Frye FP35 User Manual

FONIX
Hearing Aid Analyzer
Operator’s Manual
Ver. 4.00
®
Ver. 4.00: 5/12/08 ©2008 Frye Electronics, Inc.
All rights reserved
Table of Contents iii
Contents
Chapter 1: An Overview of the FP35
1.1 A Guide to Using this Manual..........................................................................2
1.2 Layout, Controls, & Safety .............................................................................2
1.2 .1 Lamps and LCD .................................................................................2
1.2.2 Front panel layout ...............................................................................3
1.2.3 Rear Panel Layout ...............................................................................4
1.2.4 Sound Chamber Connectors.....................................................................5
1.3 Accessories............................................................................................ 6
1.3.1 Standard Accessories ............................................................................6
1.3.2 Real-Ear Option Accessories.....................................................................7
1.3.3 Optional accessories ............................................................................8
1.4 Optional Features for the FP35 .......................................................................12
1.5 Setup .................................................................................................14
1.6 Safety ................................................................................................14
1.7 Maintenance .........................................................................................16
1.7.1 Servicing the Instrument ........................................................................16
1.7.2 Cleaning the Instrument ........................................................................17
1.7.3 Warranty........................................................................................ 17
Chapter 2: General Operation
2.1 Operation of Keys.................................................................................19
2.1.1 Using the Function Keys .........................................................................19
2.1.2 Using the Local Menus ..........................................................................21
2.1.3 Using the Help Menus...........................................................................23
2.1.4 Using the [EXIT] and [RESET] keys...............................................................23
2.2 Opening Screen ......................................................................................24
2.2.1 Entering the Opening Screen ...................................................................24
2.2.2 Opening Screen Display ........................................................................24
2.2.3 Switching Between Settings .....................................................................25
2.3 The Default Settings Menu ...........................................................................25
2.3.1 Customizing Your Instrument Default Settings ..................................................26
2.3.2 Switching between Easy and Advanced User Levels............................................26
2.3.3 Changing the use of [F1] in the Opening screen ................................................27
2.3.4 Setting the date and time .......................................................................27
2.3.5 Changing the external monitor colors ...........................................................27
2.3.6 Explaining the Settings in the Main Default Settings Menu .....................................28
2.3.7 Explaining the Settings in the Advanced Menu .................................................30
2.3.8 Explaining the Settings in the Resets Default Settings Menu ....................................33
2.4 Aid Types and Delay Times...........................................................................33
2.5 Source Types & Measurements .......................................................................34
2.5.1 Understanding Pure-Tone Signals ...............................................................35
iv FONIX FP35 Hearing Aid Analyzer
2.5.1.1 Delay Settings............................................................................35
2.5.1.2 Harmonic Distortion .....................................................................35
2.5.1.3 Noise Reduction .........................................................................36
2.5.1.4 Warble Rates ............................................................................36
2.5.1.5 Adjusting the Signal Skew................................................................37
2.5.1.6 Three-Frequency Averages ..............................................................38
2.5.2 Understanding Composite Signals ..............................................................38
2.5.2.1 Filter Type ...............................................................................39
2.5.2.2 Intermodulation Distortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
2.5.2.3 Noise Reduction.........................................................................43
2.5.3 Measuring RMS .................................................................................43
2.5.4 Measuring the RMS of the reference microphone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
2.5.5 Using the Earphone Jack ........................................................................46
2.5.6 Using Impulse Rejection ........................................................................47
2.5.7 Using an External Speaker or Sound Chamber ..................................................47
2.5.8 Measuring Telecoil ..............................................................................48
2.6 Printing ...............................................................................................50
2.6.1 Choosing the Printer............................................................................50
2.6.2 Adding a Label .................................................................................51
2.6.3 Changing the Thermal Paper ...................................................................52
2.6.4 Fixing Paper Jams ...............................................................................53
2.6.5 Minimizing Fading..............................................................................53
2.6.6. Using an External Printer .......................................................................54
2.7 Display & Data ........................................................................................54
2.7.1 Data Display ....................................................................................54
2.7.2 Curve ID Box ....................................................................................55
Chapter 3: Coupler Measurements
3.1 Coupler Multicurve Display ..........................................................................57
3.2 Leveling the Sound Chamber.........................................................................58
3.2.1 Leveling without the Reference Microphone (Standard) ........................................59
3.2.2 Leveling Using the Reference Microphone .....................................................60
3.2.3 Saving the Leveling Information ................................................................61
3.2.4 Changing the Leveling Source ...................................................................61
3.3 Hearing Aid Setup ....................................................................................62
3.3.1 Setting up a BTE ................................................................................62
3.3.2 Setting up an ITE ...............................................................................63
3.3.3 Setting up a Body Aid...........................................................................64
3.4 Frequency Responses ................................................................................64
