AmpliVox Otowave 302 Operating Manual Download Page 8

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INTRODUCTION

D-0115696-C (OM038)

– Otowave 302 Operating Manual

1.5.

WARNINGS

Throughout this manual, the following meanings of warnings and cautions apply:

The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.

The CAUTION label identifies conditions or practices that could result in damage
to the equipment.

WARNING

CAUTION

Summary of Contents for Otowave 302

Page 1: ...Otowave 302 Operating Manual...

Page 2: ...towave 302 This product is manufactured by Amplivox Ltd 6 Oasis Park Eynsham Oxfordshire OX29 4TP United Kingdom www amplivox ltd uk Amplivox Ltd 10393 West 70th Street Eden Prairie MN 55344 www ampli...

Page 3: ...rage 8 2 4 CONNECTIONS 9 2 5 CONTROLS AND INDICATORS BASE UNIT 10 2 6 CONTROLS AND INDICATORS PROBE 11 2 6 1 The Probe Head 11 2 7 LIGHT INDICATORS 12 2 8 CONTRALATERAL TRANSDUCER 12 2 9 CHOOSING THE...

Page 4: ...NAGEMENT 33 4 12 1 General 33 4 12 2 List records View Print Delete 33 4 12 3 Delete Records 34 4 12 4 Print Records 35 4 12 5 Data Transfer to noah or ampliSuite 35 4 12 6 Database Full 36 5 TROUBLES...

Page 5: ...NE 55 10 4 REFERENCE POINT FOR BASELINE VALUE 56 11 APPENDIX B BASELINE MODE 57 11 1 GENERAL 57 11 2 226 HZ TYMPANOMETRY Y COMPENSATION ONLY 57 11 3 1000 HZ TYMPANOMETRY 58 11 3 1 scalar Mode y compen...

Page 6: ...onal conditions of the middle and outer ear as well as to assess hearing functions throughout acoustic reflex testing The Otowave 302 can be used on all ages and performs the following kinds of measur...

Page 7: ...arranty card OPTIONAL COMPONENTS Sanibel MPT II Thermal Printer 8503007 Thermal Printer paper for Sanibel MPT II 8029305 Probe tip for contralateral reflex transducer 80011181 Earpiece lead for contra...

Page 8: ...this manual the following meanings of warnings and cautions apply The WARNING label identifies conditions or practices that may present danger to the patient and or user The CAUTION label identifies...

Page 9: ...medical professional 2 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 can be immediat...

Page 10: ...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 pre...

Page 11: ...lity EMC the tympanometer is designed to be used only with the medically approved mains adapter supplied which is specified as part of the equipment Do not use any other type of mains adapter with thi...

Page 12: ...ctrical System and is therefore responsible for the system to comply with these requirements If in doubt contact a qualified medical technician or your local representative When the instrument is conn...

Page 13: ...European Union it is illegal to dispose of electrical and electronic waste as unsorted municipal waste Electrical and electronic waste may contain hazardous substances and therefore have to be dispose...

Page 14: ...trical 15 way D connector 5 Printer Connection of external printer RJ12 socket 6 way 6 USB Connection for computer via USB port USB Connector Type B 7 Power Mains AC DC Adapter 2 5mm power jack Please...

Page 15: ...in process or not c Indicator LED c Indicates if testing is in process or not 1 On Off switch Short press to switch on the device long press to switch it off 2 Navigation keys Press the up and down n...

Page 16: ...rubber To remove the probe tip unscrew the nose cone and remove the probe tip from the boss A small seal will be found in the base of the probe tip This should be examined and replaced if it is blocke...

Page 17: ...ocket on Otowave The contralateral transducer is used when it is required to provide a reflex stimulus to the opposite ear to that being tested with the main probe assembly For use it should be connec...

Page 18: ...ed by a mains adapter Connect the output lead from the adapter into the POWER input socket on the back of the Otowave When power the indicator on the adapter and the Power indicator LED a on the Otowa...

