Interacoustics Eclipse User manual

Instructions for Use - US
Eclipse
D-0104783-C 05/2015

TABLE OF CONTENTS
1Introduction..................................................................................................................................... 1
1.1 About this Manual......................................................................................................................1
1.2 Intended Use.............................................................................................................................2
1.3 Product Description...................................................................................................................3
1.4 Warnings...................................................................................................................................4
2Unpacking and Installation............................................................................................................ 7
2.1 Unpacking and Inspection.........................................................................................................7
2.2 Reporting Imperfections............................................................................................................7
2.3 Markings....................................................................................................................................8
2.4 Hardware installation.................................................................................................................9
2.4.1 Grounding the patient bed..........................................................................................................10
2.4.2 Eclipse Back Panel ....................................................................................................................11
2.4.3 Eclipse Front Panel....................................................................................................................11
2.4.4 Preamplifier Buttons...................................................................................................................12
2.5 Software installation................................................................................................................12
2.5.1 To know before you Start Installation.........................................................................................12
2.5.2 Minimum PC Requirements.......................................................................................................12
2.5.3 What you will need:....................................................................................................................13
2.5.4 EPx5 Software Installation Prompts...........................................................................................13
2.5.5 Restoring Factory Default Settings in the Software....................................................................14
2.5.6 Installing a Language Pack........................................................................................................14
2.6 Reader Station ........................................................................................................................16
2.7 License....................................................................................................................................16
2.7.1 Eclipse Serial Number................................................................................................................16
2.7.2 DSP Serial Number & License Key............................................................................................16
2.8 Starting up from OtoAccessTM.................................................................................................17
2.8.1 Module Setup in OtoAccess™...................................................................................................17
2.9 Starting up from NOAH (ASSR only) ......................................................................................18
3Operating Instructions EP15/EP25............................................................................................. 19
3.1 The Record Tab ......................................................................................................................20
3.1.1 Main Menu Items........................................................................................................................20
3.1.2 Electronic Help...........................................................................................................................21
3.1.3 Viewing Historic Sessions..........................................................................................................21
3.1.4 Protocol Selection......................................................................................................................21
3.1.5 Temporary Setup .......................................................................................................................21
3.1.6 Rearrange Curves......................................................................................................................21
3.1.7 Group Waveforms......................................................................................................................21
3.1.8 Reporting ...................................................................................................................................21
3.1.9 Printing.......................................................................................................................................22
3.1.10 Display A-B Curves....................................................................................................................22
3.1.11 Display Contra Curve.................................................................................................................22
3.1.12 Talk Forward..............................................................................................................................22
3.1.13 Single Curve Display..................................................................................................................22
3.1.14 Split Screen Display...................................................................................................................23
3.1.15 Save & New...............................................................................................................................23
3.1.16 Save & Exit ................................................................................................................................23
3.1.17 Stimulus Rate Selection.............................................................................................................23