3.4.1 Running a Test Curve ...........................................................................65
3.4.2 Running a Single Frequency Measurement .....................................................67
3.5 Distortion Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
3.5.1 Measuring Harmonic Distortion.................................................................68
3.5.2 Measuring Intermodulation Distortion ..........................................................69
3.5.3 Performing an IM Distortion Sweep .............................................................71
3.5.4 Changing the Frequencies of an IM Distortion Sweep...........................................72
3.5.5 Turning on/off Impulse Rejection ...............................................................72
3.5.6 Using the Reference Microphone...............................................................73
Table of Contents v
3.6 CIC Option ...........................................................................................73
3.7 OES Option ...........................................................................................74
3.8 Advanced Testing.....................................................................................76
3.8.1 Testing Digital Hearing Aids .....................................................................76
3.8.2 Testing Directional Hearing Aids ................................................................77
3.8.3 Testing with the Reference Microphone.........................................................80
3.8.4 Reversing the Microphones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
3.8.5 Splitting the Microphones.......................................................................82
3.8.6 Changing the Signal Filters ......................................................................83
3.8.7 Running a Three-Frequency Average ...........................................................84
3.8.8 Measuring the Telecoil Response ...............................................................84
3.9 Reference.............................................................................................87
3.9.1 Defining the Function Keys......................................................................87
3.9.2 Explaining the Menu Items ......................................................................88
Chapter 4: Automated Test Sequences .................................................93
4.1 The ANSI Sequence ...................................................................................93
4.1.1 Viewing the ANSI ’96 Display ...................................................................94
4.1.2 Defining the Function Keys .....................................................................95
4.1.3 Leveling ........................................................................................96
4.1.4 Switching between ANSI 96 and ANSI 03 .......................................................96
4.1.5 Setting up for ANSI testing......................................................................96
4.1.6 Running an ANSI Test ...........................................................................98
4.1.7 Testing Digital Hearing Aids.....................................................................98
4.1.8 Understanding Menu Items.....................................................................99
4.2 IEC Testing ...........................................................................................100
4.2.1 Viewing the IEC Display .......................................................................10 0
4.2.2 Defining the Function Keys ....................................................................102
4.2.3 Setting Up the Hearing Aid for Testing .........................................................102
4.2.4 Running an IEC Test............................................................................103
4.2.5 Defining the Menu Items ......................................................................103
4.3 JIS Testing............................................................................................104
4.3.1 Viewing the JIS Display ........................................................................10 4
4.3.2 Defining the Function Keys ....................................................................106
4.3.3 Setting Up the Hearing Aid for Testing .........................................................106
4.3.4 Running the JIS Test ...........................................................................107
4.3.5 Defining the Menu Items .......................................................................107
4.4 ISI Testing ............................................................................................10 8
Chapter 5: Real-Ear Measurements ...................................................111
5.1 Introduction.........................................................................................111
5.1.1 Real-Ear Screens............................................................................... 111
5.1.2 Navigation .....................................................................................111
5.2 Real-Ear Setup ......................................................................................11 2
5.2.1 General Setup .................................................................................112
5.2.2 Internal Speaker Setup ........................................................................11 3
5.2.3 External Speaker Setup........................................................................11 4
5.2.4 Placing the Probe Tube ........................................................................115
vi FONIX FP35 Hearing Aid Analyzer
5.2.5 Placing the Sound Field Speaker ..............................................................116
5.2.6 Leveling the Sound Field Speaker .............................................................11 6
5.2.7 Testing Digital Aids ............................................................................11 8
5.2.8 Testing Body Aids..............................................................................118
5.3 Audiogram Entry Screen—Creating A Target ........................................................11 9
5.3.1 Entering the Audiogram Screen................................................................119
5.3.2 Audiogram Display ............................................................................119
5.3.3 Entering Audiometric Information & Creating A Target ........................................120
5.3.4 Creating an NAL-NL1 Target....................................................................120
5.3.5 Modifying a Target.............................................................................122
5.3.6 Measuring the Real-Ear to Coupler Difference.................................................122
5.3.6.1 Analyzer Setup for RECD ...............................................................122
5.3.6.2 Client Setup for RECD ..................................................................123
5.3.6.3 Taking the RECD Measurement.........................................................124
5.3.7 Measuring the Real-Ear to Dial Difference .....................................................124
5.3.8 Measuring the Unaided measurement ........................................................127
5.3.9 Starting a New Client ..........................................................................129
5.3.10 Defining the Menu Items .....................................................................129
5.4 Insertion Gain Testing ...............................................................................131
5.4.1 Measuring the Unaided Response.............................................................133
5.4.2 Measuring the Aided Response ...............................................................134
5.4.3 Automatic Testing..............................................................................136