Page 19: ...n order to power ON or OFF One short beep will be heard at power ON two short beeps at power OFF The green power indicator will be lit if the printer is powered by battery 2 12 3 USING THE PRINTER Pri...

Page 20: ...The level of this tone is calibrated to give 85 dB SPL 226 Hz or 79 dB SPL 1000 Hz into a 2 ml cavity The sound level this produces in the ear canal is measured using a microphone and the admittance c...

Page 21: ...this stimulus is increased in steps until the stapedial muscles respond causing the tympanic membrane to become stiffer or a preset maximum level is reached When the change in admittance exceeds a pre...

Page 22: ...ear tip in place 8 Clean the probe and insert phones regularly using a recognized disinfectant 9 Clean the probe tip regularly to ensure wax or other debris stuck in the probe tip does not affect the...

Page 23: ...is connected through the mains 4 3 HIGH FREQUENCY OPTION If the instrument is configured for high frequency operation can be verified when switching the instrumentation on On the boot up screen the Am...

Page 24: ...tympanograms in a variety of graphical formats allowing the operator to choose the most appropriate for the patient under examination Please refer to the appendix for further information on how to us...

Page 25: ...choose the maximum level of reflex stimulus to apply and the step size between the levels of the preceding stimuli The maximum level of ipsilateral stimulus may be set between 85dBHL and 100dBHL the m...

Page 26: ...of how the date is displayed DD MM YY or MM DD YY DD MM YY Hospital Name Allows the Hospital name to be entered The name will appear at the top of the print out Department Allows the Department name t...

Page 27: ...and repeat the test with the three remaining test cavities The display should show the volume of the 0 2ml 0 5ml test cavities to within 0 1ml The volume of the 5 0ml test cavity should be shown withi...

Page 28: ...8 SYSTEM INFORMATION 1 Variant Instrument version Dual Tone High Frequency option enabled 2 Ver Firmware version 3 Last Cal Last calibration date 4 Next Cal Next calibration date 5 Serial No Serial nu...

Page 29: ...tic reflex testing in one run without removing the probe Please note The protocol selected by default runs a tympanogram together with ipsilateral reflexes An instruction on the screen will guide you...

Page 30: ...ure and is held the seal is good and the pump goes just above the starting pressure The method used for the extended ear seal check places a maximum limit on the ear canal volume of 4 5 ml As soon as...

Page 31: ...mmho pressure in daPa Gr Gradient Width of compliance curve at half of peak compliance in daPa 4 Ear side L for left and R for right 5 Normative box not available for 1000 Hz tympanometry 6 Pass Refer...

Page 32: ...acoustic reflex test screen consists of the preview of the measured tympanogram Underneath the graph the tested ear side the test frequency and intensity are listed The reflex test starts with the low...

Page 33: ...of the reflex at the lowest selected frequency with the lowest level that gave a response Select the keys to move scroll through the different frequencies If Reflex autostop has not been selected the...

Page 34: ...iance in daPa 4 Four reflex traces containing frequency of the reflex stimulus lowest level of tone dBHL at which a reflex was found and the type of reflex stimulus used I for ipsilateral C for contra...

Page 35: ...inting process has to be confirmed by pressing SELECT again The Otowave will then attempt to connect to the printer To stop the print operation for example if a printer is not connected press to selec...

Page 36: ...records this same identifier may be used for different tests for the same patient To enter the data use the and keys to select a character Press and hold the key to enter the selected character To de...

Page 37: ...ith a can be selected for a review From the test result screen select the right navigation key until the PROCESS RESULTS screen is reached From here the following options are given Print the current r...

Page 38: ...e stored record View the record again 4 12 2 LIST RECORDS VIEW PRINT DELETE LIST RECORDS shows the stored tests 6 at a time most recent first The overview contains the following information to help id...

Page 39: ...the LIST VIEW after the successful deletion If only one record is available in the database a note will show on the screen that the database is empty Please note When a new test is saved as last test...

