Interacoustics Callisto User manual

Item No. 8101932 –ver. 11/2014
Instructions for Use - US
Callisto™
Portable Audiometry & REM

Instructions for Use - US

Table of Contents
1INTRODUCTION..................................................................................................................... 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
2UNPACKING 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...................................................................... 13
2.5.3 Software Installation Windows®XP...................................................................... 16
2.6 Driver Installation .............................................................................................................. 19
2.6.1 Sound Device Settings......................................................................................... 22
Sound Device Settings for Windows®7 .................................................................... 23
2.6.2 23
2.6.3 Sound Device Settings for Windows®XP: ........................................................... 24
2.7 Using with Databases ....................................................................................................... 25
2.7.1 Noah 3.7............................................................................................................... 25
2.7.2 Noah 4.................................................................................................................. 25
2.8 How to install a shortcut for launching with standalone version ...................................... 26
2.9 Licenses............................................................................................................................ 26
3OPERATING 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
3.3 REM440 Screen Elements................................................................................................ 41
3.4 Using the Print Wizard ...................................................................................................... 50
4MAINTENANCE..................................................................................................................... 53
4.1 General Maintenance Procedures .................................................................................... 53
4.2 How to clean Interacoustics products ............................................................................... 53
4.3 Concerning Repair ............................................................................................................ 54
4.4 Warranty............................................................................................................................ 54
5GENERAL TECHNICAL SPECIFICATIONS................................................................. 55
5.1 Reference Equivalent Threshold Values for transducers and Maximum hearing level
settings provided at each test frequency .......................................................................... 56
5.2 Pin Assignments ............................................................................................................... 56
5.3 Electromagnetic Compatibility (EMC) ............................................................................... 56

Callisto™Instruction for Use - US Page 1
1Introduction
1.1 About this Manual
This manual is valid for the Callisto™. The product is manufactured by:
Interacoustics A/S
Drejervænget 8
DK 5610 Assens
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]om
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.
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

Callisto™Instruction for Use - US Page 2
1.4 Included and Optional Parts and Accessories
Standard Parts for the Callisto™ Unit:
CallistoTM Unit
CallistoTM Suite DVD, incl. CE- & Operation Manual (pdf format)
Callisto Carrying Bag
Callisto Foam Insert (standard bag)
Standard USB Cable (2m)
Mouse Pad
Optional Parts for the Callisto™ Unit
Wheeled Carrying Case
Callisto™ Foam Insert (optional bag with wheels)
OtoAccess V1.01 Database CD, Complete
AC440
REM440
AC440 Standard Parts
DD45 or TDH 39 Audiometric Headset
MTH400 Monitor Headset
B71 Bone Conductor
APS3 Patient response button
AC440 Optional Parts
TDH39 Audiometric Headset
HDA300 Audiometric Headset 30° plugs
Eartone 3A Insert earphones1)
Eartone 5A Insert earphones1))
IP30 Insert earphones
B71 Bone Conductor
B81 Bone Conductor
Talk Back Microphone
Edifier –Loudspeaker + wire
SP85A Loudspeaker
SP90A Loudspeaker
Special Tests:
Optional special tests:
High Frequency audiometry (HF440)
Multi Frequency module (MF440)
Speech from hard-drive (SFH440)
SISI test
Master Hearing Aid (MHA440),
Hearing Loss Simulator (HLS440)
Loudness Scaling (LS440)
QuickSIN
TEN test
REM440 Standard Parts
IHM60 In-situ Headset (kit)
Probe Tubes 36 pcs
Edifier Loudspeaker + Wire
REM440 Optional Parts
Extra Edifier Loudspeaker + Wire
Callisto™ Coupler Base Kit which includes:
oCoupler Base
oCoupler Box
oReference Microphone
o2cc Coupler
o½” Microphone
oBTE Adaptor with O
oITE Adaptor with O
oBody Adaptor with O
oBTE Tubing 26,5mm for BTE adaptor
oSPL60 In-situ Probe Tip-set +
Coupler Adaptor1)
oCoupler Seal Wax
1) Note patient contact parts for single use.

Callisto™Instruction for Use - US Page 3
1.5 Warnings and Precautions
Throughout this manual the following meaning of warnings, cautions and notices are used:
WARNING indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous
situation which, if not avoided, could result in minor or moderate
injury.
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.
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.

Callisto™Instruction for Use - US Page 4
The internal battery shall be replaced by authorized personnel.
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 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 guaranty 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 Noah3.7. compatible Office
Systems or later releases.
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.

Callisto™Instruction for Use - US Page 5
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.
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.

