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Welch Allyn RetinaVue™ 100
Imager
Directions for use
Software version 4.5.XX
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© 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, 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.
411492, (printed copy)
DIR 80019780 Ver. B
Revision date: 2015-12
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.
Made in Taiwan
This manual applies to the 901103 Fundus Camera
Obelis S.A.
Bd. General Wahis 53,1030,
Brussels, Belgium
http://www.welchallyn.com/
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Contents
Symbols ................................................................................................... 1
Introduction ............................................................................................. 5
Using the RetinaVue 100 Imager ......................................................... 17
iii
Intended use ........................................................................................................ 5
About warnings and cautions ............................................................................... 5
General warnings and cautions ............................................................................ 5
Controls and connectors ...................................................................................... 8
RetinaVue 100 Imager screens ............................................................................ 9
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
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iv Contents Welch Allyn RetinaVue™ 100 Imager
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Symbols
Documentation symbols
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
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.
Direct current (DC)
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)
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2 Symbols Welch Allyn RetinaVue™ 100 Imager
•
No connection (X)
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
Recyclable
Keep Dry
Fragile
Atmospheric pressure limitation
Miscellaneous symbols
Product Identifier
Global Trade Item Number For indoor use only
Type BF applied part Prescription only or "For Use by or on the
Non-ionizing electromagnetic radiation Serial Number
FCC ID
The identification number assigned by
the Federal Communication Commission
Reorder Number
order of a licensed medical professional"
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Directions for use Symbols 3
Battery charge level indicators
Device is running on battery and charge
is above ninety percent.
Device is running on battery and charge
is above fifty percent.
Device is running on battery and charge
is below twenty percent. Device blinks
with alternating icons.
Device is running on battery and charge
is above seventy-five percent.
Device is running on battery and charge
is above twenty percent.
Device is connected to a power supply
and is docked.
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4 Symbols Welch Allyn RetinaVue™ 100 Imager
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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
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.
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6 Introduction Welch Allyn RetinaVue™ 100 Imager
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.
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Directions for use Introduction 7
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.
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8 Introduction Welch Allyn RetinaVue™ 100 Imager
Controls and connectors
No. Feature Description
1
Docking 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
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
7 LCD touchscreen 3.5” color HD LCD touchscreen. Displays information for charging,
Digital hand-held eye-fundus camera used to record digital
photographs of the fundus of the human eye and surrounding
area.
• 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.
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
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Directions for use Introduction 9
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
X
No connection
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10 Introduction 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
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Directions for use
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.
Introduction 11
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.
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12 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.
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).
3.
(Image Order) skips to the next image
in the sequence.
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 +)
4.
( ) Navigates to the Home screen.
5.
MANUAL switches to advanced image capture
options.
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.
Acceptable quality
Unacceptable quality
If the image is of good enough quality, it is likely to be read by a specialist.
(Range of 40 — 59)
If the image is lacking in quality, it is highly unlikely that a specialist will be able to read it.
(Range of 1 — 39)
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Directions for use
Controls (Post-acquisition)
On the Post-acquisition screen, images with a green check ( ) are of good quality
Introduction 13
(scores of 60 +), images with a yellow check (
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.
) are of acceptable quality (scores of
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
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.
(Close)
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Introduction Welch Allyn RetinaVue™ 100 Imager
14
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
Image rejected. Quality scores ranging from 1— 39.
Touch SAVE to accept all images and to return to the Home screen.
(Rejected) to view that image.
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.
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Directions for use Introduction 15
Touch (Accepted OK) to view that image.
Touch (Rejected) to view that image.
Touch
Touch
Touch
(Patient) to review patient demographics on the Patient summary screen.
(Back) to return to the Review screen.
(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.
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16 Introduction Welch Allyn RetinaVue™ 100 Imager
Manual Mode
Manual mode contains advanced image capture options.
Note
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)
A manual touch of the capture button is required to obtain an image.
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Using the RetinaVue 100 Imager
Unpack the system
The RetinaVue 100 Imager device is packaged with the following items. Confirm that all
items are included.
17
Number Item Description
RetinaVue 100 Imager device Digital hand-held eye-fundus camera used to record digital
1
Docking station Charges the RetinaVue 100 Imager device and enables USB data
2
USB cable Connects the docking station to a computer or laptop to transfer
3
4 Wall adapter plug Connects to USB cable. Match to region-specific AC wall outlet.
5 Eye cup Blocks ambient light during testing
6 Battery Rechargeable lithium ion battery
photographs and video of the fundus of the human eye and
surrounding area.
transfer to a computer or laptop. Connect to region-specific AC
wall outlet.
results. Connects the docking station to the wall adapter plug for
AC charging.
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18 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Number Item Description
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
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.
RetinaVue 100 Imager Directions for
use
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.
