Interacoustics AS608 User manual

EN Instructions for Use
DE Gebrauchsanweisung
FR Instructions d’utilisation
SV Bruksanvisning
DA Brugsanvisning
FI Käyttöohje
NO Bruksanvisning
ES Manual de instrucciones
EN Instructions for Use
DE Gebrauchsanweisung
FR Instructions d’utilisation
SV Bruksanvisning
DA Brugsanvisning
FI Käyttöohje
NO Bruksanvisning
ES Manual de instrucciones
Instructions for Use - US
AS608
Science made smarter
D-0127810-A – 2020/05

Table of Contents
1Introduction .................................................................................................................................... 1
About this Manual.................................................................................................................... 1
1.2 Intended Use ........................................................................................................................... 1
1.3 Product Description ................................................................................................................. 2
1.4 Warnings.................................................................................................................................. 3
2Unpacking and Installation ........................................................................................................... 5
Unpacking and Inspection ....................................................................................................... 5
Marking .................................................................................................................................... 6
Important safety instructions.................................................................................................... 7
2.3.1 Electrical system safety ....................................................................................................... 7
2.3.2 Electrical safety.................................................................................................................... 7
2.3.3 Explosion hazards ............................................................................................................... 8
2.3.4 Electromagnetic compatibility (EMC)................................................................................... 8
2.3.5 Cautions – General.............................................................................................................. 8
2.3.6 Environmental factors.......................................................................................................... 9
2.3.7 Disposal ............................................................................................................................... 9
3Getting Started - Setup and Installation..................................................................................... 11
AS608 - Connection Panel Dictionary ................................................................................... 11
AS608 - Operation Panel Dictionary ..................................................................................... 12
Air Conduction ....................................................................................................................... 13
Power Up and Power Off....................................................................................................... 14
Pure Tone Presenation.......................................................................................................... 14
AS608e Special Functions: ................................................................................................... 15
Display: .................................................................................................................................. 15
Setup Menu of AS608/AS608e.............................................................................................. 16
About Diagnostic Suite .......................................................................................................... 20
4Care and Maintenance ................................................................................................................. 21
4.1 General Maintenance Procedures......................................................................................... 21
4.2 How to clean Interacoustics Products ................................................................................... 22
Concerning Repair................................................................................................................. 22
4.3 Warranty ................................................................................................................................ 22
5General Technical Specifications............................................................................................... 25
Reference Equivalent Threshold Values for transducers...................................................... 27
Maximum hearing level settings provided at each test frequency......................................... 27
Pin Assignments.................................................................................................................... 28
Electromagnetic Compatibility (EMC).................................................................................... 28

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 1
1Introduction
About this Manual
This manual is valid for the AS608. This 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
The AS608 screening audiometer is designed to be a device for screening for 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 screening for hearing loss using this kind of
audiometer depends on the interaction with the patient. “normal hearing” result should not allow for ignoring
other contra indications. A full audiologic evaluation should be administered if concerns about hearing
sensitivity persist
The AS608 audiometer is intended to be used by an audiologist, hearing healthcare professionals, or trained
technicians in a quiet environment. It is recommended that the instrument be operated within an ambient
temperature range of 15-35 degree Celsius (59-95 degrees Fahrenheit)

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 2
1.3 Product Description
The AS608e extends the AS608 functionalities with the following three extra features:
•PC Integration through the Diagnostic Suite software. This enables audiograms to be transferred
and displayed in the Windows software and stored in the OtoAccess® or Noah databases. The
Diagnostic Suite also includes advanced reporting and printing features (similar to the AC440
software module.) Please refer to the Diagnostic Suite user manual for instructions about how to
use the PC software suite.
•In addition to traditional manual testing, the AS608e incorporates a Hughson Westlake patient
controlled automatic threshold test complying with ISO 8253. When the test is completed the
results are easily recalled from the internal memory of the AS608.
•Talk Forward function that makes the AS608e easy to work with particularly in sound booth
installations.
As standard AS608 is delivered with the following:
1Applied part according to IEC 60601-1
2This part is not certified according to IEC 60601-1
Included parts
DD45 Audiometric headset P3045
1
Battery Alkaline1,5V 3x
Instruction for use - Manual
AS608e
CD Diagnostic Suite + OtoAccess® + USB cable
APS3 Patient Signal Button
Optional parts
DD65v2 Audiometric Headset1
DD45 Audiometric Headset P31001
DD45AA Audiometric Headset1
TDH39 Audiometric Headset HBA1
TDH39 Audiometric Headset P3045 1
TDH39 Audiometric Headset P3100 1
TDH39AA Audiometric Headset 1
HDA280 1
IP 30 Insert Phones1
Eartone 5A 10 Ohm OEM 2
Eartone 3a 10 Ohm 2
Accessory kit Pen set/Audiogram
UE10WCP1-050200SPA. External Power Supply Medical CE Approved
APS3 Patient Signal Button 1
Carrying Bag (TC608)

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 3
1.4 Warnings
Throughout this manual the following meaning of warnings, cautions and notices 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.
WARNING
CAUTION

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 4

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 5
2Unpacking and Installation
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 AS608 comes in its own shipping carton, which is specially designed for the AS608. 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 AS608 for a period, please ensure it is stored uder the conditions specified in the
section for technical specifications.