Callisto™Instruction for Use - US Page 6

Callisto™Instruction for Use - US Page 7
2Unpacking and Installation
2.1 Unpacking and Inspection
Check box and contents for damage
When the instrument is received please check the shipping box for rough handling and damage. If the box is
damaged it should be kept until the contents of the shipment have been checked mechanically and
electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the
carrier’s inspection and insurance claim.
Keep carton for future shipment
The Callisto™comes in its own shipping carton, which is specially designed for the Callisto™. Please keep
this carton. It will be needed if the instrument has to be returned for service.
If service is required please contact your local distributor.
Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the
accessories should be checked visually for scratches and missing parts.
Report immediately any faults
Any missing part or malfunction should be reported immediately to the supplier of the instrument,along with
the invoice, serial number, and a detailed report of the problem. In the back of this manual you will find a
"Return Report" where you can describe the problem.
Please use "Return Report"
Please realise that if the service engineer does not know what problem to look for he may not find it, so using
the Return Report will be of great help to us and is your best guarantee that the correction of the problem will
be to your satisfaction.
Storage
If you need to store the Callisto™for a period, please ensure it is stored under the conditions specified in the
technical specifications:
2.2 Marking
The following marking can be found on the instrument:
Refer to instruction manual
Please refer to warning and pre-cautions
WEEE 2002/96/EC
Please refer to warning and pre-cautions
Type B applied parts.
Patient applied parts that are not conductive and can be immediately released from the
patient.
Year of manufacture

Callisto™Instruction for Use - US Page 8
2.3 Callisto™ - Connection Panel Dictionary
2.4 Callisto™ - Indicators:
GREEN-Light: Ready
RED-Light: Indicates right ear selected in REM mode
BLUE-Light: Indicates left ear selected in REM mode
PURPLE-Light: Indicates both ears selected in REM mode
Position:
Symbol:
Function:
1
Insitu L.
Connection of Insitu Headset Left
2
Insitu R.
Connection of Insitu Headset Right
3
TB/Coupler
Socket for talk back microphone or coupler base
4
TF
Socket for talk forward or microphone
5
Monitor
Socket for monitor headset
6
FF
Socket for free field speaker
7
Bone
Socket for bone conductor
8
Left
Socket for left AC headphone/Insert phone
9
Right
Socket for right AC headphone/Insert phone
10
Pat. Resp.
Socket for patient response button
11
USB/PC
Socket for USB cable to PC
8
9
7
3
4
6
5
10
1
2
11

Callisto™Instruction for Use - US Page 9
2.5 Software Installation
To know before starting the installation.
You must have administrative rights to the computer on which you are installing the Callisto™ Suite.
DO NOT connect the Callisto™ hardware to the computer before the software has been installed!
Please also refer to the section “Warnings and precautions”
What you will need:
1. Callisto™ Suite Installation DVD
2. USB Cable
3. Callisto™ Hardware
Supported Noah Office Systems
Noah 3.7 and Noah 4
AuditBase System 4
Mirage
Practice Navigator
Power Office
AkuWin
He@r-O
Entendre 2
Quasar
Acuosoft
To use the software with a database (e.g. Noah3, Noah4 or OtoAccessTM), make sure the database is
installed prior to the Callisto™ Suite installation. Follow the manufacturer’s installation instructions provided
to install the relevant database.
Note that if you are using AuditBase System 4 you must ensure to launch this office system prior to this
installation of the Callisto™ Suite.
Installation of various Windows® versions
Installation on Windows®XP (SP2 or later), Windows Vista, Windows 7 (32 and 64 bit) and Windows®8 (32
and 64 bit) systems are supported. Note that with Windows®“N” versions, Media Player needs to be in-
stalled manually for the software suite to run

Callisto™Instruction for Use - US Page 10
2.5.1 Software Installation Windows®7 and Windows®8
Insert the installation DVD and follow the steps below to install the CallistoTM Suite software. If the
installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click
the DVD/CD-RW drive to view the contents of the installation DVD. Double click the “setup.exe” file to initiate
the installation.
1. Wait for the dialog shown below to appear, then click “Install”.
2. Depending on your Windows User Account settings the following dialog may appear. Select “Yes” to
continue the installation.

Callisto™Instruction for Use - US Page 11
3. Please wait while the Callisto™ Suite is being installed.
4. If any of the dialogs below are shown, click “Install”

Callisto™Instruction for Use - US Page 12
5. When the installation is complete, the dialog box below is shown. Click “Close” to finish the
installation. The Callisto™ Suite is now installed.

Callisto™Instruction for Use - US Page 13
2.5.2 Software Installation Windows®8.1
Insert the installation DVD and follow the steps below to install the CallistoTM Suite software. If the
installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click
the DVD/CD-RW drive to view the contents of the installation DVD. Double click the “setup.exe” file to initiate
the installation.
1. Wait for the dialog shown below to appear, then click “Install”.
2. Depending on your Windows User Account settings the following dialog may appear. Select “Yes” to
continue with the installation.

Callisto™Instruction for Use - US Page 14
3. Please wait while the Callisto™ Suite is being installed.
4. If any of the dialogs below are shown, click “Install” to proceed with the installation.