Welch Allyn RETeval-DR Manual

Welch Allyn®RETeval-DR™
Directions for use

© 2018 Welch Allyn. All rights are reserved. To support the intended use of the product described in this
publication, the purchaser of the product is permitted to copy this publication, for internal distribution
only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this
publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn
assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that
may result from failure to use this product in accordance with the instructions, cautions, warnings, or
statement of intended use published in this manual.
RETeval and RETeval-DR are trademarks of LKC Technologies, Inc.
The RETeval-DR device may be covered by one or more of the following US patents and their foreign
counterparts: 7,540,613 and 9,492,098. Additional patents pending.
The RETeval-DR Sensor Strips may be covered by one or more of the following US patents and their
foreign counterparts: 9,510.762. Additional patents pending.
For information about any Welch Allyn product, contact Welch Allyn at www.welchallyn.com/about/
company/locations.
LKC is an ISO13485:2003 and EN ISO13485:2012 certified corporation.
DIR 80020080 Ver. F Revised 2018-02
This manual applies to RETeval.
Distributed By Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
LKC Technologies, Inc.
2 Professional Drive, Suite 222
Gaithersburg, MD 20879 USA
www.welchallyn.com
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Tel: [phone]
Fax: [phone]
For non-English RETeval-DR Directions for use, go to www.RETeval-DR.com.
Register your device at www.welchallyn.com/warranty.
Download firmware updates at www.welchallyn.com/softwaredownloads.

Contents
Introduction ............................................................................................. 1
Intended use ........................................................................................................ 1
Indications for use ................................................................................................ 1
Contraindications ................................................................................................. 1
Latex statement ................................................................................................... 2
Applicability .......................................................................................................... 2
Symbols and definitions ......................................................................... 3
Equipment serial number ....................................................................... 5
Locate the serial number on the device ............................................................... 5
Locate the serial number in Systems .................................................................. 5
About warnings and cautions ................................................................ 7
General warnings and cautions ............................................................................ 7
Controls and connectors ....................................................................... 11
Setup ...................................................................................................... 13
Unpack the system ............................................................................................ 13
Docking station .................................................................................................. 14
Charge the battery ............................................................................................. 14
Connect the sensor strip lead ............................................................................ 15
Thumb joystick ................................................................................................... 15
Device settings .................................................................................................. 16
Operating instructions .......................................................................... 23
Turn the RETeval-DR on and off ........................................................................ 23
Perform a test ........................................................................................ 25
Testing overview ................................................................................................ 25
Prepare the device ............................................................................................. 25
Prepare the patient ............................................................................................ 26
Device testing options ....................................................................................... 27
Test each eye ..................................................................................................... 27
Remove the sensor strips .................................................................................. 28
Test results ............................................................................................. 29
View results ....................................................................................................... 30
Delete results from the device .......................................................................... 32
iii

Manage firmware and software ........................................................... 35
Update firmware ................................................................................................ 35
Download the firmware update ......................................................................... 35
Copy the firmware to the device ....................................................................... 35
Update the firmware on the device ................................................................... 35
RETeval-DR utilities ............................................................................................ 36
Clean and disinfect ................................................................................ 37
Clean and disinfect ............................................................................................. 37
Clean the ganzfeld ............................................................................................. 37
Troubleshooting .................................................................................... 39
Specifications ........................................................................................ 43
Maintenance .......................................................................................... 45
User maintenance .............................................................................................. 45
Remove the eyecup ........................................................................................... 45
Replace the eyecup ........................................................................................... 45
Biocompatibility .................................................................................................. 45
Calibration and storage ...................................................................................... 46
Standards and compliance ................................................................... 47
General compliance and standards .................................................................... 47
Appendices ............................................................................................ 51
Approved accessories ........................................................................................ 51
DR assessment protocol .................................................................................... 51
Warranty ............................................................................................................ 54
iv Contents Welch Allyn®RETeval-DR™

