AmpliVox Otosure Operating Manual Download Page 8 | Manualshive

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D-0116492-B (OM022)

– Otosure Operating Manual

Headset

The headset must be fitted by a qualified person to ensure a proper seal and comfortable fit. The leads from
the headset are connected to the instrument and the headset is then fitted to the patient.

Patient Instructions

The patient is given the following instructions:

“Press and then release the response switch when a tone is

heard”.

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Summary of Contents for Otosure

Page 1: ...Otosure Operating Manual...

Page 2: ...d Audibase version 5 5 onwards This product is manufactured by Amplivox Ltd 10393 West 70th Street Eden Prairie MN 55344 United States Amplivox Ltd 3800 Parkside Solihull Parkway Birmingham Business P...

Page 3: ...afety 10 3 3 5 Electromagnetic compatibility EMC 11 3 3 6 Explosion hazards 11 3 3 7 Measuring Security 11 3 3 8 Miscellaneous 11 3 3 9 Use of equipment after transport and storage 12 3 4 CONNECTIONS...

Page 4: ...EAD DISCONNECTED 25 8 ROUTINE MAINTENANCE 26 8 1 GENERAL MAINTENANCE PROCEDURES 26 8 2 AUDIOMETER MAINTENANCE 26 8 3 HEADSET MAINTENANCE 27 8 4 ACCESSORIES REPLACEMENT PARTS 27 8 5 REPAIR 27 8 6 WARRA...

Page 5: ...ispensers child health professionals and hearing healthcare professionals with a similar level of education It is not recommended to utilize the equipment without the necessary knowledge and training...

Page 6: ...ese accessories until the audiometer has been calibrated to match their characteristics Shipping documentation will reference the stock number quoted above and images of the parts alongside the releva...

Page 7: ...right ear The BSA British Society of Audiology recommends starting the test at 1000 Hz to then next measure the higher frequencies When done with the high frequencies 1000 Hz shall be retested and to...

Page 8: ...ed person to ensure a proper seal and comfortable fit The leads from the headset are connected to the instrument and the headset is then fitted to the patient Patient Instructions The patient is given...

Page 9: ...f a licensed medical professional 3 2 MARKINGS The following markings can be found Symbol Explanation Type B applied parts According to IEC 60601 1 Patient applied parts that are not conductive and ca...

Page 10: ...unit is tested and calibrated for proper functioning in accordance with Amplivox s specifications Do not drop or in any other way cause undue impact to this device If the instrument is damaged return...

Page 11: ...cted 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 stan...

Page 12: ...cian If these checks are not performed EU Medical Device Directive MDD and other regulations may be violated and warranties may be void The use of non calibrated devices can lead to incorrect test res...

Page 13: ...nt or supplied by Amplivox or an Amplivox distributor These parts have been tested for use with the Amplivox Otosure audiometer for compliance with the standards IEC 60601 1 and IEC 60601 1 2 The use...

Page 14: ...ply by navigating to the location where the software was originally installed and deleting the file named Otosure exe There is no need to use the Add or Remove Programs utility This will leave Audibas...

Page 15: ...rating Manual 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 Audiba...

Page 16: ...pe currently selected The test type last used is remembered if this was a manual test the procedures may be followed if this was an automatic test the following dialogue box will be displayed To run t...

Page 17: ...utton to click on the Launch Test icon in the Audibase toolbar 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...

Page 18: ...The icon changes to this format when a response is made 5 6 CONTROL PC KEYBOARD AND MOUSE Keyboard L key selects left ear in Manual test mode Keyboard R key selects right ear in Manual test mode Keyb...

Page 19: ...iate text box above the audiogram If an error has been made simply plotting a different threshold at the selected frequency will override any previous threshold To clear all thresholds from the audiog...

Page 20: ...onse icon will change to light green when a patient response is made To view the traces of the presented tones select the Show test detail button Alternatively use the View Detail drop down menu optio...

Page 21: ...the patient response at a particular frequency was erratic or the automatic test was unable to establish a response at a particular frequency The Test One freq test drop down menu option may be used t...

Page 22: ...ail graphical representation of presented tones and patient responses or Audiogram plots of thresholds found to be selected Options this opens a dialogue box which provides access to the following opt...

Page 23: ...displayed Clicking OK will return to Audibase Use the Edit Cancel Insert Edit option or cancel toolbar button to cancel the insert operation The Otosure may then be connected and Audibase operations...

Page 24: ...rease to minimum and then the test will pause with the following message displayed on the PC screen Depending on circumstances the operator may choose to abort the test retry the frequency or ignore t...

Page 25: ...cy test but rather the test will complete but with errors see below If the audiometer manages to establish some but not all thresholds during an automatic test the following dialogue box will be displ...

Page 26: ...becomes disconnected the recommended course of action is for the operator to close the Otosure window and return to Audibase Then use the Edit Cancel Insert Edit option or cancel toolbar button to re...

Page 27: ...e instrument or accessories 5 After each patient examination ensure that there has been no contamination to the parts touching the patient General precautions must be observed in order to avoid cross...

Page 28: ...e over time We recommend that you keep theses replacement parts available 8 5 REPAIR Amplivox Ltd is only considered to be responsible for the validity of the CE marking effects on safety reliability...

Page 29: ...liable for any incidental indirect or consequential damages in connection with the purchase or use of any Amplivox Ltd product This shall apply solely to the original purchaser This warranty shall not...

Page 30: ...date of despatch if returned carriage paid to the Amplivox service department Return carriage is free of charge for customers in the UK and chargeable for overseas customers Please note The following...

Page 31: ...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 type B connector Left and Right Outputs...

Page 32: ...1 D 0116492 B OM022 Otosure Operating Manual Humidity storage transport 10 to 90 non condensing Atmospheric Pressure operating 700hPa to 1060hPa Atmospheric Pressure storage transport 500hPa to 1060hP...

Page 33: ...ransducers and cables can be found in this appendix Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inche...

Page 34: ...sions CISPR 11 Group 1 The Otosure Audiometer uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause interference in nearby electronic equipm...

Page 35: ...l or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Not applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips sho...

Page 36: ...Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity o...

Page 37: ...GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in...

Page 38: ...in order to reduce any potential hazard associated with the use of connected mains powered equipment Socket Label Socket Type Typical Connection USB Connector Computer External equipment intended for...

Page 39: ...22 Otosure Operating Manual 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 permissio...

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