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BioCare Medical ONCPRO0001, Руководство по эксплуатации

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ONCORE PRO, Operating Manual, Rev. K 

 

2 

Table of Contents 

 

Section 1. Introduction .......................................................................................................................................... 7

 

Section 2. System Specifications ............................................................................................................................ 8

 

2.1. Instrument Overview ......................................................................................................................................... 8

 

2.2. Module Overview............................................................................................................................................. 11

 

2.3. Technical Specifications ................................................................................................................................... 12

 

2.4. Accessories Included with the Oncore Pro Slide Stainer ................................................................................. 13

 

2.5. Staining Area Range ......................................................................................................................................... 14

 

Slide Dimensions ................................................................................................................................................ 14

 

Tissue Thickness and Slide Placement ............................................................................................................... 14

 

Section 3. Installation Requirements and Instructions ......................................................................................... 15

 

3.1. Installation Requirements ................................................................................................................................ 15

 

3.2. Installation Instructions ................................................................................................................................... 15

 

Contacts for Assistance ...................................................................................................................................... 16

 

Section 4. Instructions for Use ............................................................................................................................. 17

 

4.1. Starting Up the Slide Stainer ............................................................................................................................ 17

 

4.2. Preparing and Printing Labels .......................................................................................................................... 19

 

Add New Labels in the Barcode Editor ............................................................................................................... 19

 

Print Labels in the Slide Label Editor .................................................................................................................. 21

 

Move Slides to Printed Slides (for use with LIS only) ......................................................................................... 22

 

4.3. Loading Slides and Installing Chambers ........................................................................................................... 22

 

Load/Unload Slides ............................................................................................................................................ 22

 

Install/Remove Chambers .................................................................................................................................. 23

 

4.4. Assigning Protocols: Scan Slides and Manually Assign Protocols .................................................................... 24

 

4.5. Loading Reagents ............................................................................................................................................. 26

 

4.6. Reagent Vialing Specifications ......................................................................................................................... 27

 

7mL Reagent Vial Specifications......................................................................................................................... 27

 

15mL Reagent Vial Specifications ...................................................................................................................... 27

 

Instructions for Use ............................................................................................................................................ 28

 

4.7. Refill Buffer and Empty Waste ......................................................................................................................... 29

 

Refill the Wash Buffer Bottle ............................................................................................................................. 29

 

Empty the Waste Containers ............................................................................................................................. 29

 

4.8. Reagent Check: Scan Reagents ........................................................................................................................ 30

 

4.9. Starting the Run ............................................................................................................................................... 33

 

Gantt Chart ......................................................................................................................................................... 35

 

4.10. Auto Start ....................................................................................................................................................... 36

 

4.11. Completing a Run ........................................................................................................................................... 36

 

Runtime Monitoring ........................................................................................................................................... 37

 

End of Run .......................................................................................................................................................... 38

 

Aborting a Run ................................................................................................................................................... 39

 

4.12. Continuous Loading ....................................................................................................................................... 40

 

Stop the Current Run ......................................................................................................................................... 40

 

Restart the Run .................................................................................................................................................. 41

 

4.13. Shutting Down the Slide Stainer .................................................................................................................... 43

 

Section 5. System Utilities.................................................................................................................................... 44

 

5.1. Tools ................................................................................................................................................................. 44

 

Prepare Slides with Baking Slides Function ........................................................................................................ 45

 

Load a Saved Slide Map File ............................................................................................................................... 45

 

Verify the Calibration of SP1-Z1 or SP1-Z2 ......................................................................................................... 45

 

Verify the Calibration of the Barcode Reader .................................................................................................... 46

 

Содержание ONCPRO0001

Страница 1: ... Suite E Dublin CA 94568 Document Number Form 751 02 03 Revision K4 2022 04 12 For In Vitro Diagnostic Use Distributed by Biocare Medical 60 Berry Drive Pacheco CA 94553 Tel 800 799 9499 www biocare net Fax 925 603 8080 ONCORE PRO Operating Manual ...