3.1.18 Frequency Selection ..................................................................................................................24
3.1.19 Stimulus Window........................................................................................................................24
3.1.20 Manual Stimulation Window.......................................................................................................24
3.1.21 Status Window...........................................................................................................................24
3.1.22 Waveform Reproducibility..........................................................................................................24
3.1.23 Start / Stop.................................................................................................................................25
3.1.24 Pause.........................................................................................................................................25
3.1.25 Next Intensity .............................................................................................................................25
3.1.26 Fmp & Residual Noise Graph ....................................................................................................25
3.1.27 Extending the Number of Sweeps/Averages..............................................................................26
3.1.28 Raw EEG...................................................................................................................................26
3.1.29 Advanced EEG ..........................................................................................................................26
3.1.30 Display Gain...............................................................................................................................27
3.1.31 Recording Window.....................................................................................................................27
3.1.32 Selecting a waveform.................................................................................................................27
3.1.33 Moving an Individual Curve........................................................................................................27
3.1.34 Display Differential Curves.........................................................................................................27
3.2 The Edit Tab............................................................................................................................27
3.2.1 Monitoring Rejection ..................................................................................................................28
3.2.2 Placing Waveform Markers........................................................................................................28
3.2.3 Deleting Waveform Markers.......................................................................................................29
3.2.4 Suggest waveform markers .......................................................................................................29
3.2.5 Normative latency data ..............................................................................................................29
3.2.6 Deleting individual curves ..........................................................................................................30
3.2.7 Enlarge/Diminish Individual Curves............................................................................................30
3.2.8 Hiding Individual Curves ............................................................................................................30
3.2.9 Fixate Individual Curves /Comparing to a Historic Session........................................................30
3.2.10 Merging Curves (Creating a Summed Curve)............................................................................31
3.2.11 Adding Curves ...........................................................................................................................31
3.2.12 Differential Ipsi minus Contra (Ipsi-Contra) Curve......................................................................31
3.2.13 Differential A minus B (A-B (N)) Curve.......................................................................................32
3.2.14 Changing Display Filtering.........................................................................................................32
3.2.15 Recorded Curve Conditions.......................................................................................................32
3.2.16 Adding Comments to a Curve....................................................................................................33
3.2.17 Using the Cursor........................................................................................................................33
3.2.18 Signal to Noise Ratio Calculation (3:1).......................................................................................33
3.2.19 CR, RA & INC Waveform Markers.............................................................................................34
3.3 The Latency Tab .....................................................................................................................35
3.3.1 Latency Values ..........................................................................................................................35
3.3.2 Interlatency Values.....................................................................................................................35
3.3.3 Latency Graph ...........................................................................................................................36
3.3.4 Disabling Desktop Composition (EPx5 software only)...............................................................36
3.3.5 Display of the Peak to Trough Markers (SN10 marker) (EPx5 software only)............................37
3.4 Windows® Vista, 7, 8 & 8.1 fails to launch Help.....................................................................37
3.5 PC Shortcuts ...........................................................................................................................38
3.6 Patient preparation prior to Testing ........................................................................................39
3.6.1 Impedance Check......................................................................................................................39
3.6.2 Transducers...............................................................................................................................39
3.7 Making an ABR Threshold recording......................................................................................40
3.7.1 Elektrode montage.....................................................................................................................40
3.7.2 ABR threshold stimuli.................................................................................................................40
3.7.3 Editing of ABR threshold recordings..........................................................................................41
3.7.4 Interpretation and use of ABR threshold results.........................................................................41
3.8 Making a Neuro Latency recording.........................................................................................42
3.8.1 Elektrode montage.....................................................................................................................42
3.8.2 Editing of Neuro Latency recordings..........................................................................................42
3.9 Making an eABR recording .....................................................................................................44
3.9.1 Two suggested eABR Electrode Montages................................................................................44
3.9.2 Editing an eABR recording.........................................................................................................44

