsing between each pipetting of sample Spectrophotometer with interferential filters 6 wavelengths available 340 405 500 540 580 and 620 nm Halogen lamp Transmission by fibre optic Linearity Up to 3 OD Optic path of cuvettes 0 7 cm Wavelengths from 300 to 500 nm Linearity Up to 10 Million RLU Thermo regulated at 37 C 90 positions for disposable cuvettes Automatic cuvette supply by cuvette loader Loader for cube of cuvettes Contains 960 disposable cuvettes Thermostatically controlled IDS ISYS System Liquid 5 litre containers IDS iSYS Wash 10 litre containers IDS iISYS D Sorb 1 litre containers Immunoassay only IDS iSYS Triggers A amp B 250 mL each 10 litre container for liquid waste posing a biological risk Solid waste cuvettes disposed of in re usable container Voltage 220 240 V Frequency 50 60 Hertz Maximum power consumed 1000 VA Operating Principle 1 3 7 Operating Principle 1 3 Characteristics continued Selective electrodes module ISE optional Principle Measurement using specific electrodes for Sodium Potassium and Chloride levels Direct potentiometry on serum and plasma Indirect potentiometry on urine Sample Serum plasma sampled on sodium lithium heparin or lithium volume take
101. programming window opens see Section 3 7 page 52 e When all the samples have been installed close the drawer If the analyser is in the run cycle the drawer locks automatically and any new assays waiting to be carried out are added to the analyser s workload If the analyser is initialised but not in the run cycle the drawer remains unlocked and the assays will be carried out as soon as the run cycle is started When the sample drawer is opened during the run cycle new tests will be delayed The reagents will continue to be aspirated for the tests which are already running Once the drawer is closed the analyser can resume the sample workload including the new tests When using the 64 position sample tray sample cups and paediatric tubes must be placed in the tube adapters provided with the system to guarantee the quality of sampling IDS iSYS User Manual Rev C1 Use 3 6 50 Software version V4 XX Use 3 6 Loading of Calibrators Controls or Samples in the Sample Tray continued Take care when opening and closing the reagent drawer rough handling when opening and closing the drawer may cause the internal reagents to spill 3 6 3 Colour codes associated with sample positions Position free Position occupied but not identified Position of sample identified without associated profile s Position occupied by a serum or plasma sample profile associated Position occupied by a urine profi
102. r detected during the measurement on Standards A and B check the during calibration levels of Standards A and B e Carry out several start up cycles for Standard A Check the tubing circuit for Standard A Check that the pump for Standard A is working correctly e Check the reject position of the sampler in the module well Check that the electrodes are correctly installed in particular check that the toric joint of each electrode is correctly maintained 2 Presence of fibrin or salt in the tubing pathway of the electrodes carry out a Cleaning cycle Message AIRS on the 1 Air detected during the measurement on the sample or on Standard A samples check that the volume of sample installed on the analyser is sufficient e Check the level of Standard A e Carry out several priming cycles for Standard A e Check the tubing circuit for Standard A Check that the pump for Standard A is working correctly e Check the reject position of the extractor in the module well e Check that the electrodes are correctly installed in particular check that the toric joint of each electrode is correctly maintained 2 Presence of fibrin or salt in the tubing pathway of the electrodes carry out a Cleaning cycle IDS iSYS User Manual Rev C Problems amp Corrective Action 6 2 108 Software version V4 XX Appendices A 1 Waste Disposal 110 A 2 Decontaminating the Analyser 111 Cleaning Decontaminating
103. r with de ionised water e Replace the lid e When maintenance is completed click on The date and time it is carried out are recorded Ok IDS iSYS User Manual Rev C1 Maintenance 5 3 93 Software version V4 XX Maintenance 5 3 Monthly Maintenance continued 5 3 1 General Maintenance continued 5 3 1 5 Checking lamp intensity At the bottom of the main screen click on the ANALYSER STATUS button e Check the intensity values for each of the filters are between 900 and 3000 When maintenance is complete click on the corresponding Execute the maintenance button and confirm by clicking YES 5 3 2 Biochemistry ISE Maintenance 5 3 2 1 Cleaning the Standard A and Waste pump shafts WARNING OPENING CLOSING THE LID The lid must be opened for this maintenance procedure Handle the lid carefully during opening and closing as there is a risk of it falling Always open the lid fully before any intervention In the maximum height position the lid is stable and will remain open Take care not to knock the lid with your head Never open the lid partially risk of falling back at an inappropriate time e Click on the corresponding No spindle must rotate whil e Open the lid Remove the bottom partition at the rear of the rinsing well Release the Standard A pump body from its shaft by pinching the two clips at either side and gently pulling ensuring the tubes remain connected e Clean the shaf
