Welch Allyn RetinaVue 100 Imager Pro Directions For Use Manual
Welch Allyn RetinaVue™ 100
Imager Pro
Directions for use
Software version 6.XX
© 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.
Software in this product is Copyright 2018 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, reverseengineered, 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:
support.
727803, (printed copy)
DIR 80022009 Ver. B
Revision date: 2018-07
Distributed by Welch Allyn, Inc.
Medimaging Integrated Solution Inc. (MiiS)
1F, No. 7, R&D Rd II, Hsinchu Science Park,
Hsinchu, TAIWAN 30076, R.O.C.
Made in Taiwan
This manual applies to the 901103 Fundus Camera
Regulatory Affairs Representative
MedNet GmbH
Borkstrasse 10
48163 Muenster
Germany
http://www.welchallyn.com/
Contents
Symbols ................................................................................................... 1
Introduction ............................................................................................. 5
Using the RetinaVue 100 Imager Pro ................................................... 11
iii
Intended use ........................................................................................................ 5
About warnings and cautions ............................................................................... 5
General warnings, cautions, and notes ................................................................ 6
Controls and connectors ...................................................................................... 8
Unpack the system ............................................................................................ 11
Docking station .................................................................................................. 17
First time set up of the RetinaVue 100 Imager Pro .......................................... 18
RetinaVue 100 Imager Pro Home screen .......................................................... 20
Create a new patient on the RetinaVue 100 Imager Pro camera ....................... 22
About the Auto and Manual Exam modes ......................................................... 25
Adaptive software in the Auto exam mode for software 6.10.02 and higher .... 27
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
Review patient exams on the RetinaVue 100 Imager Pro ................................. 37
Transfer patient exams from the RetinaVue 100 Imager Pro to a computer ..... 39
Use the RetinaVue 100 Imager Pro SD Card to transfer patient exams to a
computer ............................................................................................................ 40
Troubleshooting .................................................................................... 41
Maintenance .......................................................................................... 47
Clean and disinfect ............................................................................................. 47
RetinaVue 100 Imager Pro Specifications ........................................... 49
Enable the RetinaVue Network ........................................................... 51
To change the camera configuration from the RV100 Pro to the RV100 (USB or
Wireless): .......................................................................................................... 51
To change the camera configuration from the RV100 (USB or Wireless) to the
RV100 Pro: ........................................................................................................ 52
Viewing or changing the RetinaVue 100 Imager Pro settings ........... 53
Power down the RetinaVue 100 Imager ............................................................ 54
Sleep mode ........................................................................................................ 55
Set the date and time ........................................................................................ 57
iv Contents Welch Allyn RetinaVue™ 100 Imager Pro
Set the Device Access Code ............................................................................ 58
General compliance and standards ..................................................... 63
EMC compliance ................................................................................................ 63
Emissions and immunity information ................................................................. 64
Navigation controls ............................................................................... 67
Navigation controls in the Training mode ........................................................... 67
Navigation controls in the Exam mode .............................................................. 68
Navigation controls in the Settings mode .......................................................... 69
Navigation controls in the Review mode ........................................................... 69
Image Pre-acquisition controls (Auto mode) ..................................................... 71
Controls (Post-acquisition) ................................................................................ 71
Exam summary controls (Post-acquisition and Review modes) ....................... 73
Update the RetinaVue 100 Imager Pro software to version 6.XX and
above ...................................................................................................... 75
RetinaVue 100 and 100 Imager Pro Accessories ............................... 77
Symbols
Documentation symbols
For information on the origin of these symbols, visit http://www.welchallyn.com/
symbolsglossary for the Welch Allyn symbols glossary.
1
Power 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.
Consult 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.
Power button
Rated power input, DC Rated power output, DC
Fuse Rechargeable battery
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.
Meets essential requirements of the
European Medical Device Directive 93/
42/EC.
Direct current (DC)
Battery Charging - Non-AC powered
2 Symbols Welch Allyn RetinaVue™ 100 Imager Pro
Connectivity symbols
USB
Wireless radio symbols
Non-ionizing electromagnetic radiation Australian Communications and Media
Authority (ACMA) Radio Compliance
Mark (RCM)
FCC ID
The identification number assigned by
the Federal Communication Commission
2AFB3WA-WEC100
IC ID
Industry Canada identification number.
The equivalent governing body to the FCC
in the United States
21375-WAWEC100
CAN ICES-3 (B)/NMB-3(B)
Shipping, storing, and environment symbols
Temperature limit
Separate collection of Electrical and
Electronic Equipment. Do not dispose as
unsorted municipal waste.
