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