LKC TECHNOLOGIES RETeval User manual

RET eval ™Device
User Manual
Issue Date: January 7, 2022
Rx only
2797

Copyright © 2012 –2022 LKC Technologies, Inc.
LKC Technologies, Inc., established in 1987, is ISO 13485:2016 certified and holds MDSAP and
FDA registrations and a CE certificate as a medical device manufacturer with quality products
installed in over fifty countries.
LKC Technologies, Inc.
2 Professional Drive, Suite 222
Gaithersburg, MD 20879 USA
T: [phone]
F: [phone]
[email protected]
www.lkc.com
Document number 96-023

RET eval Device User Manual
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Table of Contents
Welcome to RET eval ™........................................................................................................ 5
What's in the box...........................................................................................................................6
Getting Started...................................................................................................................... 7
Connect the cord to the docking station and plug in........................................................................7
Let the device charge .....................................................................................................................7
Connect the Sensor Strip lead.........................................................................................................7
Device controls ..............................................................................................................................8
Main Menu....................................................................................................................................8
Settings .........................................................................................................................................9
Performing a test................................................................................................................. 12
Viewing Results................................................................................................................... 16
Results on the device ...................................................................................................................16
Results on a PC ............................................................................................................................17
Reflex testing ...................................................................................................................... 19
Choosing a protocol............................................................................................................. 20
DR Assessment ............................................................................................................................20
Other protocols ...........................................................................................................................22
Additional Activities ............................................................................................................ 23
Removing old results from the device...........................................................................................23
Updating firmware.......................................................................................................................24
Electronic medical record (EMR) support ......................................................................................24
RETeval Flicker Option......................................................................................................... 25
Flicker protocols ..........................................................................................................................25
Custom protocols.........................................................................................................................26
Flicker test results........................................................................................................................26
RETeval-S Option ................................................................................................................. 31
RETeval-S protocols....................................................................................................................31
RETeval-S test results .................................................................................................................35
RET eval Complete Option .................................................................................................. 39
RETeval Complete protocols........................................................................................................39
Custom protocols.........................................................................................................................51
Performing a VEP test ..................................................................................................................52
RETeval Complete test results .....................................................................................................54
Reference Intervals ............................................................................................................. 67
Using reference intervals as clinical decision limits........................................................................68
Turning reference data reporting on and off .................................................................................69
Using your own reference data.....................................................................................................69
Reference data details .................................................................................................................69
Troubleshooting Hints ......................................................................................................... 75
Charge the battery when the charge is low...................................................................................75

RET eval Device User Manual
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Measure the patient’s right eye first.............................................................................................75
Place the Sensor Strips under the correct eye ...............................................................................75
The device doesn’t show the Next button after I connect to the Sensor Strip (or other electrode
type) or after pressing the Start test button, I get an “The electrodes have been disconnected” error
....................................................................................................................................................76
The device shows “Excessive electrode noise” ..............................................................................76
The device won’t let me press the Start test button when I can see the eye...................................77
After pressing the Start test button, I get an “Excessive ambient light” error.................................77
After pressing the Start test button, I get an “Unable to calibrate” error .......................................78
The screen is blank but the power light is on.................................................................................78
The RETeval device won’t connect to my PC .................................................................................78
I get a “scan and fix” error from Windows®when placing the RETeval device in the docking station
....................................................................................................................................................79
Results are “not measurable”.......................................................................................................79
Reset settings ..............................................................................................................................79
Device language is set to an unfamiliar language ..........................................................................80
An error code is reported .............................................................................................................80
Works Cited......................................................................................................................... 81
Regulatory and Safety Information ...................................................................................... 85
Applicability.................................................................................................................................85
Intended use................................................................................................................................85
Indications for use .......................................................................................................................85
Latex statement...........................................................................................................................85
Specifications...............................................................................................................................86
Contraindications.........................................................................................................................86
Cleaning and Disinfection.............................................................................................................87
Sterilization .................................................................................................................................88
Biocompatibility ..........................................................................................................................88
Calibration and Storage................................................................................................................88
Service / Repairs..........................................................................................................................88
Product performance...................................................................................................................88
Essential performance..................................................................................................................89
Operating environment................................................................................................................89
Lifetime.......................................................................................................................................89
Precautions..................................................................................................................................89
Electromagnetic compatibility (EMC)............................................................................................90
RoHS ...........................................................................................................................................94
California Proposition 65..............................................................................................................95
Symbols.......................................................................................................................................96
Equipment identification..............................................................................................................97
Approvals ....................................................................................................................................98
Intellectual Property............................................................................................................ 99
Contact Information .......................................................................................................... 100
Support .....................................................................................................................................100
Warranty...................................................................................................................................100
Purchasing Supplies and Accessories ..........................................................................................101

RET eval Device User Manual
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European Representative...........................................................................................................102
Company ...................................................................................................................................102

Welcome to RETeval ™
RET eval Device User Manual 5
Welcome to RET eval ™
Congratulations on your acquisition of the RET eval visual electrodiagnostic device. With the
RET eval device, you can offer your patients a convenient retinal diagnostic evaluation.
Every RET eval device comes with flicker-based protocols, and through optional upgrades, single-
flash based protocols become available through a protocol chooser that enables other
electroretinogram (ERG) and visual evoked potential (VEP) testing.
Test results are visible immediately on the device screen. The device automatically creates PDF
reports that include test results, protocol information, patient information and your practice or
institution information. These PDF reports can be transferred to any PC via a USB cable. The
RET eval device has an electronic medical record interface to digitally order tests for a patient
and transfer results into a supported EMR / EHR system.

