Cognivue Clarity User manual

User Manual
© 2021 COGNIVUE, INC. 7911 Rae Blvd | Victor, NY 14564 | 585.203.1969

Cognivue Clarity® User Manual
© 2021 Cognivue, Inc. UM-410-J Page 1
Contents
1.0 About Cognivue Clarity® ................................................................................................................... 3
2.0 Device Description ............................................................................................................................ 4
3.0 Recommendations for Use ............................................................................................................... 5
General Testing Location ................................................................................................................. 5
Positioning of Cognivue Clarity® and the Patient. ........................................................................... 5
Cleaning and Disinfecting Cognivue Clarity® ................................................................................... 5
Use of Personal Protective Equipment ............................................................................................ 6
4.0 Network Connectivity ....................................................................................................................... 6
Basic Wi-Fi Configuration................................................................................................................. 6
Basic Wired Connection................................................................................................................... 7
Connection Details........................................................................................................................... 8
Advanced Configuration .................................................................................................................. 8
Static IP Address Configuration .................................................................................................. 8
5.0 Logging on to Cognivue Clarity® ..................................................................................................... 11
6.0 Managing User Accounts ................................................................................................................ 12
Creating User Accounts..................................................................................................................13
Modifying User Accounts...............................................................................................................13
Deleting User Accounts.................................................................................................................. 14
Password Expiration....................................................................................................................... 15
7.0 System Information.........................................................................................................................15
8.0 System Settings...............................................................................................................................16
Enable Report Emailing..................................................................................................................16
Disable Report Printing ..................................................................................................................16
Setting a Default Printer ...........................................................................................................16
Enable Force Intro Video ............................................................................................................... 17
9.0 Practice Information ....................................................................................................................... 18
10.0 Running a Test................................................................................................................................. 18
11.0 Video Volume Control..................................................................................................................... 19
12.0 Finding and Viewing Reports .......................................................................................................... 19
13.0 Printing Reports ..............................................................................................................................22
14.0 Emailing Reports .............................................................................................................................22
15.0 Removing Reports...........................................................................................................................23
16.0 Power Management .......................................................................................................................24
Screen Sleep................................................................................................................................... 24
Screen Wake ..................................................................................................................................24
Power Alert ....................................................................................................................................24

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17.0 Technical Specifications ..................................................................................................................24
18.0 Safety Precautions and Compliance ...............................................................................................25
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 9-5pm EST at 1-585-433-2992 or
[e-mail].
UM-410-J Cognivue Clarity® User Manual, 02/2/2021
© 2020 Cognivue, Inc. | 7911 Rae Blvd | Victor, NY 14564 | 585.203.1969

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1.0 About Cognivue Clarity®
Cognivue Clarity® is a computerized cognitive assessment aid that objectively, quantitatively, and
reliably evaluates cognitive function. Upon completion of a series of 10 subtests, Cognivue Clarity®
creates a one-page easy-to-interpret patient report with a single clinical score of cognitive function and
a two-page physician report that includes the overall score, breakdown into key cognitive domains and
two key speed parameters. Using these reports, physicians are able to evaluate the patient’s cognitive
profile and decide on the proper course of action to improve patient care. If the score indicates the
patient does not have cognitive impairment, their overall and breakdown cognitive scores can be used
as a baseline for future comparison.
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
physician.
Warnings
1) Cognivue Clarity® does not identify the presence or absence of clinical diagnoses.
2) Cognivue Clarity® cannot be used as a stand-alone diagnostic.
3) Cognivue Clarity® is intended to be used in clinical settings.
Cognivue® scores ≤ 50 are consistent with being impaired (moderate to severe impairment), and scores
≥ 75 are consistent with being unimpaired (normal cognitive function) and scores between 51 and 74
are intermediate (low cognitive impairment). In the Cognivue® clinical validation study, 401 participants
completed ≥ 1 testing session, and 358 completed 2 sessions 1-2 weeks apart. The study showed that
SLUMS cut-off scores of < 21 (impairment) and > 26 (no impairment) corresponded to Cognivue® scores
of 54.5 (NPA = 0.92; PPA = 0.64) and 78.5 (NPA = 0.5; PPA = 0.79), respectively. Cognivue® classification
scores demonstrated good agreement with 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
analysis was similar to Advanced (R2 = 0.859; r = 0.927)
Additional information is available in the following references:
•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.