104. rement of Calibrator A and the measurement of Calibrator B An excessive deviation or excessive background noise measurements are indicated with error messages accompanying the printout of the results IDS iSYS User Manual Rev C1 Operating Principle 1 5 14 Software version V4 XX Operating Principle 1 5 Operating Principles continued 1 5 3 Luminescence measurements By products of luminescent acridinium esters are used as detection markers DMAE dimethylethanolamine The acridinium esters emit light after reacting with hydrogen peroxide and an alkaline solution IDS iSYS Trigger A contains hydrogen peroxide in a dilute acid medium and IDS iSYS Trigger B contains a solution of dilute sodium hydroxide The analyser automatically injects trigger solutions A and B into the reaction cuvette which results in the oxidation of the ester into an excited form The return to a stable state is accompanied by the emission of light which is measured and is expressed in relative light units RLU by the luminometer integrated in the analyser Assays are carried out using either a one site or two site method One site competitive method assay The assay is based on competition between an unknown quantity of analyte in a sample with labelled analyte in the kit In a sample where no analyte is present maximum binding of the labelled analyte is possible With the increasing analyte concentrations decreasing binding of labelled analyte is observ
105. ristics Analyser System Analyser Physical Characteristics Throughput Number of tests on line Biochemistry detection Immunoassay detection Coagulation detection Selective electrodes module ISE Samples Barcode readers IDS iSYS User Manual Rev C1 Software version V4 XX e Multidiscipline Biochemistry analyser ISE as an option Immunoassay and Coagulation Continuous loading Configurations Biochemistry ISE Immunoassay 4 washers Biochemistry ISE Immunoassay 2 washers Coagulation 2 chronometric modules Biochemistry ISE Coagulation 2 or 4 chronometric modules Analyser dimensions L 105 cm x H 70 cm x W 75 cm Overall dimensions L 124 cm xH 110 cm x W 71 cm Weight 103 kg Computer System L 60 cm x H 40 cm x W 50 cm According to configuration Biochemistry ISE 360 tests hour Immunoassay Up to 120 tests hour Assay dependent Coagulation 60 tests hour 2 chronometric modules 120 tests hour 4 chronometric modules 50 Biochemistry 3 tests ISE 15 Immunoassay or10 Coagulation Spectrophotometer with interferential filters Wavelengths from 340 to 620 nm Halogen lamp optical fibre transmission Chemiluminescence e Luminometer e Optic detection of clot Bi chromatism e Determination of Sodium Potassium Chloride levels Direct potentiometry on serum Indirect potentiometry on urine automatic pre diluti
106. rols Criteria For Validating a Calibration Calculated percentage of translation is lower than the programmed limit Immunoassay Percentage of the deviation on calibrator signal RLU is within acceptable limits provided by IDS Immunoassay e CV calculated with the RLU of each calibrator is lower than the acceptable limit Immunoassay ODs of the blank and the reaction are within the programmed limits Biochemistry Slope is within the programmed limits ISE Sensitivity is higher than the programmed limit Biochemistry Coefficient of determination of the function calculated is higher than the programmed limit e Function corresponds to configured rules Percentage transfer calculated is lower than that programmed Immunoassay e Control s is are within acceptable limits IDS iSYS User Manual Rev C1 Use 3 10 59 Software version V4 XX Use 3 10 Results continued 3 10 1 Result of a calibration continued Invalid Calibration If the calibration is invalid a message is displayed at the top of the screen indicating the cause see Section 4 1 page 75 If the calibration cannot be automatically validated the Facethecatraion tton is displayed A calibration can be forced under the operator s responsibility with or without modifications of the data used for the calculation The software allows for the exclusion of a calibrator from the calculation Biochemistry only or for the exclusio
