Interacoustics

Diagnostic Audiometer AD629 Instructions for Use Part 1 ver Feb 2012

Instructions for Use

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Instructions for Use - GB

Diagnostic Audiometer AD629

AD629 Instruction for Use – English Date: 2012-01-19

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Intended Use The AD629 diagnostic 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 AD629 audiometer is intended to be used by and audiologist, hearing healthcare professional or trained technician in an extremely quiet environment. . This instrument is intended for all patient groups regarding sex, age and health. 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.

Precautions indicates a hazardous situation which, if not avoided, could result in death or serious injury. used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. is used to address practices not related to personal injury

1. 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

1. 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. 2. 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 recognized disinfectant. Individual manufacturer's instruction should be followed for use of this disinfecting agent to provide an appropriated level of cleanliness. 3. It is recommended that the disposable foam ear tips supplied with the optional EarTone5A insert transducers are replaced after each patient tested. Disposable plugs also insure that sanitary conditions exist for each of your patients, and that periodic cleaning of a headband or cushion is no longer required.

AD629 Instruction for Use – English Date: 2012-01-19 • • • • • •

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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.

4. 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. 5. When the instrument is conneted to a PC be aware of not touching the PC and patient simultaneously

1. Be sure to use only stimulation intensities, which will be acceptable for the patient. 2. The transducers (headphones, bone conductor, etc.) supplied with the instrument are calibrated to this instrument - exchange of transducers requires a new calibration. 3. Airborne sound radiation of the bone vibrator may effect the measurement if no masking is used. Therefore, masking is mandatory when using bone vibrator. 4. 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. 5. 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. 6. To prevent system faults take appropriate precautions to avoid PC viruses and similar.

Warranty INTERACOUSTICS warrants that:  The AD629 is free from defects in material and workman ship under normal use and service for a period of 24 months from the date of delivery by Interacoustics to the first purchaser. 

Accessories are free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by Interacoustics to the first purchaser.

AD629 Instruction for Use – English Date: 2012-01-19

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If any product requires service during the applicable warranty period, the purchaser should communicate directly with the local Interacoustics service centre to determine the appropriate repair facility. Repair or replacement will be carried out at Interacoustics’ expense, subject to the terms of this warranty. The product requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in return shipment to Interacoustics shall be at purchaser's risk. In no event shall Interacoustics be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any Interacoustics product. This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Interacoustics shall not be responsible for, any loss arising in connection with the purchase or use of any Interacoustics product that has been:    

repaired by anyone other than an authorized Interacoustics service representative; altered in any way so as, in Interacoustics judgement, to affect its stability or reliability; subject to misuse or negligence or accident, or which has had the serial or lot number altered, effaced or removed; or improperly maintained or used in any manner other than in accordance with the instructions furnished by Interacoustics.

This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of Interacoustics, and Interacoustics does not give or grant, directly or indirectly, the authority to any representative or other person to assume on behalf of Interacoustics any other liability in connection with the sale of Interacoustics products. INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

Safety Regulations Electrical Safety: This audiometer is specified to comply with the international standard IEC 60601-1.

This audiometer is guaranteed according to IEC 60601-1 safety against electrical hazard only when the connected notebook/computer is powered by batteries or the computers power supply complies with IEC 60601-1 or IEC 60950-1 safety regulations.

To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth." This audiometer is not suitable for operation in an oxygen rich environment, in conjunction with flammable agents or flammable anesthetics.

AD629 Instruction for Use – English Date: 2012-01-19

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List of Symbols 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. 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.

0123

Year of manufacture

Manufacturer Interacoustics A/S Drejervænget 8 DK 5610 Assens Denmark Phone: Fax:

+45 6371 3555 +45 6371 3522

E-mail: Web:

[email protected] www.interacoustics.com

Unpacking/Inspection Check Box and Contents for Damage When the instrument is received please check the shipping box for any rough handling or 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 the nearest service office. Keep the shipping material for the carrier’s inspection and insurance claim.

Store Carton for future Shipment The AD629 comes in its own shipping carton which is specially designed for the AD629. Please store this carton; it will be needed if the instrument has to be returned for service. If service is required please contact your nearest sales and service office.

