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3DHISTECH PANNORAMIC DESK FLASH DX Instructions For Use Manual

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PANNORAMIC® DESK FLASH DX
I
U
NSTRUCTIONS FOR
SE
FOR INVESTIGATIONAL USE ONLY. THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED.

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Summary of Contents for 3DHISTECH PANNORAMIC DESK FLASH DX

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

  • Page 2: Table Of Contents

    PANNORAMIC® DESK FLASH DX ABOUT THESE INSTRUCTION FOR USE Table of Contents Table of Contents Disclaimer Declaration of Conformity and Compliance Notes on Warranty About These Instruction for Use Introduction Intended Use Labeling Limitations Compatibility Services and Maintenance Compliance Required Training Contact Information Operational Safety Safety Instructions...
  • Page 3 PANNORAMIC® DESK FLASH DX ABOUT THESE INSTRUCTION FOR USE User Interface Starting the Control PANNORAMIC® Diagnostic Scanner Software Exiting the Control PANNORAMIC® Diagnostic Scanner Software Logging in Description Slide View Event History Settings Operation Introduction Safety Image quality Scanner On/Off Connecting the Scanner Switching the Scanner on Switching the Scanner off...
  • Page 4 PANNORAMIC® DESK FLASH DX ABOUT THESE INSTRUCTION FOR USE If Interaction with the User Interface is Unavailable Maintenance Introduction Planned Maintenance Routine User Checks Program How to Access Logged Events Cleaning Preparation Tools for Cleaning Cleaning the Covers Product Disposal Introduction Passing the Scanner on to Another User Final Disposal of the Scanner...

  • Page 5: Disclaimer

    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,...
  • Page 6 ABOUT THESE INSTRUCTION FOR USE Third-party disclaimer 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 damage resulting from 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.

  • Page 7: Declaration Of Conformity And Compliance

    Declaration of Conformity and Compliance The product complies with relevant international and national standards and laws. 3DHISTECH Ltd. declares that the product Pannoramic® DESK FLASH DX is designed and produced with consideration of specified requirements according to the ISO13485 Medical devices.

  • Page 8: Notes On Warranty

    ABOUT THESE INSTRUCTION FOR USE Notes on Warranty 3DHISTECH Ltd. – as the Product Manufacturer – warrants the Pannoramic® DESK FLASH DX to be free from faults in material and workmanship at the moment of installation. Defects must be notified immediately on identification and maximum efforts must be undertaken in order to the amount of damage as small as possible.

  • Page 9: About These Instruction For Use

    PANNORAMIC® DESK FLASH DX ABOUT THESE INSTRUCTION FOR USE About These Instruction for Use The purpose of this manual is to assist users in the safe and reliable operation of the Pannoramic® DESK FLASH DX. Before operating the Scanner, you must read this manual, and adhere to all Warning! and Caution! notices.

  • Page 10: Introduction

    3DHISTECH. Intended Use The 3DHISTECH whole slide imaging system is an automated digital slide creation, viewing, and management system. The system is intended for in vitro diagnostic use as an aid to the INFORMATION FOR USE – FOR INVESTIGATIONAL USE ONLY.

  • Page 11: Labeling Limitations

    HE (hematoxylin eosin stained) tissue, IHC labeled tissue, or frozen section. The 3DHISTECH whole slide imaging system comprises the Image Management System, the Scanner, and Monitor. The system is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.

  • Page 12: Services And Maintenance

    Services and Maintenance Modifications, parts replacements, or repairs to the Pannoramic® DESK FLASH DX must be performed only by service technicians authorized by 3DHISTECH, a contracted third- party company, or distributor. Service technicians must have the proper training to carry out the necessary modification/servicing of the device.

  • Page 13: Compliance

    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 information on training.

  • Page 14: Operational Safety

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY 3 Operational Safety Safety Instructions The below chapter of this Instructions for Use contains information and warnings of a kind that must be followed by owner/operator personnel to maintain the safe use and solid performance of the device.
  • Page 15 It is strictly prohibited to use the Scanner for any purpose other than 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.