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Directions for use Using the RetinaVue 100 Imager
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.
19
Eye cup
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.
Note Do not over-tighten the screws.
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.
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20 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Set up the eye cup for a patient exam
1. Slide the eye cup over the bezel on the RetinaVue 100 Imager.
2. Use the eye cup to cover the patient's examined eye and allow them to focus on the
green fixation lights.
Docking station
Place the device in the docking station to charge the device or to connect and transfer
data to a computer or laptop PC running the RetinaVue Network™ Client software.
(Requires optional software).
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 an open USB port on a computer.
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2
3
Directions for use Using the RetinaVue 100 Imager 21
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 an open 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.
5. Before the first use, allow the RetinaVue 100 Imager to charge for 8 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.
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22 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
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Directions for use Using the RetinaVue 100 Imager 23
Patient data management
Create a list of patients on the RetinaVue 100 Imager.
To create a new patient:
1. From from the Home screen, touch Patients. The Patient list screen appears.
2.
Touch (New patient) The New Patient screen appears.
3. Touch within the Patient's Last name, First name , or Middle name entry box to
launch the on-screen keyboard. Enter the patient's information and touch OK.
4. Enter the patient's last name and first name. Touch OK. (Middle name is optional.)
5. Enter the patient's Date of Birth. (Touch within the DOB/Gender field to launch the
on-screen keyboard and to enter the patient's Date of Birth.) Touch OK.
6. Enter the patient's gender using the radio button to select male or female.
7. Enter the patient's ID. Touch OK.
8. Once all the required fields are complete, touch OK to open a new exam.
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24 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
To select a patient from the Patient list:
1. From from the Home screen, touch Patients. The Patient list screen appears.
2. Touch the Patient's name to view a summary of the patient information on the
Patient Summary screen.
3. Touch OK to open a new exam for that patient.
Required fields include Patient's Last name, Fist name, Date of birth, and
Identification number.
Review patient tests:
1.
From the Home screen, touch Review. The patient's Review screen appears.
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Directions for use Using the RetinaVue 100 Imager 25
2. Touch on a patient's information to review the patient demographics and to view
images associated with a patient.
3. The most current set of images associated with a patient appears on the Exam
summary screen.
4.
After the review is complete, touch (Back) to return to the Review
screen and then touch (Home) to return to the Home screen.
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26 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Perform an eye exam using the Auto exam mode
Auto exam mode is the default image capture mode.
Available automatic features include:
• Image capture
• Focus adjustment
• Flash brightness adjustment
• 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.
Note To ensure that the patient's pupils sufficiently dilate to at least 3.5 mm
diameter, adjust the room lighting to the lowest possible level. If
necessary, have the patient sit in a dark room for 5 minutes to dilate their
pupils.
• Ensure that the SD card is installed into the RetinaVue 100 Imager.
• Ask your patient to remove their glasses.
• Ensure that the patient sits on the edge of an exam table and stand in front of the
patient to take the image. Alternatively, ask the patient to sit in a chair and sit directly
across from the patient.
• Ask the patient to sit up straight and hold their head in a stationary position during
the entire procedure.
• Ensure that the patient is sitting in a position that allows for a straight and level
approach of the RetinaVue 100 Imager into the patient's eyes. A stable approach
minimizes the loss of the view of the eye and repeated image capture attempts.
• Keep the RetinaVue 100 Imager lens the same height as the patient's examined eye.
• Approach the patient from directly in front of the tested eye. Ensure that the
RetinaVue 100 Imager is level and straight with the patient's eye the during the
approach into the eye.
• Keep the RetinaVue 100 Imager device level and make any fine adjustments to the
patient end of RetinaVue 100 Imager rather than the LCD display end.
Note For additional information about techniques to capture the highest quality
image, see the Technique guide that came with the RetinaVue 100 Imager.
1. Press the power button .
Note To conserve power, the RetinaVue 100 Imager enters stand
by mode and returns to the Home screen if it remains idle
for approximately two minutes. Touch the LCD screen to
wake up the RetinaVue 100 Imager from stand by mode.
Note After 10 minutes of inactivity the RetinaVue 100 Imager will
enter deep sleep mode. Press the Home button to activate
the RetinaVue 100 Imager.
2. From the Home screen, touch Exam.
The Preacquistion screen appears.
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Directions for use Using the RetinaVue 100 Imager 27
3. (Optional), If necessary, touch (Settings) to adjust the illumination, or the focus.
Touch the up or down arrows in the Advanced image capture settings and touch OK.
4. Touch Start to enter the Image acquisition mode and begin the first exam of the
patient's right eye (R1).
The Exam acquisition screen appears.
5. Ask your patient to look straight forward and to cover (but not close) their
unexamined eye. Stabilize the RetinaVue 100 Imager so that it is the same height as
the patient's examined eye.
