Cognivue Thrive UM-420-T User manual

© 2022 COGNIVUE, INC. 7911 Rae Blvd | Victor, NY 14564 | 585.203.1969
User Manual

Cognivue Thrive® User Manual
© 2022 Cognivue, Inc. UM-420-T Page 2
1Contents
2 About This Guide...................................................................................................................................4
3 About Cognivue Thrive®........................................................................................................................4
3.1 Disclaimers....................................................................................................................................4
3.2 Clinical Reference Information .....................................................................................................4
4 Device Description ................................................................................................................................5
5 Power Management .............................................................................................................................6
5.1 Indicator Lights..............................................................................................................................6
5.2 Screen Sleep..................................................................................................................................6
5.3 Power Alert ...................................................................................................................................6
6 Recommendations for Use ...................................................................................................................6
6.1 General Testing Location ..............................................................................................................6
6.2 Cleaning and Disinfecting Cognivue Thrive®.................................................................................7
6.3 Use of Personal Protective Equipment .........................................................................................7
7 Network Connectivity ...........................................................................................................................7
7.1 Basic Wired Connection................................................................................................................8
7.2 Basic Wi-Fi Configuration..............................................................................................................8
7.3 Connection Details........................................................................................................................9
8 Security ...............................................................................................................................................10
8.1 Login............................................................................................................................................10
8.2 User Management ......................................................................................................................10
8.3 User Creation ..............................................................................................................................11
8.4 User Modification .......................................................................................................................12
8.5 Password Reset...........................................................................................................................12
8.6 Auto-Logout ................................................................................................................................12
8.7 Password Expiration....................................................................................................................13
8.8 Disabling Accounts......................................................................................................................13
9 System Settings...................................................................................................................................14
9.1 Client Code..................................................................................................................................14
9.2 Video Settings .............................................................................................................................15
10 Report Settings................................................................................................................................16
10.1 Report Emailing...........................................................................................................................16
10.2 Report Printing............................................................................................................................17

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10.3 Automatic Printing......................................................................................................................17
10.4 Report Composition....................................................................................................................18
10.5 Practice Information ...................................................................................................................18
11 Portal Menu ....................................................................................................................................18
12 Patient Management ......................................................................................................................19
12.1 Pre Entering Patients ..................................................................................................................19
13 Assessments....................................................................................................................................19
13.1 Run Test(Main Screen)................................................................................................................20
13.2 Run Test (Patient List Screen).....................................................................................................21
13.3 Video Volume Control.................................................................................................................22
14 Assessment Reports........................................................................................................................23
14.1 Practitioner Report .....................................................................................................................23
14.2 Patient Report.............................................................................................................................24
14.3 Cogniwell Letter..........................................................................................................................25
15 Accessing Reports ...........................................................................................................................26
15.1 Viewing Reports..........................................................................................................................26
15.2 Reviewing Reports ......................................................................................................................26
15.3 Printing........................................................................................................................................26
15.4 Emailing.......................................................................................................................................27
15.5 Drive Mapping.............................................................................................................................28
15.5.1 Setting the SMB Share Password........................................................................................28
15.5.2 Reports Mapping.................................................................................................................28
15.5.3 CSV Mapping.......................................................................................................................29
16 Technical Specifications..................................................................................................................30
17 Safety Precautions ..........................................................................................................................30
18 Product Safety Standards................................................................................................................31
19 Product Safety Symbols ..................................................................................................................32

