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Summary of Contents for AmpliVox Otowave 302
- Page 1 Otowave 302 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 Otowave 302. This product is manufactured by: Amplivox Ltd. Amplivox Ltd. 6 Oasis Park, Eynsham 10393 West 70 Street Oxfordshire, OX29 4TP... -
Page 3: Table Of Contents
..........................16 COUSTIC REFLEX MEASUREMENT USING THE OTOWAVE ............................17 4.1............................17 ENERAL PRECAUTIONS 4.2......................... 18 WITCHING THE INSTRUMENT ON AND OFF 4.3............................18 IGH FREQUENCY OPTION 4.4..............................18 ISPLAYS D-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 4 ..............................44 YMPANOMETRY 7.4............................44 COUSTIC REFLEX TESTING EMC GUIDANCE & MANUFACTURER’S DECLARATION ..................46 SAFETY PRECAUTIONS TO TAKE WHEN CONNECTING OTOWAVE 302 ...............51 APPENDIX A – 1000 HZ TYPANOMETRY & MEATUS COMPENSATION ............53 10.1..........................53 YMPANOMETRIC PROPERTIES 10.2.
- Page 5 HZ TYMPANOMETRY Y COMPEN ATION ONLY 11.3. 1000 ............................. 58 HZ TYMPANOMETRY 11.3.1. scalar Mode – y-compensation ....................... 58 11.3.2. Vector Mode – b-g-compensation ......................58 11.3.3. Component Mode – YBG ......................... 58 D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 6: Introduction
Thank you for purchasing an Amplivox Otowave 302, a desktop controlled impedance meter that will give many years of reliable service if treated with care. This operating manual applies to the Otowave 302 which is available as a standard option (with 226Hz probe tone) and as an H-option (1000Hz probe tone in addition). -
Page 7: Standard And Optional Components
1.4. STANDARD AND OPTIONAL COMPONENTS 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.ltd.uk). The required fitting instructions are supplied with each part. -
Page 8: Warnings
The WARNING label identifies conditions or practices that may present danger WARNING to the patient and/or user. The CAUTION label identifies conditions or practices that could result in damage CAUTION to the equipment. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
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
As with all instruments of this nature the measurements taken will be influenced by significant changes in altitude & pressure. The Otowave 302 tympanometer must be re-calibrated if it is to be used at elevations greater than 800 m above mean sea level. -
Page 12: Electrical And Electrostatic Safety
Do NOT use the Otowave 302 in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 13: Measuring Security
UNPACKING AND INSTALLATION 2.3.7. MEASURING SECURITY To guarantee that the Otowave 302 works properly, the instrument should be checked and calibrated at least once a year. The transducers supplied with the tympanometer are specifically calibrated with it; if these transducers are changed recalibration will be required. -
Page 14: Connections
Please note: Only connect the accessories supplied with the instrument or supplied by Amplivox or an Amplivox distributor. These parts have been tested for use with the Amplivox Otowave 302 tympanometer for compliance with the standards IEC 60601-1 and IEC 60601-1-2. The use of accessories other than those specified may compromise compliance with these standards. -
Page 15: Controls And Indicators (Base Unit)
The function of the left and right keys is usually shown on the bottom line of the display. Display Mode Quick view of the test settings currently used or change of baselinemode. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 16: Controls And Indicators (Probe)
Do not use any tools to tighten the nose cone. After replacing the tip a Daily Check should be carried out (refer to chapter 4.6). Video available on how to clean the probe tip. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 17: Light Indicators
The probe tip must be fitted with a new ear tip before it is presented to a patient’s ear canal. If a contralateral reflex stimulus is to be applied, fit a new ear tip to the contralateral transducer before presenting it to the patient’s opposite ear canal. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 18: Hardware Installation
DATE AND TIME The Otowave is equipped with a real-time clock. Before use, please set the date & time to local values in order to ensure that test data and calibration status are correctly identified. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 19: The Mpt-Ii Printer
INSTALLING THE MPT-II PRINTER The Sanibel MPT-II thermal printer is available as an option for use with the Otowave 302 and is connected using the cable supplied. The printer may be specified when ordering and only this printer should be used. It will be correctly configured for use. -
Page 20: Principles Of Operation
3.2. PRINCIPALS OF ADMITTANCE MEASUREMENT The Otowave 302 measures the admittance of the tympanic membrane and middle ear by playing a continuous tone into the ear canal at either 226 Hz or 1000 Hz. 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. -
Page 21: Acoustic Reflex Measurement
The reflex stimulus may be produced in the ear being measured (ipsilateral mode), the opposite ear (contralateral mode) or in both ears (ipsilateral mode followed by contralateral mode). For contralateral stimulation the reflex tone is produced in a separate transducer supplied with the instrument. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 22: Using The Otowave
2. Do not drop and avoid other undue impact to this device. If the instrument is dropped or in any other way damaged, return it to the manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 23: Switching The Instrument On And Off