Note Hold the RetinaVue 100 Imager with one hand and use your
other hand to make fine adjustments at the patient's eye.
Cradle the lens between your thumb and index finger and
then put your fingers on the patient’s forehead.
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28 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
6. Ask the patient to stare at the green fixation lights.
Note Instruct the patient to cover, but not close, their unexamined
eye. This will help the patient to focus on the green fixations
lights.
7. Start with the eye cup about two to three inches from the eye to be tested.
a. Continue to compress the eye cup against the examined eye.
b. Identify the white/purple reflection inside the pupil.
WARNING Patient injury risk. The eye cup should be
cleaned after each patient.
8. Line up the cross hair and move the image directly toward the reflection, allowing
the white reflection to fill the screen as you approach the eye.
9. Continue to move forward slowly until the white reflection fills the whole screen.
Note Compress the eye cup slightly to surround the eye socket.
10. Continue to move the RetinaVue 100 Imager forward by slightly compressing the
eye cup until a ghost-like bubble appears on the screen.
Note If necessary, move the patient end of the RetinaVue 100
Imager toward the ghost-like bubble and direct the ghost-like
bubble into the diamond shape located in the upper part of
the LCD touchscreen.
11. The RetinaVue 100 Imager automatically captures the image. The RetinaVue 100
Imager plays an acquire tone similar to the sound of a camera shutter.
The image appears on the LCD touchscreen for review.
Page 33
Directions for use Using the RetinaVue 100 Imager 29
12. Touch to begin the second exam of the patient's left eye (L1) and repeat the
steps until the second image is automatically captured.
13. When the two images are captured and contain a green quality acceptance check
mark, proceed to the patient's Exam summary screen.
Note Touch to review the current image. Images with a red X
denote low quality images. Touch or to
dispose of an image and touch to begin an exam
capture of a replacement image.
Perform a manual image capture while in Auto exam mode
1. From the Pre-acquistion screen, touch Start.
2. Touch (image capture) to manually capture an image.
The RetinaVue 100 Imager plays an acquire tone similar to the sound of a camera
shutter. The image appears on the LCD touchscreen for review.
Page 34
30 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Skip an image capture while in exam mode
1. From the Home screen, touch Exam.
The Pre-acquistion screen appears.
2.
Touch (Next) or touch (Image Order) to skip to the next image in
the sequence.
3. Touch Start to enter Image acquisition mode and begin the exam of the patient's
eye using the next image in the sequence.
The Exam acquisition screen appears.
4.
If this is the last image in the sequence, touch (Next) again to navigate
to the Exam summary screen.
Page 35
Directions for use Using the RetinaVue 100 Imager 31
Page 36
32 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Perform a manual image capture while in Manual exam mode
1. From the Home screen, touch Exam.
The Pre-acquistion screen appears.
2. Touch MANUAL to enter Image acquisition mode and begin the exam of the
patient's eye.
The Exam acquisition screen appears.
3. (Optional), If necessary, touch to adjust illumination, or touch to
adjust the focus.
4. Start with the eye cup about two to three inches from the eye to be tested.
a. Continue to compress the eye cup against the examined eye.
b. Identify the white/purple reflection inside the pupil.
Page 37
Directions for use Using the RetinaVue 100 Imager 33
5. Continue to move forward slowly until the white reflection fills the whole screen.
Note Compress the eye cup slightly to surround the eye socket.
6. Continue to move the RetinaVue 100 Imager forward by slightly compressing the
eye cup until a ghost-like bubble appears on the screen.
Note If necessary, move the patient end of the RetinaVue 100
Imager toward the ghost-like bubble and direct the ghost-like
bubble into the diamond shape located in the upper part of
the LCD touchscreen.
7. Touch (image capture) to manually capture an image.
The RetinaVue 100 Imager plays an acquire tone similar to the sound of a camera
shutter. The image appears on the LCD touchscreen for review.
Page 38
34 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Update the RetinaVue 100 Imager software
Note Patient list changes will only be made to the RetinaVue 100 Imager after it
is undocked from the docking station charger. (Transferring patient list
information requires the optional RetinaVue Network software.)
Note DICOM files will be available to the RetinaVue Network once the RetinaVue
100 Imager is docked.
CAUTION Do NOT remove the SD Card or AC power from the device
during boot up.
Before you begin, you will need the following :
• The SD card with the downloaded software update.
• A computer with an Internet connection.
• The RetinaVue 100 Imager you plan to update.
• The docking station charger with a USB cable connected to AC power.
1. Power down the RetinaVue 100 Imager and remove the SD card.
2. Insert the SD card into an open SD card reader port on the computer.
3. Download the software update from the Welch Allyn website and transfer the
software update to a computer.