  • Page 16: Emergency Procedure

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY Caution! The Pannoramic® DESK FLASH DX must be positioned that it is easy to access, operate, and disconnect the device if necessary. Notice: The safety level of the equipment after servicing will be identical with level of the original equipment.
  • Page 17 OPERATIONAL SAFETY Warning! Check cables, plugs and connections before operation, and if defective or cannot be replaced, contact 3DHISTECH Service for support. Warning! Check that your local line voltage is compatible with Pannoramic® DESK FLASH DX specifications before you turn power on. The device can operate at line voltages 100V to 240V and 50/60 Hz.

  • Page 18: Transportation Safety

    (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 Warning!

  • Page 19: Fire And Combustion Safety

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY Warning! Sharp edges Whenever you are handling magazines during loading and removing from the Scanner, or you are instructed to open the housing to remove a glass slide from the Scanner, always make sure that the necessary precautions are taken. Those areas and units of the Scanner where you must operate cautiously are marked with the following stickers: Pinch point hazard area Operate with care...

  • Page 20: Electromagnetic Compatibility

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY Warning! Location-specific fire regulations must be observed and applied. It is required to install fire extinguishers in the location in accordance with the regulations. Operators and users of this Scanner must be fully aware of the necessary steps that must be taken and how to use fire extinguishers in case of fire.

  • Page 21: Liquids And Safety

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY Liquids and Safety Warning! Prior to cleaning the Scanner, the power cord should be unplugged. Only use a dry or lightly damped lint-free cotton cloth to clean the Scanner. Isopropanol is recommended as a cleaning agent to clean greasy or dirty surfaces.

  • Page 22: Labels And Symbols On The Scanner

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY Labels and Symbols on the Scanner Labels The sticker on the rear panel of the Pannoramic® DESK FLASH DX includes the following information: Logo and name of manufacturer ® Scanner type – Pannoramic DESK FLASH DX SN symbol / PDESKYYMMDDXX Serial number...

  • Page 23: Symbols

    PANNORAMIC® DESK FLASH DX OPERATIONAL SAFETY Symbols Symbol Description This symbol indicates the manufacturer's serial number. This symbol indicates alternating current. This symbol indicates the manufacturer's catalog number. This symbol indicates the name and address of the legal manufacturer. This symbol indicates the date of manufacturing. This symbol indicates these instructions must be read.

  • Page 24: Pannoramic® Desk Flash Dx Software Overview

    PANNORAMIC® DESK FLASH DX SOFTWARE PANNORAMIC® DESK FLASH DX OVERVIEW 4 Pannoramic® DESK FLASH DX Software Overview About the Pannoramic® DESK FLASH DX and PANNORAMIC® Diagnostic Scanner Software The key features are: Hardware • Single loading of a slide within a single session •...

  • Page 25: System Configuration

    PANNORAMIC® DESK FLASH DX SOFTWARE PANNORAMIC® DESK FLASH DX OVERVIEW Main parts of the Pannoramic® DESK FLASH DX The following 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 Slide loader door Dehner 24V external power supply unit Power supply cable connector...

  • Page 26: Hardware Configuration

    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...

  • Page 27: Accessories

    PANNORAMIC® DESK FLASH DX SOFTWARE PANNORAMIC® DESK FLASH DX OVERVIEW Accessories ® The Pannoramic DESK WSI system is delivered including the following accessories for the Scanner: • Control computer (DELL 5820 with Xeon W-2145 CPU, 128 GB RAM) • Monitor (LG 32” / Fujitsu 27”) •...

  • Page 28: User Interface

    PANNORAMIC® DESK FLASH DX USER INTERFACE 5 User Interface Starting 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.

  • Page 29: Exiting The Control Pannoramic® Diagnostic Scanner Software

    PANNORAMIC® DESK FLASH DX USER INTERFACE Exiting the Control PANNORAMIC® Diagnostic Scanner Software 1. Make sure that all the scanning processes are completed and there is no slide in queue to be scanned. On how to abort scanning process, refer to section Aborting the Scanning Process.

