Audio Traveller AA222 Operation Manual October 2008

AA222 Instruction for Use - English Date: 2002-09-24

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Intended Use The AA222 is a combined automatic impedance audiometer and audiometer suited for clinics performing screening, as well as diagnostic work. The test battery includes tympanometry, acoustic reflex testing, ipsilateral and contralateral reflex decay testing, Eustachian tube function test and AC audiometry. The AA222 tympanometer and audiometer is intended to be used by an audiologist, hearing healthcare professional, or trained technician in a quiet environment (tymp and reflexes) and extremely quiet environment (Audiometry). Careful handling of instrument whenever in contact with patient should be of high priority. Calm and stable positioning while testing is preferred for optimal accuracy. It is recommended that the instrument be operated within an ambient temperature range of 15-35 degree Celsius (59-95 degrees Fahrenheit).

Precautions Notice - Be sure to insert the probe tip in a way, which will assure an air tight fit without causing any harm to the patient. Using a proper and clean ear tip is mandatory. Notice - We recommend using a new ear tip for each patient. If the clinician rinses the ear tips they should be subjected to standard disinfecting procedure between patients. This includes physically cleaning the ear tip 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. Notice - Be sure to use only stimulation intensities, which will be acceptable for the patient. Notice - The transducers (headphones, bone conductor, etc.) supplied with the instrument are calibrated to this instrument - exchange of transducers require a re-calibration. Notice - 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. Notice - 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 Notice - 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.

AA222 Instruction for Use - English Date: 2002-09-24

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Operation Instruction Performing Tympanometry and reflex tests 1. Switch on the instrument Make sure that the power supply is connected correctly to the mains and to the instrument. Now switch on the instrument on the connection panel of the instrument by pressing the power switch (53). 2. Clear memory of instrument Before making a test on a new patient it is always recommended to clear the internal memory of the instrument by holding down ―shift‖ (8) while pressing ―new subject‖ (11). 3. The correct eartip Check the size of the patient‘s ear canal in order to find an appropriate size eartip (6 to 22 mm) and mount it onto the probe tip. It is recommended always to use the eartips supplied by Interacoustics. 4. Select ear Now select the correct ear by pressing ―Right‖ or ―Left‖ (23 or 24) or by pressing the remote switch on the probe. 5. Testing the first ear Take the probe with one hand and insert the probe tip with the eartip mounted into the patient‘s ear canal while, with the other hand, carefully pulling backwards / upwards the pinna to straighten out the ear canal during the insertion. The probe will have an air tight fit when the indication light on the probe is green. When the status ―Leaking‖ or ―Blocked‖ is displayed in the upper right hand corner of the screen under the Status Bar, the indication light on the probe will be yellow. This indicates a bad fitting or a blocked ear tip. When a correct fit has been obtained a tympanometric test is automatically performed on the first ear. By means of the tympanometric test AA222 establishes the correct pressure in the ear canal for the subsequent reflex test. 6. Testing the next ear Now select the next ear by pressing ―Right‖ or ―Left‖ (23 or 24) or by pressing the remote switch on the probe. The test procedure is carried out as in the above section 5. 7. Print out test result To print out the test result from the internal printer press ―Print‖ (9).

Useful Information 

Before starting a test session with tympanometry and reflexes it is possible to select between two pre-programmed reflex setups, namely Test A and Test B. By pressing F6 it is possible to modify the selected Reflex Test A or B, but for the following patient only. Changing the pre-programmed Reflex Test A or B must be done from the Setup, which is reached by pressing F2 while being in the Main Menu.



Tympanometry and Reflexometry can be performed either on their own or automatically with Reflexometry following a Tympanometry Test. The ―Tymp/Reflex‖ key (12) has two indication lights which indicate whether Tympanometry and Reflexometry is performed on their own or together.