Humidity limitation
This way up Stacking limit by number
Keep Dry
Fragile
Atmospheric pressure limitation
Recyclable
Miscellaneous symbols
Product Identifier
Reorder Number
Directions for use Symbols 3
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"
Clock; time switch; timer Serial Number
Authorized Representative in the
European Community
Battery charge level indicators
Device is running on battery and charge
is between 75 and 100 percent.
Device is running on battery and charge
is below 50 percent.
Device is running on battery and charge
is below 10 percent. Device blinks with
alternating icons.
Device is running on battery and charge
is below 75 percent.
Device is running on battery and charge
is below 25 percent.
Device is connected to a power supply
and is docked.
4 Symbols Welch Allyn RetinaVue™ 100 Imager Pro
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.
5
Prescription only or "For Use by or on the order of a licensed medical professional".
Note It is the responsibility of the health care provider to protect patient health
information and to meet regulatory and HIPAA compliance. The images on
the RetinaVue 100 Imager Pro may contain identifiable patient information
and it is the responsibility of the health care provider to ensure that data
safeguards are implemented to protect patient health information.
For information on configuring the RetinaVue 100 Imager Pro device to connect to the
RetinaVue Network system, contact Welch Allyn support to discuss setting up a
RetinaVue Network account.
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.
6 Introduction Welch Allyn RetinaVue™ 100 Imager Pro
General warnings, cautions, and notes
WARNING Exposure to the RetinaVue 100 Imager flash, in rare cases,
may contribute to migraines or temporary visual disturbances, particularly in
patients with a history of light sensitivity or migraines. Multiple flashes per
eye in a single exam may increase the likelihood of occurrence.
WARNING Clean and disinfect 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.
CAUTION When manually entering patient information, do not use the
same patient identifier for multiple patients. This may result in inaccurate
data association.
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.
Directions for use Introduction 7
CAUTION Within the patient environment, only connect the equipment
(the RetinaVue 100 Imager) to computers or laptops that have passed the
safety standard for information technology equipment IEC 60601-1, EN
60601-1, ANSI/AAMI ES 60601-1 to ensure the safety of the USB electrical
connection. Outside the patient environment, only connect the equipment
(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.
Note The RetinaVue 100 Imager can be used on patients with eye implants and
intraocular lenses. While the RetinaVue 100 Imager can be used on
patients with cataracts and other eye opacities, the use of the RetinaVue
100 Imager may result in a lower quality image due to the increased
reflection of the flash off the patient's intraocular lens.
8 Introduction Welch Allyn RetinaVue™ 100 Imager Pro
Controls and connectors
No. Feature Description
1
Docking station Charges the RetinaVue 100 Imager Pro and enables data transfer
to a computer. Connect to an electrical outlet or to the “Always
On” USB port of a computer.
Note
2 RetinaVue 100 Imager device
3 SD Card port/service port SD Card slot. Insert SD Card for data storage.
4 Eye cup Blocks ambient light during testing
Digital hand-held eye-fundus camera used to record digital
photographs of the fundus of the human eye and surrounding
area.
Note The service port under the SD Card cover is for
USB ports supply power only when the
computer is on. However, many newer
computers contain a yellow “Always On” USB
port that can supply power even when the
computer is sleeping, hibernating, or turned
off. See you computer manufacturer's user
documentation for instructions on changing the
power management options and for identifying
the “Always On” USB port.
factory use only and is not for customer use.
5 Power button
• Push button to turn the device on and off.
• Push button to bring the device out of Sleep mode.
• Push button to launch a dialogue box with three options:
○ Power off
○ Sleep
Directions for use Introduction 9
No. Feature Description
○ Cancel
6 Power indicator
7 LCD touchscreen 3.5” color HD LCD touchscreen. Displays information for charging,
8 Home button Press the Home button to navigate to the Home screen (workflow
9 Battery cover Covers the battery compartment
10 Bezel Area to which the eye cup attaches
• 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.
testing, and adjustments to the device.
selection) from any screen on the device.
10 Introduction Welch Allyn RetinaVue™ 100 Imager Pro
Using the RetinaVue 100 Imager Pro
View images saved to the RetinaVue 100 Imager Pro on the LCD touchscreen. The
images saved on the SD card are in unencrypted (.jpg) format and a DICOM (.dcm)
format. To view images on a computer, use photo viewer software.
Unpack the system
The RetinaVue 100 Imager Pro device is packaged with the following items. Confirm that
all items are included.