5.4.4 Testing Directional Hearing Aids...............................................................136
5.4.5 Testing Open Fit Hearing Aids .................................................................139
5.5 The Real-Ear SPL Screen ............................................................................140
5.5.1 The SPL Display ...............................................................................141
5.5.2 Running an SPL Test ...........................................................................141
5.5.3 Important Notes on SPL Testing ...............................................................143
5.5.3.1 Speech-Weighting Effects on Pure tones ...............................................143
5.5.3.2 Target Formulas .......................................................................143
5.5.4 Important Notes on DSL Testing ...............................................................144
5.6 Live Speech Testing .................................................................................145
5.6.1 Using Speech as a Test Signal ..................................................................145
5.6.2 Measuring the occlusion effect.................................................................147
5.7 Miscellaneous Real-Ear Measurements..............................................................14 8
5.7.1 Measuring a Single Frequency Response ......................................................14 8
5.7.2 Measuring Harmonic Distortion................................................................148
5.7.3 Measuring Intermodulation Distortion.........................................................150
5.7.3.1 To perform a static IM distortion test ...................................................15 0
5.7.3.2 To perform an IM distortion sweep.....................................................151
5.7.3.3 To change the frequencies used in the sweep..........................................152
5.7.4 Using the Reference Microphone ..............................................................153
5.7.5 Viewing Target Data ............................................................................15 3
5.7.6 Measuring the Telecoil Response...............................................................154
5.8 Reference ...........................................................................................15 6
5.8.1 Viewing the Real-Ear Screens..................................................................15 6
5.8.2 Defining the Menu Items .......................................................................158
Table of Contents vii
5.9 CROS, and BICROS ..................................................................................16 2
5.9.1 Measuring the Head-Baffle Effect..............................................................162
5.9.2. Measuring the Overcoming of the Head-Baffle Effect ..........................................163
5.9.2.1 CROS ...................................................................................163
5.9.2.2 BI-CROS................................................................................163
5.9.3 Measuring Overall Insertion Gain .............................................................164
5.9.3.1 CROS ...................................................................................164
5.9.3.2 BI-CROS ................................................................................165
5.9.4 Measuring Insertion Loss to the “Good” Ear (CROS) ...........................................165
Chapter 6: 2-CC Targets ...............................................................167
6.1 Target Creation.......................................................................................168
6.2 The Coupler Target and Coupler EarSim Displays ...................................................169
6.2.1 Viewing the Coupler Target Screen ............................................................169
6.2.2 Viewing the Coupler EarSim Screen............................................................171
6.3 Measurements & Adjustments .......................................................................172
6.3.1 Taking Basic Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
6.3.2 Viewing Target Data ............................................................................173
6.3.3 Tying the Target to a Measurement Curve ......................................................174
6.4 Reference ............................................................................................175
Chapter 7: The Audiometer Option ....................................................181
7.1 Introduction .........................................................................................181
7.2 Equipment...........................................................................................181
7.3 Setup ................................................................................................181
7.3.1 Sound Field Speaker...........................................................................181
7.3.2 Insert Earphones ..............................................................................184
7.4 Taking Audiometric Measurements..................................................................184
7.4.1 Measurements in HL...........................................................................184
7.4.2 Measurements in SPL ..........................................................................184
7.4.3 Measurements in Gain.........................................................................185
7.5 Output Limitations ..................................................................................185
Chapter 8: Spectrum Analysis .........................................................187
8.1 Spectrum Analysis Measurements...................................................................187
8.2 Using the Spectrum Analysis Mode..................................................................187
8.3 Technical Details .....................................................................................188
Appendix A: Specifications ...........................................................191
Appendix B: Software Upgrades ......................................................195
Appendix C: Calibration ..............................................................199
Appendix D: Fitting Formula Tables ...................................................205
Appendix E: SPL Conversions .........................................................209
Appendix F: Digital Speech Technical Details ..........................................213
Chapter 1 1
An Overview of the FP35
Welcome to the FONIX FP35 analyzer! The FONIX FP35 provides quick, accu­rate information about how well a hearing aid works. It uses a graphical display or numerical table to show how much amplification the aid provides, which fre­quencies it amplifies, and how much distortion is creates.
The FP35 hearing aid analyzer is a lightweight instrument notable for its ease of use. It has an intuitive interface to lead novice users through the process of hearing aid prescription and real-ear testing, but the interface is versatile enough for experts to use without feeling hindered.
You can reach the menus from any screen. To make finding what you are look­ing for quick and easy, and to avoid confusion, the pop-up menu screens dis­play only the choices relevant to the application currently in use. The FP35 also offers pop-up help windows that guide you through the possible steps available from the current screen.
The FP35 uses a backlit LCD with an adjustable contrast for its main display, and it has a thermal printer built in so that you can print hard copies of gath­ered data no matter where you are. The FP35 also has an external monitor option that allows the simultaneous display of the built-in LCD and an external monitor. Most computer monitors will work with this feature, although the FP35 display is only in two colors. There is also a parallel port on the back of all FP35 analyzers, allowing the use of an external printer.
