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AmpliVox Otowave 202, Руководство по эксплуатации

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INTRODUCTION 

 

 

 

                                                             3 

D-0115692-C (OM031) 

– 

Otowave 202 Operating Manual                                                            

 

 

 

The 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  eartips  is  dependent  upon 
conditions  of  use.    These  parts  are  only  guaranteed  against  faulty 
materials or manufacture. 

 

 
 

 

CAUTION 

Содержание Otowave 202

Страница 1: ...Otowave 202 Operating Manual...

Страница 2: ...072200 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 amplivox...

Страница 3: ...the detection of possible otologic disorders in the general population associated with the functioning of the middle ear The instrument performs two types of measurement Tympanometry is used to measur...

Страница 4: ...7 3 3 TYMPANOGRAM 7 3 4 ACOUSTIC REFLEX MEASUREMENT 8 4 USING THE OTOWAVE 9 4 1 INSTALLING REPLACING BATTERIES 9 4 2 OPERATING LANGUAGE 9 4 3 CONTROLS AND INDICATORS BASE UNIT 10 4 4 INDICATORS AND SY...

Страница 5: ...TOWAVE 33 13 2 EARTIPS AND PROBE 33 13 3 CALIBRATION AND RETURN OF THE INSTRUMENT 33 14 ERROR MESSAGES FAULT CONDITIONS 35 15 TECHNICAL SPECIFICATION 38 15 1 PERFORMANCE 38 15 2 EQUIPMENT CLASSIFICATI...

Страница 6: ...omatic measurement of ear canal volume tympanic admittance peak and placement of the peak using either 226Hz or 1000Hz H probe tone with various display options for the tympanometric data Automatic de...

Страница 7: ...ructions for further details 1 6 WARNINGS Throughout this manual the following meanings of warnings and cautions apply The WARNING label identifies conditions or practices that may present danger to t...

Страница 8: ...ceptions 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 eartips is dependent upon conditions of use Th...

Страница 9: ...t is each ear tip is intended to be used once only for a single ear for a single patient Do not reuse ear tips as this will pose the risk of ear to ear or patient to patient cross infection Do not imm...

Страница 10: ...the indicator will be extinguished When the fault is cleared the adapter will operate as normal The input to the mains adapter is protected with a non replaceable fuse If this fails the adapter will n...

Страница 11: ...nated portable thermal printers for printing tympanometric test results see Section 7 Upon receipt of the printer it must be initially charged for a minimum of 15 hours prior to use 2 6 DATA TRANSFER...

Страница 12: ...he 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 ca...

Страница 13: ...his 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 pred...

Страница 14: ...in the CONFIGURATION menu By default this is ALKALINE Change the setting in the CONFIGURATION menu scroll to BATTERY TYPE as described in Section 6 To fit the cells remove the battery compartment cov...

Страница 15: ...ion keys to scroll through the menus or set values Press the right navigation key to accept a menu choice or go to the next step Press the left navigation key to cancel an operation or go back to the...

Страница 16: ...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 blocked or damag...

Страница 17: ...it the replacement part and make sure that it is screwed home firmly but do not over tighten Do not use any tools to tighten the contralateral probe tip 4 7 START UP AND MENU DISPLAYS When the Otowave...

Страница 18: ...size of 5dB between the three preceding lower levels of stimulus 5 1 PRIOR TO TESTING AND AMBIENT CONDITIONS A suitably qualified health care professional should perform a thorough otoscopic examinat...

Страница 19: ...TEST Having selected the required test settings a typical tympanogram measurement and reflex tests are carried out as follows From the MAIN MENU select NEW TEST MAIN MENU NEW TEST CONFIGURATION VIEW T...

Страница 20: ...st is only performed if a peak is found in the tympanogram This and other reflex test options may be changed in the CONFIGURATION menu see Sections 6 and 5 7 Before starting the reflex test the ear ca...

Страница 21: ...nce in daPa The Gradient in daPa Gr The Ear Canal Volume ECV in ml measured at 200 daPa A plot of admittance against pressure Normative box based on BSA recommendations Pass Refer x sign when tymp pea...

Страница 22: ...f the levels and frequencies at which a reflex was detected The dash symbol is shown if a reflex tone was not presented at the level indicated REFLEX SUMMARY dB IPSILATERAL 100 X 90 X 80 X 70 X X X Hz...

Страница 23: ...ve VIEW TEST Return to the main menu MAIN MENU See Sections 6 to 9 for more information on these options The results of the last test performed remain available even if the Otowave has been turned off...

Страница 24: ...to generate the extremes of pressure during a tympanogram measurement with this setting If difficulty is experienced in using the ear tips to create a seal the alternative EXTENDED option may be helpf...

Страница 25: ...or mode This is based on the definition given in Clause 3 17 2 of IEC 60645 5 and takes account of phase information in the measurements It is also known as B G compensation and is suitable for all pa...

Страница 26: ...odes is carried out using the function button on the probe see Section 4 4 A short press of the button will switch between the baseline offset values of 200daPa and 400daPa for Scalar and Vector H mod...

Страница 27: ...y one level will be tested in the measurement The maximum level of ipsilateral stimulus may be set to maximum 100dBHL the maximum level of contralateral stimulus may be set to 110dBHL MULTILEVEL Use t...

Страница 28: ...not available No Polarity Define the polarity of the reflex graphs if the reflex is plotted upwards UP or downwards DOWN Up Filter Use the keys to choose either 2Hz or 1 5Hz The default of 2Hz is sui...

Страница 29: ...artment Allows the Department name to be entered The name will appear at the top of the print out Defaults Reset the instrument and all profiles to the original settings Language Change the operation...

