3DHISTECH PANNORAMIC DESK FLASH DX, Instructions For Use Manual

Page 1: ...PANNORAMIC DESK FLASH DX INSTRUCTIONS FOR USE FOR INVESTIGATIONAL USE ONLY THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED ...

Page 2: ...rvices and Maintenance 11 Compliance 12 Required Training 12 Contact Information 12 3 Operational Safety 13 Safety Instructions 13 Emergency Procedure 15 Electrical Safety 15 Transportation Safety 17 Mechanical Safety 17 Fire and Combustion Safety 18 Electromagnetic Compatibility 19 Biohazard Safety 19 Cleaning Safety 19 Liquids and Safety 20 Security 20 Labels and Symbols on the Scanner 21 Labels...

Page 3: ...ng the Scanner 47 Switching the Scanner on 47 Switching the Scanner off 48 Emergency shutdown 48 Power failure 48 Loading the Scanner 48 Preparation of glass slides 48 Inserting a glass slide in the Scanner 55 Initiating the Scanning Process 56 Aborting the Scanning Process 56 Unloading the Scanner 56 Removing the Slide from the Scanner 56 Checking the Scan Results 57 Checking the Status of the Sc...

Page 4: ...h the User Interface is Unavailable 60 8 Maintenance 61 Introduction 61 Planned Maintenance 62 Routine User Checks Program 62 How to Access Logged Events 63 Cleaning 65 Preparation 65 Tools for Cleaning 65 Cleaning the Covers 65 9 Product Disposal 66 Introduction 66 Passing the Scanner on to Another User 66 Final Disposal of the Scanner 66 10 Technical Data 67 Glossary of Terms and Abbreviations 7...

Page 5: ...marks pending international and national patent applications and the other corresponding IP are the sole properties of the 3DHISTECH Ltd 3DHISTECH Ltd is not liable for damage of whatever nature including but not limited to general or specific damage indirect damage consequential damage or incidental damage including the results of the analysis of the digitized slides for example change of health ...

Page 6: ...om lost profits interruption of business loss of business information pecuniary loss or similar damage that stems from or is associated with the incorporated part of this Product that is made by a third party company THE SOFTWARE IS PROVIDED AS IS AND WITHOUT WARRANTY OF ANY KIND EXPRESSED IMPLIED OR OTHERWISE INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR...

Page 7: ...UL 61010 2 081 2019 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 081 Particular requirements for automatic and semi automatic laboratory equipment for analysis and other purposes IEC UL 61010 2 101 2018 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 2 101 Particular requirements for in vitro diagnostic ...

Page 8: ...equate repair services or by delivering a faultless product for replacement No warranty will be accepted in cases of natural wear notably wear and tear parts or improper product handling The Product Manufacturer will refuse any liability in the event of damage resulting from faulty operation negligence or unauthorized intervention into the product notably from the replacement of product parts or t...

Page 9: ...n this manual Example text in bold Words or characters that appear on the screen These include field names screen and window titles push button and menu names paths or options Keys on the keyboard For example function keys such as F11 or the Ctrl S hotkey Example text in bold and italics Cross references within this document or to other documents Warning Can cause irreversible damage or harm to th...

Page 10: ... 0 24 μm per pixel to create digital whole slide images The system is designed to be connected over a network within a hospital clinic in which the Scanner image management system and monitor can be in separate locations if desired The pathologist workstation with access to the IMS and Monitor will either be in the pathology lab or in the pathologist office Figure 1 Pannoramic Whole Slide Imaging ...

Page 11: ...ims for warranty and warranty services will be null and void in any such case Warning The Pannoramic DESK FLASH DX must be operated by a properly trained person only Operating personnel must be fully aware of the potential dangers which a particular field of application involves The Pannoramic DESK FLASH DX is a precision instrument which may suffer a significant reduction in operational functions...

Page 12: ...echnicians must have the proper training to carry out the necessary modification servicing of the device Modifications and or additions to the system must be performed in accordance with applicable laws and regulations as legally required by the relevant jurisdictions and in compliance with best engineering practices In the event of any non conforming type of use including non conforming use of as...

