Hillrom Welch Allyn RetinaVue 700 Directions For Use Manual

Directions for use

Software version 1.00.XX

© 2019 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.

Software in this product is Copyright 2019 Welch Allyn or its vendors. All rights are reserved. The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide. Under such laws, the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded. The software may not be copied, decompiled, reverse-engineered, disassembled, or otherwise reduced to human-perceivable form. This is not a sale of the software or any copy of the software; all right, title, and ownership of the software remain with Welch Allyn or its vendors.

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 source code is available on our FOSS website.

For information about any Welch Allyn product, contact Welch Allyn Technical Support: http://

www.welchallyn.com/support.

DIR 80022736 Ver. C

Revision date: 2019-06

Distributed by Welch Allyn, Inc.

4341 State Street Road

Skaneateles Falls, NY 13153 USA

Medimaging Integrated Solution Inc. (MiiS)

1F, No. 7, R&D Rd II, Hsinchu Science Park,

Hsinchu, TAIWAN 30076, R.O.C.

Made in Taiwan

http://www.welchallyn.com/opensource. Where required, a copy of FOSS

This manual applies to the 901124 Ophthalmic Camera

Symbols ..................................................................... 1

Introduction ............................................................... 5

Intended use ............................................................................ 5

About warnings and cautions ................................................... 5

General warnings, cautions, and notes .................................... 6

Controls and connectors ........................................................ 12

First time set up of the RetinaVue 700 Imager ..... 15

Unpack the system ................................................................ 15

Startup ................................................................................... 20

First time selection of practice mode .................................... 22

iii

Camera registration ................................................ 25

USB camera registration ........................................................ 25

Wi-Fi camera registration ....................................................... 27

Using the RetinaVue 700 Imager ........................... 33

Auto Exam mode ................................................................... 33

About image quality scores .................................................... 35

About the face cup ................................................................. 35

About Exam protocols ............................................................ 37

Tutorial ................................................................................... 39

Before starting an eye exam ................................................. 40

Perform a Retina eye exam ................................................... 43

Create a patient on the camera .............................................. 49

Search for a patient in the Scheduled patients list ................. 50

Search for a patient in the Saved exams list .......................... 52

Delete an image during an eye exam ................................... 55

Delete a patient ...................................................................... 57

Delete a patient and exam ..................................................... 58

Capture additional images using the same protocol .............. 60

Review of saved exams ......................................................... 61

iv Contents

Review of submitted exams .................................................. 62

Update the RetinaVue 700 Imager software (firmware) ........ 63

Controls ................................................................... 67

RetinaVue 700 Imager main Patient screen ........................... 67

Practice mode ........................................................................ 71

Select or change a clinic on the RetinaVue 700 Imager

(wireless only) ........................................................................ 77

Select or change a Multi-State clinic on the RetinaVue 700

Imager (wireless only) ............................................................ 79

View or change the RetinaVue 700 Imager settings .............. 81

Advanced features .................................................. 91

Manual Exam mode ............................................................... 91

Use the Anterior Imaging Spacer for a patient Anterior image

exam ...................................................................................... 97

Perform a Anterior image eye exam ...................................... 99

Wireless certificate support overview for the IT

department .......................................................................... 104

Troubleshooting ................................................... 107

Wireless radio messages ..................................................... 112

Maintenance .......................................................... 119

Cleaning and Disinfection .................................................... 119

Specifications ........................................................ 125

Device radio .......................................................... 129

General compliance and standards .................... 131

General radio compliance ..................................................... 132

RetinaVue 700 Imager Accessories .................... 139

Warranty ................................................................ 143

Symbols

Documentation symbols

For information on the origin of these symbols, visit http://

www.welchallyn.com/symbolsglossary for the Welch Allyn symbols

glossary.

WARNING The warning statements in this manual identify conditions or practices that could lead to illness, injury, or death. Warning symbols will appear with a grey background in a black and white document.

Caution The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data.

Consult directions for use.

