1.2 Intended Use The AD226 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.
AD226 Instruction for Use - US Page 2 1.4 Warnings Throughout this manual the following meaning of warnings, cautions and notices are used: 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.
Return Report will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction. Storage If you need to store the AD226 for a period, please ensure it is stored uder the following conditions: Temperature: Transportation: -20° to 50°...
Failing to do so may endanger the environment. 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, 0123 has approved the quality system.
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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 Never insert or in any way use the insert headset without a new clean non defect test tip.
AD226 Instruction for Use - US Page 7 3 Getting Started - Setup and Installation 3.1 Back Panel Connections – Standard Accessories When connecting to back panel connections tilt up/turn the instrument carefully for better overview. Patient Bone Left Phone...
Please refer to the Diagnostic Suite operation manual regarding hybrid mode (on-line and PC-operated mode) as well as patient/session data transfer. 3.3 Operating instructions The figure below shows the outline of the front plate of the AD226 including buttons, dials and display: (13) (14) (15)
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AD226 Instruction for Use - US Page 9 7-12 Function Keys These keys are context sensitive and depend on the selected test screen. The fuctions of these keys will be explained further in later sections. Shift The shift function will enable the clinician to activate the sub functions written in italic underneath the buttons.
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AD226 Instruction for Use - US Page 10 Mask on/off Masking channel on/off: First push: turns masking on Second push: turns masking off Sync This allows the masking attenuator to be locked to the tone attenuator. This option is used for e.g. synchronous masking.
AD226 Instruction for Use - US Page 11 Battery operation Insert batteries correct according to marking. Use 4x1.5V/1.2V Alkaline/NiMH Type AA Note: When the instrument is battery powered or USB-only powered the maximum stimuli output level is reduced 20dB 3.4 Tone test...
AD226 Instruction for Use - US Page 12 3.5 Stenger Test (12) (10) (11) Please refer to the Tone Test section above for key function descriptions for Function Keys (7), (8), (9), (10). 3.6 ABLB Test (10) (11) (12) Please refer to the Tone Test section above for key function descriptions for Function Keys (7), (8), (9),...
AD226 Instruction for Use - US Page 13 3.7 Hughson-Westlake Test (10) (11) (12) Text on screen Description Famili Select familarity Start HW test 3.8 Setup (10) (11) (12) Text on screen Description Tone Access the settings for the Tone Tests.
AD226 Instruction for Use - US Page 14 3.9 Sessions and clients 3.9.1 Save Session (12) (10) (11) Text on screen Description Save Save session under the selected client. Delete Delete the selected client. Create new client. Edit Edit the selected client.
Page 15 4 Care and Maintenance 4.1 General Maintenance Procedures The performance and reliability of the AD226 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.
Calibration procedure is available in service manual which is available on request. Do not modify this equipment without authorization. Interacoustics will make available on request relevant 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 4.2 How to clean Interacoustics Products...
Page 17 4.3 Concerning Repair Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety, reliability and performance of the equipment if: 1. assembly operations, extensions, readjustments, modifications or repairs are carried out by authorised persons, 2.
EMC Standard IEC 60601-1-2:2007 Medical CE-mark Audiometer Standards Tone: IEC 60645-1:2012/ANSI S3.6:2010 Type 3 Calibration Calibration information and instructions is located in the AD226 Service manual TDH39: ISO 389-1 1998, ANSI S3.6-2010 Conduction DD45: PTB/DTU report 2009 E.A.R Tone 3A: ISO 389-2 1994, ANSI S3.6-2010...
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AD226 Instruction for Use - US Page 20 Intensity AC: -10 to 120 dB HL BC: -10 to 80 dB 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.
AD226 Instruction for Use - US Page 21 5.1 Reference Equivalent Threshold Values for transducers See Appendix in English in the back of the manual. 5.2 Pin Assignments See Appendix in English in the back of the manual. 5.3 Electromagnetic Compatibility (EMC)
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Survey of Reference and max Hearing Level Tone Audiometer ANSI TDH39 IEC TDH39 Coupler: ANSI S3.7-1995 (NBS-9A) / Coupler: IEC 60318-3 1998 (6ccm) IEC 60318-3 1998 (6ccm) Tone Audiometer Tone Audiometer Tone Narrow Band Noise Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 ISO 389-1 1998 ISO 389-4 1994...
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ANSI EAR 3A Coupler: ANSI S3.7-1995 (HA-2 with 5mm rigid Tube) Tone Audiometer Tone Narrow Band Noise ANSI S3.6-2010 ANSI S3.6-2010 IEC EAR 3A Frequency RETSPL MaxHL RETSPL MaxHL Coupler: IEC 60318-5 2006 26.0 30.0 Tone Audiometer 22.0 26.0 Tone Narrow Band Noise 18.0 22.0...
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General properties for earphones Sound attenuation values for earphones Frequency Attenuation DD45 or TDH39 with MX41/ EAR-Tone 3A AR or PN 51 cushion [Hz] [dB] [dB] 33,5 34,5 34,5 1000 35,0 1250 1500 1600 2000 33,0 2500 3000 3150 4000 39,5 5000 6000...
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AD226 Pin assignment Socket Connector Pin 1 Pin 2 Pin 3 Ground /1.6A DC Supply Left Right Ground Signal Bone Ins. Mask. 6.3mm Mono Pat. Resp. 6.3mm Stereo Ground Signal ch. 2 Signal ch. 1 3.5mm Stereo USB (host) USB (PC)
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The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard.
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Voltage dips, short < 5% UT (>95% dip in UT) < 5% UT (>95% dip in UT) (>95% dip in UT) interruptions and voltage for 0.5 cycle for 0.5 cycle for 5 sec Mains power quality variations on power supply should be that of a typical lines 40% UT (60% dip in UT)
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Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user 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.