Interacoustics AD528 User manual

Instructions for Use
AD528
EN Instructions for Use
ES Manual de instrucciones
FR Instructions d’utilisation
DE Gebrauchsanweisung
Science made smarter
D-0121151-B – 2018/11

Table of Contents
1Introduction................................................................................................................................1
1.1 About this manual...................................................................................................................1
1.2 Intended use...........................................................................................................................1
Contraindications .........................................................................................................1
1.3 Product description.................................................................................................................2
1.4 Warnings and precautions .....................................................................................................2
2Unpacking and installation.......................................................................................................3
2.1 Unpacking and inspection ......................................................................................................3
2.2 Symbols..................................................................................................................................4
2.3 Important safety instructions ..................................................................................................5
Electrical system safety ...............................................................................................5
Electrical safety............................................................................................................5
Explosion hazards........................................................................................................6
Electromagnetic compatibility (EMC) ...........................................................................6
Cautions – General ......................................................................................................6
Environmental factors ..................................................................................................7
NOTICE:.......................................................................................................................7
2.4 Connections ...........................................................................................................................8
Safety precautions to take when connecting the AD528 .............................................8
2.5 License ...................................................................................................................................9
3Operating instructions............................................................................................................11
3.1 AD528 operation panel ........................................................................................................12
3.2 Startup & Setup ....................................................................................................................14
About..........................................................................................................................14
Instrument settings.....................................................................................................14
Common settings .......................................................................................................15
Tone settings..............................................................................................................16
Speech settings..........................................................................................................17
Auto settings ..............................................................................................................17
3.3 Clients and sessions ............................................................................................................18
Save session..............................................................................................................18
Clients ........................................................................................................................18
Edit a client or add a new client .................................................................................19
3.4 Operating instructions – audiometry ....................................................................................20
Tone audiometry test screen .....................................................................................20
Weber.........................................................................................................................21
3.4.2.1 Stenger .................................................................................................................21
3.4.2.2 SISI - Short increment sensitivity index ................................................................22
3.4.2.3 ABLB – Alternate Alternate Binaural Loudness Balancing (Fowler).....................22
3.4.2.4 Tone in noise (Langenbeck) .................................................................................22
Speech audiometry ....................................................................................................23
3.4.3.1 Adjustment of input for speech .............................................................................24
3.4.3.2 Speech in noise ....................................................................................................25
Auto testing ................................................................................................................25
3.4.4.1 Bekesy ..................................................................................................................25
3.4.4.2 Hughson-Westlake................................................................................................25

4Maintenance.............................................................................................................................27
4.1 General maintenance procedures........................................................................................28
4.2 Repair...................................................................................................................................29
4.3 Warranty...............................................................................................................................29
4.4 Calibration properties ...........................................................................................................30
5Technical specifications.........................................................................................................31
5.1 Reference equivalent threshold values for transducers & Maximum hearing level
settings .................................................................................................................................34
5.2 Pin Assignments...................................................................................................................40
5.3 Electromagnetic Compatibility (EMC) ..................................................................................41

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 1
1Introduction
1.1 About this manual
This manual is valid for Interacoustics Diagnostic Audiometer AD528. The product is 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
Indications for use
The Interacoustics AD528 is intended for use by trained operators in hospitals, nurseries, ENT clinics and
audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic
disorders.
Intended operator
Trained operators like audiologist, hearing healthcare professional, or trained technician.
Intended population
No restrictions.
Contraindications
None known.

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 2
1.3 Product description
The AD528 is a type 2 audiometer offering air, bone, speech and free field line output. It offers a wide range
of clinical test features such as SISI, ABLB, Stenger, and Békésy.
The AD528 consists of the following parts:
Included parts
AD528 instrument
Power supply
UES24LCP-120200SPA
Audiometric headset DD451/IP301
Bone conductor
B71
1
Patient response APS31
Instructions for use
Multilingual
Optional parts
Audiometric headset
DD450
1
/IP30
1
/DD45
1
Insert masking transducer IP30 single1
Monitor headset
MTH400m
Talk back EM400 Electret Microphone/EMS400 Electret Microphone
Free field speakers
SP90 w. amplifier/SP90A
Printer
HM-E300 printer/A4 printer (HP PLC 3/HP PLC3GUI)
Diagnostic Suite software/ ADI Sync
OtoAccessTM database Patient database
1.4 Warnings and precautions
Throughout this manual, the following definitions of warning, caution and notice are used:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE
NOTICE is used to address practices not related to personal injury.
Federal law restricts this device to sale by or on the order of a licensed medical practitioner
1Applied part according to IEC60601-1
WARNING
CAUTION

