Welch Allyn RetinaVue 100 Imager Manual

Welch Allyn RetinaVue™ 100
Imager
Directions for use
Software version 4.6.XX

© 2016 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.
Prescription only or "For Use by or on the order of a licensed medical professional."
Software in this product is Copyright 2015 Welch Allyn or its vendors. All rights are reserved. The software is
protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under
such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in
the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-
engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or
any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors.
For information about any Welch Allyn product, contact Welch Allyn Technical Support: http://www.welchallyn.com/
support.
411492, (printed copy)
DIR 80019780 Ver. C
Revision date: 2016-01
This manual applies to the 901103 Fundus Camera
Manufactured for Welch Allyn, Inc.
Medimaging Integrated Solution Inc. (MiiS)
1F, No. 7, R&D Rd II, Hsinchu Science Park,
Hsinchu, TAIWAN 30076, R.O.C.
Obelis S.A.
Bd. General Wahis 53,1030,
Brussels, Belgium
Made in Taiwan

Contents
Symbols ................................................................................................... 1
Introduction ............................................................................................. 5
Intended use ........................................................................................................ 5
About warnings and cautions ............................................................................... 5
General warnings and cautions ............................................................................ 5
Controls and connectors ...................................................................................... 7
RetinaVue 100 Imager Home screen ................................................................... 8
Using the RetinaVue 100 Imager ......................................................... 17
Unpack the system ............................................................................................ 17
Docking station .................................................................................................. 23
Patient data management .................................................................................. 25
Perform an eye exam using the Auto exam mode ............................................ 28
Perform a manual image capture while in Auto exam mode ............................. 34
Skip an image capture while in Auto exam mode .............................................. 35
Perform a manual image capture while in Manual exam mode ......................... 36
Update the RetinaVue 100 Imager software ..................................................... 38
Viewing or changing the RetinaVue 100 Imager settings .................................. 39
Troubleshooting .................................................................................... 41
Maintenance .......................................................................................... 45
Clean and disinfect ............................................................................................. 45
Specifications ........................................................................................ 47
Device radio ........................................................................................... 49
General compliance and standards ..................................................... 51
General radio compliance ................................................................................... 51
Approved accessories ........................................................................... 57
Accessories ....................................................................................................... 57
Warranty ................................................................................................ 59
iii

iv Contents Welch Allyn RetinaVue™ 100 Imager

Symbols
Documentation symbols
WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness, injury,
or death. Warning symbols will 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.
Consult Directions for Use
Power symbols
Power button Direct current (DC)
Rated power input, DC Rated power output, DC
Fuse Rechargeable battery
Battery Charging - Non-AC powered
Connectivity symbols
USB Wireless signal strength (requires
optional software)
• Best (4 bars)
• Good (3 bars)
• Fair (2 bars)
• Weak (1 bar)
• No signal (no bars)
1

•No connection (X)
Shipping, storing, and environment symbols
Temperature limit Keep Dry
Separate collection of Electrical and
Electronic Equipment. Do not dispose as
unsorted municipal waste.
Fragile
Humidity limitation Atmospheric pressure limitation
This way up Stacking limit by number
Recyclable
Miscellaneous symbols
Product Identifier Reorder Number
Global Trade Item Number For indoor use only
Type BF applied part Prescription only or "For Use by or on the
order of a licensed medical professional"
Non-ionizing electromagnetic radiation Serial Number
FCC ID The identification number assigned by
the Federal Communication Commission
2AFB3WA-WEC100
Clock; time switch; timer
2Symbols Welch Allyn RetinaVue™ 100 Imager

Battery charge level indicators
Device is running on battery and is fully
charged.
Device is running on battery and charge
is below 75 percent.
Device is running on battery and charge
is below 50 percent.
Device is running on battery and charge
is below 25 percent.
Device is running on battery and charge
is below 10 percent. Device blinks with
alternating icons.
Device is connected to a power supply
and is docked.
Directions for use Symbols 3

4Symbols Welch Allyn RetinaVue™ 100 Imager

Introduction
Intended use
The Welch Allyn RetinaVue 100 Imager is a digital hand-held eye-fundus camera used to
record digital photographs of the fundus (including retina, macula and optic disc) of the
human eye and surrounding area.
About warnings and cautions
Warning and caution statements can appear on the RetinaVue 100 Imager device, the
packaging, the shipping container, or in this Directions for use.
The RetinaVue 100 Imager is safe for patients and clinicians when used in accordance
with the instructions and the warning and caution statements presented in this
Directions for use.
Before using the device, you must familiarize yourself with all warnings and cautions,
with the steps to power up the device, and with the sections of this Directions for use
that pertain to your use of the device. Specific warnings and cautions are also found
throughout this manual.
•Failure to understand and observe any warning statement in this manual could lead
to patient injury or illness.
• Failure to understand and observe any caution statement in this manual could lead to
damage to the equipment or other property, or loss of patient data.
General warnings and cautions
WARNING Clean the eye cup after each patient to avoid the risk of cross-
contamination.
WARNING Operating the device in the presence of a flammable
anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched
environments; or in any other potentially explosive environment may cause
a fire and explosion hazard.
WARNING Do not use batteries from other sources. This may result in
excessive temperatures, fire, or explosion.
WARNING To prevent fire or electrical shock, do not expose the device to
rain or moisture.
5