AD629 Instruction for Use – English Date: 2012-01-19

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Contents of Shipment As standard, AD629 is delivered with the following: Included parts

DD45 Audiometric headset B71 Bone conductor APS3 Patient response button Goose neck microphone Power cable Operation manual CD Multilingual CE instructions for use

Optional parts

Diagnostic Suite software OtoAccess database 21925 Amplivox audiocups, noise reducing headset Carrying case (Standard or Trolly Style) EARTone3A/5A Audiometric insert phones HDA200 Audiometric headset with double mono 6.3mm jack TDH39 Audiometric headset HDA280 Phone headset with double mono 6.3mm jack CIR33 Insert earphone set for masking or monitoring Talk back microphone Sound field speakers SP90 (with external power amp) AP12 Power Amplifier 2x12 Watt AP70 Power Amplifier 2x70 Watt

Check numbers on AD629 The identification label on the connection panel holds the serial number. This should be checked with the manual number and written down for later service claims.

Reporting Imperfections Inspect before connection: Prior to connecting the AD629 to the Power Supply it should be inspected once more for damage. All of the cabinet and the accessories should be checked visually for scratches and missing parts. Report any faults immediately: Any missing part or malfunction should be reported immediately to the supplier of the instrument together with the invoice, serial number and detailed report of the problem. In the back of this manual a “Return Report” can be found, where you can describe the problem. Please use “Return Report”: Please realize that if the service engineer does not know what the problem is to look for, he may not find it. Therefore using the Return Record will be of great help to us and at the same time it is guaranteed that the correction to your problem will be to satisfaction.

Care and Maintenance The performance and reliability of the AD629 will be prolonged if the following recommendations for care and maintenance are adhered to: Great care when handling the headset: Great care should be considered when handling the headset as dropping it may alter the calibration.

AD629 Instruction for Use – English Date: 2012-01-19

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Annual Calibration: The AD629 had been designed to provide many years of reliable service, but annual calibration is recommended due to possible impact on transducers. We also required calibrating the AD629; if something drastic happens to a part of it (e.g. headset or bone conductor is dropped on a hard surface).

How to clean Interacoustics Products Caution:         

Before cleaning always switch off and disconnect from the power supply Use a soft cloth lightly dampened with cleaning solution to clean all exposed surfaces Do not allow liquid to come in contact with the metal parts inside the earphones / headphones Do not autoclave, sterilize or immerse the instrument or accessory in any fluid Do not use hard or pointed objects to clean any part of the instrument or accessory Do not let parts that have been in contact with fluids dry before cleaning Rubber ear-tips or foam ear-tips are single use components Ensure that isopropyl alcohol does not come into contact with any screens on the instruments Ensure that isopropyl alcohol does not come into contact with any silicone tubes or rubber parts

Recommended cleaning and disinfection solutions:   

Warm water with mild, nonabrasive cleaning solution (soap) Normal hospital bactericides 70% isopropyl alcohol only on hard cover surfaces

Procedure   

Clean the instrument by wiping outer case with a lint free cloth lightly dampened in cleaning solution. Clean cushions and patient hand switch and other parts with a lint free cloth lightly dampened in cleaning solution. Make sure not to get moisture in the speaker portion of the earphones and similar parts

AD629 Instruction for Use – English Date: 2012-01-19

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Getting Started: Setup and Installation The following shows an overview of the AD629:

Monitor speaker

Back Panel - connectors

Microphone and Headphone (Headset) mini jacks

Power on/off

Front Panel display & buttons/dials

Talk forward mic.

The top left part of the AD629 (display holder) contains monitor speaker. 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). A goose neck microphone can be plugged into the top part of the instrument just above the Talk Forward button. This can be used for talk forward. When not plugged in the goose neck microphone can be placed underneath the display. Please refer to the section about patient communication for more details. The upper right side of the instrument holds the on/off switch of the instrument.