Introduction
RETeval-DRTM Electroretinograph is designed as an aid in diagnosis and disease
management of visual pathway dysfunctions or ophthalmic disorders such as diabetic
retinopathy (DR). The DR Assessment Protocol has been clinically validated to match the
diagnosis from seven-field stereoscopic fundus images.
Test results are visible immediately on the device screen. The device automatically
creates PDF reports that include test results, patient information and your practice or
institution information. These PDF reports can be transferred to any PC via a USB cable.
Before using the device, read the sections of the manual that pertain to your use of the
RETeval-DR.
For information about any Welch Allyn product, contact Welch Allyn at
www.welchallyn.com/about/company/locations.
Intended use
The RETeval-DR device is intended to generate photic signals and measure and display
evoked responses generated by the retina and the visual nervous system.
The operators of the device are intended to be physicians, optometrists, medical
technicians, clinical medical assistants, nurses, and other health-care professionals.
Indications for use
RETeval-DR is indicated for use in the measurement of visual electrophysiological
potentials, including electroretinogram (ERG). RETeval is also indicated for use in the
measurement of pupil diameter.
RETeval-DR is intended as an aid in diagnosis and disease management in visual
pathway dysfunctions or ophthalmic disorders (e.g., diabetic retinopathy).
Contraindications
Use of the RETeval-DR device is contraindicated under these conditions:
•Do not use with patients diagnosed with photosensitive epilepsy.
• Do not use with patients who are allergic to the sensor strip gel.
• Avoid use when the orbit structure is damaged or surrounding soft tissue has an
open lesion.
1

Some patients may feel discomfort when viewing the flickering light that the RETeval-DR
device creates to test their eyes. This discomfort usually subsides quickly when the test
procedure completes.
Latex statement
The components of the RETeval-DR device that could contact the user or patient were
not made with natural rubber latex. This includes all items that could be contacted during
normal operation, and all other functions, such as user maintenance and cleaning, as are
defined in the Directions for use.
No internal components are known to be made with natural rubber latex.
Applicability
Regulatory and Safety requirements are occasionally revised. Please refer to the user
manual that originally accompanied your RETeval device for regulatory and safety
information relevant to that specific device.
2Introduction Welch Allyn®RETeval-DR™

Symbols and definitions
Documentation symbols
WARNING The warning statements in this manual identify conditions or practices that
could lead to illness, injury, or death. Warning statements appear with a grey background in
a black and white document.
CAUTION The caution statements in this manual identify conditions or practices that could
result in damage to the equipment or other property, or loss of data. This definition applies
to both yellow and black and white symbols.
Consult operating instructions/directions for use (DFU). A copy of the DFU is available on this
website. A printed copy of the DFU can be ordered from Welch Allyn for delivery within 7
calendar days.
Mandatory - Consult Directions for Use
Power symbols
Power button Direct current (DC)
Connectivity symbols
USB
3

Miscellaneous symbols
Manufacturer Date of manufacture
Product Identifier Reorder Number
Do not re-use By prescription or order of
physician
Type BF applied parts Meets essential requirements of
European Medical Device
Directive 93/42/EEC
ETL Listed mark indicating proof
of product compliance.
Conforms To:
AAMI Std ES 60601-1, CENELEC
EN Std 60601-1, IEC Std
60601-1-6, IEC Std 60601-1, IEC
Std 62366, ISO Std 15004-1, ISO
Std 15004-2, IEC 60601-2-40
Certified To:
CSA Std No. 60601-1
Temperature limit
Keep away from rain Lot Code
Expiration Date Global Trade Identification
Number
Do not dispose of in trash,
Contains Li-Metal batteries
Not made with natural rubber
latex
Serial Number Contains lithium-Ion. This symbol
indicates general recovery /
recyclable and must not be
disposed of as unsorted
municipal waste and must be
collected separately.
4Symbols and definitions Welch Allyn®RETeval-DR™

Equipment serial number
Each RETeval-DR device has a unique equipment serial number. The equipment serial
number may appear in one of two formats.
The serial number takes the form R # # # # # #.
RProduct code is R
# # # # # # Production sequence number (5 or 6 digits)
Locate the serial number on the device
1. Remove the battery cover.
2. Pivot the battery away from the device to locate the serial number.
The serial number begins with the letter "R."
Locate the serial number in Systems
1. Scroll to Settings and then press the joystick.
2. Scroll to System and then press the joystick.
The System Information screen appears showing the following information.
• The firmware version
• The serial number
• The number of tests completed
5

6Equipment serial number Welch Allyn®RETeval-DR™