Emmes EVA 14-WIN Manuale utente

USER’S MANUAL

Indications for Use Statement: The Emmes EVA product/device family is intended to assess visual acuity

performance and to be operated by healthcare professionals.

Manual Revised April 2020

Emmes EVA User’s Manual Model 14 WIN, v9.0 
April 2020 
i 
TABLE OF CONTENTS 
QUICK START GUIDE ................................................................................................................ 1 
MODEL HIGHLIGHTS ................................................................................................................ 3 
SYSTEM DESCRIPTION.............................................................................................................. 4 
TERMS AND DEFINITIONS........................................................................................................ 4 
EMMES EVA SYSTEM COMPONENTS....................................................................................... 6 
PRE-TEST HARDWARE AND SOFTWARE SETUP....................................................................... 7 
A Physical/Environment Setup 7 
B EVA Study/Data Profile Setup 7 
PRE-TEST EVA DISPLAY VERIFICATION..................................................................................... 8 
A EVA Display Size Verification 8 
B EVA Display Luminance Verification 8 
TIPS FOR SUCCESSFUL USE ...................................................................................................... 9 
BASIC USE OF THE EMMES EVA............................................................................................... 9 
A Perform a Visual Acuity Test 9 
B Data Validation Codes 10 
C View Previous Test Results 10 
DElectronically “Print” (e-Print) Test Results 10 
OTHER FEATURES OF THE EMMES EVA................................................................................. 11 
A Retrieve/Bulk Export Of Study Data 11 
B Sleep/Wake-Up The Emmes EVA 12 
C Shut Down The Emmes EVA 12 
EMMES EVA SEMI-AUTOMATED VISUAL ACUITY TESTING MODES...................................... 12 
A e-ETDRS Visual Acuity Test 12 
B e-HOTV (ATS-HOTV) Visual Acuity Test 13 
C Low-Contrast E-ETDRS Visual Acuity Test 13 
D Low-Contrast ATS-HOTV Visual Acuity Test 13 
VISUAL ACUITY CHART ACCESS.............................................................................................. 14 
FREQUENTLY ASKED QUESTIONS .......................................................................................... 14 
A System Questions 14 
TROUBLSEHOOTING GUIDE................................................................................................... 16 
A EVA iPod cannot connect to the internet. (See Figure 1) 16 
B The Emmes EVA will not turn on. 17 

Emmes EVA User’s Manual Model 14 WIN, v9.0 
April 2020 
Table of Contents Cont’d. 
 
 
 ii 
14.C Cannot remember EVA iPod Passcode 17 
14.D The EVA Display is distorted or not functioning 17 
14.E EVA Program Flash Drive Error (See Figure 2) 18 
APPENDIX A: EVA Lux Meter......................................................................................................................................19 
APPENDIX B: Regulatory Information ........................................................................................................................21 
 
 
 

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

1. QUICK START GUIDE

A. Unpack:

1. Lay all the parts from the top tray on a clean, flat surface.

2. Lay the EVA Display screen down on a clean, flat surface.

3. Open the EVA iPod box and remove the EVA Program Flash Drive EVA iPod

charging cable

B. Assemble:

1. EVA Display –connect display base to display head

a. Pull up EVA Display arm.

b. Matching up arrows, slide EVA Display base onto EVA Display arm.

c. Turn thumb nut to secure EVA Display arm to EVA Display base, then folder

thumb lever flat

2. EVA PC –attach the EVA PC to the back of the EVA Display

a. Stand EVA Display on its base and turn it so the screen is facing away from

you.

b. The two screw/pegs on the EVA PC slide into the slots on the metal plate on

the EVA Display.

c. Slide EVA PC down to lock it to metal plate.

C. Connect

1. Insert the EVA Display power cable into appropriate receptacle on the EVA

Display.

2. Insert one end of the EVA Display (HDMI) cable into appropriate receptacle on the

EVA Display.

3. Insert the EVA PC power cable into the appropriate receptacle on the EVA PC.

4. Insert the remaining end of the EVA Display (HDMI) cable into the appropriate

receptable on the EVA PC.

5. Insert the EVA iPod charging cable into YELLOW USB PORT (fast charge). Always

reserve this port for charging the EVA iPod.

6. Insert the EVA iPod charging cable into the EVA iPod

7. Insert EVA Program Flash Drive into USB port next to the one reserved for the

EVA iPod.

D. Orient:

1. Turn entire connected assembly around so the screen is facing you.

2. Organize all cables as necessary, being mindful of where available power outlets

are located.