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 3
2Unpacking and installation
2.1 Unpacking and inspection
Keep the shipping box for future shipment
Please store the AD528 shipping box. It will be needed if the instrument has to be returned for service. If
service is required please contact your local distributor.
Inspect before connection
Prior to connecting the product it should be inspected for damage again. 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. In case of a serious incident the manufacturer should
be notified as well as the competent authority in patient’s home country.
Please use the ‘Return Report’
Use of the Return Report provides the service engineer with the relevant information to investigate the
reported issue. Without this information, there may be difficulty in determining the fault and repairing the
device. Please always return the device with a completed Return Report in order to guarantee that correction
of the problem will be to your satisfaction.
Storage
If you need to store the AD528 for a period, please ensure that it is stored under the conditions specified in
the section for technical specifications.

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 4
2.2 Symbols
The following symbols can be found on the instrument, accessories or packaging:
Symbol
Explanation
Type B applied parts
Follow instructions for use
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 recycling.
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
Manufacturer
Serial number
Reference number
Indicates a component is intended for one use, or for use on a single patient during
a single procedure. Cross contamination risk.
Stand by
Keep dry
Transport and storage temperature range
Transport and storage humidity limitations
ETL listing mark
Logo
REF

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 5
2.3 Important safety instructions
Read these instructions carefully and completely before using the product
Electrical system safety
When connecting the instrument to the computer, the following warnings must
be observed:
This equipment is intended to be connected to other equipment thus forming a
Medical Electrical System. External equipment intended for connection to
signal input, signal output or other connectors shall comply with the relevant
product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series
for medical electrical equipment. In addition, all such combinations – Medical
Electrical Systems – shall comply with the safety requirements stated the
general standard IEC 60601-1, edition 3, clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601-1 shall be kept
outside the patient environment i.e. at least 1.5 m from the patient support or
shall be supplied via a separation transformer to reduce the leakage currents.
Any person who connects external equipment to signal input, signal output or
other connectors has formed a Medical Electrical System and is therefore
responsible for the system to comply with the requirements. If in doubt, contact
qualified medical technician or your local representative. If the instrument is
connected to a PC (IT equipment forming a system) ensure not to touch the
patient while operating the PC.
A Separation Device (isolation device) is needed to isolate the equipment
located outside the patient environment from the equipment located inside the
patient environment. In particular such a Separation Device is required when a
network connection is made. The requirement for the Separation Device is
defined in IEC 60601-1 clause 16
Electrical safety
Do not modify this equipment without authorization of Interacoustics Do not
disassemble or modify the product as this may impact on the safety and/or
performance of the device. Refer servicing to qualified personnel.
For maximum electrical safety, turn off the power when it is left unused
The power plug shall be placed so it is easy to pull out the plug
Do not use any additional multiple socket-outlet or extension cord. For safe
setup please refer to section 2.4.1.
Do not use the equipment if it is showing visible signs of damage.
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.
The instrument is not protected against ingress of water or other liquids. If any
spillage occurs, check the instrument carefully before use or return for service.
WARNING
WARNING