The FP35 features three different pure-tone tests. The normal sweep covers a detailed range of frequencies; the fast sweep offers a continuous signal, updat­ing as fast as once every three seconds; the short sweep is a quick test (under two seconds) covering standard audiometric frequencies. You can view the curves in either gain or sound pressure level.
Indications for use
The FONIX FP35 Hearing Aid Analyzer allows the user to test the characteris­tics of a hearing aid using coupler and optional real-ear measurements. These characteristics include: Frequency response, harmonic distortion, equivalent input noise, and compression. Coupler measurements are performed inside a sound chamber. Real-ear measurements are performed with a small probe microphone inside the patient’s ear. This manual provides detailed instructions on the measurement capabilities and user interface of the FONIX FP35.
2 FONIX FP35 Hearing Aid Analyzer
1.1 A Guide to Using this Manual
The FP35 is easy to use. You can begin testing right away, and, if you do happen to get stuck, the pop-up help menus will guide you through what to do next. In addition, this manual contains detailed instructions and information about all the different testing capabilities and options that the FP35 gives you.
The FP35 Operator’s Manual follows a logical, sequential order and is meant to be read in order. If you come across a section that contains information you are already familiar with, skip to the next section.
Notations are consistent throughout the manual. Key names are contained in brackets, for instance [START/STOP]. Selections and settings are written in all capitals without brackets, such as PURETONE. Screen names are capitalized, such as Coupler screen.
The up-down arrow keys are represented by these symbols: [∧, ∨]. The right-left arrow keys are represented by these symbols: [<, >].
1.2 Layout, Controls, & Safety
The basic layout of the FP35 analyzer and special information pertaining to safety regulations are described in this section.
1.2 .1 Lamps and LCD
The FP35 uses a 1/4 VGA LCD screen to display graphs and numerical data. An optional external monitor connection is also available. The FP35 analyzer is equipped with a screen saver that will turn off the display automatically if the FP35 is not used for a period of ten minutes or some other length of time specified by the user in the Default Settings Menu (see Section 2.3, The Default Settings Menu). To activate the screen after the screen saver has turned it off, press any key.
The FP35 has only one LED. It is above the [OPERATE] key (see Figure 1.2.1). The LED can indicate several different things by its color and by how quickly it flashes.
• Green (not flashing)—Normal operation
• Green fast flash (every second)—Screen saver mode
•Green slow flash (every three seconds)—Off, but the circuit continues to
receive power
• Red—Error condition; unit should not be used
• Red & Green alternating—Software upload mode
An Overview of the FP35 3
Figure 1.2.1—FP35 front panel
1.2.2 Front panel layout
The front panel of the FP35 analyzer consists of 8 function keys, 4 arrow keys, and 9 other keys with varying operations. Together, these keys are used to con­trol all the operations of the FP35 analyzer.
Function Keys:
There are five “function keys” located just below the FP35’s front panel, labeled [F1] through [F5]. The function of these keys change from screen to screen, according to the need of the screen. There are three basic uses of the function keys:
•Tonavigatefromscreentoscreen
•Totoggleaselection
•Topop-upupaselectionmenu
For example, in the Opening Screen, pressing [F3] will take you into the Coupler Multi-Curve screen where you can test an aid in the sound chamber.
Other Keys:
[MENU] Enters and exits the menu relevant to the current screen.
[EXIT] Exits the current screen, returning you to the a measurement
screen or the Opening Screen. Unlike the [RESET] key, press­ing [EXIT] does not erase any data.
4 FONIX FP35 Hearing Aid Analyzer
VIDEO
EARPHONESPEAKER CONTRAST RS232 PRINTER POWER
VIDEO
EARPHONE SPEAKER
CONTRAST
RS232
PRINTER KEYBOARD POWER
[NEXT] [BACK] Moves back and forth between screens that are in a sequenc-
es. Examples include menus and the real-ear measurement screens.
[∧, ∨] Moves the cursor up and down in a menu screen and in the
Audiogram Entry screen. Adjusts the level of the source ampli­tude in a measurement screen.
[< , >] Cycles through available menu choices, adjusts the frequency
selection in a single tone measurement, and adjusts the ampli­tude levels in an audiogram in the Audiogram Entry screen.
[START/STOP] Starts or stops the current selected function.
[OPERATE] Powers up and down the analyzer. When powered down, the
LCD display is turned off and all data is cleared, but the main power is not turned off. The green LED will flash once every 3 seconds.
[RESET] Interrupts any current running measurement and returns the
FP35 to the Opening Screen. [RESET] will not clear leveling or calibration, but it will clear any data you have collected.
[HELP] Pops up a help window containing instructions for the current
[PRINT/FEED] Prints the current screen when you press and release this key.