11
Number Item Description
Digital hand-held eye-fundus camera used to record digital
1 RetinaVue 100 Imager Pro device
2 Docking station
3 USB cable
4 Wall adapter plug Connects to USB cable. Match to region-specific AC wall outlet.
photographs of the fundus of the human eye and surrounding
area.
Charges the RetinaVue 100 Imager Pro device and enables USB
data transfer to a computer or laptop. Connect to region-specific
AC wall outlet.
Connects the docking station to a computer or laptop to transfer
results. Connects the docking station to the wall adapter plug for
AC charging.
12 Using the RetinaVue 100 Imager Pro Welch Allyn RetinaVue™ 100 Imager Pro
Number Item Description
5 Eye cup Blocks ambient light during testing
6 Battery Rechargeable lithium ion battery
7 Screwdriver Phillips screwdriver to remove battery cover screws
Not shown
Not shown SD Card SD Card installed in the SD Card slot for data storage
Not shown Lens spray RetinaVue 100 Imager lens cleaner
Not shown Lens cloth RetinaVue 100 Imager lens cleaning cloth
RetinaVue 100 Imager Pro Directions
for use
If any item is missing, contact Welch Allyn Technical Support: www.welchallyn.com/
service. We recommend that you save the shipping box and packing materials in case
you need to store or ship the system.
Battery installation and replacement
Use the device on battery power once the battery is installed and charged. The battery is
charged through contact pins on the device and the docking station.
Install the battery/replace the battery
Set the RetinaVue 100 Imager on a flat, clean surface with the LED display facing down.
WARNING Personal injury risk. Improper handling of the battery can lead
to heat generation, smoke, explosion, or fire. Do not short-circuit, crush,
incinerate, or disassemble the battery. Never dispose of batteries in refuse
containers. Always recycle batteries according to national or local
regulations.
This document. The Directions for use (DFU) is also available on
the Welch Allyn web site.
WARNING Use only Welch Allyn approved accessories, and use them
according to the manufacturer’s directions for use. Using unapproved
accessories with the camera can affect patient and operator safety and can
compromise product performance and accuracy, and void the product
warranty.
1. Loosen the screw at the left side of the battery cover.
2. Loosen the screw at the right side of the battery cover.
3. Push in the battery cover tab and then lift up the battery cover. Slide open the
battery cover by tilting the cover upward.
Directions for use Using the RetinaVue 100 Imager Pro 13
4. For first-time setup of the RetinaVue 100 Imager, insert the battery into the battery
compartment. For battery replacement, remove the existing battery and then insert
the new replacement battery into the battery compartment.
a. This procedure applies to first-time setup of the RetinaVue 100 Imager. Insert
the battery into the battery compartment. Match the polarity of the battery to the
+ and - markings on the RetinaVue 100 Imager.
b. This procedure only applies to battery replacement. Remove the existing battery
from the battery compartment and insert the new replacement battery into the
battery compartment. Match the polarity of the battery to the + and - markings
on the RetinaVue 100 Imager.
5. Rotate the raised flat edge of the battery until it sets in the back notch of the battery
compartment.
6. Insert the two battery cover tabs into the slot, then push in the tab to close the
battery compartment.
7. Tighten the screw at the left side of the battery cover.
8. Tighten the screw at the right side of the battery cover.
14 Using the RetinaVue 100 Imager Pro Welch Allyn RetinaVue™ 100 Imager Pro
Note Do not over-tighten the screws.
Eye cup
The eye cup blocks ambient light during testing and covers the patient's eye socket to
allow them to best focus on the green fixation lights. The eye cup works on the patient's
left and right eye.
Set up the eye cup for a patient exam
1. Remove the lens cap from the RetinaVue 100 Imager.
2. Slide the eye cup over the bezel on the RetinaVue 100 Imager.
3. Use the eye cup to cover the patient's examined eye and allow them to focus on the
green fixation lights.
Directions for use Using the RetinaVue 100 Imager Pro 15
Hold the RetinaVue 100 Imager for a patient exam
The RetinaVue 100 Imager must be held level and in line with your patient’s eye.
There are two recommended techniques to properly hold the RetinaVue 100 Imager for a
quick and successful retinal exam:
Telescope Grip
16 Using the RetinaVue 100 Imager Pro Welch Allyn RetinaVue™ 100 Imager Pro
Smart phone Grip
Make micro adjustments with your guide hand to fine tune the focus of the RetinaVue
100 Imager.
Guide (Patient End) Hand
Hold the patient end of the RetinaVue 100 Imager with just the thumb and forefinger.
Use the small and ring finger to steady the RetinaVue 100 Imager by anchoring them
gently on the patient’s forehead.
