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BioCare Medical intelliPATH FLX, Manual

The BioCare Medical intelliPATH FLX user manual is available for free download on our website. This comprehensive and detailed manual provides step-by-step instructions on operating and maintaining the intelliPATH FLX, ensuring optimal performance and accuracy. Access the manual directly from manualshive.com to enhance your experience with this advanced medical product.

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Introduction

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Intended Use .............................................................................................................................................................. 1
About the 

intelliPATH

 ................................................................................................................................................... 1

Instrument Specifications ............................................................................................................................................. 1
Instrument Components ............................................................................................................................................... 2
Storage and Handling .................................................................................................................................................. 5
Waste Disposal ............................................................................................................................................................ 5
Instrument Disposal ..................................................................................................................................................... 5
Installation Site Requirements ...................................................................................................................................... 5
Environmental Conditions ............................................................................................................................................. 6
Support  ..................................................................................................................................................................... 6

Safety Precations

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Reagents and Chemicals .............................................................................................................................................. 7
Instrument .................................................................................................................................................................. 7
Warning Symbols ......................................................................................................................................................... 8

Software Features & Functions

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User access ................................................................................................................................................................ 9
Login .......................................................................................................................................................................... 9
Module Selection ......................................................................................................................................................... 9
Module Descriptions .................................................................................................................................................. 10

Stainer Application Module ............................................................................................................................... 10
User Manager Module ....................................................................................................................................... 14
Reagent Manager Module .................................................................................................................................. 15
Reagent Groups ................................................................................................................................................ 16
Protocol Manager Module .................................................................................................................................. 20
System Setup Module ....................................................................................................................................... 21
System Parameters ........................................................................................................................................... 22
Generate Reports Module .................................................................................................................................. 23
System Cleanup Module .................................................................................................................................... 24
Reagent Inventory Manager Module .................................................................................................................... 25

Administrative Program Preparation & Setup ........................................................................................................................... 26

Assign or modify users ............................................................................................................................................... 26
Modify passwords ...................................................................................................................................................... 27
Assign or modify reagents ........................................................................................................................................... 28
Assign or modify protocols .......................................................................................................................................... 32

Before Starting a Run

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Tissue Preparation  .................................................................................................................................................... 37
Instrument Preparation  ............................................................................................................................................. 37

Prepare and Start a Run

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Process Overview ....................................................................................................................................................... 38
Login to intelliPATH Software ...................................................................................................................................... 38
Select Stainer Application Module ............................................................................................................................... 39
Select an Operation Mode  ......................................................................................................................................... 39
Start Programming ..................................................................................................................................................... 40
Prepare Cases ........................................................................................................................................................... 40
Select Protocols ........................................................................................................................................................ 41
Preview & Print Labels ............................................................................................................................................... 43
Load & Map Slides .................................................................................................................................................... 44
Load & map reagents ................................................................................................................................................. 45
Pre-Start Checklist ..................................................................................................................................................... 47

System Cleaning

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Troubleshooting

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Table of Contents

Summary of Contents for intelliPATH FLX

Page 1: ...www biocare net intelliPATH Manual Automated Slide Stainer ...

Page 2: ...Technical Support 800 799 9499 Option 3 Customer Service 800 799 9499 Fax 925 603 8080 Corporate Office 60 Berry Drive Pacheco CA 94553 www biocare net EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands ...

Page 3: ...anager Module 20 System Setup Module 21 System Parameters 22 Generate Reports Module 23 System Cleanup Module 24 Reagent Inventory Manager Module 25 Administrative Program Preparation Setup 26 Assign or modify users 26 Modify passwords 27 Assign or modify reagents 28 Assign or modify protocols 32 Before Starting a Run 37 Tissue Preparation 37 Instrument Preparation 37 Prepare and Start a Run 38 Pr...

Page 4: ...d spot temperature range 2 8 C 35 46 F Mixing vial capacity 18 6 ml vials Reagent dispensing range Delivers 100 μl to 600 μl Multi dispensing range 4 5 ml Buffer inlets 3 Waste separation Separated hazardous and non hazardous LIS Compatible with XML and HL 7 messaging standards Electrical requirements 900W 115V 230V 50 60 Hz Instrument Dimensions W x H x D 40 X 24 X 25 102 cm X 61 cm X 64 cm Instr...