If the instrument is configured for high frequency operation can be verified when switching the instrumentation on. On the boot-up screen the Amplivox logo will show and below the product name with an ‘H’ in addition, to symbolize that the high frequency test option is enabled. -
Page 24: Configuration
226 Hz tone frequency may be set to 226Hz or 1000Hz. Baseline Mode: The Otowave 302 can display tympanograms in a variety of graphical 226 Hz formats allowing the operator to choose the most appropriate for the patient under examination. Please refer to the appendix for further... -
Page 25: Reflex Settings
By setting Reflex Auto-Stop to NO the Otowave will test for a reflex at all selected levels. Filter: Choose either 2Hz or 1.5Hz. 2 Hz 2Hz is suitable for most circumstances. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 26: System Settings
The selection will now be stored. To cancel the entry, move the selection on the #-key and ◄ hold the key. You will be brought back to the SYSTEM SETTINGS. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 27: Daily Check
Selected frequencies for reflex testing (marked with a when selected), max. Frequencies and Level: level to test and step size. Probe #: Serial number of probe used. Contra #: Serial number of contra phone calibrated to equipment. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 28: System Information
Instrument version (Dual Tone = High Frequency option enabled) Ver.: Firmware version Last Cal: Last calibration date Next Cal: Next calibration date Serial No: Serial number of Otowave Date and Time: User defined date and time D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 29: Performing A Test
In some cases no pressure can be build up and the test sequence will stay in the EQUALIZE PRESSURE SCREEN. This situation can occur for the several reasons. Solution to this issue can be found in the TROUBLESHOOTING SECTION. D-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 30 Please note: If BOTH EARS had been selected to be tested, the test sequence of the other ear will be continued from the test review screen. Selecting the right navigation ► will start the test procedure on the other ear. D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 31: Understanding The Tympanometry Test Result
(Y) or susceptance (B) or conductance (G) view. The view is changed with either the Display Mode (base unit) or the Function button (probe). Please refer to the Appendix to read more about the Baseline Mode. The test frequency [Hz] D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 32: Performing Tympanometry And Acoustic Reflex Testing
After the test has been successfully performed, three different actions can be taken from here in order to ► proceed working with the data obtained. Selecting the right navigation key will bring you to PROCESS RESULTS screen from where the data can be printed, stored or reviewed again. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 33: Understanding The Acoustic Reflex Test Result
Selecting the navigation key will show the PROCESS RESULTS screen, from where the measurement outcomes can be processed. ► If contralateral reflex measurements were taken pressing the key will display similar results for these reflexes. D-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 34 Single frequency used: Diagrams contain the different levels tested for the specific frequency. Several frequencies used: each diagram represents 1 frequency, showing only the intensity where a reflex was detected. “” if a reflex was found, otherwise “X” D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 35: Immediate Process Of Results
GENERAL After a test has been finished, the data can either be printer and/or stored to the internal database of the instrument or the NOAH or the Amplivox ampliSuite. ► From the test result screen select the right navigation key until the PROCESS RESULTS screen is reached. - Page 36 . The save record option is now removed. RESULTS screen ◄ To cancel the entry, delete all three characters and hold the key. You will be brought back to the PROCESS RESULTS screen. D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 37: (Re)View The Last Test(S)
4.11. (RE)VIEW THE LAST TEST(S) The Otowave 302 offers a short-term memory that allows you to store a test per ear until a new test has been conducted. The symbols or X are used to signify whether results are available for each ear. -
Page 38: Data Management
(2) ears When a record is selected the PROCESS RECORD menu will be displayed. This accesses the following functions: View the selected record Print the selected record Delete a record D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 39: Delete Records
4.12.3. DELETE RECORDS DELETE RECORDS allows a group of records to be deleted. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 40: Print Records
4.12.5. DATA TRANSFER TO NOAH OR AMPLISUITE The Otowave 302 is supplied with software to allow 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, the Amplivox NOAH Impedance module must be installed on to a computer. -
Page 41: Database Full
OVERWRITE OLDEST will overwrite the oldest record in memory with the results being stored. BACK will return to the previous menu. D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 42: Troubleshooting
Probe is blocked Check that the probe is not Indicator LED c steady light. inserted into a test cavity at Probe placed incorrectly start-up. Please ensure the probe is not blocked or obstructed. D-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 43 and base unit cannot be Ensure connection established. between printer and base unit is established. If difficulties resolving fault conditions occur the equipment distributor (or Amplivox if purchased directly) should be consulted. D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 44: Routine Maintenance
