Welch Allyn RetinaVue 100 Imager Directions For Use Manual
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Welch Allyn RetinaVue 100 Imager Directions For Use Manual

Welch Allyn RetinaVue 100 Imager Directions For Use Manual

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Welch Allyn RetinaVue™ 100
Imager
Directions for use
Software version 4.5.XX

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Summary of Contents for Welch Allyn RetinaVue 100 Imager

  • Page 1 Welch Allyn RetinaVue™ 100 Imager Directions for use Software version 4.5.XX...
  • Page 2 © 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.

  • Page 3: Table Of Contents

    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 .....................
  • Page 4 Contents Welch Allyn RetinaVue™ 100 Imager...

  • Page 5: Symbols

    Symbols Documentation symbols WARNING The warning statements in Caution The caution statements in this this manual identify conditions or manual identify conditions or practices practices that could lead to illness, injury, that could result in damage to the or death. Warning symbols will appear equipment or other property, or loss of with a grey background in a black and data.
  • Page 6 2 Symbols Welch Allyn RetinaVue™ 100 Imager • No connection (X) Shipping, storing, and environment symbols Temperature limit Keep Dry Fragile Separate collection of Electrical and Electronic Equipment. Do not dispose as unsorted municipal waste. Atmospheric pressure limitation Humidity limitation...
  • Page 7 Directions for use Symbols 3 Battery charge level indicators Device is running on battery and charge Device is running on battery and charge is above ninety percent. is above seventy-five percent. Device is running on battery and charge Device is running on battery and charge is above fifty percent.
  • Page 8 4 Symbols Welch Allyn RetinaVue™ 100 Imager...

  • Page 9: Introduction

    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. 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.
  • Page 10 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.
  • Page 11 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.

  • Page 12: Controls And Connectors

    Controls and connectors No. Feature Description 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.

  • Page 13: Retinavue 100 Imager Screens

    Directions for use Introduction 9 RetinaVue 100 Imager screens The RetinaVue 100 Imager Home screen includes the following areas: Item Area Device status Content Device Status Area The Device Status Area, located at the top of the Home screen, displays the following information from left to right: •...
  • Page 14 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). •...
  • Page 15 Directions for use Introduction 11 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.
  • Page 16 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 START enters automatic image acquisition mode. ) Navigates to the Home screen. MANUAL switches to advanced image capture options.
  • Page 17 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.
  • Page 18 CAUTION Unsaved images are discarded if the RetinaVue 100 Imager loses battery power or if it enters deep sleep mode. If the RetinaVue 100 Imager enters stand by mode when left idle for Note approximately two minutes, wake up the RetinaVue 100 Imager by touching the LCD screen or by pressing the Home button.
  • Page 19 Directions for use Introduction 15 Touch (Accepted OK) to view that image. Touch (Rejected) to view that image. Touch (Patient) to review patient demographics on the Patient summary screen. Touch (Back) to return to the Review screen. Touch (Home) to return to the Home screen. About the Auto and Manual modes Auto Mode Auto Mode is the default image capture mode.
  • Page 20 16 Introduction Welch Allyn RetinaVue™ 100 Imager Manual Mode Manual mode contains advanced image capture options. Note A manual touch of the capture button is required to obtain an image. Available manual features include: • Image capture • Focus adjustment (from the Acquisition screen , values range from -1 to +1) •...

  • Page 21: Using The Retinavue 100 Imager

    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. Number Item Description RetinaVue 100 Imager device Digital hand-held eye-fundus camera used to record digital photographs and video of the fundus of the human eye and surrounding area.
  • Page 22 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.
  • Page 23 Directions for use Using the RetinaVue 100 Imager 19 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.

  • Page 24: Docking Station

    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.
  • Page 25 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.
  • Page 26 22 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager...

  • Page 27: Patient Data Management

    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.
  • Page 28 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.
  • Page 29 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.

  • Page 30: Perform An Eye Exam Using The Auto Exam Mode

    • 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.
  • Page 31 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.
  • Page 32 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...

  • Page 33: 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: Skip An Image Capture While In Exam Mode

    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.
  • Page 35 Directions for use Using the RetinaVue 100 Imager 31...

  • Page 36: Perform A Manual Image Capture While In Manual Exam Mode

    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.
  • Page 37 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: Update The Retinavue 100 Imager Software

    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.)

  • Page 39: Viewing Or Changing The Retinavue 100 Imager Settings

    Directions for use Using the RetinaVue 100 Imager 35 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.
  • Page 40 36 Using the RetinaVue 100 Imager Welch Allyn RetinaVue™ 100 Imager...

  • Page 41: Troubleshooting

    Welch Allyn. To correct an error, follow these instructions or contact Welch Allyn Technical Support: www.welchallyn.com/service. Troubleshooting image quality...
  • 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. • Ensure that the patient is covering their other eye with the palm of their hand.

  • Page 43: Maintenance

    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..
  • 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 ® Super HDQ ® Cleancide Sani-Cloth Plus ® Clorox HealthCare Bleach Germicidal Cleaner Super Sani-Cloth Virex II (256) ®...

  • Page 45: Specifications

    Specifications Specifications View Angle 45 Degree (Typical) 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 Infrared LED Lighting Camera / video Natural White Light Emitting Diode (LED) flash light Focus...
  • Page 46 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.

  • Page 47: Device Radio

    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.
  • Page 48 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

    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...
  • Page 50 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.
  • Page 51 Directions for use General compliance and standards 47 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.
  • 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.
  • Page 53 Directions for use General compliance and standards 49 Electromagnetic immunity Surge ± 1 kV differential ± 1 kV differential Mains power quality should be that of a typical mode mode commercial or hospital environment. IEC 61000-4-5 ± 2 kV common mode ±...
  • 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.

  • Page 55: Approved 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.
  • Page 56 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;...

  • Page 57: Warranty

    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.
  • Page 58 Material No. 411492...

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