AmpliVox Otowave 302 User manual

Otowave 302
Operating Manual

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D-0115696-C (OM038) –Otowave 302 Operating 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.
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.us
For all enquiries please contact us under:
Tel: [phone]
Fax: [phone]
[email protected]k
Tel: [phone]
Fax: [phone]
[email protected]

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D-0115696-C (OM038) –Otowave 302 Operating Manual
TABLE OF CONTENTS
1. INTRODUCTION.................................................................................................................................................. 1
1.1. THANK YOU........................................................................................................................................................... 1
1.2. INTENDED APPLICATIONS ......................................................................................................................................... 1
1.3. CONTRADICTIONS................................................................................................................................................... 1
1.4. STANDARD AND OPTIONAL COMPONENTS.................................................................................................................... 2
1.5. WARNINGS ........................................................................................................................................................... 3
2. UNPACKING AND INSTALLATION........................................................................................................................ 4
2.1. GENERAL .............................................................................................................................................................. 4
2.2. MARKINGS............................................................................................................................................................ 4
2.3. SAFETY INSTRUCTIONS............................................................................................................................................. 5
2.3.1. General ..................................................................................................................................................... 5
2.3.2. Cautions –General ................................................................................................................................... 5
2.3.3. Environmental factors .............................................................................................................................. 6
2.3.4. Electrical and electrostatic safety............................................................................................................. 7
2.3.5. Electromagnetic compatibility (EMC) ....................................................................................................... 7
2.3.6. Explosion hazards ..................................................................................................................................... 7
2.3.7. Measuring Security ................................................................................................................................... 8
2.3.8. Miscellaneous ........................................................................................................................................... 8
2.3.9. Use of equipment after transport and storage......................................................................................... 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 CORRECT EAR TIPSIZE ...................................................................................................................... 12
2.10. HARDWARE INSTALLATION ..................................................................................................................................... 13
2.11. INITIAL SETTINGS .................................................................................................................................................. 13
2.11.1. Operating language................................................................................................................................ 13
2.11.2. Date and time ......................................................................................................................................... 13
2.12. THE MPT-II PRINTER .............................................................................................................................................. 14
2.12.1. Installing the mpt-ii printer..................................................................................................................... 14
2.12.2. switching the printer on and off ............................................................................................................. 14
2.12.3. Using the printer..................................................................................................................................... 14
3. PRINCIPLES OF OPERATION ...............................................................................................................................15
3.1. OTOSCOPIC EXAMINATION ..................................................................................................................................... 15
3.2. PRINCIPALS OF ADMITTANCE MEASUREMENT............................................................................................................. 15
3.3. TYMPANOGRAM .................................................................................................................................................. 15
3.4. ACOUSTIC REFLEX MEASUREMENT............................................................................................................................ 16
4. USING THE OTOWAVE .......................................................................................................................................17
4.1. GENERAL PRECAUTIONS......................................................................................................................................... 17
4.2. SWITCHING THE INSTRUMENT ON AND OFF................................................................................................................ 18
4.3. HIGH FREQUENCY OPTION...................................................................................................................................... 18
4.4. MENU DISPLAYS .................................................................................................................................................. 18

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D-0115696-C (OM038) –Otowave 302 Operating Manual
4.5. CONFIGURATION.................................................................................................................................................. 19
4.5.1. Sweep Settings........................................................................................................................................ 19
4.5.2. Reflex Settings ........................................................................................................................................ 20
4.5.3. System Settings....................................................................................................................................... 21
4.6. DAILY CHECK....................................................................................................................................................... 22
4.7. DISPLAY MODE.................................................................................................................................................... 22
4.8. SYSTEM INFORMATION.......................................................................................................................................... 23
4.9. PERFORMING A TEST ............................................................................................................................................. 24
4.9.1. Selecting the ear side.............................................................................................................................. 24
4.9.2. Performing tympanometry ..................................................................................................................... 24
4.9.3. Understanding the tympanometry test result ........................................................................................ 26
4.9.4. Performing tympanometry and acoustic reflex testing .......................................................................... 27
4.9.5. Understanding the acoustic reflex test result......................................................................................... 28
4.10. IMMEDIATE PROCESS OF RESULTS ........................................................................................................................ 30
4.10.1. General ................................................................................................................................................... 30
4.10.2. Sending Results to a Printer.................................................................................................................... 30
4.10.3. Saving Results to the Internal Database................................................................................................. 30
4.11. (RE)VIEW THE LAST TEST(S)................................................................................................................................... 32
4.12. DATA MANAGEMENT............................................................................................................................................ 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. TROUBLESHOOTING ..........................................................................................................................................37
6. ROUTINE MAINTENANCE...................................................................................................................................39
6.1. GENERAL MAINTENANCE PROCEDURES .................................................................................................................... 39
6.2. CLEANING THE OTOWAVE ...................................................................................................................................... 40
6.3. CLEANING THE PROBE ........................................................................................................................................... 40
6.4. DISPOSABLES....................................................................................................................................................... 40
6.5. ACCESSORIES/REPLACEMENT PARTS ......................................................................................................................... 41
6.6. REPAIR............................................................................................................................................................... 41
6.7. WARRANTY......................................................................................................................................................... 41
6.8. WARRANTY CARD (UK CUSTOMERS ONLY)................................................................................................................ 42
6.9. CALIBRATION AND RETURN OF THE INSTRUMENT........................................................................................................ 42
7. TECHNICAL SPECIFICATIONS..............................................................................................................................43
7.1. STANDARD AND REGULATORY ................................................................................................................................. 43
7.2. GENERAL ............................................................................................................................................................ 43
7.3. TYMPANOMETRY.................................................................................................................................................. 44
7.4. ACOUSTIC REFLEX TESTING ..................................................................................................................................... 44
8. EMC GUIDANCE & MANUFACTURER’S DECLARATION .......................................................................................46
9. SAFETY PRECAUTIONS TO TAKE WHEN CONNECTING OTOWAVE 302 ...............................................................51
10. APPENDIX A –1000 HZ TYPANOMETRY & MEATUS COMPENSATION............................................................53
10.1. TYMPANOMETRIC PROPERTIES ................................................................................................................................ 53
10.2. TYMPANOMETRIC MEASUREMENTS ......................................................................................................................... 53