Страница 2: ...IS only 22 4 3 Loading Slides and Installing Chambers 22 Load Unload Slides 22 Install Remove Chambers 23 4 4 Assigning Protocols Scan Slides and Manually Assign Protocols 24 4 5 Loading Reagents 26 4 6 Reagent Vialing Specifications 27 7mL Reagent Vial Specifications 27 15mL Reagent Vial Specifications 27 Instructions for Use 28 4 7 Refill Buffer and Empty Waste 29 Refill the Wash Buffer Bottle 2...

Страница 3: ...in the PR Manager 56 Assigning Negative Controls 58 Adding Reagents and Protocols in the Reagent Editor 59 Preparing RFID Reagent Tags with the RFID Tag Editor 61 Creating Custom Groups 63 Creating Custom Panels 64 5 3 Security 65 Change Password 65 User Administration 65 5 4 Settings 66 Baking Slide Settings 67 2D Barcode Format 67 Save All Customizations 69 Device Version 69 Baking Slides Option...

Страница 4: ... 84 Chamber 84 Tubing and Pumps 84 7 2 Weekly Maintenance Recommendation 85 Modules and Deck Plate 85 Wash Station and Z1 Z2 Probes 85 Tubing and Pumps 85 7 3 Monthly Maintenance Recommendation 86 Chambers 86 Tubing 86 Robotic Arm 86 Computer 86 7 4 Annual Semi Annual Maintenance 86 Section 8 General Precautions 87 ...

Страница 5: ...the terms of this license HOWEVER USE OF THIS SOFTWARE INDICATES YOUR ACCEPTANCE OF THESE TERMS AND CONDITIONS In return for the payment of the applicable one time license fee included with the purchase price of the Oncore Pro Slide Stainer BioCare grants the user a license to use one copy of the Software subject to the following terms and conditions No title or ownership of the Software is confer...

Страница 6: ...ion Never tamper with the safety interlock system Use of Hazardous Reagents Some reagents used on the instrument may be considered hazardous Hazardous reagent wastes must be disposed of according to local state and federal regulations Wear appropriate Personal Protective Equipment to prevent exposure It is the responsibility of the user to comply with the local state and federal regulations Mainte...

Страница 7: ... and slide loading maps and a convenient run time display Each staining run can process 1 to 36 microscope slides Each slide can be programmed to run a different protocol Economic Use The Oncore Pro Slide Stainer maximizes efficiency by operating with small volumes of reagent and wash buffer effectively reducing supply and waste disposal costs The system provides the flexibility to optimize reagen...

Страница 8: ... from left to right 3 Y axis mechanism carries the Z head assembly and moves the arm from front to back 4 Z head Assembly consists of 2 independent Z axes Z1 and Z2 situated on the Y arm 5 Power Button turns the instrument on off 6 Door controls access to the instrument 7 Linear Solenoid locks the door 8 Safety Interlock Switch blocks unsafe access to the instrument while the robotic arm is in mot...

Страница 9: ...the reagent probes There is a purging position for the reagent waste and a percolating position for cleaning the outside of the probe each time a new reagent is used 7 Hazardous Wash Waste Station is a second probe wash station dedicated to hazardous reagents Hazardous reagents will be separately dispensed into the hazardous waste station and will be collected in the Hazardous Waste Container 8 Z1...

Страница 10: ...the position to plug in the power cord 5 Fan provides cooling to the instrument and its electrical components 6 USB Port is the position to plug in the USB cable 7 U Ring is the position to attach an anti theft chain to the computer 8 Waste Tubing Blue connects the waste station to the waste container to transfer waste gravity fed 9 Hazardous Waste Tubing Black connects the waste station to the ha...

Страница 11: ...the chamber Moves to controlled angles to facilitate incubation and reagent dispensation waste extraction 6 Chamber consumable holds reagent buffer on the slide during the incubation and washes 7 Side Rails 2 secure the slide on the left right 8 Heater maintains temperature during incubation 9 Slide Clip secures the slide at the front Not pictured 10 Glass Slide is a standard microscope slide to w...

Страница 12: ...00µL maximum Computer controller requirements BioCare reserves the right to change the computer controller specifications at any time Intel Core i5 2410M CPU 2 3GHz 4GB RAM 500GB Hard drive 4 USB 2 0 communication ports Computer Monitor Laptop or Desktop Computer Operating System Windows 7 10 Printer Zebra TLP 3844 Z Zebra GX430t or Zebra ZD620t Surge Protector 120 240 VAC 15 Amps 50 60 Hz LIS Con...

