Interacoustics AC40 User manual

D-0107562-D – 2017/05
Instructions for Use
AC40
Clinical Audiometer
Instructions forUse
Manual deinstrucciones
Instruções de Utilização
Οδηγίες χρήσης
Naudojimo instrukcijos
Upute za uporabu
Lietosanas instrukcija
Instrukcja obsługi
Návod k použitı
Navodila za uporabo naprave
Brugsanvisning
Bruksanvisning
Käyttöohjeet
Gebrauchsanweisung
Istruzioni per l'uso
Instructions d’utilisation
Gebruikshandleiding
Инструкция по применению
Instructions for Use (USA)

Instructions for Use - EN
Clinical Audiometer AC40

Table of Contents
1INTRODUCTION...........................................................................................................................1
1.1 About this Manual ...............................................................................................................1
1.2 Intended Use.......................................................................................................................1
1.3 Product Description.............................................................................................................1
1.4 Warnings.............................................................................................................................2
2UNPACKING AND INSTALLATION ............................................................................................3
2.1 Unpacking and Inspection...................................................................................................3
2.2 Marking................................................................................................................................ 4
2.3 General Warnings and Precautions....................................................................................4
3GETTING STARTED - SETUP AND INSTALLATION................................................................. 7
3.1 Back Panel External Connections – Standard Accessories ...............................................8
3.2 PC-Interface........................................................................................................................8
3.3 Patient Communication and Monitoring..............................................................................9
3.3.1 Talk Forward.............................................................................................................9
3.3.2 Talk Back ................................................................................................................9
3.3.3 Assistant Monitor ......................................................................................................9
3.3.4 Monitoring ................................................................................................................9
3.4 Operating instructions .......................................................................................................10
3.5 Tests Screens and Function Key Descriptions.................................................................18
3.5.1 Tone Test ..............................................................................................................19
3.5.2 Stenger Test ...........................................................................................................20
3.5.3 ABLB - Fowler Test.................................................................................................20
3.5.4 Tone in Noise Test (Langenbeck Test)...................................................................20
3.5.5 Weber ..............................................................................................................21
3.5.6 Pediatric Noise Stimuli............................................................................................21
3.5.7 Speech Test............................................................................................................22
3.6 Setup ................................................................................................................................33
3.6.1 Instrument Setup.....................................................................................................34
3.6.2 Common settings - AUD.........................................................................................34
3.6.3 Tone setting ............................................................................................................36
3.6.4 Speech settings ......................................................................................................37
3.6.5 Auto settings ...........................................................................................................38
3.6.6 MLD settings...........................................................................................................39
3.6.7 Sessions and clients...............................................................................................40
3.7 Printing ..............................................................................................................................41
3.8 AC40 Stand Alone Unit, Print Logo Update......................................................................41
3.9 Diagnostic Suite ................................................................................................................43
3.9.1 Instrument setup.....................................................................................................43
3.9.2 SYNC Mode............................................................................................................44
3.9.3 The Sync Tab..........................................................................................................44
3.9.4 Client Upload ..........................................................................................................44
3.9.5 Session download...................................................................................................45
3.10 Hybrid (Online/PC-Controlled) Mode ................................................................................46
4MAINTENANCE..........................................................................................................................47
4.1 General Maintenance Procedures ....................................................................................47
4.2 How to clean Interacoustics Products...............................................................................48
4.3 Concerning Repair ............................................................................................................48
4.4 Warranty............................................................................................................................49
5GENERAL TECHNICAL SPECIFICATIONS..............................................................................51
5.1 Reference Equivalent Threshold Values for transducers .................................................53
5.2 Maximum hearing level settings provided at each test frequency....................................53
5.3 Pin Assignments ...............................................................................................................53
5.4 Electromagnetic Compatibility (EMC) ...............................................................................53