After an automatic reflex session it is possible to perform manual reflexes simply by pressing ―Man/Auto‖ (17). Now, by means of ―Frequency Decr/Incr‖ (27 and 28) and ―HL dB‖ rotary dial (29, 30), it is possible to alter the reflex parameters. To present the stimuli for the reflex press ―Tone Switch‖ (31). To store the manual reflex press ―Store‖ (20).

AA222 Instruction for Use - English Date: 2002-09-24

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Performing Audiometry tests 1. Switch on the instrument Make sure that the power supply is connected correctly to the mains and to the instrument. Now switch on the instrument on the connection panel of the instrument by pressing the power switch (53). 2. Select Audiometry Now press ―Tone‖ (14) in order to to select the AA222 audiometer function. In order to perform manual audiometry press ―Man/Auto‖ (17). 3. Clear memory of instrument Before making a test on a new patient it is always recommended to clear the internal memory of the instrument by holding down ―shift‖ (8) while pressing ―new subject‖ (11). 4. Communicating with Patient Talk to patient through the built-in swan neck. Simply hold down the ―Talk Forward‖ button (10) in order to talk to the Patient. The volume is controlled by dialing the "HL dB" rotary dial (29). 5. Present Pure Tones Select " Right" (23) or " Left" (24). Present a tone to the patient by touching "Tone Switch" (31). Control intensity by dialing the "HL dB " rotary dial (29) and the frequency by pressing "Frequency Decr Incr " (27) or (28). To be able to present intensities above 100 dB activate "ext. range" (29) by holding down ―shift‖ (8) while dialing the ―HL dB‖ rotary dial (29). 6. Bone Conduction Press "Bone R L" (25) once or twice to select right or left ear. Touch the "Tone Switch" (31) to present a tone to the patient. Control the intensity by dialing the "HL dB " rotary dial (29) and the frequency by pressing "Frequency Decr Incr " (27) or (28). 7. Warble Tones To select warble tones press F5. 8. Pulsed Tone To select pulsing tones press F4. 9. Masking To switch on masking rotate the right hand side "HL dB" rotary dial (30). Masking intensity is controlled by dialing the "HL dB‖ rotary dial (30). To synchronise (lock) the masking channel attenuator with the tone channel attenuator press "Synchr" (F6). To switch off masking hold down "shift" (8) while decreasing the masking intensity with ―HL dB‖ (30).

Auto Threshold In order to perform an automatic threshold test press "Man/Auto" (17). Make sure that the led is switched on below ‖Auto‖. To switch on the auto threshold test press the blinking ―Pause‖ button (11). Now both ears are tested automatically. The thresholds are stored in the internal memory of AA222. A preceding familiarisation procedure for the patient is available by selecting "Famili" (F2).

Storage of Thresholds When performing manual audiometry press "Store" (20) after each threshold is found. Individual storage is available for both ears in AC and BC and for FF1 and FF2.

AA222 Instruction for Use - English Date: 2002-09-24

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Storage of UCL values (uncomfortable level) Normally AA222 works in HL. However, by holding down "shift" (8) while pressing "hl/ucl" (25) it is possible to test and store values which will be designated as UCL. When AA222 is in UCL mode this will be indicated in the display.

Delete To delete stored data in a selected mode, AC or BC, Left or Right, simply press ―F1‖. The stored data is deleted for the selected transducer and ear only. In order to delete all data for a patient press ―new subject‖ (11) while holding down―shift‖ (8).

Speech Testing Select "Mic" (15) or "CD1/CD2" (16). Select desired output ―Right‖ or ―Left‖ (23) or (24), ―Bone R L‖ (25) or ―FF 1 2‖ (26). Select desired HL level by rotating the ―HL dB‖ rotary dial (29). Now simply present words. Note: To calibrate speech carried out via the built-in swan neck microphone hold down ―shift‖ (8) while pressing ―Mic‖ (15) for approx. one second. The Ch1 VU meter is now adjust so that VU-meter deflections are just reaching "0" during speech presentation. Press ―Store‖ (20) when calibration has been carried out. This calibration should be carried before every new patient is tested. To calibrate speech carried out via CD1 and /or CD2 hold down ―shift‖ (8) while pressing ―CD1/CD2‖ (16) for approx. one second. The Ch1 VU meter is now adjusted so that VU-meter deflections are just reaching "0" during speech presentation. Press ―CD1/CD2‖ (16) to calibrate Ch 2 in the same way. Press ―Store‖ (20) when calibration has been carried out. This calibration should be carried out only once.