3.9.3 Electrical Threshold Estimation for cochlear implant Fitting.......................................................45
3.10 Making an ECochG recording.................................................................................................46
3.10.1 EcochG Electrode Montages .....................................................................................................46
TipTrode...................................................................................................................................................46
3.10.2 Editing an ECochG recording.....................................................................................................47
3.11 Making an CM recording.........................................................................................................48
Patient preparation...................................................................................................................................48
3.11.1 CM Electrode Montage ..............................................................................................................48
3.11.2 Stimuli for CM recordings...........................................................................................................48
3.11.3 Example of a CM recording........................................................................................................48
3.11.4 Interpretation of the CM result....................................................................................................48
3.12 Making a AMLR recording.......................................................................................................49
3.12.1 Example of Electrode montage AMLR.......................................................................................49
3.12.2 Available AMLR stimuli ..............................................................................................................49
3.12.3 Example of AMLR recording......................................................................................................50
3.13 Making a ALR recording / Cortical ERA..................................................................................51
3.13.1 Example of electrode montage for an ALR threshold recording.................................................51
3.13.2 Stimuli........................................................................................................................................51
3.13.3 Interpretation of the ALR result..................................................................................................52
3.13.4 Electrophysiological Threshold Estimation and Infant Hearing Instrument Fitting......................52
3.14 Making a P300/MMN recording...............................................................................................53
3.14.1 Example of electrode montage for P300/MMN ..........................................................................53
3.14.2 Available P300/MMN stimuli ......................................................................................................53
3.14.3 Summary of parameters for P300 and MMN..............................................................................54
3.15 System Performance / Loop Back (LBK15) Testing ...............................................................55
4Operating Instructions TEOAE25 ............................................................................................... 57
4.1 Using the TEOAE25 module...................................................................................................57
4.2 OAE Probe Tips ......................................................................................................................57
4.3 Mounting & Dismounting the Probe Tip ..................................................................................58
4.3.1 Mounting the Probe Tip..............................................................................................................58
4.3.2 Dismounting the Neonatal Probe Tip .........................................................................................58
4.4 Handling and selection of ear tips...........................................................................................59
4.5 The TEOAE25 Test Screen ....................................................................................................60
4.5.1 Main Menu Items........................................................................................................................60
4.5.2 Electronic Help...........................................................................................................................61
4.5.3 Viewing Historic Sessions..........................................................................................................61
4.5.4 Protocol Selection......................................................................................................................61
4.5.5 Temporary Setup .......................................................................................................................61
4.5.6 Reporting ...................................................................................................................................61
4.5.7 Printing.......................................................................................................................................61
4.5.8 Display A-B Curves....................................................................................................................61
4.5.9 Save & Exit ................................................................................................................................62
4.5.10 Status.........................................................................................................................................62
4.5.11 Rejection Level ..........................................................................................................................62
4.5.12 Obtained Records......................................................................................................................62
4.5.13 Ear Selection..............................................................................................................................62
4.6 Making a TEOAE recording ....................................................................................................63
4.6.1 Probe Check..............................................................................................................................63
4.6.2 Start, Stop & Pause....................................................................................................................63
4.6.3 Probe Check Graph ...................................................................................................................63
4.6.4 Stimulus Graph..........................................................................................................................63
4.6.5 TEOAE Response Graph...........................................................................................................64
4.6.6 Pass & Refer Labels ..................................................................................................................64
4.6.7 Response Waveform Graph.......................................................................................................65

5Operating Instructions DPOAE20............................................................................................... 67
5.1 Using the DPOAE20 module...................................................................................................67
5.2 OAE Probe Tips ......................................................................................................................67
5.3 Mounting & Dismounting the Probe Tip ..................................................................................68
5.3.1 Mounting the Probe Tip..............................................................................................................68
5.3.2 Dismounting the Neonatal Probe Tip .........................................................................................68
5.4 Handling and selection of ear tips...........................................................................................69
5.5 The DPOAE20 Test Screen....................................................................................................70
5.5.1 Main Menu Items........................................................................................................................70
5.5.2 Electronic Help...........................................................................................................................71
5.5.3 Viewing Historic Sessions..........................................................................................................71
5.5.4 Protocol Selection......................................................................................................................71
5.5.5 Temporary Setup .......................................................................................................................71
5.5.6 Reporting ...................................................................................................................................71
5.5.7 Printing.......................................................................................................................................71
5.5.8 Save & Exit ................................................................................................................................71
5.5.9 Save & New...............................................................................................................................72
5.5.10 Status Window...........................................................................................................................72
5.5.11 Stimuli Window ..........................................................................................................................72
5.5.12 Obtained Records......................................................................................................................72
5.5.13 Rejection Level dB SPL .............................................................................................................73
5.5.14 Ear Selection..............................................................................................................................73
5.6 Making a DPOAE recording....................................................................................................74
5.6.1 Probe Check..............................................................................................................................74
5.6.2 Start, Stop, Pause & Next..........................................................................................................74
5.6.3 Probe Check Graph ...................................................................................................................74
5.6.4 Level Graph ...............................................................................................................................74
5.6.5 DPOAE Graph ...........................................................................................................................75
5.6.6 DP- Response Graph.................................................................................................................75
5.6.7 2f1-f2Graph................................................................................................................................76
6Operating Instructions ASSR...................................................................................................... 77
6.1 Using the ASSR module .........................................................................................................77
6.2 Preparations prior to the ASSR Test.......................................................................................78
6.3 Preparations prior to Testing...................................................................................................78
6.3.1 Preparation of the Skin...............................................................................................................78
6.3.2 Placement of Electrodes............................................................................................................78
6.3.3 Impedance Check......................................................................................................................78
6.3.4 Mounting Electrodes ..................................................................................................................79
6.4 Impedance Check ...................................................................................................................79
6.5 System Performance / Loop Back (LBK15) Testing ...............................................................79
6.6 The ASSR Tab........................................................................................................................80
6.6.1 Main Menu Items........................................................................................................................80
6.6.2 Protocol Selection......................................................................................................................80
6.6.3 Temporary Setup .......................................................................................................................81
6.6.4 Reporting ...................................................................................................................................81
6.6.5 Printing.......................................................................................................................................81
6.6.6 Save & Exit ................................................................................................................................81
6.6.7 Viewing Historic Sessions..........................................................................................................81
6.6.8 Stimulus Window........................................................................................................................81
6.6.9 Total Session Status Window ....................................................................................................82
6.6.10 Stimulus Rate.............................................................................................................................82
6.7 Making an ASSR recording.....................................................................................................82
6.7.1 Start & Stop................................................................................................................................82
6.7.2 Pause.........................................................................................................................................82

