Interacoustics Luna User manual

Instructions for Use - US
Luna
Science made smarter
D-0128842-A– 2020/12

Copyright©Interacoustics A/S: 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
permission of Interacoustics A/S.

Table of contents
1Introduction .................................................................................................................................... 1
1.1 About this manual ..................................................................................................................... 1
1.2 Intended use ............................................................................................................................. 1
1.3 Contraindications ...................................................................................................................... 1
1.4 Product description ................................................................................................................... 1
1.5 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)................................................................................. 3
1.5.5 Cautions – General............................................................................................................ 3
1.5.6 Environmental factors ........................................................................................................ 4
1.5.7 NOTICE ............................................................................................................................. 4
1.6 Complaints/safety reporting: ..................................................................................................... 5
2Unpacking and installation ........................................................................................................... 7
2.1 Inspection and system requirements ........................................................................................ 7
2.2 Definition of symbol................................................................................................................... 8
2.3 Software installation.................................................................................................................. 9
3Operating instructions................................................................................................................. 13
3.1 Language editor ...................................................................................................................... 13
3.2 How to create an operator (the opening screen) .................................................................... 14
3.3 How to create a new patient ................................................................................................... 15
3.4 PDF editor ............................................................................................................................... 16
3.5 How to enter set-up mode of hearing tests............................................................................. 16
3.6 Operating panel – automatic testing ....................................................................................... 17
3.7 Description of automatic random test and settings................................................................. 19
3.7.1 Description of settings: .................................................................................................... 19
3.8 Description of automatic test and settings .............................................................................. 21
3.8.1 Description of the settings: .............................................................................................. 21
3.9 Description of manual test and settings.................................................................................. 22
3.9.1 Description of settings ..................................................................................................... 23
3.10 Special features................................................................................................................... 25
3.10.1 Overlays........................................................................................................................... 25
3.10.2 Re-testing manually in automatic mode .......................................................................... 26
4Care and maintenance ................................................................................................................. 29
4.1 General maintenance procedures........................................................................................... 29
4.2 General cleaning procedures.................................................................................................. 29
4.3Concerning repair.................................................................................................................... 30
4.4 Warranty.................................................................................................................................. 30
5General technical specifications ................................................................................................ 31
5.1 Technical specifications .......................................................................................................... 31
5.2 Reference equivalent threshold values for transducers.......................................................... 32

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1Introduction
About this manual
This manual is valid for the Luna screening audiometer, Luna Suite PC software included.
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.dk
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. Any detected hearing loss must always lead to consulting a hearing specialist.
Contraindications
Patient is too young to undergo a hearing test. If the headset can not be fitted.
Patient is uncooperative. The professional operator’s evaluation.
The hearing test has to be performed in a separate room, no silent booth required.
Product description
Luna is delivered with the following:
Headset mounted with DD65 transducers and USB cable, patient response, carrying bag, PC software
(through online download), quick guide and calibration certificate.
The Luna headset delivers a tone to the patient’s ear. When the patient hears the presented tone, he
presses the response button, and the result is noted automatically in the audiogram.

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Warnings and precautions
The following safety warnings are used throughout the manual to alert you to important information regarding
safe and appropriate use of the product.
The WARNING label identifies conditions or practices that may present
danger to the patient and/or user.
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.
Electrical system safety
When connecting the instrument to the computer, the following warnings must
be observed:
This equipment is intended to be connected to other equipment thus forming a
Medical Electrical System. External equipment intended for connection to signal
input, signal output or other connectors shall comply with the relevant product
standard e.g. IEC 62368-1 for IT equipment and the IEC 60601-series for
medical electrical equipment. In addition, all such combinations – Medical
Electrical Systems – shall comply with the safety requirements stated the
general standard IEC 60601-1, edition 3, clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601-1 shall be kept
outside the patient environment i.e. at least 1.5 m from the patient support or
shall be supplied via a separation transformer to reduce the leakage currents.
Any person who connects external equipment to signal input, signal output or
other connectors has formed a Medical Electrical System and is therefore
responsible for the system to comply with the requirements. If in doubt, contact
qualified medical technician or your local representative. If the instrument is
connected to a PC (IT equipment forming a system) ensure not to touch the
patient while operating the PC.
A Separation Device (isolation device) is needed to isolate the equipment
located outside the patient environment from the equipment located inside the
patient environment. In particular such a Separation Device is required when a
network connection is made. 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.
For maximum electrical safety, turn off the power when it is left unused
The power plug shall be placed so it is easy to pull out the plug
Do not use any additional multiple socket-outlet or extension cord. For safe
setup please refer to section 2.
Do not use the equipment if it is showing visible signs of damage.
WARNING
CAUTION