  • Page 30: Description

    PANNORAMIC® DESK FLASH DX USER INTERFACE Description The GUI (Graphic User Interface) of the PANNORAMIC® Diagnostic Scanner Software can be divided into the following view panels: Figure 6: GUI of PANNORAMIC® Diagnostic Scanner Software 1 – Slide view (see section Slide view) 2 –...

  • Page 31: Slide View

    PANNORAMIC® DESK FLASH DX USER INTERFACE Slide View Figure 7: Slide view In Slide View, the slide information bar includes the slide thumbnail image, slide name, and a message/information. The preview image of the slide is recorded by the preview camera, and displayed at the right side of the window.
  • Page 32 PANNORAMIC® DESK FLASH DX USER INTERFACE Slide information bar Scanning status of a slide is visible in the information bar of the slide. Any event (change in status/warning/error/malfunction) that occurred during the scanning process is promptly displayed at the right end of the slide information bar. For example, if the scanning of slide was stopped, “Scanning has been stopped”...
  • Page 33 PANNORAMIC® DESK FLASH DX USER INTERFACE • Slide index Index of the slide finished in the scanning session – displayed after the slide was scanned; otherwise, this area is empty. • Preview image / progress indicator This area is empty until the preview image is taken. The slide preview is displayed in landscape orientation.

  • Page 34: Event History

    PANNORAMIC® DESK FLASH DX USER INTERFACE Conversion status During slide conversion, the ongoing processes and the actual status of slides can be tracked in a pop-up window. In Slide View, the actual conversion statuses are traceable at the left of the slide information bar. Event History The Event History panel 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...
  • Page 35 PANNORAMIC® DESK FLASH DX USER INTERFACE A detailed scanning process-related information of a slide can be listed upon double-clicking on its information bar. These data include the time when the preview image was taken, or the barcode grabbing was performed, and slide naming has taken place, and also the time when scanning was started and finished.

  • Page 36: Settings

    PANNORAMIC® DESK FLASH DX USER INTERFACE Settings Scanning 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.
  • Page 37 PANNORAMIC® DESK FLASH DX USER INTERFACE Figure 14: Scanning properties – Scan to Server • Scan to Local – location on a local storage Scan to Server – location on a server • Server settings (available only if Scan to Server is selected) The following must be defined to establish a server connection: o Server –...
  • Page 38 PANNORAMIC® DESK FLASH DX USER INTERFACE o Click New o Enter Display name, Host name, then select the Protocol type o Click Save to create connection How to delete a connection o Click the icon of the connection you want to delete o Click Yes in the pop-up window •...
  • Page 39 PANNORAMIC® DESK FLASH DX USER INTERFACE If you click Add new item ... on the list, blank input fields will be displayed. ▪ Define/modify profile name in the Name input field, 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...
  • Page 40 PANNORAMIC® DESK FLASH DX USER INTERFACE ▪ If the option Separator is selected at Parsing mode, the character (for example: / or *) used as a separator in the selected barcode type can be defined in the Separator input field. ▪...
  • Page 41 PANNORAMIC® DESK FLASH DX USER INTERFACE Profile marker icons indicate the scanning location and the conversion 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: •...
  • Page 42 PANNORAMIC® DESK FLASH DX USER INTERFACE On this panel the Administrator can perform administration settings grouped into the following separate sections: • User list panel (User / Authentication / Level) with settings • Login type • Automatic logout • User engagement There are three different levels of user authentication, which are marked by a specific number of shields (1, 2, or 3, depending on the set of access rights): General user can perform scanning, calibration, change magazine priority,...
  • Page 43 PANNORAMIC® DESK FLASH DX USER INTERFACE Warning! The Scanner will become accessible if the option None is selected. If an unauthorized person has access to the Scanner, the security of the room or location must be ensured by an access control or security system.
  • Page 44 PANNORAMIC® DESK FLASH DX USER INTERFACE Click Close to exit the Create User window. Notice: The length of PIN code must be not less than 4 digits, and cannot start with 0. Duplicate name or PIN is not allowed. How to Edit a User’s Name The name of a registered user cannot be modified.
  • Page 45 PANNORAMIC® DESK FLASH DX USER INTERFACE How to Adjust the Login Procedure 1) Select Settings panel / User management tab. 2) Set Login type option User authentication or No authentication. 3) Click Apply to save changes. How to Adjust the Automatic Logout Setting 4) Select Settings panel / User management tab.
  • Page 46 PANNORAMIC® DESK FLASH DX USER INTERFACE 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 INFORMATION FOR USE – FOR INVESTIGATIONAL USE ONLY. THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED.