2
3
Directions for use Using the RetinaVue 100 Imager Pro 17
Docking station
Place the device into the docking station to charge the device or to connect and transfer
data to a computer or laptop.
Set up the docking station for charging
1. Turn the docking station over.
2. Connect the USB cable to the docking station.
3. Either plug the USB cable into the wall adapter plug and then plug the wall adapter
into an AC outlet, or plug the USB cable into the “Always On” USB port on a
computer.
a. Plug the USB cable into the wall adapter plug and then plug the wall adapter into
an AC outlet.
b. (Optional) Plug the USB cable into the “Always On” USB port on a computer.
4. Place the RetinaVue 100 Imager on the docking station charger with the contact pins
of the RetinaVue 100 Imager touching the contact pins of the docking station
charger.
18 Using the RetinaVue 100 Imager Pro Welch Allyn RetinaVue™ 100 Imager Pro
5. Before the first use, allow the RetinaVue 100 Imager to charge for 5 hours on the
docking station charger.
Note The power indicator light turns amber to indicate that the
RetinaVue 100 Imager is in the processing of charging. If the
power indicator light does not turn on, ensure that the
contact pins of the RetinaVue 100 Imager are touching the
contact pins of the docking station charger and reseat the
RetinaVue 100 Imager into the docking station. Charging is
impacted if the pins are not properly touching.
Note The removal of the plug from the socket provides the means
of isolation from the mains power supply. The user is
reminded to keep this means of disconnection easily
accessible in case of emergency.
First time set up of the RetinaVue 100 Imager Pro
The RetinaVue 100 Imager Pro runs a brief diagnostic self-test each time it powers up.
CAUTION Always use the RetinaVue 100 Imager Pro with an adequately
charged and properly functioning battery.
Directions for use Using the RetinaVue 100 Imager Pro 19
1. Press to power up the RetinaVue 100 Imager Pro.
As the device is powering up, the RetinaVue 100 Imager Pro displays the Welch
Allyn logo and the model number. After powering up, the Home screen appears.
Note If the battery is in a discharged state, the time and date need
to be set.
2. Touch (up) or (down) to adjust the hour, minute (Min), Continent, and
Location. Use the radio buttons to select the 24-hour or 12-hour format. Touch
(Back) to return to the Settings screen.
3. Touch Date.
4. Touch (up) or (down) to adjust the day, month, and year in the DD/MM/
YY format. Touch (Back) to return to the Settings screen.
20 Using the RetinaVue 100 Imager Pro Welch Allyn RetinaVue™ 100 Imager Pro
RetinaVue 100 Imager Pro Home screen
The RetinaVue 100 Imager Pro 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 and the device model number. Estimated battery capacity is displayed in a
charged or discharged status format.
In the Exam Summary and Review screens, the Device Status Area displays:
•
the device model number
• the battery condition
Content Area
The Content Area includes four workflow selection buttons and a Training button.
Touching one of the five buttons navigates to the next screen associated with that
workflow or training.
Patients: Presents a list of patients created on the RetinaVue 100 Imager Pro until
•
the exams are completed.
• Exam: The Exam workflow provides a guided approach to image capture. To
maintain consistent and complete exam submissions, a prescribed image acquisition
Directions for use Using the RetinaVue 100 Imager Pro 21
sequence is used to complete an exam. The Exam workflow also presents controls,
status, and previews of images.
• Review: Presents images and exams from a list of patient IDs contained on the
RetinaVue 100 Imager Pro .
• Settings. Provides controls to view or change the following:
○
Volume
○
Time
○
Date
○
Advanced settings:
– Device access code
– Advanced settings code
– Format SD
– Restore factory defaults
○
Exam setup
– 1-image (Macula-centered)
– 2-image (Macula and Optic Disc-centered)
○
Camera configuration
Switch between RV100/RV100 Pro
– RV100 Pro
Unencrypted images only (no RetinaVue Network compatibility)
– RV100
RetinaVue Network required (USB or Wireless)
– Export log
○
About
– Software version
○
Regulatory Information
• Training: Provides demonstrations and interactive training exercises on the
RetinaVue 100 Imager Pro. Short video clips and interactive training help you practice
the three key steps necessary to master the RetinaVue 100 Imager Pro.
22 Using the RetinaVue 100 Imager Pro Welch Allyn RetinaVue™ 100 Imager Pro
Create a new patient on the RetinaVue 100 Imager Pro camera
1. From the Home screen, touch Patients.
2. After the Patients screen appears, touch (New patient).
The New Patient screen appears.
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