107. s Samples incomplete processing of another workload The assays programmed for this position were not completed due to a problem encountered before the end of the assays Samples the results are stored in accordance with the criteria defined for automatic filing and transferred to a centralised computer system if the connection is activated Only when the connection with a centralised computer system is activated Samples the profile is completed but the results have not been sent received by a centralised computer system IDS iSYS User Manual Rev C1 Use 3 10 57 Software version V4 XX Use 3 10 Results continued 3 10 1 Result of a calibration e Click on Calibration Control The list of tests from the personal library is displayed with the status of the last calibration performed for each reagent lot on board O Calibration validated O Calibration not validated Calibration correct with control s out of range To display the calibration curve for a test double click on the reagent lot number Calibration GLUCOSE Calibration Calibration Date Method Vv m 19 11 2008 11 07 39 Linear regression Analyte GLUCOSE Unit g l Calibration contral Status Date Value Target Deviation 19 11 2008 OK 11 10 13 1 11 1 17 16 The software displays the date and the status of the calibration and controls The value calculated for each control associated with the calibrat
108. support f Status of analyser Fo Selt Checki From the list of elements select ABS READER then click BB setcheckna The analyser carries out a measurement for each of its filters When the procedure is finished exit this menu e Click on the ANALYSER STATUS button and check the intensity values for each of the filters are between 1300 and 3000 IDS iSYS User Manual Rev C1 Maintenance 5 4 97 Software version V4 XX Maintenance 5 4 Analyser Interventions continued 5 4 2 Replacement of probe WARNING RISK OF BIOLOGICAL CONTAMINATION This part of the analyser is in contact with biological samples There is therefore a potential risk of infection Wear disposable gloves for all handling procedures e Open the lid e Unscrew the probe requiring replacement Install the new probe by screwing it in by hand as far as possible to avoid risk of leakage Take care not to twist or bend the probe always handling it by the threaded screw connector Check the probe reference position Maintenance Set up File Sessions data Management of Lots Window Help Initialization Priming 5 ie E Sel checking gz XY adjustment Factory maintenance Technical support j Daily maintenance Bg Status of analyser Fa Weekly maintenance Monthly maintenance Maintenances history Select Needle position calibration then click
109. t of the pump with a cloth soaked in alcohol e Return the pump body to its shaft Proceed in the same manner for the Waste pump e Replace cover and close the lid Execute the maintenance button in front of each item in this maintenance list his maintenance is beingicarried out k When maintenance is completed click on A The date and time it is carried out are recorded IDS iSYS User Manual Rev C1 Maintenance 5 3 94 Software version V4 XX Maintenance 5 3 Monthly Maintenance continued 5 3 3 Immunoassay Maintenance 5 3 3 1 Cleaning the IDS iISYS Wash Solution pump and level sensor shafts Remove the cover located on the right hand side of the analyser Click on the corresponding Execute the maintenance button in front of this item in this maintenance list No spindle must rotate operate while this maintenance is being carried out Follow the instructions displayed on the screen e Release the IDS iSYS Wash pump body from its shaft by pinching the two clips at either side and gently pulling ensuring the tubes remain connected e Clean the shaft of the pump with a cloth soaked in alcohol Return the pump body to its shaft e Carry out this procedure for the other pumps To clean the level sensor use absorbent paper soaked in de ionised water may ri ae mo ans a When maintenance is completed click The date and time it is carried out are recorded Replace cover on the right han
110. tests 6 If the problem persists contact IDS Service amp Support personnel CCSB CCS1 x10 Ratio 1 Replace the IDS iSYS Triggers A and B outside limits eo i 2 Check the probe XY reference position see Section 5 4 2 page 98 3 Replace the CCS cartridge 4 Repeat the CCS1 and CCSB tests 5 If the problem persists contact IDS Service amp Support personnel IDS iSYS User Manual Rev C Problems amp Corrective Action 6 1 106 Software version V4 XX Problems amp Corrective Action 6 2 Resolving Errors in Selective Electrodes Problem Possible cause amp corrective action i Calibration slopes 1 Incorrect alignment of the electrodes remove the 4 electrodes from the outside limits module and reinstall them in the following order from bottom to top Reference Chloride Potassium Sodium Na lt 45 mV dec or Na gt 63 9 _ Deterioration in calibration solutions first replace Standard B If the mV dec problem persists replace Standard A K lt 45 mV dec or K gt 63 3 Deterioration of an electrode carry out a cleaning cycle If the problem mV dec persists replace the electrode 4 Air bubble on the membrane of the reference electrode remove the CI lt 35 mV dec or CI gt 63 reference electrode Tap to dislodge the bubble then reinstall the electrode MOET 5 Deterioration of the reference electrode replace the electrode 6 Interaction between the electrodes replace the Chloride electro