Page 13: ...ECH representative upon request refer to section Contact Information for details Required Training It is the responsibility of the owner individual group company of the Pannoramic DESK FLASH DX to ensure that all users of the equipment are properly trained in accordance with local laws or regulations before using the system Please contact 3DHISTECH or your local 3DHISTECH representative for more i...

Page 14: ...e the device other than specified by the manufacturer otherwise if operating the device by not observing warnings cautions and instructions the level of safety the quality of the acquired image and the performance of the Scanner will decrease Warning Maintenance and Errors If any part of the Scanner is found or likely to be defective or maladjusted it is forbidden to use the Scanner until the nece...

Page 15: ...han for which it is intended and with any device or equipment other than those 3DHISTECH recognizes as compatible If the Scanner is used for unintended purposes or it is used with incompatible device or equipment can result in death or other serious personal injury and can also lead to clinical misdiagnosis or mistreatment Warning Pannoramic DESK FLASH DX does not include any special devices for p...

Page 16: ... In case of emergency the power cord should be unplugged from the power outlet Warning The power outlet and plugs should be easily accessible at all times Electrical Safety Warning Cables fuses and covers Remove cables or fuses and or open the housing only if you are instructed to do so by the control software or it is required during a service cleaning or maintenance task performed according to t...

Page 17: ...evice in a socket with protective grounding earth contact The Pannoramic DESK FLASH DX has a built in protection which must not be rendered ineffective by extension cables without protective earth ground conductor Warning If protective devices are found to be ineffective the Pannoramic DESK FLASH DX must be shut down and precautions must be taken to prevent unintended usage For necessary repair wo...

Page 18: ...f this instrument in an environment where air humidity is below 35 especially if synthetic materials are present synthetic clothing carpets etc may cause damaging electrostatic discharges that may cause erroneous results Transportation Safety Warning The Scanner should not be moved after installation Contact 3DHISTECH Service if the Scanner must be moved to another location Mechanical Safety Warni...

Page 19: ...ctive gloves Caution Precision instrument The Pannoramic DESK FLASH DX is a precision medical device that must be operated with care and in accordance with the instructions in this IFU Avoid external shocks and vibrations and accidental influences to a maximum possible degree as such phenomena can affect and reduce performance and the expected lifespan of the Scanner Dirt or dust may adversely imp...

Page 20: ...f fire Do NOT use water other fluids or materials to extinguish electrical fire as it could lead to fatal or serious injuries or death Electromagnetic Compatibility The Pannoramic DESK FLASH DX is tested and complies with the standard IEC 61010 Biohazard Safety Warning Do not use the Scanner for slides with biohazardous materials Warning Slides that are not used any longer do not classify as domes...

Page 21: ... User name and Password on the user interface must be entered to access and enable full functionality of the control software Caution The Pannoramic DESK FLASH DX cannot be operated without user authentication during login to the control software Caution The automatic logout function of the Pannoramic Diagnostic Scanner Software prevents the device from unwanted access by logging the user out auto...

Page 22: ...H DX includes the following information Logo and name of manufacturer Scanner type Pannoramic DESK FLASH DX SN symbol Serial number PDESKYYMMDDXX AC symbol Input voltage Voltage frequency power consumption Read instructions symbol QR code REF symbol Article number PFLMBADCO00A001O001 Name and address of manufacturer Date of Production YYYY MM Made in Hungary Label identifier LBL102904 WEEE symbol ...

Page 23: ...ymbol indicates the name and address of the legal manufacturer This symbol indicates the date of manufacturing This symbol indicates these instructions must be read This symbol indicates to dispose of the device in accordance with the WEEE directive See chapter Product Disposal for more information This symbol indicates pinch point hazard area Keep fingers or skin away from such areas This symbol ...

Page 24: ...canned area in single layer Anti vibration components in the structure for maximum stability and image quality Robust construction for heavy duty use High resolution imaging Software PANNORAMIC Diagnostic Scanner Software developed for Pannoramic Diagnostic Scanners such as Pannoramic 1000 FLASH DX Pannoramic 300 FLASH DX and Pannoramic DESK FLASH DX Direct scanning to CaseManager server Multiple ...

