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Micromedical VisualEyes 505 Instructions For Use Manual

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Instructions for Use - US
Micromedical
TM
VisualEyes
505
by Interacoustics
D-0115288 – C – 2018/02

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Summary of Contents for Micromedical VisualEyes 505

  • Page 1 Instructions for Use - US Micromedical VisualEyes by Interacoustics D-0115288 – C – 2018/02...
  • Page 2 Copyright © 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 or its licensees.

  • Page 3: Table Of Contents

    External room camera .................... 12 Connection layout ......................13 PATIENT ENTRY ........................15 Entering patient information ....................15 Licensing ........................... 16 Micromedical VisualEyes™ main screen ................17 Room recording......................... 17 Patient preparation ......................17 Testing the Patient ......................18 4.6.1 Starting the test ....................... 18 4.6.2...
  • Page 4 GENERAL TECHNICAL SPECIFICATIONS ................23 PC Hardware and Software ....................23 Operation and storage specifications ................23 Standards .......................... 23 Component specifications ....................23 Electromagnetic compatibility (EMC) ................25 6.5.1 Electromagnetic compatibility (EMC) for top-mounted goggles ......25 6.5.2 Electromagnetic compatibility (EMC) for side mounted goggles ......27...

  • Page 5: Introduction

    +45 6371 3555 Fax: +45 6371 3522 E-mail: info@interacoustics.com Web: www.interacoustics.com Distribution and service: Micromedical Technologies Inc. 10 Kemp Drive Chatham, IL 62629 Tel.: 1 (800) 334-4154 Web: www.micromedical.com Intended use he VisualEyes™ 505 is a Video Frenzel system which provides information to assist in the evaluation, diagnosis and documentation of vestibular disorders.

  • Page 6: Minimum Requirements To Pc

    VisualEyes™ 505 Instructions for Use – US Page 2 1.3.2 Minimum requirements to PC Laptop PC: One 34 mm PCExpressCard slot available (for side mount FireWire® camera goggles only). Desktop PC: One PCIExpress card available. (for side mount FireWire® camera goggles only). Intel i5 processor 2.5 GHz or better.
  • Page 7 VisualEyes™ 505 Instructions for Use – US Page 3 BG4.0KUSB goggle w. top mounted cameras Goggles USB Asian faceplate binocular Two 15’ USB cables A to Mini B 7-port USB 3.0 hub w. external power supply BG4.0USB goggle w. top mounted cameras Goggles USB binocular Two 15’...

  • Page 8: Warnings And Precautions

    VisualEyes™ 505 Instructions for Use – US Page 4 Warnings and precautions WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE NOTICE is used to address practices not related to personal injury.
  • Page 9 VisualEyes™ 505 Instructions for Use – US Page 5 9. It is recommended that parts which are in direct contact with the patient (e.g. disposable goggle foam pads) should only be used with one patient, and should therefore be discarded after each session.
  • Page 10 VisualEyes™ 505 Instructions for Use – US Page 6...

  • Page 11: Unpacking And Inspection

    VisualEyes™ 505 Instructions for Use - US Page 7 2 Unpacking and inspection Unpacking and inspection Check box and contents for damage When the instrument 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™ 505 Instructions for Use - US Page 8 Marking The following marking can be found on the instrument: Symbol Explanation Type BF applied parts. Type B applied parts. Follow instructions for use. WEEE (EU-directive). This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling.

  • Page 13: Setup And Installation

    The VisualEyes™ software will be pre-installed on the computer purchased from the Interacoustics or Micromedical. In the event when the software must be re-installed, please follow these instructions. 1. Insert the VisualEyes™ Installation CD or thumb drive into the computer.

  • Page 14: Hardware Setup

    Hardware setup The VisualEyes™ 505 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 15: Top Mount Camera Goggles

    VisualEyes™ 505 Instructions for Use - US Page 11 3.5.4 Top mount camera goggles The top mount camera goggles block out ambient light with the removable cover over the portal for vision- denied testing. Side-lights on the goggle provide guidance/ illumination when placing the cover on the goggles.

  • Page 16: Visualeyes™ Remote Control

    VisualEyes™ 505 Instructions for Use - US Page 12 VisualEyes™ remote control 3.5.7 The remote control provides a hand held option for controlling and performing tests within the VisualEyes™ suite. The operator can operate the software using the remote control while remaining at the patient’s side during testing.