AC40 Instructions for Use - EN Page 1
1Introduction
1.1 About this Manual
This manual is valid for the AC40. These products are manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
1.2 Intended Use
The AC40 audiometer is designed to be a device for diagnosing hearing loss. Output and specificity of this
type of device are based on the test characteristics defined by the user, and may vary depending on
environmental and operating conditions. The diagnosing of hearing loss using this kind of diagnostic
audiometer depends on the interaction with the patient. However, for patients not responding well
possibilities of various tests allow the tester to have at least some evaluative result. Thus, a “normal hearing”
result should not allow for ignoring other contra indications in this case. A full audiologic evaluation should be
administered if concerns about hearing sensitivity persist.
The AC40 audiometer is intended to be used by an audiologist, hearing healthcare professional or trained
technician in an extremely quiet environment according to the ISO standard 8253-1. This instrument is
intended for all patient groups regarding sex, age and health provided that the patient is able to respond to
the signals in a rational way.Careful handling of the instrument whenever in contact with a patient should be
of high priority. Calm and stable positioning while testing is preferred for optimal accuracy.
1.3 Product Description
The AC40 is a full 2 channel clinical audiometer offering air, bone, speech and built in free field amplier. It
offers a wide range of clinical test features such as high frequency, multi frequency, weber, SISI, etc.
Included Parts
AC40
Goose neck 1059 microphone
DD45 Audiometric headset
B81 bone conductor headset
2 x APS3 Patient response switch
HDA300 Phone headset for HF
Cleaning cloth
Power cable
Instructions for Use AC40
Monitor Headset with boom

AC40 Instructions for Use - EN Page 2
Optional Parts
TDH39AA with Amplivox Headset
DD450 Audiometric headset
Eartone 5A 10 Ohm
B71 bone conductor headset
Eartone 3A 10 Ohm
IP30 insert phone 10 Ohm
CIR33 insert earphone kit for masking or
monitoring
Amplivox audiocups, noise reducing headset
Talk back microphone
Sound field speakers SP90 (with external
power amp)
AP12 Power Amplifier 2x12 Watt
AP70 Power Amplifier 2x70 Watt
Cable USB 2m
Diagnostic Suite
OtoAccess™ database
1.4 Warnings
Throughout this manual the following meaning of warnings, cautions and notices are used:
WARNING indicates a hazardous situation which, if not avoided, could result
in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in damage of the equipment..
NOTICE NOTICE is used to address practices not related to personal injury or
damage of the equipment.

AC40 Instructions for Use - EN Page 3
2Unpacking and Installation
2.1 Unpacking and Inspection
Check box and contents for damage
When the instrument is received please check the shipping box for rough handling and damage. If the box is
damaged it should be kept until the contents of the shipment have been checked mechanically and
electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the
carrier’s inspection and insurance claim.
Keep carton for future shipment
The AC40 comes in its own shipping carton, which is specially designed for the AC40. Please keep this
carton. It will be needed if the instrument has to be returned for service.
If service is required please contact your local distributor.
Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the
accessories should be checked visually for scratches and missing parts.
Report immediately any faults
Any missing part or malfunction should be reported immediately to the supplier of the instrument together with
the invoice, serial number, and a detailed report of the problem. In the back of this manual you will find a
"Return Report" where you can describe the problem.
Please use "Return Report"
Please realise that if the service engineer does not know what problem to look for he may not find it, so using
the Return Report will be of great help to us and is your best guarantee that the correction of the problem will
be to your satisfaction.
Storage
If you need to store the AC40 for a period, please ensure it is stored uder the conditions specified in the
section for technical specifications:

AC40 Instructions for Use - EN Page 4
2.2 Marking
The following marking can be found on the instrument:
Symbol
Explanation
Type B applied parts.
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.
0123
The CE-mark indicates that Interacoustics A/S 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.
Year of manufacture
Do not re-use
Parts like ear-tips and similar are for single use only
Display Port Connection – HDMI type
2.3 General Warnings and Precautions
External equipment intended for connection to signal input, signal output or other connectors shall comply
with relevant IEC standard (e.g. IEC 60950 for IT equipment). In these situations an optical isolator is
recommended to fulfill the requirements. Equipment not complying with IEC 60601-1 shall be kept outside
the patient environment, as defined in the standard (usually 1.5 meter). If in doubt, contact qualified medical
technician or your local representative.
This instrument does not incorporate any separation devices at connections for PCs, printers, active
speakers etc. (Medical Electrical System).

