Welch Allyn Spot VS100 Manual

Welch Allyn®Spot™Vision
Screener Model VS100
Directions For Use
Software version 3.1.XX

© 2019 Welch Allyn, Inc. 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, 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
indications for use published in this manual.
Welch Allyn®is a registered trademark of Welch Allyn, Inc.
Spot is trademark of Welch Allyn.
Software in this product is copyright 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 within
this instrument as intended in the operation of the product in which it is embedded. The software may
not be copied, decompiled, reverse-engineered, disassembled or otherwise reduced to human-
perceivable form. This is not a sale of the software or any copy of the software; all right, title and
ownership of the software remains with Welch Allyn or its vendors.
This product may contain software known as “free” or “open source” software (FOSS). Welch Allyn
uses and supports the use of FOSS. We believe that FOSS makes our products more robust and secure,
and gives us and our customers greater flexibility. To learn more about FOSS that may be used in this
product, please visit our FOSS website at www.welchallyn.com/opensource. Where required, a copy of
FOSS source code is available on our FOSS website.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact Welch Allyn Technical Support:
www.welchallyn.com/about/company/locations.htm.
DIR 80024081 Ver. B
Revision date: 2019-04 This manual applies to the 901029 Vision Screener.
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 U.S.A
www.welchallyn.com

Contents
Introduction ............................................................................................. 1
About this document ........................................................................................... 1
Intended use ........................................................................................................ 1
Indications for use ................................................................................................ 1
Contraindications ................................................................................................. 1
Symbols ............................................................................................................... 2
Warnings and cautions ......................................................................................... 5
Controls, display window, and connections ......................................... 9
Features ............................................................................................................... 9
Display window .................................................................................................. 11
Tools .................................................................................................................. 12
Setting up the vision screener ............................................................. 15
Contents checklist ............................................................................................. 15
To turn on the vision screener ........................................................................... 15
To charge the vision screener ............................................................................ 16
To set the language ........................................................................................... 17
To set the system clock ..................................................................................... 17
Screening subjects ................................................................................ 19
Subject Information screen ................................................................................ 19
To screen a subject ............................................................................................ 19
The Subject Results screen ............................................................................... 22
To screen in monocular mode ........................................................................... 23
Overview: Conducting a mass screening .......................................................... 23
To delete records ............................................................................................... 24
Advanced settings on the vision screener .......................................... 25
Before configuring network security .................................................................. 25
Connecting a device to the network .................................................................. 25
Printing ............................................................................................................... 26
About importing and exporting .......................................................................... 30
Custom banner .................................................................................................. 33
Web access ....................................................................................................... 34
Vision screener criteria ....................................................................................... 34
About licensing .................................................................................................. 35
To enable/disable security on the vision screener ............................................. 35
To lock/unlock the vision screener ..................................................................... 36
To check the storage capacity ........................................................................... 36
Maintenance and cleaning ................................................................... 37
Cleaning the vision screener .............................................................................. 37
iii

Storing the equipment ....................................................................................... 38
Disposing of electronic equipment .................................................................... 38
Troubleshooting .................................................................................... 39
System restart ................................................................................................... 39
System freeze .................................................................................................... 39
Printer issues ..................................................................................................... 39
Wireless issues .................................................................................................. 40
Battery Issues .................................................................................................... 40
Restoring and restarting system messages ...................................................... 40
Screening tips .................................................................................................... 41
Screening Issues ................................................................................................ 41
Import/Export Issues .......................................................................................... 42
Specifications ........................................................................................ 43
Guidance and manufacturer's declaration .......................................................... 45
Warranty ................................................................................................ 55
Service policy ........................................................................................ 57
Configuration options for the VS100 vision screener ........................ 59
iv Contents Welch Allyn®Spot™Vision Screener Model VS100

Introduction
About this document
This Directions for use manual is a comprehensive guide designed to help you
understand the capabilities and operation of your Spot Vision Screener VS100. The
information in this manual includes all options available with the Spot Vision Screener.
The applicability of some sections of this manual depends on the configuration of your
particular device. Read this manual thoroughly before attempting to use the device.
The vision screener is a hand-held instrument with a video display on the rear of the unit
that provides subject visualization and alignment. Video display also provides user
interface functionality for data input and display. The vision screener provides visual and
audible cues to attract subject’s attention and gaze. The device provides a fast data
collect for easy evaluation of the most difficult pediatric subjects of limited compliance.
Each screening provides simultaneous binocular assessment of the subject’s refraction,
pupil size and gaze.
Intended use
The Spot Vision Screener is intended to produce optical images that can help identify
refractive errors and ocular misalignments by detecting special light reflexes from each
eye during screening. The Spot Vision Screener evaluates these light reflexes from the
retina to estimate refractive error. It also estimates pupil size, pupil distance and eye
gaze deviation. It is intended for use on subjects six months of age through adults.
Indications for use
The Spot Vision Screener is indicated for use by healthcare professionals or under the
direction of a healthcare professional to screen or evaluate individuals for potential
refractive errors associated with poor vision. This type of photoretinoscopy device is
intended to help the healthcare professional assess whether the subject should be
referred to an eye care specialist for further evaluation or simply be monitored at future
screenings. This screening is not intended to replace a full eye examination.
Contraindications
The Spot Vision Screener has no known contraindications.
1