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2About This Guide
This User Manual contains information that describes the operation of Cognivue Thrive®.
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 [e-mail].
UM-420-T Cognivue Thrive® User Manual 12/19/2022
© 2022 Cognivue, Inc. | 7911 Rae Blvd | Victor, NY 14564 | 585.203.1969
3About Cognivue Thrive®
Cognivue Thrive® is a computerized cognitive assessment device to evaluate cognitive function
objectively, quantitatively, and reliably. Cognivue Thrive® relies on a series of 6 subtests. Using the
results from these subtests, Cognivue Thrive® creates a short, easy-to-interpret report. The report
shows three cognitive domain scores: Memory, Visuospatial, and Executive Function. Below these are
two metrics on Reaction Time and Speed Processing. Normative ranges appear below the visual of each
cognitive domain score and metric. These segment into classifications of good, moderate, or poor
ability. These cognitive scores and classifications provide a baseline for future comparison and enable
discussion between the clinician and the test-taker about cognitive health.
3.1 Disclaimers
Cognivue Thrive® is indicated for use as an adjunctive tool for evaluating cognitive function in ages 18
and over. It is not a stand-alone diagnostic tool. The device results are to be assessed and interpreted by
a licensed clinician.
Warnings
1) Cognivue Thrive® does not identify the presence or absence of clinical diagnoses.
2) Cognivue Thrive® cannot be used as a stand-alone diagnostic.
3) Cognivue Thrive® is intended to be used in clinical professional offices or similar settings.
3.2 Clinical Reference Information
Cognivue Thrive® is based on the same technology as Cognivue® Advanced and Cognivue® Clarity.
Cognivue Thrive uses a subset of the Cognivue Advanced® algorithms to provide a similar breakdown of
cognitive scores in a shorter duration test.
Cognivue Thrive® algorithms have been compared vs. Cognivue Advanced® in a clinical trial with 100
subjects. The correlation between Advanced and Thrive was in the same category of Advanced vs.
Advanced, which was statistically significant (moderate positive 0.57), and Thrive’s test reliability was
high positive (0.74).
Additional information is available in the following references:
•Cognivue Advanced De Novo Clearance, DEN130033

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•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.
4Device Description
The Cognivue Thrive® 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. The CogniCover® and CogniWheel® are designed to fold for
portability.
Figure 1 Cognivue Device (Front)
CogniCover
®
Power Button
Battery Indicator Lights &
Headphone Jack
CogniWheel
®
Figure 2 Cognivue Device (Rear)
Battery Charger
Ethernet
USB (for Keyboard)

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5Power Management
The Cognivue Thrive®, 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.
The battery recharges in approximately 4 hours if depleted completely.
5.1 Indicator Lights
There are two indicator lights on the right side of the device.
Left Light
Right Light
Device is unpowered
Off
Off
Device is discharging
Orange
Off
Device is charging
Green/Off
Orange
Plugged in and fully
charged
Green/Off
Green
Table 1 Charging Lights
5.2 Screen Sleep
When the Cognivue Thrive device is not in use for 10 minutes, the screen will go into sleep mode. When
the screen is asleep, it can be awakened by clicking or pressing a key on the keyboard.
5.3 Power Alert
When the 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. Plugging in the device will allow tests to be administered. In order to
avoid running out of power during a test, please charge the device for at least one hour before again
administering tests on battery power.
6Recommendations for Use
6.1 General Testing Location
When possible, choose a test location that reduces distractions (e.g. an exam room, office, or
conference room rather than a busy hallway).
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 Thrive® in a location where there may be distractions behind the device
which are visible to the patient.

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DO NOT place the device on the patient’s lap for the test. This does not provide a stable surface during
the administration of the test. This interferes with a patient’s ability to take the test.
6.2 Cleaning and Disinfecting Cognivue Thrive®
Cognivue recommends sanitizing the Cognivue Thrive® before and after administering a test using one
of the following procedures:
•Preferred: Use sanitizing or disinfectant wipes to thoroughly wipe the CogniWheel® and the
base of the device where the patient palm rests. DO NOT wipe the screen!
•Please turn the power off on the Cognivue Keyboard using the appropriate slider switch prior to
cleaning/transport; this prevents unintentional keypress combinations on the device.
•In the event wipes are not available, spray a sanitizer onto a paper towel, being careful not to
oversaturate the paper towel, and thoroughly wipe the CogniWheel® and the base of the device
where the patient palm rests. DO NOT wipe the screen, and do NOT spray sanitizer or
disinfectant directly onto the device!
6.3 Use of Personal Protective Equipment
In addition to sanitizing the device, Cognivue recommends that operators and patients wear a
disposable mask while interacting with the device. If it is not possible to sanitize the device between
patients, Cognivue recommends operators and patients use disposable gloves.
7Network Connectivity
Cognivue Thrive® requires connection to a qualified network for initial setup and configuration but
thereafter can be used to administer assessments offline. However certain features like Portal Sync,
Printing, and Drive Mapping will be unavailable until the device is reconnected to a qualified network. In
addition to these features, continued connection to qualified networks allows Cognivue to deploy both
general purpose and security patches to the devices.
Avoid Distractions in the
Patient Viewing Area
Behind the Device
Figure 3 Example Setup