Speech Score While being in speech mode with either "Mic" (15) or ―CD1/CD2" (16) activated, "Incor" (227) and "Correct" (28) are used as buttons to score incorrect and correct answers for automatic speech score calculation.

ABLB, Stenger and SISI To enter the ABLA, Stenger or SISI test press "Function" (18). This is possible only from one of the three Audiometry modes ―Tone‖ (14), ―Mic‖ (15) or ―CD1/CD2‖ (16). In order to select the special test procedure of one of the three individual tests press ―F1, F2 or F3‖ depending on the which of the three tests that is wanted for testing the patient.

AA222 Instruction for Use - English Date: 2002-09-24

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AA222 - Operation Panel Dictionary Position:

Symbol:

Function:

1-6

F1 – F6

7 8

Back shift

9 9 + shift 10 11

Print print screen Talk Forward Pause

11 + shift 12

new subject Tymp/Reflex

13 14 15 16 17 18 19

EFT Tone Mic CD1/CD2 Man/Auto Function Monitor TB

19

Monitor TB

19 20

Monitor TB Store

20 + shift 21 22 23 24 25 26 27

no response Ipsi Contra Right Left Bone R L FF 1 2 Frequency Decr

28

Frequency Incr

29 29+shift 30 30 + shiht 31

HL dB ext. range HL dB off Tone Switch

Function keys related to the functions indicated in the display above the individual function key. Pressing ―Back‖ will always take you one level back. Activates the function written in Italic below the buttons 10, 16, 17, 25 and 26. Prints out from internal printer. Prints out the present screen / display. Talk forward to patient Selects manual start of automatic tympanometry, reflexometry and audiometry tests. Clears the internal memory of the instrument. Selects between tympanometry, reflexometry and tympanometry + reflexometry. Selects Eustachian Tube Function test. Selects tone audiometry. Selects speech audiometry with built-in microphone. Selects speech audiometry with recorded speech and/or noise. Select between manual and automatic audiometry. Selects pre-programmed tests: ABLB, Stenger, SISI First push: Monitor active (the presentation to patient from e.g. tape can be heard through monitor headset or built-in speaker). Second push: Talk Back active (the patient´s comment can be heard through monitor headset or built-in speaker). Third push: Monitor as well as Talk Back is active. Stores threshold in manual audiometry and stores manual tympanometry curves and reflexes. Inserts ―no response‖ sign in the audiogram. Selects ipsilateral reflex stimulation. Selects contralateral reflex stimulation. Selects right ear. Selects left ear. Selects bone conductor for left or right ear. Selects Free Field presentation via loudspeakers. Reduces frequency in reflexometry and audiometry. Furthermore it indicates an incorrect answer when carrying out a speech score. Increases frequency in reflexometry and audiometry. Furthermore it indicates a correct answer when carrying out a speech score. Adjusts intensity in reflexometry and audiometry in Ch. 1. Selects extended range in reflexometry and audiometry. Adjusts masking intensity in Ch. 2. Turns off Ch. 2. Presents stimulus in manual reflexometry and audiometry.

AA222 Instruction for Use - English Date: 2002-09-24

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AA222 - Connection Panel Dictionary Position:

Symbol:

Function:

40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57

CD1 CD2 FF1 FF2 Left Right Bone Contra Talk Back Mic Transducer Air Patient Response Power Keyboard Monitor USB Mains

Connector for tape recorder or CD player Connector for tape recorder or CD player Connector for FF1 Amplifier. Connector for FF2 Amplifier. Connector for left headphone TDH39. Connector for right headphone TDH39. Connector for bone conductor. Plug for contra telephone. Connector for talk back microphone. Connector for external microphone. Plug for cable from probe system. Plug for the air hose of the probe system. Plug for patient response switch. Turns power on/off. Connector for keyboard. Connector for monitor headset. Plug for computer connection. Plug for mains cable (UPS400 Power Supply).