Welcome to RETeval ™
RET eval Device User Manual 6
What's in the box
The RET eval device is packaged with these items. Check that all items are present.
RET eval device
Measures the response of the eye to light.
Docking station
Charges the RET eval device and enables data transfer to a PC. Connect to an
electrical outlet using the power brick.
Dust cover (not
shown)
Protects the device from dust while not in use.
Sensor Strip lead
Connects the device to Sensor Strips for testing.
USB cable
Connects the device to a PC to transfer results.
Power brick and
plates
Connects the device to an electrical outlet. Use the wall-plug option that
matches available electrical outlets.
User Manual
This document. The manual is available as a PDF located on the root directory
of the RET eval device.
Sensor Strips
Skin electrode arrays for measuring the eye’s electrical response. One box of
50 Sensor Strip pairs is provided.
DIN adapter
cable
Connects DIN electrodes, supplied with RET eval Complete.

Getting Started
RET eval Device User Manual 7
Getting Started
Connect the cord to the docking station and plug in
Attach the power brick plate that matches your electrical outlet to the power brick.
Connect the power cord to the docking station.
Connect the power brick to an electrical outlet. The power supply accepts 100 –240 VAC, 50/60
Hz.
Let the device charge
The RET eval device charges its battery when in the docking station from either the USB or power
brick connection. If the power brick is connected, charging will be significantly faster than if only
a USB connection is present. The charging status is shown on the display. If the display is blank,
press the power button to turn it on. The RET eval device is shipped with a partial charge.
Connect the Sensor Strip lead
Connect the Sensor Strip lead to the blue Sensor Strip lead connector.
The Sensor Strip lead for regular Sensor Strips has one Sensor Strip clip,
the Sensor Strip lead for the Small Sensor Strips has two Sensor Strip
clips.
Sensor Strip Lead is long enough for most circumstances; however, if
your application requires additional length, a 24” (61 cm) long extension
is available (see Purchasing Supplies and Accessories). If an extension

Getting Started
RET eval Device User Manual 8
cable is used, it is necessary to loop the cable over the patient’s ear or tape the cable to the
patient’s cheek to prevent the weight of the extension from impacting test measurements.
Device controls
The RET eval device has an up/down/right/left/select joystick and an on-off power button.
Turning the device off
You can turn the device off at any time by pressing the power button and holding it down for at
least 1 second.
The screen goes blank immediately, but the device takes a few more seconds to turn off
completely.
Wait a few seconds after the power indicator light stops blinking before turning the device back
on.
Joystick
The joystick provides a simple and intuitive user interface. Use your thumb to push the joystick
in the desired direction.
UP and DOWN move the selection highlight up or down.
Go back one screen:
Press LEFTwhen the cursor is at the left edge of the screen.
Go forward one screen:
Press RIGHT when the cursor is at the right edge of the
screen.
Select a highlighted item:
Press SELECT.
Main Menu
The RETeval device main menu has a top status bar, four buttons, and at
the bottom a description of the currently-selected protocol. The status
bar shows the time, date, and battery charge state. The four buttons
enable the operator to start a new test, view previous results, change
system settings, and choose the protocol that will run when starting a
new test. At the bottom of the screen, the currently selected protocol is
displayed.

Getting Started
RET eval Device User Manual 9
Settings
Set up the RETeval device for use in your practice.
Step 1. Turn on the device.
The device goes through a brief internal test and initialization.
Step 2. Select Settings.
Step 3. Adjust each setting as you prefer.
Language
Select the language you want to use for the device’s user interface and
PDF reports.
If you select a right-to-left language (i.e., Arabic), the RIGHTand LEFT
joystick directions are swapped from the description in this manual.
Date / Time
Use the joystick to select each element of the current date. Use the
RIGHT and LEFT joystick directions to move between pages. The
device uses the date and time to label results and to compute the
patient’s age. The date and time can also be updated via scanning a
barcode at the beginning of a test using the free data barcode
application which runs on Windows (https://bit.ly/retevalbarcodereader) and smartphones
(search for RETeval on your phone’s app store).
Backlight
The LCD backlight for the operator’s display can be adjusted separately
for light-adapted and dark-adapted testing. The device will
automatically switch between those two modes as appropriate during a
test. Brighter settings may be more visible, but will slightly reduce the
number of patients you can test before needing to recharge in the
docking station. For dark adapted testing, brighter settings reduce the
time the operator needs to dark adapt to be able to see the screen clearly
but may affect the patient’s rod sensitivity. For light adapted testing, the
operator’s display can be set to high, medium, or low brightness. There
is also a “red” option that makes the display only use red light. For dark
adapted testing, there are three levels of brightness that only use red light as well as dim full-
color. The default values are medium brightness for light adapted scenarios and dim red for dark
adapted testing.