Welch Allyn Spot VS100 Directions For Use Manual

Welch Allyn

®

Spot

™

Vision Screener Model VS100

Directions for use

Software version 3.1.XX

ii Welch Allyn Spot Vision Screener VS100

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 the 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.

Welch Allyn

®

is a registered trademark of Welch Allyn.

Spot

™

is a trademark of Welch Allyn.

is protected by United States of America copyright laws and international treaty provisions applicable

worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with

this instrument as intended in the operation of the product in which it is embedded. The software may not

be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable

form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the

software remain with Welch Allyn or its vendors.

This product may contain "free" or "open source" software (FOSS). To learn more about Welch Allyn's use

and support of FOSS, please visit http://www.welchallyn.com/opensource.

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 80024271 Ver. A

Revision date: 2018-12

Welch Allyn, Inc.

4341 State Street Road

Skaneateles Falls, NY 13153 USA

This manual applies to 901029 Vision Screener.

Directions for use iii

Introduction.....................................................1

Intended use...........................................................1

Indications for use ......................................................1

Contraindications .......................................................1

Symbols ..............................................................2

Documentation symbols ..............................................2

Power symbols .....................................................2

Miscellaneous symbols ...............................................3

User Interface Symbols ...............................................3

Warnings, cautions and notes .............................................5

Contents Checklist ......................................................7

Controls, Display Window, and Connections ...........................9

Features ..............................................................9

Display Window .......................................................11

Subject Information Screen ..............................................12

Understanding the Results ...............................................13

Tools ................................................................14

Setting up the Vision Screener .....................................15

Charging .........................................................15

Powering the vision screener on and off .................................15

Tripod mount ......................................................15

Helpful hints .......................................................15

Wireless network configuration ...........................................16

To add/change the network name (SSID): ................................16

To add/change the WPA/2 PSK passphrase (password): ....................16

To add/change the WPA/2 EAP-PEAP username and password: ..............16

To add/change the WEP key (password): ................................16

To enable or disable the wireless capabilities on the vision screener:...........17

To view advanced network settings: ....................................17

Printer configuration ....................................................17

To select or change a default printer: ...................................17

To configure a printer................................................17

To delete a printer ..................................................17

To reset the printer system ...........................................18

Adding a network printer .............................................18

Adding a direct connect (USB) printer ...................................18

Importing/exporting files ................................................19

Export............................................................19

Import............................................................20

Custom banner.....................................................20

To add a custom banner..............................................20

Web access .......................................................21

Licensing .........................................................21

Vision Screener operation.........................................23

Screening Environment .................................................23

Screening a Subject .................................................23

iv Welch Allyn Spot Vision Screener VS100

How to focus the vision screener ......................................24

Monocular mode ...................................................25

Viewing the results .................................................26

Understanding the Results............................................27

Vision Screener criteria ..............................................28

Subjects ..........................................................28

Troubleshooting ................................................31

System restart .....................................................31

System freeze .....................................................31

Printer issues ......................................................31

Wireless issues ....................................................31

System messages ..................................................32

Cleaning the Vision Screener ......................................35

Clean the Vision Screener ............................................35

70 percent isopropyl alcohol ..........................................35

10 percent chlorine bleach solution .....................................35

Specifications ..................................................37

Power supply specifications...........................................38

Vision Screener specifications .........................................38

Screening capacity ..................................................38

Storing the equipment ...............................................39

Disposing of electronic equipment .....................................39

EMC compliance ...................................................40

Emissions and immunity information....................................41

FCC compliance statement ...........................................45

Vision Screener radio ................................................46

International radio compliance .........................................47

General radio compliance.............................................48

Industry Canada (IC) emissions ........................................48

European Union ....................................................49

Vision Screener........................................................51

1

Introduction

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.

2 Introduction Welch Allyn Spot Vision Screener VS100

Symbols

For information on the origin of these symbols, visit http://www.welchallyn.com/

symbolsglossary for the Welch Allyn symbols glossary.

Documentation symbols

Power symbols

Consult operating instructions/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 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.

Rated power input, DC

Battery inside (Not user replaceable)

Power On/Off

USB port

DC power input port, Center pin positive

Directions for use Introduction 3

Miscellaneous symbols

User Interface Symbols

IPXØ

Equipment is not protected against the ingress of liquid

Non-ionizing electromagnetic radiation

This symbol is applicable for EC member countries only. To avoid potential negative consequences for the environment and

possibly human health, this instrument should be disposed of (i) for EU member countries - in accordance with WEEE

(Directive on Waste Electrical and Electronic Equipment) or (ii) for all other countries, in accordance with local disposal and

recycling laws.

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

IP

4 Introduction Welch Allyn Spot Vision Screener VS100

Unknown network

Cannot connect to configured network

Sound off

Sound on

Continue

Back

Exit

Print job in progress

?

