Table of Contents
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Table of Contents
Related Manuals for AmpliVox Otosure
Summary of Contents for AmpliVox Otosure
- Page 1 Otosure Operating Manual...
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Page 2: About This Manual
ABOUT THIS MANUAL READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT. This manual is valid for the Otosure (applies from serial number 58000 and Audibase version 5.5 onwards). This product is manufactured by: Amplivox Ltd. Amplivox Ltd. 10393 West 70th Street... -
Page 3: Table Of Contents
..............................16 NITIATING A 5.5............................... 17 ONTROL UTTONS 5.6. - PC K ........................17 ONTROL EYBOARD AND OUSE 5.7..............................17 ANUAL ESTING 5.8.............................. 19 OMPUTER ESTING 5.9........................... 20 INGLE FREQUENCY ESTING D-0116492-B (OM022) – Otosure Operating Manual... - Page 4 9.2..............................30 NPUT UTPUT 9.3..............................30 UDIOMETRIC 9.4....................30 ARPHONE OUND TTENUATION HARACTERISTICS 9.5. & ..........................30 HYSICAL ENVIRONMENTAL EMC GUIDANCE & MANUFACTURER’S DECLARATION ...................32 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT ..................37 D-0116492-B (OM022) – Otosure Operating Manual...
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Page 5: Introduction
PC, application of audiogram categorisation schemes, printing of audiograms and data exchange with other PC applications. This operator's manual enables you to take full and safe advantage of the features offered by the Otosure audiometer. Therefore, PLEASE READ IT THOROUGHLY before using the audiometer. -
Page 6: Warnings
Shipping documentation will reference the stock number quoted above, and images of the parts alongside the relevant stock number are available on the Amplivox website (www.amplivox.com). The required fitting instructions are supplied with each part. -
Page 7: Principles Of Operation
The patient is seated in front of the desk facing away from the operator. The patient wears a headset (see below) and responds to test stimuli by use of a hand-held switch which is also connected to the instrument. D-0116492-B (OM022) – Otosure Operating Manual... - Page 8 Patient Instructions The patient is given the following instructions: “Press and then release the response switch when a tone is heard”. D-0116492-B (OM022) – Otosure Operating Manual...
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Page 9: Unpacking And Installation
Failing to do so may endanger the environment. The CE-mark indicates that Amplivox Ltd. meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system. -
Page 10: Safety Instructions
Amplivox Ltd. is aware that safety rules within individual organizations vary. If a conflict exists between the instructions in this manual and the rules of the organization using this instrument, the more stringent rules should take precedence. -
Page 11: Environmental Factors
No parts of the equipment can be serviced or maintained while in use with the patient. Connect only accessories purchased from Amplivox Ltd. to the Otosure. Only accessories which have been stated by Amplivox Ltd. to be compatible are allowed to be connected to the device or cradle. 3.3.3. -
Page 12: Electromagnetic Compatibility (Emc)
3.3.7. MEASURING SECURITY To guarantee that the Otosure works properly, the instrument should be checked and calibrated at least once a year. The transducers supplied with the audiometer are specifically calibrated with it; if these transducers are changed recalibration will be required. -
Page 13: Use Of Equipment After Transport And Storage
All other connections should be made before connecting the audiometer to the PC. A USB cable is provided to connect the Otosure to a PC. The connected port on the PC must be to USB specification 1.0 or 2.0. Connect the headset and the patient response switch to the Otosure and then make the connection from the Otosure to the PC. -
Page 14: Installing Software & Operational Check
Close any dialogue boxes in the Otosure window and select the Manual Test option: Move the mouse pointer over the “Present” icon in the Otosure window and ensure a tone is heard from an earphone. Use the arrow keys on the PC keyboard to change the level and frequency of the tone. Use the “L”... - Page 15 The above will demonstrate the basic functionality of the audiometer. When closing the Otosure window remember to use the “Edit > Cancel Insert/Edit” option or cancel toolbar button in Audibase to cancel the test operation. D-0116492-B (OM022) – Otosure Operating Manual...
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Page 16: Using The Otosure
Alternatively use the “Test > Launch Test” drop-down menu selection at the top of the Audibase window. A new window will open for the Otosure software. If the patient has more than one set of audiometric results stored in Audibase the most recent audiogram is transferred and displayed in the Otosure window. -
Page 17: Mixed Testing
Alternatively use the “Test > Launch Test” drop-down menu selection at the top of the Audibase window. A new window will open for the Otosure software. If the patient has more than one set of audiometric results stored in Audibase the most recent audiogram is transferred and displayed in the Otosure window. -
Page 18: Control Buttons
5.7. MANUAL TESTING Click the Manual test button (the button will then be highlighted) Alternatively use the “Test > Manual” drop-down menu selection at the top of the Otosure window. The following screen is displayed: D-0116492-B (OM022) – Otosure Operating Manual... - Page 19 Use the controls described above to build up a complete audiogram for the patient. Once satisfactorily completed, click on “Exit” at the top of the Otosure window and confirm to exit Otosure. The Otosure window will close and the Audibase window will display the test results. Refer to the Audibase user manual for additional options, but it should be noted that the results must be saved in Audibase to be retained in the database.