AC40 Instructions for Use - EN Page 5
When the instrument is connected to a PC and other items of equipment of a medical electrical system
assure that the total leakage current cannot exceed the safety limits and that separations have the dielectric
strength, creepage clearances and air clearances required fulfilling the requirements of IEC/ES 60601-1.
When the instrument is connected to a PC and other similar items be aware of not touching the PC and
patient simultaneously
To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective
earth.Do not use any additional multiple socket-outlet or extension cord.
This instrument contains a coin-type lithium battery. The cell can only be changed by service personnel.
Batteries may explode or cause burns, if disassembled, crushed or exposed to fire or high temperatures. Do
not short-circuit.
No modification of this equipment is allowed without Interacoustics authorization.
Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, or other information that will assist service personnel to repair those parts of this audiometer that
are designated by the Interacoustics as repairable by service personnel
Never insert or in any way use the insert headset without a new clean non defect test tip. Always make sure
that foam or ear-tip is mounted correctly. Ear tips and foam are single use.
The instrument is not intended to be used in environments exposed to fluid spills.
It is recommended that the disposable foam ear tips supplied with the optional insert transducers are
replaced after testing each patient. Disposable plugs also ensure that sanitary conditions exist for each of
your patients, and that periodic cleaning of a headband or cushion is no longer required.
•The black tubing protruding the foam ear tip is attached to the sound tube nipple of the insert
transducer.
•Roll the foam tip into the smallest possible diameter.
•Insert into the ear canal of the patient.
•Hold the foam tip until expanded and a seal is achieved.
•After testing the patient the foam tip including the black tubing is detached from the sound tube
nipple.
•The insert transducer should be examined prior to attaching a new foam tip.
The instrument is not intended to be used in oxygen rich environments or use in conjunction with flammable
agents.
To ensure correct cooling of the device, please ensure free air flow on all sides of the instrument. Make sure
that cooling ribbons are not covered. It is recommended to place the instrument on a hard surface.
NOTICE
To prevent system faults take appropriate precautions to avoid PC viruses and similar.
Use only transducers calibrated with actual instrument. To identify a valid calibration, the serial number for
the instrument will be marked on the transducer.
Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used adjacent
to other equipment it must be observed that no mutual disturbance appears.Please also refer to EMC
concideration in the appendix.

AC40 Instructions for Use - EN Page 6
Within the European Union it is illegal to dispose electric and electronic waste as unsorted
municipal waste. Electric and electronic waste may contain hazardous substances and
therefore has to be collected separately. Such products will be marked with the crossed-out
wheeled bin shown below. The cooperation of the user is important in order to ensure a high
level of reuse and recycling of electric and electronic waste. Failing to recycle such waste
products in an appropriate way may endanger the environment and consequently the health of
human beings.
To prevent system faults take appropriate precautions to avoid PC viruses and similar.

AC40 Instructions for Use - EN Page 7
3Getting Started - Setup and Installation
The following shows an overview of the AC40:
The top left part of the AC40 (display holder) contains the two monitor speakers.
The left side of the instrument contains two mini jack connectors for a microphone and a headphone – or
a headset. This is used for talkback headphone/speaker (TB) and talk forward microphone (TF). Next to
that two USB connectors are located. These can be used for connecting external printers/keybaords and
USB sticks for installing firmware/wave file material.
A swan neck microphone can be plugged into the top part of the instrument by top part of Talk Forward
button. This can be used for talk forward. When not in the swan neck microphone can be placed
underneath the display. Please refer to the section about patient communication for more.
The upper right side of the instrument holds the on/off switch of the instrument.
Make sure that the audiometer is placed so that the patient cannot see/hear the clinician’s use of the
instrument.
Back Panel – connectors – see next page
Microphone
and
Headphnoe
(Headset)
mini jacks +
2 USB
connectors
Power
on/off
Front Panel
display &
buttons/dials
Talk forward mic.
Monitors
peaker