!

Directions for use Introduction 5

Warnings, cautions and notes

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 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 patient leakage currents.

WARNING Risk of electric shock. No modification of this equipment is allowed.

WARNING Risk of electric shock. 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 void

product warranty.

WARNING Risk of electric shock. Do not allow the patient 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

patient 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 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 Lithium ion battery. Risk of fire, explosion, and burns. Do not handle

or disassemble the battery pack.

WARNING Use only accessories approved by Welch Allyn. Visit

www.welchallyn.com. The use of any other accessories can result in inaccurate

patient data, can damage the equipment, and can void your product warranty.

WARNING Injury risk and equipment damage risk. When charging the device,

properly secure all DC transformer cords to minimize trip hazards.

WARNING Patient injury risk. Verify patient identity on the device after manual

entry and before printing or transferring patient 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 may not be used directly for the prescription

of corrective eyewear.

6 Introduction Welch Allyn Spot Vision Screener VS100

Caution The device contains high-quality, fragile parts. Do not subject it to

physical shock.

Caution Do not use the wrist strap as a means to carry the device; it is not

designed to carry the weight of the device.

Caution The device is not waterproof. If you accidentally drop it into liquid or

liquid is spilled on the device, contact Welch Allyn Technical Support

immediately. If minor water droplets are found on the device, wipe off with a

soft dry cloth.

Caution Do not store the device in the foam or case while the DC power

adapter is plugged in; this may cause damage to the power cord and to the

device.

Caution Do not leave the device in excessive heat or in direct sunlight. High

temperatures can cause the device to malfunction.

Caution When plugging the DC power connector into the device, do not force

the power connector into the device; this may cause damage to the device,

which will not be covered under warranty.

Caution Do not push or scratch the touchscreen display with stiff or rigid

objects. This may cause damage to the device. A stylus is acceptable for use

with the device.

Note If the pupils are too small, the vision screener will notify you on screen to

adjust the lighting in the room. For best results, subject’s pupils should be 5mm

or greater.

Note The power cord set may not be used with any other equipment other than

the Welch Allyn Spot Vision Screener VS100.

Directions for use Introduction 7

Contents Checklist

The main shipping box contains the vision screener, Directions for use, and the Accessory

box. The Accessory box contains:

AC Power Cord.

Power Supply/Charger.

Cleaning Cloth.

Velcro Cable Straps.

If you purchased a carrying case, place the foam from the shipping box inside the carrying

case for safer transport. Do not store your vision screener in the foam or case while the

Power cord is plugged in.

Note

Please do not discard the box and foam. Damages incurred by shipping the device

in non-approved packing material will void the limited warranty (see warranty for

details).

8 Introduction Welch Allyn Spot Vision Screener VS100

2

9

Controls, Display Window, and

Connections

Drawings and text are representative of the Spot Vision Screener with all available

options.

Features

Rear View of Vision Screener

1 LCD Screen

2 Neck Strap Mount

3 AC Power Connector

4 Power Button

5 Wrist Strap Mount

6 Serial Number Label

7 Tripod Mount

8 Battery Charge Green LED Indicator

(Flashing) or charged (Continuous)

10 Controls, Display Window, and Connections Welch Allyn Spot Vision Screener

Front View of Vision Screener

9 USB Port

10 Ambient Light Sensor

1 Range Finder

2 Front Glass

3 Speaker

Directions for use Controls, Display Window, and Connections 11

Display Window

When the vision screener is powered on, the main menu or Home Screen will appear. If

the vision screener is connected to a network, the network name and IP address will be

visible in the upper left corner in the black bar.

1. Age Range

To begin instant screening, with no personal subject data, select an age range of the

subject from the Home screen. You will be able to enter subject data after the screening

if desired.

2. START Button

The START button will allow you to:

• Enter subject information such as ID, First and Last Name, Gender and Date of

Birth (DOB)/Age (Required)

• Find queued subjects (exact match on the ID screen)

• Begin the screening process (Binocular and Monocular available)

• Review and print screening results

3. Icons on Bottom of Screen

• Queue – View, select or search for queued subjects from a list to begin the

screening process.

• History – View already screened subjects (completed records).

• Tools – A variety of options to customize the vision screener.

12 Controls, Display Window, and Connections Welch Allyn Spot Vision Screener

Subject Information Screen

On the subject information screen, confirm all data is correct. You can modify information

by touching the field you wish to change. After the change is completed select OK and

you will come back to the subject information screen. Date of Birth/Age is required and

will highlight in red if there is no age or if it is not a valid birthdate or age (under 6 months).

Select GO to begin the screening process.