111. the Westgard rules if activated One of the reagents or a diluent required for the test has been detected as missing One of the reagents or a diluent is empty When issues preventing test completion have been resolved the test will be automatically restarted IDS iSYS User Manual Rev C1 Use 3 8 53 Software version V4 XX Use 3 8 Assays continued 3 8 2 Adding samples during an assay If the analyser is not connected to a centralised computer system programme the profile s to be performed on the samples If the light is green open the drawer Scan the barcode with the reader located on the front face The analyser will beep when the barcode has been correctly read e Within 5 seconds place the sample in a free position on the rack If the sample is recognised the analyser will beep a second time On the interface the display will indicate that the position has been identified If no second beep is heard the position is considered to be occupied but not identified In this case re start the barcode reading and installation process If the barcode label is illegible click on MN Bunton Use the keyboard to enter the barcode identifier Select Vial association with samples tray and click OK Select the appropriate identifier Sample Calibrator Control e Click on Configure The position is now configured Proceed in the same way for other samples to be added Close the draw
112. the keyboard to enter the barcode iWUthifier Enter Barcode Select Vial association with samples tray and click OK Select the appropriate Sample Calibrator or Control e Click on Configure The position is configured Close the drawer again The analyser starts initiating tests again once the drawer is locked and deals with the STAT sample immediately after completion of calibrator control assays IDS iSYS User Manual Rev C1 Use 3 9 56 Software version V4 XX Use 3 10 Results As the run cycle progresses the status of the sample tray position changes when all the tests associated with this position have been completed The colour code associated with the output of results is as follows 5 Calibrators Controls Samples assays in process Calibrator all calibrations are correct Control all results are within the limits defined Samples results calculated without any message Calibrators Calibrations are completed but one of the parameters is not within the criteria set for automatic validation Controls all results are calculated but at least one of the results is outside the limits defined Samples all results are calculated but at least one of the results has an attention message Calibrators Controls Samples a lack of reagent sample or another fault prevents the requested assays being carried out in full Only when assays are stopped Calibrators Control
113. tray positions If the profiles are sent through by a centralised computer system the category of STAT is already associated with the profile The priority of any sample can be raised to STAT as long as it has not already been incorporated into the analyser workflow brown colour code Otherwise the profile must be programmed before the sample is installed on the tray Click on B wore enon click on 2 mas Enter the identifier SID Select the container PT primary tube cup ST Secondary tube Select the type of sample serum urine other e Click in front of STAT Enter the full name optional field Then select the assays to be carried out by clicking in front of the desired analyte When an assay is selected a black tick is displayed e When all the analyses to be carried out have been selected click on If the light is green open the drawer Scan the barcode with the reader located on the front face The analyser will beep when the barcode has been correctly read Within 5 seconds place the sample in a free position on the rack If the sample is recognised the analyser will beep a second time On the interface the display will indicate that the position has been identified If no second beep is heard the position is considered to be occupied but not identified In this case re start the barcode reading and installation process If the barcode label is illegible click on Use
