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Related Manuals for AmpliVox Otowave 102-C
Summary of Contents for AmpliVox Otowave 102-C
- Page 1 Otowave 102-C Operating Manual...
- Page 2 ABOUT THIS MANUAL READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT. This manual is valid for the Otowave 102-C (applies from firmware version 1.0.0.084600 onwards – see System Information screen). This product is manufactured by: Amplivox Ltd. 3800 Parkside, Solihull Parkway,...
- Page 3 If supplied in the US, please note: Caution: Federal Law restricts this device to sale by or on the order of a licenced medical professional.
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Page 4: Table Of Contents
Database full ................................19 Communication ..............................20 Transferring the Results ............................21 9.1. Sending the results to a printer ..........................21 9.2. Data transfer to NOAH or ampliSuite ......................... 21 Data Management .............................. 22 D-0014930xxxxxxx-A – Otowave 102-C Operating Manual... - Page 5 Technical Specification ............................29 15.1. Performance ................................29 15.2. Equipment classification ............................. 30 15.3. Symbols..................................31 Disposal Information ............................32 EMC Guidance & Manufacturer’s Declaration ..................... 33 Use with Non-medical Electrical Equipment ......................37 D-0014930–A - Otowave 102-C Operating Manual...
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Page 6: Introduction
INTRODUCTION 1. INTRODUCTION 1.1. THANK YOU Thank you for purchasing an Amplivox Otowave 102-C, a hand-held, portable tympanometer that will give many years of reliable service if treated with care. 1.2. INTENDED APPLICATIONS The Otowave 102-C is designed for use by audiologists, general practitioners, hearing aid dispensers and child health professionals. -
Page 7: Guarantee
Amplivox service department. Return carriage is free of charge for customers in the UK and chargeable for overseas customers. -
Page 8: Important Safety Instructions
As with all instruments of this nature, the measurements taken will be influenced by significant changes in altitude & pressure. The Otowave 102-C tympanometer must be re-calibrated at the intended operating elevation if it is to be used at elevations greater than 1000m above mean sea level. -
Page 9: Principles Of Operation
3.2. PRINCIPALS OF ADMITTANCE MEASUREMENT The Otowave 102-C measures the admittance of the tympanic membrane and middle ear by playing a continuous tone into the ear canal at 226 Hz. The level of this tone is calibrated to give 85 dB SPL (226 Hz) into a 2 ml cavity. - Page 10 The stapedial reflex is measured at the static ear canal pressure that produces the maximum membrane admittance, so reflex measurements are taken after the tympanogram is measured when the peak admittance pressure has been established. The reflex stimulus is produced in the ear being measured. D-0014930-A – Otowave 102-C Operating Manual...
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Page 11: Using The Otowave
CONFIGURATION menu. 4.3. THE CRADLE 4.3.1. GENERAL The Otowave 102-C is powered by a rechargeable Nickel-Metal Hydride (NiMH) battery-pack which is fitted in the instrument. If the instrument is placed onto its cradle the battery will trickle chage. 4.3.2. CONNECTORS The mains adapter is supplied as part of the equipment. -
Page 12: Indicators
Amplivox or an Amplivox distributor. These WARNING parts have been tested for use with the Otowave 102-C 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 13: Controls And Indicators Handheld Unit
The function of the left and right keys is usually shown on the bottom line of the display. When not performing a test the Otowave 102-C will switch off automatically after 90 or 180 seconds if no key is pressed (see Section 6 to make this selection). -
Page 14: The Probe
After replacing the tip a Daily Check should be carried out (see Section 11). 4.6. START-UP AND MENU DISPLAYS When the Otowave 102-C is turned on the start-up screen is shown while internal tests are performed and the pump is initialised. When the start-up sequence is complete the MAIN MENU is displayed:... -
Page 15: Initial Settings
Use the CONFIGURATION options (see Section 6) to select the following options as required: • display contrast for ease of viewing • correct local date and time • date format (DD/MM/YY or MM/DD/YY) • power-off delay (90 or 180 seconds) D-0014930-A – Otowave 102-C Operating Manual... -
Page 16: Taking Measurements
Tympanometric and reflex testing should always be performed in a quiet room. 5.2. EAR TIP(S) Amplivox YouTube video is available for assistance on how to choose the right ear tip. These must be selected and fitted by a practitioner qualified to perform tympanometric tests. - Page 17 When the measurement is complete the indicator on the instrument changes from flashing green to steady green. The display confirms that the test has been completed along with the instruction WITHDRAW PROBE. Remove the probe from the patient and after a short period the tympanogram will be displayed. D-0014930-A – Otowave 102-C Operating Manual...