Symbols
For information on the origin of these symbols, visit http://www.welchallyn.com/
symbolsglossary for the Welch Allyn symbols glossary.
Documentation symbols
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.
WARNING The warning statements in
this manual identify conditions or
practices that could lead to illness, injury,
or death.
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. This definition applies to both
yellow and black and white symbols.
Power symbols
Rated power input, DC Rechargeable battery
Power on/off USB
DC power input port, Center pin positive
Miscellaneous symbols
IPXO Not protected against the ingress of
water. Non-ionizing electromagnetic radiation
Manufacturer Reorder Number
Product Identifier Serial Number
Authorized Representative in the
European Community Global Trade Item Number
2Introduction Welch Allyn®Spot™Vision Screener Model VS100

User Interface Symbols
Battery status/level
indicator Battery charging
Wireless On/Off button Connected to the wireless network
No wireless network in
range No IP address assigned by the router
Unknown network Cannot connect to configured network
Sound off Sound on
Continue Back
Exit Print job in progress
Shipping, storing, and environment symbols
This way up Keep Dry
Fragile Humidity limitation
Temperature limit Atmospheric pressure limitation
Directions For Use Introduction 3

Separate collection of batteries. Do not
dispose as unsorted municipal waste. Recyclable
Separate collection of Electrical and
Electronic Equipment. Do not dispose as
unsorted municipal waste.
Keep away from sunlight
Lithium ion battery
4Introduction Welch Allyn®Spot™Vision Screener Model VS100

Warnings and cautions
WARNING The warning statements in this manual identify conditions or
practices that could lead to loss of data, illness, injury, or death.
CAUTION The caution statements in this manual identify conditions or
practices that could result in damage to the equipment or other property.
WARNING The Directions for Use (DFU) contains important instructions
for successful and safe use, maintenance, cleaning, transport, storage, and
operation of the device as well as a troubleshooting guide with additional
support. Read instructions thoroughly and store the DFU for future
reference. Contact Welch Allyn if any instructions are not understood.
Patient Safety
WARNING Photosensitivity risk. While this device is considered low risk
according to IEEE 1789, Practices for Modulating Current in High-
Brightness LEDs for Mitigating Health Risks to Viewers, this device uses
flickering lights to attract patient attention. A very small percentage of
individuals may experience epileptic seizures when exposed to certain light
patterns or flashing lights. Apply clinical judgment when using this device.
WARNING Exposure to sound. This device uses sound cues to attract
patient attention. If the sound creates discomfort for the patient, please
mute the device in the settings.
Data and Performance
WARNING Risk of data loss. If a reboot is required during a system freeze,
data loss, such as printer configuration and subject data, can occur.
WARNING Use only accessories approved by Welch Allyn. Visit
www.welchallyn.com. The use of any other accessories can result in
inaccurate subject data, can damage the equipment, and can void your
product warranty.
WARNING Subject injury risk. Verify subject identity on the device after
manual entry and before printing or transferring subject records.
WARNING False positive and false negative results may occur in a
healthcare screening. Vision screening does not replace a complete eye
examination by an ophthalmologist or optometrist.
WARNING The use of screening results for recommending therapy is
reserved exclusively for eye care professionals.
WARNING The screening results of this autorefractor are not to be used
directly for the prescription of corrective eyewear.
WARNING If the pupils are too small, the vision screener notifies you on
screen. You may want to adjust the lighting in the room.
CAUTION HIPAA and GDPR requires healthcare providers to protect
patient data from unauthorized viewing and use. Use of lock screen and
other data security protections available on this device are recommended.
Directions For Use Introduction 5

WARNING The VS100 transmits patient data as read-only PDFs.
Nevertheless, the possibility of security breaches cannot be completely
excluded. Verify that patient data matches the correct record and that it has
not been altered prior to making treatment decisions.
CAUTION Product security exploits can cause the device or device data to
become unavailable or cause data security breaches. Avoid inserting
uncontrolled or unsecured USB drives into the USB port or connecting to a
wireless network with incomplete security.
WARNING Patient Risk - selecting "hide recommendation" causes the
device to not show Pass/Refer messages during screening.
WARNING Patient Risk - When performing repeated measurements, use
the first reading (and referral) for most accurate results.
WARNING Device System Date is used in Pass/Refer determination.
Insure that the System Time is correct to prevent incorrect referrals
WARNING Risk of false positive and false negative results. Modification of
referral criteria should be performed only by a vision specialist.
Electrical and Fire
WARNING Risk of electric shock. All signal input and output (SIP/SOP)
connectors are intended for connection of only other medical devices,
medical systems or non-medical devices complying with IEC 60601-1, or
other IEC standards appropriate to the device. For example, a printer
connected via USB must comply with IEC 60950. Connecting additional
unapproved devices to the device might increase chassis or subject
leakage currents.
WARNING Risk of electric shock. No modification of this equipment is
allowed. Do not open the device or attempt repairs. The device has no
user-serviceable internal parts. Only perform routine cleaning and
maintenance procedures specifically described in this manual. Inspection
and servicing of internal parts shall only be performed by qualified service
personnel. Attempt to modify this device may result in bodily harm and will
voids product warranty.
WARNING Risk of electric shock. Do not allow the subject to make
contact with accessible conductive parts (DC adaptor output connector,
power input connector and USB port). Additionally, you should not make
contact with the subject and any accessible conductive parts at the same
time.
WARNING To avoid a possible explosion, do not use the device in the
presence of flammable anesthetics: mixtures containing air, oxygen, or
nitrous oxide.
WARNING Lithium ion battery. Risk of fire, explosion, and burns. Do not
handle or disassemble the battery pack.
WARNING Injury risk and equipment damage risk. When charging the
device, properly secure all DC transformer cords to minimize trip hazards.
WARNING The power cord set may not be used with any other
equipment other than the Welch Allyn Spot Vision Screener VS100.
6Introduction Welch Allyn®Spot™Vision Screener Model VS100