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 6
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.
Failing to do so may endanger the environment.
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

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 7
Important safety instructions
Read these instructions carefully and completely before using the product
If this apparatus is connected to one or more other devices with medical CE marking, to make up a system
or pack, the CE marking is only valid also for the combination if the supplier has issued a declaration
stating that the requirements in the Medical Device Directive article 12 are fulfilled for the combination.
2.3.1 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
2.3.2 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.
Do not use the equipment if it is showing visible signs of damage.
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
No part of the equipment can be serviced or maintained while in use with the
patient.

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 8
2.3.3 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.
2.3.4 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.
2.3.5 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.
CAUTION
CAUTION

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 9
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.
In case of a serious incident with serious health impact for the patient or user
Interacoustics shall be informed. Beside that the competent authority in
patient’s home country shall be informed. Interacoustics has a vigilance
system to help with this.
2.3.6 Environmental factors
Storage outside temperature range as specified in Section 2.1 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.
2.3.7 Disposal
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.
CAUTION

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 10
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.
Be sure to use only stimulation intensities, which will be acceptable for the
patient.
The transducers (headphones, bone conductor, etc.) supplied with the instrument
are calibrated to this instrument - exchange of transducers require a recalibration.
It is recommended that parts which are in direct contact with the patient (e.g.
earphone cushions) are subjected to standard disinfecting procedure between
patients. This includes physically cleaning and use of a recognised disinfectant.
Individual manufacturer's instruction should be followed for use of this disinfecting
agent to provide an appropriated level of cleanliness.
Please note that the CE Marking is only legal if this Instruction is translated into
the national language of the user no later than at the delivery to him, if the
national legislation demands a text in the national language according to MDD
article 4.4.

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 11
3Getting Started - Setup and Installation
AS608 - Connection Panel Dictionary
Position:
Symbol:
Function:
1
Battery
Battery holder for three batteries AA/LR6 (Alkaline).
2
Power / USB
Socket for external power supply ASA30M
3
Patient Resp.
Socket for patient response switch APS3.
4
Right
Socket for right headphone DD65.
5
Left
Socket for left headphone DD65.
5
4
3
2
1

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 12
AS608 - Operation Panel Dictionary
Position:
Symbol:
Function:
F1
Right
Selects Right headphone. L/R toggle on AS608e
F2
Left
Selects Left headphone on 608 / Store threshold on AS608e
F3
Man / Pulse
Select Man to have the tone presented when Tone Switch is
activated. Select Pulse to present pulsing tones when the
Tone Switch is activated.
F4
Pure Tone / Warble
Select Pure tone or Warble tone as stimulus.
1
Frequency Hz
Selects stimulus frequency.
2
HL dB
Adjustment of Intensity
3
Tone Switch
Presents stimulus.
A
Tone
Indicates presentation.
B
Response
Indicates response from patient.
C
External Power / Battery
status
Indication of external power supply / battery status.
1
2
3
A
B
C
A B C

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 13
Air Conduction
Hearing threshold levels can be determined by presenting test signals to the test subject with the included
earphones (air conduction – AC). The purpose of AC audiometry is to establish the hearing sensitivity at
various frequencies. The test can specify the AC loss but cannot distinguish between abnormality in the
conductive mechanism and sensor neural mechanism.
Headset Placement:
Remove eye glasses and ear rings if possible and position the headband directly over the top of
the head. Place the rubber cushions so that the diaphragms are aimed directly at the opening
into the ear canal. Pull down the yokes of the phones and adjust for tight fit. If the cushions are
not tight to the ears, the test results may be false at lower frequencies.
Background Noise:
Background noise can also produce false test results, especially at lower frequencies. If
necessary, the DD65 can be equipped with noise excluding enclosures. Please contact the
distributor for more information.
Instruction of Subject:
Prior to hearing threshold level measurements, the following instructions should be given. "You
will now hear a variety of pitches with various loudness levels. Please push the signal button
when you hear a tone and release the button when you no longer hear it. If not using the
response button, ask the patient to “raise their left or right hand when you hear the tone in the
left or right ear".
Threshold Determination:
The test normally starts at 1000 Hz on the patient's better ear with the L/R switch adjusted
accordingly.
Familiarization:
Present a tone at 1000 Hz which can easily be perceived (i.e. 50dB) If necessary, increase with
steps of 10 dB until the tone is clearly perceived.
Threshold Determination:
The hearing threshold is defined as the lowest level at which more than half of the stimuli are
heard. This threshold is found by the following procedure.
1) Present a tone which is 10 dB lower than the level at which familiarization was finished.
2) Decrease the level in steps of 10 dB until response fails.
3) Increase the level in steps of 5 dB until the subject responds again.
4) Repeat 2) and 3) two or three times until the threshold appears at the same level.
The time intervals in between the stimuli should be varied to prevent the subject to react on the
rhythm.
5) Change to the next frequency and repeat the procedure until all frequencies are measured.
Repeat the procedure at 1000 Hz. If the difference to the previously found threshold is then
5dB or less go to the other ear. If the difference is 10 dB or higher, repeat the test at the
other frequencies, until agreement to 5 dB or less has been obtained.
6) Proceed until both ears have been tested.
Screening Procedure:
It is common to test at one dB level for preliminary hearing screenings as is often done in schools and
primary practice clinics. In this instance you would follow the same familiarization and instruction
procedures as stated above, but present a single dB level (i.e. 25dB) at just 4 frequencies (500, 1000,
2000 & 4000 Hz) in each ear. In this instance, you simply record a response or no response to the single
tone presentations at each frequency.

