Interacoustics Luna User manual

Service Manual
Luna
Screening Audiometer
Science
made
smarter
Item no. 8525776– D-0128163-C – 2021/06

Table of Contents
1Introduction ...................................................................................................................................................... 1
1.1 About this manual .................................................................................................................................... 1
1.2 About warnings and cautions .................................................................................................................. 1
1.3 General information ................................................................................................................................. 1
2Maintenance and Disassembly....................................................................................................................... 2
2.1 General cleaning and maintenance procedure ....................................................................................... 2
2.2 Connecting the USB cable to Luna ......................................................................................................... 3
2.3 Disassembling Luna ................................................................................................................................ 4
3Calibration Procedure ..................................................................................................................................... 7
3.1 Service, adjustment, and repair............................................................................................................... 7
Hardware calibration - requirements ........................................................................................... 7
Equipment for the calibration....................................................................................................... 7
Installation of the Luna Suite software ........................................................................................ 8
Using the calibration software for Windows®10........................................................................ 10
Main startup of the calibration software..................................................................................... 10
3.2 Calibration of transducer ....................................................................................................................... 11
Calibration standard .................................................................................................................. 11
Selecting a transducer/how-to-guide......................................................................................... 12
Attenuator test ........................................................................................................................... 13
Room monitor calibration........................................................................................................... 14
4Troubleshooting............................................................................................................................................. 15
5Appendix A – Technical Specifications.......................................................................................................... i
5.1 Reference equivalent threshold values for transducers ...........................................................................ii
5.2 Survey of reference and max hearing level tone audiometer...................................................................ii
6Appendix B – Electromagnetic Compatibility (EMC) .................................................................................. iii
7Appendix C – Parts & Accessories ............................................................................................................. viii
8Appendix D – Update History ........................................................................................................................ ix

Service Manual
Luna Screening Audiometer
1
1 Introduction
1.1 About this manual
This manual is for the Luna screening audiometer. The manual content covers instrument related data, such as
disassembly and calibration. Technical specifications along with the parts & accessories list can be found as
appendices in the back of the manual.
1.2 About warnings and cautions
The below warnings, cautions and notices are applied throughout the manual, indicating the level of attention
required for a given action:
WARNING identifies conditions or practices that may present danger to the
patient and/or user.
CAUTION identifies conditions or practices that could result in damage to the
equipment.
NOTICE NOTICE is used to address practices not related to personal injury.
1.3 General information
We continuously strive to improve our products and their performance, hence the specifications in this service
manual are subject to change without further notice.
The performance and specifications of our products can only be guaranteed if technical maintenance is
conducted routinely every year. Technical maintenance should be carried out by qualified personnel authorized
by Interacoustics.
We are happy to receive any inquiries about our products. Our contact details are:
Interacoustics A/S
Phone:
[phone]
Audiometer Allé 1
Fax:
[phone]
5500 Middelfart
Mail:
[e-mail]
Denmark
Web:
www.interacoustics.com
WARNING
CAUTION

Service Manual
Luna Screening Audiometer
2
2 Maintenance and Disassembly
2.1 General cleaning and maintenance procedure
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 of ear cushion by means of covers and
disinfection fluids, please consult your supplier.
•Before cleaning always switch off and disconnect from the power supply
•Follow local best practice and safety guidelines if available
•Use a soft cloth lightly dampened with cleaning solution to clean all exposed surfaces
•Do not allow liquid to come into contact with the metal parts inside the earphones / headphones
•Do not autoclave, sterilize or immerse the instrument or accessory in any fluid
•Do not use hard or pointed objects to clean any part of the instrument or accessory
•Do not let parts that have been in contact with fluids dry before cleaning
Recommended cleaning and disinfection solutions
•Warm water with mild, nonabrasive cleaning solution (soap)
Procedure
•Clean the instrument by wiping outer case with a lint free cloth lightly dampened in cleaning solution
•Clean cushions and patient hand switch and other parts with a lint free cloth lightly dampened in
cleaning solution
•Make sure to not get moisture in the speaker portion of the earphones and similar parts
To maintain electrical safety during the lifetime of the instrument, a safety check must be made regularly
according to IEC 60601-1, Class 1, Type B. E.g., when yearly calibration is done.
CAUTION

Service Manual
Luna Screening Audiometer
3
2.2 Connecting the USB cable to Luna
Always make sure to connect cables to Luna as described below.
Never twist the connector in the socket or breakage will occur.
Disassemble/assemble the shell and the USB cable. Note the specifics on the shell and
the cable (red circles).
Finally mount the 2 screws in the shell
.
Fig. 1

