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Instructions for Use - US
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Table of Contents
Related Manuals for Interacoustics AS608
Summary of Contents for Interacoustics AS608
- Page 1 Science made smarter Instructions for Use - US AS608 Instructions for Use Instructions for Use Gebrauchsanweisung Gebrauchsanweisung Instructions d’utilisation Instructions d’utilisation Bruksanvisning Bruksanvisning Brugsanvisning Brugsanvisning Käyttöohje Käyttöohje Bruksanvisning Bruksanvisning Manual de instrucciones Manual de instrucciones...
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Page 3: Table Of Contents
Environmental factors ......................9 2.3.7 Disposal ..........................9 Getting Started - Setup and Installation..................11 AS608 - Connection Panel Dictionary ................... 11 AS608 - Operation Panel Dictionary ..................12 Air Conduction ........................13 Power Up and Power Off ....................... 14 Pure Tone Presenation ...................... -
Page 5: Introduction
1.2 Intended Use The AS608 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. -
Page 6: Product Description
1.3 Product Description 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 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... -
Page 7: Warnings
CAUTION The CAUTION label identifies conditions or practices that could result in damage to the equipment. NOTICE NOTICE is used to address practices not related to personal injury. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 3... - Page 8 D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 4...
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Page 9: Unpacking And Installation
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 AS608 for a period, please ensure it is stored uder the conditions specified in the section for technical specifications. D-0127810-A – 2020/05... -
Page 10: Marking
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. -
Page 11: Important Safety Instructions
IEC 60601-1 clause 16 2.3.2 Electrical safety Do not modify this equipment without authorization of Interacoustics Do not disassemble or modify the product as this may impact on the safety and/or performance of the device. Refer servicing to qualified personnel. -
Page 12: Explosion Hazards
Interacoustics as repairable by service personnel. No parts of the equipment can be serviced or maintained while in use with the patient. -
Page 13: Environmental Factors
Connect only accessories purchased from Interacoustics to the instrument. Only accessories which have been stated by Interacoustics to be compatible are allowed to be connected to the device. Never insert, or in any way use, the insert headset without a new clean and non-defective ear-tip. - Page 14 MDD article 4.4. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 10...
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Page 15: Getting Started - Setup And Installation
Power / USB Socket for external power supply ASA30M Patient Resp. Socket for patient response switch APS3. Right Socket for right headphone DD65. Left Socket for left headphone DD65. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 11... -
Page 16: As608 - Operation Panel Dictionary
Adjustment of Intensity Tone Switch Presents stimulus. Tone Indicates presentation. Response Indicates response from patient. External Power / Battery Indication of external power supply / battery status. status D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 12... -
Page 17: Air Conduction
(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. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 13... -
Page 18: Power Up And Power Off
3) Present tone by touching Tone Switch. An indication will be on Display (see below). 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. -
Page 19: As608E Special Functions
Response: When using the APS3 response button, a response is indicated in the middle of display header. 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. -
Page 20: Setup Menu Of As608/As608E
Setup Menu of AS608/AS608e To access the AS608/AS608e setup menu press F1 and F4 simultaneously for 2-3 seconds. Change setting Browse up in the setup menu Browse down in the setup menu Save settings and Back to previous screen display –... - Page 21 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. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 17...
- Page 22 Press Change to set the lower limit and determine when to move on to the next frequency. The lower limit can be set between -10 and 20 dB. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 18...
- Page 23 License. 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.
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Page 24: About Diagnostic Suite
It works by checking the file and folder content of your software version. This is using an SHA-256 algorithm. On opening the checksum you will see a string of characters and numbers, you can copy this by double clicking on it. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 20... -
Page 25: Care And Maintenance
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. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 21... -
Page 26: How To Clean Interacoustics Products
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. D-0127810-A – 2020/05 AS608 - Instructions for Use - US... - Page 27 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.
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Page 29: General Technical Specifications
PTB Report 1.61-64/04 (HDA280). PTB Report 1.61-4039503/09 (DD65) 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. TÜV Product Service, Identification No. 0123, has approved the quality system. Frequencies and Intensities: Freq. - Page 30 External Power Supply (through USB connector): Accepts 5 VDC – minimum 150 mA The recommended UE10WCP1-050200SPA (5 Volt, 2 A) is approved with the AS608/AS608e. UE10WCP1-050220SPA: Input 100-240VAC 50/60 Hz, 500 mA, Output 5.0 V 2.0 A. (Class II) Construction: Plastic cabinet.
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Page 31: Reference Equivalent Threshold Values For Transducers
Air Conduction Air Conduction Air Conduction Air Conduction Air Conduction Air Conduction TDH39 DD65 v2 DD45 HDA280 EARtone 3A EARtone 5A 1000 1500 2000 3000 4000 6000 8000 D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 27... -
Page 32: Pin Assignments
Uses sleeve + tip mono 6.3mm jack. impedance: Connection: Other electrical specifications: Warble 5 Hz sine, ±5% modulation Electromagnetic Compatibility (EMC) See Appendix in English in the back of the manual. D-0127810-A – 2020/05 AS608 - Instructions for Use - US Page 28... - Page 33 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.