AD629 Instruction for Use – English Date: 2012-01-19

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Back Panel External Connections – Standard Accessories The back panel contains all the rest of the main connectors (sockets):

USB B Connector for PC connection

Power connector

4 USB A connectors for printer , mouse keyboard and memory stick

LAN (for future use)

Standard Headphones DD45/TDH39/ HDA200

Free Field 1 and 2 (external amplification)

Bone conductor B71

Standard Insert Phone EarTone 3A

Insert masking

Patient Response Switch

Extra Talk forward mic., e.g. for table mic.

For Talk Back Mic.

External CD / MP3 input

PC-Interface

Please refer to the Diagnostic Suite operation manual regarding on-line and PC-operated mode as well as patient/session data transfer.

AD629 Instruction for Use – English Date: 2012-01-19

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Functions of Buttons The figure below shows the outline of the front plate of the AD629 including buttons, dials and display:

(5)

(4)

(6)

(3) (2)

(7) (8) (15)

(1)

(9) (10) (11) (12) (13) (14)

(16)

(17) (18) (19) (20)

(21)

(22)

(23)

(24)

(25)

(29)

(30)

(31)

(32)

(41)

(42)

(26)

(33)

(34)

(37)

(38)

(39)

(40)

(27)

(28)

(35)

(36)

(43)

The following table describes the functions of the various buttons and dials. Name(s)/Function(s)

Description

Microphone

For live voice speech and talk forward instruction to the patient in the test cabin.

Talk back Speaker

For speech feedback from the patient in the test cabin.

Color Display Screen

For displaying the different test screens. Will be further explained in the sections describing the individual tests.

Tone and Response Indicator

Indication light seen when a tone is presented to the patient. Indication light seen when the patient activates the patient signal using the patient response.

Channel 1

Indicates intensity level for channel 1, e.g.:

AD629 Instruction for Use – English Date: 2012-01-19

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Masking / Channel 2

Indicates masking or Intensity level for channel 2, e.g.:

7-14

Function Keys

Shift

These keys are context sensitive and depend on the selected test screen. Will be further explained in the sections describing the individual tests. The shift function will enable the clinician to activate the sub functions written in italic underneath the buttons.

Temp Setup

Allows the clinician to make temporary changes in certain settings within each test. To save the changes as default (for the next session) press “Shift (15)” and then (14). Choose between the different settings using the right rotary wheel (43). Change the individual settings using the left rotary wheel (41).

Setup / Tests

The common setting menu can be accessed for more specific tests and changes to general settings can be made. This is also where the special tests are accessed: Auto tests (HW, Békésy), MHA, SISI. To save the changes as default (for the next session) press “Shift (15)” and then (14). Choose between the different settings using the right rotary wheel (43). Change the individual settings using the left rotary wheel (41).

Delete / del curve

Delete points during testing delete. Delete the entire test curve of a graph by holding “Shift (15)” together with this button.

Save Session/ New Session

Saving a session after testing or alternatively add a new session by holding the “Shift (15)” together with this button. (A new session will recall the default settings saved in 16 and 17)

Talk Forward

Allows results to be printed directly after testing (via a supported USB printer). Instruction to the patient directly through his headphones via the microphone can be given. The intensity changes by turning the “HL dB” (41) while holding the “Talk Forward” button.

Tone / Warble

Pure tones or warble tones can be chosen as stimuli by activating this button once or twice. The stimuli chosen will be shown on the display, e.g.:

Wavefile

Enables one to perform speech testing using loaded wavefiles, i.e. pre-recorded speech material. Please see setup under Temp Setup (15). Requires installation of speech material.

Mic

For live speech testing through the microphone (1). The VU meter can be seen on the display screen. Adjust the microphone gain by holding down the Mic button for one second.

AD629 Instruction for Use – English Date: 2012-01-19

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1 CD 2

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.

Ext Range

Ch 1 Monitor 2

Extended Range: Usually the maximum output is e.g. 100dB but if a higher output e.g. 120 dB is needed then “Ext Range” can be activated when reaching a certain level. With the activation of this button, presentation to the patient from e.g. CD can be heard through the built in monitor of the AD629 or monitor headset in both channel 1 or 2. Adjust the gain by holding down the button for one second.