Page 25: ...wing figure shows the main outer parts of the Scanner Figure 2 Main outer parts of the Pannoramic DESK FLASH DX and the 24V external power supply unit 1 Slide loader door 2 Dehner 24V external power supply unit 3 Power supply cable connector 4 Power supply switch System Configuration Pannoramic WSI system The main components of the Pannoramic WSI system are the following 1 Pannoramic DESK FLASH DX...

Page 26: ...ED 25 Hardware Configuration Camera Adimec QUARTZ Q 12A180 1 CMOS camera for high quality brightfield applications allowing ultra fast scanning up to 180 fps Warning The replacement or reinstallation of the camera in Pannoramic DESK FLASH DX can be carried out by 3DHISTECH service technicians only Camera adapters 1 6 adapter Objectives Plan Apochromat 20 NA 0 8 Plan Apochromat 40 NA 1 2 ...

Page 27: ...145 CPU 128 GB RAM Monitor LG 32 Fujitsu 27 Dehner 24V external power supply unit Cables o Control USB cable between Scanner and control computer o Preview camera USB cable between Scanner and control computer o Adimec CoaXPress cables between Adimec camera and control computer o Video cable between monitor and control computer o Power supply cable between 230V 110V outlet and monitor o Power supp...

Page 28: ...the Control PANNORAMIC Diagnostic Scanner Software Make sure that the Scanner is switched on Click on the desktop to run the PANNORAMIC Diagnostic Scanner Software Once the control software of the Scanner is launched the splash screen is visible on the monitor during initialization Figure 3 Splash screen After initialization the main screen of the user interface appears Figure 4 Main screen ...

Page 29: ...rm exit from the control software by clicking Yes in the confirmation window or No to cancel exit Logging in The users of PANNORAMIC DESK FLASH DX must give their user credentials prior to performing any operation through the GUI Graphic User Interface of the PANNORAMIC Diagnostic Scanner Software Registered users can access the control software only by entering either their user name and password...

Page 30: ...the following view panels Figure 6 GUI of PANNORAMIC Diagnostic Scanner Software 1 Slide view see section Slide view 2 Scanning history see section Event History At the rest of the menu bar there are additional function buttons available 3 Scanning properties see section Settings 4 Stop start scanning process 5 Log out 6 Program settings see section Settings 7 Help The name of the user currently l...

Page 31: ...ed at that moment scanning aborting etc Note that a green scanner bar appears above the preview of the currently processed slide either it is being scanned or if preview image is taken of it or it is involved in a conversion process Slide toolbar Figure 8 Slide toolbar 1 Settings card selector Assign a predefined parameter set for the selected magazine The setting of parameters of a profile can be...

Page 32: ...ation bar has the following structure and contains the following information Figure 9 Slide information bar Scan status indicator Indicates the actual status of the slide The following table lists the possible indicator statuses Indicator Description The slide is not yet processed Indicates that the slide has successfully been loaded and further processes are being performed Conversion to DICOM fo...

Page 33: ... fully scanned Thumbnail image of the slide if the slide has been fully scanned The label area displays nothing until the barcode image is taken The label area displays the barcode image once it was recorded If the slide has already been scanned the preview always displays the thumbnail image of the slide instead of the preview image If scanning is in progress the progress bar displays the process...

Page 34: ...nel lists scanning events occurred during the last session but any specific date on which scanning was performed can be selected with a calendar tool see Filter for interval function The following slide scanning events Event statuses are logged Finished scanning has finished successfully Process was cancelled The slide was not unloaded Multiple errors and warnings See details Figure 10 Scanning hi...

Page 35: ...med and slide naming has taken place and also the time when scanning was started and finished Filter for interval Once clicked the icon a date panel is opened where a range can be set and all the scanning processes performed within this interval will be automatically listed Set a starting and an end date to defined the date interval Figure 11 Filter for interval Filter for user Click to list all t...