3. Plug wall-side ends of power cables into available receptacles.

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

E. Turn on:

1. Power on the EVA Display –single press once the right-most button on the EVA

Display until it lights up any color (orange or blue).

2. Power on the EVA PC –single press the power button until blue light turns on.

3. Power on the EVA iPod –single press and briefly hold the power button

F. Wait:

1. **NOTE** This step is important every time the device is restarted

or powered on

2. Once ALL components are on and fully booted (EVA iPod shows lock-screen;

display shows “Testing Requirements”) WAIT at least 30 seconds BEFORE

launching the EVA App on the EVA iPod.

G. Launch:

1. Single-tap the EVA App on the EVA iPod screen below the arrow.

2. WAIT for the EVA App to load: it may take several moments.

3. Once the EVA App loads, you should see the following sub-applications:

a. E-EDTRS

b. ATS-HOTV

c. Low Contrast E-ETDRS

d. Low Contrast ATS-HOTV

e. Chart

f. Test Results

g. Settings

h. Sleep/Wake Up

i. Shutdown.

4. Try an E-ETDRS Test

a. In the EVA App, tap E-ETDRS, select NON STUDY, proceed and familiarize

yourself with the prompts.

b. Complete/finish the test and note the results screen.

5. Look up the previous NON STUDY test result

a. In the EVA App, tap “Test Results”, select NON STUDY, proceed as necessary

to look up the previous test.

6. Enable Study Study/Data Profiles

a. In the EVA App, tap Settings > Manage Studies and scroll through available

Study/Data Profiles. If you don’t see the study you’re looking for, contact

Emmes EVA Support

•IMPORTANT: Regardless of any error messages you see…

oDO NOT re-configure the EVA iPod WiFi settings.

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

oDO NOT connect the EVA iPod WiFi to any network.

oFor example: DO NOT connect the EVA iPod to your local WiFi network.

•Electrical Safety: Inspect all cords before operating the Emmes EVA. If any cords

look damaged,

oDO NOT power on the Emmes EVA and contact Emmes EVA Support.

•The Emmes EVA is a turn-on-and-go design!

•If the Quick-Start Guide was followed and the Emmes EVA is not working,

DO NOT attempt to troubleshoot a solution, please contact Emmes EVA Support:

Web: eva.emmes.com

Email: [email protected] (preferred route for faster support)

Phone: 1.888.315.4039 (toll free)

oInclude the following information in the request for support:

▪Study

▪Site Number

▪Serial Number (e.g. T002000)

▪Issue

2. MODEL HIGHLIGHTS

•Model 14-WIN is a desktop Emmes EVA capable of Low Contrast visual acuity testing.

•System controlled remotely via iPod Touch.

•Able to display letters down to 20/10.

•E-ETDRS algorithm available in 5% and 2.5% low contrast levels.

•Sleep option to make the Display dark without turning it off.

•System is ~8.50” deep and ~16” to top of Display with PC mounted on the back of the

Display (Display is ~22.25” wide).

•Test results are stored as encrypted files per HIPAA requirements.

Model 14-WIN Emmes EVA is configured and calibrated for low contrast testing.

DO NOT adjust the Display settings. If the Display does not fall within range

(greater than 106 lux on the EVA Lux Meter) contact Emmes EVA Support.

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

3. SYSTEM DESCRIPTION

The Emmes Electronic Visual Acuity (Emmes EVA) Tester features wireless proctor control to

administer semi-automated visual acuity tests.

For normal (high contrast) testing, stimuli are high-contrast, black letters with luminance of

95 cd/m2or higher and contrast of 98%. The system can present single letters or lines of letters.

Single letters are framed with crowding bars around the letter. For low contrast testing, stimuli

are gray letters with a contrast of either 2.5% or 5% compared to the white background. Letters

are framed with crowding bars of the same contrast.

For lines of letters in the Chart application, five (5) letters are displayed for sizes smaller than

20/100; a decreasing number of letters is displayed as letter size increases. With a 23.6-inch

LCD/LED Display at 1920 x 1080 pixels, the system is capable of displaying letters from 20/800 (1.6

logMAR) to 20/6 (-0.5 logMAR), at a test distance of 3 meters. Letter size corresponds to the

logMAR progression of the ETDRS charts.

The EVA iPod provides direct, wireless control of the Emmes EVA. The EVA iPod provides

information to the technician and displays the letter that is being shown on the EVA Display. For

the semi-automated tests (ATS-HOTV, E-ETDRS) the size and sequence of letter presentations is

determined from a computer algorithm based on the recorded subject’s responses.

