Frye FONIX Hearing Evaluator FA-10 User manual

FONIX®FA-10
Hearing Evaluator™
Digital Audiometer
Operator’s Manual
version 1.22
© 2010, Frye Electronics, Inc.
All Rights Reserved 6/09
Revised 06/18/10

Note on this Manual
We have organized this manual on the assumption that the
user is already trained in how to do hearing tests. However,
should that not be the case, or if the operator needs some help,
Chapter Six, "Hearing Tests," may be consulted. Section 4.5
describes special tests that can be performed on the FA-10.
These are not included as standard functions, but can be added
for an additional charge.

Table of Contents
Chapter 1: Introduction.........................................1
1.1 Description ........................................................1
1.2 Audiometer Type...................................................1
1.3 Error Detection ....................................................1
1.4 Service............................................................1
1.5 Safety.............................................................2
1.6 Cleaning the FA-10 .................................................4
1.7 Standard Accessories ...............................................5
1.8 Optional Accessories................................................6
Chapter 2: Specications........................................9
Chapter 3: Setting Up the Audiometer ..........................15
3.1 Rear Panel Connections ............................................15
3.2 Rear Panel “See Manual” Symbols ..................................16
3.3 Audiometer Self Test...............................................16
Chapter 4: Operation ..........................................17
4.1 Input Selections ...................................................17
4.2 Output (Both Left and Right Channel) ...............................19
4.3 Presenting the Signal ..............................................20
4.3.1 Hearing Level Selection .....................................20
4.3.2 Frequency Selection .........................................20
4.3.3 Stimulus button ............................................20
4.3.4 Reverse button .............................................21
4.3.5 -2.5 dB button ..............................................21
4.3.6 Digital VU Meters ..........................................21
4.4 Miscellaneous Controls and Indicators ...............................21
4.4.1 Output Reverse .............................................22
4.4.2 Pulsed ....................................................22
4.4.3 Warble.....................................................22
4.4.4 Talk Forward ...............................................22
4.4.5 Mic (Control) ...............................................22
4.4.6 External (Control) ..........................................23
4.4.7 Talk Back (Control)..........................................23
4.4.8 Stereo Monitor (Control) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
4.4.9 Patient Response ...........................................23
4.4.10 Power ....................................................23
4.5 Special Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

4.6 RS232 Option .....................................................28
4.7 Dual Calibration Option............................................29
4.8 Connecting an iPod to the Audiometer ...............................29
4.9 Using the FA-10 with a CD player or iPod ............................31
Chapter 5: Using the FA-10 to Help Select a Hearing Aid .........37
5.1 Quick Reference Guide to Using the Hearing Aid Simulator ............37
5.2 Complete Instructions for Using the Hearing Aid Simulator.............39
5.2.1 Selecting Gain and Frequency Response........................39
5.2.2 Selecting Maximum Output (SSPL 90) .........................42
Chapter 6: Hearing Tests with the Hearing Evaluator .............45
6.1 Preparing to Test ..................................................45
6.2 The Speech Reception Threshold (SRT)...............................45
6.3 Puretone Audiometry..............................................47
6.3.1 Air-Conduction Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
6.3.2 Bone-Conduction Tests ......................................48
6.4 Supra-Threshold (above threshold) Tests .............................51
6.4.1 The Most Comfortable Level (MCL) for Speech .................51
6.4.2 The Uncomfortable Level (UCL) for Speech.....................52
6.4.3 The Speech Discrimination Score (SDS) ........................52
6.5 Setting the Masking Levels for Thresholds ............................53
6.5.1 The Plateau Procedure .......................................54
6.5.2 The One-Level Method ......................................54
Appendix A: Operational Indicators & Error Messages............57
Appendix B: Accessories.......................................61
Appendix C: Spondee Words...................................65
Appendix D: Phonetically Balanced (PB) Words..................67
Appendix E: Technical Description of Masking ..................71
Appendix F: Sound Field Calibration Instructions................73
Appendix G: Bone Calibration Tables...........................79
Appendix H: Earphone Calibration Tables.......................81
Appendix I: Calibrating the FA-10 ..............................83

Frye Electronics FONIX FA-10 Hearing Evaluator 1
Chapter 1: Introduction
1.1 Description
The FONIX FA-10 Hearing Evaluator is a digital audiometer with a built-in hearing aid simu-
lator designed especially for hearing instrument dispensers. The unit includes air, bone, and
speech audiometry as standard features. Also included in a standard unit are the Stenger test,
and talkover function. A complete monitoring feature is available when the monitor headset
or the boom microphone monitor headset is purchased.
The FA-10 is a basic, good quality, light weight, moderately priced audiometer with optional
sound eld testing and optional accessories, such as a soft carrying case, patient response
switch, external speech microphones, monitor headphone, and talkback microphone.
It is a microprocessor-based product with no internal mechanical calibration potentiometers.
Calibration is accomplished without opening the instrument case.
Programming options include an RS232 computer interface, Special Test Options, and a Dual
Calibration Option. Special tests are: SISI1, MLB2, and ABLB3. (See section 4.5 for special test
descriptions.)
1.2 Audiometer Type
The FA-10 meets the requirements of Type 3A audiometers.
The FA-10 conforms to ANSI S3.6–1996 and IEC 60645-1 1992 standards.
1.3 Error Detection
The Hearing Evaluator is designed to test itself and to indicate, to the operator or service
person, if an error exists and where it is located. Appendix A is a list of the possible error
conditions and the way that the instrument indicates these errors with ashing LEDs on the
front panel.
1.4 Service
Contact Frye Electronics, Inc., P.O. Box 22391, Tigard, Oregon 97281-3391, U.S.A.
Shipments to 9826 SW Tigard St., Tigard, Oregon 97223.
Telephone: [phone] in U.S. and Canada; 503/620-2722; Fax [phone]; e-mail: ser-
[email protected]. Or contact your local FONIX representative.
1SISI – Short Increment Sensitivity Index
2MLB – Monaural Loudness Balance
3ABLB – Alternate Binaural Loudness Balance

