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Cognivue Clarity User Manual

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User Manual
© 2024 COGNIVUE, INC.
7911 Rae Blvd |
Victor, NY 14564 |
1.585.433.2992

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Summary of Contents for Cognivue Clarity

  • Page 1 User Manual © 2024 COGNIVUE, INC. 7911 Rae Blvd | Victor, NY 14564 | 1.585.433.2992...

  • Page 2: Table Of Contents

    Screen Sleep ..........................9 Power Alert ........................... 9 Recommendations for Use ......................... 10 General Testing Location ......................10 Cleaning and Disinfecting Cognivue Clarity® ................10 Use of Personal Protective Equipment ..................10 Network Connectivity ......................... 11 Basic Wired Connection ......................11 Basic Wi-Fi Configuration ......................
  • Page 3 Run Test (Patient List Screen) ..................... 23 13.3 Video Volume Control ......................... 23 Assessment Reports ........................24 14.1 Physician Report ......................... 24 14.2 Clarity Patient Report ........................25 14.3 Clarity Scores Report ........................25 14.4 Clarity Traces Report ........................26 14.5 Physician Information Sheet ....................... 27 14.6...

  • Page 4: About This Guide

    This User Manual contains information that describes the operation of Cognivue Clarity®. Additional information can be found at www.cognivue.com. Cognivue Support personnel can be reached via at 1-585-433-2992 from 9-5 pm ET or by emailing support@cognivue.com. UM-510-C Cognivue Clarity® User Manual 5/7/2024 ©...

  • Page 5: About Cognivue Clarity

    SLUMS scores (weighted κ 0.57; 95%CI: 0.50-0.63). Reliability analyses showed similar scores across repeated testing for Cognivue® (R2 = 0.81; r = 0.90) and SLUMS (R2 =0.67; r = 0.82). Cognivue Clarity® has been validated with Cognivue Advanced® in a clinical trial with 31 subjects. The correlation between Advanced and Clarity was very high positive (0.943), and Clarity’s test reliability...
  • Page 6 Cognivue Advanced De Novo Clearance, DEN130033 • Diego Cahn-Hidalgo, Paul W Estes, Reina Benabou, “Validity, reliability, and psychometric properties of a computerized cognitive assessment test (Cognivue®),” World Journal of Psychiatry 2020 January 19; 10(1): 1-11. • Cognivue Clinical Analysis Report CAR-401-A.

  • Page 7: Device Description

    Cognivue Clarity® User Manual 4 Device Description The Cognivue Clarity® is a portable, battery-powered, laptop-like device that includes a wireless keyboard with a touchpad, a rotary CogniWheel®, and a CogniCover®. The CogniWheel® is the sole patient input device. The CogniCover® is designed for privacy and to reduce distraction and light reflections on the computer screen.
  • Page 8 Cognivue Clarity® User Manual Clarity Model 1 USB Ports Battery Charging Port Ethernet Port (for Keyboard) Clarity Model 2 USB (for Keyboard) Ethernet Port Headphone Jack Battery Charger Power Button Battery Indicator © 2024 Cognivue, Inc. UM-510-C Page 8...

  • Page 9: Power Management

    5.3 Power Alert When the Cognivue Clarity® device is low on battery charge and not plugged in, if an attempt is made to start a testing session, e.g., upon clicking the Run a Test button on the main screen, it will display an alert and not allow the testing session to begin.

  • Page 10: Recommendations For Use

    Put the device on a flat, stable surface that is ergonomically comfortable for the patient. The patient should be able to comfortably reach and manipulate the CogniWheel® and view the computer screen. Avoid placing the Cognivue Clarity® in a location where there may be distractions behind the device which are visible to the patient.

  • Page 11: Network Connectivity

    1. Connect one end of a standard network cable to an active network jack at your location 2. Connect the other end to the network port on the back of the Cognivue Clarity® device 3. If not automatically connected, follow the instructions above, selecting Wired Connection 1.

  • Page 12: Connection Details

    In the future, the device will remember the network and automatically connect when possible. 7.3 Connection Details When logged on to a Cognivue Clarity® device, administrators can view and test the current network configuration information on the Network Settings window To open the Network Configuration window 1.

