Interacoustics VisualEyes 515 Instructions For Use Manual
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Interacoustics VisualEyes 515 Instructions For Use Manual

Micromedical
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Instructions for Use - US
Micromedical
VisualEyes™ 515
VisualEyes™ 525
by Interacoustics
D-0107857-B - 2018/02

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Summary of Contents for Interacoustics VisualEyes 515

  • Page 1 Instructions for Use - US Micromedical VisualEyes™ 515 VisualEyes™ 525 by Interacoustics D-0107857-B - 2018/02...
  • Page 2 Copyright © February 1, 2018 by Interacoustics. All rights reserved. Information in this document is subject to change without notice. Companies, names, and data used in example herein are fictitious unless otherwise noted. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without express written permission of Interacoustics A/S, Micromedical Technologies or its licensees.

  • Page 3: Table Of Contents

    Table of Contents INTRODUCTION ........................... 1 About this manual ....................... 1 Intended use ........................1 Contraindications ........................ 1 Product description ......................2 1.4.1 Minimum requirements to PC ................... 2 1.4.2 Included and optional parts ..................3 Warnings and precautions ....................5 UNPACKING AND INSPECTION ....................
  • Page 4 4.8.6 Caloric test ......................26 4.8.7 Rotary chair tests ....................27 Rotary chair error messages ..................... 29 4.9.1 Rotary chair speed error ..................29 4.9.2 Patient safety error ....................29 4.9.3 Emergency stop error ..................... 29 4.9.4 Chair servo error state error ................... 29 4.9.5 Reclined chair error ....................

  • Page 5: Introduction

    VisualEyes™ 515/525 Instructions for Use – US Page 1 1 Introduction 1.1 About this manual his manual is valid for the VisualEyes™ 515 and VisualEyes™ 525 Software version 2.1. These products are manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555...

  • Page 6: Product Description

    VisualEyes™ 515/525 Instructions for Use – US Page 2 1.4 Product description The VisualEyes™ system is a sophisticated, videonystagmography (VNG) analysis software platform that is available in two different versions: VisualEyes™ 515 and VisualEyes™ 525. Both systems consist of a laptop/desktop PC, goggles (top mounted/ side mounted/ front mounted cameras) and other parts as specified in section 1.4.2.

  • Page 7: Included And Optional Parts

    VisualEyes™ 515/525 Instructions for Use – US Page 3 1.4.2 Included and optional parts The VisualEyes™ system is delivered with the following items based on system configuration. ® USB camera systems FireWire camera systems Included parts Hand held RF remote control and/or foot pedal VisualEyes™...
  • Page 8 VisualEyes™ 515/525 Instructions for Use – US Page 4 Optional parts Using the Orion rotary chair Using the Nydiag 200 rotary chair based on Orion rotary chair Nydiag 200 rotary chair reclining chair USB cable Ethernet to USB chair cable type Emergency stop button with Ethernet Emergency stop button with Ethernet...

  • Page 9: Warnings And Precautions

    VisualEyes™ 515/525 Instructions for Use – US Page 5 1.5 Warnings and precautions Federal law restricts the sale, distribution, or use of this system to, by, or on the order of a licensed medical practitioner. The system components should not be modified without consulting the manufacturer. General warnings and precautions WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury.
  • Page 10 VisualEyes™ 515/525 Instructions for Use – US Page 6 1. Use this device only as described in this manual. 2. The system must be serviced at least once a year. The service must include a safety test. 3. Do not use the equipment if the equipment is damaged; have the equipment serviced. 4.

  • Page 11: Unpacking And Inspection

    VisualEyes™ 515/525 Instructions for Use – US Page 7 2 Unpacking and inspection 2.1 Unpacking and inspection Check shipping containers and contents for damage When the system is received, please check the shipping box for rough handling and damage. If the box is damaged it should be kept until the contents of the shipment have been checked mechanically and electrically.

  • Page 12: Marking

    VisualEyes™ 515/525 Instructions for Use – US Page 8 2.3 Marking The following marking can be found on the instrument: Symbol Explanation Type BF applied parts. Type B applied parts. Read and understand instructions for use before operating this device. WEEE (EU-directive).

  • Page 13: Setup And Installation

    NOTICE The OtoAccess™ database must be installed prior to installing VisualEyes™ software. The VisualEyes™ software will be pre-installed on the computer purchased from Interacoustics. In the event that software must be re-installed, please follow these instructions. 1. Insert the VisualEyes™ Installation CD or flash drive into the computer.

  • Page 14: Installing Drivers For System 2000 Reclining Chair

    3.4.2 Installing drivers for System 2000 reclining chair Open Windows® Explorer. Navigate to the following location: C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles Run the program icalsetup.exe. Click on Setup to begin installing InstaCal. Choose to install InstaCal to the default location of C:\Program Files (x86)\Measurement Computing\DAQ\.