  • Page 17: Connection Layout

    VisualEyes™ 505 Instructions for Use - US Page 13 Connection layout Figure 3.6.1 Tower PC connection diagram Figure 3.6.2 Laptop PC connection diagram NOTICE Always connect other IT-equipment before powering up the computer. Power on all connected IT-equipment before starting the VisualEyes™ software. Always power off the FireWire®...
  • Page 18 VisualEyes™ 505 Instructions for Use - US Page 14 (Valid for all configurations). This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. External equipment intended for connection to signal input, signal output or other connectors must comply with the relevant product standard e.g.

  • Page 19: Patient Entry

    New Client button is pressed)  save the patient details by pressing the Save client button Figure 4.1.1 OtoAccess™ main screen 4. Double click Micromedical VisualEyes™ in the Select Instrument box. (Figure 4.1.2). Figure 4.1.2 Micromedical VisualEyes™ instrument...

  • Page 20: Licensing

    VisualEyes™ 505 Instructions for Use - US Page 16 NOTICE For further instructions about working with the OtoAccess™ database, please see the operation manual for OtoAccess™. Licensing The VisualEyes™ 505 system is licensed and will require specific license key or keys to be put into the software upon its initial launch to make the Video Frenzel available.

  • Page 21: Micromedical Visualeyes™ Main Screen

    Page 17 Micromedical VisualEyes™ main screen When the Micromedical VisualEyes™ software is launched, the main screen will appear. Patient information is retrieved from the OtoAccess database and is displayed on the main screen (highlighted in Figure 4.3.1). The patient name will be displayed in all test screens.

  • Page 22: Testing The Patient

    VisualEyes™ 505 Instructions for Use - US Page 18 4.6 Testing the Patient 4.6.1 Starting the test 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 23: Care And Maintenance

    VisualEyes™ 505 Instruction for Use - US Page 19 Care and maintenance 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 24: Warranty And Service

    Micromedical. This warranty applies only to the original purchaser and is not transferable. Micromedical's liability is limited to replacing or repairing, at its option, any of its products that are returned during the warranty period. Micromedical's liabilities on any claim for loss or damage arising out of the sale, resale or use of any of its products shall in no event exceed the selling price of the unit.

  • Page 25: Products Returned For Repair

    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. The customer will be responsible for paying shipping charges to Micromedical, as well as any repairs that result from shipping damage due to packaging problems.
  • Page 26 VisualEyes™ 505 Instruction for Use - US Page 22...

  • Page 27: General Technical Specifications

    VisualEyes™ 505 Instructions for Use - US Page 23 General technical specifications PC Hardware and Software Laptop: 34mm PCExpressCard slot (for side mount FireWire® goggles only). Desktop: 1 free PCI Express slot (for side mount FireWire® goggles only). Intel i5 processor 2.5 GHz or better. Minimum 4 GB RAM or more.
  • Page 28 VisualEyes™ 505 Instructions for Use - US Page 24 Goggle Weight: Binocular VNG cameras 345g (occluded view) without cables. Component Specifications Front mount VNG goggle Monnocular video eye tracking goggles. Swivel eye portal cover for vision enabled or vision denied recording. USB 2.0, 4.5m cable to PC.

  • Page 29: Electromagnetic Compatibility (Emc)

    Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Contact Micromedical for approved replacement parts.
  • Page 30 VisualEyes™ 505 Instructions for Use - US Page 26 Guidance and Manufacturer’s declaration – Electromagnetic Immunity The VNG is intended for use in the electromagnetic environment specified below. The customer or the user of the VNG should assure that it is used in such an environment. Immunity Test IEC 60601 test level Compliance Level...

  • Page 31: Electromagnetic Compatibility (Emc) For Side Mounted Goggles

    VisualEyes™ 505 Instructions for Use - US Page 27 6.5.2 Electromagnetic compatibility (EMC) for side mounted goggles Portable and mobile RF communications equipment can affect the VisualEyes™ system. Install and operate VisualEyes™ according to the EMC information presented in this chapter. VisualEyes™...
  • Page 32 VisualEyes™ 505 Instructions for Use - US Page 28 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 33 VisualEyes™ 505 Instructions for Use - US Page 29 Radiated RF 3 V/m 3 V/m  2 , 1 IEC / EN 61000-4-3 80 MHz to 2,5 GHz 80 MHz to 800 MHz  800 MHz to 2,5 Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is...
  • Page 34 VisualEyes™ 505 Instructions for Use - US Page 30 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 FireWire®...

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