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7.1 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 Thrive® device
3. If not automatically connected, follow the instructions above, selecting Wired Connection 1.
4. Success is indicated when the icon in the top left corner is the Network icon.
7.2 Basic Wi-Fi Configuration
1. Click on the Network icon in the status
bar at the upper left corner of the screen
2. From the drop-down menu, select the
available Wi-Fi network to which you wish
to connect
a. If there are a large number of
networks available, you may see a
More networks option which you
can check if you do not see your
network listed.
Figure 4 Network Menu
3. Enter the Wi-Fi password for the
selected network
4. Click Connect
Figure 5 Authentication Prompt

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7.3 Connection Details
When logged on to a Cognivue Thrive® device, administrators can view and test the current network
configuration information on the Network Configuration window
To open the Network Configuration window
1. Log in
2. Select Device Administration >> Settings
3. Click the Network tab
The Network Configuration window contains network configuration properties and their values
Advanced Configuration is intended for use by network administrators and/or Cognivue Support Staff.
The most common usage of this functionality is outlined in the guide for Static IP Configuration
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.
In the future, the device will remember the network and
automatically connect when possible.
Figure 6 Network Selection Menu
•The Refresh button refreshes
the displayed connection
values
•The Test Connection button
confirms that the device has
network connectivity
•The Advanced Configuration
button opens settings for
more advanced networking
options
Figure 7 Network Configuration Screen

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8Security
8.1 Login
The user Login window is how you log in to a device.
It is how you log in to the device. Logging in with an individual account ensures an audit trail for viewing
patient reports and running assessments.
The Shutdown button appears on the Login window can be used by anyone to power down the device.
Clicking the Shutdown button will prompt confirmation before shutting down the device.
Note: This is the preferred way to shut down the device. The physical power button should be used only
if necessary.
8.2 User Management
Each Cognivue Thrive® 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.
Administrator
Operator
Setting up new accounts
X
Delete accounts
X
Changing accounts
X
Configure network connection
X
X
Entering patient data & running a test
X
X
Running a test with an intro video
X
X
Viewing past test reports
X
Table 8-1
Figure 8 Login Screen

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8.3 User Creation
From the User Management Screen
1. Click Create
2. Fill out form
3. Click Save
4. Click Yes to confirm when prompted
To open the User Management Screen
1. Log in
2.
Select Device Administration >> Settings
3. Click the Users tab
Figure 9 User Management Screen
Figure 10 User Creation Screen

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8.4 User Modification
8.5 Password Reset
8.6 Auto-Logout
The device will be logged out after 30 minutes of inactivity to prevent unauthorized access.
From the User Management Screen
1. Select a user from the list
2. Click Edit
3. Make the desired changes
4. Click Save
5.
Click Yes to confirm when prompted
Figure 11 User Modification Screen
From the User Management Screen
1. Select a user from the list
2. Click Set Password
3. Fill out the Set Password form
4. Click Save
5. Click Yes to confirm when prompted
Figure 12 Password Reset