Page 5: ...ystem Door Z Head Carboy Tubing Connections LED Indicators Slide Racks Power Switch Mixing Vials Wash Station Cold Spot Reagent Vials Z head Components 2D Matrix Scanner Wash Nozzle Air Nozzle Reagent Probe Liquid Level Sensor ...

Page 6: ...Sensors Buffer 2 Buffer 1 Deionized Water Hazardous Waste Waste Overflow Carboy Tubing Connector Carboy Connections DI Water yellow Hazardous Waste black Buffer 1 blue Buffer 2 white Waste green Fluid Level Sensor Connector Carboy Level Sensor Hub ...

Page 7: ...be The probe is washed inside and out before each new reagent is applied There is no need for disposable pipette tips Liquid Level Sensor The ultrasonic level sensor detects the reagent volume level and sends a signal to the software without contacting the reagent The system will provide visual and audible alarms if there is insufficient reagent to complete the run The run will not start if reagen...

Page 8: ...all exposed surfaces disinfected using Lysol brand industrial cleaner before it is disposed of in accordance with local State and Federal regulations Installation Site Requirements Performance checks are conducted by the manufacturer prior to shipping Biocare Medical field service personnel will unpack or supervise the unpacking of the intelliPATH Biocare field service personnel will verify the sy...

Page 9: ...st ventilation unless required by safety regulations when using certain reagents Humidity Avoid humidity extremes Low humidity can cause electrostatic problems that may affect the computer High humidity may create condensation Temperature The intelliPATH automated slide stainer must be placed in a location away from direct sunlight and extreme heat or cold Water Quality The intelliPATH requires CL...

Page 10: ...edures may recommend the use of flammable chemicals These procedures specify solutions with concentrations below the flash point of the chemicals and are to be used only when the instrument has been disconnected from the power source Instrument Use only the authorized software program that is supplied with the instrument or authorized updates Do not install any other software applications onto the...

Page 11: ...ppear on the instrument label Warning Biohazardous materials may be present Personal Protection is required CE marking Manufacturer Serial number Consult instructions for use consult operating instruction Electrical Earth Ground Main Power ON OFF ...

Page 12: ...inistrator privileges have access to all the screens available to regular users but have some additional privileges Screens used by both kinds of user are described in this chapter The software only allows one administrative account Login To log in double click on the intelliPATH icon on the desktop enter your username and password in the dialog box and press Login to continue Note Default User ID...

Page 13: ...eports Used to generate and print reports System Cleanup Enables manual and automatic cleaning of instrument parts Reagent Inventory Manager Track reagent lot numbers expiration dates and reagent volume The Reagent Manager Protocol Manager and User Manager are available to regular users to only view not to modify from the Stainer Application screen Stainer Application Module Use the Stainer Applic...

Page 14: ...eagent Inventory Manager Tools Menu The Tools menu allows the user to access the Stainer Options Print Slide Layout Report Print Reagent Layout Report Print Run Log Report Print Reports Clear Used up Reagents Turn on the Cold Spot Reset Carboys Drain Waste and Prime Buffers Prime Probe Dilution Calculator System Cleaning and Label Designer A View Menu The View menu allows access to Display Error L...

Page 15: ...ew staining run If the user selects Yes then the Prepare Case List dialog box will appear and the user will follow the sequence of steps to start a new staining run The STAT button allows the user to designate a run as STAT Slide rack E must be available to start a STAT run The software will prioritize slide rack E to process first If the user clicks the STAT button a message will appear asking fo...

Page 16: ...reagents User may load the slides or reagents in any order Mixed Mode Programming involves selecting either labeled slides or labeled reagents For the option not labeled the software will generate a layout map for the user to follow Alternatively user can select the manual map option for unlabeled reagents or slides LIS Mode Requires a software patch for uni or bi directional communication between...

Page 17: ...e discretion of the end user Password Admin users can assign temporary passwords to new Regular users or users who have forgotten passwords Regular user may change their password through the User Preferences link Full Name Enter user first and last names The Full Name may be duplicated but the User ID must remain unique Title List end user title This is a free form text field Access Level Access l...

Page 18: ... 5 Highlighting a group in the Reagent Group list will display a list of reagent group members in the upper right of the Reagent Manager screen Use Search or Sub Group field to narrow the reagent list results 6 Highlighting a reagent in the Reagent list will display information about the reagent in the Reagent Details box in the lower right side of the Reagent Manager screen Note The intelliPATH a...