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D-0115696-C (OM038) –Otowave 302 Operating Manual
10.3. SCALAR VS.VECTOR BASELINE ................................................................................................................................. 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-compensation............................................................................................................... 58
11.3.2. Vector Mode –b-g-compensation .......................................................................................................... 58
11.3.3. Component Mode –YBG......................................................................................................................... 58

INTRODUCTION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
1. INTRODUCTION
1.1. THANK YOU
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).
1.2. INTENDED APPLICATIONS
This instrument is designed for use by trained personnel only, such as audiologists, ENT surgeons, doctors,
general practitioners, hearing aid dispensers, child health professionals and hearing healthcare professionals
with a similar level of education. It is not recommended to utilize the equipment without the necessary
knowledge and training.
The Otowave is to be used to obtain information on medical and functional 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 measurements:
Tympanometry: To measure the compliance of the tympanic membrane and middle ear at 226 or
1000 Hz over a range of pressures.
Acoustic Reflex Testing: The Otowave measures both ipsilateral and contralateral acoustical
reflexes. The tests are performed either at ambient or peak pressure, based on the outcome of the
tympanometry.
1.3. CONTRADICTIONS
Always visually inspect the outer ear and the external auditory canal for abnormalities before testing. Testing
should not be performed on patients in the following items is applicable.
Acute external auditory canal trauma
Discomfort (e.g. severe otitis externa)
Occlusion of the external auditory canal
Discharging ear
Recent stapedectomy or middle ear surgery
Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when
high intensity stimuli are used

INTRODUCTION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
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.
STANDARD COMPONENTS
Otowave 302 Tympanometer
8508021
Contralateral reflex transducer (probe
tip & earpiece lead)
85021771
Power Supply - FW7660M/05
8006059
Set of disposable ear-tips
80293441
CD with Software (ampliSuite and
Noah impedance module) and
Operating Manuals
8506719
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)
8507230
Carrying case
8507539
Calibration certificate
Warranty 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 contralateral
reflex transducer
8004447
Additional sets of ear tips
Probe tip
80025921
Otowave probe assembly
W0071
Seal (in probe tip)
80020091
OTHER COMPONENTS TO REORDER
Printer cable –Otowave to Sanibel
MPT-II
A102
Power supply for printer
Probe tip for contralateral reflex
transducer
80011181
Earpiece lead for contralateral
reflex transducer
8004447
Otowave probe assembly
W0071
Seal (in probe tip)
80020091
Ear tip Otowave 3-5mm
T205
Ear tip Otowave 4-7mm
T206
Ear tip Otowave 7mm
T207
Ear tip Otowave 8mm
T208
Ear tip Otowave 9mm
T209
Ear tip Otowave 10mm
T210
Ear tip Otowave 11mm
T211
Ear tip Otowave 12mm
T212
Ear tip Otowave 13mm
T213
Ear tip Otowave 14mm
T214
Ear tip Otowave 15mm
T215
Ear tip Otowave 19mm
T219
1
Applied part as according to IEC 60601-1

INTRODUCTION
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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

UNPACKING AND INSTALLATION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
2. UNPACKING AND INSTALLATION
2.1. GENERAL
Please check the contents of the shipping carton against the delivery note to make sure that all items ordered
have been included. If anything is missing, please contact the distributor who supplied the tympanometer or
Amplivox if purchased directly.
Please retain the carton and packaging as the instrument will need calibrating on an annual basis and should
be returned to Amplivox in its original shipping carton.
For supply in US only: Federal Law restricts this device to sale by or on the order of a licensed 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 immediately released from the
patient.
Refer to instruction manual.
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product, it must be
sent to separate collection facilities for recovery and recycling. Failing to do so may
endanger the environment.
0476
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.
Serial number.
Date of manufacture.
The output from the mains AC adapter is Direct Current.
Do not re-use.
Ear-tips and similar are for single use only.
CAUTION

UNPACKING AND INSTALLATION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
Keep dry.
Transport and storage humidity range.
Transport and storage temperature range.
Logo.
Turns the instrument on or off. Long press to turn off. Short press to wake the device
from sleep mode (display off).
2.3. SAFETY INSTRUCTIONS
2.3.1. GENERAL
The following safety precautions must be observed at all times. General safety precautions must be followed
when operating electrical equipment. Failure to observe these precautions could result in damage to the
equipment and injury to the operator or patient.
The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the
regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to
illness or injury.
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.
The Otowave 302 is intended to be used by hearing healthcare professionals (i.e. ENT doctors, audiologists),
nurses or technicians who have been trained in the proper use of the device.
2.3.2. CAUTIONS –GENERAL
If the system is not functioning properly, do not operate it until all necessary repairs are made and the unit is
tested and calibrated for proper functioning in accordance with Amplivox’s specifications.
Do not drop or in any other way cause undue impact to this device. If the instrument is damaged, return it to
the manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected.
This product and its components will perform reliably only when operated and maintained in accordance with
the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should not
CAUTION