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Page 20: Computer Testing
The Computer test will run according to the test options selected with the test status indicated at the bottom left of the Otosure window. The “Present” icon will re-appear and indicate when tones are presented, and the “Response” icon will change to light green when a patient response is made. -
Page 21: Single-Frequency Testing
To accept the results and transfer them to Audibase click on the “Accept” button. The Otosure window will close and the Audibase window will be displayed. Refer to the Audibase user manual for additional options, but it should be noted that the results must be saved in Audibase to be retained in the database. -
Page 22: Options Available To Set-Up
6. OPTIONS AVAILABLE TO SET-UP 6.1. GENERAL The Otosure software stores the most recent test configuration and will initially use this to run any subsequent tests. However, there are a number of options available for setting up, modifying and controlling a test. -
Page 23: Troubleshooting
7. TROUBLESHOOTING 7.1. GENERAL The Otosure is straightforward to use with an intuitive user interface, and if the instructions are followed the testing process should be performed easily. The product has been designed to detect and report a number of errors that could be encountered while performing audiometric testing and these are described below. -
Page 24: Response Switch Held On
Check that the patient fully understands the instructions previously given regarding use of the response switch. Check also that the response switch is connected and operating and that tones are being output from the headphones. D-0116492-B (OM022) – Otosure Operating Manual... -
Page 25: Erratic Patient Response
Audibase 7.6. EXIT OTOSURE WITH NO RESULTS If the Otosure Software is closed without obtaining any test results the following warning will be displayed in Audibase: Click OK and then use the “Edit > Cancel Insert/Edit” option or cancel toolbar button to cancel the operation. -
Page 26: Usb Lead Disconnected
Once the message has been acknowledged, it will be possible to select control buttons and menu options in the Otosure window on the PC but these will have no effect. If the Otosure cable becomes disconnected, the recommended course of action is for the operator to close the Otosure window and return to Audibase. Then use the “Edit >... -
Page 27: Routine Maintenance
70% isopropyl alcohol only on hard cover surfaces 8.2. AUDIOMETER MAINTENANCE The Otosure audiometer is a precision instrument. Handle it carefully in order to ensure its continued accuracy and service. When cleaning the instrument, use a soft damp cloth and mild detergent to clean the instrument panel. -
Page 28: Headset Maintenance
United Kingdom hello@amplivox.com This should also be done every time an instrument is returned to Amplivox Ltd. (This of course also applies in the unlikely worst case scenario of death or serious injury to a patient or user). When packing the instrument for shipping, please use the original shipping carton and packing materials. Place the instrument parts in plastic bags before packing. -
Page 29: Warranty
This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Amplivox Ltd. shall not be responsible for, any loss arising in connection with the purchase or use of any Amplivox Ltd. product that has been: •... -
Page 30: Guarantee
Amplivox service department. Return carriage is free of charge for customers in the UK and chargeable for overseas customers. -
Page 31: Technical Specifications
Continuous operation Equipment mobility: Portable The Otosure audiometer is classified as a Class IIa device under Annex IX of the Medical Devices Directive. It is intended for transient use as a screening hearing test instrument. 9.2. INPUT/OUTPUT Connection to PC: USB (version 1.0 or 2.0);... - Page 32 Humidity storage/transport): 10% to 90% (non-condensing) Atmospheric Pressure (operating): 700hPa to 1060hPa Atmospheric Pressure 500hPa to 1060hPa (storage/transport): D-0116492-B (OM022) – Otosure Operating Manual...
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Page 33: Emc Guidance & Manufacturer'sdeclaration
NOTICE: There are no deviations from the collateral standard and allowances uses NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in the general maintenance section in this instruction. No further steps required. D-0116492-B (OM022) – Otosure Operating Manual... - Page 34 Guidance and manufacturer’s declaration – electromagnetic emissions The Otosure Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otosure Audiometer should assure that it is used in such an environment. Electromagnetic environment – guidance...
- Page 35 Guidance and manufacturer’s declaration – electromagnetic immunity The Otosure Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otosure Audiometer should assure that it is used in such an environment. Electromagnetic environment –...
- Page 36 Guidance and manufacturer’s declaration – electromagnetic immunity The Otosure Audiometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otosure Audiometer should assure that it is used in such an environment. Electromagnetic environment – guidance...
- Page 37 NOTE 3 WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30cm (12 inches) to any part of the Otosure audiometer including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.
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Page 38: Use With Non-Medical Electrical Equipment
Refer to the diagram below for a typical configuration of a connected computer. Refer to Amplivox Ltd at the address given on the front of this user manual if advice is required regarding the use of peripheral equipment. - Page 39 Copyright © 2019 Amplivox Ltd. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Amplivox Ltd. D-0116492-B (OM022) – Otosure Operating Manual...
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Hi I had Error 14 type 0 USB instrument attatched does not have the requested functionality