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Summary of Contents for Interacoustics Luna
- Page 1 Science made smarter Instructions for Use - US Luna...
- Page 2 All rights reserved. Information in this document is proprietary to Interacoustics A/S. The information in this document is subject to change without notice. No part of this document may be reproduced or transmitted in any form or by any means without a prior written...
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Page 3: Table Of Contents
Table of contents Introduction ............................ 1 About this manual ........................1 Intended use ..........................1 Contraindications ........................1 Product description ........................1 Warnings and precautions ......................2 1.5.1 Electrical system safety ..................... 2 1.5.2 Electrical safety ........................2 1.5.3 Explosion hazards ......................3 1.5.4 Electromagnetic compatibility (EMC) ................. -
Page 5: Introduction
Intended use Luna is a PC-based screening audiometer intended to be used for assessing the hearing level of the patient by means of either manual or automatic tests. Luna should be used by hearing care professionals such as special trained nurses, peditricians or any other special trained personnel. Even a normal hearing assessement may not refrain the professional from referring the patient to a specialist, if any doubt is related to the result. -
Page 6: Warnings And Precautions
IEC 60601-1 clause 16 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 7: Explosion Hazards
EMC. Use of accessories, transducers, and cables other than specified, with the exception of transducers and cables sold by Interacoustics or representatives, may result in increased emission or decreased immunity of the equipment. For a list of accessories, transducers and cables that fulfil the requirements please also refer to the appendix regarding EMC.. -
Page 8: Environmental Factors
There is no warm-up time for the instrument, but allow it to become acclimatised before use. The specification for the instrument is valid if the instrument is operated within the environmental limits specified in technical specifications. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 4... -
Page 9: Complaints/Safety Reporting
(serious adverse events), local distributor shall report to Interacoustics through its appropriate vigilance system. Interacoustics shall ensure that the regulatory authority in patient’s home country is informed according to the vigilance requirements. Interacoustics shall handle all the product complaints and adverse events as per the internal procedure. - Page 10 D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 6...
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Page 11: Unpacking And Installation
Your local distributor holds the responsibility for coordinating any service/return procedure and related formalities. Storage If you need to store the Luna for a period, please ensure it is stored under the appropriate conditions. D-0128842-A – 2020/12 Luna - Instructions for Use - US... -
Page 12: Definition Of Symbol
The following symbols can be found on the instrument: Symbol Explanation Type B applied parts. Follow Instructions for Use The CE-mark indicates that Interacoustics A/S meets the requirements of Regulation (EU) 2017/745 (MDR)” Annex IX of the Product Service, 0123 Identification No. -
Page 13: Software Installation
Luna software. NB: Keep the link for the Luna software in a safe place, in case you want to install it on a different computer. In this case you will need to require a new license key. - Page 14 After installation the software will leave this icon on your desktop for easy access to your Luna software: By double clicking the key icon, the Luna software will open, and you are ready to enter the software key: D-0128842-A – 2020/12...
- Page 15 This is only required once. You will receive the license key together with your Luna audiometer. Insert it here Finish the key activation by pressing “activate” D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 11...
- Page 16 D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 12...
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Page 17: Operating Instructions
3 Operating instructions After succesfully installing the Luna PC software, you are ready to use yor device. Language editor When installing the Luna Suite software, the system automatically chooses the language in accordance with the language setting of your PC. -
Page 18: How To Create An Operator (The Opening Screen)
How to create an operator (the opening screen) 1. Entering the software key. 2. System status for correct connection. 3. Minimize/maximize. 4. Exit your Luna. Remember to save before exit. 5. Add a new operator. 6. Search for an operator. 7. Delete an operator. -
Page 19: How To Create A New Patient
2. If further information about the patient is relevant you may enter it here. 3. Anamnesis information or other relevant information with potential impact on test result. 4. Remember to press ”create” in order to save the settings. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 15... -
Page 20: Pdf Editor
How to enter set-up mode of hearing tests By clicking these icons you will enter the settings of the various hearing tests. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 16... -
Page 21: Operating Panel - Automatic Testing
Operating panel – automatic testing 1. Test frequencies. All frequencies will be tested. 2. Start/stop test. 3. Right ear color indication. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 17... - Page 22 2. Color indication (green bar) of how much of the allowed time the patient uses before answering. 3. Tested – but not heard. 4. Left ear color indication. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 18...
