Screening Audiometer AS608 and AS608e Instructions for Use Oct 2010

AS608/AS608e Instruction for Use - English Date: 2009-04-27

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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 15-35 degree Celsius (59-95 degrees Fahrenheit)

Extended Functions 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 Wondows software and stored in the OtoAccess(TM) 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.

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.

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 require a recalibration. 3. 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.

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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. Disposal of batteries must be made according to national regulations. 6. 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. 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.

Basic Pure Tone Operation Instruction A)

Select desired test ear Left or Right ear on F1 or F2 respectively (toggle F1 on AS608e)

B)

Select frequency with the ―Frequency Hz‖ dial (1).

C)

Select desired intensity with the ―HL dB‖ dial (2).

D)

Present tone by touching ―Tone Switch‖ (3).

Pulse:

Pulsing tones is available by pressing the "Pulse" (F3) button.

Warble: Warble or pure tones are available by pressing the "Pure Tone / Warble" (F4) button.

AS608e Functions 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 AS608e F-key functionalities can be access by pressing the frequency rortary 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 memnory 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. Setup To access the AS608/AS608e setup menu press F1 and F4 simultaneously for 2-3 seconds.

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AS608/AS608e - Operation Panel Dictionary Position: F1 F2 F3

Symbol: Right Left Man / Pulse

F4

Pure Tone / Warble

Function: Selects Right headphone. L/R toggle on AS608e Selects Left headphone on 608 / Store threshold on AS608e Select Man to have the tone presented when Tone Switch is activated. Select Pulse to present pulsing tones when the Tone Switch is activated. Select Pure tone or Warble tone as stimulus.

1 2 3

Frequency Hz HL dB Tone Switch

Selects stimulus frequency. Adjustment of Intensity Presents stimulus.

A B C

Tone Indicates presentation. Response Indicates response from patient. External Power / Battery Indication of external power supply / battery status. status

A

B

C

3

2

A

B

1

C

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AS608/AS608e - Connection Panel Dictionary Position: 1 2 3 4 5

Symbol: Battery Power / USB Patient Resp. Right Left

5

Function: Battery holder for three batteries AA/LR6. Socket for external power supply ASA30M Socket for patient response switch APS3. Socket for right headphone DD45. Socket for left headphone DD45.

4

3

2

1

Explanation to symbols which can be found on the instrument: I O

 !

On (Power: connection to the mains) Off (Power: disconnection from the mains) Alternating current Fuse Ground Dangerous voltage See explanation in manual Type B equipment

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Technical Specifications The technical specifications provided here covers the general aspects of the instrument, while more specific details are found in the Operation Manual in English. Standards: Audiometer Safety EMC

: : :

IEC 60645-1/ANSI S3.6, Type 4 IEC 60601-1 IEC 60601-1-2

Calibration: ISO 389-1 (DD45) ISO 389-2 (EAR-Tone 3A and 5A) PTB Report 1.61-64/04 (HDA280). PTB Report 1.61-4039503/09 (DD45) Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no. 0123. Frequencies and Maximum Intensities; Freq. Hz. 125 250 500 750 1000 1500 2000 3000 4000 6000 8000

AC dB HL 70 90 100 100 100 100 100 100 100 100 90

Inputs: Tone, Warble Tone. Outputs: Left AC, Right AC. Attenuator: -10 to 100 dB HL in 5 dB steps. Tone Presentation: Manual or reverse (chosen in Setup Menu). Multiple pulses 250 or 500msec (chosen in Setup Menu). On/off. Talk Forward (AS608e):

Built in talk forward microphone. 0-110dB SPL. Adjustable.

Auto Threshold

Patient controlled Hughson Westlake procedure according to ISO 8253-1.

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(AS608e): Store Function (AS608e):

Softkey (F-key) store button and internal memory for AC L/R. Stored Measurements can be viewed on the build in display or transferred to the PC using the Diagnostic Suite Audiogram software module.

PC Software / Interface (608e): The Diagnostic Suite PC software with advanced reporting and printing features. OtoAccess(TM) and Noah compatible. Modulation: Warble +/- 5% 5 Hz. Calibration: Air Conduction

:

ISO 389-1/ANSI S3.6 (DD45).

Dimensions: WxDxH : 22.5 x 18 x 5.5 cm / 8,9 x 7.1 x 2,2 inches Weight : 1.0 kg/2.2 lbs – including batteries and headset. (1.6 kg/3.5 lbs – including TC608 carrying bag incl. peltor noise reducing headset, audiogram charts etc.) Power: 3 pieces of batteries type AA/LR6 or ASA30M, External Power Supply 5V DC 100, 110 – 120V AC 10%, 50 – 60 Hz. 220 - 240 V AC 10%, 50 – 60 Hz. Construction: Plastic cabinet. Detachable Parts  DD45 Audiometric Headset.  200 AF12 Audiogram Charts.  Pen Set, 3 pens.  Carrying Bag  Operation Manual.  CE Manual.

Concerning repair 1

Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety, reliability and performance of the equipment if: assembly operations, extensions, readjustments, modifications or repairs are carried out by authorised persons, a 1 year service interval is maintained the electrical installation of the relevant room complies with the appropriate requirements, and the equipment is used by authorised personnel in accordance with the documentation supplied by Interacoustics.

2

It is important that the customer (agent) fills out the RETURN REPORT every time a problem arises and sends it to Interacoustics, Drejervænget 8, DK-5610 Assens, Denmark. This should

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also be done every time an instrument is returned to Interacoustics. (This of course also applies in the unthinkable worst case of death or serious deterioration to patient or user). 3

When instrument fuses need renewal, the correct type as stated on the instrument shall be used.

General Maintenance Procedures The performance and safety of the instrument will be kept if the following recommendations for care and maintenance are observed: It is recommended to let the instrument go through at least one annual evaluation, to ensure that the acoustical, electrical and mechanical properties are correct. This should be made by an experienced workshop in order to guarantee proper service and repair. Before the connection to the mains, be sure that the local mains voltage corresponds to the voltage labelled on the instrument. Observe that no damage is present on the insulation of the mains cable or the connectors and that it is not exposed to any kind of mechanical load, which could involve damage. For maximum electrical safety, turn off the power from a mains powered instrument when it is left unused. Do not place the instrument next to a heat source of any kind, and allow sufficient space around the instrument to ensure proper ventilation. To ensure the reliability of the instrument, periodic biological measurements should be performed on a person with known data. This person could be the operator him/herself. If the surface of the instrument or parts of it is dirty, it can be cleaned using a soft cloth moistened with a mild solution of water and dish washing cleaner or similar. The use of organic solvents and aromatic oils must be avoided. Always disconnect the mains plug during the cleaning process, and be careful that no fluid is entering the inside of the instrument or the accessories. After each examination of a patient, proper cleaning must ensure that there is no contamination on the parts in connection with patients. General precautions must be observed to prevent transmission of disease from one patient to another. If the ear cushions or ear tips are contaminated, it is strongly recommended to remove them from the transducer before they are cleaned. Frequent cleaning using water may be used, but periodic use of a mild disinfectant may also be used. The use of organic solvents and aromatic oils must be avoided. Great care should be exercised by the handling of earphones and other transducers, as mechanical shock may cause change of calibration.