Model 14-WIN automatically saves test results as encrypted records in a database on the Emmes

EVA hard drive and can be configured to also save results to an external removable storage (e.g.

a USB flash drive).

4. TERMS AND DEFINITIONS

The Emmes EVA (EVA)

All core components that make up the Emmes EVA: the EVA PC, the EVA Display, the EVA iPod.

EVA PC

The personal computer (PC) sent with the Emmes EVA.

EVA Display

The primary/large display that displays optotypes/letters to the test subject

EVA iPod

The iPod Touch that is used as the controller for the Emmes EVA.

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

EVA Study/Data Profile

Customized data entry profile created by the Emmes EVA Team for a specific study or testing

effort. The EVA Study/Data Profile determines what data will be collected for each test and

enforces format entry of values, such as “Subject ID” or “Technician ID”.

EVA Study/Data Profile PIN

Study/Data Profile-specific four-digit value required to retrieve study test results from the

database.

EVA Lux Meter

Used to ensure Emmes EVA Display can provide sufficient luminance prior to running a test.

EVA Program Flash Drive

Portable memory device used to store printable test results (optional) and retrieved data. The

flash drive must be inserted in a USB port to run a visual acuity test.

EVA Retrieval Flash Drive

Used to retrieve study data from the Emmes EVA database. The flash drive must be inserted

before the data can be retrieved.

EVA Testing Requirements Screen

The initial screen when Emmes EVA starts up. Emmes EVA Testing Requirements are displayed

with a white square outlined in black in the middle of the screen. The square is used for EVA

Display verification.

Serial Number (Txxxxxx)

Unique identifier for the Emmes EVA. This has also been referred to in the past as “TowerID”, but

this is a serial number uniquely identifying the device. This unique identifier is printed on a label

attached to the Emmes EVA PC; example “T000123”. This unique identifier also appears in the

name of the wireless connection between the EVA iPod and Emmes EVA PC.

Data Validation Codes

Coded values representing test date, identifier (e.g., patient ID), eye, and test result that can be

used during data entry to confirm test results are correctly entered on the case report forms.

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

5. EMMES EVA SYSTEM COMPONENTS

The shipment should include the components listed below:

EVA PC (bears Serial Number)

EVA iPod (bears Serial Number)

Power adapter, EVA PC

EVA iPod USB charging cable

EVA Display (23.6” Flat-Panel Display) (bears

Serial Number)

EVA Program Flash Drive

Power adapter, EVA Display

EVA Lux Meter

HDMI cable

Plastic Ruler

Power Adapter(s) (Non-US units only)

EVA Tape Measure

Note: *Components may vary slightly in appearance from figures referenced in this manual*

*A keyboard and mouse are not used with the Emmes EVA and are not included*

Emmes EVA User’s Manual Model 14 WIN, v9.0

April 2020

6. PRE-TEST HARDWARE AND SOFTWARE SETUP

Follow these instructions to set up the Emmes EVA.

6.A Physical/Environment Setup

1. Follow the Quick-Start Guide in its entirety before proceeding.

2. Ensure the front-center of the EVA Display and/or subject chair are such that the line

of sight from the front-center of the EVA Display to the front surface of the subject’s

eyes, is 3-meters (118 inches) in length. If the surface for the Emmes EVA and the

seating surface for the subject are height-adjustable, this 3-meter line-of-sight

distance can be achieved in a variety of configurations.

3. Double-check: Confirm testing distance is 3-meters (118 inches) from the subject’s

eyes to the EVA Display.

4. Testing room ambient lighting should be dim and diffuse. No light source should be

competing with the EVA Display. The EVA Display should be the brightest source of

light in the room by a good margin.

6.B EVA Study/Data Profile Setup

The Emmes EVA ships with a base package of studies that have data entry programs for patient

testing. Before using the Emmes EVA, you must enable the studies in which your clinical site is

participating. The enabled studies will be displayed when an E-ETDRS or ATS-HOTV test is

performed. The package also includes a “NON STUDY” profile (no custom data entry) that is

always enabled. The NON STUDY profile is NOT valid for use in clinical trials.

Enable the Emmes EVA Study/Data Profiles relevant for the testing to be performed. This

enablement is a one-time configuration and the EVA Study/Data Profile will remain in its last saved

state (e.g. enabled).

•On the EVA iPod, tap Settings on the EVA App Home screen, then tap Manage

Studies.

•Under Current Studies, tap the switch to activate the study

•When finished activating studies for your site, tap Save.

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