CAUTION Avoid subjecting the device to vibration or shock.
CAUTION Avoid using the device in a dusty environment.
CAUTION Keep the power cord away from any heat source.
CAUTION Do not sterilize the device.
CAUTION All servicing of this equipment is to be performed by Welch
Allyn, Inc. or by a center approved by Welch Allyn, Inc.
CAUTION This device needs to be installed and put into service according
to the EMC information provided herein.
CAUTION Portable and mobile RF communications equipment can affect
the RetinaVue 100 Imager performance.
CAUTION Input overload can occur in proximity to defibrillator or
electrocautery devices.
CAUTION This device is not protected against the ingress of water and
should not be used in the presence of liquids which may enter the device.
CAUTION Results deleted on the device cannot be recovered.
CAUTION Do not modify this equipment without authorization of the
manufacturer.
CAUTION Do not use the device in direct sunlight. Strong ambient light
may affect results.
CAUTION Only connect the RetinaVue 100 Imager to computers or
laptops that have passed the safety standard for information technology
equipment IEC 60950-1, EN 60950-1, UL 60950-1 to ensure the safety of
the USB electrical connection.
CAUTION Do not turn off the device while saving data from a patient test.
Turning off the device while saving patient data may delete the data.
CAUTION Do not use the device adjacent to or stacked with other
equipment. If the device is used adjacent or stacked with other equipment,
the device should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION Do not submerge the device in liquid or allow liquid to enter the
interior of the device.
CAUTION Do not use automatic cleansing machines or sterilization.
CAUTION Consult the cleaning agent and germicidal cleaner agent
manufacturer instructions for their proper use and germicidal efficacy prior
to their use.
CAUTION Only use the cleaning or germicidal cleaner agent types listed or
damage may occur.
6Introduction Welch Allyn RetinaVue™ 100 Imager

Controls and connectors
No. Feature Description
1Docking station Charges the RetinaVue 100 Imager and enables data transfer to a
PC running the RetinaVue™ Network software. (Requires optional
software). Connect to an electrical outlet or to a USB port of a
computer.
2 RetinaVue 100 Imager device Digital hand-held eye-fundus camera used to record digital
photographs of the fundus of the human eye and surrounding
area.
3 SD Card port SD Card slot. Insert SD Card for data storage.
4 Eye cup Blocks ambient light during testing
5 Power button Push button to turn the device on and off.
6 Power indicator • When the LED light is green, it indicates that the device is
docked and is fully powered.
• When the LED light is amber, it indicates that the device is
docked and is in the process of charging.
• When the device is not docked the LED is off.
7 LCD touchscreen 3.5” color HD LCD touchscreen. Displays information for charging,
testing, and adjustments to the device.
8 Home button Press the Home button to navigate to the Home screen (workflow
selection) from any screen on the device.
9 Battery cover Covers the battery compartment
10 Bezel Area to which the eye cup attaches
Directions for use Introduction 7

RetinaVue 100 Imager Home screen
The RetinaVue 100 Imager Home screen includes the following areas:
Item Area
1 Device status
2 Content
Device Status Area
The Device Status Area, located at the top of the Home screen, displays the Battery
condition. Estimated battery capacity is displayed in a charged or discharged status
format.
In the Exam Summary and Review screens, the Device Status Area displays:
•Patient Icon and Patient name. The format of the Patient name is last name, first
name.
• Connection status. The icons indicate which connection type, if any, is currently
active.
Note Your model might not contain all of these features.
Icon Connection type
USB
8Introduction Welch Allyn RetinaVue™ 100 Imager

• Battery condition. Estimated battery capacity is displayed in a charged or discharged
status format.
Content Area
The Content Area includes four workflow selection buttons. Touching one of the four
buttons navigates to the next screen associated with that workflow.
•Patients: Presents a list of patients created on the RetinaVue 100 Imager or
transferred from the RetinaVue™ Network (requires optional software).
•Exam: The Exam workflow provides a guided approach to image capture. To
maintain consistent and complete exam submissions, a prescribed image acquisition
sequence is used to complete an exam. The Exam workflow also presents controls,
status, and previews of images. (The Exam Workflow requires optional RetinaVue™
Network software to submit images to an overread service.)
•Review: Presents images and exams from a list of patients contained on the
RetinaVue 100 Imager.
•Settings. Provides controls to view or change the following:
○Volume
○Time
○Date
○Advanced Settings:
– Device access code
– Advanced settings code
– Format SD
– Factory reset
– Export log
• About
○Software Version
Directions for use Introduction 9