Страница 13: ...tings Stores the in line wash buffer Waste Container Set of two 4L plastic bottles with cap Stores the reagent waste generated during the run Label Printer 2D barcode printer thermal transfer Labels Size 19 05mm 0 75in x 25 4mm 1in 1000 labels roll Ribbon Media ribbon for the printer USB Cable Connects the instrument and computer Power Cord Instrument Computer Pre configured for use with instrumen...

Страница 14: ...and Slide Placement The recommended tissue thickness is 2 5 microns The circled area is the recommended tissue placement area The yellow highlighted region is the staining area range This range may be expanded to the blue highlighted regions however staining results may not be ideal in these areas Figure 5 The IHC staining area extends to the 40 mm line on the slide The ISH staining area extends t...

Страница 15: ...ckaged in a wooden crate mounted on a pallet Unlatch all fasteners and remove the lid on top of the crate first Remove the computer accessories box and label printer from the shelf inside the crate Remove the shelf and the sides of the crate Installation Requires 2 people Each person should pick up one end of the instrument and carefully lift it out of the crate Carefully move the instrument to th...

Страница 16: ...ion This feature may cause unexpected crashes during instrument operation Figure 6 For Windows 7 systems Configure Internet Time Settings within Windows Date and Time Uncheck the box Synchronize with an Internet time server For Windows 10 systems Configure Time Language settings within Windows Settings Toggle Off the Date and time options as shown Figure 7 Load the ribbon and media on the barcode ...

Страница 17: ...ows User Account Control to grant access permissions Login to the main user interface Default User ID Supervisor Password Supervisor Figure 8 Refer to Security p 65 for information on managing User IDs and Passwords Close the door of the Slide Stainer and click Enter to access the Main screen and begin system initialization The system will take a few minutes to verify all connections between the i...

Страница 18: ...s printed with a 2D barcode required to identify the slide Load Unload Slides to lift and lower lids for inserting and removing slides Auto Start to automatically start the run after loading the labeled slides and tagged reagents Scan Slides to scan the barcode labels on the slides Assign Protocols to manually assign a protocol to a slide Scan Reagents to scan the RFID tags on the reagent vials Sy...

Страница 19: ...and other required label information into the designated fields Note caret and tilde characters are not permitted in the entry fields Optional Select the Date Time of the label Optional Select the name of the Doctor from the dropdown list To add new names to the list refer to 2D Barcode Format p 67 Optional To print the Block ID field to the slide label the user must change the default label forma...

Страница 20: ...ocols by selecting a custom group from the Custom Group dropdown list Figure 13 Refer to Creating Custom Groups p 62 for more information on creating custom groups Figure 14 To remove protocols from the list of Selected Protocols select protocol s from the list and click Remove Optional To add a positive and or negative control to the Selected Protocols select the protocol and check the boxes Add ...

Страница 21: ...r may continue preparing labels for the next case Click Return to close the Barcode Editor By default the input patient information is retained in the entry fields for the next set of labels To change this setting refer to 2D Barcode Format p 67 Print Labels in the Slide Label Editor All unprinted label entries are listed under New Slides in the Slide Label Editors This list is automatically sorte...

Страница 22: ...rmats Please contact Technical Support for more information From the Main screen click Load Unload Slides to raise all module lids Peel the labels from the label roll and affix them to the frosted side of the slide Slides are loaded individually onto each module For slides that must be baked prior to staining refer to Prepare Slides with Baking Slides Function p 45 Refer to Staining Area Range p 2...

Страница 23: ...22 To install the chamber slide the chamber into the recess under the module lid and push up on the chamber until it locks into place Verify that all 4 corners of the chamber sit flat in place Tip Push up on the underside of the chamber surface to verify the integrity of the chamber gasket If the chamber gasket is loose or damaged it is time to replace the chamber To remove the chamber gently push...

