Interacoustics Callisto AC440 User manual

Instructions for Use – US
Callisto™
Science made smarter
D-0101246-M – 2020/05

Table of Contents
1. INTRODUCTION ............................................................................................................................... 1
1.1 About this manual ......................................................................................................................... 1
1.2 Intended use.................................................................................................................................. 1
1.3 Product description ....................................................................................................................... 1
1.4 Included and optional parts and accessories................................................................................ 2
1.5 Warnings and precautions ............................................................................................................ 3
2. UNPACKING AND INSTALLATION........................................................................................... 7
2.1 Unpacking and inspection ............................................................................................................. 7
2.2 Marking.......................................................................................................................................... 7
2.3 Callisto™ - connection panel dictionary........................................................................................ 8
2.4 Callisto™ - indicators: ................................................................................................................... 8
2.5 Software installation ...................................................................................................................... 9
2.5.1 Software installation Windows®7 and Windows®8 ........................................................10
2.5.2 Software installation Windows®8.1.................................................................................14
2.5.3 Software installation Windows®10..................................................................................18
2.6 Driver installation......................................................................................................................... 22
2.6.1 Sound device settings .....................................................................................................22
2.6.2 Sound device settings for Windows®7/ Windows®8/Windows®10................................23
2.7 Using with databases .................................................................................................................. 24
2.7.1 Noah 4.............................................................................................................................24
2.7.2 Working with OtoAccess®...............................................................................................24
2.8 Standalone version ..................................................................................................................... 24
2.9 How to configure an alternative data recovery location .............................................................. 24
2.10 License ........................................................................................................................................ 24
2.11 About Callisto Suite..................................................................................................................... 25
3. OPERATING INSTRUCTIONS................................................................................................... 27
3.1 AC440 using the tone screen elements ...................................................................................... 28
3.2 Using the speech screen............................................................................................................. 34
3.2.1 Speech audiometry in graph mode .................................................................................36
3.2.2 Speech audiometry in table mode...................................................................................37
3.2.3 PC keyboard shortcuts manager.....................................................................................39
3.2.4 Technical specifications of the AC440 software .............................................................40
3.3 REM440 screen elements........................................................................................................... 42
3.3.1 REM software - Technical specifications ........................................................................49
3.4 The HIT440 screen ..................................................................................................................... 50
3.4.1 HIT440 software - Technical specifications.....................................................................55
3.5 Using the print wizard.................................................................................................................. 56
4. MAINTENANCE............................................................................................................................... 59
4.1 General maintenance procedures............................................................................................... 59
4.2 How to clean Interacoustics products ......................................................................................... 59
4.3 Concerning repair........................................................................................................................ 60
4.4 Warranty...................................................................................................................................... 60
5. GENERAL TECHNICAL SPECIFICATIONS ......................................................................... 61
5.1 Reference equivalent threshold values for transducers and maximum hearing level settings
provided at each test frequency .................................................................................................. 61
5.2 Pin assignments.......................................................................................................................... 61
5.3 Electromagnetic Compatibility (EMC) ......................................................................................... 61

D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US Page 1
1. Introduction
1.1 About this manual
This manual is valid for the Callisto™. 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 Callisto™ is intended for determination of hearing threshold levels and for verifying hearing aid
performance in the fitting situation.
Intended Operator
The Callisto™ is intended to be operated by an Audiologist, ENT professional or a person with equivalent
knowledge. Using the instrument without adequate knowledge may lead to erroneous results and may
endanger the patients hearing
Intended Patient Population
This instrument is intended for all patient groups regarding sex, age and health. For audiology examinations
the patient must be able to respond to the test signal in a rational way.
Contraindications
None known.
1.3 Product description
The Callisto™ is a Hearing Aid Analyzer that interfaces with integrated audiologic software modules on a
PC. Depending on the installed software modules they can perform:
•Audiometry (AC440)
•Real Ear Measurements (REM440) including Visible Speech Mapping
•Hearing Instrument Testing (HIT)

D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US Page 2
1.4 Included and optional parts and accessories
AC440
REM440
HIT440
Standard Parts
•DD451Audiometric
Headset
•MTH400m Monitor
Headset
•B71 Bone Conductor1
•APS3 Patient response
button1
•Callisto suite software
•Callisto carrying bag
•Standard USB cable
Optional Parts
•TDH391Audiometric
Headset
•DD65 v21
•HDA300 Audiometric
Headset130° plugs
•DD450 High frequency
headset1
•Eartone 3A Insert
earphones1/2
•Eartone 5A Insert
earphones1/2
•IP30 Insert earphones1
•B71 Bone Conductor1
•B81 Bone Conductor1
•EMS400 Talk Back
Microphone
•SP70 Loudspeaker +
wire
•SP85A Loudspeaker
•SP90A Loudspeaker
•OtoAccess® Database
•Accessory bracket
•Wheelded trolly
Standard Parts
•IHM60 In-situ Headset
(kit)1/2
•Probe Tubes 36 pcs1
•SP70 Loudspeaker + Wire
•Callisto suite software
•Callisto carrying bag
•Standard USB cable
Optional Parts
•Extra Edifier Loudspeaker
+ Wire
•Callisto™ Coupler Base Kit
which includes:
•Coupler Base
•Coupler Box
o2cc coupler
o½” microphone
oReference mic.
oITE adaptor
oBTE adapter
oBody HA adaptor
oBTE tubing
•SPL60 In-situ Probe Tip-set
+ Coupler Adaptor1
•Coupler Seal Wax
•OtoAccess® Database
•Accessory bracket
•Wheelded trolly
Standard Parts:
•TBS10 Test Box
•Coupler Box
o2cc coupler
o½” microphone
oReference mic.
oITE adaptor
oBTE adapter
oBody HA adaptor
oBTE tubing
•Coupler seal wax
Optional parts:
•Couplers 1.2CC and 0.6CC:
ITE, BTE, Ear simulator
•Calibration adaptor
•OtoAccess® Database
•Wheelded trolly
1) Applied part as according to IEC60601-1
2) This part is not certified according to IEC 60601-1.