Page 36: ...ning properties Click to open the Slide Save Settings panel on which the destination of scanning barcode parsing and conversion settings can be performed both for scanning to a local folder or to a designated server You can create up to 5 different profiles marked with different colors that are selectable on the left side of the panel Figure 13 Scanning properties Scan to Local ...

Page 37: ...ted The following must be defined to establish a server connection o Server Select a server from the list or select Add new item at the bottom of the list to create a new connection o User name Type your user name registered for your account on the server o Password Enter your password registered for your account on the server Click Connect to establish connection to server and Disconnect to inter...

Page 38: ...icon of the connection you want to delete o Click Yes in the pop up window Slide naming Slide name can be defined manually or automatically o Barcode parsing Select the type of barcode profile from the drop down list for slide naming though parsing the barcode string By using Default barcode profile the barcode of the slide is being matched with all the barcode types Click at the left of a list it...

Page 39: ...select barcode type from the Type drop down list Define modify ranges within the barcode string when Range is selected at Parsing mode to extract necessary information Slide name Profile Case Block Root folder for example slide name is extracted from sting based on the range of 1 to 4 profile from 2 to 4 etc NOTE This setting is effective only if barcode parsing is enabled and when server side bar...

Page 40: ...tomatically selected as scanning destination based on the CaseID containing slide and patient data stored on HIS LIS Therefore Folder Case Block and Slide name field data cannot be modified only a profile can be selected Select All Types from the drop down list to analyze all barcode types when parsing o Generate Activate this option to create slide name automatically based on the criteria defined...

Page 41: ...n type for example Scanning to server No conversion Scanning to local storage Conversion to DICOM format Program settings Click at the main toolbar to open the Settings panel that consists of the following three tabs User management Scanner settings General settings User management Figure 15 User management This tab is available for Administrators only who have administrator authorization rights t...

Page 42: ... tasks change magazine priority and initiate shutdown Administrator user in addition to the access rights of service user is allowed to export software log into file perform user management tasks and change login type Notice The user privileges are listed in the Engagements of users per level panel at the right side of the window Each user has granted one user engagement level only Login type Set ...

Page 43: ...t Settings panel User management tab Click at the top of the left panel Figure 16 Create User Enter User name set User level then set Generate Initial Password or fill in Password and Confirm password fields Upon selecting the Generate Initial Password option a random password string is generated with which the user can access the software at the first logon This initial password then must be chan...

Page 44: ...leting a user from the list How to Edit a User s Password 1 Select Settings panel User management tab 2 Select the user from the list 3 Click at the top of the user list panel 4 Click Reset password then copy and share the generated new password with the user 5 Click Close to exit the Edit User window How to Edit Rights for Users 1 Select Settings panel User management tab 2 Select the user from t...

Page 45: ... Apply to save changes How to Adjust the Automatic Logout Setting 4 Select Settings panel User management tab 5 Set Automatic logout None 5 mins 20 mins or 50 mins 6 Click Apply to save changes Scanner settings Figure 19 Scanner settings The Scanner settings panel lists various information about the Scanner and its settings The information is grouped into the following separate sections Microscope...

Page 46: ...ESTIGATIONAL USE ONLY THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED 45 General settings This tab includes one general setting only The skin of the GUI can be set from the Theme drop down list select Classic or Flat Figure 20 General settings ...

Page 47: ...nding the operating instructions and safety procedures the risk of causing harm will become so high that it can lead to serious or fatal injury to the person and to clinical misdiagnosis or mistreatment of the patient Warning Before operating the Pannoramic DESK FLASH DX the user must check that the periodic maintenance tasks have been performed For more information on these tasks refer to chapter...

Page 48: ...mes parts of certain images may be out of focus This phenomenon occurs when the tissue sample in the scanned area within the FOV is not of uniform thickness Scanner On Off Connecting the Scanner The Pannoramic DESK FLASH DX system is installed assembled and connected to the main power supply by a 3DHISTECH service technician on site Switching the Scanner on Caution Before turning the Scanner on th...