  • Page 15: Installing Drivers For The Orion Rotary Chair

    3.4.3 Installing drivers for the Orion rotary chair Open Windows® Explorer. Navigate to the following location: C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles Run the program icalsetup.exe. Click on Setup to begin installing InstaCal. Choose to install InstaCal to the default location of C:\Program Files (x86)\Measurement Computing\DAQ\.
  • Page 16 VisualEyes™ 515/525 Instructions for Use – US Page 12 Figure 3.4.4 Configure the Orion rotary chair in InstaCal...

  • Page 17: Uninstall Software

    3.6 Hardware setup The VisualEyes™ system is composed of several selected pieces of equipment. The software is designed to be compatible with both Interacoustics a/s and Micromedical Technologies Inc. equipment. Each piece of equipment, its function and installation is described below.

  • Page 18: Side Mount Camera Goggles

    VisualEyes™ 515/525 Instructions for Use – US Page 14 3.6.3 Side mount camera goggles The VisualEyes™ goggles allow for recording of eye movements during various test conditions, both with and without visual stimulation. The VisualEyes™ side mount goggles hold FireWire® or USB cameras that are used to record the eye images.

  • Page 19: Top Mount Camera Goggles

    VisualEyes™ 515/525 Instructions for Use – US Page 15 3.6.4 Top mount camera goggles The binocular video goggles (Figure 3.6.5) block out ambient light with the easy-to-place cover over the portal for vision-denied testing. Side-lights on the goggles are programmed to flash to remind the operator which ear to irrigate during the caloric test and are also used to provide illumination when placing the cover on the goggles.

  • Page 20: Reclining Rotary Chair (Optional)

    VisualEyes™ 515/525 Instructions for Use – US Page 16 3.6.6 Rotary chair (optional) The reclining rotary chair provides sinusoidal harmonic acceleration (SHA) test and step test capability to the VisualEyes™ system. The reclining rotary chair can also be used as the exam table for positional and caloric testing.

  • Page 21: Visualeyes™ Remote Control (Optional)

    VisualEyes™ 515/525 Instructions for Use – US Page 17 3.6.8 VisualEyes™ remote control (optional) The remote control (Error! Reference source not found.Figure 3.6.9) provides a hand held option for controlling and performing tests within the VisualEyes™ VNG suite, allowing ease of use when looking after the patient (e.g.

  • Page 22: Connection Layout

    VisualEyes™ 515/525 Instructions for Use – US Page 18 3.7 Connection layout 3.7.1 VisualEyes™ setup with mid-tower computer using top mount or side mount (USB or ® FireWire ) cameras 3.7.2 VisualEyes™ setup with laptop computer using top mount or side mount (USB) cameras...

  • Page 23: Reclining Rotary Chair Setup

    VisualEyes™ 515/525 Instructions for Use – US Page 19 3.7.3 Rotary chair setup VisualEyes™ with NyDiag 200 rotary chair VisualEyes™ with System 2000 reclining chair option...

  • Page 24: Visualeyes™ Setup Precautions

    VisualEyes™ 515/525 Instructions for Use – US Page 20 VisualEyes™ with Orion rotary chair option For complete installation instructions regarding the rotary chairs, please refer to the NyDiag 200, Orion and System 2000 rotary chair installation manuals. 3.7.4 VisualEyes™ setup precautions VisualEyes™...

  • Page 25: Operating Instructions

    VisualEyes™ 515/525 Instructions for Use - US Page 21 4 Operating instructions 4.1 System startup Turn on the projector or TV prior to turning on the computer. This order of operation will ensure that the computer will automatically find the TV or projector and configure it appropriately as a second display. ®...

  • Page 26: Starting The Visualeyes™ Software

    VisualEyes™ 515/525 Instructions for Use - US Page 22 Tap the Save Client icon to save the information to the OtoAccess database Figure 4.3.1 OtoAccess Patient information fields If the patient is returning for a repeat visit, select the client record from the list at the bottom of the screen, or tap the Search Client icon to use the patient information for search parameters.

  • Page 27: Placing The Goggles On The Patient

    VisualEyes™ 515/525 Instructions for Use - US Page 23 4.6.2 Placing the goggles on the patient Remove the vision-denied cover to allow vision during goggles placement. Place the goggles on the patient’s face and adjust the strap for a snug fit. For vision-denied testing, place the cover back on the goggles.

  • Page 28: Calibration

    VisualEyes™ 515/525 Instructions for Use - US Page 24 4.7 Calibration If using the Orion or Nydiag 200 rotary chair, click on the Home Chair button to rotate the patient in the chair to face the television screen or projection image. If the patient is not centered in front of the stimulus, then rotate the chair to center the patient in front of the stimulus.

  • Page 29: Testing The Patient

    VisualEyes™ 515/525 Instructions for Use - US Page 25 4.8 Testing the patient 4.8.1 Performing tests Tests can be started in one of three ways: • Tap on the START button on the test screen. This option is available for all tests •...

  • Page 30: Positional

    VisualEyes™ 515/525 Instructions for Use - US Page 26 4.8.4 Positional Install the head support on the chair (Orion and System 2000). Lock the chair with the foot brake if using the System 2000 reclining chair. Leave the Velcro® straps (Orion and System 2000) from the head support detached from the goggles because the patient’s head will be in different positions during this test.

