AmpliVox Otosure User manual

Otosure
Operating Manual

i
D-0116492-B (OM022) –Otosure Operating Manual
ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT.
This manual is valid for the Otosure (applies from serial number 58000 and Audibase version 5.5 onwards).
This product is manufactured by:
Amplivox Ltd.
10393 West 70th Street
Eden Prairie
MN 55344
United States
Amplivox Ltd.
3800 Parkside, Solihull Parkway,
Birmingham Business Park,
Birmingham, West Midlands,
B37 7YG
United Kingdom
www.amplivox.com
For all enquiries please contact us under:
Tel: [phone]
Fax: [phone]
[email protected]
Tel: [phone]
[email protected]

ii
D-0116492-B (OM022) –Otosure Operating Manual
TABLE OF CONTENTS
1. INTRODUCTION.................................................................................................................................................. 4
1.1. THANK YOU...........................................................................................................................................................4
1.2. INTENDED APPLICATIONS .........................................................................................................................................4
1.3. CONTRADICTIONS................................................................................................................................................... 4
1.4. STANDARD AND OPTIONAL COMPONENTS....................................................................................................................4
1.5. WARNINGS ...........................................................................................................................................................5
2. PRINCIPLES OF OPERATION ................................................................................................................................ 6
2.1. OTOSCOPIC EXAMINATION .......................................................................................................................................6
2.2. PRINCIPALS OF PURE TONE AUDIOMETRY ...................................................................................................................6
2.3. AUDIOMETRY PREPARATION .....................................................................................................................................6
3. UNPACKING AND INSTALLATION........................................................................................................................ 8
3.1. GENERAL..............................................................................................................................................................8
3.2. MARKINGS............................................................................................................................................................8
3.3. SAFETY INSTRUCTIONS............................................................................................................................................. 9
3.3.1. General ..................................................................................................................................................... 9
3.3.2. Cautions –General ................................................................................................................................... 9
3.3.3. Environmental factors ............................................................................................................................ 10
3.3.4. Electrical and electrostatic safety........................................................................................................... 10
3.3.5. Electromagnetic compatibility (EMC) ..................................................................................................... 11
3.3.6. Explosion hazards ................................................................................................................................... 11
3.3.7. Measuring Security ................................................................................................................................. 11
3.3.8. Miscellaneous ......................................................................................................................................... 11
3.3.9. Use of equipment after transport and storage....................................................................................... 12
3.4. CONNECTIONS .....................................................................................................................................................12
3.5. HARDWARE INSTALLATION .....................................................................................................................................12
4. INSTALLING SOFTWARE & OPERATIONAL CHECK ..............................................................................................13
4.1. GENERAL ............................................................................................................................................................13
4.2. INSTALLATION...................................................................................................................................................... 13
4.3. UNINSTALLING THE OTOSURE PROGRAM ..................................................................................................................13
4.4. OPERATIONAL CHECK............................................................................................................................................13
5. USING THE OTOSURE ........................................................................................................................................15
5.1. EQUIPMENT PREPARATION ..................................................................................................................................... 15
5.2. STARTING THE SOFTWARE.......................................................................................................................................15
5.3. AVAILABLE TEST MODES ........................................................................................................................................15
5.3.1. Manual Testing....................................................................................................................................... 15
5.3.2. Computer Testing ................................................................................................................................... 15
5.3.3. Mixed Testing ......................................................................................................................................... 16
5.4. INITIATING A TEST ................................................................................................................................................16
5.5. CONTROL BUTTONS..............................................................................................................................................17
5.6. CONTROL -PC KEYBOARD AND MOUSE...................................................................................................................17
5.7. MANUAL TESTING................................................................................................................................................17
5.8. COMPUTER TESTING .............................................................................................................................................19
5.9. SINGLE-FREQUENCY TESTING ..................................................................................................................................20

iii
D-0116492-B (OM022) –Otosure Operating Manual
5.10. MIXED-MODE TESTING..........................................................................................................................................20
6. OPTIONS AVAILABLE TO SET-UP........................................................................................................................21
6.1. GENERAL ............................................................................................................................................................21
6.2. MENU COMMANDS..............................................................................................................................................21
7. TROUBLESHOOTING ..........................................................................................................................................22
7.1. GENERAL ............................................................................................................................................................22
7.2. NO INSTRUMENT FOUND....................................................................................................................................... 22
7.3. NO RESPONSE FROM PATIENT ................................................................................................................................ 22
7.4. RESPONSE SWITCH HELD ON..................................................................................................................................23
7.5. ERRATIC PATIENT RESPONSE...................................................................................................................................24
7.6. EXIT OTOSURE WITH NO RESULTS........................................................................................................................... 24
7.7. USB LEAD DISCONNECTED.....................................................................................................................................25
8. ROUTINE MAINTENANCE...................................................................................................................................26
8.1. GENERAL MAINTENANCE PROCEDURES ....................................................................................................................26
8.2. AUDIOMETER MAINTENANCE..................................................................................................................................26
8.3. HEADSET MAINTENANCE ....................................................................................................................................... 27
8.4. ACCESSORIES/REPLACEMENT PARTS .........................................................................................................................27
8.5. REPAIR...............................................................................................................................................................27
8.6. WARRANTY.........................................................................................................................................................28
8.7. CALIBRATION AND RETURN OF THE INSTRUMENT........................................................................................................28
8.8. GUARANTEE........................................................................................................................................................ 29
9. TECHNICAL SPECIFICATIONS..............................................................................................................................30
9.1. STANDARDS AND REGULATORY................................................................................................................................ 30
9.2. INPUT/OUTPUT ...................................................................................................................................................30
9.3. AUDIOMETRIC .....................................................................................................................................................30
9.4. EARPHONE SOUND ATTENUATION CHARACTERISTICS ..................................................................................................30
9.5. PHYSICAL &ENVIRONMENTAL.................................................................................................................................30
10. EMC GUIDANCE & MANUFACTURER’S DECLARATION...................................................................................32
11. USE WITH NON-MEDICAL ELECTRICAL EQUIPMENT ......................................................................................37