Страница 30: ...test to refer to stored records this same identifier may be used for different tests for the same patient 7 1 DATA ENTRY PATIENT INITIALS _ _ _ ABCDEFGHIJKLM NOPQRSTUVWXYZ 01233456789 Hold to enter ca...

Страница 31: ...erring the data to a computer for permanent storage The Otowave sends data to the printer through a small window on the right of the base unit The data is received through a window in the front of the...

Страница 32: ...k must not be broken once a connection has been established If the printer or Otowave are moved or an object between them breaks the link the printed results may be corrupted or the Otowave may not re...

Страница 33: ...ed annotated printed This software is supplied on a CD which includes this operating manual Refer to the installation operating instructions provided with the NOAH Impedance Module or ampliSuite for f...

Страница 34: ...ons operate on groups of records 10 1 LIST RECORDS LIST RECORDS shows the stored tests 6 at a time most recent first Records Stored 6 18 ABC 02 06 17 14 15 2 DEF 31 05 17 09 43 L 1SF 20 05 17 11 54 R...

Страница 35: ...letion is required 10 3 PRINT RECORDS PRINT RECORDS allows a group of records to be sent to the printer It is possible to print all stored records or just those records that have not already been prin...

Страница 36: ...the hole at the 2ml end of the test cavity Make sure that the probe is pushed fully home and is held tight against the stop The probe must be square to the end of the test cavity The display should s...

Страница 37: ...INFORMATION 1 Variant Instrument version Dual Tone High Frequency option enabled 2 Battery Voltage information 3 Last Cal Last calibration date 4 Next Cal Next calibration date 5 Serial No Serial numb...

Страница 38: ...o dry before cleaning 13 2 EARTIPS AND PROBE Ear tips should be replaced after a single use This applies to ear tips used with the main probe assembly and the contralateral transducer The probe tip an...

Страница 39: ...service repair There are no user serviceable parts within it When packing the instrument for shipping please use the original shipping carton and packing materials Place the instrument parts in plast...

Страница 40: ...place the probe tip Reposition the probe Change the ear tip No reflex test is conducted after the tympanometry even though the reflex test is active in the REFLEX SEQUENCE In REFLEX SELECTION the sett...

Страница 41: ...e unit If problem persists contact your Amplivox service center AIRFLOW ERROR RESTART THE UNIT Indicator LED c steady light Fault with air system and or pump Restart the unit If problem persists conta...

Страница 42: ...the appropriate software NOAH Interface or ampliSuite has been installed and the Otowave 202 has the main menu displayed The message Awaiting PC OK to disconnect is displayed if the connection is succ...

Страница 43: ...levels and accuracy referenced to 2ml calibration volume compensates for measured ear volume Ipsilateral configurable over range 500Hz 1kHz 2kHz 4kHz 2 70dBHL to100dBHL 3dB 2kHz level is restricted t...

Страница 44: ...mps Time and date stamp applied to all recordings and to the last calibration date Backup power supply 30 days without main batteries fitted Languages Operating Languages English German French Spanish...

Страница 45: ...f protection against ingress of water Not protected Mode of operation Continuous operation Equipment mobility Portable The Otowave 202 Tympanometer is classified as a Class IIa device under Annex IX S...

Страница 46: ...Ear tip Otowave 13mm T214 Ear tip Otowave 14mm T215 Ear tip Otowave 15mm T219 Ear tip Otowave 19mm T007 Otowave probe assembly with interconnections T040 Contralateral reflex transducer probe tip earp...

Страница 47: ...ation of waste electrical items from the general waste stream and into reuse recovery and recycling routes Therefore for any waste electrical units purchased from Amplivox that either bear the crossed...

Страница 48: ...domestic purposes Harmonic emissions 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...

Страница 49: ...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 202 Tympanometer...

Страница 50: ...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...

Страница 51: ...ave 202 Tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Otowave 202 Tympanometer can help prevent el...

Страница 52: ...puts and outputs on the Otowave 202 tympanometer are electrically isolated to the requirements of IEC 60601 1 Socket Label Socket Type Typical Connection USB Connector Type B Computer These measures a...

Страница 53: ...ON MEDICAL ELECTRICAL EQUIPMENT 48 D 0115692 C OM031 Otowave 202 Operating Manual Diagram 1 Otowave 202 used with the medically approved mains adapter Mains Outlet Medical Mains Adapter Otowave 202 Ty...

Страница 54: ...MEDICAL ELECTRICAL EQUIPMENT 49 D 0115692 C OM031 Otowave 202 Operating Manual Diagram 2 Otowave 202 used with the supplied printer Mains Outlet Printer via IrDA Link Printer Power Supply Otowave 202...

Страница 55: ...ve 202 Operating Manual Diagram 3 Otowave 202 used with the medically approved mains adapter and a computer Mains Outlet Medical Mains Adapter Otowave 202 Tympanometer Mains Outlet Computer Power Supp...

Страница 56: ...both behave quite like a simple stiffness and use of the term compliance is appropriate to an approximation However at higher frequencies such as 1000Hz this simplification breaks down as described be...

Страница 57: ...ressure can be defined with greater certainty An additional feature of the Otowave 202 not found on other screening tympanometers is that the user can decide whether to use 200daPa or 400daPa as the r...

Страница 58: ...alar subtraction _ is adequate Contrast this with Figure 2 where the phase angles are very different and a scalar subtraction would erroneously give a value close to zero instead of the length of the...

Страница 59: ...N 54 D 0115692 C OM031 Otowave 202 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...

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