6.7.3 Raw EEG Graphs.......................................................................................................................82
6.7.4 Test Frequency Graph...............................................................................................................83
6.7.5 ASSR Table...............................................................................................................................83
6.7.6 Extending the Test Time............................................................................................................84
6.7.7 Adjusting the Stimulus Intensity .................................................................................................84
6.7.8 Stopping a Test Frequency/Intensity..........................................................................................85
6.8 The Audiogram Tab ................................................................................................................86
6.8.1 Estimated Audiogram.................................................................................................................86
6.8.2 Selected Correction Factor ........................................................................................................87
6.9 PC Shortcuts ...........................................................................................................................88
7Maintenance.................................................................................................................................. 89
7.1 General Maintenance Procedures ..........................................................................................89
7.2 How to clean Interacoustics Products.....................................................................................89
7.3 Cleaning the OAE Probe Tip...................................................................................................90
7.4 Concerning Repair ..................................................................................................................91
7.5 Warranty..................................................................................................................................92
8Technical Specifications ............................................................................................................. 93
8.1 Technical Specifications - Eclipse Hardware..........................................................................93
8.2 Technical Specifications EP15/EP25......................................................................................94
7.5.1 peSPL to nHL Correction Values...............................................................................................96
8.3 Technical Specifications TEOAE25 ........................................................................................97
8.4 Technical Specifications DPOAE20........................................................................................98
8.5 Technical Specifications ASSR...............................................................................................99
8.7 Electromagnetic Compatibility (EMC) ...................................................................................100
8.8 Eclipse Software Module Overview.......................................................................................103
8.8.1 EP15/EP25 Modules................................................................................................................103
8.8.2 TEOAE25 Module....................................................................................................................103
8.8.3 DPOAE20 Module....................................................................................................................104
8.8.4 ASSR Module ..........................................................................................................................104

Eclipse Instructions for Use - US Page 1
1Introduction
1.1 About this Manual
This manual is valid for the Eclipse EP15/25 v4.4, DPOAE20 v1.03.1, TEOAE25 v3.04.2, and ASSR v
1.2.4.
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
It is the purpose of this manual to provide users of Interacoustics EP15, EP25, TEOAE25, DPOAE20, and
ASSR modules with the information required to carry out safe and reliable measurements.
Some of the software modules described may not be included in your license. Please contact your local
distributor if you want to upgrade your license to include other modules.