4. Transfer the software update from the computer to the SD card.
5. Remove the SD card from the computer.
6. Insert the SD card into the RetinaVue 100 Imager.
7. Place the RetinaVue 100 Imager on the docking station charger, connect to AC
power, and then power up the RetinaVue 100 Imager.
8. After the RetinaVue 100 Imager boots up, confirm the software upgrade.
a. Touch Settings.
b. Touch About to view the software version.
You are ready to use the updated software.
Troubleshooting software updates
Note The RetinaVue 100 Imager boots up normally after a successful software
update, however if a software update fails, the RetinaVue 100 Imager
displays a failed update error message.
Power loss during software update:
•
If a power loss occurs during the software update or if there are hardware issues,
the RetinaVue 100 Imager posts a blank screen. Remove the battery, reinstall it, and
restart RetinaVue 100 Imager. By performing this power cycle, the RetinaVue 100
Imager reverts to a previous version of software. Repeat the steps to perform the
update again.
Corrupted software files:
If the software update on the SD card is corrupted, the RetinaVue 100 Imager
•
displays a failed update error message indicating that theRetinaVue 100 Imager is
unable to load the software from the SD card. Remove the SD card, reformat it on a
PC. Repeat the steps to perform the update again.
Page 39
Directions for use Using the RetinaVue 100 Imager
Viewing or changing the RetinaVue 100 Imager settings
To view or change the settings
Touch Settings.
• Touch Volume.
Touch (up) or (down) to adjust the device sound volume. Touch OK to return
to the Settings screen.
• Touch Time.
Touch (up) or (down) to adjust the hour, minute, Continent, and location.
Touch (Back) to return to the Settings screen.
• Touch Date.
35
Touch to enter the month, day, and year in the MM/DD/YYYY format. Touch OK.
Touch (Back) to return to the Settings screen.
Touch Advanced Settings.
Modify the settings as desired
•
Device access code. Set the Device access numeric code, retype the code to
confirm, and touch OK to return to the Advanced Settings screen.
• Advanced settings code. Set the Advanced settings numeric code, retype the code
to confirm, and touch OK to return to the Advanced Settings screen.
• Format SD. Touch OK to format the SD card to the default settings and touch OK
again to return to the Advanced Settings screen.
• Factory reset. Touch OK to reset the device to the default settings and touch OK
again to return to the Advanced Settings screen.
• Export log. The log files are exported to the SD card. Touch OK to return to the
Advanced Settings screen. Touch OK. Touch
Settings screen.
Touch About to view the software version. Touch OK.
(Back) to return to the
Touch
(Home) to return to the Home screen.
Page 40
36 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager
Page 41
Troubleshooting
CAUTION A defective device should not be used. Parts which may be
broken or missing or are visibly worn, distorted, or contaminated should be
replaced immediately with clean, genuine replacement parts manufactured
by or available from Welch Allyn.
To correct an error, follow these instructions or contact Welch Allyn Technical Support:
www.welchallyn.com/service.
37
Troubleshooting image quality
A quality image will appear without any problems
Problem
Full dark circle around the outside
Dark semi circle on top Move the patient side of the RetinaVue 100 Imager down
Dark semi circle on bottom Move the patient side of the RetinaVue 100 Imager up and
Solution
Move the RetinaVue 100 Imager closer to the eye slowly
until the screen is filled with the white/gray circle.
and away from dark semi-circle.
away from dark semi-circle.
Bubble is too wide for Auto-capture to capture image Back the RetinaVue 100 Imager away from patient eye
slowly until a smaller bubble is visible and inside the
circular alignment target.
Page 42
38 Troubleshooting Welch Allyn RetinaVue™ 100 Imager
Problem Solution
The eyelids are closed. Ask the patient to open their eyes.
An eyelid is obscuring all or part of the pupil.
The patient isn’t looking at the green fixation lights. The green fixation lights should be near the pupil. If the
• Ensure that the patient is covering their other eye
with the palm of their hand.
• Ask the patient to open their eyes wider. Drooping
eyelids that cover part of the pupil may require the
clinician to manually hold them open wider during the
test.
• Use the eyecup to keep the eyelid open by using the
thumb and forefinger to simultaneously gently lift the
patient’s eyebrow upwards and gently pull down on
the skin below the eye while securing the eyecup in
place.
patient is not looking at the green fixation lights, ask the
patient to look at the green fixation lights. Ask the patient
to cover their unexamined eye.
Page 43
Maintenance
Clean and disinfect
CAUTION Never submerge the RetinaVue 100 Imager in water or any
other liquid.
CAUTION Never use abrasive cleaning agents, thinners or benzene for
cleaning and never immerse the instrument in water or other cleaning
liquids.
39
CAUTION Never insert a sharp object into the device or any open surface
on the RetinaVue 100 Imager.
CAUTION Do not use unapproved cleaning or disinfection agents. Use of
these agents may cause damage to components.