AC40 Instructions for Use - EN Page 8
3.1 Back Panel External Connections – Standard Accessories
The back panel contains all the rest of the main connectors (sockets):
Special notes:
•The HLS (hearing loss simulator) connector is currently not used. Use the Standard Headphone
and HF Headphone connectors for HLS. This is prepared for future use.
•In addition to the standard DD45 headset, four other air conduction transducers may be used
(they all connect to specific outputs on the AC40):
•HDA300: High Frequency requires a HF headset.
•CIR33 for insert masking: Insert phone CIR33 for insert masking has a limited sound
quality, making it only adequate for masking noise presentation.
•EAR-Tone 3A or 5A general purpose insert phone: Insert headphone EAR-Tone 3A or
5A are high quality transducers that may be used instead of the DD45/TDH39. It
improves cross hearing from the normal approximately 40dB of the TDH39 to
approximately 70dB. Masking as well as avoiding over-masking is thus easier with this
type of headphone.
•IP30 insert phone is the standard insert phone with same properties as EAR-Tone 3A
•Currently FF3/FF4 (both the powered and non-powered) is not used. This is prepared for future
use.
•Assistant Monitor: There is always a direct connection through the goose neck microphone to the
assistant wearing a headset connected to the “Assistant Monitor” output.
•The LAN connection is currently not used for any application (only internally in production).
•Mic 2: Please refer to the section about Patient Communication (Talk Forward and Talk Back).
•When using the HDMI output the output resolution will be the saved as on the build in 8,4 inch
display: 800x600.
•CD-input: It is required that any attached CD-player has a linear frequency response in order to
comply with the requirements of IEC 60645-2.
•USB connections is used for:
•PC connection to Diagnostic Suite (the large USB connector)
•Direct print
•PC-keyboard (for entering client names)
3.2 PC-Interface
Please refer to the Diagnostic Suite operation manual regarding hybrid mode (on-line and PC-operated
mode) as well as patient/session data transfer.
Power
connector
LAN (for
future use)
USB connectors
for printer, PC-
connection &
keyboard
HDMI output
for external
monitor (e.g.
for patient
counceling)
Free Field 1
and 2
(external
amplificatio
n needed)
Standard
Headphone
s
DD45/TDH3
9/HDA300
Bone conductor
B81 /B81
1 / 2
Insert
masking
Patient
Response
Switch 1 / 2
Extra Talk
forward
mic., e.g.
for table
mic.
External
CD / MP3
input
For Talk
Back
Speaker
High Freq.
Left / Right
Amplified
Free Field
outputs
(2x20
Control
output
Assistant
Monitor
Standard
Insert Phone
EarTone 3A
/ IP30

