Related Manuals for Interacoustics VisualEyes 505
Summary of Contents for Interacoustics VisualEyes 505
- Page 1 Science made smarter Instructions for Use - US VisualEyes™ Micromedical by Interacoustics...
- Page 2 Copyright © Interacoustics A/S All rights reserved. Information in this document is proprietary to Interacoustics A/S. The information in this document is subject to change without notice. No part of this document may be reproduced or transmitted in any form or by any means without a prior written permission of Interacoustics A/S.
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Page 3: Table Of Contents
Table of Contents INTRODUCTION ........................... 1 About this manual ....................... 1 Intended use ........................1 Contraindications ........................ 1 Product description ......................1 1.4.1 Minimum PC requirements ..................1 1.4.2 Included and optional parts ..................2 Warnings and precautions ....................4 Complaints handling ...................... - Page 4 GENERAL TECHNICAL SPECIFICATIONS ................24 PC Hardware and Software ....................24 Standards .......................... 24 Operation and storage specifications ................24 Component specifications ....................25 Electromagnetic compatibility (EMC) ................27...
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Page 5: Introduction
1 Introduction About this manual his manual is valid for VisualEyes™ 505 software version 3.0. This product is manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: info@interacoustics.com Web: www.interacoustics.com Definitions: Wherever ‘operator’... -
Page 6: Product Description
VisualEyes™ 505 is licensed, requiring a specific license key to be put into the software upon its initial launch to make the test battery available. The VisualEyes™ licenses are not time limited, and the same license can be installed on more than one computer, allowing one to move the cameras between two or more workstations. Refer to ‘Additional information’... -
Page 7: Included And Optional Parts
1.4.2 Included and optional parts VisualEyes™ 505 is delivered with the following items based on the system configuration. Please refer to Table 1.4-2 for details. Table 1.4-2 Detailed Description of Included and Optional components of VisualEyes USB camera systems FireWire® camera systems Included VisualEyes™... - Page 8 USB camera systems FireWire® camera systems Optional BPPV module and/or VORTEQTM IMU / VORTEQTM VLink (Head rotation rate sensor) parts based VORTEQ Note: *- the system may include other minor accessories like custom cables, adapters, logo badges, cable wrap, cable tie and cleaning cloth for goggles etc., may be included in the package according to the choice of product configurations.
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Page 9: Warnings And Precautions
Always refer to qualified/authorized personnel for product service. No modification (if necessary) should be done to this equipment/its component without authorization from Interacoustics. 3. This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. - Page 10 9. For maximum electrical safety, turn off the power from a mains powered instrument when it is left unused. 10. The instrument is not protected against harmful ingress of water or other liquids. If any spillage occurs check the instrument carefully before use or return for service. 11.
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Page 11: Complaints Handling
(serious adverse events), Interacoustics shall ensure that the regulatory authority in patient’s home country is informed according to the vigilance requirements. Interacoustics shall handle all the product complaints and adverse events as per the internal procedure. - Page 12 D-0126472-A – 2020/08 VisualEyes™ 505 Instructions for Use -US Page 7...
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Page 13: Unpacking And Inspection
Failing to do so may endanger the environment. The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. - Page 14 Medical Device. Manufacturer. Date of Manufacture. Indicates a component is intended for one use, or for use on a single patient during a single procedure. Cross contamination risk. Reference number Do-not-push symbol used with components that could easily tip over, such as the Digital Light Bar Chinese RoHS compliance standard where the product contains less than the maximum concentration value of lead, mercury, cadmium, hexavalent...
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Page 15: Setup And Installation
If the operator wants to install OtoAccess® Database in any computer (not of interacoustics) or in the event of re-installation, please read the instructions for use that are included with the OtoAccess® Database installation media (CD or flash drive) or contact your distributor. -
Page 16: Hardware Setup
Its software is designed to be compatible with both Interacoustics A/S and Micromedical Technologies Inc. equipment. 3.3.1 Laptop / PC The operator can choose between a laptop or desktop PC from Interacoustics, which comes with pre-installed software (Figure 3.3-1). Laptop systems are configured with an externally powered USB hub to connect additional devices. -
Page 17: Top Mount Camera Goggles
The front cover plate of the side mounted goggle is magnetically fixed and can easily be removed for visual stimulation tests (i.e. oculomotor). The mask has an adjustable Velcro head strap that comfortably secures the goggles to the patient. The side mounted camera goggles can be configured with one camera and cover for monocular systems. -
Page 18: Vorteq™ Imu
Figure 3.3-5 EyeSeeCam camera and goggle with built-in IMU. 3.3.6 VORTEQ™ IMU The VORTEQ™ IMU sensor (Figure 3.3-6) connects to the laptop or mid-tower computer either by USB cable or wirelessly through Bluetooth with the accompanying Bluetooth receiver dongle. The VORTEQ™ IMU measures head position in space, allowing the VisualEyes™... -
Page 19: Foot Pedal
3.3.7 Foot Pedal The foot pedal (Figure 3.3-8) allows you to begin the measurement testing by pressing the foot switch so you have both hands free to look after the patient (e.g. Dix Hallpike). Connection with the PC is via a USB port. Figure 3.3-8 VisualEyes™... -
Page 20: External Room Camera
3.3.9 External room camera The room camera (Figure 3.3-10) is an external device connected to the computer’s USB port. It serves to record the external environment and patient testing process from the beginning. The external room camera provides additional flexibility in recording the testing procedure, though the laptop’s integrated observation camera can be used with orienting the computer towards the patient. -
Page 21: System Configurations
System configurations VisualEyes™ 505 can be configured with either monocular camera or binocular camera goggles. Eye images are displayed and stored in the software for future reference in these configurations. Goggles can be connected to PC via USB/FireWire or via USB to laptop. Other accessories like RF remote, foot pedel, ecternal room camera can be connected to PC/laptop via USB. - Page 22 D-0126472-A – 2020/08 VisualEyes™ 505 Instructions for Use -US Page 17...