1.2.3 Rear Panel Layout
The rear panel contains most of the external connections for the FP35 analyzer. There are two versions of the FP35 rear panel. The new rear panel (Figure
1.2.3A) was added in February 2007. All analyzers manufactured before this date (that haven’t had a hardware upgrade) will have the older rear panel pic­tured in Figure 1.2.3B.
Figure 1.2.3A—New FP35 rear panel layout
screen.
Feeds the thermal paper when you press and hold this key.
Figure 1.2.3B—Old FP35 rear panel layout
An Overview of the FP35 5
0086
Video Connects to an external monitor (optional).
Earphone Connects an insert earphone to the FP35 in order to perform
RECD or audiometric measurements. It can also be used to connect a Telewand or telecoil board for telecoil measurements.
Speaker Connects an external sound field speaker or external sound
chamber to the FP35 analyzer. Can also be used to connect an external telecoil board or Telewand (new rear panel only)
Contrast Changes the contrast of the LCD display.
RS232 Connects to a computer in order to run a computer program or
to upgrade your software.
Printer Connects the FP35 to an external printer.
Keyboard This connector has no function (only found on old rear panel
layout)
Power Connects the FP35 to its power supply. We recommend that
you attach the power supply to the FP35 before plugging it into the wall.
The following symbols can be found on the back and on the bottom of the FP35:
Meaning of Symbols
Read the accompanying documents. Please read this manual
before operating the FP35. A separate maintenance manual exists for the FP35. If you wish to obtain a maintenance man­ual please contact Frye Electronics, Inc., or your Frye represen­tative.
For purposes of safety classification under IEC 60601-1, the
FP35 is class 1 equipment, Type B.
This symbol indicates that Frye Electronics conforms to the
Medical Device Directive 93/42/EEC. If an external printer is used, it should also have a CE mark for the FP35 to remain compliant.
1.2.4 Sound Chamber Connectors
There are two jacks in the sound chamber. The jack at the bottom of the cham­ber is for the microphones, and the jack at the top of the chamber is for the internal speaker.
6 FONIX FP35 Hearing Aid Analyzer
1.3 Accessories
1.3.1 Standard Accessories
HA-1 2-cc Coupler Dimensions per requirements of ANSI S3.7 for testing in-the-ear hearing aids
HA-2 2-cc Coupler Dimensions per requirements of ANSI S3.7 for testing ear level, eyeglass and body aids
Ear-Level (BTE) Adapter Snaps into the 1/4 in (6.35 mm) diam­eter cavity in the HA-2 2-cc coupler. Equipped with a 0.6 in (15 mm) length of
0.076 in (1.93 mm) ID tubing, the adapter allows ANSI S3.22 specified connection of an ear-level aid to the coupler.
An Overview of the FP35 7
Coupler-only Microphone Shipped with all units that do not have the Real-Ear Option. See optional acces­sories list for a sound chamber-only two microphone setup.
Microphone Adapter 14 mm to 1-inch diameter microphone size. Couples the microphone to a cali­brator.
Other Standard Accessories
•StandardExternalPowerSupply
•RollofPaper
•Operator’sManual
•Fun-Tak
•RS232Cable
1.3.2 Real-Ear Option Accessories
Probe Microphone Probe and reference microphone attached to Y cable (6 ft. / 1.9 m) replaces single mic when Real-Ear Option is ordered.
Mounting Sleeves
For securing microphones to the earhook.
8 FONIX FP35 Hearing Aid Analyzer
Wedge Style Earhook Standard size. Holds probe and refer­ence microphones during real-ear test­ing. Improved design eliminates need for Velcro headband.
Other Real-Ear Option Accessories:
• Probe Calibration Adapter—Provides a means of coupling the probe micro- phone to a calibrator.
• Calibration Clip—Used to couple the probe and reference microphones together for calibration purposes.
• Extension Pole—This extra pole (6 1/2” long), lets you use two different speaker heights when testing in the Real-ear Mode.
•Probe Tubes—set of 25
•Felt Pen—Red, Dry-erase
1.3.3 Optional accessories
Soft Carrying Case An attractive, sturdy soft carrying case that fits the FP35 and accessories.
An Overview of the FP35 9
External Monitor Option
Used for the external display of the FP35 analyzer. Requires the external monitor option.
Quest QC-10 Sound Level Calibrator For calibration of microphone amplifier; operates at 1000 Hz at a level of 114 dB SPL.
Swing Arm Speaker Gives you a wide range of speaker-posi­tion angles and heights to work with when testing in real ear.
Medical Grade External Power Supply For the FP35 to qualify as a medical grade unit, all connections must be with medical grade equipment. This power supply meets medical grade standards.
10 FONIX FP35 Hearing Aid Analyzer
Child Size Wedge Style Earhook Holds probe and reference microphones during real-ear testing.