  • Page 13: Security

    Clicking the Shutdown button will prompt confirmation before shutting down the device. 8.2 User Management Each Cognivue Clarity® user should have their own user account to ensure audit trail and safety of patient data. User accounts can be assigned as an Administrator or an Operator on the User Management Screen.

  • Page 14: User Creation

    Cognivue Clarity® User Manual To open the User Management Screen 1. Log in 2. Select Administration >> Device Settings 3. Click the Users tab 8.3 User Creation From the User Management Screen 1. Click Create 2. Fill out form 3. Click Save 4.

  • Page 15: User Modification

    4. Click Save Click Yes to confirm when prompted 8.5 Password Reset If a Cognivue Clarity® user is unable to remember their password, the process to reset their password can be initiated from the device’s Login Screen: 1. Click Reset Password 2.

  • Page 16: Auto-Logout

    Cognivue Clarity® User Manual 8.6 Auto-Logout To prevent unauthorized access, the Cognivue Clarity® device will automatically log out the active user after 30 minutes of inactivity. 8.7 Password Expiration Password expiration forces users to change their account passwords after a set number of days.

  • Page 17: Disabling Accounts

    3. Click Yes to confirm when prompted 9 System Settings The Cognivue Clarity® device includes several configurable options. The ability to make these configuration changes is available only to Administrator users on the System Settings screen The System Settings Screen is on the System tab of the Device Administration page To open the System Settings Screen 1.

  • Page 18: Video Settings

    A selection here results in this option always being selected 10 Report Settings The Clarity reports are configurable to meet the needs of the practice using the device. These configuration changes are available only to Administrator user accounts on the Report Configuration screen.

  • Page 19: Report Emailing

    Cognivue Clarity® User Manual 10.1 Report Emailing Cognivue Clarity® provides the ability to send the test report via an encrypted email to a patient following completion of a test. This feature is enabled by default. An Administrator can disable this functionality by unchecking the Enable Report Emailing checkbox.

  • Page 20: Automatic Printing

    Cognivue Clarity® User Manual 10.3 Automatic Printing Cognivue Clarity® provides the ability to automatically print the associated report upon completion of a test. Automatic printing of test reports is disabled by default. An Administrator can enable this functionality by checking the Auto Print checkbox 10.4 Report Composition...

  • Page 21: Practice Information

    Cognivue Clarity® User Manual 10.5 Practice Information To open the Practice Information Screen 1. Log in 2. Select Administration >> Report Settings 3. Click the Practice tab 11 Portal Menu For details about how to setup and utilize the Portal see the Portal User Manual...

  • Page 22: Pre Entering Patients

    4. Click OK to confirm when prompted 13 Assessments Test administration is the core feature of Cognivue Clarity®. There are two paths to starting an assessment: From the Main Screen and from the Patient List Screen. © 2024 Cognivue, Inc.

  • Page 23: Run Test (Main Screen)

    Cognivue Clarity® User Manual 13.1 Run Test (Patient Screen) From the Patient List Screen 1. Select a patient 2. Click the Start Test button 3. Patient data (Name and date of birth) 4. Select the patient’s preferred language for the test (English or Spanish) 5.

  • Page 24: Video Volume Control

    Cognivue Clarity® User Manual 13.2 Video Volume Control Before starting Cognitive Assessments test the audio using the Test Audio button on the Assessment Setup Screen In order to control the volume of video playback, the volume control keys on the keyboard can be used.

  • Page 25: Clarity Patient Report

    Cognivue Clarity® User Manual 14.1 Clarity Scores Report This report contains a more detailed breakdown of the patient’s scores and indicates the normative range of scores for the patient’s age group. © 2024 Cognivue, Inc. UM-510-C Page 25...

  • Page 26: Clarity Traces Report

    Cognivue Clarity® User Manual 14.2 Clarity Traces Report This report contains response traces for each of the ten subtests executed as part of the Cognivue Clarity® assessment. © 2024 Cognivue, Inc. UM-510-C Page 26...

