CognitiveTPG Clarity User Manual

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Victor, NY 14564

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Summary of Contents for CognitiveTPG Clarity

Page 2: Table Of Contents
3.3 Power Alert ..........................5 Recommendations for Use ........................6 4.1 General Testing Location ......................6 4.2 Positioning of Cognivue Clarity® and the Patient ..............6 4.3 Cleaning and Disinfecting Cognivue Clarity® ................6 4.4 Use of Personal Protective Equipment ..................7 Network Connectivity..........................
Page 3 21.0 Product Safety Standards and Symbols .................... 39 About This Guide This User Manual contains information that describes the installation and operation of Cognivue Clarity®. Additional information can be found at www.cognivue.com. Cognivue Support personnel can be reached from 9-5 pm ET at 1- 585-433-2992 support@cognivue.com.
Page 4: About Cognivue Clarity
1.1 Disclaimers Cognivue Clarity® is indicated for use as an adjunctive tool for evaluating cognitive function. It is not a stand-alone diagnostic tool. The device results are to be assessed and interpreted by a licensed clinician. Warnings 1) Cognivue Clarity®...
Page 5: Device Description
Cognivue Clarity® User Manual 2.0 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 6: Power Management
Cognivue Clarity® User Manual 3.0 Power Management The Cognivue Clarity®, much like a laptop, is designed to be battery-powered during regular use but can also be used when the provided charging adapter is plugged in. The battery sustains 4 hours of intensive, off charger usage but can last for over 8 hours typical usage.
Page 7: Recommendations For Use
Put the device on a flat, stable surface that is ergonomically comfortable for the patient (see below). 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 8: Use Of Personal Protective Equipment
5.1 Basic Wired Connection 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 (see figure 2.2).
Page 9 Cognivue Clarity® User Manual 3. Enter the Wi-Fi password for the selected network Figure 5.2 Wi-Fi Authentication dialog 4. Click Connect 5. Connection can take a few seconds. A successful connection is indicated by when the network icon in the top left changes to the Wi-Fi connection strength icon indicating network connectivity.
Page 10: Connection Details
Cognivue Clarity® User Manual 5.3 Connection Details When logged on to a Cognivue Clarity® device, administrators can view and test the current network configuration information on the Network Configuration window. Figure 5.4 Network Configuration window To open the Network Configuration window 1.
Page 11 Cognivue Clarity® User Manual 1. Click on the connection named for your SSID 2. Click the Gear icon. Gear icon Network Connections wizard 3. On the pop-up window that appears, click on the IPV4 Settings tab. Network Configuration Editor © 2022 Cognivue, Inc.
Page 12 Cognivue Clarity® User Manual 4. Click the Method drop-down-menu button and select Manual. Network Configuration Editor 5. Click the Add button. 6. In the Address field, enter your static or reserved IP (obtained from your network team). 7. In the Netmask field, enter the Subnet mask (obtained from your network team).
Page 13: Security
6.0 Security 6.1 Logging on to Cognivue Clarity® The user Login window is how you log in to a device. It is how you log in to the device. Logging in with a unique account ensures an audit trail for viewing patient reports and running assessments.
Page 14: Shutting Down
Note: This is the preferred way to shut down the device. The physical power button should be used only if necessary. 7.0 Managing User Accounts 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 Operator.
Page 15: Managing User Accounts
Cognivue Clarity® User Manual 7.3 Managing User Accounts User accounts must be managed directly on the Cognivue Clarity® device. To reach the User Management screen 1. Log in as an Administrator user (like the one created during device Configuration, See Installation Guide) 2.
Page 16: Creating User Accounts
Cognivue Clarity® User Manual 7.4 Creating User Accounts 1. Click Create User Creation window 2. Fill out form 3. Click Save 4. Click Yes to confirm when prompted © 2022 Cognivue, Inc. UM-410-P Page 15...
Page 17: Modifying User Accounts
Cognivue Clarity® User Manual 7.5 Modifying User Accounts 1. Select a user from the list 2. Click Edit User Modification window 3. Make the desired changes 4. Click Save 5. Click Yes to confirm when prompted © 2022 Cognivue, Inc.
Page 18: Changing Passwords
Cognivue Clarity® User Manual 7.6 Changing Passwords 1. Select a user from the list 2. Click Edit Modify Account window 3. Click Set Password Set User Password window 3. Click Save 4. Click Yes to confirm when prompted © 2022 Cognivue, Inc.
Page 19: Disabling User Accounts
Cognivue Clarity® User Manual 7.7 Disabling User Accounts To maintain an audit trail, User Accounts cannot be fully removed from the system. Disabling prevents the user from logging in. Disabled accounts can be reactivated in the future. 1. Click on a user in the list 2.
Page 20: System Information
Cognivue Clarity® User Manual 8.0 System Information Basic system information about Cognivue Clarity® is available to any logged-in user in the About window (accessed by clicking About >> About on the Primary window). The information displayed here will be useful when contacting support.
Page 21: Video Options
Cognivue Clarity® User Manual 9.1 Video Options Video Settings Window This screen allows Administrators to ensure certain videos will always be shown to patients. If the option is unchecked here, the choice is left to the Operator who sets up the test for the patient.
Page 22: Report Configuration