AC40 Instructions for Use - EN Page 9
3.3 Patient Communication and Monitoring
3.3.1 Talk Forward
Talk Forward is activated by the “Talk Forward” button (24). AC40 contains three microphone connectors
which will work in the following priority (depending on which one(s) is connected):
•Priority 1: The mini jack in the left side of the instrument – can be used with a headset together with
the headphone connector. This has the first priority.
•Priority 2: The swan neck microphone (1) of the AC40 is located above the “Talk Forward” (24)
button. If no mic. is connected to the priority 1 mic., this with be used.
The image below will be shown while the talk forward is active (by hold the button down) where the
calibration (gain) level and intensity level for patient communication can be adjusted. To change the
calibration level the clinician would adjust the HL dB dial (57) to the appropriate level. To adjust the
Intensity level the dial in channel 2 (58) would be used.
3.3.2 Talk Back
The operator may use Talk Back (38) in one of the following ways:
•If no headphone is connected to the Talk Back (left side connector), the voice is wired through
the Talk Back speakers next to the display (2)(3).
•If a headphone/headset is connected to the instrument, talk back will come through this instead.
To adjust the TB level, hold down the TB button and use left/right totary wheels to adjust the level.
3.3.3 Assistant Monitor
There is always a direct connection through the goose neck microphone to the assistant wearing a
headset connected to the “Assistant Monitor” output.
3.3.4 Monitoring
Monitoring of channel 1, 2 or both channels together is available by selecting the “Monitor” button (52)
once, twice or three times. Selecting it a fourth time will switch off the monitoring function again. To adjust
the monitor levels, hold down the monitor button and use left/right totary wheels to adjust the level.
Selecting desired way of listening:
The monitor signal will be available through the monitor headset if connected, the internal monitor
speaker, or through the power monitor output driving an external speaker.

AC40 Instructions for Use - EN Page 10
3.4 Operating instructions
The figure below shows the outline of the front plate of the AC40 including buttons, dials and display:
The following table describes the functions of the various buttons and dials.
Name(s)/Function(s)
Description
1
Microphone
For live voice speech and talk forward instruction to the patient in
the test cabin. Can be deattached and stored in the compartment
under the display.
2
Talk back / Monitor
Speaker
For speech feedback from the patient in the test cabin. To adjust
the TB / monitor levels, hold down the TB / monitor button and use
left/right totary wheels to adjust the level.
3
Talk back / Monitor
Speaker
For speech feedback from the patient in the test cabin. To adjust
the TB / monitor level, hold down the monitor button and use
left/right totary wheels to adjust the level.
4
Color Display Screen
For displaying the different test screens. Will be further explained
in the sections describing the individual tests.
5
Tone Indicator
Channel 1
Indication light is seen when a tone stimuli is presented to the
patient on channel 1 (“Stim”).
6
Tone Indicator
Channel 2
Indication light is seen when a tone stimuli is presented to the
patient on channel 2 (“Stim”).
(1)
(2)
(3)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25)
(26)
(27)
(28)
(29)
(30)
(31)
(32)
(33)
(34)
(35)
(36)
(37)
(38)
(39)
(40)
(41)
(42)
(43)
(44)
(45)
(46)
(47)
(48)
(49)
(50)
(51)
(52)
(53)
(54)
(55)
(56)
(57)
(58)
(59)
(60)
(4)
(5)
(6)
(7)
(9)
(8)

AC40 Instructions for Use - EN Page 11
7
Response Indicator /
VU meter
Indication light is seen when the patient activates the patient
signal using the patient response. A red indicator is used for
patient response 1 and a blue is used for patient response 2:
VU meter indicator:
Hold in the Mic (27) and CD (28) button in to adjust the live voice
or CD input level using the left and right rotary wheels. Adjust the
levels for the until you reach
an average of approximately 0 dB VU on the VU meter.
8
Channel 1
Indicates intensity level for channel 1, e.g.:
9
Channel 2 / Masking
Indicates intensity level or masking level for channel 2, e.g.:
10-17 Function Keys These keys are context sensitive and depend on the selected test
screen. The fuctions of these keys will be explained further in later
sections.
18 Shift The shift function will enable the clinician to activate the sub
functions written in italic underneath the buttons.
It can also be used for the following important operations:
To activate binaural two channel tone/speech testing – e.g. route
Tone/Speeh in both Right and Left channels binaurally. In this
case both the Right and Left buttons lights will be on.
When running wave file in manual mode, it can be used to select
which word to play, i.e. by holding down shift in combination with
the left rotary wheel (57). Use the tone switch (59) to play the
selected word before scoring it.
To activate Uninstall under Common settings.
19
Setup
Allows the clinician to make changes in certain settings within
each test and to change the common settings for the instrument.
A single push will by default enter the selected Test Settings
menu. To enter other settings menus, hold the “Setup” button and
use on of the rotary wheels (57)/(58) to select:

AC40 Instructions for Use - EN Page 12
To save the settings use “Save all settings as...”.
To use another user setting (protocol/profile) use “Load user
settings: ....”.
Inside a settings menu, choose between the different settings
using the right rotary wheel (58). Change the individual settings
using the left rotary wheel (57). Here is an example from the Tone
settings dialog where “Aided” is in focus:
20
Tests
Allows the clinician to access special tests. Hold down the “Tests”
button and use one of the rotary wheels (57)/(58) to select the
Individual test.

