Interacoustics PA5 Instructions For Use Manual
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- Instructions for use manual (138 pages) ,
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- Instructions for use manual (20 pages)
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Table of Contents
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Summary of Contents for Interacoustics PA5
- Page 1 Science made smarter Instructions for Use - EN...
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Page 2: Table Of Contents
Intended purpose ........................1 Intended user ..........................1 Indications for use ........................1 Target population ........................1 Contraindications ........................1 Delivered items with PA5: ......................1 Warnings ............................. 2 Unpacking and installation ......................... 3 Unpacking and inspection ......................3 Marking ............................4 General warnings and precautions ..................... -
Page 3: Introduction
In addition to auditory stimuli, visual stimuli are also provided to facilitate the assessment of behavioral responses to the acoustic signals. The PA5 system aims to assist in the early detection of hearing impairments. The device should only be used in quiet surroundings. -
Page 4: Warnings
CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in damage of the equipment. NOTICE is used to address practices not related to personal injury or NOTICE damage of the equipment. Page 2 D-0131298-B 2025/01 PA5 Instructions for Use - EN... -
Page 5: 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 PA5 for a period, please ensure it is stored under the conditions specified in the section for technical specifications. Page 3... -
Page 6: Marking
This symbol indicates that when the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling. The CE-mark in combination with MD symbol indicates that Interacoustics A/S meets the requirements of the Medical Device Regulation (EU) 2017/745. -
Page 7: Malfunction
Interacoustics and the local national competent authority. Disposal of the product Interacoustics is committed to ensuring that our products are safely disposed of when they are no longer usable. The cooperation of the user is important to ensure this. Interacoustics therefore expects that local sorting and waste regulations for disposal of electric and electronic equipment are followed, and that the device is not discarded together with unsorted waste. -
Page 8: Getting Started - Setup And Installation
20 and 80 dB, HL can be selected in steps of 10 dB when the distance between the ear and the loudspeaker of the PA5 is 50 cm or the PA5 is switched off by leaving the intensity control switch in the “Off”... -
Page 9: Replacing Batteries
Battery Description Replacing Batteries: To replace old batteries, unscrew the small black lid in the narrow end of PA5 and the batteries can be taken out. Replace with three new AA batteries. When inserting the new batteries make sure that they are inserted correctly according to the small drawing in the bottom part of the control panel. -
Page 10: Replacing Batteries
Replacing batteries To replace old batteries, unscrew the small black lid in the narrow end of PA5 and the batteries can be removed. Replace with three new AA batteries. When inserting the new batteries please make sure that they are inserted correctly according to the small drawing in the bottom part of the control panel. -
Page 11: Description Of Various Tests
Other responses than the APR can be arousal from sleep, crying or diminished activity. The COR Test: The Paediatric Audiometer PA5 can perform Conditioned Orientation Audiometry based on a technique described by Suzuki and Ogiba (1961). The phenomenon called “Orientation Reflex” is not a learned response, but a natural reflex movement elicited by sound or visual stimulation. -
Page 12: Maturation Of Auditory Response
Sound localisation to the side and direct below. MRL: 25-35 dB. Minimum response level, dB HL. The MRL levels are recorded in sound cabins. In noisy surroundings the levels will have to be correspondingly higher. Page 11 D-0131298-B 2025/01 PA5 Instructions for Use - EN... - Page 13 MRL: 25-35 dB. 16-21 months of age Direct sound localisation to the side, below, indirect above. MRL: 25-35 dB. 21-24 months of age Locates directly sound at any angle. MRL: 25-30 dB. Page 12 D-0131298-B 2025/01 PA5 Instructions for Use - EN...
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Page 14: Maintenance
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 Page 13 D-0131298-B 2025/01 PA5 Instructions for Use - EN... -
Page 15: Concerning Repair
Warranty Interacoustics warrants that: • The PA5 is free from defects in material and workmanship under normal use and service for a period of 24 months from the date of delivery by Interacoustics to the first purchaser • Accessories are free from defects in material and workmanship under normal use and service for... -
Page 16: Technical Specifications
Technical specifications Medical CE- The CE-mark in combination with MD symbol indicates that Interacoustics A/S mark meets the requirements of the Medical Device Regulation (EU) 2017/745. Approval of the quality system is made by TÜV – identification no. 0123. Safety... -
Page 17: Calibration Values
0 dB 1000 2000 -1,5 -1,5 3000 -6,0 -4,0 4000 -6,5 -5,0 Maximaler [dBHL] for dis. 50 cm [ dBHL] Stim Speaker TDH39 Freq. Tone Tone 1000 2000 3000 4000 Page 16 D-0131298-B 2025/01 PA5 Instructions for Use - EN... - Page 18 SOUND ATTENUATION VALUES FOR EARPHONES ATTENUATION FREQUENCY TDH39 with MX41/AR or PN 51 Cushion [Hz] [dB]* 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000 6300 8000 *ISO 8253-1 2010 Page 17 D-0131298-B 2025/01 PA5 Instructions for Use - EN...
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Page 19: Pin Assignment
Pin assignment Socket Pin 1 Pin 2 Pin 3 Connector Ground Signal Phone 3.5 mm Mono Page 18 D-0131298-B 2025/01 PA5 Instructions for Use - EN... -
Page 20: Electromagnetic Compatibility (Emc)
Screened (Yes/No) Audiometric headset The use of the accessories, transducers, and cables with medical equipment/system other than this equipment may result in increased emissions or decreased immunity of the medical equipment/system. Page 19 D-0131298-B 2025/01 PA5 Instructions for Use - EN... - Page 21 Guidance and manufacturer’s declaration - electromagnetic emissions The Instrument (PA5) is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment. Emissions Test...
- Page 22 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Instrument (PA5) is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment. Immunity Test...
- Page 23 Guidance and manufacturer’s declaration — electromagnetic immunity The Instrument (PA5) is intended for use in the electromagnetic environment specified below. The customer or the user of the Instrument should assure that it is used in such an environment, Immunity test...
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Page 24: Return Report
Other : Date : Person : Please provide e-mail address 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.
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