114. uest the calibration and the controls If necessary install the required calibrators and controls on the analyser To cancel the calibration request click on This action will be detailed in the Records Then release to restart the test All the results are identified by the message W If another rule is violated the test is stopped Perform the necessary actions to correct the problem and request a calibration or a single control Each time a violation occurs a message displayed in the WARNING window allows the release of the violation whatever rule is violated To release a test click This action will be detailed in the Records All the results are identified by the message W Me IDS iSYS User Manual Rev C1 Use 3 10 61 Software version V4 XX Use 3 10 Results continued 3 10 3 Sample results Click on the position occupied by the sample The results obtained are displayed with any associated messages In the case of multiple replicates the last result is displayed on a yellow background e Double click on the result to view the results for all replicates To confirm a result an analysis can be repeated To do this check the box in front of the analyte to be repeated The results can be printed out 3 10 4 Work list results Clk o then cick Work List Search by Name Standard Tabular ID Posit Name Status a 1000655 2 Completed Q a 9 iO GLUCOSE
115. ulative analysis continued Quality control Product Lot Period of time last 30 days last 60 days Other dates Select the control The software displays the stored lots Select the lot number the time period of interest then click on EB vae Then select the test in the pop up menu Anabte GLUCISE _ _ Results Graps Traceabilty Unts gA y Excepted value f5A2 2008 11 10 1 06 DK 15 42 2008 11 10 HNR NE e period along with the calculated mean To Exclude a Value from Statistical Calculation The statistics can be calculated with values removed by clicking in the box in front of the date and time of the result The red tick indicates that this value has been removed from the calculation The chart is displayed by clicking on the tab Graphs IDS iSYS User Manual Rev C1 Use 3 13 69 Software version V4 XX Use 3 13 Quality Control Management continued 3 13 2 Westgard rules The Westgard rules are selected for each test in the QUALITY CONTROL tab of the analytical configuration with an application of 1 or 2 levels of control Inthe DATA menu select File Sessions PESA Maintenance Set up Management of Lots Window Help Calibrations FS Results storage F4 Quality Contrals LEYEY JEMMINGS Records WESTGARD working panel History by Product Master curves Printings Counters analyte x Begin 03 01 2009 End 0247 2009 Chart Graph Accepted
116. value 1 10 OK ACIDE URIQUE value 46 1 OK 10 NY 2 OQ 20 TRIGLYCERIDES value 1 81 OK E 1000878 3 Completed Q Wa 0 lt Q GLUCOSE value 2 52 OK j o E OE value 94 5 OK 19 Na Qo O EGEE eus Aa EK 0 0 O j Feo value 1 98 OK m oO oO TRIGLYCERIDES value 1 57 OK O 0 8 Q 28 Q 48 Q Q Q 1 pa EA Add Wed Store Transfer To display the measurements conducted in relation to an analysis double click on the result To repeat a test select the result and click on IDS iSYS User Manual Rev C1 Use 3 10 62 Software version V4 XX Use 3 10 Results continued 3 10 4 Work list results continued To print out the results click on Ee Selection of printing C Print the work list C Print results toed i Validate e Select Print results and click on B vise The results of the work list can be displayed in tabular mode At the top of the screen select Tabulated 2 Work List C Display only requests Search by Name Standard Tabulated F C Display only results OK Other Completed 15 12 2008 11 36 09 522 90 Other 1 Completed 15 12 2008 11 31 48 116 0 OK Other Completed 15 12 2006 11 32 10 550 33 OK Other Completed 15 12 2008 11 37 38 1199 80 OK Other Completed 15 12 2008 11 33 14 251 9 OK Other Completed 15 12 2008 11 33 58 242 8 OK 247 3 26 2 Other Completed 15 12 2006 11 33 36 657 67 OK Other Co
117. wing options from the main screen F2 Work list F3 Start the run cycle F4 Storage F5 Calibrations F6 Run cycle monitoring F8 Status of analyser F9 Stop run cycle IDS iSYS User Manual Rev C1 User Interface Software 2 4 31 Software version V4 XX SECTION 3 7 Use E Section 3 Section 3 Use 32 3 1 Start up 33 3 1 1 Initial Start up 33 3 1 2 Start up from standby mode 33 3 2 Installation of Reagents 34 3 2 1 Colour codes associated with reagent positions in the reagent compartment 38 3 3 Installation of Ancillary Reagents 39 3 3 1 Installation of internal ancillary reagents 40 3 3 2 Installation of external ancillary reagents 41 3 3 3 Installation of IDS iSYS cuvettes 42 3 4 System Performance Checks Immunoassay only 43 3 4 1 Programming the qualification profile 43 3 4 2 Programming the automatic qualification profile 44 3 4 3 Management of results 44 3 5 Programming Calibrations and Controls 45 3 6 Loading of Calibrators Controls or Samples in the Sample Tray 48 3 6 1 Installation using a barcode 48 3 6 2 Installation without barcode 50 3 6 3 Colour codes associated with sample positions 51 3 7 Programming Samples 52 3 8 Assays 53 3 8 1 Performing assays 53 3 8 2 Adding samples during an assay 54 3 8 3 Adding or replacing a reagent during an assay 54 3 8 4 Releasing an alarm during an assay 55 3 9 Adding an Emergency STAT Sample 56 3 10 Results 57 3 10 1 Result of a calibration 58