Infant Headband Package
Used for performing real-ear measure­ments on infants and small children. Includes infant, child, and adult head­bands, six flexible ear hooks, and two sets of “animal ears.”
Single Insert Earphone (RECD)
Consists of one ER3A earphone with a phono plug, a 72 inch cable, an assort­ment of ear tips, a calibration certificate, and a lapel clip. This package is suitable for performing an RECD measurement with the FP35 analyzer. It can also be used for performing audiometric mea­surements with the Audiometer option.
Dual Insert Earphones Pair of insert earphones with special con­nector for performing audiometric mea­surements. Can also be used for RECD measurements.
An Overview of the FP35 11
Dual Insert Earphones Y Cable
3.5 mm stereo phone plug to 1/4” phone jack. Connects dual insert earphone to FP35. Included with the Dual Insert Earphone Option.
Two Microphone System This two microphone setup can be ordered for sound chamber-only FP35 analyzers in order to enable testing with a reference microphone.
Earphone Calibration Adapter
Connects the Insert Earphone to the HA­2 coupler. Included with the Audiometer Option.
Open Fit Coupler Non-standard coupler used for realistic testing of open fit hearing aids.
12 FONIX FP35 Hearing Aid Analyzer
Telewand Allows the measurement of telecoil per ANSI S3.22-1996 and ANSI S3.22-2003. Also allows real-ear telecoil measure­ments.
Telecoil Board Allows the measurement of telecoil in sound chamber measurements.
1.4 Optional Features for the FP35
Real-time Testing: The Composite/Digital Speech Signal Option
In addition to pure-tone test signals, you can purchase the FP35 with the Composite Option, which provides real-time testing capabilities. Besides instantly displaying a curve that updates up to five times a second, this test signal is a more realistic test of compression aids than is a pure-tone sweep. It is a complex signal, made up of seventy-nine speech-weighted frequencies pre­sented simultaneously, that more closely resembles real-world sounds.
The composite signal can uncover the presence of intermodulation distortion in a hearing aid. The curve “breaks up” more and more as the amount of intermod­ulation distortion increases.
External Sound Chamber Connect the FP35 analyzer to an external sound chamber for better sound isolation and positioning. Sound chamber models 6040 and 6050 can be used.
An Overview of the FP35 13
The composite signal is especially important for the measurement of automatic gain control and signal processing hearing aids.
The digital speech signal is a randomly interrupted composite signal used for testing high-end digital aids with “noise-reduction” or “speech enhancement” features. See Appendix F for details.
Real-Ear Option
You can order the FP35 with the Real-Ear Option so that you can do tests on the hearing aid while it is in the client’s ear. It is then possible to individualize the fitting of a hearing aid—a necessary step since a coupler measurement can sel­dom tell the operator exactly what sound is received by the client. Many factors affect sound on its way to the eardrum. By measuring with a probe microphone, you will know what is really happening in your client’s ear.
The probe microphone can also be used as a reference microphone while mak­ing coupler measurements.
External Monitor Option
This hardware option allows the connection of the FP35 analyzer to an external monitor. When connected, the FP35 displays on both its internal LCD monitor and the connected external monitor. Although the display is always only in two colors, most standard flat screen and VGA computer monitors can be used.
IEC
You can add the IEC (International Electrotechnical Commission) test sequence to your FP35 analyzer. This automated sequence lets you test the performance of hearing aids in accordance with the IEC 118-7 standard as amended in 1994.
JIS
An automated test sequence that follows the JIS standard, widely used in Japan.
ANSI
The ANSI 96 and ANSI 03 automated test sequences are available as an option on your FP35. They provide you with the means to quickly and accurately test a hearing aid in accordance with the ANSI S3.22 standard.
CIC Option
This option consists of a 0.4 cc CIC coupler and software correction factors. The CIC correction factors are available in the Coupler Mode by selecting the CIC coupler in the Coupler Menu.
Audiometer Option
This adds pure-tone air audiometric measurements to your FP35 hearing aid analyzer. You can either take the measurements with insert earphones or with a sound field speaker. See Chapter 9 for more details.
14 FONIX FP35 Hearing Aid Analyzer
Note: The FP35 is fully upgradeable. These options can be added to an existing unit.
ISI
An automated test sequence conforming to the Indian ISI IS-10775-1984 standard.
1.5 Setup
Unpack and locate all of the accessories. If you ordered the briefcase as an optional accessory, the FP35 and its accessories will be packed inside. Otherwise, the instrument and its accessories will be packed in boxes.
Keep the shipping box in case you need to send the unit in to us for repair.
Choose a location for your FP35 that is relatively free of ambient noise. Begin by plugging in the power supply to the back panel. See Figure 1.2.3 for an illustra­tion of the back panel.
The FP35 will power up as soon as you plug the power cord into the wall. To power it down again, either unplug it, or push the [OPERATE] key. Unplugging the FP35 turns it completely off; pushing the [OPERATE] key powers the unit down, but the circuit continues to receive power.