4
D-0116492-B (OM022) –Otosure Operating Manual
1.INTRODUCTION
1.1. THANK YOU
Thank you for purchasing an Amplivox audiometer. The Otosure is a compact, automatic air-conduction
screening audiometer, driven and controlled by a computer (PC). It provides a cost-effective solution for
today's health care environment.
The Otosure is used with the Amplivox Audibase software, which allows electronic storage of audiometric
test records on a PC, application of audiogram categorisation schemes, printing of audiograms and data
exchange with other PC applications.
This operator's manual enables you to take full and safe advantage of the features offered by the Otosure
audiometer. Therefore, PLEASE READ IT THOROUGHLY before using the audiometer.
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.
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.
1. The presence of other sensitivity to loud sounds may contraindicate testing when high intensity stimuli
are used.
2. Recent outer ear surgery.
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.com). The required fitting
instructions are supplied with each part.
STANDARD COMPONENTS
Otosure audiometer
8508019
Audiometric headset (DD45)
8509615
Patient response switch
8011155
HBA audiometric headband
8010882
Cable USB A to USB B (2.0 m)
8011241
Carrying case
8004651
Calibration certificate
USB with Audibase Software and
manuals

5
D-0116492-B (OM022) –Otosure Operating Manual
OTHER COMPONENTS TO REORDER
Audiocups (noise reducing earphone enclosures)
8010855
Headband (standard
headphone)
8010840
Audiocup ear cushion
8010835
Earphone cushion
8010857
Audiocup headband
8507381
Earphones DD45 *
8010876
Audiocup headband cover
8010834
Headset lead
8010822
Booth Leads
851095
Accessories marked * require calibration with the specific audiometer to be used. Do not attempt to
use these accessories until the audiometer has been calibrated to match their characteristics.
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.
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

6
D-0116492-B (OM022) –Otosure Operating Manual
2.PRINCIPLES OF OPERATION
2.1. OTOSCOPIC EXAMINATION
A suitably-qualified health care professional should perform a thorough otoscopic examination to establish that
the condition of the ear is suitable for the test options selected and that no contraindications are present. The
latter would include obstruction of the external ear canal due to excessive wax and/or hairs, both of which
would need to be removed. This is required to ensure that the probe tone delivered by the probe are able to
reach the ear drum and are not reflected by cerumen or debris and thereby alter the test result.
2.2. PRINCIPALS OF PURE TONE AUDIOMETRY
Ideally, hearing tests are conducted in a soundproof room. The purpose of pure tone audiometry is to measure
the patient’s hearing threshold which is then compared to the hearing threshold of an average normal hearing
person. The examination starts with air conduction on the ear with better hearing, or if not specified differently,
on the right ear. The BSA (British Society of Audiology) recommends starting the test at 1000 Hz to then next
measure the higher frequencies. When done with the high frequencies 1000 Hz shall be retested and to then
continue with the lower frequencies.
2.3. AUDIOMETRY PREPARATION
Refer to the various audiometric standards and other relevant publications for guidance on audiometric testing.
Ambient Conditions
Audiometric testing should always be performed in quiet conditions (e.g. a quiet room or an acoustic booth).
The optional Audiocups can provide an additional level of isolation from ambient noise. For further
explanation on permissible ambient noise levels, please refer to the audiometry standard ISO 6189.
Test System Arrangement
The schematic diagram below shows a typical example of the use of audiometric test equipment. The
audiometer is located on the desk of a seated operator as shown.
The patient is seated in front of the desk facing away from the operator. The patient wears a headset (see
below) and responds to test stimuli by use of a hand-held switch which is also connected to the instrument.
Operator
Otosure
Audiometer
Computer (e.g. Tablet/Laptop)
Patient, wearing headset
Headset lead
Response switch & lead

7
D-0116492-B (OM022) –Otosure Operating Manual
Headset
The headset must be fitted by a qualified person to ensure a proper seal and comfortable fit. The leads from
the headset are connected to the instrument and the headset is then fitted to the patient.
Patient Instructions
The patient is given the following instructions: “Press and then release the response switch when a tone is
heard”.

8
D-0116492-B (OM022) –Otosure Operating Manual
3.UNPACKING AND INSTALLATION
3.1. 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 audiometer 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.
3.2. 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.
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.
Manufacturer.
Keep dry.
Transport and storage humidity range.
CAUTION

9
D-0116492-B (OM022) –Otosure Operating Manual
Transport and storage temperature range.
Logo.
3.3. SAFETY INSTRUCTIONS
3.3.1. 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 Otosure 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.
3.3.2. 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
be used. Make sure all connections to external accessories are secured properly. Parts which may be broken
or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from Amplivox Ltd.
Equipment is not user repairable. Repairs must be performed by an authorized service representative only.
No modifications of the equipment are allowed by anyone other than a qualified Amplivox Ltd. representative.
Modification of the equipment could be hazardous.
Amplivox Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibrations
instructions, or other information that will assist authorized service personnel to repair those parts of this
instrument that are designated by Amplivox Ltd. as repairable by service personnel.
CAUTION