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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 Malfunction ..........................4 Disposal of the product ......................4 Unpacking and installation ......................5 Inspection and system requirements .................. -
Page 4: 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, pediatricians, or any other special trained personnel. Even a normal hearing assessment may not refrain the professional from referring the patient to a specialist, if any doubt is related to the result. -
Page 5: Warnings And Precautions
The requirement for the Separation Device is defined in 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 6 EMC. Use of accessories, transducers, and cables other than specified, except for 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.
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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: 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, ensure it is stored under the appropriate conditions (see section 5.1 Technical Specifications). D-0128842-E – 2023/10... -
Page 9: Definition Of Symbol
Type B applied parts. Follow Instructions for Use 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. -
Page 10: Software Installation
Microsoft Windows® 10 Microsoft Windows® 11 Maximum scaling: 125% Citrix: If your computer runs on a Citrix server, the Luna Suite will work if the Luna Suite is installed locally on your computer. Windows is a registered trademark of Microsoft Corporation in the United States and other countries. - Page 11 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 12 The installer will now copy all necessary files to the PC. This process may take several minutes. When the installation is complete, the dialog box below is shown Click “Close” to finish the installation. The Luna Suite is now installed. D-0128842-E – 2023/10...
- Page 13 License key When opening the Luna Suite for the first time, the system will ask for the product key to activate the Luna headset. To access the License key, click on the key icon at the top bar. This box will then open where the license key can be entered.
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Page 14: Operating Instructions
3 Operating instructions Suite setup When the license has been activated for the Luna headset, the front-page window will now look like this: By clicking in the top bar, a new window will appear with standard suite setting D-0128842-E – 2023/10... - Page 15 Windows File Explorer will open, and it is possible to choose a path directly on the PC. By clicking in the top bar, the Instructions for Use will open in a new window in the language selected under global settings. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 12...
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Page 16: How To Create An Operator
Notes written in here will only be visible here. All optional information will be shown in the PDF file under “Printed by” First and last name will be shown in the PDF file under “Performed by” D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 13... -
Page 17: How To Create A New Patient
This will delete the operator with a pop-up asking if the user is sure that they want to delete the operator and settings. How to create a new patient When choosing an operator, it is now possible to create a patient under the operator. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 14... - Page 18 Search for an operator already in the system. It does not matter if it is the first or last name that is being typed. By clicking the icon in the top bar with patients, it becomes possible to edit what information should be shown about the patients. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 15...
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Page 19: User Settings
In the front page of the patient overview, it is still possible to click the settings wheel in the top bar. Now there are also user settings available. Print setup By clicking the PDF icon , settings for printout will open in a new window. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 16... - Page 20 Create new print template Edit existing print template Delete print template Select a template and set it for default to be the one used when printing to PDF. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 17...
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Page 21: Symbol Set
When clicking on the field under Logo and Signature, a popup window from file explorer will open. This gives the option to upload the logo and signature to the print template. Symbol set This setting is for future development and will not change anything yet. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 18... -
Page 22: Hearing Loss Index
CPT-AMA will be calculated according to below table: PLH shift from baseline, which is an initial test. PLH is evaluated by comparing two sets of tests based on the PLH table. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 19... -
Page 23: Keyboard Shortcuts
Import/export functions It is possible to import patients to the Luna Suite. They must be saved in XML files to be able to be read in the Luna suite. Only correct files will be shown when searching for patients to import. - Page 24 When exporting tests, it is possible to choose dates of tests, to filter them. Otherwise, all tests from the chosen patient will be exported. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 21...
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Page 25: Tests
ISO 8253. Green color indicates acceptable noise levels. Yellow indicates slightly too much noise, and adjustments in surroundings should be made. Orange indicates not acceptable levels for testing. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 22... -
Page 26: Automatic Random Test
At the bottom of the screen, a small panel will appear where the tone can be activated by clicking the microphone, and the frequencies can be changed by using the mouse or by touch to place the marker to selected frequency and intensity. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 23... - Page 27 Tone length 0.3 – 2 sec. The duration of the tone given from the earphone. Response window 2 – 9 sec. The duration of time the patient must answer. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 24...
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Page 28: Automatic Test
This can also be done during test. Settings and tests screen will be like Automatic Random Test – See section 3.5.2. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 25... -
Page 29: Hughson Westlake Test
At the bottom of the screen, a small panel will appear where the tone can be activated by clicking the microphone, and the frequencies can be changed by using the mouse or by touch to place the marker to selected frequency and intensity. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 26... - Page 30 Your dB will never exceed X dB. Test frequencies 125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000, 8000 Hz Start frequencies The frequency you want your test to begin with. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 27...
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Page 31: Manual Test
Send the test tone when clicked. This can also be activated by using spacebar on the keyboard The arrows are used to navigate in frequencies and intensities. Arrows on keyboard can also be used D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 28... - Page 32 Right will be set as default Autostore Allows the system to set the mark for when the patient response. If no response is registered, the mark for no response will be set instead. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 29...
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Page 33: Overlays
In the left side of the Suite, a fold out menu is available with different overlays and features for the audiogram The top one will display the severity overlay D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 30... - Page 34 By clicking this icon in the foldout bar, the audiograms will change sides so the left will be shown left, and the right will be shown to the right, if clicked. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 31...
- Page 35 Clicking this icon will combine the two audiograms and show the measures on the same audiogram graph. This can help the user compare the two ear sides. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 32...
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Page 36: Maintenance
General maintenance procedures Your Luna may be gently cleaned by means of a soft cloth dampened with lukewarm 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 37: 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 38: General Technical Specifications
Construction: Plastic cabinet. Power: USB-powered Average: 300mA (Max: 500mA) Operation environment: Ambient noise: The Luna audiometer should be used in a quiet place such as a separate room Rel. Humidity: 15 – 90% 10-35° Temperature: 98 kPa – 104 kPa... -
Page 39: Technical Specifications
Subject response system Fixed USB cable from headset to type A male connector. Optional: 4-pin to USB Micro cable. Optional: 4-pin to USB C cable. Replaceable by technician. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 36... -
Page 40: 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-E – 2023/10 Luna - Instructions for Use - US Page 37... -
Page 41: Appendix A: Electromagnetic Compatibility (Emc)
NOTICE: There are no deviations from the collateral standard and allowances uses NOTICE: All necessary instruction for maintaining compliance regarding EMC can be found in the general maintenance section in this instruction. No further steps required. D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 38... - Page 42 60601-1-2 standard. Guidance and manufacturer’s declaration – electromagnetic emissions The Instrument (Luna) 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.
- Page 43 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Instrument (Luna) 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 44 Guidance and manufacturer’s declaration — electromagnetic immunity The Instrument (Luna) 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 45 Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable lengths are as specified below: Description Length (m) Screened (Yes/No) Patient response switch USB cable D-0128842-E – 2023/10 Luna - Instructions for Use - US Page 42...
- Page 46 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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