CAUTION Do not use chemicals other than isopropyl or ethyl alcohol on
the lens.
The RetinaVue 100 Imager can be cleaned and an intermediate-level of disinfection can
be achieved using the following method.
Cleaning the RetinaVue 100 Imager lens
Wipe the surface of the lens with a cleaning cloth or a lens cleaning tissue such as
Thorlabs Inc.. Avoid touching the lens except when cleaning is required.
Cleaning the RetinaVue 100 Imager
Power off the RetinaVue 100 Imager before cleaning it.
Use a pre-moistened wipe or soft cloth slightly moistened with an approved cleaner to
gently clean the RetinaVue 100 Imager.
Disinfecting the RetinaVue 100 Imager
Use a pre-moistened wipe or soft cloth slightly moistened with an approved disinfectant
to disinfect the RetinaVue 100 Imager. Follow the manufacturers recommendations.
Note
After cleaning or disinfecting, wait at least 10 minutes before taking
another measurement.
Page 44
40 Maintenance Welch Allyn RetinaVue™ 100 Imager
Approved cleaning agents
Use only the following approved cleaning agents on the RetinaVue 100 Imager:
CaviWipes
Sani-Cloth® Plus
Super Sani-Cloth
Sani-Cloth® Bleach
Oxiver Tb Tuffie5 Cleaning Wipes
Clinell® Universal Wipes
Accel INTERVention 10% bleach (.5% - 1% Sodium Hypochlorite)
Accel TB
®
Super HDQ® L10
Cleancide
Clorox HealthCare Bleach Germicidal Cleaner
Virex II (256)
70% IPA
Welch Allyn has validated these instructions as being capable of preparing the RetinaVue
100 Imager for re-use. You must ensure that cleaning and disinfection as actually
performed by your personnel, with your equipment and materials, achieves the desired
result. This may require validation and routine monitoring of your actual process.
Page 45
Specifications
2000mAh
Specifications
41
View Angle
Diopter -20 ~ +20D (Typical)
Dimensions L 8.8 inches (224.2 mm) × W 4.2 inches (106.7 mm) × H 4.1 inches (105.2 mm)
Weight 565 Grams ±5%
Search Fundus
Lighting
Camera / video
flash light
Focus Auto Focus and Manual Focus
Camera Resolution 1920 × 1080 pixels
LCD Monitor 3.5 inch Full Color TFT-LCD
Image Format JPEG (Photograph)
Interface Micro USB, AV out port
File Transfer Micro USB Port to PC running RetinaVue Network Client (requires additional software)
45 Degree (Typical)
Infrared LED
Natural White Light Emitting Diode (LED)
File Storage SD Card, default 8GB. Supports 2G to 32GB by FAT32 format.
Power Source Rechargeable Lithium Battery 3.6V / 1950mAh
External Power Source: 100~240 VAC, 50/60 Hz
Power Adapter
Spec.
Charger Station
Input Spec.
Operating Time 3 hours at at 5 minutes working mode and 15 minutes deep sleep mode as one cycle
Input Spec. : 100~240 VAC, 50/60 Hz, 0.3A; Output Spec. : 5V DC, 2A
5V DC, 1.2A
Page 46
42
Specifications Welch Allyn RetinaVue™ 100 Imager
Charging Time 5 hours through docking station
All specifications are subject to change.
Operating environment
Criterion Environmental conditions
Temperature + 10 °C to + 35 °C
Relative humidity 30 % to 90 %
Atmospheric pressure 800 hPa to 1 060 hPa
Storage environment
Criterion Environmental conditions
Temperature − 10 °C to + 55 °C
Relative humidity 10 % to 95 %
Atmospheric pressure 700 hPa to 1060 hPa
Transportation environment
Criterion
Temperature − 40 °C to + 70 °C
Relative humidity 10 % to 95 %
Atmospheric pressure 500 hPa to 1 060 hPa
Device lifetime
The lifetime of the device is five (5) years. The manufacture date of the device can be
found on the device labels.
Welch Allyn will service RetinaVue 100 Imager devices that are within their lifetime.
Firmware updates and support may require an annual subscription service after the initial
one (1) year warranty period. The expected battery life is at least one (1) year. If the
RetinaVue 100 Imager device fails to hold a charge, a new battery can be ordered.
Environmental conditions
Page 47
Device radio
The RetinaVue 100 Imager's radio operates on Welch Allyn FlexNet™ or other 802.11
networks. For information regarding the configuration of network connections and
recommended settings, see the best practices documents at www.welchallyn.com/
promotions/Network_Installation_Best_Practices.htm. Note: Your model might not
contain all of these features.