Talk Back

Talk back, when active allows the clinician to hear comments or responses from the patient through the AD629 or monitor headset. Adjust the gain by holding down the button for one second.

Right / Insert

For selecting the right ear during testing. Insert phones for the right ear can be activated by pressing twice.

Left / Insert

For selecting the left ear during testing. Insert phones for the left ear can be activated by pressing twice.

R Bone L

For bone conduction testing.  First push: selects the right ear for testing.  Second push: selects the left ear for testing.

1 FF 2

Pressing “1 FF 2” will select free field speaker as output for Channel 1.  First push: Free Field speaker 1  Second push: Free Field speaker 2

Man / Rev

Manual / Reverse tone presentation modes:  First push: Manual tone presentation each time “Tone Switch” (42) is activated.  Second push: The reverse function- continuous tone presentation which will be interrupted each time “Tone Switch” (42) is activated.

Single / Multi

Pulsing modes:  First push: the tone presented will have a pre-set length when “Tone Switch” is activated. (Set up in the “Setup/Tests” (17)).  Second push: the tone will be pulsing continuously.  Third push: returns back to normal mode.

AD629 Instruction for Use – English Date: 2012-01-19

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Mask On/Off

Masking channel on/off:  First push: turns masking on  Second push: turns masking off

Sync

This allows the masking attenuator to the tone attenuator to be activated. This option is used for e.g. synchronous masking.

Store

Use this function to store test thresholds / results.

No Resp

Use this function if the patient has shown no response to stimuli.

Down / Incorrect

Used to decrease the frequency level. The AD629 has an incorporated automatic speech score counter. Therefore as a second function you can use this button as an “Incorrect” button when performing speech tests. For automatic speech score counting while testing speech push this button after each word not heard correctly by the patient.

Up / Correct

Used to increase the frequency level. The AD629 has an incorporated automatic speech score counter. Therefore as a second function you can use this button as a “Correct” button when performing speech tests. For automatic speech score counting while testing speech push this button after each word heard correctly by the patient.

HL db Channel 1

Tone Switch / Enter

This allows for the adjusting of the intensity in channel 1 shown at (5) in the display. Used for tone presentation where the “Tone” light (4) will show. Can also be used as “Enter” (selection) button.

Masking Channel 2

Adjust the intensity level in channel 2 or masking levels when masking is used. Shown at (6) in the display.

AD629 Instruction for Use – English Date: 2012-01-19

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Technical Specifications Safety Standards

IEC 60601-1, ES60601-1, CAN/CSA-C22.2 No.60601-1 Class I, Applied parts type B, Continuous operation

EMC Standard

IEC 60601-1-2:2001 + A1:2004

Audiometer Standards

Tone Audiometer: IEC 60645 -1, ANSI S3.6 -2010, Type 2, HF IEC 60645-4. Speech Audiometer: IEC 60645-2/ANSI S3.6 type B or B-E. Auto threshold tests: ISO 8253-1

Calibration

Calibration information and instructions is located in the AD629 Service manual Air Conduction

DD45: PTB/DTU report 2009 TDH39: ISO 389-1 1998, ANSI S3.6-2010 HDA200: ISO 389-8 2006, ANSI S3.6-2010 HDA280 PTB report 2004 E.A.R Tone 3A/5A: ISO 389-2 1994, ANSI S3.6-2010 CIR 33 ISO 389-2

Bone Conduction

B71: Placement:

Free Field

ISO 389-7 2005, ANSI S3.6-2010

High Frequency

ISO 389-5 2004, ANSI S3.6-2010

Effective masking

ISO 389-4 1994, ANSI S3.6-2010

ISO 389-3 1994, ANSI S3.6-2010 Mastoid

Transducers

DD45 Headband Static Force 4.5N 0.5N TDH39 Headband Static Force 4.5N 0.5N HDA200 Headband Static Force 4.5N 0.5N HDA280 Headband Static Force 5N 0.5N B71 Bone Headband Static Force 5.4N 0.5N E.A.R Tone 3A/5A: CIR 33

Patient Response switch

One hand held push button.

Patient communication

Talk Forward (TF) and Talk Back (TB).