Power symbols

Power button

Direct current (DC)

Rated power input, DC

Rated power output, DC

Fuse

2 Symbols

Rechargeable battery

Connectivity symbols

USB

Wireless

Wireless radio symbols

Non-ionizing electromagnetic radiation

Wireless signal strength

• Best (4 bars)

• Good (3 bars)

• Fair (2 bars)

• Weak (1 bar)

• No signal (no bars)

FCC ID

The identification number assigned by the Federal Communication Commission

Shipping, storing, and environment symbols

Temperature limit

Keep Dry

Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste.

Fragile

Directions for use Symbols 3

Humidity limitation

Atmospheric pressure limitation

This way up

Stacking limit by number

Recyclable

Miscellaneous symbols

Product Identifier

Reorder Number

Global Trade Item Number

For indoor use only

Type BF applied part

Class II equipment

Prescription only or "For Use by or on the order of a licensed medical professional"

Clock; time switch; timer

Serial Number

Manufacturer

Call for maintenance

4 Symbols

Process indicator for activities like connecting to network or connecting to computer

Battery charge level indicators

Device is running on battery and charge is between 75 and 100 percent.

Device is running on battery and charge is below 75 percent.

Device is running on battery and charge is below 50 percent.

Device is running on battery and charge is below 25 percent.

Device is running on battery and charge is near 0 percent.

Device is connected to a power supply.

Introduction

Intended use

The Welch Allyn RetinaVue 700 Imager (RV700) is a high-resolution ophthalmic camera used to acquire, save and transmit digital images of the human eye. Anterior and posterior ocular structures such as the surface of the eye, cornea, and fundus including retina, macula and optic disc can be imaged. It is a prescription use only medical device.

About warnings and cautions

Warning and caution statements can appear on the RetinaVue 700 Imager device, the packaging, the shipping container, or in this Directions for use.

The RetinaVue 700 Imager is safe for patients and clinicians when used in accordance with the instructions and the warning and caution statements presented in this Directions for use.

Before using the device, you must familiarize yourself with all warnings and cautions, with the steps to power up the device, and with the sections of this Directions for use that pertain to your use of the device. Specific warnings and cautions are also found throughout this manual.

Failure to understand and observe any warning statement in this manual could

• lead to patient injury or illness.

• Failure to understand and observe any caution statement in this manual could lead to damage to the equipment or other property, or loss of patient data.

6 Introduction

General warnings, cautions, and notes

WARNING When manually entering patient information, do not use the same patient identifier for multiple patients. This may result in inaccurate data association.

WARNING Operating the device in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide; in oxygen-enriched environments; or in any other potentially explosive environment may cause a fire and explosion hazard.

WARNING Do not use batteries from other sources. This may result in excessive temperatures, fire, or explosion.

WARNING To prevent fire or electrical shock, do not expose the device to rain or moisture.

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.

WARNING Exposure to the RetinaVue 700 Imager flash, in rare cases, may contribute to migraines or temporary visual disturbances, particularly in patients with a history of light sensitivity or migraines. Multiple flashes per eye in a single exam may increase the likelihood of occurrence.

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.

Directions for use Introduction 7

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 700 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 Data 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 Within the patient environment, only connect the equipment (the RetinaVue 700 Imager) to computers or laptops that have passed the safety standard for information technology equipment IEC 60601-1, EN 60601-1, ANSI/AAMI ES 60601-1 to ensure the safety of the USB electrical connection. Outside the patient environment, only connect the equipment (the RetinaVue 700 Imager) to computers or laptops that have passed the safety standard for information technology equipment IEC 60950-1, EN 60950-1, UL 60950-1 to ensure the safety of the USB electrical connection.

CAUTION Do not turn off the device while saving data from a patient test. Turning off the device while saving patient data may cause data loss.

8 Introduction

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 and disinfection agent manufacturer instructions for their proper use and germicidal efficacy, prior to their use.

CAUTION Consult your facility's procedures and the cleaning and disinfection agent manufacturer instructions for recommended Personal Protective Equipment and other safety precautions such as ventilation, etc..