  • Page 47: Operation

    PANNORAMIC® DESK FLASH DX OPERATION 6 Operation Introduction This chapter includes detailed information on how the control software of the Pannoramic® DESK FLASH DX works, what features are available and how it should be operated by the user. Safety Warning! Before operating the Pannoramic®...

  • Page 48: Scanner On/Off

    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, the user must switch the control computer and the monitor To switch the Pannoramic®...

  • Page 49: Switching The Scanner Off

    PANNORAMIC® DESK FLASH DX OPERATION If the Scanner won’t turn on, check the power supply cables and connectors, and the state of the power on/off rocker switch. See Figure 2 for the exact location of the power on/off switch. Switching the Scanner off To switch the Pannoramic®...
  • Page 50 PANNORAMIC® DESK FLASH DX OPERATION Warning! Do not use a slide when it is broken or its edges are not properly cut or grounded. Using such slides can lead to injury. Warning! Ensure that edges of the mounted coverslip and the label do not stick out of the slide. Both the coverslip and the label must be placed flat on the glass slide.
  • Page 51 PANNORAMIC® DESK FLASH DX OPERATION Preparation of tissue and the glass slide Caution! The quality of tissue and slide preparation highly affects the quality of the final digital image. Laboratory instructions and protocol must always be followed during tissue preparation. The tissue after the preparation must not be damaged in any way (torn, bubbled, wrinkled, folded, over exposed, poorly- or over-stained) and has uniform thickness).
  • Page 52 PANNORAMIC® DESK FLASH DX OPERATION • Clean mounting media residue from the slide. Figure 23: Placing the coverslip • As the final step of slide preparation, check that the surfaces of the glass slide are clean (free from residue of mounting media, fingerprints and markers), and the mounting media is dried so the coverslip is fixed.
  • Page 53 PANNORAMIC® DESK FLASH DX OPERATION The following criteria must be taken into account to ensure safe barcode reading and case identification: • Barcode label is printed correctly • There are no smears, scratches, markers, stain or dirt on the label •...
  • Page 54 PANNORAMIC® DESK FLASH DX OPERATION • IATA 2 of 5 • Matrix 2 of 5 • Telepen • Code 93 • Code 11 • MSI • Codabar • Patch Code • Pharmacode • EAN-13 • EAN-8 • UPC-A • UPC-E 2D barcode types •...
  • Page 55 PANNORAMIC® DESK FLASH DX OPERATION There are some recommendations and restrictions 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 •...

  • Page 56: Inserting A Glass Slide In The Scanner

    PANNORAMIC® DESK FLASH DX OPERATION Inserting a glass slide in the Scanner Figure 28: Inserting a magazine into the Scanner 1. Click to move the glass slide holder to loading position. 2. Open the slide insert door (1) by sliding it to the left. Caution! When sliding the door, fingers may be pinched during operation.

  • Page 57: Initiating The Scanning Process

    PANNORAMIC® DESK FLASH DX OPERATION Initiating the Scanning Process Warning! The door of the Scanner must always be closed while operated! Never open door unless prompted accordingly by the PANNORAMIC® Diagnostic Scanner Software. The door is equipped with an interlock switch. It automatically stops a running digitization process whenever it is opened.

  • Page 58: Checking The Scan Results

    PANNORAMIC® DESK FLASH DX OPERATION 3. Open the slide insert door (Figure 28 – 1) by pushing it to the left. 4. Open the fixing lever by pulling it to the left. 5. Remove the slide (Figure 28 – 3). 6.

  • Page 59: Troubleshooting

    Some type of errors, malfunctions or problems can occur during the operation of the Scanner, but most of these issues can be solved by following the actions listed in this section. If a problem persists or it can be solved only by a 3DHISTECH service technician, please contact us at: support@3dhistech.com...