Directions for use Controls, Display Window, and Connections 13

Understanding the Results

1 Pupillary Distance

2 Pupil Size Indicator

3 Right Eye (OD), Left Eye (OS)

4 Complete refraction

SE - Spherical equivalent

DS - Sphere

DC – Cylinder

Axis – Axis

5 Screening Result

6 Home

7 Cylinder Convention

8 Alignment Indicator

9 Degree, Horizontal, Vertical

14 Controls, Display Window, and Connections Welch Allyn Spot Vision Screener

Tools

The Tools menu will allow you to customize and configure the vision screener with the

following options:

Displays firmware version, software application version and serial number. Also displayed

is a quick reference of important vision screener features, including memory storage levels

of the device.

View the age-based criteria settings used for exam recommendations that are currently

active on the vision screener.

Allows you to set the current date and time for your vision screener.

Enables you to import and export using an inserted USB storage device.

Location allows you to set a location for a screening and all subjects will be tied to that

location.

Allows you to connect the vision screener to a wireless network. You can manually enter

your network name (SSID), select the security type, and enter the passphrase for your

network. From this page you can view and change your TCP/IP settings.

Allows you to configure a network printer and print a test page. It also lets you view printer

status.

Allows you to configure how data is displayed on the “Results” screen when a screening

is complete. This includes data format, cylinder convention, displaying or hiding screening

results and recommendations, setting default screening display and screening time-outs.

Helps you set a security PIN for your device for added security. If enabled a PIN will be

required whenever you start the device or upon waking it.

Activates the license on the device.

Allows you to select the language that will display on the vision screener.

3

15

Setting up the Vision Screener

Charging

1. Connect the provided DC cord set and power supply/charger together.

2. Gently lift the back of the vision screener to view the available connections.

3. Locate the DC power connector on the vision screener and connect the power

supply/charger. The DC power connector on the power supply/charger will easily

insert into the DC power connector on the vision screener. Using force to connect the

power charger can damage the device and will void the warranty.

4. Plug the DC power cord into an available wall outlet to charge the device.

Powering the vision screener on and off

1. To turn the vision screener on, press and release the power button (start-up process

takes approximately 30 seconds). Once powered on, you will see the Main Menu.

2. To turn the device off, press and hold power button for two seconds. A confirmation

screen will appear to confirm shut down.

3. A flashing green light means the unit is charging, a steady green light means the unit

is fully charged.

Tripod mount

The vision screener can be mounted to a standard photographic tripod. A ¼-20 threaded

mount located on the bottom of the device is available for attaching a tripod.

Helpful hints

• No activity on the vision screener — After 60 seconds the screen will dim; after 5

minutes the screen will automatically turn black to conserve battery power. Tap the

screen to ‘wake up’ the vision screener or press the power button. If the screen does

not light up, plug in the power cord and try again.

• Exporting/Clear All — Verify you have successfully exported desired data to a USB

drive before you select Clear All.

• Routinely delete ALL records from the vision screener —GototheHistory screen

and select Clear All icon. Select Delete All Records. You may also delete all queued

records.

• Avoid powering off during a screening — Once the screening takes place, exit by

selecting the Exit button, then power down the device normally.

16 Setting up the Vision Screener Welch Allyn Spot Vision Screener

• Input Screen — Holding down the Back button on any input (keyboard) screen will

delete all data from the field.

• Low Battery — When the battery level reaches a very low level, a notice will appear

to the user indicating they should insert the power cable or the device will shut down.

If no power cable is inserted, the device will automatically shut down due to low

voltage.

Wireless network configuration

From the Tools menu, touch Network. Current network settings are displayed on

the screen. To add or edit any of the fields, see instructions below. If they are correct,

touch (Exit) to be returned to the Tools menu.

To add/change the network name (SSID):

1. Touch the SSID Name field; a keyboard will appear.

2. Enter the SSID (case sensitive); select OK to save your changes and return to the

previous screen. The OK button will turn dark when changes have been made and are

available to be saved.

To add/change the WPA/2 PSK passphrase (password):

1. Set the encryption type to WPA/2 PSK and touch the Passphrase button; a keyboard

will appear.

2. Enter the passphrase (case sensitive) and select OK.

3. On the Network screen, select OK to save changes, otherwise changes will not be

applied.

To add/change the WPA/2 EAP-PEAP username and password:

1. Set the encryption type to WPA/2 EAP-PEAP and touch Passphrase; a keyboard will

appear.

2. Enter the user name (case sensitive) and select OK.

3. Enter the network password (case sensitive) and select OK.

4. On the Network screen, select OK to save changes, otherwise changes will not be

applied.

To add/change the WEP key (password):

1. Touch the Passphrase button; a keyboard will appear (this is only available when the

security field is set to WEP or WPA).

2. Enter the WEP key (case sensitive password) and select OK.

3. On the Network screen, select OK to save changes, otherwise changes will not be

applied.

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