Note The RetinaVue 700 Imager can be used on patients with

eye implants and intraocular lenses. While the RetinaVue 700 Imager can be used on patients with cataracts and other eye opacities, images will likely be blurry or unreadable because of the refractive nature of the opacities.

Residual risk of magnets

WARNING Patient injury risk - magnetic fields. Exercise

caution when using the RetinaVue 700 Imager in close proximity to implanted devices such as, but not limited to, cranial implants, adjustable CSF shunts, and pacemakers.

Design and protective measures have been implemented to limit magnetic interference to be lower than the limit set by the Active Implantable Medical Devices standards. Nevertheless, in the event the device is placed in close proximity to these life supportive devices, patient harm associated with magnetic field hazards cannot be completely excluded.

Directions for use Introduction 9

Warnings related to RetinaVue 700 Imager applied parts components

Warnings related to the face cup

WARNING Clean and disinfect the face cup after each

patient to avoid the risk of cross-contamination.

WARNING Patient injury risk. The face cup of the RetinaVue 700 Imager uses magnets to attach to the device. If your patient has any type of cranial implant, it is advisable to reduce direct contact of the face cup's magnets with the patient's skin surface containing the implant.

Warnings and cautions related to accessories

Cautions related to the pedestal

CAUTION To avoid camera damage, remove camera

from pedestal prior to transport.

CAUTION To avoid camera damage, position the pedestal on a stable surface to reduce the likelihood of shock, bump, or vibration hazards.

Warnings and cautions related to the Anterior Imaging Spacer

WARNING Patient injury risk. The Anterior Imaging

Spacer of the RetinaVue 700 Imager uses magnets to attach to the device and to the face cup. If your patient has any type of cranial implant, it is advisable to reduce direct contact of the Anterior Imaging Spacer or the face cup's magnets with the patient's skin surface containing the implant.

CAUTION Failure to remove the Anterior Imaging Spacer before a Retina exam may result in unacceptable image quality or failure to capture an image.

10 Introduction

CAUTION Failure to install the Anterior Imaging Spacer before an Anterior image exam may result in unacceptable image quality or failure to capture an image.

Warnings, cautions, and notes related to the battery charger

WARNING The battery charger (non-medical electrical

equipment) shall be situated outside the patient environment (reference IEC 60601-1-1).

WARNING Electric shock hazard. Do not open the battery charger or attempt repairs. The battery charger has no user-serviceable internal parts. Inspection and servicing of internal parts shall only be performed by qualified service personnel.

WARNING Electric shock hazard. Before cleaning the battery charger, disconnect the AC power cord from the mains outlet and the power source.

WARNING Do not use batteries from other sources. This may result in excessive temperatures, fire, or explosion.

CAUTION Do not modify this equipment without authorization of the manufacturer.

CAUTION Use appropriate power plug for your country.

Note The removal of the plug from the socket provides the

means of isolation from the mains power supply. The user is reminded to keep this means of disconnection easily accessible in case of emergency.

Directions for use Introduction 11

Caution related to the EMR test server

CAUTION Incorrectly setting up the RetinaVue 700

Imager to connect to a Wi-Fi test server may result in loss of exam data. The test server is NOT intended to be used for patient exams and is only intended for use by a software integrator on an EMR integration team. A patient's exam data cannot be recovered once sent to the Wi-Fi test server.

12 Introduction

Controls and connectors

No. Feature Description

1 Power button

• Push button to turn the device on and off.

• Push button to bring the device out of Sleep mode.

• Push button to launch a dialogue box with three options:

○ Power down ○ Sleep ○ Cancel

2 LCD touchscreen 4.3 inch diagonal color LCD touchscreen.

3 USB port Data transfer port

4 Charging port and power indicator Connect AC power supply

• When the LED light is green, it indicates that the device is fully powered.

• When the LED light is orange, it indicates that the device is in the process of charging.

• When the device is not charging the LED is off.

5 Face cup Helps align the patient's eyes to the camera and blocks

ambient light during testing

Directions for use Introduction 13

Bottom

No. Feature Description

5 Face cup Helps align the patient's eyes to the camera and blocks

6 Pedestal mounting Pedestal mounting well (¼-20 thread) and locator ridge

7 Battery cover Covers the battery compartment

ambient light during testing

The two service ports under the battery

Note

cover are for factory use only and are not for customer use.