  • Page 31: Rotary Chair Tests

    VisualEyes™ 515/525 Instructions for Use - US Page 27 When the Caloric test is selected, VisualEyes™ will initialize the irrigator for the selected warm or cool temperature. The irrigator status will be displayed in the left menu panel. When the appropriate temperature has been reached, the status will change to ‘Ready’...
  • Page 32 VisualEyes™ 515/525 Instructions for Use - US Page 28 To ensure the safety of the patient before rotating the patient in the chair, please use this checklist as a guide to ensure the patient’s safety during the test. Is the patient’s lap belt securely fastened? Is the patient’s head restrained to the head support? Is the area around the chair (5 feet/1.5m) clear of obstructions? Cancel...

  • Page 33: Rotary Chair Error Messages

    VisualEyes™ 515/525 Instructions for Use - US Page 29 4.9 Rotary chair error messages 4.9.1 Rotary chair speed error If the rotary chair has not been calibrated previously, then the chair’s tachometer and signal traces will not align, resulting in the chair spinning slower or faster than intended. The following message is given in this case.

  • Page 34: Reclined Chair Error

    VisualEyes™ 515/525 Instructions for Use - US Page 30 4.9.5 Rotary chair error If the Orion rotary or System 2000 reclining chair is reclined during a rotary chair test, the software will present an error message to the operator. The operator can resume rotary chair testing by setting the chair upright and restarting the test.

  • Page 35: Care And Maintenance

    VisualEyes™ 515/525 Instructions for Use - US Page 31 Care and maintenance 5.1 General maintenance procedures Camera lenses and IR coated mirrors must be checked regularly for stains and dust, and should be cleaned with lens cleaning cloth. Goggles cushions for the side mount cameras are single use only and must be exchanged between patients.

  • Page 36: Warranty And Service

    VisualEyes™ 515/525 Instructions for Use - US Page 32 5.3 Warranty and Service Micromedical Technologies, Inc. (“Micromedical”) warrants the products it manufactures to be free from defects caused by faulty materials or poor workmanship for a period of twelve months from date of shipment from Micromedical.

  • Page 37: Products Returned For Repair

    VisualEyes™ 515/525 Instructions for Use - US Page 33 If Micromedical requests that you return the product for evaluation or repair, pack the product well, preferably in the original shipping container, addressed to: Micromedical Technologies, 10 Kemp Drive, Chatham, IL 62629 with the RMA number given by Micromedical. Insure the product with the shipper and choose the shipping method to meet your required schedule.
  • Page 38 VisualEyes™ 515/525 Instructions for Use - US Page 34...

  • Page 39: General Technical Specifications

    VisualEyes™ 515/525 Instructions for Use - US Page 35 General technical specifications 6.1 Computer specifications Hardware and software Laptop PC: One 34mm PCExpressCard slot available (FireWire® systems only). Desktop PC: One PCI Express card available (FireWire® systems only). USB port required (expanded by USB hub) Intel i5 processor 2.5 GHz or better, and not older than 2 generation Minimum 8 GB RAM or more.
  • Page 40 VisualEyes™ 515/525 Instructions for Use - US Page 36 Goggles weight: Binocular VNG cameras 345g (occluded view) without cables. Component specifications side mount VNG goggles Monocular/binocular video eye tracking goggles. Removable eye cover for vision-enabled or vision-denied recording USB 2.0 or FireWire® 400, 4.5m cables to PC. Capture Resolution: 640 x 480 Pixels @ 100 fps.

  • Page 41: Electromagnetic Compatibility (Emc)

    VisualEyes™ 515/525 Instructions for Use - US Page 37 6.5 Electromagnetic compatibility (EMC) 6.5.1 Electromagnetic compatibility (EMC) for goggles with top-mounted cameras Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided. Caution Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VNG including cables...
  • Page 42 VisualEyes™ 515/525 Instructions for Use - US Page 38 Radiated RF Stress 4.5 V/M Stress 4.5 V/M Not Applicable Immunity IEC 61000-4-3 Electrical fast +/- 2 kV for power supply +/- 2 kV for power Mains power quality transient/burst lines supply lines.

  • Page 43: Electromagnetic Compatibility (Emc) For Goggles With Side-Mounted Cameras

    The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device.
  • Page 44 VisualEyes™ 515/525 Instructions for Use - US Page 40 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity VisualEyes™ is intended for use in the electromagnetic environment specified below. The customer or the user of VisualEyes™ should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance...
  • Page 45 VisualEyes™ 515/525 Instructions for Use - US Page 41 Conducted RF 3 Vrms 3 Vrms 2 , 1 IEC / EN 61000-4-6 150kHz to 80 MHz 2 , 1 80 MHz to 800 Radiated RF 3 V/m 3 V/m IEC / EN 61000-4-3 80 MHz to 2,5 GHz 800 MHz to 2,5 Where P is the maximum output...
  • Page 46 VisualEyes™ 515/525 Instructions for Use - US Page 42 To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only the following accessories: EUT Support Equipment ITEM MANUFACTURER MODEL UE15WCP1 DC Power Supply ®...

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Visualeyes 525

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