43
WLAN standard
Frequency Range
Data Rate
Modulation
Host interface
Encryption
Channel availability
Antenna
IEEE802.11b/g/n, Wi-Fi compliant
2.412 to 2.484 GHz
802.11b: 11, 5.5, 2, 1 Mbps DSSS
802.11g: 54, 48, 36, 24, 18, 12, 9, 6 Mbps OFDM
802.11n: HT20 MCS0~7, HT40 MCS0~7
802.11b: CCK, DQPSK, DBPSK
802.11g: 64 QAM, 16 QAM, QPSK, BPSK
802.11n: BPSK, QPSK, 16-QAM, 64-QAM
USB 2.0
WPA, WPA-PSK, WPA2, WPA2-PSK, WEP 64bit & 128bit, IEEE 802.11x, IEEE
802.11i
2.4GHz:
(Ch. 1-11) – United States
(Ch. 1-13) – Europe
(Ch. 1-14) – Japan
PCB-37x6-15U.FL with I-PEX cable, Max Gain: 1.3 dBi
Agency approvals
US: FCC 15.247:2014, KDB 558074 V3, Part 18, ANSI C63.10.2013
Europe: Annex 3.2 R&TTED in 2.4 GHz bands, EN 300 328 V1.9.1:2015, EN 301
489-17 V2.2.1:2012, EN 301 489-01 V1.9.2:2011, EN62479
Canada: (IC) RSS-210:2010 RSS-Gen:2014, RSS-02:2015
Channel restrictions in the 5-GHz band are determined by country.
Marking by the symbol ( ! ) indicates that usage restrictions apply.
Page 48
44 Device radio Welch Allyn RetinaVue™ 100 Imager
To ensure compliance with local regulations, be sure the correct country in which the
access point is installed is selected. This product can be used with the following
restriction(s):
Norway - Does not apply for the geographical area within a radius of 20 km from the
center of Ny-Ålesund.
France - Outdoor use is limited to 10 mW EIRP within the band 2454 to 2483.5 MHz.
Note Effective Isotropic Radiated Power (EIRP).
Note Some countries restrict the use of 5-GHz bands. The 802.11a radio in the
RetinaVue 100 Imager uses only the channels indicated by the access point
with which the radio associates. The hospital IT department must configure
access points to operate with approved domains.
Page 49
General compliance and standards
The RetinaVue 100 Imager complies with the following standards:
IEC 60601-1：2005 (EN 60601-1：2006)
IEC 60601-1-2：2007 (EN 60601-1-2：2007)
ISO 15004-1：2006
45
ISO 15004-2：2007
ISO 10940：2009
Directive 2002/96/EC-WEEE:
Disposal of noncontaminated electrical and electronic equipment
This product and its accessories must be disposed of according to local laws and
regulations. Do not dispose of this product as unsorted municipal waste. Prepare this
product for reuse or separate collection as specified by Directive 2002/96/EC of the
European Parliament and the Council of the European Union on Waste Electronic and
Electrical Equipment (WEEE). If this product is contaminated, this directive does not
apply.
For more specific disposal or compliance information, see www.welchallyn.com/weee,
or contact Welch Allyn Customer Service at +44 207 365 6780.
General radio compliance
The wireless features of this monitor must be used in strict accordance with the
manufacturer’s instructions as described in the user documentation that comes with the
product.
This device complies with Part 15 of the FCC rules and with the rules of the Canadian
ICES-003 as described below.
Federal Communications Commission (FCC)
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions:
This device may not cause harmful interference.
•
Page 50
46
General compliance and standards Welch Allyn RetinaVue™ 100 Imager
• This device must accept any interference received, including interference that may
cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy. If not installed and
used in accordance with the instructions, it may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the
user is encouraged to try and correct the interference by one or more of the following
measures:
• Reorient or relocate the receiving antenna
• Increase the distance between the equipment and the receiver
• Connect the equipment to an outlet on a circuit different from that to which the
receiver is connected
• Consult the dealer or an experienced radio/TV technician for help
The user may find the following booklet prepared by the Federal Communications
Commission helpful:
The Interference Handbook
This booklet is available from the U.S. Government Printing Office, Washington, D.C.
20402. Stock No. 004-000-0034504.
Welch Allyn is not responsible for any radio or television interference caused by
unauthorized modification of the devices included with this Welch Allyn product, or the
substitution or attachment of connecting cables and equipment other than specified by
Welch Allyn.
The correction of interference caused by such unauthorized modification, substitution, or
attachment will be the responsibility of the user.
The device is designed and tested to meet the applicable limits for radio frequency (RF)
exposure established by the Federal Communications Commission (U.S.A.) Specific
Absorption Rate; (SAR) refers to the rate at which the body absorbs RF energy.
The maximum allowable SAR limit is 4.0 W/kg, averaged over 10 gram of tissue for the
device. The following SAR values were measured during product certification, 0.012 W/
kg with a (0mm gap) a value well below the maximum allowable limit of 4.0 W/kg.