8 Wrist or neck strap bracket Wrist or neck strap mounting bracket

14 Introduction

First time set up of the RetinaVue 700 Imager

Refer to the following topics when setting up the RetinaVue 700 Imager for the first time.

View images saved to the RetinaVue 700 Imager on the LCD touchscreen. The images saved on the RetinaVue 700 Imager are encrypted. To view the images on the computer, install the RetinaVue Network software application. For information on the RetinaVue Network software visit www.RetinaVue.com.

Unpack the system

The RetinaVue 700 Imager device is packaged with the following items. Confirm that all items are included.

Number

1 RetinaVue 700 Imager device

Item Description

Digital hand-held eye-fundus camera used to record digital photographs of the fundus of the

16 First time set up of the RetinaVue 700 Imager

Number Item Description

human eye and anterior and posterior ocular structures such as the cornea, lens and fundus including retina, macula and optic disc.

2 USB cable

4 Lithium-ion battery Battery

8 Lens cloth RetinaVue 700 Imager lens cloth

Wall adapter plug and AC power cord

Anterior Imaging Spacer Attaches to the device (only for Anterior imaging

Wrist strap Attaches to the device and slips over the wrist

RetinaVue 700 Imager Directions for

use

Connects the device to a computer or laptop to transfer data.

Connects the device to the wall adapter plug for AC charging. Match to region-specific AC wall outlet.

exams)

to hold the device.

This document. The Directions for use (DFU) is also available on the Welch Allyn web site.

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.

Install the wrist strap

Note The strap can be mounted on the right or left side of the

RetinaVue 700 Imager. Follow the manufacturer's instructions on wrist strap packaging.

1. Turn the RetinaVue 700 Imager over to access the wrist strap mounting bracket and set the RetinaVue 700 Imager on a flat, clean surface.

2. Detach the Uni-Loop system connector from the neoprene strap at the quick disconnect. Slide the ¼-inch webbing through the wrist strap mounting bracket and create an opening large enough to loop the Uni-Loop system connector through. Pull the Uni-Loop system connector tight to form a secure

Directions for use First time set up of the RetinaVue 700 Imager 17

hold onto the RetinaVue 700 Imager. Pull the neoprene strap all the way through to secure the strap to the mounting bracket. Click the Uni-Loop system connector to the neoprene strap to finish assembly. Slip the strap over your wrist and tighten the security slide to keep the strap firmly in place.

Battery installation and replacement

Use the device on battery power once the battery is installed and charged.

Note To charge the battery, plug the AC power cable into the

device and the AC power supply.

Install the battery/replace the battery

Turn the RetinaVue 700 Imager over to access the battery cover and set the RetinaVue 700 Imager on a flat, clean surface.

WARNING

an explosion or contamination hazard. Never dispose of batteries in refuse containers. Always recycle batteries according to local regulations.

WARNING Risk of fire, explosion, and burns. Do not short-circuit, crush, incinerate, or disassemble the battery.

Improper disposal of batteries may create

18 First time set up of the RetinaVue 700 Imager

1. Use a coin to loosen the screw at the edge of the battery cover.

2. Slide open the battery cover by tilting the cover upward.

3. For first-time setup of the RetinaVue 700 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.

Insert the two battery cover tabs into the slots, then push in the tab to close the battery cover.

5. Tighten the screw at the edge of the battery cover.

Directions for use First time set up of the RetinaVue 700 Imager 19

Note Do not over-tighten the screw.

Connect the power supply to the RetinaVue 700 Imager

1. Locate the power connector charging port on the RetinaVue 700 Imager and plug the power supply connector plug into the RetinaVue 700 Imager.

CAUTION The power supply connector easily inserts into the RetinaVue 700 Imager. Using force to connect the power supply connector plug can damage the device and will void the warranty.

2. Plug the power cord into an available wall outlet to charge the device. When the power indicator LED light is orange, it indicates that the device is in the process of charging.