Page 19: ... to the primary antibody of interest For your own references you have the option to indicate the Clone Species and Diluent associate with the antibody of interest Below the reagents table the Show Titers and Create Titers links are available One of them will be accessible depending on whether the highlighted reagent includes associated titers Antibody Titer Use the Create Titers View Titers screen...

Page 20: ... addition modification and deletion of chromogens The Chromogen reagent group includes elements not found on most groups screens At the bottom of the Reagent Details box the following information is displayed Waste Disposal Properties Specifies whether the used reagent is considered hazardous Note The designation of Hazardous or Non Hazardous is dependent upon local and national government regulat...

Page 21: ...he Add button to add to the list on the right 2 Click on the Volume field drop down menu to select the desired volume in μL of buffer 3 Add Enzyme Components to the list in the same way The minimum volume which may be selected is 100 μl 4 To delete a component from the list on the right of the screen highlight it in either list and click the Subtract button 5 Click Save then click Close to exit Co...

Page 22: ...iPATH to perform on board mixing of these reagents 1 To add a mixing component reagent click the Sub Group drop down menu on the top right of the screen and select the desired sub group category 2 Click on the Add button 3 Enter the Name Catalog number Short Name Vendor and Incubation time 4 Select Stability Stable or Unstable to designate whether the reagent needs to be refrigerated while being l...

Page 23: ... left side of the Protocol Manager screen 5 The information about the selected protocol will appear in the Protocol Properties and Details sections on the right side of the screen 5a The Protocol Properties section allows you to view the Reagent Volume per Slide and the Dispense Zone In the Dispense Zone diagram the slide is divided into top middle and bottom sections Blue color in a section indic...

Page 24: ...menu item Dispense Properties Dispense Zone Set the default dispense zone Dispense zone options are Bottom Middle Top Bottom Middle Top Bottom Top Middle Full Slide Total Volume Slide Set the default dispense volume in μl The dispense volume is divided by the number of dispense zones Set the minimum dispense volume at 100 μl for one zone 150 μl for two zones and 200 μl for three zones Default Disp...

Page 25: ...lication at the end of the run Buffer Interval Time in minutes between application of designated buffer or DI water at the end of a run Minimum of a 30 minute interval Default Vendor User to enter vendor information Buffer Slides After Completion Set option to buffer slides or to end run dry to True or False Default Delay User can choose the number of hours to delay their run Use Touch Screen Keyb...

Page 26: ...de IHC Report by Run Provides a summary of all the slides in a run with the protocol for each slide IHC Report by Case Provides a summary of all the slides in a case with the protocol for each slide Protocol Validation Provides a report for a protocol indicating all the steps performed a comment section and sign off section for the pathologist Protocol List Generates a list of all protocols Case S...

Page 27: ... in the specified order and check the boxes as you complete the tasks Mix 5 ml hydrochloric acid with 95 ml of ethanol Pour the mixture into the waste sink Wait for 30 minutes Fill 4 liters of deionized DI water into the DI Water carboy Fill 4 liters of buffer into the Buffer 1 carboy Mix 0 5 ml of DAB Away Reagent 1 0 5 ml DAB Away Reagent 2 and 4 ml of DI water in a reagent vial Place the vial i...

Page 28: ...umber The serial number is a unique identifier for each vial of a reagent Biocare reagents will be pre coded with a lot expiration date and serial number The intelliPATH software will track the Current Volume based on the reagent usage Note The serial number must be a unique identifier for each reagent The user can not add duplicate items to the Reagent Inventory The software will generate a warni...

Page 29: ...nstrument Assign or modify users Only Administrative users can assign or modify user accounts Regular Users can modify their own passwords 1 From the Module Selection menu select the User Manager Module Press Execute to proceed Assign a user account 2 To add a new user press the Add button at the bottom left side of the screen 3 Enter the appropriate user information and press Save ...

Page 30: ...dit button at the bottom left side of the screen Modify passwords Users may change their password through the User Preference link 1 From the top right side of the Module Selection menu select the User Preferences Module From the Change My Information window update the password information and click OK to proceed ...

Page 31: ...tion Cat No M3M532 Secondary MACH 3 Mouse Probe MP530 for 10 min Tertiary MACH 3 Mouse AP Polymer MAP532 for 10 min Chromogen iP Warp Red Cat No IPK5024 for 7 min CounterStain iP FLX Hematoxylin Cat No IPCS5006 for 5 min 1 From the Module Selection menu select Reagent Manager Module Press Execute to proceed 2 Go through each Reagent Group and set up the appropriate reagents and conditions 2a Pre T...