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8.7 Password Expiration
Password expiration forces users to change their account passwords after a set number of days.
Password expiration applies to all user accounts but is disabled by default.
Users are warned about password expiration for three days before it expires. Once expired, the user will
be forced to change their passwords before they can log in.
To enable/disable password expiration:
1. Navigate to Device Administration >> Settings
2. Click the Enable Password Expiration checkbox
3. When this feature is enabled, a password lifetime must be specified
4. Enter the number of days in the text field labeled Password Expires after
8.8 Disabling 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.
From the User Management Screen
1. Click on a user in the list
2. Click the Disable User button
3. Click Yes to confirm when prompted
Figure 15 Disable User Prompt
Figure 14 Password Expiration Section
Figure 14 Password Expiration Prompt

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9System Settings
The Cognivue Thrive® 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
9.1 Client Code
The Cognivue Thrive® device provides the option to include a custom code on all tests for purposes of
categorization. Any sequence of up to 100 characters can be entered for each patient test session.
A user account with the Administrator role can enable it by checking the Enable Client Code checkbox
on the System Settings screen. Making this selection will add the Client Code text box to the
Assessment Setup screen before each assessment, where operators can enter the client code.
Figure 18 System Settings Screen (Client Code)
Figure 17 Assessment Setup Screen (Client Code)
To open the System Settings Screen
1. Log in
2. Select Device Administration
>> Settings
3. Click the System tab
Figure 16 System Settings Screen
Results in this section
being available

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9.2 Video Settings
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.
•Always Play Intro Video →Play the introduction video before every test
•Always Play Instructional Videos →Plays short instructional videos during the test
•Always Play Post Test Video →Plays a congratulatory video when the test completes
Figure 20 Assessment Setup Screen (Videos)
Figure 20 Default Video Setting Screen
Results in this option
always being selected

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10 Report Settings
The Thrive 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.
10.1 Report Emailing
Cognivue Thrive® 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.
When enabled, the option for the patient to receive a copy of the test report via encrypted email will be
provided on the Assessment Setup Screen.
Figure 21 Default Report Settings Screen
Figure 22 Report Settings Screen
Figure 23 Assessment Setup Screen (Email)
Results in this section
being available

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10.2 Report Printing
Cognivue Thrive® provides the ability to print the test report to a configured, connected printer. Printing
test reports from Cognivue Thrive® is enabled by default. An Administrator can disable this functionality
by unchecking the Enable Report Printing checkbox.
When enabled, a Print button will be displayed on the top navigation bar of the Report Viewer screen.
10.3 Automatic Printing
Cognivue Thrive® 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
Figure 27 Automatic Print Post Assessment Prompt
Figure 27 Reports Settings Screen
Figure 24 Report Viewer Screen
Figure 25 Report Settings Screen
Results in this button
being available

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10.4 Report Composition
Report Composition allows the inclusion of the Coginwell Information Sheet and picking one or both
reports.
WARNING Only the report generated will be available.
10.5 Practice Information
11 Portal Menu
For details about how to setup and utilize the Portal see the Portal User Manual
To open the Report Settings Screen
1. Log in
2. Select Device Administration >>
Report Settings
3. Click the Composition tab
Figure 28 Report Composition Screen
To open the Practice Information
Screen
1. Log in
2. Select Device Administration
>> Report Settings
3. Click the Practice tab
Figure 29 Practice Info Screen

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12 Patient Management
12.1 Pre Entering Patients
13 Assessments
Test administration is the core feature of Cognivue Thrive®. There are two paths to starting an
assessment: From the Main Screen and from the Patient List Screen.
To open the Patient List Screen
1. Log in
2. Click the Patient button
Figure 30 Patient List Screen
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 Screen
2. Fill out form
3. Click Save
4. Click OK to confirm when prompted
Figure 31 Patient Creation Screen

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13.1 Run Test (Main Screen)
Figure 13-1 Main Screen (Administrator)
1. From the Main Screen Click the Run
a Test button
2. Fill out patient data (Name, *sex,
date of birth)
3. Select the patient’s preferred
language for the test (English or
Spanish)
4. Enter any additional information as
desired
5. Select appropriate video options or
use the defaults
6. Click Run Test
7. The patient should turn the
CogniWheel when ready to begin
Figure 13-2 Assessment Setup Screen
Figure 32 Start of the Cognivue Assessment