Operation Manual

Screening Audiometer AS216

Valid from serial 160252 software version 1.08 80693201 ver. 11/2005

Table of Contents
Table of Contents ............................................................................... 1 Introduction......................................................................................... 2 Intended use............................................................................... 2 Precautions ................................................................................ 2 Basic Functions .................................................................................. 4 Patient Communication .............................................................. 4 Patient Signal ............................................................................. 4 Print-out ...................................................................................... 4 Pure Tone Presentation ..................................................................... 6 Air Conduction............................................................................ 7 Hughson Westlake ............................................................................. 9 Functions of Buttons ....................................................................... 11 Technical Specifications.................................................................. 14 Parts ......................................................................................... 16 Electrical Installation................................................................. 17 External Connections - Standard Accessories......................... 18 Unpacking / Inspection .................................................................... 19 Contents of Shipment............................................................... 19 Reporting Imperfections ........................................................... 20 Care and Maintenance ............................................................. 20 Trouble Shooting .............................................................................. 22 Dictionary .......................................................................................... 23 Appendix: Changing Setup Items ................................................... 24 Contents ................................................................................... 24 Introduction............................................................................... 24 Setup items............................................................................... 25 Appendix B: General Maintenance Procedures ............................ 29 Return Report.................................................................................... 31 Drawing of front plate ...................................................................... 33

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Introduction
Intended use
The AS216 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 clinical audiometer depends on the interaction with the patient. However, for patients not responding well possibilities of various tests allow the tester of having 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

Precautions
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 new 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. 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
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declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for the combination. Notice - Do not site the instrument next to a heat source of any kind, and allow sufficient space around the instrument to ensure proper ventilation. 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 - 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.

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Basic Functions
Patient Communication
The operator may talk to the patient through the patient's headset by turning the HL dB (8) while pressing the "Shift" button (1). The same function is used to adjust the volume in the patients headset. The microphone is located in the upper left corner (A).

Patient Signal
The AS216 can indicate responses from a patient signal. The red indicator light (B) lights up accordingly for left and right ear. Furthermore, the response switch may be used for running the Auto Threshold - Hughson Westlake test.

Delete Function
To delete old test results stored in the memory of the AS216 activate the Shift (1) button while pressing the dB 1 5 (6) simultaneously. 1) Pressing the buttons for one second - all data for the selected ear will be deleted, and To delete all data (reset for a new patient) hold down the buttons until All data deleted is written in the display.

2)

Print-out
The data from the AS216 can be printed out in two ways: Computer: If the AS216 is connected via the RS232C interface to a computer with the IaBase II, PrintView or NOAH program installed, it is possible to transfer the air conduction and
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bone conduction results to the computer and from there print the results. MTP10: The AS216 can be connected to the MTP10 (Desk Unit for the handheld impedance audiometer MT10, with built-in thermal printer) and print out the threshold found with the AS216.

Cable: IFC69 / IFC59

(Computer: with IaBase II, Print View or NOAH installed)

Cable: IFC69

(MTP10)

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Pure Tone Presentation

A) B) C) D) Select desired test ear with Left or Right button (4). Select frequency with the "Frequency" button (9). Select desired intensity with the HL dB (8). Present tone by touching Tone Switch (10).

10

Warble: Warble or pure tones is available by pressing the "Warble" (6) button. Pulse: Pulsing tones or Reverse are available by pressing the "Rev / Pulse" (5) button.

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Air Conduction
Hearing threshold levels can be determined by air conduction. The test signal is presented to the test subject by earphones. The purpose of Air Conduction 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 eyeglasses and earrings 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 result will be false at lower frequencies. Instruction of subject: Prior to hearing threshold level measurements, the following instruction of the subject about the test tones and how to respond via the patient signal button or raising the hand shall be carried out: "You will now hear different tones in the earphones with various intensities. Please push the signal button when you hear the tone and release it when you do not hear the tone or raise your L/R hand when you hear the tone in the L/R ear". Threshold Determination: The test normally starts at 1000 Hz on the patient's best ear, and the L/R button is adjusted accordingly. Familiarisation: Present a tone of 40 dB to the test ear. Often this tone is sufficient to evoke a clear response from the subject. Then present a tone completely attenuated. If the subject does not respond to a tone of 40 dB, present tones, which are successively 10 dB higher until a response occurs. Then reduce the tone level by 20 dB.