Page 32: ...e appropriate information in the Reagent Details section Press Save 2c Antibody Group Select Antibody from Reagent Group at the left side of the screen Locate Ki 67 from the reagent list by viewing the entire reagent list or using the Search box to type ki 67 To add a new antibody click the Add button Enter the appropriate information in the Reagent Details section Press Save ...

Page 33: ...dary from Reagent Group at the left side of the screen Select MACH 3 Mouse Probe AP as your secondary reagent To add MACH 3 Mouse Probe AP click the Add button Enter the appropriate information in the Reagent Details section Press Save 2f Tertiary Group Select Tertiary from Reagent Group at the left side of the screen Select MACH 3 Mouse AP Polymer as your tertiary reagent To add MACH 3 Mouse AP P...

Page 34: ...e appropriate information in the Reagent Details section Press Save 2h Counter Stain Group Select Counter Stain from Reagent Group at the left side of the screen Select iP FLX Hematoxylin as your counter stain reagent To add a new chromogen click the Add button Enter the appropriate information in the Reagent Details section Press Save 3 Select Protocol Manager Link to continue ...

Page 35: ...k Peroxidazed 1 Cat No PX968 for 5 min Antibody Ki 67 M Cat No IP375 Detection MACH 3 Mouse AP Polymer Detection Cat No M3M532 Secondary MACH 3 Mouse Probe MP530 for 10 min Tertiary MACH 3 Mouse AP Polymer MAP532 for 10 min Chromogen iP Warp Red Cat No IPK5024 for 7 min CounterStain iP FLX Hematoxylin Cat No IPCS5006 for 5 min 1 From the Module Selection menu select Protocol Manager Module Press E...

Page 36: ... of the Template Manager screen below the user can edit details such as Blow Volume Incubation time Wash type and Count by clicking on the desired area Name and Reagent fields cannot be altered at this stage Note Click on the Insert Step button to enter step in the list above the highlighted step Add Step button to enter step at the end of the list Click on the Delete Step button to remove step fr...

Page 37: ...lick Create 3 From the Antibody field drop down menu in the Details table select the Antibody of choice The Antibody and Pre Treatment fields are linked Thus selection of the primary antibody then clicking outside of the field will update the Pre Treament reagent 4 Click Save to save the protocol Note If a template is deleted all protocols associated with the template become invalid 5 Click Close ...

Page 38: ... to create groups of Protocols utilized by the laboratory rather than having to scroll through the list of All Protocols 1 Select Custom Groups in the Filter by drop down menu Select the Group Manager link 2 To add a new Group from the Manage Protocol Groups window click the Add button 3 In the New Protocol Group screen enter the Custom Name and click Create Group ...

Page 39: ...Custom Groups or All Protocols Highlight the desired Protocols to include in the Custom Group To select concurrent protocols highlight the first protocol then hold down the Shift key on your keyboard before selecting the last protocol To select multiple protocols highlight protocols while holding down the Ctrl Control key Click Select 6 To delete Protocols click Delete Protocols to add additional ...

Page 40: ...ve Process Control Include more than one antibody and its control If one is positive the process worked Instrument Preparation 1 Make sure both waste carboys are empty and properly connected to the instrument 2 Make sure Buffer and DI Water carboys are prepared and filled with appropriate water or reagent and properly connected to the instrument 3 Make sure there are no obstructions to the movemen...

Page 41: ...e logging into the intelliPATH software otherwise software will automatically open in demo mode not allowing an actual run to start Process Overview Summary of the run setup process Details of each are provided throughout this chapter Login to intelliPATH Software 1 Login to intelliPATH software Enter your username and password in the dialog box Login Prepare Cases Complete Prestart Checklist Star...

Page 42: ...manual map option for reagents and slides 2 D Matrix Mode Programming involves labeling the slides and reagents the software scans for the slides and reagents User may place the slides or reagents in any order Mixed Mode Programming involves selecting either labeled slides or labeled reagents For the option not labeled the software will generate a layout map for the user to follow Alternatively us...

Page 43: ...ks Add a New Case Import from Pending List Import from Saved Lists or Import from Recent Batches 6 To add a new case enter the patient case number in the Case Details section right side of the screen The software automatically assigns a Test ID The other fields on the right side of the Create a New Case screen are optional 7 Click on the Add Protocols Save button to proceed ...