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 6
No part of the equipment can be serviced or maintained while in use with the
patient.
Explosion hazards
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the instrument in a highly oxygen-enriched environment, such as
a hyperbaric chamber, oxygen tent, etc.
Before cleaning make sure to disconnect power source
Electromagnetic compatibility (EMC)
Although the instrument fulfills 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 the
appendix regarding EMC.
Use of accessories, transducers and cables other than specified, with the
exception of transducers and cables sold by Interacoustics or representatives,
may result in increased emission or decreased immunity of the equipment. For
a list of accessories, transducers and cables that fulfil the requirements please
also refer to the appendix regarding EMC..
Cautions – General
If the system is not functioning properly, do not operate it until all necessary
repairs are made and the unit is tested and calibrated for proper functioning in
accordance with Interacoustics’ specifications.
Do not drop or in any other way cause undue impact to this device. If the
instrument is damaged, return it to the manufacturer for repair and/or
calibration. Do not use the instrument if any damage is suspected.
This product and its components will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual,
accompanying labels, and/or inserts. A defective product should not be used.
Make sure all connections to external accessories are secured properly. Parts
which may be broken or missing or are visibly worn, distorted, or contaminated
should be replaced immediately with clean, genuine replacement parts
manufactured by or available from Interacoustics.
Interacoustics will make available on request circuit diagrams, component part
lists, descriptions, calibration instructions, or other information that will assist
authorized service personnel to repair those parts of this instrument that are
designated by Interacoustics as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the
patient.
WARNING
CAUTION
CAUTION

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 7
Connect only accessories purchased from Interacoustics to the instrument.
Only accessories which have been stated by Interacoustics to be compatible
are allowed to be connected to the device.
Never insert, or in any way use, the insert headset without a new clean and
non-defective ear-tip. Always make sure that the foam or ear-tip is mounted
correctly. Ear-tips and foam are for single use only.
The instrument is not intended for use in environments exposed to fluid spills.
Check calibration if any parts of the equipment are exposed to shock or rough
handling.
Components marked for ‘single use’ are intended for a single patient during a
single procedure, and there is a risk of contamination if the component is re-
used.
Components marked for ‘single use’ are not intended to be reprocessed.
Use only transducers calibrated with the actual instrument.
Environmental factors
Storage outside temperature range as specified in Section 5 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can come into contact with
any of the electronic components or wiring. Should the user suspect fluids have
contacted the system components or accessories, the unit should not be used
until deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind, and allow
sufficient space around the instrument to ensure proper ventilation.
NOTICE
To prevent system faults take appropriate precautions to avoid PC viruses and
similar.
Within the European Union, it is illegal to dispose of electric and electronic items
in 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 symbol, 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.
Outside the European Union, local regulations should be followed when disposing
of the product after end of life.
CAUTION

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 8
2.4 Connections
Name
Description
Power
Use only power supply UES24LCP-120200SPA
PC USB
For PC connection
USB
For printer/mouse/keyboard/USB pen
Pat. Resp.
Patient response
TB
Input for talk back microphone
TF
Talk forward in headset
Monitor
Monitor headset
AUX
AUX (stereo mini jack)
FF1
Free field 1
FF2
Free field 2
Bone
Bone conductor
Ins. Left
Ins. Mask.
Insert left
Insert masking
Ins. Right
Insert right
Left
Audiometry left output
Right
Audiometry right output
Safety precautions to take when connecting the AD528
Use only power supply UES24LCP-120200SPA.
The separable mains plug for UES24LCP-120200SPA is used to safely
disconnect mains from the device. Do not position the power supply in a
position so that it is difficult to disconnect the device.
Please note that if connections are made to standard equipment such as
printers and networks, special precautions must be taken in order to maintain
medical safety. Please follow the instructions below.
WARNING
WARNING
WARNING

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 9
Fig 1. AD528 used with the medically approved power supply.
Fig. 2. AD528 used with a wired connection to a PC and printer.
Fig. 3 AD528 used with a direct printer.
Fig. 4 AD528 used with a thermal printer.
2.5 License
When you receive the AD528, it already contains the license you have ordered. If you would like to add
licenses that are available for the AD528, please contact your local distributer.

