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INTRODUCTION

OTOWAVE 302+ INSTRUCTION FOR USE

1.4.

STANDARD AND OPTIONAL ACCESSORIES

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.

STANDARD ACCESSORIES

Otowave 302+ Tympanometer base unit

8519028

Contralateral reflex transducer (probe tip
& earpiece lead)

8502177

Power Supply - FW7660M/05

8512734

Set of disposable ear-tips

8029344

USB with Software (ampliSuite and Noah
impedance module) and Operating
Manuals

8517685

4 in 1 cavity assembly
(0.2 ml/0.5 ml/2.0 ml/5.0 ml)

8011362

Cable USB a to USB B (1.8 m)

8011241

Carrying case

8507857

Calibration certificate

8011512

OPTIONAL ACCESSORIES

Sanibel

MPT-II

Thermal

Printer

(standard in US conf.)

8503007

Thermal Printer paper for Sanibel
MPT-II (standard in US conf.)

8029305

Printer cable

–

Otowave to Sanibel MPT-

II (standard in US conf.)

8004419

Earpiece lead for contralateral reflex
transducer

8004447

Probe tip for contralateral reflex
transducer

8001118

Probe tip

8002592

Additional sets of ear tips

Seal (in probe tip)

8002009

Otowave probe assembly

8502005

ACCESSORIES TO REORDER

Ear tip Otowave 3-5mm, 25 pieces

8012963

Ear tip Otowave 4-7mm, 25 pieces

8012965

Ear tip Otowave 7mm, 25 pieces

8013001

Ear tip Otowave 8mm, 25 pieces

8013003

Ear tip Otowave 9mm, 25 pieces

8012969

Ear tip Otowave 10mm, 25 pieces

8012971

Ear tip Otowave 11mm, 25 pieces

8012973

Ear tip Otowave 12mm, 25 pieces

8012975

Ear tip Otowave 13mm, 25 pieces

8012977

Ear tip Otowave 14mm, 25 pieces

8012979

Ear tip Otowave 15mm, 25 pieces

8012981

Ear tip Otowave 19mm, 25 pieces

8012983

Applied part as according to IEC 60601-1

Содержание Otowave 302+

Страница 1: ...D 0126546 C INSTRUCTION FOR USE...

Страница 2: ...oduct is manufactured by Amplivox Ltd 3800 Parkside Solihull Parkway Birmingham Business Park Birmingham West Midlands B37 7YG www amplivox com For all enquiries please contact us under Amplivox Ltd 1...

Страница 3: ...accuracy 11 2 3 8 Miscellaneous 12 2 3 9 Use of equipment after transport and storage 12 2 4 CONNECTIONS 13 2 5 CONTROLS AND INDICATORS BASE UNIT 14 2 6 THE PROBE 15 2 6 1 Controls and Indicators Prob...

Страница 4: ...Performing tympanometry and acoustic reflex testing 34 4 9 5 Understanding the acoustic reflex test result 35 4 10 PROCESS RESULTS 37 4 10 1 General 37 4 10 2 Sending Results to a Printer 37 4 10 3 Sa...

Страница 5: ...TRY MEATUS COMPENSATION 58 10 1 TYMPANOMETRIC PROPERTIES 58 10 2 TYMPANOMETRIC MEASUREMENTS 58 10 3 SCALAR VS VECTOR BASELINE 60 10 4 REFERENCE POINT FOR BASELINE VALUE 61 11 APPENDIX B BASELINE MODE...

Страница 6: ...ghout acoustic reflex testing The Otowave 302 can be used on all ages and performs two types of measurement Tympanometry To measure the compliance of the tympanic membrane and middle ear at 226 Hz or...

Страница 7: ...ONAL ACCESSORIES Sanibel MPT II Thermal Printer standard in US conf 8503007 Thermal Printer paper for Sanibel MPT II standard in US conf 8029305 Printer cable Otowave to Sanibel MPT II standard in US...