  • Page 27: Physician Information Sheet

    Cognivue Clarity® User Manual 14.3 Cogniwell Letter The CogniWell Lifestyle Letter provides information about modifiable lifestyle factors that can have an impact on cognitive performance. © 2024 Cognivue, Inc. UM-510-C Page 27...

  • Page 28: Clarity Test Descriptors

    Cognivue Clarity® User Manual 14.4 Clarity Test Descriptors This document contains descriptions of each of the ten subtests executed as part of the Cognivue Clarity® assessment. © 2024 Cognivue, Inc. UM-510-C Page 28...

  • Page 29: Accessing Reports

    Cognivue Clarity® User Manual 15 Accessing Reports 15.1 Viewing Reports After a Cognitive Assessment has been completed the report can be reviewed by going to the Report List Screen. 15.2 Reviewing Reports Administrators can review the test report by Selecting the Reports button from the Main Menu Screen.

  • Page 30: Printing

    Cognivue Clarity® User Manual 15.3 Printing Test reports may be printed from the Clarity device whenever a report is opened in the report viewer. The print feature prints to the device’s default printer. The Default printer can be set from any screen 1.

  • Page 31: Emailing

    Cognivue Clarity® User Manual 15.4 Emailing Emailing reports from the device requires consent on a per assessment basis. The checkbox on the start assessment screen or the re-entry of a pre-existing patient’s email serves as this consent. If the email cannot be sent after the assessment due to network interruption the email can be resent once the network is restored via the Email Menu on the Main Screen for an administrator user.

  • Page 32: Drive Mapping

    Cognivue Clarity® User Manual 15.5 Drive Mapping 15.5.1 Setting the SMB Share Password The SMB password can be set and reset on device by an administrator user. From the System Settings Screen 1. Click the SMB Share Button 2. Enter a password that meets all the requirements 3.

  • Page 33: Reports Mapping

    Cognivue Clarity® User Manual 15.5.2 Reports Mapping This mapping provides access to the report pdfs sorted into folders based on the name and date of birth of the patient. To map this drive, follow the appropriate Drive Mapping Instructions available at https://cognivue.com/customer-resource-center/.
  • Page 34 Cognivue Clarity® User Manual • Letter Memory Subtest • Word Memory Subtest • Shape Memory Subtest • Motion Memory Subtest • Average Score • Visuospatial • Executive Function/Attention • Naming/Language • Memory • Delayed Recall • Abstraction • Adaptive Motor Control Reaction Time (ms) •...

  • Page 35: Technical Specifications

    Cognivue Clarity® User Manual 16 Technical Specifications Parameter Clarity Model 1 Clarity Model 2 10 to 30 °C (50 to 86 °F) Operating 10% to 85% Relative humidity, non-condensing Environment 70 to 106 kPa Atmospheric Pressure Transport and -20 to 50 °C (-4 to 122 °F)

  • Page 36: Safety Precautions

    Cognivue Clarity® User Manual 17 Safety Precautions Observe the following precautions to ensure safety and to prevent damage to Cognivue Clarity®: • Do not place on uneven or unstable surfaces. • Do not make any modifications or alterations to the device.

  • Page 37: Product Safety Standards

    Cognivue Clarity® User Manual 18 Product Safety Standards This device meets the following product safety standards: ANSI/AAMI ES60601-1:2005+A2 (R2012) +A1 - Medical Electrical Equipment—Part 1: General requirements for safety and essential performance Canada CAN/CSA C22.2 No. 60601-1:2014 - Medical Electrical Equipment—Part 1: General requirements for safety and essential performance (includes Amendment 1) IEC 60601-1-2:2014 includes EMC requirements and tests.

  • Page 38: Product Safety Symbols

    Cognivue Clarity® User Manual 19 Product Safety Symbols The following symbols may be used for marking on this equipment: Follow the operating instructions Type B applied part Serial Number DC input Manufacturer Date Manufacturer’s name and address NRTL Mark (Safety Certification...
  • Page 39 Cognivue Clarity® User Manual Manufactured by: United Kingdom Responsible Person Cognivue, Inc. Donawa Lifescience Limited 7911 Rae Blvd Aviation Business Park Victor, NY 14564 Christchurch BH23 6NX © 2024 Cognivue, Inc. UM-510-C Page 39...

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