Monitor

Output through built-in speaker or through external earphone or speaker.

Special tests/test battery

SISI. ABLB. Stenger. Stenger Speech. Langenbeck (tone in noise). Békésy Test. 2 channel speech, 2 channels Master Hearing Aid, Auto threshold. Auto threshold tests: Available time for patient to respond: Same as tone presentation Increment of hearing level: 5dB. Auto threshold test (Békésy): Mode of operation: Rate of level change: Smallest increment of level:

Békésy 2.5 dB/s ±20% 0.5 dB

Stimuli Tone

125-20000Hz separated in two ranges 125-8000Hz and 8000-20000Hz. Resolution 1/2-1/24 octave.

Warble Tone

1-10 Hz sine +/- 5% modulation

Wave file

44100Hz sampling, 16 bits, 2 channels

AD629 Instruction for Use – English Date: 2012-01-19 Masking

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Automatic selection of narrow band noise (or white noise) for tone presentation and speech noise for speech presentation. Narrow band noise: IEC 60645-1:2001, 5/12 Octave filter with the same centre frequency resolution as pure Tone. White noise: 80-20000Hz measured with constant bandwidth Speech Noise. IEC 60645-2:1993 125-6000Hz falling 12dB/octave above 1KHz +/-5dB

Presentation

Manual or Reverse. Single or multiple pulses.

Intensity

Check the accompanying Appendix Available Intensity Steps is 1, 2 or 5dB Extended range function: If not activated, the Air Conduction output will be limited to 20 dB below maximum output.

Frequency range

125Hz to 8kHz (Optional High Frequency: 8 kHz to 20 kHz) 125Hz, 250Hz, 750Hz, 1500Hz and 8kHz may freely be deselected

Speech

Frequency Response: (Typical)

Frequecy (Hz)

Linear (dB) Ext sign1 Int. Sign2

FFequv (dB Ext sign1 Int. Sign2

TDH39 (IEC 60318-3 Coupler)

125-250 250-4000 4000-6300

+0/-2 +2/-2 +1/-0

+0/-2 +2/-1 +1/-0

+0/-8 +2/-2 +1/-0

DD45 (IEC 60318-3 Coupler)

125-250 250-4000 4000-6300

+0/-2 +1/-1 +0/-2

+1/-0 +1/-1 +0/-2

+0/+2/-2 +1/-1

+0/-7 +2/-3 +1/-1

E.A.R Tone 3A (IEC 60318-5 Coupler)

250-4000

+2/-3

+4/-1

(Non linear)

B71 Bone Conductor (IEC 60318-6 Coupler)

250-4000

+12/-12

(Non linear)

2% THD at 1000 Hz max output +9 dB (increasing at lower frequency) Level range: -10 to 50 dB HL 1. Ext. sign: CD input External signal

2. Int. sign: Wave files

Speech replaying equipment connected to the CD input must have a signal-to-noise ratio of 45 dB or higher. The speech material used must include a calibration signal suitable for adjusting the input to 0 dBVU.

Free Field

Power amplifier and loudspeakers With an input of 7 Vrms - Amplifier and loudspeakers must be able to create a Sound Pressure Level of 100 dB in a distance of 1 meter - and meet the following requirements: Frequency Response 125-250 Hz +0/-10 dB 250-4000 Hz ±3 dB 4000-6300 Hz ±5 dB

Internal storage

Total Harmonic Distortion 80 dB SPL < 3% 100 dB SPL < 10%

250 patients and unlimited sessions/measurements/audiograms

AD629 Instruction for Use – English Date: 2012-01-19 Signal Indicator(VU)

Time weighting: Dynamic range: Rectifier characteristics:

Page 15/17 300mS 23dB RMS

Selectable inputs are provide with an attenuator by which the level can be adjusted to the indicator reference position(0dB) Data Connections (sockets)

4 x USB A (compatible with USB 1.1 and later) 1 x USB B (compatible with USB 1.1 and later) 1 x LAN Ethernet

External devices (USB)

Standard PC mouse and keyboard (for data entry) Supported printers: Standard PCL3 printers (HP, Epson, Canon)