Service Manual
Luna Screening Audiometer
4
2.3 Disassembling Luna
Grab hold of the foam hygiene cushion and release it
from the (red) shell.
Fig. 2
Once the foam hygiene cushion has been removed,
remove the black mesh cover and the white foam
cushion.
Fig. 3
Remove the 2 screws from the transducer. Use a star-
point screwdriver.
Fig. 4
After removing the transducer from the shell, then
remove the wire connected to the transducer from the
PCA board.
Fig. 5
Remove the 4 screws from the PCA board. Use a star-
point screwdriver.
Fig. 6
The PCA Board has now been removed from the
transducer.
Fig. 7

Service Manual
Luna Screening Audiometer
5
To disassemble the parts in the blue shell, simply repeat
the previous actions.
Fig. 8
Overview of parts.
Fig. 9
When re-assembling the device, remember to properly
tighten the 2 screws fastening the transducer to the shell.
Fig. 10
Please notice which wire goes where from the PCA board to the transducer in the blue shell when re-assembling.
Fig. 11
Rear side
Front side

Service Manual
Luna Screening Audiometer
6
NOTICE
If PCA board has been disconnected it must be re-calibrated
Please refer to Appendix C - Parts & Accessories and Appendix B in the back of this manual.

Service Manual
Luna Screening Audiometer
7
3 Calibration Procedure
This section contains calibration standards for Luna.
3.1 Service, adjustment, and repair
This instrument can be serviced, adjusted and repaired without losing the validity of the CE-marking, provided
the measuring equipment fulfills the below requirements, the adjustment procedures are adhered to and staff
has the necessary qualifications as approved by Interacoustics. Service and calibration must only be performed
by authorized personnel.
Before any attempt is made to calibrate Luna, it must have been powered on for 3-5 minutes in an ambient
temperature that is both stable and comfortable.
Hardware calibration - requirements
The hardware calibration is typically only performed during the production of the device and therefore does not
require adjustment in the field, except in certain circumstances. Refer to Appendices - Technical specifications
for further information.
Equipment for the calibration
To ensure proper calibration of audiometric equipment, test instruments must be reliable, stable and their
calibration certified.
Minimum requirements for measuring equipment:
•Measuring amplifier with input for condenser microphone or a sound level meter, fulfilling the
demands of IEC 61672 Type 1
•Artificial ear fulfilling the demands of IEC 60318-1
•It is recommended to have an acoustic calibrator for the control of the complete measuring chain
Additional equipment for hardware calibration:
•General purpose frequency counter
•General purpose digital multimeter
•General purpose oscilloscope to trace and monitor signals

Service Manual
Luna Screening Audiometer
8
Installation of the Luna Suite software
To download the Luna Suite software, go to www.interacoustics.com/luna where you will find the latest version
of the software.
Tick the box ‘I agree to the license terms and conditions’ and click ‘install’.
Click ‘Yes’ in the safety pop-up.
Click ‘Close’ to conclude the installation.
First boot and activation
On your PC desktop/Windows® tablet you will now find this icon:
Double-click on this icon.

Service Manual
Luna Screening Audiometer
9
The Luna Suite will open:
Click on the key icon
You may now enter the product key which you received
together with the Luna audiometer.
The code consists of 16 randomly chosen letters and figures.
Hereafter click ‘Activate’ and you are ready to use your
audiometer.
.

Service Manual
Luna Screening Audiometer
10
Using the calibration software for Windows®10
Download the calibration software called Calibration Luna from the Interacoustics extranet.
See further instructions in the following section.
Main startup of the calibration software
Connect the Luna headset to the computer with a USB cable. Open the calibration software.
When opened, the calibration startup screen should look like the below screenshot, with the Connect button low
lighted to indicate connection.
If the Connect button is highlighted due to missing connection to Luna, reconnect the device, and then click
Connect.
Fig. 12
TIP
Save … saves the present values at
any point. This action saves all
values in all screens
Save & Close ... saves all values in all
screens, and exits the
calibration tool

Service Manual
Luna Screening Audiometer
11
3.2 Calibration of transducer
This chapter contains calibration standards for Luna. Included here is an explanatory guide and a complete set-
up of how to calibrate the transducer.
Calibration standard
Tone standard is selected via AUD and ‘Standard’. The options are IEC or ANSI.
Calibration method is selected via AUD and ‘Calibration method’. The options are SPL mode or HL mode.
SPL mode
In SPL mode, the attenuator is adjusted according to the standard correction for each stimuli and frequency. In
that way the target level can be the same SPL level for all stimuli, and the microphone correction is the only
thing that should be added.
HL mode
In HL mode, the attenuator values are rounded and the target level in SPL varies and will be similar to the
values known from older HL-calibrated devices. The standard correction will be reflected as the difference
between the given HL and SPL level. Microphone correction should be added to the target level.
Fig. 13

Service Manual
Luna Screening Audiometer
12
Selecting a transducer/how-to-guide
Equipment required:
•Measuring amplifier
•Acoustical IEC 60318-1 coupler
•Frequency counter
•Correction values for coupler
From the AUD menu, select Transducer
calibration.
Place the transducer on the IEC 60318-1
coupler (the distance from the underside
of the table to the topside of the metal
disc should be 145 mm).
Adjust the slider until the calibration level
is obtained on the measurement amplifier
(i.e. 90 dB SPL).
Check the frequency accuracy with a
frequency counter. The accuracy has to
be better than ±1%.
When the intended calibration level is
obtained, use Enter to get the next
frequency.
Repeat until all stimuli are calibrated, for
both the left and right transducer.
Fig. 14
NOTICE
Do not forget to add or subtract the correction for
your microphone.