Industry Canada (IC) emissions
This device complies with RSS 210 of Industry Canada.
Operation is subject to the following two conditions: (1) this device may not cause
interference, and (2) this device must accept any interference, including interference that
may cause undesired operation of this device.
L’utilisation de ce dispositif est autorisée seulement aux conditions suivantes: (1) il ne
doit pas produire de brouillage et (2) l’ utilisateur du dispositif doit étre prêt à accepter
tout brouillage radioélectrique reçu, même si ce brouillage est susceptible de
compromettre le fonctionnement du dispositif.
This Class B digital apparatus complies with Canadian ICES-003.
Page 51
Directions for use General compliance and standards
Cet appareil numérique de la classe B est conform à la norme NMB-003 du Canada.
RF Radiation Hazard Warning
Using higher gain antennas and types of antennas not certified for use with this product
is not allowed. The device shall not be co-located with another transmitter.
Cet avertissement de sécurité est conforme aux limites d'exposition définies par la
norme CNR-102 at relative aux fréquences radio.
This radio transmitter (Contains IC ID: 3147A-BT800) has been approved by Industry
Canada to operate with the antenna types listed in table above with the maximum
permissible gain and required antenna impedance for each antenna type indicated.
Antenna types not included in this list, having a gain greater than the maximum gain
indicated for that type, are strictly prohibited for use with this device.
Le présent émetteur radio (Contains IC ID: 3147A-BT800) a été approuvé par Industrie
Canada pour fonctionner avec les types d'antenne énumérés ci-dessous et ayant un gain
admissible maximal et l'impédance requise pour chaque type d'antenne. Les types
d'antenne non inclus dans cette liste, ou dont le gain est supérieur au gain maximal
indiqué, sont strictement interdits pour l'exploitation de l'émetteur.
47
Under Industry Canada regulations, this radio transmitter may only operate using an
antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry
Canada. To reduce potential radio interference to other users, the antenna type and its
gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not
more than that necessary for successful communication.
Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d'un type et d'un gain maximal (ou inférieur) approuvé
pour l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage
radioélectrique à l'intention des autres utilisateurs, il faut choisir le type d'antenne et son
gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas
l'intensité nécessaire à l'établissement d'une communication satisfaisante.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may cause
undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1)
l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en
compromettre le fonctionnement.
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC EN 60601-1-2:2007.
All medical electrical equipment must be installed and put into service in accordance
•
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The 901103 Imager complies with all applicable and required standards for
electromagnetic interference.
Page 52
48 General compliance and standards Welch Allyn RetinaVue™ 100 Imager
• It does not normally affect nearby equipment and devices.
• It is not normally affected by nearby equipment and devices.
• However, it is good practice to avoid using the 901103 Imager in extremely close
proximity to other equipment.
• It is not safe to operate the 901103 Imager in the presence of high-frequency
surgical equipment.
Emissions and immunity information
Electromagnetic emissions
The 901103 is intended for use in the electromagnetic environment specified below. The customer or user of the 901103
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
a
The 901103 contains a 5-GHz orthogonal frequency-division multiplexing transmitter or a 2.4-GHz frequency hopping
spread-spectrum transmitter for the purpose of wireless communication. The radio is operated according to the
requirements of various agencies, including FCC 47 CFR 15.247 and R&TTE Directive (1995/5/EC). The transmitter is
excluded from the EMC requirements of 60601-1-2, but should be considered when addressing possible interference
issues between this and other devices.
Group 1 The 901103 uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment.
Class B
Class A
Complies
The 901103 is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage
power supply network that supplies buildings used for domestic
purposes.
WARNING This equipment/system is intended for
use by healthcare professionals only. This
equipment/ system may cause radio interference or
may disrupt the operation of nearby equipment a. It
may be necessary to take mitigation measures, such
as re-orienting or relocating the 901103 or shielding
the location.
Electromagnetic immunity
The 901103 is intended for use in the electromagnetic environment specified below. The customer or the user of the
901103 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
±6 kV contact
± 8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
± 6 kV contact
± 8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Page 53
Directions for use General compliance and standards 49
Electromagnetic immunity
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
± 1 kV differential
mode
± 2 kV common mode
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip for 25 cycles
>95% dip in 5 seconds
± 1 kV differential
mode
± 2 kV common mode
>95% dip in 0.5 cycle
60% dip in 5 cycles
30% dip for 25 cycles
>95% dip in 5 seconds
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the 901103 requires continued operation
during power mains interruptions, it is
recommended that the 901103 be powered
from an uninterruptible power supply or a
battery.