Страница 24: ...ol s of labeled slides to the appropriate position on the slide map Tip Click drag on the slide map to select specific slide positions to scan Refer to Editing Protocols p 51 and Change Protocol Template p 55 for more information on generating protocols Figure 23 To manually assign protocols to unlabeled slides click drag on the slide map to select the slide position s The slide position s will be...

Страница 25: ...through the protocol list highlight the desired protocol and click Select to assign the protocol to the highlighted slides Click Clear to cancel the selection and close the window Tip The user may quickly scroll through the protocol list by typing the first few letters of the protocol name Figure 25 To clear the protocol assignment s click drag to highlight the slide position s and then click drag...

Страница 26: ...gent Consumption Priority p 69 A For on rack mixing of reagents place an empty 7mL vial in the designated position 40 and or 39 as prompted by the system B For on board mixing of reagents avoid placing the second reagent component Reagent B in the last two rows of the reagent rack as the Z2 probe will be unable to reach it Load the reagent rack onto the designated reagent plate on the instrument V...

Страница 27: ...vial option is designated for light sensitive reagents such as probes and chromogens Contact Customer Service for ordering information 7mL Reagent Vial Specifications The 7mL vial is specially designed for efficient use of antibodies and probes by minimizing dead volume Max capacity 9mL Note Although the 7mL vial can hold up to 9mL it is recommended to fill below 7 5mL to avoid triggering liquid v...

Страница 28: ... AP and HRP Select the reagent from any one of the applicable Reagent Type categories in the RFID Editor to program the RFID tag To calculate the required volume Volume number of tests x protocol volume x draw factor 1 08 dead volume of the vial Note An additional 8 extra volume is required to compensate for reagent evaporation and amount adhering to tubing probe Tip Use the Reagent Check screen t...

Страница 29: ...sh Buffer Container and remove it from the instrument 3 Refill the Wash Buffer Container 4 Reconnect the Wash Buffer Container and place it back onto the instrument 5 Prime Z1 and Z2 and visually inspect the lines to ensure that air is not present Empty the Waste Containers The standard Waste Containers have a maximum capacity of 4000mL with a secondary containment provided for each waste containe...

Страница 30: ... required reagents A network or USB printer is required Figure 31 To scan all reagents with the RFID reader close the door and click Scan Reagents The robotic arm will move the RFID reader antenna over each reagent vial position and read out the stored RFID tag information The system will continue scanning until all required reagents have been detected or all 40 positions have been scanned Tip1 Cl...

Страница 31: ... add additional vials when the reagent is insufficient or missing Up to 5 vials of the same reagent may be placed on the rack Manual assignment or a re scan of the reagent rack is required to proceed Note A warning will appear when insufficient reagent is detected Additional tests may be added either by 1 refilling the reagent vial and reprogramming the test number or 2 adding additional vials of ...

Страница 32: ...ng position on the Reagent Rack and that it has sufficient volume before proceeding For more information on reading and writing RFID tags refer to Preparing RFID Reagent Tags with the RFID Tag Editor p 59 To review a previously run Reagent Map click Load Reagent Map File and select the map file from the list of reagent map logs Each log is labeled with the date and time of the run Open the log and...

Страница 33: ...are complete the system will unlock the door and prompt the user to verify the volume of in line wash buffer and the remaining waste capacity A The robotic arm will automatically move to the center of the instrument to allow the user to add more buffer if needed B The waste containers are located under the instrument work surface and should be emptied as needed Note The calculated waste volume ref...

Страница 34: ... several protocols running multiple detection systems will result in a longer runtime To increase overall lab throughput it is recommended to run shorter runs during the day and save longer more complex runs for overnight To delay the start of the run to a later date or time click Delay Start Staining Process from the Reagent Check screen Figure 38 Enter the Date and Time that the run is expected ...

Страница 35: ...he Gantt tab Figure 40 The purple line tracks the progress of the staining run The time is measured in thousands of seconds Each bar represents a batch step for a group of slides The maximum group size is 18 1 The red bar represents a reagent addition step 2 The blue bar represents a quick wash step using wash buffer 3 The green bar represents a quick wash step using a reagent 4 The purple bar rep...