2 Chapter 1: Introduction
1.5 Safety
Rear Panel Mains Fuses for 120 VAC use: 0.5A 250V slow 3AG.
Rear Panel Mains Fuses for 220V/240V use: two each 0.16A, 250V, type T.
For the FA-10 to comply with IEC 60601-1, all mains connected electrical equipment attached
to the FA-10 must also comply with IEC 60601-1. All computer and audio equipment attached
to the FA-10 must be medical grade or else used with a medical grade isolation transformer
Symbol Meaning
“Read the accompanying documents.” Please read this manual before
operating the FA-10. A separate maintenance manual also exists. If you
wish to obtain one, please contact Frye Electronics or your Frye repre-
sentative.
For purposes of safety classication under IEC 60601-1, the FA-10 is
class 1, type B, ordinary equipment suitable for continuous operation.
This Symbol indicates that Frye Elecctronics, Inc. is a Registered Firm
of British Standards Institution, and we conform to the ISO 13485
standard.
Keep dry. The FA10 should not be exposed to water or other uids.
The shipping/storage temperature of the FA-10 is -20 to 60 degrees
Celsius (-4 to 140 degrees Fahrenheit).
The shipping/storage humidity of the FA-10 is 5 to 95% relative hu-
midity (non-condensing).
This symbol on the insert earphone eartip packaging indicates that
eartips should be discarded after use in order to prevent the possible
spread of infection. They cannot be cleaned, sterilized, or reused.
95%

Frye Electronics FONIX FA-10 Hearing Evaluator 3
Safety Classication for IEC 60601-1
Type of protection against electric shock: Class I
Degree of protection against electric shock: Type B
Protection against harmful ingress of water: Ordinary
Mode of operation: Continuous
The FA-10 does not require sterilization or disinfection.
Warning: This equipment is not suitable for use in the presence of ammable anaesthetic
mixture with air or with oxygen or nitrous oxide.
Connection of peripheral equipment to the FA-10
Compliance with IEC 60601-1-1 Safety requirements for medical electrical systems must be
determined on a case-by-case basis.
All electrical equipment attached to the FA-10, such as video monitors, computer equipment,
etc. must, at a minimum, meet one of the following conditions:
a. The equipment complies with IEC 60601-1
b. The equipment complies with relevant IEC and ISO safety standards and is supplied
from a medical grade isolation transformer.
c. The equipment complies with relevant IEC and ISO safety standards and is kept at
least 1.5 meters from the patient.
The allowable leakage currents of IEC 60601-1-1 must not be exceeded. IEC 60601-1-1 should
be consulted when assembling such a system.
Electromagnetic compatibility
The FA-10 complies with IEC 60601-1-2.
The FA-10 generates and uses radio frequency energy. In some cases the FA-10 could cause
interference to radio or television reception. You can determine if the FA-10 is the source of
such interference by turning the unit off and on.
If you are experiencing interference caused by the FA-10, you may be able to correct it by one
or more of the following measures:
1. Relocate or reorient the receiving antenna.
2. Increase the distance between the FA-10 and the receiver.
3. Connect the FA-10 to a different outlet than the receiver.

4 Chapter 1: Introduction
In some cases radio transmitting devices, such as cellular telephones, may cause interference
to the FA-10. In this case try increasing the distance between the transmitter and the FA-10.
Disposal of the FA-10 and accessories
The FA-10 and some of its accessories contain lead. At the end of its useful life, please recycle
or dispose of the FA-10 according to local regulations.
If you are located in the European Union, please report all safety-related concerns to our
authorized representative:
Siemens Hearing Instruments Ltd.
Alexandra House
Newton Road
Manor Royal
Crawley
West Sussex RH109TT
ENGLAND
Otherwise, please report all safety-related concerns to:
Frye Electronics, Inc
PO Box 23391
Tigard, OR 97281-3391
USA
1.6 Cleaning the FA-10
For your safety, disconnect the FA-10 from electrical power while cleaning.
Wipe the FA-10 case with a slightly moist cloth. Use plain water or water with mild dish-
washing detergent. Wipe away any detergent with a clean cloth moistened with water, then
dry the FA-10. Avoid solvents and abrasives, they can cause permanent damage to the FA-10.
Never allow uid to enter:
• the electronics module
• the power switch
• the power entry module
• the electrical connectors
• the keyboard push buttons or rotary controls
Cleaning the earphones:
Although the danger of spreading disease through the audiometric earphones is low, it is not
non-existent. The manufacturer of the ear cushions recommends the use of any OSHA (Occu-
pation Safety and Health Agency) recommended anti-bacterial soap. Disposable acoustically
transparent covers are also available commercially. Insert earphone eartips are single use
only can cannot be cleaned.