Page 40: ...w connection to a computer for the transfer of test results You must use the designated USB cable which is available from Amplivox To transfer test results stored within the Otowave to a NOAH database...

Page 41: ...ase is full when attempting to save a test Selecting MANAGE RECORDS will display the DATA MANAGEMENT menu which provides options for printing or transferring data to a computer prior to deleting recor...

Page 42: ...d immediately BLOCKED PROBE Indicator LED b and c flash fast Probe is blocked Probe placed against ear canal skin Probe disconnected from base unit Examine the probe tip for contamination and clean or...

Page 43: ...ests can still be performed Recalibration needed before further tests are performed WARNING DEVICE UNCALIBRATED Indicator LED c steady light One or more default values require recalibration before fur...

Page 44: ...on of water and detergent or similar Always disconnect the mains power adaptor during the cleaning process and be careful that no fluid enters the inside of the instrument or accessories 5 After each...

Page 45: ...liquid from the wipe does not seep into any sensitive areas such as connectors and seams where plastic pieces connect such as under the rubber buttons on the Otowave Follow the instructions on the dis...

Page 46: ...e use the original shipping carton and packing materials Place the instrument parts in plastic bags before packing to prevent dirt and dust getting into the probe 6 7 WARRANTY Amplivox therefore gives...

Page 47: ...mplivox Ltd This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of Amplivox Ltd Amplivox Ltd does not give or grant directly or indirectly t...

Page 48: ...t room temperature Idle current 70 mA Current while testing 230 mA Environmental Operating temperature 15 C to 35 C 59 F to 95 F Operating humidity 30 to 90 RH non condensing Operating atmospheric pre...

Page 49: ...0 200 or 300 daPa sec Analysis Admittance peak level in ml or m pressure at peak Gradient in daPa for 226Hz and 1000Hz Ear Canal Volume ECV 200 daPa or 400 daPa Number of samples stored 100 per tympan...

Page 50: ...p size s available 110 105 100dBHL max with 5dB or 10dB steps 95 90 85dBHL max with 5dB steps General THD 5 Reflex analysis Reflex pass fail at each level tested maximum amplitude of each reflex nomin...

Page 51: ...list of accessories transducers 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 clos...

Page 52: ...issions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic immunity 1 The Otowave 302 Tympanometer is intended...

Page 53: ...for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Otowave 302 Tympanometer...

Page 54: ...anometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P 80MHz to...

Page 55: ...ave 302 Tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Otowave 302 Tympanometer can help prevent el...

Page 56: ...like printers and networks special precautions must be taken in order to maintain medical safety Please follow instructions given in this chapter Diagram 1 Otowave 302 used with the medically approve...

Page 57: ...AVE 302 52 D 0115696 C OM038 Otowave 302 Operating Manual Diagram 3 Otowave 302 used with the medically approved mains adapter and a computer Mains Outlet Medical Mains Adapter Otowave 302 Mains Outle...

Page 58: ...lues easy to separate If considered as impedances these components are in parallel which makes their separation much more difficult to calculate and to visualize For example the ear canal admittance i...

Page 59: ...r the probe tone at all nonetheless the approximation is sufficient for clinical purposes This value is subtracted from each of the tympanogram measurements in turn to generate the meatus compensated...

Page 60: ...th of a line joining two points in 2 D space and can therefore never be negative This can cause a tympanogram to rise up at the end opposite to that used for the baseline reference If that is the case...

Page 61: ...OM038 Otowave 302 Operating Manual 10 4 REFERENCE POINT FOR BASELINE VALUE An additional feature of the Otowave 302 not found on other screening tympanometers is that the user can decide whether to u...

Page 62: ...SET in the instrument menus and the accompanying documentation The tympanogram is initially presented using default settings for display mode and baseline offset Additionally whenever a tympanogram is...

Page 63: ...note that a consequence of the vector mode calculation is that the resulting tympanogram cannot take negative values It is thus theoretically possible for the trace to appear to rise i e take higher p...

Page 64: ...Otowave 302 Operating Manual Copyright 2018 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 permiss...

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