Страница 36: ...ited access is provided to prepare labels In the case of an emergency click Exit to abort the staining run All run progress will be lost Please heed the following precautions while the run is in progress Disable Wi Fi and local internet connection Do not attempt to log in out of Windows or switch users while the instrument is still in operation This will cause a fatal system error and cause the sy...

Страница 37: ...8 for more information B The system monitors the module function during the course of the staining run If a module fails its position on the slide map will be marked in red and display a Module Malfunction warning The module will be disabled and cannot be used again until the error has been cleared The user is advised to perform a module check after the run to verify the module function Refer to C...

Страница 38: ...pt the user Run Successfully Ended The slide chambers are filled with wash buffer during the last step to prevent the slides from drying out before they are unloaded from the system However if an error or warning was encountered during the run the system will instead prompt the user Run Ended with Warnings Figure 45 The user can review the slide map and report data to identify the slide s which ma...

Страница 39: ...d the system will prompt the user Run Aborted The staining run progress cannot be recovered upon system abort Contact service support to verify that the system abort is not caused by a serious issue on the instrument Figure 46 Note In an emergency case the user may manually abort the staining process Click Exit to close the main interface or power off the system to immediately stop the instrument ...

Страница 40: ...further assistance Stop the Current Run To stop the current run click Load New Slides The system will stop the progress of each slide as it reaches a safe stopping point in its staining protocol The wait times will vary for each circumstance Figure 47 After the system has stopped the progress of all slides the door will unlock and a popup message will alert the user Run Successfully Stopped The sl...

Страница 41: ... the lid Down position and those slides cannot be unloaded from the instrument Unload all Finished slides before loading any additional slides Scan the new slides to automatically assign the protocols or manually assign new protocols to the available slide positions The positions marked as Stopped are locked and cannot be assigned a new protocol Figure 49 Load any additional reagents that may be r...

Страница 42: ...ority and will run separately until they catch up with the Stopped slides The Stopped slides will resume progress when the new slides have reached the same point as the Stopped slides Figure 51 Continuous loading can be repeated on successive steps in the new run schedule however the overall runtime for the Stopped slides will increase with each load of slides ...

Страница 43: ...er down Wait a few minutes after powering down to ensure the instrument powers down completely Optional Turn off the power supply switch on the back of the instrument Shut down the computer from the Start Menu Do not set the module lids to the down position for any extended period of time Modules should rest in the extract position when idle Before shutting down the Slide Stainer for an extended p...

Страница 44: ...ng the functions found under the Tools tab 1 Baking Slides 2 Load Slide Map File 3 SP1 Z1 Calibration 4 SP1 Z2 Calibration 5 Barcode Calibration 6 Tubing Clean 7 Move Arm Aside 8 Option Tubing Clean Log 9 Option Module Chamber Tracking 10 Generate Reports 11 Initialize System 12 Check Modules 13 Prime Pump Z1 and Z2 14 Prime Pump Z1 15 Prime Pump Z2 16 Lock Door 17 Unlock Door 18 Backup Report Dat...

Страница 45: ...aches 0 00 00 Click Stop to manually stop baking Refer to Baking Slides Settings p 67 to set up slides for automatic baking before every run Load a Saved Slide Map File Click Load Slide Map File to load and view a previously run slide map on the Main screen The system automatically saves the slide map file for each set of slides run on the instrument Figure 55 Verify the Calibration of SP1 Z1 or S...

Страница 46: ...1 Bleach to remove Hematoxylin DAB precipitate in the Z1 tubing Place Z2 cleaning solution in reagent rack position 5 Recommendations Use Slide Brite to remove wax residues in the Z2 tubing Close the door and click OK to initiate the tubing clean process The Z1 and Z2 probes will both aspirate 5mL of cleaning solution into the tubing from their respective reagent rack positions The system will the...

Страница 47: ... 0 Figure 58 Click Show Tubing Clean Records to review the entire log of tubing cleans performed to date Click Remove to clear all cleaning records before the set Date Before Alternative option Click Remove All to clear all tubing records to date Figure 59 Optional Reset the Module Chamber Usage Counter If Module Chamber Tracking is enabled the system tracks the number of slides processed on each ...