Eclipse Instructions for Use - US Page 2
1.2 Intended Use
Intended use of the EP15 & EP25
The Eclipse EP15 and EP25 are intended for use in the electrophysiological evaluation, documentation and
diagnosis of ear disorders in humans. EP15/EP25 is a 2 channel evoked potential system that allows for
recording waveforms that can be used for screening and diagnostic applications.
The EP15 allows for the recording of ABRs (Auditory Brainstem Responses) while the EP25 allows for
recording ABRs, middle and late latency potentials. The target population for EP15 and EP25 includes all
ages.
Intended use of the TEOAE25
The Eclipse TEOAE25 is intended for use in the audiologic evaluation and documentation of ear disorders
using Transient Evoked Otoacoustic Emissions. The target population for Eclipse TEOAE25 includes all
ages.
Intended use of the DPOAE20 System
The Eclipse DPOAE20 system is intended for use in the audiologic evaluation and documentation of ear
disorders using Distortion Product Otoacoustic Emissions. The target population for the Eclipse DPOAE20
includes all ages.
Intended use of ASSR
The Eclipse ASSR (Auditory Steady-State Response) is intended for use in the recording and analysis of
human physiological data for the diagnosis of auditory and hearing-related functions. The target population
for Eclipse ASSR includes all ages.
The Eclipse System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors,
hearing healthcare professionals or personnel with a similar level of education. The device should not be
used without the necessary knowledge and training to understand its use and how results should be
interpreted.

Eclipse Instructions for Use - US Page 3
1.3 Product Description
The Eclipse is a multifunctional screening and/or diagnostic device that interfaces with integrated
audiologic software modules on a PC. Depending on the installed software modules and licenses, it can
perform the following via OtoAccess™:
•Early, middle and late latency evoked potential testing (EP15/25)
•Transient Evoked Otoacoustic Emissions (TEOAE25)
•Distortion Product Otoacoustic Emissions (DPOAE20)
•Auditory Steady-State Response testing (ASSR)
The system consists of the following included parts:
EP15/EP25/
DPOAE20/TEOAE25
ASSR
Eclipse
EPA Preamplifier
EPA4 cable collector
USB cable
Power cable
LBK15
EarTone ABR inserts including
eartips
Neonatal Insert Ear tips
4.0 mm, 3.5 mm
ETB Standard Electrode Cables
with Buttons
Pinch Clip Electrode Cables
NuPrep gel 4oz/114g tube
(SPG15)
Gauze Swabs
PEG15 Pregel foam snap
electrodes (25 pcs)
Alcohol Pads
Ten20 Electrode Paste
8 oz/228 jar
EP15/25 software
OtoAccess™ software
Instructions for Use Manual on
CD
Additional Information Manual
on CD
EP25:
ECochG Starter Kit including
cable, gel and 2 electrodes
DPOAE20
Eclipse
OAE Probe complete
Power cable
USB cable
DPOAE20 software
BET25 Ear Tip Assortment Box
Cleaning tool
Probe tips
OtoAccess™ Software
Instructions for Use
Additional Information Manual
TEOAE25
Eclipse
OAE Probe complete
Power Cable
Country specific
USB connection cable
TEOAE25 software
BET25 Assortment Box with ear
tips for OAE
Cleaning tool
Probe tip
OtoAccess™ Software
Instructions for Use Manual on
CD
Additional Information Manual
on CD
Eclipse
EPA Preamplifier
EPA4 cable collector
USB cable
Power cable
EarTone ABR inserts including
eartips
Neonatal Insert Ear tips
4.0 mm, 3.5 mm
ETB Standard Electrode Cables
with Buttons
Pinch Clip Electrode Cables
NuPrep gel 4oz/114g tube
(SPG15)
Gauze Swabs
PEG15 Pregel foam snap
electrodes (25 pcs)
Alcohol Pads
Ten20 Electrode Paste 8oz/228
g jar
ASSR software
OtoAccess™ software
Instructions for Use Manual on
CD
Additional Information Manual
on CD
Optional parts:
Refer to the current Sanibel Disposables & Accessories brochure (www.interacoustics.com) or contact your
local distributor.

