Leica Microsystems PROVEO 8x Manual

3d digital ophthalmic microscope cybersecurity manual

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From Eye to Insight
PROVEO 8x
Cybersecurity Manual
10 735 164 version 01
Date of issue: 2024-12-19

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Summary of Contents for Leica Microsystems PROVEO 8x

  • Page 1 From Eye to Insight PROVEO 8x Cybersecurity Manual 10 735 164 version 01 Date of issue: 2024-12-19...
  • Page 2 The information provided by this manual is directly related to the operation of the equipment. Medical decision remains the responsibility of the clinician. Leica Microsystems has made every effort to provide a complete and clear user manual highlighting the key areas of product use. Should additional information regarding the use of the product be required, please contact your local Leica representative.
  • Page 3: Table Of Contents

    Configuring and verifying DICOM settings Running audit report Elevating Windows access Update system date and time Resetting user password Generating license request and installing license updates Software updates Cybersecurity incident reporting PROVEO 8x / Ref. 10 735 164 / Version 01...
  • Page 4 PROVEO 8x / Ref. 10 735 164 / Version 01...
  • Page 5: Introduction

    This user manual documents the purpose of connecting PROVEO 8x to network and other hospital equipment; define the set of PROVEO 8x is intended to be used within operating room in a cybersecurity controls used to secure the Leica Microsystems hospital.
  • Page 6 PROVEO 8x – Purpose and requirements of networked connections PROVEO 8x provides an export capability to copy images (JPG, PNG) during manufacturing. The trusted root needs to be identified as an and videos (MP4) to the external media. The external media is accepted trusted root on the certificate store of the 3rd party device treated as a USB mass storage device class (MDC).
  • Page 7: Cybersecurity Controls

    Encryption Measures: Leica Microsystems and are active for a predefined lifetime and are All information stored on the hard disc of the PROVEO 8x is traceable to individual associates. These accounts do not have the encrypted with a strong encryption algorithm using the Windows ability to access patient information on the system.
  • Page 8: Digital Signatures

    • Retrieving and viewing OS elevated access credentials communications, encrypted communications are selected by • License dongle insertion default. If the DICOM nodes that PROVEO 8x connects to accept only • Automatic user activated on dongle insertion unencrypted data transport, the system may be configured to allow •...
  • Page 9 • Update user password Secure by Default: PROVEO 8x security features are enabled by default; there are some security features that may be disabled at the discretion of IT users. These decisions on security configuration are applied to all system users once applied;...
  • Page 10: Advanced Feature Configuration And Use For It Users

    These changes would include but are not limited to network configuration changes, connection of additional items to the microscope, disconnection of items from the microscope, update of equipment. Select Hospital IT. PROVEO 8x / Ref. 10 735 164 / Version 01...
  • Page 11: Configuring Proveo 8X Application Security Settings

    • Hospital Logo: Choose to enable or disable display of hospital logo on screen. This will overwrite surgeon profile – media settings to display hospital logo on screen and recording. PROVEO 8x / Ref. 10 735 164 / Version 01...
  • Page 12: Configuring And Verifying Dicom Settings

    "Storage" identifies the node as a location where PROVEO 8x should export data. "MWL" identifies the node as a location where PROVEO 8x should get a modality work list of which patients are scheduled for the microscope. "MWL and Storage" identifies the node as being used for both purposes.
  • Page 13: Running Audit Report

    Select "Save" to save the changes for the node At any time, select "Back" to discard the changes Running audit report Insert trusted USB into PROVEO 8x USB connector for use as a location to export the audit log Authenticate as an IT User Wait for Verification Status to populate with results.
  • Page 14: Elevating Windows Access

    Enter CTRL + ALT + DEL on the keyboard, then press "Sign Out" on the screen Select LeicaUser as User and enter credentials recorded in prior Power cycle the microscope to return to PROVEO 8x application. step Windows launches with Command Shell viewable NOTE Elevated credentials are only valid for 15 minutes.
  • Page 15: Resetting User Password

    4.8.1 Installing license Tap the reset password icon of the respective user Connect USB drive with the license to the PROVEO 8x USB port Click Menu (1) Tap the reset icon Click "System Settings" (2) The password reset is confirmed...
  • Page 16 Authenticate as an IT User and enter Hospital IT Support Select "User Management" Click "OK" IT user may reset password, enable/disable users or create users Check the expected licenses are activated accordingly PROVEO 8x / Ref. 10 735 164 / Version 01...
  • Page 17 Enter default username and password, then select Confirm First time logging onto system default accounts PROVEO 8x is delivered with a single use, default clinical user and hospital IT user account. Your Leica support specialist will provide you with the initial password for each account (Clinical and IT). After...
  • Page 18 Specialist for Hospital IT Enter default username (clinical or IT) and local account password for the account type, then select Confirm PROVEO 8x / Ref. 10 735 164 / Version 01 PROVEO 8x / Ref. 10 735 164 / Version 01...
  • Page 19: Software Updates

    (e.g., PHI, PII, we serve. Among them are an unwavering commitment to the etc.) as a part of any submissions to Leica Microsystems. Please safety and security of our instruments and services. In response to...
  • Page 20 CONNECT WITH US! Leica Microsystems (Schweiz) AG · Max-Schmidheiny-Strasse 201 · CH-9435 Heerbrugg T +41 71 726 3333 www.leica-microsystems.com...

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