Страница 48: ...e lids move up to Home Then each pump will initialize over its respective waste station Check for Module Malfunction Click Check Modules to check the function of the modules The Check Modules window will open to display 36 module checkboxes Select the modules using the check boxes then select the option to check Figure 61 Click Start to initialize the system and start the countdown timer Click Can...

Страница 49: ...Protocols may not be assigned to a slide position with a malfunctioning module until the module is replaced or repaired and a new module check is performed to clear the error Contact Customer Service to repair replace any malfunctioning heaters or modules Flush Tubing with Prime Pump Z1 and Z2 Function To flush out the tubing connect a bottle of distilled water To clear the tubing lines connect an...

Страница 50: ...al Rev K 50 Backup Report Data Click Backup Report Data to make a backup copy of the report data Refer to Section 6 Reports p 74 for more information Access the protocol reagent and RFID editors under the Editors tab Figure 64 ...

Страница 51: ...rove morphology or improve over staining by reducing the strength of antigen retrieval C DSE 50 Select this option to apply a protease enzyme incubated at 58C instead of Dewax Solution 2 To customize the TR reagent for an IHC protocol select n from the dropdown list under AR Option A TR1 This is the default option Antigen Retrieval solution 1 high pH 9 is applied B TR2 Select this option to apply ...

Страница 52: ... incubation time to 45min 1hr to increase staining intensity Click Save to apply the customizations to the selected protocol s All protocols that have been modified from the manufacturer s default protocol will be Marked as Changed Figure 66 The user may backup these protocol customizations under System Utilities Settings and click Save All Customizations Refer to p 69 Save All Customizations for ...

Страница 53: ...Backup the protocol customizations if necessary before refreshing the protocols Any recent customizations that have not been backed up using Save all Customizations will be overwritten during the refresh process Refer to Save All Customizations p 69 for more details To restore the selected protocol s using the saved customizations select the protocol s and click Refresh Protocols with Customizatio...

Страница 54: ...rotocols in the Protocol Editor Special protocols are listed under the Special tab These protocols offer the flexibility to customize any step in the staining protocol However special protocols must be generated in an external application and may be imported to the system using the Protocols and Reagents Manager Refer to p 56 Importing Protocols Contact Technical Support for assistance with specia...

Страница 55: ...itten To change to a new protocol template select the appropriate protocol type and click Select New The Select Template screen will open displaying the available protocol templates Select a new protocol template from the Protocol Templates list and click Return to close the screen Protocol templates must be generated in an external application and may be imported to the system using the Protocols...

Страница 56: ...ick Browse in the field for Import File and select an export package compressed zip folder Tip It is advised to make a backup copy of the data before making upgrades to the SW or protocols Please contact Technical Support for assistance The new protocol s template s special protocol s to be imported are listed under Import Protocols The associated reagent s to be imported are listed under Import R...

Страница 57: ... process Figure 76 After the system has imported a new protocol the system will automatically refresh all protocols Save all customizations before performing an import otherwise some recent protocol modifications may be lost Note Protocols cannot be transferred between different protocol versions The protocol import process will abort if the current protocol version number does not match the versi...

Страница 58: ...ed Protocols to clear the protocol selection s displayed on the screen To view the negative control assigned to a protocol select the protocol from the list and click Show Links to Negative The negative control linked to the protocol will be highlighted under the Negative Control list Click Clear Selected Negative to clear the negative control selection displayed on the screen Figure 78 To assign ...

Страница 59: ...ol Name in the field provided if needed To avoid conflicts with positive or negative controls in the programming software please refrain from using the symbols and at the end of the protocol name The option This reagent is ready to use is set by default This field stores the mixing parameters of the reagent The Viscosity Level is automatically set by default for all antibodies This field determine...

Страница 60: ...Protocol Editor Alternatively the user may delete the protocol directly in the Protocol Editor Note The user may not delete the manufacturer s pre installed reagents and protocols Click Return to exit the Reagent Editor To add test protocols for antibody titrations add the titers as new reagents in the Reagent Editor Manually prepare the antibody titrations in 7mL vials Refer to p 27 Reagent Viali...

Страница 61: ...ich will store all the information associated with that reagent The RFID tag may be reprogrammed for multiple uses if needed Load the removable vial holder into bottom right corner of the reagent rack and then load the rack onto the instrument Close the door and click RFID Editor to launch the RFID Tag Editor The robotic arm will position the RFID antenna over the vial holder Place a user programm...