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Page 23: Description Of Automatic Random Test And Settings
D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 19... - Page 24 In which side the test should commence. Step size: When a tone is ”not heard” the dB automatically increases with either 5 or 10 dB. Signal: You may choose between Tone, Warble, Pulse. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 20...
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Page 25: Description Of Automatic Test And Settings
The frequency you want your test to begin with. Start test earside: When a tone is ”not heard” the dB automatically increases with either 5 or 10 dB. Signal: You may choose between Tone, Warble, Pulse. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 21... -
Page 26: Description Of Manual Test And Settings
Left arrow dB level down Up arrow dB level up Down arrow Signal type Step size Ear side Tone Space Delete Delete Heard Not heard Left ear Right ear D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 22... -
Page 27: Description Of Settings
With this setting you may decide which dB level you want by change of fequency. Example: If you only want to test at 20dB, and never below, you set this value at 20 dB. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 23... - Page 28 Start test ear side: When a tone is ”not heard” the dB automatically increases with either 5 or 10 dB. Signal: You may choose between Tone, Warble, Pulse. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 24...
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Page 29: Special Features
Show data in one or two audiograms. Old tests on each patient. May be used as overlay in current test. Only values different from the first test are shown. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 25... -
Page 30: Re-Testing Manually In Automatic Mode
You may experience odd results on a particular frequency, and if you want to be sure, you may re-test this frequency manually. Click here: the one test result will disappear. To make the manual test panel available click here: D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 26... - Page 31 You may set the tone anywhere, and from there you may test again until you are certain of the correct reault. Click save, and ths test will be saved as the original automatic test. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 27...
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Page 33: Care And Maintenance
General maintenance procedures Your Luna may be gently cleaned by means of a soft cloth dampened with luke warm water. The black mesh in each ear cup may also be rinsed gently. For further protection by means of ear cushion covers and disinfection fluids, please consult your supplier. -
Page 34: Concerning Repair
Warranty Interacoustics warrants that: The Luna is free from defects in material and workmanship under normal use and service for a • period of 12 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 •... -
Page 35: General Technical Specifications
5 General technical specifications The CE-mark indicates that Interacoustics A/S meets the requirements of the EU Regulation Medical CE-mark: 2017/745 (MDR). Approval of the quality system is made by TÜV – identification no. 0123 IEC 60601-1 2005/EN 60601-1 2006 and A1 2012... -
Page 36: Reference Equivalent Threshold Values For Transducers
Reference equivalent threshold values for transducers Max dB level HL 1000 1500 2000 3000 4000 6000 8000 D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 32... - Page 37 NOTICE: There are no deviations from the collateral standard and allowances uses NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in the general maintenance section in this instruction. No further steps required. D-0128842-A – 2020/12 Luna - Instructions for Use - US Page 33...
- Page 38 EMC information presented in this chapter. The LUNA has been tested for EMC emissions and immunity as a standalone instrument. Do not use the LUNA adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
- Page 39 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The LUNA is intended for use in the electromagnetic environment specified below. The customer or the user of the LUNA should assure that it is used in such an environment. Immunity Test IEC 60601 Test...
- Page 40 Guidance and manufacturer’s declaration — electromagnetic immunity The LUNA is intended for use in the electromagnetic environment specified below. The customer or the user of the LUNA should assure that it is used in such an environment, Immunity test IEC / EN 60601...
- Page 41 If the measured field strength in the location in which the LUNA is used exceeds the applicable RF compliance level above, the LUNA should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the LUNA.
- Page 43 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.
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