Eclipse Instructions for Use - US Page 4
1.4 Warnings
Throughout this manual the following meaning of warnings, cautions and notices are used:
1. If the instrument is damaged during transport, a hazardous situation may exist and the instrument
should be repaired and or/safety inspected before use.
2. Before connecting the instrument to mains power, be sure that the local mains voltage corresponds
to the voltage labelled on the instrument.
3. Do not place the instrument next to a heat source of any kind, and allow sufficient space around
the instrument to ensure proper ventilation.
4. Keep small parts (probe tip and ear tips etc.) outside the reach of children to prevent accidental
swallowing.
5. Due to patient safety, the Eclipse system must not be used during surgery if High Frequency
cutting (diathermy) is used. Please disconnect the Eclipse from the patient in this case.
6. There might be a risk of safety hazard when using simultaneously connected patient equipment.
For example, the use of defibrillators may damage or break the Eclipse device. The Eclipse device
may also absorb some of the defibrillator energy, resulting in an insufficient defibrillator treatment.
Please disconnect the Eclipse device when defibrillators are used.
7. If the Eclipse is connected to one or more other devices with medical CE marking, to make up a
system or pack, the CE marking is valid for the combination only if the supplier has issued a
declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for
the combination. The summation of electrical leakage currents, when several pieces of equipment
are interconnected, may cause a safety hazard.
8. External equipment intended for connection to signal input, signal output or other connectors shall
comply with relevant IEC standard (e.g. IEC 60950 for IT equipment and the IEC 60601 series for
medical electrical equipment). In these situations the use of an optical isolator is recommended to
fulfill the requirements. Equipment not complying with IEC 60601-1 shall be kept outside the patient
environment, as defined in the standard (at least 1.5m from the patient).
9. Any person who connects external equipment to signal input, signal output or other connectors has
created a system and is therefore responsible for the system complying with the requirements of
IEC 60601-1. If in doubt, contact your service technician or local representative for help.
10.This instrument does not incorporate any separation devices at the connections for PC’s, printers,
active speakers etc. Use of an optical USB is required to fulfill patient safety.
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.

Eclipse Instructions for Use - US Page 5
11.When the instrument is connected to a PC and/or other items of equipment, ensure that the total
leakage current does not exceed the safety limits, in order for the dielectric strength, creepage
clearances and air clearances to be fulfilled according to the IEC/ES 60601-1.
12.When the instrument is connected to a PC and/or other electrical items, do not touch the Eclipse or
other connected electrical items, and the patient simultaneously.
13.To avoid the risk of electric shock, this equipment must only be connected to supply mains with a
protective earth. Do not use any additional multiple socket-outlets or extension cords.
14.Do not disassemble or modify the product as this may impact the safety and/or performance of the
device.
15.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 equipmenthat are designated by Interacoustics as repairable by service personnel
1. Only skilled and qualified personnel may use the Eclipse device.
2. Do not switch the power on/off for the Eclipse device while a patient is connected.
3. The specifications for the device are valid if the device is operated within the environmental limits.
4. Although the Eclipse device meets the requirements of the IEC60601-1-2 EMC standard, you
should not use cell phones, pagers or any kind of radio transmitters in close vicinity to the Eclipse
device, as this may disturb the measurements and lead to prolonged test times or, in severe cases,
make testing impossible.
5. When connecting the device to its accessories, use only the dedicated socket as described in the
section “Eclipse back panel”. If the wrong socket is selected for the transducer, the stimulus sound
pressure level (SPL) will not meet the calibrated level as set in the user interface and this could
lead to an incorrect diagnosis.
6. Never insert the OAE/ABR probe into the ear canal without an ear tip mounted.
7. To ensure safe operation and valid measurements, the Eclipse device and its accessories must be
checked and calibrated at least once a year or more frequently, if required by local regulations or if
there is any doubt about correct Eclipse device function.
8. Use only sound stimulation intensities that will be acceptable to the patient.
9. The transducers (headphones, bone conductor etc.) supplied with the device are calibrated to this
specific device - exchange of a transducer requires a new calibration.
10.It is recommended that parts which are in direct contact with the patient (e.g. the probe) are
subjected to standard infection control procedures between testing patients. This includes
physically cleaning and use of an approved disinfectant. The individual disinfecting agent’s
manufacturer's instructions should be followed to maintain appropriate levels of infection control.
11.Ensure that the right/left transducer is connected to the corresponding ear of the patient and that
the correct test ear is selected from within the user interface.