Input Specifications

100uVrms at max. gain for 0dB reading Input impedance : 3.2KOhm

Mic.2

100uVrms at max. gain for 0dB reading Input impedance : 3.2KOhm

7mVrms at max. gain for 0dB reading Input impedance : 47KOhm

TF (side panel)

100uVrms at max. gain for 0dB reading Input impedance : 3.2KOhm

TF (front panel)

100uVrms at max. gain for 0dB reading Input impedance : 3.2KOhm

Wave files

Plays wave file from hard disk drive

FF1 & 2

7Vrms at min. 2KOhm load 60-20000Hz -3dB

Left & Right

7Vrms at 10 Ohms load 60-20000Hz -3dB

Ins. Left & Right

7Vrms at 10 Ohms load 60-20000Hz -3dB

Bone

7Vrms at 10 Ohms load 60-10000Hz -3dB

Ins. Mask

7Vrms at 10 Ohms load 60-20000Hz -3dB

Monitor(side panel)

2x 3Vrms at 32 Ohms / 1.5Vrms at 8 Ohms load 60-20000Hz -3dB

Output Specifications

Display

5,7 inch high resolution color display 640x480 pixels

Compatible software

Diagnostic Suite - Noah, OtoAccess and XML compatible

Dimensions (LxWxH)

36.5 x 29.5 x 6.5 cm / 14.4 x 11.6 x 2.6 inches

Weight

3.3kg/6.3lb

Power supply

100-240 V~, 50-60Hz max 0.5A

Operation environment

Temperature: Re. Humidity:

15-35°C 30-90% Non condensing

Transport and storage

Transport temperature: Storage temperature: Re. Humidity:

-20-50°C 0-50°C 10-95% Non condensing

AD629 Instruction for Use – English Date: 2012-01-19

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Reference Equivalent Threshold Values for transducers See Appendix in English in the bag of the manual.

Maximum hearing level settings provided at each test frequency See Appendix in English in the bag of the manual.

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Pin Assignment Socket

Connector

Mains

Pin 1

Pin 2

Pin 3

Live

Neutral

Earth

Ground

Signal

Ground

DC bias

Signal

IEC C6 Left & Right Ins. Left & Right Bone Ins. Mask

6.3mm Mono

TB Mic.2 TF (front panel) Pat.Resp.

6.3mm Stereo

Ground

CD2

CD1

TF (side panel)

Ground

DC bias

Signal

Ground

Right

Left

Ground

Signal

Monitor(side panel)

3.5mm Stereo

FF1 & FF2 RCA

USB A (4 x Host)

USB B (Device)

+5 VDC

Data -

Data +

Ground

LAN Ethernet

RJ45 Socket

RJ45 Cable Plug

TX+

Transmit Data+

TX-

Transmit Data-

RX+

Receive Data+

Not connected

RX-

Not connected

Receive Data-

Survey of Reference and max Hearing Level Tone Audiometer. ANSI TDH39 Coupler: ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL 125 45.0 90 49.0 75 160¹ 37.5 95 41.5 85 200¹ 31.5 100 35.5 90 250 25.5 110 29.5 95 315¹ 20.0 115 24.0 100 400¹ 15.0 120 19.0 105 500 11.5 120 15.5 110 630¹ 8.5 120 13.5 110 750 8.0 120 13.0 110 800¹ 7.0 120 12.0 110 1000 7.0 120 13.0 110 1250¹ 6.5 120 12.5 110 1500 6.5 120 12.5 110 1600¹ 7.0 120 13.0 110 2000 9.0 120 15.0 110 2500¹ 9.5 120 15.5 110 3000 10.0 120 16.0 110 3150¹ 10.0 120 16.0 110 4000 9.5 120 14.5 110 5000¹ 13.0 120 18.0 110 6000 15.5 120 20.5 110 6300¹ 15.0 120 20.0 110 8000 13.0 110 18.0 100 WhiteNoise 0.0 120 TenNoise 25.0 110 ¹ The RETSPL is copy from ISO389-1 1998