Page 49: ...fore switching the Scanner off the user must assure that digitization process is completely finished and there is no slide in the scanner Emergency shutdown In case of emergency press the 0 side down of the power on off rocker switch of the 24V external power supply unit to turn off the Scanner immediately Power failure After an emergency shutdown or power failure if no UPS is used upon restarting...

Page 50: ...p can be shifted that makes slide insertion less reliable Not completely dried embedding might also influence the operation of objectives and other device parts Caution Do NOT scratch any circular marker onto the glass surface of a slide use a soft tip pen instead for marking area of interest You can use both standard and large slides and coverslips that meet the following specifications Definitio...

Page 51: ...lity When cutting the tissue with microtome the thickness must be set between 3 5μm Use sharp blades only for cutting and cut slowly so the uniform thickness is ensured Tissue is properly stained Use clean glass slides Place the tissue on the glass slide avoiding wrinkles or folds keeping at least 3mm distance between the tissue and the slide edges The tissue is wet mounted permanent on the glass ...

Page 52: ...eck slide quality Affixing Barcode Labels to Slides This section describes how to affix barcode labels to slides Caution Barcodes must be placed on the frosted end label area of each slide as case identifiers to enable virtual slide identification Caution Ensure that a marginal space of 1 2 mm remains on all sides between the label and the label area outer limits It is vital for barcode identifica...

Page 53: ...d firmly on the label area on the upper surface at the frosted end of the glass slide Keep the required distances between the coverslip and edges when placing the barcode label see Figure 30 Figure 25 Standard and large format slides with barcode labels The label area 1 is recorded by the preview camera and can be displayed by the control and viewer software To affix barcode labels to slides do th...

Page 54: ...bar Patch Code Pharmacode EAN 13 EAN 8 UPC A UPC E 2D barcode types Aztec Data Matrix PDF417 Compact Micro PDF417 QR Micro QR MaxiCode Labeling Recommendations and Restrictions It is highly important to affix labels to glass slides appropriately The user must always make sure that the barcode label is readable and identifiable by the Scanner thus preventing erroneous or incorrect identification or...

Page 55: ...estrictions on how and how not to perform affixing barcode labels to glass slides Code orientation Not superimposed Not oversized Not folded No markings No scratches Use only one label Use barcode labels Figure 26 Examples of incorrect barcode labels Figure 27 Example of a correct barcode label Notice Case ID is stored in the barcode and is identified by the PANNORAMIC Diagnostic Scanner Software ...

Page 56: ...g it firmly with your thumb and index finger at the label area coverslip and the label area should be on the top Warning ALWAYS be cautious when handling removing or loading a slide and avoid contact with areas marked with and at the slide insertion area of the Scanner Always make sure that the slide is correctly inserted on the specimen holder Incorrect slide insertion may break the glass The edg...

Page 57: ...being performed after initiating the scanning process Aborting the Scanning Process Click at the function bar of the PANNORAMIC Diagnostic Scanner Software to stop the scanning process Note that the actual slide is being scanned but the rest of the slides in the queue will not be The scanning process can be continued by clicking again Unloading the Scanner Removing the Slide from the Scanner 1 Cli...

Page 58: ...can be differences between the digital image of the slide and the macro image Follow these steps to view the digitized image of the slide 1 Select the slide in Slide View first then double click the thumbnail image at the left of the slide information bar to open the digital slide in the Viewer program 2 Make sure that the digital slide includes all the tissue area selected for scanning Checking t...

Page 59: ... technician please contact us at support 3dhistech com or 36 1 467 5600 Event Logging Notice Due to cybersecurity reasons the logged events are accessible only through the Central Log Service tool Notice Each software operation or task performed by the Scanner is logged in a database This database can be accessed through the Central Log Service web application and logged events can be retrieved on...

Page 60: ...Only one barcode is visible on the label area o Solution The glass slide must be identified with one single barcode only o There is no dirt smear bleaching or staining on the label area o Solution Clean the label surface or print a new one o Label orientation or location is not correct See chapter Preparation of Glass Slides for more information on how labels can be affixed on slides o Solution Re...