AC40 Instructions for Use - EN Page 13
Note that the tests available in this list depends on the test
licenses installed on the instrument. This may also vary from
country to country.
21
Del Point /
del curve
Delete points during testing by selecting a point using the “Down”
(55) and “Up” (56) buttons and pressing the “Delete Point” button.
Delete the entire test curve of a graph by holding “Shift” (18) and
pressing the “Del Point” button.
22
Save Session/
New Session
Save a session after testing or alternatively create a new session
by holding “Shift” (18) and pressing the “Save Session” button.
In the Save Session menu it is possible to save sessions, delete
and create clients and edit client names.
The maximum capacity is 1000 clients. Please see section below
for a screenshot of the Save Session dialogue.
23
Print
Clients
Allows results to be printed directly after testing (via a supported
USB printer – please contact Interacoustics customer service for a
list of supported PC printers if in doubt). The printout logo can be
configured via the Diagnostic Suite (in the General Setup a logo
image can be downloaded to the instrument from the PC). Please
refer to the Diagnostic Suite manual.

AC40 Instructions for Use - EN Page 14
Hold ”Shift” (18) and press “Print” to access the clients and
sessions stored on the device.
24
Talk Forward
Instruction to the patient directly through his headphones via the
microphone (1) can be given. Change the gain by turning the left
rotary wheel (57) while holding the “Talk Forward” button. Change
the intensity by turning the right rotary wheel (58) while holding
the “Talk Forward” button. Please read more about Talk
Forward/Talk Back in later section about “Patient
Communication”.
25
Tone/Warble
Channel 1
Pure tones or warble tones can be chosen as stimuli on channel 1
by activating this button once or twice. The stimuli chosen will be
shown on the display, e.g.:
The (optional) Pediactric Noise stimuli can be acticated from the
Test (20) menu. When this stimulusi is selected the Warble light
indicater will blink in a slow interval.
26
Wavefile
Channel 1
Enables one to perform speech testing on channel 1 using loaded
wave files, i.e. pre-recorded speech material. Requires installation
of speech material.
27
1 Mic 2
Channel 1
For live speech testing through the microphone (1) (or
alternatively Mic 2 if connected) on channel 1. The VU meter can
be seen on the display screen. Adjust the microphone gain by
holding down the Mic button for one second and turning one of the
rotary wheels (57)/(58) while holding the Mic button.
28
1 CD 2
Channel 1
By pressing this function once or twice it is possible to have
recorded speech in either channel 1 or channel 2 separately.
Adjust the gain of CD 1 and 2 by holding down the CD button for
one second and turning one of the rotary wheels (57)/(58).
29
NB N
Channel 1
Choose between Narrow Band Noise and Broad Band Noise on
channel 1.
30
1 2 5
Choose between 1, 2 and 5 dB intervals when adjusting the
intensity levels in channel 1 and 2 or adjusting the masking level
when masking is used.
31
Ext Range
Extended Range: Usually the maximum output is e.g. 100 dB but
if a higher output e.g. 120 dB is needed then “Ext Range” can be
activated when reaching a certain level.
32
Sync
This allows the masking attenuator to the tone attenuator to be
activated. This option is used for e.g. synchronous masking.
33
Tone / Warble
Channel 2
Pure tones or warble tones can be chosen as stimuli on channel 2
by activating this button once or twice. The stimulus chosen will
be shown on the display, e.g.: