Welch Allyn RetinaVue 100 Imager Manual

Welch Allyn RetinaVue™ 100
Imager
Directions for use
Software version 4.5.XX

© 2015 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.
Caution Federal US law restricts sale of the device identified in this manual to, or on the order of, a licensed
physician.
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. B
Revision date: 2015-12
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 ...................................................................................... 8
RetinaVue 100 Imager screens ............................................................................ 9
Using the RetinaVue 100 Imager ......................................................... 17
Unpack the system ............................................................................................ 17
Docking station .................................................................................................. 20
Patient data management .................................................................................. 23
Perform an eye exam using the Auto exam mode ............................................ 26
Perform a manual image capture while in Auto exam mode ............................. 29
Skip an image capture while in exam mode ...................................................... 30
Perform a manual image capture while in Manual exam mode ......................... 32
Update the RetinaVue 100 Imager software ..................................................... 34
Viewing or changing the RetinaVue 100 Imager settings .................................. 35
Troubleshooting .................................................................................... 37
Maintenance .......................................................................................... 39
Clean and disinfect ............................................................................................. 39
Specifications ........................................................................................ 41
Device radio ........................................................................................... 43
General compliance and standards ..................................................... 45
General radio compliance ................................................................................... 45
Approved accessories ........................................................................... 51
Accessories ....................................................................................................... 51
Warranty ................................................................................................ 53
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
2Symbols Welch Allyn RetinaVue™ 100 Imager

Battery charge level indicators
Device is running on battery and charge
is above ninety percent.
Device is running on battery and charge
is above seventy-five percent.
Device is running on battery and charge
is above fifty percent.
Device is running on battery and charge
is above twenty percent.
Device is running on battery and charge
is below twenty 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 Patient injury risk. The eye cup should be cleaned after each
patient.
WARNING Fire and explosion hazard. Do not operate 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.
WARNING Fire and explosion hazard. Do not use batteries from other
sources. This may result in excessive temperatures, fire, or explosion.
5

WARNING When using the RetinaVue 100 Imager, no acute optical
radiation hazards are identified. However, Welch Allyn recommends
limiting the intensity of the light directed into the patient’s eye to the
minimum level that is necessary for diagnosis. Infants, aphakes, and
persons with diseased eyes are at a greater risk. The risk is also increased
if the examined person has had any exposure with the same instrument or
any other ophthalmic instrument using a visible light source within the
previous 24 hours. This will apply particularly if the eye has had exposure to
retinal photography. The intended use of this device is for routine
ophthalmic exams on the order of typically less than 60 seconds per eye.
Although there is a benefit versus risk factor in any medical procedure,
these more complicated exams should not exceed a three minute exam
time in 24 hours. Significant use of this device beyond its intended use is
not recommended; it may cause harm to the eyes.
WARNING To prevent fire or electrical shock, do not expose the device to
rain or moisture.
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.
6Introduction Welch Allyn RetinaVue™ 100 Imager

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.
Directions for use Introduction 7

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
8Introduction Welch Allyn RetinaVue™ 100 Imager

RetinaVue 100 Imager screens
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 following
information from left to right:
•Patient Icon
• 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
XNo connection
Directions for use Introduction 9

• 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
10 Introduction Welch Allyn RetinaVue™ 100 Imager

Pre-, post-, and acquisition navigation
The Navigation area is located at the bottom of the RetinaVue 100 Imager screen.
Navigation controls change with the mode and include:
Pre-acquisition
Home: Displays the RetinaVue 100 Imager workflow selection buttons and
navigates to the Home screen.
Next: Navigates to the next image capture within a prescribed image
capture sequence or to the next step in a sequence of steps.
Image acquisition navigation: Navigates to images within the prescribed sequence.
Provides a visual representation of the prescribed sequential capture, 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 is accepted.
Image inspection: Navigates to the Image inspection screen.
Exam summary and Settings
Back: Navigates to a previous dialog or step.
Directions for use Introduction 11

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 in the
image capture sequence or navigates to the Exam
summary screen if this is the last image.
About image quality scores
Good quality If the image is of good quality, it is very likely to be read by a specialist.
(Scores of 60 +)
Acceptable quality If the image is of good enough quality, it is likely to be read by a specialist.
(Range of 40 — 59)
Unacceptable quality If the image is lacking in quality, it is highly unlikely that a specialist will be able to read it.
(Range of 1 — 39)
12 Introduction Welch Allyn RetinaVue™ 100 Imager

Controls (Post-acquisition)
On the Post-acquisition screen, images with a green check ( ) are of good quality
(scores of 60 +), images with a yellow check ( ) are of acceptable quality (scores of
40 — 59), and those with a red x ( ) are of unacceptable quality (scores of 1 — 39).
Use the RetinaVue 100 Imager touchscreen inspection control to navigate to
the Inspection screen, then zoom in or out with a pinch or pull.
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. On the Image inspection screen , touch (Close)
to return to Post-acquisition screen and accept or reject the acquired image.
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 captured.
Exam summary controls (Post-acquisition and Review modes)
Exam summary from the Post-acquisition screen
From the Post-acquisition screen, touch the (Image accepted button) to navigate to
the Exam summary screen. Each image on the Exam summary screen contains a quality
score and status. For images with a low quality score (range 1— 39), touch Override to
accept the image.
Directions for use Introduction 13

CAUTION Captured images require patient context before the images can
be saved.
CAUTION Unsaved images are discarded if the RetinaVue 100 Imager
loses battery power or if it enters deep sleep mode.
Note If the RetinaVue 100 Imager enters stand by mode when left idle for
approximately two minutes, wake up the RetinaVue 100 Imager by
touching the LCD screen or by pressing the Home button. When prompted
to leave the screen and discard the image, touch Cancel.
Add the missing patient context information. Touch and then touch to
create the patient.
Note For images with a low quality score (range 1— 39), the Save option is
disabled until Override is touched.
Touch (Accepted good) to view that image.
Image accepted, good quality. Quality scores of 60+.
Touch (Accepted OK) to view that image.
Image accepted, quality OK. Quality scores ranging from 40 — 59.
Touch (Rejected) to view that image.
Image rejected. Quality scores ranging from 1— 39.
Touch SAVE to accept all images and to return to the Home screen.
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) to view that image.
14 Introduction Welch Allyn RetinaVue™ 100 Imager

Touch (Accepted OK) to view that image.
Touch (Rejected) to view that 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.
About the Auto and Manual modes
Auto Mode
Auto Mode is the default image capture mode. Available automatic features include:
•Image capture
• Focus adjustment (from the Advanced image capture settings screen, values range
from -1 to +1)
• Flash brightness adjustment (from the Advanced image capture settings screen, values
range from -2 to +2)
• Sequential image capture order of the right and left eye
• Navigation to the image Inspection screen
In addition to automatic image capture, manual capture is also available.
Directions for use Introduction 15

Manual Mode
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:
•Image capture
• Focus adjustment (from the Acquisition screen , values range from -1 to +1)
• Flash brightness adjustment (from the Acquisition screen. values range from -2 to +2)
16 Introduction Welch Allyn RetinaVue™ 100 Imager