Eclipse Instructions for Use - US Page 6
12.Single use items such as ear tips and electrodes should not be reused. Reuse of such items can
lead to the spread of infection from patient to patient.
1. The LBK15 unit is not valid for performing a functional check of ASSR due to the nature of ASSR
algorithms. For functional testing (detection of false passes), a patient must be connected with
electrodes, in the absence of a stimulus (disconnected transducer).
2. Within the European Union it is illegal to dispose electric and electronic waste as 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 wheelie-bin
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 its
useful life.

Eclipse Instructions 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 Eclipse comes in its own shipping carton, which is specially designed for the Eclipse. 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.
2.2 Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. The cabinet and the
accessories should be checked visually for scratches and missing parts.
Report immediately any faults
Any missing parts or malfunction should be reported immediately to the supplier of the instrument together
with the invoice, serial number, and a detailed report of the problem. At the back of this manual you will find
a "Return Report" where you can describe the problem.
Please use the "Return Report"
Use of the return report provides the service engineer with the relevant information to investigate the
reported issue. Without this information, there may be difficulty in determining the fault and repairing the
device. Please always return the device with a completed Return Report in order to guarantee that correction
of the problem will be to your satisfaction.
Storage
If you need to store the instrument for a long period of time, please ensure it is stored under the conditions
specified in the technical specification’s section.

Eclipse Instructions for Use - US Page 8
2.3 Markings
The following markings can be found on the instrument:
Symbol
Explanation
Type B applied parts.
This is used for parts applied to the patient that require only ordinary electrical
protection e.g., headphones.
Type BF applied parts.
This is used for parts applied to the patient that require a higher degree of
electrical protection e.g., patient coupled electrodes.
or
Refer to instruction manual.
0123
The CE-mark indicates that Interacoustics A/S meets the
requirements of Annex II of the Medical Device Directive
93/42/EEC. TÜV Product Service, Identification No. 0123,
has approved the quality system.
Year of manufacture.
Do not re-use.
Parts like ear-tips and similar are for single use only.
I On (Power: connection to the mains).
Equipotentiality
O Off (Power: disconnection from the mains).
This label is located on the backside of the Eclipse Hardware.
The label to the left shows manufacturer and
address.
Eclipse serial number is SN802872
Produced year 2011

Eclipse Instructions for Use - US Page 9
2.4 Hardware installation
When connecting the Eclipse to the mains supply and to a computer, the following warnings must be
observed:
1. The Eclipse contains a built-in, medically approved safety transformer and must, in all cases, be
connected to a wall outlet with a proper ground.
2. The Eclipse should not be connected to an external safety transformer as this is not required and
may cause excess noise in the recordings.
3. If a connection is made to standard equipment such as a printer or network, special precautions
must be taken in order to maintain medical/patient safety.
4. All contact between the conductive parts of electrodes or their connectors, including the neutral
electrode and other conductive parts including earth must be avoided.
5. Avoid any mixing of cables ex. USB cables/power cord etc. mixed up with the electrode/Preamplifier
cable used for the EP system.
6. 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 BF if used for ABR measurements.
For OAE measurements the instrument must be tested according to IEC60601-1, Class I, Type B.
7. DO NOT connect the Eclipse hardware to the computer before the software has been installed!
8. When the Eclipse is connected to a patient using surface electrodes and to a computer which is
connected to a power outlet and/or is connected to a printer or a network, the electrical/patient safety
is no longer applicable without the use of an optical USB isolator. Contact your local distributor to
purchase an optical USB isolator if required.
9. The following diagrams indicate how to ensure that the Eclipse is installed correctly and patient
safety is maintained.