  • Page 60: If The Scanner Cannot Read The Barcode On The Label Area

    PANNORAMIC® DESK FLASH DX TROUBLESHOOTING • Possible cause: Typing error • Solution: Make sure that User name and Password strings or the PIN code are all entered correctly and Caps Lock is off, as these fields are case-sensitive. Notice: Upon unsuccessful login despite entering credentials/PIN correctly, contact your system administrator.

  • Page 61: If The Scanner Shuts Down Automatically Before All Slides Have Been Scanned

    PANNORAMIC® DESK FLASH DX TROUBLESHOOTING If the Scanner Shuts Down Automatically Before All Slides Have Been Scanned If the Scanner 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.

  • Page 62: Maintenance

    If you find that the Scanner does not operate or cannot be operated as intended, contact 3DHISTECH or the local distributor for servicing. If a component or unit is defective, it must be replaced by an original replacement part or unit.

  • Page 63: Planned Maintenance

    Routine user checks are necessary if the control software instructs you to do so. These tasks are simple, but can be performed by trained users only. Repair and maintenance service provided by 3DHISTECH is always carried out in accordance with the contractual agreement. 3DHISTECH service technicians are qualified and holding a license, therefore, are authorized to perform any maintenance and repair tasks on the Scanner.

  • Page 64: How To Access Logged Events

    PANNORAMIC® DESK FLASH DX MAINTENANCE Warning! The Pannoramic® DESK FLASH DX must be powered off first before performing any routine inspection task on the device. How to Access Logged Events Accessing 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.
  • Page 65 PANNORAMIC® DESK FLASH DX MAINTENANCE Click Clients to display different clients registered 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.

  • Page 66: Cleaning

    PANNORAMIC® DESK FLASH DX MAINTENANCE Browse for the event on the list, see details of the event, and contact support if necessary, specifying the symptom (details of a possible malfunction). Cleaning Warning! Dust, specks and humidity may decrease or harm the operating capability of the device. Protect it with dust cover when not in use.

  • Page 67: Product Disposal

    PANNORAMIC® DESK FLASH DX PRODUCT DISPOSAL 9 Product Disposal Introduction The Pannoramic® DESK FLASH DX is designed and manufactured to comply with the relevant guidelines for environmental protection. If the device is disposed improperly, it presents environmental risk. As an electric device, Pannoramic® DESK FLASH DX consists of components that can be recycled (e.g.

  • Page 68: Technical Data

    PANNORAMIC® DESK FLASH DX TECHNICAL DATA 10 Technical Data Weight and Dimensions Measurement Value Weight 53lb (24.3 kg) Width 14.96 inches (380 mm) Depth 12.04 inches (306 mm) Height 9.8 inches (249 mm) Table 5: Weight and dimension specifications Environmental Conditions Transportation / Shipment (packed) Permissible ambient temperature -40°F to 158°F (-40°C to +70°C)
  • Page 69 PANNORAMIC® DESK FLASH DX TECHNICAL DATA Pannoramic® DESK FLASH DX General Performance Throughput – Scanning time of a 15×15mm benchmark tissue size at 20× equivalence is ~35 seconds, and at 40× equivalence is ~120 seconds (15×15 mm area, with adaptive focus point algorithm, local scanning, single layer, JPEG compression, MRXS file format) Tissue detection –...
  • Page 70 PANNORAMIC® DESK FLASH DX TECHNICAL DATA External Power Supply Unit Definition Specification Mains type Single phase load (hot, service neutral, separate ground) Input voltage range 100-240 Vac Line input frequency 47/63 Hz Max freq. deviation ±1 Hz Secondary voltage 24V DC Secondary current max.
  • Page 71 PANNORAMIC® DESK FLASH DX TECHNICAL DATA • 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) INFORMATION FOR USE –...

  • Page 72: Glossary Of Terms And Abbreviations

    PANNORAMIC® DESK FLASH DX TECHNICAL DATA Glossary of Terms and Abbreviations Term Description Digital Slide / A digital image of a thin glass plate on which specimens are mounted for Slide 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.

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