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The instrument is not protected against ingress of water or other liquids. If any
spillage occurs, check the instrument carefully before use or return for service
No part of the equipment can be serviced or maintained while in use with the
patient.
Explosion hazards
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the instrument in a highly oxygen-enriched environment, such as a
hyperbaric chamber, oxygen tent, etc.
Before cleaning make sure to disconnect power source
Electromagnetic compatibility (EMC)
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 the
appendix regarding 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..
Cautions – General
If the system is not functioning properly, do not operate it until all necessary
repairs are made and the unit is tested and calibrated for proper functioning in
accordance with Interacoustics’ specifications.
Do not drop or in any other way cause undue impact to this device. If the
instrument is damaged, return it to the manufacturer for repair and/or
calibration. Do not use the instrument if any damage is suspected.
This product and its components will perform reliably only when operated and
maintained in accordance with the instructions contained in this manual,
accompanying labels, and/or inserts. A defective product should not be used.
Make sure all connections to external accessories are secured properly. Parts
which may be broken or missing or are visibly worn, distorted, or contaminated
should be replaced immediately with clean, genuine replacement parts
manufactured by or available from Interacoustics.
The manufacturer will make available on request circuit diagrams, component
part lists, descriptions, calibration instructions, or other information that will
assist authorized service personnel to repair those parts of this instrument that
are designated by Interacoustics as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the
patient.
Connect only accessories purchased from the manufacturer to the instrument.
Only accessories which have been stated by the manufacturer to be compatible
are allowed to be connected to the device.
Check calibration if any parts of the equipment are exposed to shock or rough
handling.

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Components marked for ‘single use’ are intended for a single patient during a
single procedure, and there is a risk of contamination if the component is re-
used.
Components marked for ‘single use’ are not intended to be reprocessed.
Environmental factors
Storage outside temperature range as specified in Section 5 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can come into contact with
any of the electronic components or wiring. Should the user suspect fluids have
contacted the system components or accessories, the unit should not be used
until deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind, and allow
sufficient space around the instrument to ensure proper ventilation.
NOTICE
To prevent system faults take appropriate precautions to avoid PC viruses and
similar.
Please note that connecting the device to a PC implies connecting the device to
an IT-network. The connectinon to an IT-network may result in previously un-
identified risks which must be identified, analysed, evaluated and mitigated by
the responsible organisation.
Any change to the IT-network (network configuration, (dis)connection of items,
update or upgrade of equipment) may introduce new risks that require
additional analysis.
Within the European Union, it is illegal to dispose of electric and electronic
items in unsorted municipal waste. Electric and electronic waste may contain
hazardous substances and therefore has to be collected separately. Such
products will be marked with the crossed-out wheeled bin symbol, shown
below. The cooperation of the user is important in order 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.
Outside the European Union, local regulations should be followed when
disposing of the product after end of life.
If this apparatus is connected to one or more other devices with medical CE
marking, to make up a system or pack, the CE marking is only valid also for the
combination if the supplier has issued a declaration stating that the
requirements in the Medical Device Directive article 12 are fulfilled for the
combination.
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.

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Complaints/safety reporting:
Please contact your local distributor in case of any incident related to product defects (hardware
defects or software bugs) or adverse events (which does not necessarily have a causal
association to the product). It is recommended for a user to report all the known facts about the
incident. Upon receipt of any serious incident with serious health impact for the patient or user
(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.