Страница 62: ...nter the Number of Tests Left 15 ml vials should be tagged as 60 tests 7 ml vials should be tagged as 30 tests Vials must be filled properly to the line indicated Note1 The system may permit the user to reuse reprogram user programmed vials Please ensure vials are thoroughly cleaned and dried before re use Note2 The system may block access for reprogramming reagent kit vials Enter the Lot Number u...

Страница 63: ...s in the custom group will be listed under Selected Protocols To add a custom group click Add New Custom Group enter a new name and click Add Figure 83 Figure 84 To add protocol s to a custom group select the protocol s listed under Available Protocols click Add Protocol and click Save To remove protocol s from a custom group select the protocol s listed under Selected Protocols click Remove Proto...

Страница 64: ...ols To add a new panel click Add New Panel enter a new name and click Add Figure 85 Figure 86 To add protocol s to a panel select the protocol s listed under Available Protocols click Add Protocol and click Save The user is able to include a positive and or negative control with each protocol if desired To remove protocol s from a panel select the protocol s listed under Selected Protocols click R...

Страница 65: ...o change the current user login password Figure 88 User Administration Click User Administration to view the list of users Figure 89 Users at the Supervisor level will have full access to Tools and Editors and limited access to Security and Settings Users at the Technician level will have limited access to Tools Security Settings and Editors ...

Страница 66: ...ure 90 Enter the Name User ID and Password and set the Access Level Note Only users with the Supervisor access level may create additional user accounts To remove a user select the user in the grid and click Delete User View system information and adjust system settings under the Settings tab Figure 91 ...

Страница 67: ...or LIS systems only to display the unique slide ID received from the LIS system in the Slide Label Editor This allows the user to identify slides ordered by the LIS system For LIS systems only Select the option Print Barcode Using Slide UID to generate the 2D barcode label using the unique slide ID received from the LIS system instead of the system generated ID For LIS systems only Select the opti...

Страница 68: ...rom the dropdown list for each line Click Save to save changes to the label format Note Please verify that the printed data will not overlap with the 2D barcode label Click Edit Doctor Name List to add new doctors to the dropdown list in the Barcode Label Editor Figure 95 To add a new doctor enter a new name and click Add To remove an existing doctor select a name from the dropdown list and click ...

Страница 69: ...the start of every run Figure 97 Detect Waste Overflow Option Check the box Detect Waste Overflow to enable waste overflow detection of the wash stations Click Save When the system detects overflow of a waste station it will warn the user with a pop up message and an alarm If the non hazardous waste station has overflowed the system will divert waste to the hazardous waste station Run Without RFID...

Страница 70: ...l block the user from starting a new staining process until the tubing cleaning has been performed Module Tracking Option Figure 100 Check the box Enable Module Tracking to track the number of slides run on each module since the last reset Enter the Maximum Slides Run The counter for each chamber is displayed on the upper right corner of its grid on the slide map It is incremented after each stain...

Страница 71: ...o the network Figure 101 All system s connected to the current system will be listed under Network Machines To test the connection click Test Connection to check if the current system is properly connected to the selected network machine main server PC To avoid unexpected errors please ensure that all network machines are connected to the network during instrument operation If the connection is no...

Страница 72: ...of the network machine is the same as the computer name Figure 102 Alternatively if the machine is not detected click The machine that I want is not listed to manually input the name Figure 103 Click Add and input the User ID and Password when prompted Note Use the computer login ID and password Figure 104 To remove a network machine click Remove ...

Страница 73: ...tem in Windows Devices and Printers and share the printer Do not share more than one printer on the network Uncheck any other shared printers as they many cause unexpected errors Note If a printed label is not recognized make sure that all systems are connected to the network as this will ensure that the record of printed labels is up to date across all systems Note2 the label records are shared w...

Страница 74: ...reader will scan the unique 2D barcode on the label and trace the slide in the data logs Figure 107 A Click Slide Report to generate the report for the scanned slide Refer to Report Types p 82 for more information B Click Show All Runs For This Slide to generate a Run List of all runs that include the scanned slide Note The Run List may associate 2 or more runs with a given slide if its run proces...