Electromagnetic immunity
The 901103 is intended for use in the electromagnetic environment specified below. The customer or the user of the
901103 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the 901103, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
3 Vrms
3 Vrms
150 kHz to 80 MHz
3 V/m 80 MHz to 1 GHz 3 V/m
d= (1.17)
d= (1.17) 80 to 800 MHz
IEC 61000-4-3
d= (2.33) 800 MHz to 2,5 GHz
whereP is the maximum output power rating of
the transmitter in watts (W) andd is the
recommended separation distance in meters
(m). Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb. Interference
may occur in the vicinity of equipment marked
with the following symbol:
Note1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To
Page 54
50 General compliance and standards Welch Allyn RetinaVue™ 100 Imager
Electromagnetic immunity
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the 901103 is used exceeds the applicable RF
compliance level above, the 901103 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the 901103.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications
equipment and the 901103
The 901103 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or user of the 901103 can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the 901103 as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated max. output
power of transmitter
(W)
0.01 0.11667 0.11667 0.23333
0.1 0.36894 0.36894 0.73785
1 1.1667 1.1667 2.3333
10 3.6894 3.6894 7.3785
100 11.667 11.667 23.3333
For transmitters rated at a maximum output power not listed above, the recommended separation distanced in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
150 kHz to 80 MHz
d= (1.17)
80 MHz to 800 MHz
d= (1.17)
800 MHz to 2.5 GHz
d= (2.23)
Page 55
Approved accessories
The following table lists the approved RetinaVue 100 Imager accessories.
WARNING Use only Welch Allyn approved accessories and use them
according to the manufacturer’s directions for use. Using unapproved
accessories with the RetinaVue 100 Imager can affect patient and operator
safety and can compromise product performance and accuracy, and void
the product warranty.
51
Accessories
Miscellaneous items
Part number
RV100 RetinaVue 100 Imager with lithium-ion battery
106401 Charging Dock for Welch AllynRetinaVue 100 Imager; 100-240 V,
106404 Reusable Eye Cups for Welch AllynRetinaVue 100 Imager: Qty. 5
106405 Battery for Welch AllynRetinaVue 100 Imager; Lithium-Ion
106406 Replacement USB Cable for Welch AllynRetinaVue 100 Imager
106507
106541 RetinaVue 100 Imager Chin rest adapter
106547 RetinaVue 100 Imager Chin rest
Description
50-60 Hz
Power supply wall adapter for Welch Allyn RetinaVue 100 Imager.
100-240 V, 50-60 Hz; IEC Plug Type B (US)
236200-2 Welch AllynRetinaVue 100 Imager replacement screwdriver for battery
cover. #1 Phillips Screwdriver w/ Logo
106558 Laptop for RetinaVue Network Client
Page 56
52 Approved accessories Welch Allyn RetinaVue™ 100 Imager
Service
Part number Description
S1-RV100-1 Welch Allyn Partners in Care Comprehensive Partnership Program
Service Agreement for RetinaVue 100 Imager; 1 year
S1-RV100-2 Welch Allyn Partners in Care Comprehensive Partnership Program
Service Agreement for RetinaVue 100 Imager; 2 year
S1-RV100-5 Welch Allyn Partners in Care Comprehensive Partnership Program
Service Agreement for RetinaVue 100 Imager; 5 year
S4-RV100-1 Welch Allyn Partners In Care Extended Warranty Program for
RetinaVue 100 Imager; 1 year
S4-RV100-2 Welch Allyn Partners In Care Extended Warranty Program for
RetinaVue 100 Imager; 2 year
S4-RV100-5 Welch Allyn Partners In Care Extended Warranty Program for
Literature/Documentation
Part number
411492 RetinaVue 100 Imager Directions for use
723617 RetinaVue 100 Imager Startup guide
724147 RetinaVue 100 Imager System network guide
411513 Chin rest assembly guide
724146 RetinaVue 100 Imager Technique guide
RetinaVue 100 Imager; 5 year
Description
Page 57
Warranty
Welch Allyn warrants the product to be free of defects in material and workmanship and
to perform in accordance with manufacturer's specifications for the period of one year
from the date of purchase from Welch Allyn or its authorized distributors or agents.
The warranty period shall start on the date of purchase. The date of purchase is: 1) the
invoiced ship date if the device was purchased directly from Welch Allyn, 2) the date
specified during product registration, 3) the date of purchase of the product from a
Welch Allyn authorized distributor as documented from a receipt from said distributor.
53
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.
Shipping cost to return a device to a Welch Allyn Service center is not included.
A service notification number must be obtained from Welch Allyn prior to returning any
products or accessories to Welch Allyn's designated service centers for repair. To obtain
a service notification number, contact Welch Allyn Technical Support.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S
OBLIGATION UNDER THIS WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT
OF PRODUCTS CONTAINING A DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR
ANY INDIRECT OR CONSEQUENTIAL DAMAGES RESULTING FROM A PRODUCT
DEFECT COVERED BY THE WARRANTY.
Page 58
Material No.
411492
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