Page 61: ...r shuts down due to power failure and can be turned on again and the built in auto recovery feature of the software resumes the last session and the process will resume where it left off If a Warning or Error Message Appears on the User Interface Solution Perform action s accordingly follow steps described in the message box If Interaction with the User Interface is Unavailable Possible cause Unkn...

Page 62: ...ning for more details The user must visually inspect certain units of the Scanner Warning It is legally required that the Pannoramic DESK FLASH DX is serviced in specified intervals and servicing must be carried out by 3DHISTECH service technicians or contracted personnel only The PANNORAMIC Diagnostic Scanner Software does NOT instruct you to perform a cleaning task or maintenance procedure or to...

Page 63: ...nd holding a license therefore are authorized to perform any maintenance and repair tasks on the Scanner Routine User Checks Program Warning Under the contract with the manufacturer distributor the owner of the equipment is obliged to provide users with adequate training and to make sure that the equipment is used properly It is the owner s responsibility to ensure that routine user checks and mai...

Page 64: ...cessing a list of logged events can be necessary when contacting the Service to include an operational background data when giving specific details of a defective operational symptom or incident Notice The database of logged events is NOT accessible for General users You can log into Central Log Service only if you are a Local IT user or Maintenance user 1 Launch Central Log Service web applicatio...

Page 65: ...d in the database Client types can be selected from the drop down list at the top right corner of the Clients panel Select the client of which you want to list the event log data then the list is automatically displayed Click to modify start and end date of event logging in the Interval section Also the Scanner device of the same type for which the events are logged is selectable from the Microsco...

Page 66: ...ning the Scanner as it can cause short circuits and other electrical problems You can only use a cloth pre moistened with tap water for cleaning the outer surface of the Scanner To clean greasy surfaces it is recommended to apply Isopropanol on a piece of lint free cotton cloth and gently rub the surface The use of any other types of substance for example abrasive polishes cleaning agents solvents...

Page 67: ...n rubber plastic that cannot be recycled Before disposing of this device please refer to local environmental guidelines on the proper method of disposing electronic medical devices Passing the Scanner on to Another User If the owner of the Scanner wants to pass or donate the Scanner on to another user and if the purchase contract includes a clause describing the owner s liabilities they must act a...

Page 68: ...ns Environmental Conditions Transportation Shipment packed Permissible ambient temperature 40 F to 158 F 40 C to 70 C Storage Permissible ambient temperature 32 F to 140 F 0 C to 60 C Permissible relative air humidity non condensing 25 75 Operation Permissible ambient temperature 50 F to 95 F 10 C to 35 C Permissible relative air humidity 75 Altitude at installation site max 6561ft 2000m Atmospher...

Page 69: ...n AI based Glass Slides Definition Slide Coverslip Length 75 0 to 76 0 mm max 50 mm Width standard slide 25 0 to 26 0 mm max 24 mm recommended 22 mm Width large slide 51 0 to 52 0 mm max 50 mm Thickness 0 90 to 1 2 mm No 1 and No 1 5 0 13 to 0 16 mm and 0 16 to 0 19 mm Corners 45 beveled corners N A Edges Ground or cut N A Table 7 Glass slide specifications Digital Slide Images Definition Specific...

Page 70: ...ountries the connector must be approved by the relevant local safety regulations for this application Electromagnetic Compatibility The Scanner is intended for use in the electromagnetic environment specified below The owner of the Scanner must assure that it is used in such environment RF emissions Group1 The Scanner RF emissions are very low and are not likely to cause any interference in nearby...

Page 71: ...CTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED Video cable between monitor and control computer Power supply cable between 230V 110V outlet and monitor Power supply cable between 230V 110V outlet and control computer Power supply cable between the outlet of the 24V external power supply unit and the Scanner ...

Page 72: ...e A digital image of a thin glass plate on which specimens are mounted for microscopic study a dynamic interactive image that you can manage save magnify zoom name evaluate annotate mark and comment send to a colleague electronically for co operation or advice and so on Thumbnail A static preview image on the GUI of a Pannoramic Slide or a magazine loaded into the Scanner FOV Field of View NA Nume...