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In either case gradually increase the level until a response occurs. Repeat the tone presentation at the same level. If the responses are consistent, the familiarisation is completed. If not, it should be repeated. Threshold Determination: 1) Present a tone 10 dB lower than the threshold obtained during the familiarisation procedure. If response fails, increase in 5 dB steps until the subject responds. 2) Decrease the level by 10 dB and perform another ascending level series until response. Repeat 2). Continue until three responses out of a maximum of five occur at the same level and store the threshold. Almost the same results will be obtained, when accepting two responses out of three tone presentations as the threshold at that frequency. 4) Proceed to the next frequency. Repeat 2) and 3). Finish all frequencies on one ear. Repeat the procedure at 1000 Hz. If the difference is 5 dB or less go to the other ear. If the difference is 10 dB or higher, repeat the test at further frequencies in the same order, until agreement to 5 dB or less has been obtained. 5) Proceed until both ears have been tested.

3)

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Hughson Westlake
Hughson Westlake is an automatic pure tone test procedure. Threshold is defined as 2 out of 3 correct responses at a certain level in a 5 dB increase and 10 dB decrease test procedure.

10

Instruct the patient that he will hear tones with different frequencies and that he is supposed to push the patient response button whenever a tone is audible to him. A) Reset the AS216 for a new patient by activating Warble/ del (6) while pressing Shift (1). Select desired test ear by means of Right / Left (4). Activate the "Auto Threshold button (5) while pressing the Shift button (1) to start the test. When all frequencies are tested the test automatically continues on the other ear. However, if audiometric data are already present for this other ear the test will not be
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B) C)

D)

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continued, as this would delete the previously entered data without warning. To view the stored threshold select disp thr (7) while holding down Shift (1). The thresholds for the various frequencies will now be displayed in the LCD. To get back to normal mode turn the Frequency dial anticlockwise (off) while activate the Shift (1) button. Testing only a limited frequency range. In the Modification register no. 8 you can select to have some of the frequencies deactivated in the Auto Threshold mode (see page 27)

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Functions of Buttons
See the drawing at the back of this manual for reference: A) Microphone: Microphone used for Talk Forward / instruction of patient, e.g. when using a sound cabin. Tone: Response: Indication lights light up when tone is presented. Indication lights light up when the patient activates the patient signal.

B) C)

D) 1)

LCD Display: 7 segment Shift: The Shift button will enable you to activate the sub functions of the other buttons as written in italic. The light indication of the buttons can be adjusted by means of the LED Adj.

2)

LED adj.:

3)

Store / no response: For storing the various thresholds found. The no response indication may also be stored by activating Store/no response (3) while pressing Shift (1). Right or Left / bone: For selecting the test ear. Bone conduction may be selected and performed if an optional bone conductor is supplied and connected on the rear-panel. Simply activate Bone (4) while holding down the Shift (1) button. A b in the display indicates that bone conduction is selected. Rev Pulse / auto thr: First push: Continuous Tone presentation interrupted by means of the Tone Switch (10). Second push: The tone will pulsate continuously.
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4)

5)

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The Auto Threshold test based on the Hughson Westlake method can be performed by activating Auto thr (5) while holding down Shift (1) . 6) Warble Tone / del: Warble tones can be used as stimuli by activating Warble (6). The thresholds can be deleted by activating Warble/del (6)while pressing Shift (1). Extended Range / disp thr: Usually, the max output is 100 dB but if a higher output up to 120 dB is needed Ext. Range should be activated (7) when 100 dB is reached. Taking the attenuator below 100 dB the extended range function will switch off automatically. The thresholds stored can be viewed in the LCD by activating Extended Range/disp thr (7) while pressing Shift(1). To return to the test mode turn the Frequency dial anti-clockwise (off) while activate the Shift (1) button. HL dB / talk forward : Selection of the intensity. The HL dB attenuator is used to turn on the Talk Forward Microphone (A) by dialling the HL dB (8) dial while activating Shift (1) button.

7)

8)

9)

Frequency / off : Selection of frequency. The Frequency/off (9) dial is used to return to the test mode by dialling the Frequency dial anticlockwise (off) while activating Shift (1).

10) Tone presentation: For tone presentation. Light indication will be on. Tone (B).

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When the AS216 is connected to the MTP10 activate Tone Switch/print (10) while pressing the Shift (1) button to print the threshold stored.