118. ws XP or Vista The PC is linked to the analyser via an Ethernet cable The analyser uses embedded software which interprets instructions from the user interface application software into actions to be performed by the analyser It also records the data obtained This data is then sent to the user interface application software for final result calculation and storage In the event of any interruption in the connection with the user interface this software configuration allows the analyser to continue to carry out its workload and store the raw data produced When the connection is restored synchronisation will occur automatically without any data loss or interruption to the analytical process IDS iSYS User Manual Rev C1 User Interface Software 2 1 18 Software version V4 XX User Interface Software 2 2 Main Screen When the application is opened and a valid access code entered the main screen is displayed Menu Bar Standard B Position ISE Information buttons CX File Sessions Datas Maintenance Set up Management of Lots Window E od mam 19 o O 0 a 3 8 B alyser initialized 9 Q 90 0 9 209 9O 290 59 ae Q 2 Q Q 290 1 2177 m m m m 2 Q sew OM Q7 O7 O Q Analyser status Warning i Alarm 79 29 ke 59 E 9 9 9 O di M 0 eco 90 7 30 0 790 wa lt one an O 20 0 9 ain aa S 78 8 0 20 29 Q g 39 29 59 ae E amo
119. y The calibration used for calculating the result was obtained with one of the replicates for calibrator excluded All fields The result was calculated after a dilution The value given takes into account the dilution factor Biochemistry The result was calculated from absorbances measured with an unstable lamp Immunoassay Problem with luminometer stability Biochemistry Detection of enzymatic hyperactivity The change in absorbance per minute AA min calculated between the injection of the sample and the first measurement used in the calculation exceeds the programmed limit The sample will be automatically diluted If the SUB message accompanies the message RED enzymatic hyperactivity is still detected after dilution n this case the sample must be re diluted to a level higher than that programmed in the analytical configuration then tested again All fields Temperature of the carousel outside limits during the assay All fields Storage temperature of reagents outside limits during the assay All fields One of the Westgard rules applied for this analyte has been violated Messages 4 3 80 Messages 4 4 Warning Messages Warning messages are displayed in the WARNING window either before the start or during the run cycle If messages affecting the operation of the current workload appear the button is displayed in orange with the number of messages indicated Warning bi a a The appearance o
120. y date In use stability Available volume and number of tests remaining IDS iSYS User Manual Rev C1 User Interface Software 2 2 20 Software version V4 XX User Interface Software 2 2 Main Screen continued Information Application Buttons Provides access to information regarding the analyser status including Analyser status General status of the apparatus initialised standing etc e Status of the various modules Allowed forbidden assays depending on the field Temperatures reagent compartment carousel ambient Status of reagents e Status of reagent drawer samples drawer lid Bralyser initializer The general status is indicated by a colour code Green Operational e Orange Caution one of the elements is outside the optimal operating conditions for example temperature Red Error fault Yellow Analyser not initialised standing Provides information covering the workload requested including Warning Missing reagents required to perform queued assays E o ooo Expired reagents a a e Unavailable tests Tests stopped during the cycle due to calibration failures Westgard rules violation etc Automatic requests for calibrations and controls generated by the system If messages affecting the current workload appear the button is displayed in orange with the number of warning messages indicated If automatic requests have been generated a f

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