Страница 75: ...e to i Select another slide in the same run by clicking the empty grid in the leftmost column the row will be highlighted in blue Click Slide Report to generate the report for the selected slide Refer to Report Types p 82 for more information ii Click Slide Summary Report to generate the report for summary of the slides in the run Refer to Report Types p 82 for more information iii Click Reagent U...

Страница 76: ...x Search Patient ID Sort the list by any column by clicking the column header Figure 111 From the Patient Information list the user may choose to i Select a slide by clicking the empty grid in the leftmost column the row will be highlighted in blue Click Slide Report to generate the report for the selected slide ii Select a slide by clicking the empty grid in the leftmost column the row will be hi...

Страница 77: ...es the run summary for an individual slide The report can be generated by scanning a slide using the Slide Barcode Option or by selecting a slide from a Slide List or Patient Information list Figure 112 The first line displays the date and time that the report was generated ...

Страница 78: ...gative LIS yes no Start Time and End Time Note The table will display 2 or more sets of Start End times if the run process was interrupted by the continuous loading feature The fourth table displays the Run Status logging any warnings errors that occurred during the run and the final status Finished Note The Stopped status indicates that the run process was interrupted by the continuous loading fe...

Страница 79: ...using the Lot Number The report can be generated from any Slide List Figure 113 The first line displays the date and time the report was generated The first table displays the Instrument Serial Number the Operator Name the Start Time and End Time the Run Status the Total Slides and the unique Run ID The second table displays a summary of all reagents used in the run Reagent Name Tag ID Test Contai...

Страница 80: ...e generated from any Run List Figure 114 The first line displays the date and time the report was generated The first table displays the user specified time period used to generate the list Note The report can also be generated using a Run List for an individual slide The second table displays a list of all reagents and the number of tests used for each The last line of the table displays the tota...

Страница 81: ...ONCORE PRO Operating Manual Rev K 81 Slide Summary Report The Slide Summary Report provides an overall summary of total slides in a specified run The report can be generated from any Run List ...

Страница 82: ...en processed on the system is displayed at the bottom of the list Select a Start Date and End Date to display all runs in a given time period Figure 116 From the Run List the user may choose to i Select a run by clicking the empty grid in the leftmost column the row will be highlighted in blue Click Show All Slides in Selected Run to generate a Slide List of all slides in the run ii Click Reagent ...

Страница 83: ...y Click Backup Report Data to access the backup feature Select Enter a date to Backup Report Data Before and click Backup Figure 117 To retain the selected data after performing the backup select the option Keep selected files after backup To remove the selected data after performing the backup select the option Remove selected files after backup Select a folder location where the backup will be s...

Страница 84: ...Fill two of the provided empty vials labeled DI Water with distilled water b Load a Clean 1 Clean 2 Clean 3 and two full DI Water vials onto the reagent rack A second Clean 3 may be needed for sufficient volume c Remove all reagent vial caps d Click System Utilities Tools Move Arm Aside Always move the robotic arm aside before adding or removing the reagent rack 2 Load clean blank slides onto all ...

Страница 85: ...es The waste stations and probes should be cleaned routinely to prevent salt obstructions 1 Use a lint free alcohol wipe to wipe away any reagent residues and salt deposits that have accumulated on the surface of the wash stations and probes 2 Click System Utilities Tools Move Arm Aside to gain access to the wash station and probes Take care not to bend the probes Verify the alignment of the Z1 an...

Страница 86: ...libration to verify the alignment of the Z1 and Z2 probes 2 Verify that the robotic arm is operating smoothly 3 System calibration may be performed by a trained service technician if the probe becomes severely bent Contact Customer Service for assistance Computer The C PathCom folder should be backed up routinely onto a flash drive external device Please contact Technical Support for additional as...

Страница 87: ...multitask or run CD DVD players on the computer while the instrument is in operation Multitasking is defined as running more than one software application at a time This may lock up the instrument Disable Windows Automatic Update and other background programs while the instrument is in operation Disable the Local Wireless Internet Connection The system should not be connected to the Internet Do no...

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