Страница 8: ...he following exceptions apply The pressure pump and transducers may go out of calibration due to rough handling or impact dropping The lifetime of probe probe seals and ear tips is dependent upon cond...

Страница 9: ...dical 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 immediatel...

Страница 10: ...control or eliminate any hazards or other exposure to illness or injury Amplivox Ltd is aware that safety rules within individual organisations vary If a conflict exists between the instructions in t...

Страница 11: ...and IEC 60601 1 2 for electromagnetic compatibility 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 n...

Страница 12: ...sponsible for the system to comply with these requirements If in doubt contact a qualified medical technician or your local representative When the instrument is connected to a PC or other similar ite...

Страница 13: ...is illegal to dispose of electrical and electronic waste as unsorted municipal waste Electrical and electronic waste may contain hazardous substances and therefore must be disposed of separately Such...

Страница 14: ...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 note O...

Страница 15: ...e instrument 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 navigation keys to scroll through the menus or set values Press the...

Страница 16: ...ust be kept clear If these become blocked a warning message will be displayed The probe tip must be removed and replaced To remove the probe tip unscrew the nose cone and remove the probe tip from the...

Страница 17: ...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 connected to the CONTRA so...

Страница 18: ...e 302 probe tip must be kept clear If these become blocked a warning message will be displayed The probe tip must be removed and replaced 2 10 HARDWARE INSTALLATION The instrument is shipped with the...

Страница 19: ...e 1 Open the lid by pushing on the sides insert paper roll as shown and close the lid 2 Insert the battery 2 12 2 SWITCHING THE PRINTER ON AND OFF Push POWER BUTTON for two seconds in order to power O...

Страница 20: ...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 calculated...

Страница 21: ...mulus 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 predetermin...

Страница 22: ...ithout a correct insert ear tip in place 8 Clean the probe and contra earphone regularly using a recognized disinfectant 9 Check the probe tip regularly to ensure wax or other debris stuck in the prob...

Страница 23: ...s connected to the mains 4 3 MENU DISPLAYS From the MAIN MENU you can reach different submenus Use the navigation keys up and down or the Softkeys S1 to S6 to navigate the options and select submenus...

Страница 24: ...enabled 0 02 ml threshold Contralateral Reflexes Disabled 4 4 2 CHANGING PROFILES When the start up sequence is complete the PROFILE selection screen is displayed Select a profile to be brought to th...

Страница 25: ...want to overwrite either the current selected one or all profiles 3 Select the profile you want to copy the settings from After selection confirm the overwrite 4 4 4 RESET PROFILE SETTINGS TO FACTORY...

Страница 26: ...ent selected profile ensure that the MAIN MENU is displayed and then press and hold the function button on the probe to display the TEST SETTINGS screen as shown below 1 Profile Current selected Profi...

Страница 27: ...ngs Acoustic reflex only Default Sweep Reflex Copy Sweep Reflex Function Profiles Rename Profile When selecting one of the sub settings the target profile is required to be selected first in order to...

Страница 28: ...e 200daPa Scalar 2S Sequence Define the order in which the ears are to be tested when BOTH ears are to be tested in one session Right Left Ear Seal The STANDARD option is adequate for most tests altho...

Страница 29: ...el of contralateral stimulus may be set between 85dBHL and 110dBHL 100 dB 5 dB steps Freqs Use the key to scroll through the frequencies available for each of the ipsilateral and contralateral stimuli...

Страница 30: ...ovided by the thermal printer PRINT CAL Dates Date Mode Set the format of how the date is displayed DD MM YY or MM DD YY DD MM YY Hospital Allows the Hospital name to be entered The name will appear a...

Страница 31: ...must be square to the end of the test cavity Remove the probe wait until INSERT PROBE is displayed and repeat the test with the three remaining holes The display should show the volume for the 0 2 ml...

Страница 32: ...coustic 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...

Страница 33: ...is repeated at a pressure higher than ambient Otherwise the process restarts If the higher pressure is sufficiently above the ambient pressure and is held the seal is good and the pump goes just abov...