Rubber ear-tips or foam ear-tips are single use components Recommended cleaning and disinfection solutions: Warm water with mild, nonabrasive cleaning solution (soap) 70% isopropyl alcohol only on hard cover surfaces D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 45: Cleaning The Otowave
These should be discarded after use. They cannot be disinfected. In the event of re-use of the single-use disposables, you enhance the risk of CAUTION cross contamination! D-0115696-C (OM038) – Otowave 302 Operating Manual... -
Page 46: Accessories/Replacement Parts
OX29 4TP customerservice@amplivox.ltd.uk 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 to prevent dirt and dust getting into the probe. -
Page 47: Warranty Card (Uk Customers Only)
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 48: Technical Specifications
7. TECHNICAL SPECIFICATIONS 7.1. STANDARD AND REGULATORY Medical CE mark The CE mark indicates that Amplivox Ltd. Meets the requirements of Annex II of the Medical Device Directive. Class The Otowave 302 Tympanometer is classified as a Class IIa device under Annex IX (Section 1) of the EU Medical Devices Directive. -
Page 49: Tympanometry
500Hz, 1kHz, 2kHz & 4kHz (±2%) Level: Configurable over range: 500Hz, 1kHz, 2kHz & 4kHz (+/-2%) 70dBHL to110dBHL (+/-3dB) (1kHz level is restricted to minimum 75dBHL for ear canal volumes less than ~0.2ml) D-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 50 Reflex stimulus control Stimulus presented at all levels, or Stimulus ceases when a reflex is found Reflex detection 0.01ml to 0.5ml ±0.01ml (configurable in 0.01ml steps) threshold and accuracy Reflex tone duration 0.6 seconds D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 51: Emc Guidance & Manufacturer's Declaration
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-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 52 Guidance and manufacturer’s declaration – electromagnetic emissions The Otowave 302 Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 302 Tympanometer should assure that it is used in such an environment.
- Page 53 Power frequency magnetic fields should be at levels (50/60 characteristic of a typical location in a typical magnetic field commercial or hospital environment. IEC 61000-4-8 NOTE U is the a.c. mains voltage prior to the application of the test level. D-0115696-C (OM038) – Otowave 302 Operating Manual...
- Page 54 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Otowave 302 Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 302 Tympanometer should assure that it is used in such an environment.
- Page 55 The Otowave 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 electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Otowave 302 Tympanometer as recommended below, according to the maximum output power of the communications equipment.
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Page 56: Safety Precautions To Take When Connecting Otowave 302
Please note that if connections are made to standard equipment 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-approved mains adapter Mains Outlet... - Page 57 SAFETY PRECAUTIONS TO TAKE WHEN CONNECTING OTOWAVE 302 Diagram 3: Otowave 302 used with the medically-approved mains adapter and a computer Mains Outlet Medical Mains Adapter Otowave 302 Computer via USB Mains Outlet Computer Power Supply socket D-0115696-C (OM038) – Otowave 302 Operating Manual...
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Page 58: Appendix A - 1000 Hz Typanometry & Meatus Compensation
��_���� = ��_�������� − ��_���� D-0115696-C (OM038) – Otowave 302 Operating Manual... - Page 59 ��_�������� − ��_���� The baseline value (Y ) is the measured admittance of the ear when at maximum pressure (normally +200daPa for the Otowave 302). This approximates Y because the applied pressure reduces Y towards 0 (but not all the way to 0, otherwise it would not be possible to hear the probe tone at all; nonetheless the approximation is sufficient for clinical purposes).
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Page 60: Calar Vs Vector Baseline
Although vector subtraction is the only correct solution at 1 kHz, it may be unfamiliar to users and therefore the Otowave 302 offers the option of selecting either scalar or vector baseline compensation for 1 kHz tympanograms. Use of scalar baseline compensation will give results similar to those from some other instruments and be comparable with publications that have used scalar baseline compensation. -
Page 61: Reference Point For Baseline Value
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 or + 200 daPa as the reference point for the baseline value. -
Page 62: Appendix B -Baseline Mode
11. APPENDIX B –BASELINE MODE 11.1. GENERAL The Otowave 302 can display tympanograms in a variety of graphical formats allowing the operator to choose the most appropriate for the patient under examination. This is achieved by altering the DISPLAY MODE and the meatus compensation (or BASELINE OFFSET). -
Page 63: 1000 Hz Tympanometry
COMPONENT MODE – YBG The Otowave 302 also provides a component display when using a 1 kHz probe tone where separate uncompensated Y, B and G traces can be shown. These may help to interpret the tympanograms and help to define the middle-ear pressure in cases where the Y display alone gives misleading or ambiguous conclusions. - Page 64 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 permission of Amplivox Ltd. D-0115696-C (OM038) – Otowave 302 Operating Manual...
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