Navigation controls in the Exam mode
The Navigation area is located at the bottom of the RetinaVue 100 Imager screen.
Navigation controls change with the mode. The navigation controls for Pre-, post-, and
acquisition in Exam mode include:
Pre-acquisition
Home: Displays the RetinaVue 100 Imager workflow selection buttons and
navigates to the Home screen.
Next: Navigates to the next image acquisition within a prescribed image
acquisition sequence or to the next step in a sequence of steps.
Image acquisition navigation: Navigates to the image acquisition position within the
prescribed sequence. Provides a visual representation of the prescribed sequential
acquisition, including the right eye ( ) and the left eye ( ). Provides a status of
acquired images for acceptance or dismissal.
Acquisition
Exit: Navigates to the Pre-acquisition screen.
Post-acquisition
Discard image: or Navigates to the Acquisition screen.
Accept image: Navigates to the Exam summary screen when the last exam in the
sequence has been accepted.
Image inspection: Navigates to the Image inspection screen.
Navigation controls in the Review mode and Settings mode
The Navigation area is located at the bottom of the RetinaVue 100 Imager screen. The
navigation control for the Review mode and the Settings mode includes the back button.
Back: Navigates to a previous dialog or step.
10 Introduction Welch Allyn RetinaVue™ 100 Imager

Image Pre-acquisition controls (Auto mode)
From the Home screen touch Exam. The Exam Pre-acquisition screen appears.
No. Feature No. Feature
1. START enters automatic image acquisition
mode. 4.
Navigates to the Home screen.
2. (Image Acquisition Settings) navigates to
the Advanced image capture settings screen.
Adjust the flash brightness (-2 to +2) or the focus
settings (-1 to +1).
5. MANUAL switches to advanced image capture
options.
3. (Image Order) skips to the next image in
the sequence. 6.
(Next) skips to the next image acquisition within
a prescribed image acquisition sequence or navigates to
the Exam summary screen if the last image has been
acquired.
Directions for use Introduction 11

About image quality scores
Good quality
green
If the image is of good quality, it is very likely to be read by a specialist.
(Scores of 40 +)
Acceptable quality
yellow
If the image is of good enough quality, it is likely to be read by a specialist.
(Range of 20 — 39)
Unacceptable quality
red
If the image is lacking in quality, it is highly unlikely that a specialist will be able to read it.
(Range of 0 — 19)
Controls (Post-acquisition)
On the Post-acquisition screen, images with a green check ( ) are of good quality
(scores of 40 +), images with a yellow check ( ) are of acceptable quality (scores of
20 — 39), and those with a red x ( ) are of unacceptable quality (scores of 0 — 19).
12 Introduction Welch Allyn RetinaVue™ 100 Imager

Use the RetinaVue 100 Imager touchscreen inspection control to navigate to the
Inspection screen, then zoom in or out with a pinch or pull. Touch (Close) to return
to the Post-acquisition screen and accept or reject the acquired image.
On the Post-acquisition screen, touch (Trash) or (Discard) to discard the image.
At the dialogue screen, touch Delete to confirm the discard and to return to the Pre-
acquisition screen to acquire again.
Touch (Accept) to accept the image and to navigate to the next image. Or touch
(Accept) to navigate to the Exam summary screen once the last image of the exam
is acquired.
Exam summary controls (Post-acquisition and Review modes)
Exam summary from the Post-acquisition screen
From the Post-acquisition screen, touch (Accept) to navigate to the Exam summary
screen. Each image on the Exam summary screen contains a quality score and status. If
an image is missing touch Override to access the Save button and to save the one
image.
Touch (Accepted good) to view that image.
Image accepted, good quality. Quality scores of 40+.
Touch (Accepted OK) to view that image.
Directions for use Introduction 13

Image accepted, quality OK. Quality scores ranging from 20 — 39.
Touch (Rejected) to view that image.
Image rejected. Quality scores ranging from 0 — 19.
Touch SAVE to accept all images and to return to the Home screen.
CAUTION Captured images require patient context before the images can
be saved.
Note To add missing patient context information touch and then touch
to create a new patient, or touch on an existing patient's name
from within the Patients screen to select that patient.
Exam summary from the Review screen
Touch Review.
Touch on a patient's name. The Exam summary screen appears for that patient.
Touch (Accepted good), (Accepted OK) , or (Rejected) to view the
image.
Touch (Patient) to review patient demographics on the Patient summary screen.
Touch (Back) to return to the Review screen.
Touch (Home) to return to the Home screen.
14 Introduction Welch Allyn RetinaVue™ 100 Imager

About the Auto and Manual Exam modes
Auto Mode
Auto Mode is the default image capture mode. Available automatic features include:
•Image capture
• Focus
• Flash brightness
• Sequential image capture order of the right and left eye
• Navigation to the image Inspection screen
In addition to the automatic features, manual capture, manual focus adjustment, and manual flash
brightness adjustment are also available. (Manual focus adjustment and flash brightness are
accessed from the Advanced image capture settings screen.)
Manual Mode
Directions for use Introduction 15

Manual mode contains advanced image capture options.
Note A manual touch of the capture button is required to obtain an image.
Available manual features include:
• Focus adjustment (values range from -1 to +1)
• Flash brightness adjustment (values range from -2 to +2)
• Image capture
16 Introduction Welch Allyn RetinaVue™ 100 Imager