40 44

41

42

43 45

46

52

53 54

47

50

48

49

55

57

51 56

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

AA222 Instruction for Use - English Date: 2002-09-24

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

: : :

EN 60645-1, ANSI S3.6, Type 2, B-E Speech Audiometer EN 61027, ANSI S3.39, Type 2 EN 60601-1, Class 1, Type B, EMC: EN60601-1-2

The CE mark indicates that the instrument is made to fulfil the demands of the Council Directive 93/42/EEC concerning medical devices and that TÜV Product Service, identification no. 0123, has approved the quality system of Interacoustics. Impedance: Probe Tone Frequency: Probe Tone Intensity : Pressure Range : Accuracy : Compliance Range : Compliance Accuracy :

226 Hz 1% 85 dB SPL 1.5 dB +300 to -600 daPa 5% or 10 daPa 0.1-6 ml. 5% or 0.1 ml.

Reflex: Manual or automatic testing with 18 stimuli to each ear. Auto Reflex Detection. Multiple Reflex stimuli. Stimulus Duration : 1.0 sec. Reflex Acceptance : Adjustable between 2% and 6%, or 0.05 – 0.15 ml change of ear canal volume. Ipsi Frequencies : 500, 1000, 2000, 3000, 4000 Hz, wide band, high and low pass. Intensity (Max.) : 100, 105, 110 dBHL. Contra Frequencies : 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz, wide band, high and low pass. Intensity (Max.) : 90, 100, 120, dBHL. Reflex Decay: Stimulus Duration Stimulus Frequency Stimulus Intensity

: : :

10 sec.

{ Ipsi and Contra as above.

Audiometer: Type 4 according to EN 60645-1, ANSI S3.6. Frequencies Hz: 125 250 500 1000 2000 3000 4000 6000 8000

Intensities dBHL: -10 to 90 -10 to 90 -10 to 120 -10 to 120 -10 to 120 -10 to 120 -10 to 120 -10 to 120 -10 to 110

Auto Threshold Determination (Modified Hughson Westlake).

AA222 Instruction for Use - English Date: 2002-09-24

Tests: Tympanometry : Reflexometry incl. decay: Audiometry : Eustachian Tube

:

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Automatic Automatic or Manual. Manual or Auto Threshold (Patient controlled Hughson Westlake test after ISO 8253) Semi Automatic function test. Williams Test (non perforated eardrums)

Calibration: Impedance : EN 61027, ANSI S3.39 Audiometer : ISO 389-1, ANSI S3.6 Calibration is performed via the instrument's front panel and is stored in a permanent memory. Computer Communication: Built-in USB input/output computer interface. One mode allows the computer to both monitor and control the AA222. Control actions will be indicated on the operation panel and the display. Power supply: Type Input Fuses Output

: : : :

UPS400 100 - 240V AC +/-10%, 50 - 60Hz, 48W max 2xT1A 5Vdc, 12VDC and -12VDC

Dimensions: W x D x H: 36 x 26 x 10 cm, 14 x 10 x 4 inches. Weight: 2.8 kg / 6 lbs. Included Parts  AA235-ATP Standard Probe System  TDH39 Single Contralateral Earphone  B71 Bone Conductor  UPS400 External Switch Mode Power Supply  Power Cable (110/220V, please specify)  BET50 Box of 65 Assorted Eartips  TPR35 3 Rolls of Recording Paper  PCR-AA235 Dust Cover  Operation/Multilingual CE manuals

AA222 Instruction for Use - English Date: 2002-09-24

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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, Drejervaenget 8, DK-5610 Assens, Denmark. This should 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.

AA222 - Operation Panel

Manuale D’Uso - I

Audio Traveller AA222