ANSI HDA 280 Coupler ANSI S3.7-1995 (NBS-9A) / IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Narrow Band Noise PTB PTB Frequency RETSPL MaxHL RETSPL MaxHL 125 38.5 105 42.5 75 160¹ 33.5 110 37.5 80 200¹ 29.5 115 33.5 85 250 25.0 120 29.0 90 315¹ 21.0 120 25.0 95 400¹ 17.0 120 21.0 95 500 13.0 120 17.0 100 630¹ 10.5 120 15.5 100 750 9.0 120 14.0 105 800¹ 8.5 120 13.5 105 1000 7.5 120 13.5 105 1250¹ 8.5 120 14.5 105 1500 9.5 120 15.5 105 1600¹ 9.0 120 15.0 105 2000 8.0 120 14.0 105 2500¹ 7.0 120 13.0 105 3000 6.5 120 12.5 105 3150¹ 7.0 120 13.0 105 4000 9.5 120 14.5 105 5000¹ 12.0 120 17.0 105 6000 19.0 115 24.0 95 6300¹ 19.0 115 24.0 95 8000 18.0 105 23.0 90 WhiteNoise 0.0 120 ¹ This value is interpolated on Interacoustics

IEC TDH39 Coupler: IEC 60318-3 1998 (6ccm)

Frequency 125 160 200 250 315 400 500 630 750 800 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 WhiteNoise TenNoise

Tone Audiometer Tone Narrow Band Noise ISO 389-1 1998 ISO 389-4 1994 RETSPL MaxHL RETSPL MaxHL 45.0 90 49.0 75 37.5 95 41.5 85 31.5 100 35.5 90 25.5 110 29.5 95 20.0 115 24.0 100 15.0 120 19.0 105 11.5 120 15.5 110 8.5 120 13.5 110 7.5 120 12.5 110 7.0 120 12.0 110 7.0 120 13.0 110 6.5 120 12.5 110 6.5 120 12.5 110 7.0 120 13.0 110 9.0 120 15.0 110 9.5 120 15.5 110 10.0 120 16.0 110 10.0 120 16.0 110 9.5 120 14.5 110 13.0 120 18.0 110 15.5 120 20.5 110 15.0 120 20.0 110 13.0 110 18.0 100 0.0 120 25.0 110

IEC HDA 280 Coupler IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Narrow Band Noise PTB ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL MaxHL 125 38.5 105 42.5 75 160¹ 33.5 110 37.5 80 200¹ 29.5 115 33.5 85 250 25.0 120 29.0 90 315¹ 21.0 120 25.0 95 400¹ 17.0 120 21.0 95 500 13.0 120 17.0 100 630¹ 10.5 120 15.5 100 750 9.0 120 14.0 105 800¹ 8.5 120 13.5 105 1000 7.5 120 13.5 105 1250¹ 8.5 120 14.5 105 1500 9.5 120 15.5 105 1600¹ 9.0 120 15.0 105 2000 8.0 120 14.0 105 2500¹ 7.0 120 13.0 105 3000 6.5 120 12.5 105 3150¹ 7.0 120 13.0 105 4000 9.5 120 14.5 105 5000¹ 12.0 120 17.0 105 6000 19.0 115 24.0 95 6300¹ 19.0 115 24.0 95 8000 18.0 105 23.0 90 WhiteNoise 0.0 120 ¹ This value is interpolated on Interacoustics

ANSI HDA 200 Coupler: IEC60318-2 with type 1 adaptor Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL 1/3 MaxHL 125 30.5 100 34.5 75 160¹ 26.0 105 30.0 80 200¹ 22.0 105 26.0 80 250 18.0 110 22.0 85 315¹ 15.5 115 19.5 90 400¹ 13.5 115 17.5 95 500 11.0 115 15.0 95 630¹ 8.0 120 13.0 95 750 6.0 120 11.0 100 800¹ 6.0 120 11.0 100 1000 5.5 120 11.5 100 1250¹ 6.0 110 12.0 95 1500 5.5 115 11.5 100 1600¹ 5.5 115 11.5 100 2000 4.5 115 10.5 100 2500¹ 3.0 115 9.0 100 3000 2.5 115 8.5 100 3150¹ 4.0 115 10.0 100 4000 9.5 115 14.5 100 5000¹ 14.0 105 19.0 95 6000 17.0 105 22.0 90 6300¹ 17.5 105 22.5 90 8000 17.5 105 22.5 90 9000 19.0 100 24.0 85 10000 22.0 100 27.0 85 11200 23.0 95 28.0 80 12500 27.5 90 32.5 75 14000 35.0 80 40.0 70 16000 56.0 60 61.0 50 18000² 72.0 40 77.0 25 20000² 86.0 25 91.0 10 WhiteNoise 0.0 115 ¹ The RETSPL is copy from ISO389-8 2001. ² 18-20 kHz is estimated of Interacoustics.