Страница 34: ...m where the data can be printed stored or reviewed again 4 9 3 UNDERSTANDING THE TYMPANOMETRY TEST RESULT 1 y axis label in ml for 226 Hz and mmho for 1000 Hz 2 y axis ranging from 0 to 1 ml in this e...

Страница 35: ...y default the acoustic reflex testing is only performed if a peak is found in the tympanogram This setting can be changed in the SETTINGS menu The acoustic reflex test screen consists of the preview o...

Страница 36: ...elected the tympanogram remains on the left hand side of the screen with a larger scale trace of the reflex at the lowest selected frequency with the lowest level that gave a response Select the keys...

Страница 37: ...aPa 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 contralateral 5...

Страница 38: ...e three characters printed in the NAME field followed by the Otowave 302 graphical displays the analysis and the results There is space for additional details to be handwritten by the clinician patien...

Страница 39: ...fer to stored 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 ch...

Страница 40: ...y test results with a can be selected for review From the test result screen select the right navigation key until the PROCESS RESULTS screen is reached From here the following options are available P...

Страница 41: ...stored record S2 View the record again S3 4 12 2 LIST RECORDS VIEW PRINT DELETE LIST RECORDS displays the stored tests 6 at a time most recent first The overview contains the following information to...

Страница 42: ...e database a note will show on the screen that the database is empty Please note When a new test is saved as last test the baseline mode most recently viewed will be saved although any of the other mo...

Страница 43: ...uite allows data to be transferred to a computer and subsequently viewed annotated printed This software is supplied on a USB stick which also includes this operating manual The computer will automati...

Страница 44: ...r the tympanometry even though the reflex test is active in the REFLEX SEQUENCE In REFLEX SELECTION the setting is set to ONLY IF PEAK IS FOUND or NEVER MEASURE Change settings in REFLEX SELECTION to...

Страница 45: ...and or pump Restart the unit If problem persists contact your Amplivox service centre WARNING CALIBRATION EXPIRED Indicator LED c steady light The current date is later than the next calibration date...

Страница 46: ...ater 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 patient...

Страница 47: ...her than a spray product Make sure that excess 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...

Страница 48: ...ons Notice of the fault is given to Amplivox within the Warranty period The instrument is forwarded carriage paid to Amplivox Limited at the above address or as otherwise directed Return carriage is f...

Страница 49: ...x Ltd Amplivox Ltd does not give or grant directly or indirectly the authority to any representative or other person to assume on behalf of Amplivox Ltd any other liability in connection with the sale...

Страница 50: ...5 g 0 25 lbs Interconnection probe to base 1 5 m combined electrical cable and air tube Power Supply Mains power 100 240 Vac 50 60 Hz 0 4 A Warm up period None at room temperature Idle current 70 mA C...

Страница 51: ...10 whichever is larger over range 0 1 ml to 6 ml Limits safety cutout 600 and 800 daPa Sweep Speed Selectable 100 200 or 300 daPa sec Analysis Admittance peak level in ml or m pressure at peak Gradie...

Страница 52: ...is Reflex pass fail at each level tested maximum amplitude of each reflex nominal pressure used for the reflex test computer display only Pressure used for reflex measurement Pressure at tympanogram p...

Страница 53: ...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 closer than...

Страница 54: ...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 for use...

Страница 55: ...cles 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 require...

Страница 56: ...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 800MHz0...

Страница 57: ...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 electroma...

Страница 58: ...Please follow instructions given in this section Diagram 1 Otowave 302 used with the medically approved mains adapter Diagram 2 Otowave 302 used with the medically approved mains adapter and printer...

Страница 59: ...easy to separate If considered as impedances these components are in parallel which makes their separation much more difficult to calculate and to visualise For example the ear canal admittance impeda...

Страница 60: ...e 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 tymp...

Страница 61: ...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 changi...

Страница 62: ...WAVE 302 INSTRUCTION FOR USE 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 use 400...

Страница 63: ...he 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 shown i...

Страница 64: ...t 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 positive...

Страница 65: ...0126546 C Copyright 2021 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...

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