- Page 18 If the Otowave 102-C was set to test for a reflex at all levels of the stimulus press ► to view an additional display following the reflex graphs. This shows a summary of the levels and frequencies at which a reflex was detected.
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Page 19: Ear Seal Check
However, if difficulty is experienced in using the ear tips to create a seal the alternative EXTENDED option may be helpful. This checks that a range of pressures will be available before starting a test by means of a visual indication of the quality of the seal: D-0014930-A – Otowave 102-C Operating Manual... -
Page 20: Error Messages
The ear canal volume is below 0.1ml. Check that the WITHDRAW PROBE probe is not blocked and correctly inserted into the ear. INSERT PROBE Yellow Flashing The seal was lost. Reinsert the probe to repeat the test. D-0014930-A – Otowave 102-C Operating Manual... -
Page 21: Configuration
The EXTENDED function is especially helpful for small ear canal volumes which should not experience excessive pressure. Reload Reset the sweep settings to its original settings. Defaults: 6.2. REFLEX OPTIONS Amplivox YouTube Video available on how to add ipsilateral reflexes to test protocol. ITEM DESCRIPTION DEFAULT Level Mode: Multilevel Please note: Depending on the LEVEL MODE selection, the LEVELS screen will contain different content. -
Page 22: System Settings
By default the reflex test at each frequency will stop at the lowest level of stimulus that produces a response. By setting REFLEX AUTO-STOP to NO the Otowave 102-C will test for a reflex at all selected levels. (Note that 100dBHL at 4000Hz is not available). - Page 23 Allows the department name to be entered. The name will appear at the top of the print-out. Defaults: Reset the system settings to the original settings. Language: Change the operation language to English, German, French, English Spanish, Portuguese or Italian. D-0014930-A – Otowave 102-C Operating Manual...
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Page 24: Saving Results In The Internal Database
SAVING RESULTS IN THE INTERNAL DATABASE 7. SAVING RESULTS IN THE INTERNAL DATABASE Up to 32 tests can be saved in the Otowave 102-C internal database. To save the results of a test select SAVE RESULTS from the PROCESS RESULTS menu that is displayed on completion of a test. -
Page 25: Communication
COMMUNICATION 8. COMMUNICATION The Otowave 102-C can send test results to a dedicated thermal printer or a suitably-equipped computer via a USB link. When printing directly to the printer, the data is received through a cable connected between the cradle and the printer. -
Page 26: Transferring The Results
To transfer test results stored within the tympanometer to a NOAH database the Amplivox NOAH Impedance module must be installed on to a computer. Alternatively, Amplivox ampliSuite allows data to be transferred to a computer and subsequently viewed, annotated & printed. This software is supplied on a USB stick which includes this operating manual. -
Page 27: Data Management
DATA MANAGEMENT 10. DATA MANAGEMENT Records stored in the database of the Otowave 102-C can be listed, viewed, deleted, printed or sent to a computer using the DATA MANAGEMENT option of the main menu: DATA MANAGEMENT LIST RECORDS DELETE RECORDS PRINT RECORDS ... -
Page 28: Delete 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 printed. If printing the entire database it is recommended that a full roll of paper is loaded into the printer. D-0014930-A – Otowave 102-C Operating Manual... -
Page 29: Performing Daily Checks
PERFORMING DAILY CHECKS 11. PERFORMING DAILY CHECKS The operation of the Otowave 102-C should be checked daily using the 4 in 1 test cavity supplied with the instrument. Select the DAILY CHECK option in the main menu: DAILY CHECK INSERT PROBE Cancel Wait until “Open”... -
Page 30: System Information
12. SYSTEM INFORMATION Battery: Remaining battery capacity Last Cal: Last calibration date Next Cal: Next calibration date Serial No: Serial number of Otowave Ver.: Firmware version Date and Time: User defined date and time D-0014930-A – Otowave 102-C Operating Manual... -
Page 31: Routine Maintenance
13.3. CALIBRATION AND REPAIR OF THE INSTRUMENT Amplivox recommends that the Otowave 102-C is calibrated annually. Please contact Amplivox for details. If the instrument is to be used at elevations above that specified re-calibration must be undertaken at the intended operating elevation. -
Page 32: Error Messages & Fault Conditions
If the problem persists, check is set to EXTENDED • fast. contact your Amplivox service Pump failed to achieve the centre. starting pressure within 4 s. • Pressure failed to reach -400 daPa within 12 s. D-0014930-A – Otowave 102-C Operating Manual... - Page 33 Cable between printer and Restart the printer • cradle not connected. Charge printer • Connect the cable If difficulties resolving fault conditions occur the equipment distributor (or Amplivox if purchased directly) should be consulted. D-0014930-A – Otowave 102-C Operating Manual...