20 First time set up of the RetinaVue 700 Imager

Note For first time use, the device needs to be charged for 5 hours

before use.

Note The removal of the plug from the socket provides the means

of isolation from the mains power supply. The user is reminded to keep this means of disconnection easily accessible in case of emergency.

Startup

Power

The Power button, located on the upper-left corner of the RetinaVue 700 Imager, performs multiple functions:

powers up the RetinaVue 700 Imager

•

• wakes the RetinaVue 700 Imager from Sleep mode

• opens a dialogue screen with controls to power down, enter Sleep mode, or to cancel and return to the prior screen, depending on the option you choose

Power up the RetinaVue 700 Imager

The RetinaVue 700 Imager runs a brief diagnostic self-test each time it powers up.

CAUTION

an adequately charged and properly functioning battery.

1. Press to power up the RetinaVue 700 Imager.

Always use the RetinaVue 700 Imager with

Directions for use First time set up of the RetinaVue 700 Imager 21

As the device is powering up, the RetinaVue 700 Imager displays the startup screen.

If this is the first time set up, select your preferred language from the dropdown list and then touch Next.

3. Touch (up) or (down) to enter, or adjust, the Day, Month, and Year.

4. Touch (up) or (down) to enter, or adjust, the Hour, Minute (Min), Continent, and Location. Touch Next.

Note Use the radio buttons to select the 24-hour or 12-hour format.

22 First time set up of the RetinaVue 700 Imager

5. If you want to use the camera in practice mode before registering the camera, touch Yes - I want to practice.

a. If you want to proceed to registering the camera, touch No - take

me to registration and then touch Next.

First time selection of practice mode

Practice mode allows RetinaVue 700 Imager users to become familiar with the camera features and does not require camera registration. Screens in the Practice mode prominently display the text "Practice mode" and a blue banner also appears at the top of the screen. Most users prefer to run through Practice mode after registering the camera and just before performing their first exam. For further instruction about using Practice mode and returning to Practice mode after device registration, see the topic Practice mode.

CAUTION

data collected in Practice mode will be deleted when Practice mode is exited and cannot be recovered.

If you want to use the camera in practice mode before registering the camera, touch Yes - I want to practice and touch Next.

No data is preserved in Practice mode. Any

Directions for use First time set up of the RetinaVue 700 Imager 23

The Practice mode screen appears.

For instructions about using Practice mode see the topic Practice mode.

Exiting Practice mode

Touch and then touch Exit.

2. Touch OK at the prompt: "Exit practice mode and return to camera registration?" to leave Practice mode and to complete the camera registration.

24 First time set up of the RetinaVue 700 Imager

Camera registration

The RetinaVue 700 Imager needs to be registered and your clinic needs to have an account set up with RetinaVue Network to send exams for overread. There are two types of camera registration. Depending on your needs, select the USB registration or the Wi-Fi registration:

•

Select the USB registration to use the RetinaVue 700 Imager with a USB cable and a computer connected to the Internet. The RetinaVue Network software application must be installed onto the computer to register the camera and to send exams to the RetinaVue Network.

• Select Wi-Fi registration and follow the instructions in the Wi-Fi camera registration topic to set up your RetinaVue 700 Imager to be used with your Wi-Fi network and the RetinaVue Network.

USB camera registration

1. Touch RetinaVue Network - USB to select the USB workflow and touch Next.

2. Touch OK at the Setup complete screen and follow the touchscreen instructions to connect the camera to a computer.

26 Camera registration

Note For the USB workflow, the RetinaVue 700 Imager must be

connected to a computer running the RetinaVue Network software application (requires additional software) to transfer exams.

Note If needed, the USB camera registration settings can be reset

after the initial set up. Touch > Settings > Advanced settings > Reset factory defaults. Touch Restore Settings at the prompt: "Do you want to restore to factory defaults?

This will reset all device settings. Any saved exams on this camera will be deleted." Touch OK at the prompt: "Reset all settings to defaults? Any saved exams on this camera will be deleted."

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