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Technical Specifications
Standards: Audiometer: EN 60645-1, ANSI S3.6, Type 3 Safety: EN 60601-1. EMC: EN 60601-1-2 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. TV Product Service, Identification No. 0123, has approved the quality system. Frequencies and Maximum Intensities: Freq. Hz. 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 AC dBHL TDH39 90 110 120 120 120 120 120 120 120 120 110 AC dBHL EarTone5A 90 105 110 115 120 120 120 120 115 100 95 BC dBHL B71 45 65 70 70 70 75 80 80 55 50

Extended Range Function: If not selected the AC output will be limited to 20dB below maximum output. Input: Tone, Warble Tone +5%, 5Hz (true sine wave frequency modulation).

Masking stimulus: NB Noise / White Noise. Output: Left, Right, Bone L+R, Insert Phones, Insert Masking.
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Transducers: TDH39 Audiometric Headset (standard) EAR-Tone5A Insert Phones (optional) B71 Bone Conductor Talk Forward: Built-in talk forward microphone. 0-110dB SPL continuously adjustable on operation panel. Tone Presentation: Manual or reverse. Single Pulse. Multiple pulses 250-500 msec. On/off. Auto Threshold: Patient controlled Hughson Westlake procedure according to ISO 8253 or OSHA procedure according to NIOSH. Frequency selection: 125Hz, 250Hz, 750Hz, 1500Hz or 8 kHz may freely be deselected if a quicker test routine is desired. Synchronous Masking: Locks channel 2 attenuator to channel 1 attenuator. Store Function: Internal memory for AC L/R and BC L/R. Tests: SISI with auto score calculation (5 dB included for familiarisation). ABLB: Stenger (binaural pure tone stimulation), Langenbeck (Tone in Noise). Bksy test: Pure Tone or Narrow Band stimulation. Fixed frequency. Continuous and pulsed tone. OSHA automatic pure tone test procedure.

Display: Alpha-Numeric Display. Patient Signal: Reed switch push button.

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Interface: Bi-directional RS232C, output for MTP10 Printer, laser printer with HP GL/2 language, output for Ink Jet or Matrix printer using IBM mode (optional). Examples of Compatible Windows Software: IaBase II database program. PrintView for on-line PC monitoring and printing. NOAH hearing aid fitting software. CONNEX hearing aid fitting software. Construction: Plastic cabinet. Attenuator controls: Rotary switches (push buttons optional) Power supply: External UPS400 (included). 100-115 V or 230 V, 50-60 Hz, fuse : T 1A. Consumption: 40 VA Dimensions: WxDxH: 300 x 230 x 90 mm / 12 x 9 x 4 inches Weight: 1.3 kg / 2.9 lbs. (External power supply UPS400 + 0.8 kg / 1.8 lbs.).

Parts
Included Parts: TDH39 Audiometric Headset B71 Bone Conductor APS2 Patient Response Button UPS400 External Power Supply (Medically approved) 200 AF12 Audiogram Charts 3 pens Operation Manual Multilingual CE Instructions for use Additional Parts:
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21925 Amplivox Audiocups, noise reducing headset 50250 Peltor noise reducing headset (may be supplied at no extra cost) ACC216 Carrying Case EARTone5A Audiometric Insert Phones IPA26 printer adaptor for IBM printer mode IFC59 (25 pins) computer cable IFC69 (9 pins) computer cable

Electrical Installation

Socket for external power supply (UPS400 or equivalent)

To maintain the validity of the CE-mark of the AS216 when using an external power supply, the power supply must be medically CE approved.

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External Connections - Standard Accessories

Standard Headphones TDH39 or EarTone 5A Insert Phones

Patient Response Switch APS2

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Unpacking / 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 the nearest service office. Keep the shipping material for the carriers inspection and insurance claim. Keep carton for future shipment: The AS216 comes in its own shipping carton, which is specially designed for the AS216 . Please keep 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.

Contents of Shipment
Delivered items with AS216: AS216 is as standard is delivered with the following: Quantity Item 1 1 Instrument Audiometric Headset (Peltor noise reducing headset may be supplied at no extra cost) Bone Conductor External Power Supply Patient Response Button Audiogram Forms Pen Set, 3 pens Operation manual Multilingual CE Instructions for Use Order No. AS216 TDH39

1 1 1 200 1 1 1

B71 UPS400 APS2 AF12

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Check numbers on AS216 and Manual: The identification label on the rear plate holds the serial number. This should be checked with the manual number, and written down for later service claims. To maintain the validity of the CE-mark of the AS216 when using an external power supply, the power supply must be CE-medical approved. When AS216 is supplied with the external power supply model UPS400 write down the serial number located on the bottom plate.