Eclipse Instructions for Use - US Page 10
The following diagrams indicate how to ensure that the Eclipse is installed correctly and patient safety is
maintained.
Fig.1: Eclipse is connected with a standard USB cable to a laptop PC running on battery only.
Fig.2: Eclipse is connected to a computer via an optical USB.
Optical USB 1.1 isolation MED, #8013227 is optional from Interacoustics.
Fulfils IEC 60601-1, IEC 60601-1-2. Supports Windows®XP, Windows®7(64/32bit) & Windows®8.
Please consult with a medical device safety specialist if in doubt.
2.4.1 Grounding the patient bed
The ground plug on the back of the Eclipse can be used to further reduce noise in the test environment
during evoked potential testing.
1. Unscrew the Ground outlet bolt from the back of the Eclipse.
2. Attach the looped end of the ground wire around the metal screw and reattach the bolt.
3. Attach the clamp at the other end of the wire to either the patient bed or chair used during evoked
potential testing. Ensure it is connected to a conductive metal part (unpainted) such as screw or bolt
on the bed/chair.
Please consult with a medical device safety specialist if in doubt.

Eclipse Instructions for Use - US Page 11
2.4.2 Eclipse Back Panel
Position:
Symbol:
Function:
1
Power
Turns power on/off
2
Mains 50-60 Hz
Plug for mains cable
3
Aux Out
For future use
4
Preamp.
Plug for Preamplifier
5
Pat. Resp.
Plug for patient response button
6
Trigger In/Out
Connector for trigger input/output
E.g. eABR (cochlear implant) testing etc.
7
Talk Back
Connector for talk back microphone
8
Talk Forward
Connector for talk forward microphone
9
OAE
Plug for the eight pin OAE probe
10
Left
Plug for left headphone/insert
11
Right
Plug for right headphone/insert
12
Bone
Plug for bone conductor
13
USB/PC
Plug for USB cable to connect to PC
14
DC
Plug for power supply for an optical USB
15
Connection for equipotentiality
2.4.3 Eclipse Front Panel
Position:
Symbol:
Function:
1
Power indication
Power on – blue light. Power off - no light.

Eclipse Instructions for Use - US Page 12
2.4.4 Preamplifier Buttons
The preamplifier is used for the EP15, EP25, and ASSR modules.
For further instruction on how to use, please read the module chapter.
Position:
Symbol:
Function:
1
Dial
Dial used to determine surface electrode impedance.
2
Button
Press button (Imp.) to select impedance mode. Button flashes with a
blue light when in this mode.
3
LED
Green or Red lights indicate the electrode impedance.
4
Button
Press button (-20dB) to reduce the gain for relevant tests. Blue button
light remains stable.
2.5 Software installation
2.5.1 To know before you Start Installation
You must have administrative rights to the computer on which you are installing the Eclipse module software.
1. DO NOT connect the Eclipse hardware to the computer before the software has been installed!
2. Interacoustics will not make any guarantee to the functionality of the system if third party software is
installed, with the exception of the OtoAccess™ or a Noah 4.0 or higher.
3. When running the EP15/EP25 on Windows® 7, desktop composition must be disabled for optimal
user interface actions.
2.5.2 Minimum PC Requirements
The Eclipse is a medical device requiring to be used with a PC that meets certain minimum specifications.
•2 GHz Dual Core CPU or better (Intel recommended)
•4 GB RAM or better.
•Hard drive with minimum 10 GB space.
•Minimum display resolution of 1024x768 pixels or higher.
•DirectX 9.0c compatible graphics (Intel/NVidia recommended) or newer.
•One or more USB ports, version 1.1 or 2.0.
•DVD-ROM drive.
A list of recommended compatible PC's to be used with the Eclipse can be found at
http://www.interacoustics.com/eclipse/specifications
If a non-compatible PC is used, it may be difficult to troubleshoot and deliver optimal support in the case of
incidents.