ANSI EAR 3A Coupler: ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Tone Audiometer Narrow Band Tone Noise ANSI S3.6-2010 ANSI S3.6-2010 Frequency RETSPL MaxHL RETSPL MaxHL 125 26.0 90 30.0 90 160 22.0 95 26.0 95 200 18.0 100 22.0 100 250 14.0 105 18.0 105 315 12.0 105 16.0 105 400 9.0 110 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 115 7.0 110 800 1.5 115 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 115 10.5 110 5000 5.0 105 10.0 105 6000 2.0 100 7.0 100 6300 2.0 100 7.0 100 8000 0.0 95 5.0 95 WhiteNoise 0.0 110

IEC HDA 200 Coupler: IEC60318-1 with type 1 adaptor Tone Audiometer Tone Narrow Band Noise ISO 389-8 2004 ISO 389-4 1994 Frequency RETSPL MaxHL RETSPL 1/3 MaxHL 125 30.5 100 34.5 75 160 26.0 105 30.0 80 200 22.0 105 26.0 80 250 18.0 110 22.0 85 315 15.5 115 19.5 90 400 13.5 115 17.5 95 500 11.0 115 15.0 95 630 8.0 120 13.0 95 750 6.0 120 11.0 100 800 6.0 120 11.0 100 1000 5.5 120 11.5 100 1250 6.0 110 12.0 95 1500 5.5 115 11.5 100 1600 5.5 115 11.5 100 2000 4.5 115 10.5 100 2500 3.0 115 9.0 100 3000 2.5 115 8.5 100 3150 4.0 115 10.0 100 4000 9.5 115 14.5 100 5000 14.0 105 19.0 95 6000 17.0 105 22.0 95 6300 17.5 105 22.5 95 8000 17.5 105 22.5 90 ISO 389-5 2006 ISO 389-5 2006 + 5 dB 8000 17.5 105 22.5 90 9000 19.0 100 24.0 85 10000 22.0 100 27.0 85 11200 23.0 95 28.0 80 12500 27.5 90 32.5 75 14000 35.0 80 40.0 70 16000 56.0 60 61.0 50 18000² 72.0 40 77.0 25 20000² 86.0 25 91.0 10 WhiteNoise 0.0 115 ² 18-20 kHz is estimated of Interacoustics.

Frequency

WhiteNoise

IEC EAR 3A Coupler: IEC 60318-5 2006 2ccm Tone Audiometer Tone Narrow Band Noise ISO 389-2 1994 ISO 389-4 1994 RETSP L MaxHL RETSPL MaxHL 125 26.0 90 30.0 90 160 22.0 95 26.0 95 200 18.0 100 22.0 100 250 14.0 105 18.0 105 315 12.0 105 16.0 105 400 9.0 110 13.0 105 500 5.5 110 9.5 110 630 4.0 115 9.0 110 750 2.0 115 7.0 110 800 1.5 115 6.5 110 1000 0.0 120 6.0 110 1250 2.0 120 8.0 110 1500 2.0 120 8.0 110 1600 2.0 120 8.0 110 2000 3.0 120 9.0 110 2500 5.0 120 11.0 110 3000 3.5 120 9.5 110 3150 4.0 120 10.0 110 4000 5.5 115 10.5 110 5000 5.0 105 10.0 105 6000 2.0 100 7.0 100 6300 2.0 100 7.0 100 8000 0.0 95 5.0 95 0.0 110

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