Screening Audiometer AS608 and AS608e Instructions for Use ver Oct 2009

Table of Contents Table of Contents ... 1 Introduction ... 1 Intended Use ... 1 Extended Function ... 1 Precautions ... 2 Warranty ... 5 Air Conduction ... 7 Functions of Buttons & Display ... 10 Power Up and Power Off: ... 10 Pure Tone Presentation ... 10 AS608e Special Functions: ... 11 Display: ... 12 Setup Menu of AS608/AS608e ... 14 Technical Specifications ... 19 Parts... 22 Electrical Installation ... 22 External Connections - Standard Accessories ... 24 Unpacking / Inspection ... 25 Contents of Shipment ... 25 Reporting Imperfections... 26 Operating Temperature ... 27 Care and Maintenance ... 27 Trouble Shooting ... 28 Dictionary ... 29 Appendix: General Maintenance Procedures ... 30 Drawing of Front Plate ... 33 Return Report ... 35

Introduction Intended Use The AS608/AS608e 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/AS608e 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 1535 degree Celsius (59-95 degrees Fahrenheit)

Extended Function 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 TM 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. AS608/AS608e

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Precautions WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE is used to address practices not related to personal injury. Be sure to use only stimulation intensities, which will be acceptable for the patient. The transducers 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. Never insert or in any way use the insert headset without a new clean non defect test tip.

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External equipment intended for connection to signal input, signal output or other connector, shall comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment). In addition, all such combinations – systems – shall comply with the standard 60601-1-1, Safety requirements for medical electrical systems. Equipment not complying with IEC 60601 shall be kept outside patient environment, as defined in standard (at least 1.5 m from the patient). Any person who connects external equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601-1-1. If in doubt, contact your service technician or local representative for help. If connection is made to a standard PC which is powered through the mains network, special precautions must be taken in order to maintain medical safety. A standard USB cable can only be used, if the connected PC is: • running on battery, or • medical approved, or • powered via a medical approved safety transformer. In all other cases, a galvanic separator must be inserted in the USB connection. The AS608/AS608e is intended to be powered from a PC as described above, from batteries or from a medical power supply type ASA30M-0301. Using other supplies is not allowed. Do not site the AS608/AS608e next to a radiator or any other heat source. Allow six inches between the back panel and the wall to ensure proper ventilation. In operation the instrument should not be subject to temperatures below 15C° or above 35C°. If the instrument is moved from AS608/AS608e

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a cold location to a warmer one, there will be a risk of condensation. If condensation occurs the instrument must be allowed to achieve normal temperature before it is turned on. 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. To avoid damage to the instrument and leakage from the batteries, please remove the batteries if the instrument is unlikely to be used for some time. It is important that instructions set forth in this manual are followed closely in order to maintain the safety and full functionality of the instrument. External power supply through USB socket.

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. Disposal of batteries must be made according to national regulations.

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Warranty INTERACOUSTICS warrants that: •

•

The AS608/AS608e is free from defects in material and workmanship under normal use and service for a period of 12 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.

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

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•

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

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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 DD45 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.

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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) 2) 3) 4)

Present a tone which is 10 dB lower than the level at which familiarization was finished. Decrease the level in steps of 10 dB until response fails. Increase the level in steps of 5 dB until the subject responds again. 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)

6)

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. 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.

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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 OtoAccessTM 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.

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Functions of Buttons & Display The AS608/AS608e front plate:

A B C

2

1 3

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 Presentation 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). AS608/AS608e

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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.

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 The Talk 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. AS608/AS608e

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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.

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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.

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Setup Menu of AS608/AS608e To access the AS608/AS608e setup menu press F1 and F4 simultaneously for 2-3 seconds. F1 F2 F3 F4

Change setting Browse up in the setup menu Browse down in the setup menu 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

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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. Power Off setting

Press Change to toggle between Never, 1, 2, 3, 4 or 5 minutes. Pulse Length

Press Change to toggle between 250msec and 500msec. Language

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Press Change to toggle between English, German, Spanish and French. LCD Contrast.

Press Change to toggle between settings ranging from 0 (very bright) to 6 (very dark). HW Test... (only on AS608e)

Press Change to go to the Hughson Westlake (HW) automatic test procedure setup.

Press Change to toggle between Familiarization On/Off. Familiarization is used to train the patient

Press Change to toggle between “2 correct out of 3 answers” and “3 correct out of 5 answers”. The conditions used before going to the next frequency. AS608/AS608e

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Select the frequencies to include in the HW test. Press Change to toggle between frequencies On/Off. Press Save to return to the main HW setup menu. Frequencies

Press Change to access the default frequency range from 125Hz to 8 kHz for daily operation.

7 frequencies are available to change: 125, 250, 750, 1,500, 3,000, 6,000 and 8,000. Press Change to toggle between On or Off. Press Save to return to the main setup menu. License.

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Press Change to access the license key of the AS608/AS608e instrument.

Press Change to enter and/or modify the license key of the AS608/AS608e instrument. Use button 2 to change the letter and button 1 to move the cursor Press Save to return to the main setup menu. About

Press Change to access the information in the About section.

Press Back to return to the main setup menu. Press Save to return to measurement screen of the AS608/AS608e.

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