System Settings) 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 (see 16.0 Emailing Reports). This feature is enabled by default. An Administrator can disable this functionality by unchecking the Enable Report Emailing checkbox.
Page 23: Report Printing
Cognivue Clarity® User Manual 10.2 Report Printing Cognivue Clarity® provides the ability to print the test report to a configured, connected printer. Printing test reports from Cognivue Clarity® (see 15.0 Printing Reports) is enabled by default. An Administrator can disable this functionality by unchecking the Enable Report Printing checkbox.
Page 24: Practice Information
Practice Information window 11.0 Portal Menu Cognivue Clarity® can sync test data to a secure Provider Portal, when enabled. If enabled, the device will sync test data with the cloud after completion of a test if connected to the internet.
Page 25: Enabling The Portal
The online portal can be accessed using a web browser at the site https://portal.cognivue.com/ 12.0 Running a Test Test administration is the core feature of Cognivue Clarity®. 1. Login to the device (see 6.1 Logging on to Cognivue Clarity®) © 2022 Cognivue, Inc. UM-410-P Page 24...
Page 26 Cognivue Clarity® User Manual 2. Click the Run a Test button 3. Fill out patient data (Name, gender/sex, date of birth) 4. Select the patients preferred language for the test (English or Spanish) 5. Select appropriate video options or use the defaults 6.
Page 27 Cognivue Clarity® User Manual Note – Video options will appear checked when selected for play. The option will appear greyed out if an Administrator has selected to enforce a video always being played. If enabled by an Administrator (see 10.1 Report Emailing), there is an option for emailing the report. If that option is selected, the operator will be prompted to enter the patient’s email address and then...
Page 28: Video Volume Control
Cognivue Clarity® User Manual 10.2 Report Printing, the Operator will be able to click a Print button on the report viewer header bar to print the report. When finished viewing/printing the report, the Operator can click the Close Report button on the header bar of the report viewer to close the report viewer and return to the Main Menu Screen.
Page 29 Cognivue Clarity® User Manual 10.2 Report Printing), the Administrator will be able to click a Print button on the report viewer header bar to print the report. Report List window © 2022 Cognivue, Inc. UM-410-P Page 28...
Page 30 Cognivue Clarity® User Manual There are four options for the report. See 10.4 Report Composition for selecting the pages of the report. Note: appropriate clinical contextualization is required. 1. Physician Report: This report is intended for the physician. It displays the average test score and the scores in various areas of cognitive function and health.
Page 31 Cognivue Clarity® User Manual 2. Reaction Time and Speed Processing: This page is intended for the physician. It provides scores for reaction time and speed processing of the test taker. Clinical contextualization is required. Reaction Time and Speed Processing © 2022 Cognivue, Inc.
Page 32 Cognivue Clarity® User Manual 3. Patient Report: This report is intended for the patient. It will contain an overall average score. Clinical contextualization is required. Patient Report © 2022 Cognivue, Inc. UM-410-P Page 31...
Page 33 Cognivue Clarity® User Manual 4. Physician Information: This page provides general information about the normalized ranges for the overall score. Clinical contextualization is required. Physician Information © 2022 Cognivue, Inc. UM-410-P Page 32...
Page 34: Printing Reports
Cognivue Clarity® User Manual 5. Cogniwell Information Sheet: This page provides information about Cognivue’s Cogniwell program. Cogniwell Informational Sheet 15.0 Printing Reports Test reports may be printed from the device whenever a report is opened in the report viewer (see 10.0 Report Configuration and 14.0 Finding and Viewing Reports), provided the Report Printing option has...
Page 35: Emailing Reports
Cognivue Clarity® User Manual Printer Configuration window Press the Refresh button to discover network printers (please work with your IT team to connect your printer to your network). Right-click on the desired printer to open a drop-down menu and select the Set as Default option.
Page 36: Csv Data Export
Cognivue Clarity® User Manual Once the emails have been sent, a dialog box will display indicating the number successfully sent. Note: Due to the additional encryption and network latency, it can take up to 15 minutes or more to send the email.
Page 37: Patient Management
Users have the ability to pre-enter patient demographic information, and have the ability to run tests with existing patients. To reach the Patient List screen 1. Log in as an Administrator user (see 6.1 Logging on to Cognivue Clarity®) 2. Click the Patients button Patient List window The Patient List screen lists all patients that have already taken a test or have been pre-entered.
Page 38: Pre-Entering Patients
Cognivue Clarity® User Manual 18.1 Pre-Entering Patients Patient demographic information can be pre-filled to speed up the test setup process. 1. Click on the Create button to display the Patient Creation window Patient Creation window 2. Fill out form 3. Click Save 4.
Page 39: Technical Specifications
20 dBm max output power for 2.4 GHz 802.11b/g/n 23 dBm max output power for 5.0 GHz 802.11a/n/ac 20.0 Safety Precautions Observe the following precautions to ensure safety and prevent damage to Cognivue Clarity®: • Do not place on uneven or unstable surfaces.
Page 40: Product Safety Standards And Symbols
Cognivue Clarity® User Manual any part of Cognivue Clarity®. Otherwise, degradation of the performance of this equipment could result. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services.
Page 41 Cognivue Clarity® User Manual 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 Mark)