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 10

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 11
3Operating instructions
When operating the instrument, please observe the following guidelines:
1. Use this device only as described in this manual.
2. Use only the disposable SanibelTM ear-tips designed for use with this instrument.
3. Always use a new ear-tip for each patient to avoid cross-contamination. The ear-tip is not designed
for reuse.
4. Keep the box of ear-tips outside the reach of the patient. Risk of choking.
5. Be sure to use only stimulation intensities acceptable to the patient.
6. Clean the headphone cushion regularly using a recognized disinfectant (70% isopropyl alcohol), or
use the disposable ear cushion covers.
7. The presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing
when high intensity stimuli are used.
NOTICE
1. The AD528 should be operated in a quiet environment, so that measurements are not influenced by
external acoustic noises. This may be determined by an appropriately skilled person trained in
acoustics. ISO 8253-1 section 11, defines guidelines for permissible ambient noise for audiometric
hearing testing.
2. It is recommended that the instrument be operated within an ambient temperature range of as
specified in technical specifications.
3. The headphone and insert phone are calibrated to the AD528 – introducing transducers from other
equipment requires a recalibration.
4. Never clean the transducer housing with water or insert non-specified instruments into the
transducer.
5. Do not drop or cause any other undue impact to this device. If the instrument is dropped or in any
other way damaged, return it to the manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
CAUTION

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 12
3.1 AD528 operation panel
No
Name
Description
1
Speaker
The speaker is used for the talk back and monitor if the speaker in the monitor
headset is not plugged in.
2
Microphone
The microphone is used for the talk forward if the microphone in the monitor
headset is not plugged in.
Hardkeys
3
Turns AD528 ON/OFF.
4
Shift
The shift key activates the sub functions of the other keys.
5
Setup
Hold down Setup and use the wheels to select the desired setup menu. Let go
of the Setup button to open it.
6
Function keys
The 6 function keys hold functions displayed on the screen directly above the
individual F-key. The function depends on the test screen.
7
Del Point
Del curve
Delete points during audiometry testing.
Delete the entire audiometry threshold curve of a graph by holding shift together
with this button.
8
Save session
New session
Saves the current session.
Create a new session by pressing shift together with this button. A new session
will recall the default settings.
9
Print
Clients
Prints the session to the printer set in Instrument settings – Printer.
Press the Clients button to open a window in which a client can be selected,
session viewed and if needed deleted.

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 13
Patient communication
10
Talk Forward
Allows for communication with the patient, talking through the microphone by the
operator and heard by the patient in the selected transducer headset.
The microphone used for talk forward is the one plugged into the socket TF as
first priority. If a microphone is not plugged in, the internal microphone will be
used.
The output level for talk forward is changed by turning the left wheel while
holding the Talk Forward button.
The gain of the MIC can be adjusted pressing Talk forward and turning the right
wheel. Please refer to the speech section for more detail how to set the MIC gain
level for testing.
11
Monitor/TB
Monitor/TB activates the monitor and Talk Back (TB) from the patient in the test
cabin. With the activation the monitor presentation to the patient can be heard
through the built in speaker monitor or the monitor headset.
Adjust the Monitor/TB gain for Ch 1, Ch 2 or TB by long pressing on the
Monitor/TB button.
Transducer selection
12
Right
Selects right test ear, and toggles between headset and insert earphone
transducers.
13
Left
Selects left test ear, and toggles between headset and insert earphone
transducers.
14
Bone
Press this button to use the bone conductor for audiometry. First push selects
the right ear for testing, while the second push selects the left ear for testing.
The light above the button will indicate the ear selected.
15
FF
Press 1 FF 2 to select the free field speaker as output for channel 1. First push
will present the sound through free field speaker 1, while second push will
present the signal through free field speaker 2.
Test selection
16
Tone/Warble
Pressing this button let you toggle between pure tones or warble tones during
audiometry. If in the speech test this button can be used to enter the tone
audiometry.
17
Speech
Allows for presentation of speech material using build in wave files, aux or mic
input. The speech material must be installed and set up in the speech settings.
18
Tests
Hold down Tests and use the wheel to select the desired test. Let go of the
button to make your selection.
Operation keys
19
Store
No response
Stores threshold.
Allows for storage of a no response when the patient does not respond to the
presented tone/signal.
20
Ext. range
Allows for testing at higher intensity levels during audiometry. The light above
the button will turn slightly orange when extend range is available.
21
Wheel
The wheel is multifunctional. It is used for adjusting the level of the output for
channel 1 during audiometry.
22
Tone Switch
Enter
Used for tone switch in audiometry.
In menus enter is used for making selections.