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2.0 Device Description
The Cognivue Clarity® is a portable, battery powered, and 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.
CogniWheel
®
CogniCover
®
Battery Indicator Lights &
Headphone Jack
USB (for Keyboard)
Ethernet
Battery Charger
Power Button

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Avoid Distractions in the
Patient Viewing Area
Behind the Device
3.0 Recommendations for Use
To provide the best experience for patients and to produce repeatable test results, Cognivue
recommends the following when using Cognivue Clarity®.
General Testing Location
When possible, choose a test location that reduces distractions (for example, an exam room, office or
conference room rather than a busy hallway).
Positioning of Cognivue Clarity® and the Patient.
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.
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 and may lead to the patient not being able to consistently use the
CogniWheel®.
Cleaning and Disinfecting Cognivue Clarity®
Cognivue recommends sanitizing the Cognivue Clarity® 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!
•In the event wipes are not available, sanitizing or disinfecting spray may be used as follows:
Spray twice onto a 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!

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Use of Personal Protective Equipment
While Cognivue recommends sanitizing the device (see Cleaning and Disinfecting Cognivue Clarity®)
before and after administering a test, Cognivue also recommends that operators and patients wear a
disposable mask while interacting with the device. In the event it is not possible to sanitize the device
between patients, Cognivue recommends that operators and patients also use disposable gloves.
4.0 Network Connectivity
Network connectivity is essential to utilize the full capability of the Cognivue Clarity® device. Connecting
to a network will allow your facility to access reports from other computers within the same network. In
addition, Cognivue remotely provides regular software updates that enable new features, fix issues, and
ensure that the system configuration remains secure. These automatic software updates require
Cognivue Clarity® to be connected periodically through your network to Cognivue back-end services.
While it does not need to be connected to run a test, it should be regularly re-connected to a network,
ideally on a daily basis. Cognivue recommends that Clarity devices be connected to a network when
they are plugged into a power source for charging.
Basic Wi-Fi Configuration
To establish a basic network connection, click on the Network icon in the status bar at the upper left
corner of the screen. From the drop-down menu, select the available Wi-Fi network to which you wish
to connect. In this example, the network is “Cognivue”, but you will connect to your network with a
different name. If there is 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.
Network icon

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Upon selecting a network, you will be prompted to enter the Wi-Fi password for the selected network.
Wifi Authentication dialog
Upon entering a correct password and clicking the Connect button, the Cognivue Clarity® device will be
connected. Note that the icon in the top left has now changed to the Wi-Fi connection strength icon
indicating network connectivity.
Wi-Fi Connection Strength icon
The first time the device is connected to any network, it will be necessary to follow this procedure to
select the network and enter the credentials for that network. Once connected to a network, the device
will remember the credentials so that when moving from one previously-connected network to another,
it will be necessary to simply click the Network icon and select the desired network.
Basic Wired Connection
To establish a wired connection to a network, connect one end of a standard network cable to an active
network jack at your location and the other end into the RJ-45 network port on the back of the Cognivue
Clarity® device. Follow the same instructions as above, but this time select Wired Connection 1. The
icon in the top, left corner will now be the Network icon.

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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.
Network Configuration window
To open the Network Configuration window, on the Primary window (see 5.0 Logging on to Cognivue
Clarity®) select Device Administration >> Settings and then click the Network tab. The Network
Configuration window contains network configuration properties and their values, as well as
instructions for setting up a basic connection as described above. To ensure the displayed connection
property values are current, click the Refresh button. If all the property values are blank, the device is
not connected and you will need to follow the instructions to establish a connection. Once there are
property values displayed, you can use the Test Connection button to confirm that the device has
network connectivity and is able to connect to the Cognivue back-end systems.
Advanced Configuration
When more advanced network configuration is required, an administrator can log on to the Cognivue
Clarity® device and open the Network Configuration window as described above. Generally, this more
advanced configuration will be done during a consultation with a network administrator and/or
Cognivue Support staff; however, one of the more common advanced configurations is described in the
following subsection.
Static IP Address Configuration
Click the Advanced Configuration button on the Network Configuration window.

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A Network Connections configuration wizard window will appear. Click on the connection named for
your SSID and then click the Gear icon.
Network Connections wizard
On the pop-up window that appears, click on the IPV4 Settings tab.
Network Configuration Editor
Gear icon