1.6 Safety
Once you have power to the unit, you are ready to proceed.
Safety Classification 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 FP35 does not require sterilization or disinfection.
Warning: This equipment is not suitable for use in the presence of flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
Connection of peripheral equipment to the FP35
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 FP35, 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
An Overview of the FP35
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 FP35 complies with IEC 60601-1-2.
The FP35 generates and uses radio frequency energy. In some cases the FP35 could cause interference to radio or television reception. You can determine if the FP35 is the source of such interference by turning the unit off and on.
If you are experiencing interference caused by the FP35, 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 FP35 and the receiver.
3. Connect the FP35 to a different outlet than the receiver.
15
In some cases radio transmitting devices, such as cellular telephones, may cause interference to the FP35. In this case try increasing the distance between the transmitter and the FP35.
Disposal of the FP35 and accessories
The FP35 and some of its accessories contain lead. At the end of its useful life, please recycle or dispose of the FP35 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 the Frye factory:
Frye Electronics, Inc.
9826 SW Tigard St. Tigard, OR 97223 Ph: (503) 620-2722 or (800) 547-8209 Fax: (503) 639-0128 email: support @frye.com sales@frye.com
16 FONIX FP35 Hearing Aid Analyzer
Frye Electronics, Inc. is a Registered Firm of British Standards Institution, and we conform to the ISO 13485 standard.
Safety Classification for IEC 60601-1
Protection against electric shock—Class 1, Type B
Protection against harmful ingress of water—Ordinary
Mode of operation—Continuous
Warning: This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
Warning: Connect only to the power supply packaged with the FP35.
Warning: To comply with IEC 60601-1, all electrical equipment attached to the
FP35 must also comply with these standards. Any video monitors, computer equipment, etc. must be “medical grade” or used with a medical grade isolation transformer.
1.7 Maintenance
We recommend checking the calibration of the FP35 analyzer once a year. See Appendix C for details. Because of the configuration of the FP35, the micro­phones should not go out of calibration. If you perform the checks described in Appendix C and find that the microphones are in need of calibration, contact your local service representative or Frye Electronics because this could be a sign that further repairs to your system are needed.
When used in a hospital environment, where such test equipment is commonly available, periodic current-leakage testing should be done on the power supply while the FP35 is connected. Testing on a yearly basis is sufficient.
1.7.1 Servicing the Instrument
Contact Frye Electronics, Inc., P.O. Box 23391, Tigard, Oregon 97281-3391 for service. Our toll-free number is 1-800-547-8209. Our regular number is (503) 620-2722, or you may contact your local Frye representative. We are also avail­able on the internet. Our e-mail address is: service@frye.com, and our web site is www.frye.com.
Units may be returned to Frye Electronics, Inc., 9826 S.W. Tigard St., Tigard, Oregon 97223. Please contact the company or your local Frye representative
An Overview of the FP35
first, since many problems can be fixed without returning the whole unit. If something must be returned, a return authorization number (RMA) will be issued to be attached to all returned materials.
When contacting the factory, please have the serial number of your instrument on hand. Look for this number on the rear panel of the instrument. It will also be helpful for you to be able to tell us the software version installed on your machine. Check the Opening Screen for this information.
1.7.2 Cleaning the Instrument
For your safety, disconnect the FP35 power supply from the mains power while cleaning.
Wipe the FP35 case with a slightly moist, but not dripping, soft cloth. Use plain water or water with mild dishwashing detergent. Wipe away any detergent with a slightly moist cloth, then dry the FP35.
The LCD surface can be easily damaged so wipe lightly and use a soft, water­dampened cloth to clean it. Do not allow liquid to enter the LCD opening.
The microphones should be wiped with a dry cloth. Excess moisture may dam­age the microphone.
17
The external power supply may be cleaned with a cloth dampened with clean­ing alcohol. Clean the outside of the enclosure only.
Warning: Do not immerse the power supply in water or a safety hazard could arise during use.
Never allow fluid to enter:
• TheLiquidCrystalDisplay(LCD)
• Theelectronicsmodule
• Theelectricalconnectors
• Theexternalpowersupply
Solvents and abrasives will cause permanent damage to the FP35.
1.7.3 Warranty
The FONIX FP35 and its accessories are guaranteed to be free of manufactur­ing defects which would prevent the products from meeting the specifications (given in Appendix A of this manual) for a period of one year from the date of purchase.
Chapter 2 19
General Operation
This chapter describes the general operation of the FP35 analyzer, including basic operation of the keys, screen navigation, default settings, source types, and printing.
2.1 Operation of Keys
The general operation of the various keys on the FP35 analyzer is described in this section. This includes a description of the function keys, the arrow keys, and the Menu, Help, Reset, Exit, Level, Feed, Print, Stop, and Start keys.
