Interacoustics PA5 User manual

Instructions for Use - US
PA5
Science
made
smarter
8530526 – D-0131335-A – 2021/09

Table of contents
1Introduction.......................................................................................................................................... 1
1.1 About this manual ....................................................................................................................... 1
1.2 Intended use................................................................................................................................ 1
1.3 Product description ..................................................................................................................... 1
1.4 Warnings ..................................................................................................................................... 1
2Unpacking and installation................................................................................................................. 3
2.1 Unpacking and inspection ........................................................................................................... 3
2.2 Marking........................................................................................................................................ 4
2.3 General warnings and precautions ............................................................................................. 4
2.4 Malfunction .................................................................................................................................. 5
3Getting started - setup and installation............................................................................................. 7
3.1 Replacing batteries ..................................................................................................................... 9
Approximate battery lifetime ........................................................................................... 9
3.2 Description of various tests ....................................................................................................... 10
3.3 Reflex audiometry by Neonates................................................................................................ 10
3.4 Maturation of audiotory response.............................................................................................. 11
4Maintenance....................................................................................................................................... 13
4.1 How to clean Interacoustics products ....................................................................................... 13
4.2 Concerning repair...................................................................................................................... 14
4.3 Warranty.................................................................................................................................... 14
5Technical specifications................................................................................................................... 15
5.1 Calibration values...................................................................................................................... 16
5.2 Standards for production and calibration................................................................................... 16

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1Introduction
1.1 About this manual
This manual is valid for the PA5. The product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail:[e-mail]
Web: www.interacoustics.com
1.2 Intended use
The PA5 handheld paediatric screening audiometer is designed to be a device for screening for hearing loss
primarily amongst children. 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 audiometer depends on the interaction with the patient. However, for children
not responding well, various test possibilities 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.
1.3 Product description
Delivered items with PA5:
•PA5 Paediatric Free Field Audiometer
•3 AA Batteries
•PA5 Handbag
•Instructions for Use
•Service Manual
Optional parts:
•TDH39 Headphone
•TDH39S Headphone
Check numbers on PA5 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.
1.4 Warnings
Throughout this manual the following meaning of warnings, cautions and notices are used:
The WARNING label identifies conditions or practices that may present
danger to the patient and/or user.
CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in damage of the equipment.
NOTICE NOTICE is used to address practices not related to personal injury or
damage of the equipment.

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2Unpacking and installation
2.1 Unpacking and 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 your local distributor. Keep the shipping
material for the carrier’s inspection and insurance claim.
Keep carton for future shipment
The PA5 comes in its own shipping carton, which is specially designed for the PA5. Please keep this
carton. It will be needed if the instrument must be returned for service.
If service is required, please contact your local distributor.
Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. 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 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:

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2.2 Marking
The following marking can be found on the instrument:
Symbol
Explanation
Type B applied parts.
Patient applied parts that are not conductive and can be immediately
released from the patient.
WEEE (EU-directive)
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.
0123
The CE-mark in combination with MD symbol indicates that Interacoustics
A/S meets the requirements of the Medical Device Regulation (EU)
2017/745. Approval of the quality system is made by TÜV – identification no.
0123.
Medical Device
Year of manufacture
Manufacturer
2.3 General warnings and 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 recalibration.
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
Always remove the batteries when the instrument is left unused for more than a month.

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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.
Disposal of batteries must be made according to national regulations.
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. Please also
refer to EMC consideration in the appendix.
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 must be collected separately. Such products will be
marked with the crossed-out wheeled bin shown below. The cooperation of the user
is important 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.
2.4 Malfunction
In the event of a product malfunction, it is important to protect patients, users, and other
persons against harm. Therefore, if the product has caused, or potentially could cause
such harm, it must be quarantined immediately.
Both harmful and harmless malfunctions, related to the product itself or to its use, must
immediately be reported to the distributor where the product was acquired. Please
remember to include as many details as possible e.g., the type of harm, serial number of
the product, software version, connected accessories and any other relevant information.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Interacoustics and the local national competent authority.

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