D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US Page 3
1.5 Warnings and precautions
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.
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.
When connecting this device to a computer it is essential to insert a galvanic
separation between the device and the computer, unless the computer is
battery operated or supplied by a medical approved power supply. If connecting
directly to a PC it must be supplied from a medical isolation transformer fulfilling
the requirements of IEC/ES 60601-1.
Please note that if connection is made to standard equipment like an active
speaker, special precautions must be taken in order to maintain medical safety.
If used without galvanic separation, it must be supplied from a medical isolation
transformer fulfilling the requirements of IEC/ES 60601-1.
Do not touch the patient while operating PC, printer etc.
No modification of this equipment is allowed without Interacoustics
authorization.
Interacoustics will make available on request circuit diagrams, component part
lists, descriptions, calibration instructions, or other information that will assist
service personnel to repair those parts of this.
No part of the equipment can be serviced or maintained while in use with the
patient.
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, e.g. unwanted noise in
headphones. If disturbances are observed, try to separate the Callisto from the
disturbing device. Please refer to the section for Electromagnetic Compatibility
(EMC).
Do not disassemble or modify the product as this may impact the safety and/or
performance of the device.
The internal battery shall be replaced by authorized personnel.
WARNING
CAUTION

D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US Page 4
When using insert ear phones, make sure that foam or ear-tip is mounted
correctly.
It is recommended that the disposable foam ear-tips supplied with the optional
IP30, E.A.R Tone 3A or E.A.R Tone 5A insert transducers are replaced after
each client tested. Disposable plugs also insure that sanitary conditions exist for
each of your clients.
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 recognized disinfectant.
Individual manufacturer's instruction should be followed for use of this
disinfecting agent to provide an appropriated level of cleanliness.
The transducers (headphones, bone conductor, etc.) supplied with the
instrument are calibrated to this instrument - exchange of transducers requires
a new calibration.
Interacoustics will not make any guarantee to the functionality of the system if
any other software is installed, with exception of the Interacoustics
measurement (AC440/REM440) modules and AuditBase system4, OtoAccess®
or a Noahcompatible Office Systems or later releases.
NOTICE
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.
The instrument is intended for continued use. However, there is a risk of
damaging the transducers if they are operated at the highest intensities for
longer periods.
The transducers (headphones etc.) supplied with the instrument are calibrated
to this instrument - exchange of transducers requires a new calibration.
No installation precautions are necessary to avoid unwanted sound radiation
from the audiometer.
There is no warm-up time for the instrument, but allow it to become
acclimatised before use.
Be sure to use only stimulation intensities, which will be acceptable for the
patient.
The reference and the probe microphones can be verified using the procedures
described in calibration software.
Within the European Union it is illegal to dispose of electrical and electronic
waste as unsorted municipal waste. Electrical and electronic waste may contain
hazardous substances and therefore have to be disposed of separately. Such
products will be marked with the crossed-out wheelie-bin image shown to the
left. User cooperation is important in order to ensure a high level of reuse and
recycling of electrical and electronic waste. Failure to recycle such waste
products in an appropriate way may endanger the environment and
consequently the health of human beings.

D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US Page 5
Only recorded speech material with a stated relationship with the calibration
signal should be used. In the calibration of the instrument it is assumed that the
calibration signal level is equal to the average level for the speech material. If
this is not the case, the calibration of the sound pressure levels will be invalid
and the instrument needs recalibration.
To establish conformity with the IEC 60645-2 standard, it is important that the
speech input level is adjusted to 0VU. It is equally important that any free field
installation is calibrated at the site where it is used and under the conditions that
exists during normal operation.
Great care should be exercised by the handling of earphones and other
transducers, as mechanical shock may cause change of calibration.
The specification for the instrument is valid if the instrument is operated within
the environmental limits specified in technical specifications.
Supply voltage: USB-powered (USB Type B connector).
To prevent system faults take appropriate precautions to avoid PC viruses and
similar.
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. Interacoustics A/S recommends you to always use Microsoft
supported operating systems that are kept fully security updated.

D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US Page 6