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Page 34: Technical Specification
Records listed in reverse chronological order (latest first), with indication of data stored as described above Real Time Clock Time stamps Time and date stamp applied to all recordings, and to the last calibration date D-0014930-A – Otowave 102-C Operating Manual... -
Page 35: Equipment Classification
Degree of protection against ingress of water Not protected Mode of operation Continuous operation Equipment mobility Portable The Otowave 102-C Tympanometer is classified as a Class IIa device under Annex IX of the EU Medical Devices Directive. D-0014930-A – Otowave 102-C Operating Manual... -
Page 36: Symbols
Type B applied part, particularly regarding allowable patient leakage current and patient auxiliary current. The applied part is the ear tip. Definition: Date of Manufacture Definition: Manufacturer D-0014930-A – Otowave 102-C Operating Manual... -
Page 37: Disposal Information
DISPOSAL INFORMATION 16. DISPOSAL INFORMATION Amplivox Limited is fully compliant with the WEEE (Waste Electrical and Electronic Equipment) Regulations. Our PRN (Producer Registration Number) is WEE/GA0116XU and we are registered with the approved WEEE Compliance Scheme, B2B Compliance, approval number WEE/MP3338PT/SCH. -
Page 38: Emc Guidance & Manufacturer's Declaration
Guidance and manufacturer’s declaration – electromagnetic emissions The Otowave 102-C Tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 102-C tympanometer should assure that it is used in such an environment. - Page 39 IEC 61000-4-8 location in a typical commercial or hospital environment. NOTE U is the a.c. mains voltage prior to the application of the test level D-0014930-A – Otowave 102-C Operating Manual...
- Page 40 Guidance and manufacturer’s declaration – electromagnetic immunity (2) The Otowave 102-C tympanometer is intended for use in the electromagnetic environment specified below. The customer or user of the Otowave 102-C tympanometer should assure that it is used in such an environment.
- Page 41 The Otowave 102-C tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Otowave 102-C tympanometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Otowave 102-C tympanometer as recommended below, according to the maximum output power of the communications equipment.
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Page 42: Use With Non-Medical Electrical Equipment
Refer to Diagrams 1 & 2 below for typical configurations of connected peripheral equipment. Refer to Amplivox Limited at the address given on the front of this user manual if advice is required regarding the use of peripheral equipment. - Page 43 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 1: Otowave 102-C used with the designated printer Mains Outlet Printer via USB Cradle Connection Printer Power Supply Otowave 102-C Tympanometer D-0014930-A – Otowave 102-C Operating Manual...
- Page 44 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Diagram 2: Otowave 102-C used with a computer & USB connection Mains Outlet Computer via USB Cradle Connection Computer Power Supply Otowave 102-C Tympanometer D-0014930-A – Otowave 102-C Operating Manual...
- Page 45 USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT Copyright © 2020 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-0014930-A – Otowave 102-C Operating Manual...
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