Reporting Imperfections
Inspect before connection: Prior to connecting the AS216 to the mains, 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 Record will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction.

Care and Maintenance

The performance and reliability of AS216 is prolonged if the following recommendations for care and maintenance are adhered to:

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Using an External power Supply e.g. UPS400 - turn off at the mains socket. Great care when handling the headset. Great care should be exercised when handling the headset as dropping it may alter the calibration. Annual calibration headset: The AS216 has been designed to provide many years of reliable service, but annual calibration is recommended due to possible impact on transducers. We do also recommend to calibrate the AS216 if something drastic happens to part of it (e.g. headset or bone conductor is dropped).

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Trouble Shooting
AS216 does not turn on: Using External Power Supply: The power cable must be correctly connected to the mains and the connection of the mains cable to the UPS400 should be checked. The mains switch must be "on", the power switch on the external power supply and the AS216 power switch must be "on". If still nothing happens a fuse in the external power supply may be blown. Renew fuses with exactly the same types.

No tones in the TDH39 headphone: Left (4) or Right (4) ear must be selected. The Attenuator (8) must be turned up. The Tone presentation signal (10) must be activated by touching the Tone Switch. If still no sound appears check that the headphone is correctly connected to the phone outputs and that the jack is inserted.

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Dictionary
No. Symbol 1 2 3 4 5 6 7 8 9 10 A B C D Shift LED Adj Store / no response Right Left / bone Rev Pulse / auto thr Warble / del Ext Range / disp thr HL dB Frequency Decr /off Tone Switch Tone Response Explanation (English) Used to activate the second function of the various buttons. Used to adjust the light indication of the buttons. Used to store the threshold found or to store the not heard symbol. Selects Right or Left headphone or select Right or Left bone conduction. Selects Reverse or Pulse or the Auto Threshold test. Selects Warble tone or deletes the data stored. Selects extended range +20dB or displays the stored data in the display. Adjustment of Intensity Selects stimulus frequency or turns off and returns to test mode. Presents stimulus. Microphone for Talk Forward Indicate when tone is presented. Indicate response from patient. LCD Display - 7 segments

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Appendix: Changing Setup Items

Contents
Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item Setup Item 1 2 3 4 5 6 7 8 9 10 11 12 13 Baudrate ............................................................25 Headset type......................................................25 Bone Output.......................................................25 Multipulse Speed ...............................................26 Line btw. Not Heard symbols on printouts.........26 Attenuator Position ............................................26 Button type.........................................................26 Frequency Deactivation .....................................27 Freq. Deactivation in Man. Threshold................27 Automatic Print...................................................27 Bone Output.......................................................28 RS232 - Handshake ..........................................28 Transmit on Store ..............................................28

Introduction
The Setup Item number can be changed by activating the Intensity Increase / Decrease Keys in channel 2. The contents of the setup Item can be changed by activating the Increase / Decrease Keys in channel 1. To set the Items to factory setting, hold down "shift" while pressing "Ext Range" when the AS216 is in calibration mode. To Enter the Setup, hold down "shift" while dialling the Increase / Decrease Keys in channel 2 clockwise. To Leave the Setup, hold down "shift" while dialling the Increase / Decrease Keys in channel 2 anticlockwise.

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Setup items
Setup Item 1 Baud rate

The LCD display will show this after entering the setup, with a flashing S:

1 S 38.4

[38.4, 19.2, 9.6]

The first number on the LCD is Setup-Item number. Next to the S it is the baud rate (RS232 transmission speed). The possibilities are 38.4, 19.2, 9.6 K baud.

Setup Item 2

Headset type

Used to select between Insert Phones (EAR-Tone5A) and Phones (TDH39).

2 S InS
Setup Item 3 Bone Output

[Ins, Ph]

Used to select the maximum output on Bone, depending on the bone conductor used. Possibilities are A20 and B71.

3 S b71

[b71, A20]

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Setup Item 4

Multi-pulse Speed

Used to select the pulse speed. The pulse speed can be changed from 250 mS to 5000mS, in 50 mS step.

4 S 500

[250,3004950,5000]

Setup Item 5

Line btw. Not Heard symbols on printouts

Used to enable/disable lines between not heard symbols on printouts.

5 S LinE

[LinE, OFF]

Setup Item 6

Attenuator Position

Used to select the attenuator position when a new transducer is activated. It can be selected from -10 to 50 dB, in 5 dB steps, or Off.