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2Unpacking and installation
2.1 Inspection and system requirements
Check for damage
When the instrument is received, ensure that you have received all the components on the shipping
checklist. All the components should be checked visually for scratches and missing parts before use. All the
contents of the shipment have to be checked for their mechanical and electrical functioning. If the equipment
is found faulty, please contact your local distributor immediately. Keep the shipping materials for the carrier’s
inspection and insurance claim.
Keep carton for future shipment
The instrument comes with shipping cartons, which are specifically designed for the components. It is
recommended to keep the cartons for future shipments in case of any need for return or service.
Reporting and returning procedure
Any missing part or malfunction or any damaged components (due to shipment) should be reported
immediately to the supplier/local distributor along with the invoice, serial number and a detailed report of the
issue. For any on-site service-related information, please contact your local distributor. If the system /
components are to be returned for service, please fill all the details related to product issues in the ‘Return
Report’, which is attached to this manual. It is very important that you describe all the known facts about the
issue in the return report, as this will help the engineer to understand and solve the problem to your
satisfaction. 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.

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Definition of symbol
The following symbols can be found on the instrument:
Symbol
Explanation
Type B applied parts.
Follow Instructions for Use
0123
The CE-mark indicates that Interacoustics A/S meets the requirements of
Annex IX of the Regulation (EU) 2017/745 (MDR)” Product Service,
Identification No. 0123, has approved the quality system
WEEE 2002/96/EC
Please refer to warning and pre-cautions
Medical Device
Manufacturer
Date of manufacture.
Serial number
Reference number
4005727
Conforms to
ANSI/AAMI ES60601-1:2005/A1:2
C er t i f i ed t o
CAN/CSA-C22.2 No. 60601-1:20
ETL CLASSIFIED
ETL listing mark
Company Logo
REF

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Software installation
Minimum system requirements:
Luna Suite is built to run Windows OS Framework 4.7.
NOTICE: As a part of data protection, ensure to be compliant with the following points
1. Use Microsoft supported operating systems
2. Ensure operating systems are security patched
3. Enable database encryption
4. Use individual user accounts and passwords
5. Secure physical and network access to computers with local data storage
6. Use updated antivirus and firewall and anti-malware software
7. Implement appropriate backup policy
8. Implement appropriate log retention policy
System requirements:
Processor: 2 GHz
RAM: 2 GB
Display: 1366x768px (standard)
Supported operating systems:
Microsoft Windows® 10 Pro
Maximum scaling: 125%
Windows®is a registered trademark of Microsoft Corporation in the United States and other countries.
Citrix: If your computer runs on a citrix sever the Luna Suite will work as long as the Luna Suite is installed
locally on your computer.
NOTICE: Using operating systems where Microsoft have discontinued software and security support will
increase the risk for viruses and malware, which may result in breakdowns, data loss and data theft and
misuse.
Interacoustics A/S cannot be held liable for your data. Some Interacoustics A/S products support or may
work with operating systems unsupported by Microsoft.
Installation
Included with your Luna audiometer you will find a link to download of the software as well as a license key
to open and activate the 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.
Interfaces:
Luna Suite is equipped with a general XML interface for easy interfacing to any other patient file system you
may wish.

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When clicking on the link an automatic installation will start, showing the below window:
The version of the software you are about to
download
Click to agree to install
Click to install
Allow your computer to
continue the installation
of the Luna Suite by clicking
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:

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Click here
This screen will open allowing you to enter
the unique product key.
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”

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3Operating 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.
If you want to change the language, do the follwoing:
Click here:
Then choose your language by means of the drop down menu:
The language change will take effect once you re-boot the Luna Suite.

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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. 8. Edit operator information.
Enter a new operator:
Each test setting will be connected to the operator you have chosen.
1. Mandatory information. 3. Other information if relevant.
2. Optional Information. 4. Press”create” to save settings.
1
2
3
4
8
6
5
7
1
3
2
4

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How to create a new patient
1. Back to previous screen. 2. Search for a patient.
3. Enter a new patient. 4. Edit information bar.
5. Delete a patient (irreversible). 6. Edit patient information.
7. If you only want to see your patients, click here.
Entering a patient:
1. Mandatory patient information. You may use social security number or a randomly generated ID.
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.
2
3
4
6
5
1
1
2
3
4
7

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PDF editor
If needed you may create your own PDF document for saving or printing.
The setting of the PDF is attached to the operator. Thus, each operator can have their own special PDF
layout if needed.
If you want to create a new PDF setting, click here:
What you set up is the labeling of information on the print out –
not the content of each area.
How to enter set-up mode of hearing tests
By clicking these icons you will enter the settings of the various
hearing tests.