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Page 23: Operating Instructions
4 Operating Instructions System Startup 4.1.1 Turn on the power sources and accessories Ensure that the laptop/PC systems and USB hub are power connected. • Ensure that the goggle cameras (binocular or monocular) are connected to the computer. • If applicable ensure that the VORTEQ IMU/VLink or EyeSeeCam is connected and powered via USB •... -
Page 24: Patient Preparation
4.5 Patient preparation The operator and the patient should be aware of the below-listed points before starting a test. 1. Before starting a test, it is very important that the patient is provided with all the relevant information about a test and what he/she/guardian can expect from the test such as general precaution, adverse effects etc. -
Page 25: Video Frenzel
4.6.2 Video Frenzel Video Frenzel is a basic test, which can record patient eye movement without any analytical assessments. There is no time limit for eye recording in this test and there is no calibration requirement to perform this test. 4.6.3 Spontaneous Nystagmus This is a vision-denied test and the patient will look straight ahead with the goggle cover on. -
Page 26: Session Review And Write Report
4.7 Session Review and Write Report Once all of the tests have been completed, the software will show the Session Review screen. By clicking or touching Write Report, the user can create a report for the video frenzel tests performed and any findings seen during testing. -
Page 27: Care And Maintenance
The VisualEyes™ system is free from defects in material and workmanship under normal use and service for a period of 12 months from the date of delivery by Interacoustics to the first purchaser Accessories are free from defects in material and workmanship under normal use and service for a •... -
Page 28: Concerning Product Repair / Service
This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Interacoustics shall not be responsible for, any loss arising in connection with the purchase or use of any Interacoustics product that has been: repaired by anyone other than an authorized Interacoustics service representative;... -
Page 29: General Technical Specifications
Interacoustics A/S cannot be held liable for your data. Some Interacoustics A/S products support or may work with operating systems unsupported by Microsoft. -
Page 30: Component Specifications
Component specifications VLink Specifications Dimensions: 4.8 x 4.0 x 1.5 inches (12 x 10 x 3 cm) Weight: 0.65 lbs (0.30 kg) Power: 5 VDC supplied by PC USB VORTEQ Inertial Measurement Unit (IMU) Specifications Dimensions without cable (L x W x H): 2 x 1.1 x 0.9 inches (5.0 x 2.8 x 2.2 cm) Weight without cable: 0.05 lbs (0.02 kg) Power: 5 VDC supplied by PC USB Component specifications top mounted VNG goggles... - Page 31 Component specifications front mounted VNG goggles Monocular video eye tracking goggles. Swivel eye portal cover for vision-enabled or vision-denied recording. USB 2.0, 4.5 m cable to PC. Capture Resolution: 640 x 480 Pixels @ 50 fps. Video Resolution: 640 x 480 Pixels @ 25 fps Dimensions (L x W x H) 165 x 165 x 89 mm.
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Page 32: Electromagnetic Compatibility (Emc)
No further steps required. To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only the following accessories as applicable: Item Manufacturer Model Goggle, 2-D VOGfw Interacoustics 2D VOGfw Goggle, BG4.0USB Interacoustics BG4.0USB Goggle, USB2.1A Interacoustics USB2.1A... - Page 33 Guidance and manufacturer’s declaration - electromagnetic emissions The Instrument is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions Group 1...
- Page 34 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Instrument is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment. Immunity Test IEC 60601 Test level Compliance Electromagnetic environment - guidance...
- Page 35 Guidance and manufacturer’s declaration — electromagnetic immunity The Instrument is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment, Immunity test IEC / EN 60601 test Compliance level Electromagnetic environment –...
- Page 36 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
- Page 37 Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item.