6 S 30

[-10,-545,50]

Setup Item 7

Button type

Used to tell the instrument which type of buttons that are used as Intensity and Frequency buttons. The values are but for push buttons and rot for rotary keys.

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7 S rot Frequency Deactivation Setup Item 8

[rot, but]

Used to deactivate one or more of the following frequencies: 125 Hz, 250 Hz, 750 Hz, 1500 Hz, 8000 Hz. Press the Store key (3) to activate/deactivate a frequency, and Intensity Increase/Decrease (8) to shift between frequencies. The last number in frequency is flashing when deactivated.

8 S 125

[125,250,750,1500,8000]

Setup Item 9

Freq. Deactivation in Man. Threshold

Used to select between all frequencies or reduced frequencies selected in Item 8 in manual threshold mode.

9 S ALL

[ALL,SEL]

Setup Item 10

Automatic Print

Used to enable/disable automatic printout after an ended Auto Threshold.

10 S PrOn

[PrOn, PrOF]

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Setup Item 11

Bone Output

Is used to select between Bone Conductor and Loudspeaker, as the connected transducer to the bone output.

11 S bone

[bone,SPEA]

Setup Item 2

RS232 - Handshake

Is used to turn ON/OFF the handshake control between a PC and the instrument. Handshake is used with RS232 communication in order to make the flow of data correct. In some cases the computers requires this option to be HAOn.

12 S HAOF

[HAOF,HAOn]

Setup Item 13

Transmit on Store

By selecting trOn in this field you can get the AS216 to send a total instrument status each time you press the Store key.

13 S trOF

[trOn,trOF]

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Appendix B: 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 overhaul, to ensure that the acoustical, electrical and mechanical properties are correct. This should be made by an authorised workshop in order to guaranty proper service and repair. Before the connection to the mains network, be sure that the local mains voltage corresponds to the voltage labelled on the instrument. Always disconnect the power cord if the instrument is opened or by control / replacement of the mains fuses. 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 site the instrument next to a heat source of any kind, and allow sufficient space around the instrument to ensure proper ventilation. To ensure that the reliability of the instrument is kept, it is recommended that the operator at short intervals, for instance once a day, perform a test on a person with known data. This person could be the operator him/herself. A plastic cover can be provided to protect the instrument against the accumulation of dust. The cover should only be used when the instrument is left unused with the power turned off. If the surface of the instrument or parts of it are contaminated, 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 conductor during the cleaning process, and be careful that no fluid is entering the inside of the instrument or the accessories.
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AS216

After each examination of a patient, it should be ensured that there is no contamination on the parts in connection with the patient. General precautions must be observed in order to avoid that disease from one patient is conducted to others. If ear cushions or eartips are contaminated, it is strongly recommended to remove them from the transducer before they are cleaned. By frequent cleaning water should be used, but by severe contamination it may be necessary to use a disinfectant. 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. After each examination of a patient, it should be ensured that there is no contamination on the parts in connection with the patient. General precautions must be observed in order to avoid that disease from one patient is conducted to others. If ear cushions or eartips are contaminated, it is strongly recommended to remove them from the transducer before they are cleaned. By frequent cleaning water should be used, but by severe contamination it may be necessary to use a disinfectant. 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.

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Return Report Form 001

Opr. date: 2003-02-24 by: EC Rev. date: 2003-02-24 by: EC Rev. no.: 1

Company: Address:

Address Drejervnget 8 DK-5610 Assens Denmark Phone (+45) 63713555

Phone: Fax:

Fax (+45) 63713522

Date : Contact person: Following item is reported to be: returned to INTERACOUSTICS for: repair, exchange, defective as described below with request of assistance repaired locally as described below showing general problems as described below Item: Type: Serial No.: Included parts: Quantity: Supplied by:

other:

Description of problem or the performed local repair:

Returned according to agreement with: Date :

Interacoustics,

Other : Person :

The above mentioned item is reported to be dangerous to patient or user 1

In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item. Please note that the goods must be carefully packed, preferably in original packing, in order to avoid damage during transport. (Packing material may be ordered from Interacoustics.

1 EC Medical Device Directive rules require immediate report to be sent, if the device by malfunction deterioration of performance or characteristics and/or by inadequacy in labelling or instructions for use, has caused or could have caused death or serious deterioration of health to patient or user.

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Drawing of front plate

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