Page 44: ...creen Click on the Add Protocols on the screen s lower left side The selected protocols will then be displayed on the right To select multiple protocols highlight protocols while holding down the Ctrl Control key To remove selected protocols from the case highlight the list on the right and then click Remove Protocols 10 For each selected protocol user has the option to select positive and negativ...

Page 45: ...42 12 In the window below you have the option to Add a New Case see button on lower left side of the screen Otherwise press Save Close to proceed ...

Page 46: ...slide labels by first pressing the Preview button followed by selecting Slide Labels at the bottom of the screen 14 Preview the slide labels on the right side of the screen To print the slide labels click on Print Labels at the bottom right side of the screen 15 Click on Close to proceed ...

Page 47: ...ffinization and retrieval 16 Click on Load Slides 16a For Open Mode or Mixed Mode 2 D Matrix Reagents select Auto Map or Manual Map Auto Map The instrument will suggest the slide positions Manual Map The user specifies the slide positions 16b For 2 D Matrix or Mixed Mode 2 D Matrix Slides select Scan Slides The Select Slide Tray dialog box will appear Select loaded trays Click Ok Next click on Sta...

Page 48: ...eck the Select All to select all reagents to print reagent labels if needed Click on Load Reagents in the bottom right side of the screen to load reagents 18a For Open Mode or Mixed Mode 2 D Matrix Slides select Auto Map or Manual Map 18b For 2 D Matrix or Mixed Mode 2 D Matrix Reagents select Scan Reagents Click on Start Scan to proceed ...

Page 49: ...46 19 Click Next 20 Verify Reagent levels by first checking the Reagent and Mixing vials are loaded as specified checkbox Click on Verify Reagents Upon reagent volume verification press Proceed ...

Page 50: ...creen for first run of the day 24 The Pre Start Checklist includes buttons to Estimate Run Time Home Arm Drain Waste Prime Probe and Print Layout Maps for slides and reagents 25 It is recommended that the user selects the Rinse Slides before the Run checkbox to ensure that the slides will be solvated to allow the reagents to adequately spread across the slide Start the Run 26 Start the run by clic...

Page 51: ...e reagents ready to load to prevent slides in process from over incubating STAT This button allows the user to designate a run as STAT Slide rack E must be available to start a STAT run The software will prioritize slide rack E to process first 1 Click on the STAT button on the top right corner of the intelliPATH Staining System window 2 A dialog box appears asking whether you want to Add STAT Sli...

Page 52: ... lines using a 10 Lysol solution Fill Buffer 1 DI and Buffer 2 carboy if used with at least 2L of a 10 Lysol solution Shake the carboys so the walls of the carboys are well washed Log in to the IntelliPATH system Execute the Stainer Application Within the tools menu click prime probe and prime the probe for 30 seconds Within the tools menu click on Drain Waste and Prime Buffers Click the Prime Buf...

Page 53: ... incubation time for the AEC or divide the AEC incubation into two protocol steps of the same total incubation time Use blow step between AEC steps Non standard background appearance Cause Buffer and deionized water in their respective carboys are not at proper capacity Resolution Fill carboys Cause Slides positioned incorrectly in slide racks Instrument and slides must be horizontal verified by l...

Page 54: ... Cause Buffer has incorrect concentration of Tween 20 Resolution Remix buffer to contain Tween 20 in prescribed concentration of 0 1 Cause De paraffinizing procedure not followed properly Resolution Review procedure and results for possible errors Cause Slide level is inaccurate Resolution Verify by level gauge If unable to level instrument contact technical support Cause Buffer nozzle is obstruct...

Page 55: ...al support Check waste level sensor by manually activating sensor and observing waste pump operation Electrical Problem Possible Causes Solutions The Power On LED green light is off indicating no power to instrument Cause Instrument is unplugged Resolution Plug cord into working outlet via the surge control unit and confirm circuit breakers between power outlet and instrument are switched on Cause...

Page 56: ... malfunctioned Resolution Call Technical Support to have valve changed Note that despite the inconvenience of mixed waste streams the instrument continues to function and remains safe to operate Waste is flowing out of overflow tube large diameter clear tube Cause Waste pump has malfunctioned or level of waste generated during the staining process reaches level of over flow tubing Resolution Call ...

Page 57: ...54 ...

Page 58: ...800 799 9499 60 Berry Drive Pacheco CA 94553 www biocare net 904 002 071817 ...

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