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 14
Auto Threshold:
In addition to traditional manual testing, the AS608e incorporates a Hughson Westlake patient controlled
automatic threshold test complying with ISO 8253. When the test is completed the results are easily
recalled from the internal memory of the AS608e and transferred to the Diagnostic Suite PC software and
stored in OtoAccess® or Noah.
Hughson Westlake is an automatic pure tone test procedure. Threshold is defined as 2 out of 3 (or 3 out
of 5) correct responses at a certain level in a 5 dB increase and 10 dB decrease test procedure. The
Hughson Westlake is used to obtain pure tone thresholds automatically.
Talk Forward
The Talk Forward function makes the AS608e easy to work with particularly in sound booth installations.
Power Up and Power Off
To turn on the audiometer press the Tone Switch (3) button. To power off the audiometer hold down the
two rotary wheel buttons, 1) and 2), simultaneously for a few seconds. The audiometer will also
automatically power off after 1, 2, 3, 4 or 5 minutes depending on the settings (see next section).
Pure Tone Presenation
1) Select desired frequency with the "Frequency" button
2) Select desired intensity with the HL dB.
3) Present tone by touching Tone Switch. An indication will be on Display (see below).
F1) On AS608: Select the Right ear. On AS608e: Toggle between Right and Left.
F2) On AS608: Select the Left ear. On As608e: Store threshold.
F3) Manual or Pulse:
Manual: Manual Tone presentation as long as the Tone Switch is activated.
Pulse: Pulsing Tone will be presented as long as the Tone Switch is activated.
F4) Pure Tone or Warble:
If Tone is selected pure tones will be presented to the subject when the Tone Switch is activated.
If Warble is selected warble tones will be presented to the subject when the Tone Switch is activated.

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 15
AS608e Special Functions:
Talk Forward: On the AS608e Talk Forward is activated by holding down the HL db (3) rotary wheel.
While holding down the Tone Switch button (3), the talk forward level can be adjusted.
The following F-key functionalities can be access by pressing the frequency rotary wheel (1):
F1: Delete all thresholds stored in the internal memory of the AS608e.
F2: Store a Not Heard threshold point.
F3: Display the L/R thresholds stored in the internal memory of the AS608e.
F4: Start the Hughson Westlake (HW) automatic test procedure. Please refer to the next chapter for
instructions about how to setup the HW test.
Display:
A) Tone: A tone presentation indicator is provided in the top left corner of the display header.
B) Response: When using the APS3 response button, a response is indicated in the middle of display
header.
C) Power On or Battery status: The power status of the AS608/AS608e is indicated in the top right
corner of the display header.
The icon will change depending on whether the instrument is powered via an external source (power
supply or USB connection to computer) or batteries.
When powered by batteries, the battery icon will change depending on the battery power level. When
batteries are running low the display will read Low Battery and flash.
The Power Off settings of the instrument can be adjusted at different time intervals or set to never
power off – please see Setup section for details.

D-0127810-A – 2020/05
AS608 - Instructions for Use - US Page 16
Setup Menu of AS608/AS608e
To access the AS608/AS608e setup menu press F1 and F4 simultaneously for 2-3 seconds.
F1
Change setting
F2
Browse up in the setup menu
F3
Browse down in the setup menu
F4
Save settings and Back to previous screen display –
see below for details
Power up Tone
Press Change to toggle between Manual and Reverse.
Power up Ear
Press Change to toggle between Right and Left ear as the default ear for Power Up
Default Intensity
The default intensity when changing ear side. Choose between: Off, -10dB, -5dB, 0dB, 5dB, 10dB, 15dB,
20dB, 25dB, 30dB, 35dB, 40dB, 45dB and 50dB.
Intensity Steps
Choose Between: 1 dB and 5 dB.