2.1.1 Using the Function Keys
There are four basic uses of the function keys:
• Tonavigatefromscreentoscreen
• Totoggleaselection
• Topop-upupaselectionmenu
• Toperformanaction
A short description of the function of the key is always displayed above the key on the bottom of the FP35 display.
Navigation
In the Opening screen, the function keys are used to navigate the various mea­surement screens. See Figure 2.1.1A for a flowchart of the available screens on the FP35 analyzer.
[F2] takes you to one of the real-ear screens: Audiogram Entry, Insertion Gain, Unaided and Aided, or Real-Ear SPL. Once you are in one of these screens, you can move to one of the other screens by using the [NEXT] and [BACK] keys. Audiogram Entry is the default screen, but [F2] will always take you back to the last real-ear screen entered. These screens are only available when the Real-Ear Option is ordered.
[F3] takes you to one of the coupler multicurve screens: Coupler Multicurve, Coupler Target, or Coupler EarSim. You can navigate between these screens using the [NEXT] and [BACK] keys. Coupler Multicurve is the default screen, but [F3] will always take you back to the last coupler multicruve screen entered. Coupler Target and Coupler EarSim are only available with the Real-Ear Option.
[F4] and [F5] are used to take you to an automated test sequence screen. The four available automated test sequences on the FP35 analyzer are: ANSI 96, ACIC, IEC, JIS, and ISI. Only the automated test sequences that you have ordered will be available.
20 FONIX FP35 Hearing Aid Analyzer
Audiogram
Entry
Real-Ear
SPL
Unaided
& Aided
Insertion
Gain
OPENING
SCREEN
Coupler
Multicurve
Coupler
Target
Coupler
EarSim
F2 F3 F4/F5
ANSI
IEC
JIS
ISI
Note: To exit from any screen, press the [EXIT] key.
Figure 2.1.1A—Flowchart of the FP35 screens
Toggle
Pressing a function key in a measurement screen will usually toggle a selection. For instance, pressing [F2] in the Coupler Multicurve screen will toggle through the various curves.
Pop-up Menu
In some cases, a particular function key will have several different available settings. For example, in the Coupler Multicurve screen, [F4] selects the source type for a frequency measurement. You can either push the function key repeat­edly until the desired setting appears, or you can push and hold the key down for half a second to pop up a function key balloon menu.
A function key balloon menu is a listing of all available selections for that key. Choose the desired selection with [ push and hold the function key for half a second again. Figure 2.1.1B shows an example of a Function Key Balloon Menu.
∨, ∧]. When satisfied, press [START/STOP] or
General Operation 21
Action
Sometimes function keys perform an action. For instance, in most measurement screens, [F5] levels the sound chamber. By looking at the label of the function key, you should be able to determine the action of the function key.
Figure 2.1.1B—Function key balloon menu
2.1.2 Using the Local Menus
Each screen contains a local menu that is displayed when you press the [MENU] key.The local menu, overlaid on the current screen, contains only set­tings that pertain to that screen. See Figure 2.1.3. For example, the local menu of a real-ear measurement screen will contain a selection for OUTPUT LIMIT. This setting does not pertain to coupler measurements, so you won’t find that particular item in the local menu of a coupler screen.
In order for the FP35 to be highly configurable for the advanced user, yet easy to operate for the beginner user, we divided the local menus into several different sections. In most cases, these are: the menu, the advanced menu, and the cus­tom menu.
When the [MENU] key is first pressed (in a screen other than the Opening screen), the basic local menu is displayed. This basic menu contains the selec­tions most important to the displayed screen. Advanced users can open the advanced and custom menus by using the [NEXT] and [BACK] keys.
22 FONIX FP35 Hearing Aid Analyzer
There are three different types of menu items: local variables that are only active within the current screen, global variables that are available in all screens that use it, and resetable variables that change to a default value when [RESET] is pressed or the unit is first turned on. Resetable variables can be local or global. Most global and resetable variables are available in the Default Settings menu. Local variables are not available in the Default Settings screen.
You can always tell what type a variable is by looking at the dash sequence next to it in one of the menus. Local variables use a series of small dots. Global vari­ables use a series of large dots. Resetable variables use a series of short dashes. See Figure 2.1.2.
Figure 2.1.2—Local menu of the Coupler Multicurve screen
Details on the behavior of menu items:
Local variables are not available in the Default Settings menu. When the analyz­er is first powered on, local variables are set to a factory defined default setting, but they are not normally changed back to the default setting when [RESET] is pressed. (There are some exceptions.)
When you change a resetable variable in the Default Settings menu, it will impact that variable in all local menus where it is available. However, chang­ing a resetable variable in a local menu will not change its value in the Default Settings menu. When [RESET] is pressed, the local variable will revert back to the value defined in the Default Settings menu.
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