Service Manual
Luna Screening Audiometer
13
Attenuator test
Via TEST, click Attenuators.
Then, follow the on-screen instructions.
Fig. 15

Service Manual
Luna Screening Audiometer
14
Room monitor calibration
Insert the calibration adaptor ½” into the
calibrator.
Fig. 16
Switch on the calibrator.
Connect the calibration adaptor to the
room monitor microphone opening on the
outside of the left transducer.
Fig. 1
7 Fig. 18
Fig. 19
Open the calibration software
-
section Room Monitor.
Adjust the slider until the
measured level is 94 dB.
(depending on your
calibrator).
Tools needed:
Calibration
adaptor
DD65v2A

Service Manual
Luna Screening Audiometer
15
4 Troubleshooting
ERROR MESSAGE OR PROBLEM WHAT TO DO
Headset not recognized by Luna Software
a. Please note that only Windows® 10 is supported for
now. Luna is not recognized on Windows® 7/8.
b. Check that 2x “USB Serial Device (COMx)” are
shown in device manager when plugging in the
headset.
c. Make sure that only one instance of the Luna Suite
Software is running.

Service Manual
Luna Screening Audiometer
i
5 Appendix A – Technical Specifications
Medical CE-mark: 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.
Standards: Safety:
IEC 60601-1 2005/EN 60601-1 2006 and A1 2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Type B applied parts
EMC:
IEC 60601-1-2 (2014)
Audiometer Tone:
Tone Audiometer: IEC 60645 -1 (2017), ANSI S3.6 (2018),
Type 4
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:
Temperature:
Ambient Pressure:
15 – 90%
10-35°
98 kPa – 104 kPa
Transport
temperature:
-20-50 °C
Storage
temperature:
0-50 °C
Humidity
transportation &
storage:
10% to 95% RH. Non-condensing
Transducers
[A]
– two earphones
[A]
Hearing levels from -10 to 105 dB HL for air conductors
[A]
Frequency from 250 Hz to 8 kHz for air conductors (250 Hz,
500 Hz, 750 Hz, 1 kHz, 1.5 kHz, 2 kHz, 3 kHz, 4 kHz, 6 kHz, 8 kHz)
[A]
Output level control in 5 dB HL steps
Test signal switching
[A]
– presentation/interruption
[A]
– continuous pure-tone
[A]
– pulsed pure-tone
[A]
– warble-tone freq. 10 Hz Sinus
[A]
– warble-tone modulation depth 10%
[A]
Subject response system
[A]
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.

Service Manual
Luna Screening Audiometer
ii
5.1 Reference equivalent threshold values for transducers
Hz
Max dB level HL
125
75
250
90
500
100
750
100
1000
100
1500
105
2000
105
3000
105
4000
100
6000
90
8000
85
5.2 Survey of reference and max hearing level tone audiometer
AAU / PTB (2018) DD65 v2
Coupler: ANSI S3.7-1995 (NBS-9A) /
IEC 60318-1:2009 (6ccm)
Tone Audiometer
Tone
Frequency
RETSPL
MaxHL
125
30,5
85
250
17
100
500
8
110
750
5,5
115
1000
4,5
115
1500
2,5
115
2000
2,5
115
3000
2
115
4000
9,5
110
6000
21
100
8000
21
95

Service Manual
Luna Screening Audiometer
iii
6 Appendix B – Electromagnetic Compatibility (EMC)
•This instrument is suitable in hospital environments except for near active HF surgical equipment
and RF shielded rooms of systems for magnetic resonance imaging, where the intensity of
electromagnetic disturbance is high
•Use of this instrument adjacent to or stacked with other equipment should be avoided because it
could result in improper operation. If such use is necessary, this instrument and the other equipment
should be observed to verify that they are operating normally
•Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation. The list of accessories,
transducers and cables can be found in this appendix.
•Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of this instrument, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result
NOTICE ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as:
•This instrument does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL
PERFORMANCE cannot lead to any unacceptable immediate risk
•Final diagnosis shall always be based on clinical knowledge There are no deviations from the
collateral standard and allowances uses
•This instrument is in compliance with IEC60601-1-2:2014, emission class B group 1
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.