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 14
23
Incorrect/Down
Incorrect is used during speech audiometry for storing an incorrect word. Down
is used to decrease in frequency during audiometry.
24
Correct/Up
Correct is used during speech audiometry for storing a correct word.
Up is used to increase in frequency during audiometry.
25
Wheel
Sync
Masking is turned off by turning the wheel all the way counter clockwise
The masking can be turned off from a loud intensity by pressing shift + turning
the masking wheel counter clockwise.
Shift + turning masking wheel clockwise will enable sync. Turning masking off
will disable sync again. When the channels are in sync a small icon will indicate
it in the display.
3.2 Startup & Setup
The AD528 will always start up in the pure tone audiometry test screen. A setting can be saved permanently
by pressing save or temporarily by pressing back when leaving the setup menu.
About
Shift+Setup opens the About box that provides information about the firmware version, calibration and
standards. In addition, it states which transducers the device is calibrated with and the license configuration
for the device.
Instrument settings
Instrument settings contains all the general. Hold the setup button and select Instrument settings by rotating
the wheel. From instruments settings License, Language, Backlight, Keyboard LED, Printer, Keep session
on save, and date and time can be adjusted. Use the left wheel to go up and down in the list and change the
setting using the right wheel.
License
Displays license key e.g. 01B5W4UXN7Y8DKTF134BH3D
Language
Chinese, Czech, English, Finnish, French, German, Greek, Italian, Japanese,
Korean, Norwegian, Polish, Brazilian Portuguese, Russian, Spanish, Turkish
Backlight
10%-100%
Keyboard LED´s
10%-100%
Printer
HM-E300, HP PCL3, HP PCL3GUI
Keep session on save
On/off
Time & Date
Date, Date format, Time, Time format
Keep session on save will keep the session on the device when pressing save session.
Printer let you select which printer to print from. By default, the HM-E300 thermal printer is selected. The list
below shows the printers and printer language supported.

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 15
Common settings
Intensity steps
1,2,5
Intensity when changing output
Off, -10 dB-50 dB
Ch2 default
On/off
Ch2 start intensity
-10 -50 dB
Ch2 intensity when changing frequency
Off, 0,5,10
Symbols scheme
ISO, ASHA, German, French
Below is an overview of the symbols schemes available.
Air condition
Phones, inserts
(apply when both transducer types are calibrated)
Bone masking
Opposite Ch1, Insert masking
(apply when calibrated for insert masking)
Patient response sound
Off-100
Save IP measurement as AC
On/off.
On will make insert phone symbols appear as phone.
Speech filter
Non-linear (default), linear, FF Equ.
Symbols are shown as unmasked/ masked for each symbols scheme available.
ISO
Headphone
Not heard
AC
Insert phone
Not heard
AC
Bone conduction
Not heard
BC
Free field
Not heard
FF
Most comfortable level
Not heard
MCL
Uncomfortable level
Not heard
UCL
ASHA
Headphone
Not heard
AC
Insert phone
Not heard
AC
Bone conduction
Not heard
BC
Free field
Not heard
FF
Most comfortable level
Not heard
MCL
Uncomfortable level
Not heard
UCL

D-0121151-B – 2018/11
AD528 - Instructions for Use - EN Page 16
French
Headphone
Not heard
AC
Insert phone
Not heard
AC
Bone conduction
Not heard
BC
Free field
Not heard
FF
Most comfortable level
Not heard
MCL
Uncomfortable level
Not heard
UCL
German
Headphone
Not heard
AC
Insert phone
Not heard
AC
Bone conduction
Not heard
BC
Free field
Not heard
FF
Most comfortable level
Not heard
MCL
Uncomfortable level
Not heard
UCL
Tone settings
Masking type
WN, NB
Jump strategy
None (default), Bottom up, Butterfly
Intensity change when changing frequency
-10-30 dB
Single audiogram
On/off
Presentation – Ch1
Single pulse/multi pulse/continuous
Multi pulse length
200 ms-5000 ms
Single pulse length
200 ms-5000 ms
Manual/reverse
Manual, reverse
Show PTA (Fletcher) index
On/off
PTA frequencies…
Adjust included PTA frequencies for the PTA
calculation
Frequencies…
Set the frequencies part of testing