Eclipse Instructions for Use March 2015

TABLE OF CONTENTS 1

2

Introduction ... 1 1.1

About this Manual... 1

1.2

Intended Use ... 2

1.3

Product Description ... 3

1.4

Warnings ... 4

Unpacking 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 2.4.2 2.4.3 2.4.4

2.5

Software installation ... 12 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 2.5.6

2.6 2.7

License ... 16

3

Eclipse Serial Number... 16 DSP Serial Number & License Key ... 16

Starting up from OtoAccess 2.8.1

2.9

To know before you Start Installation ... 12 Minimum PC Requirements ... 12 What you will need: ... 13 EPx5 Software Installation Prompts ... 13 Restoring Factory Default Settings in the Software ... 14 Installing a Language Pack ... 14

Reader Station ... 16 2.7.1 2.7.2

2.8

Grounding the patient bed ... 10 Eclipse Back Panel ... 11 Eclipse Front Panel ... 11 Preamplifier Buttons ... 12

TM

... 17

Module Setup in OtoAccess™ ... 17

Starting up from NOAH (ASSR only) ... 18

Operating Instructions EP15/EP25 ... 19 3.1

The Record Tab ... 20 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9 3.1.10 3.1.11 3.1.12 3.1.13 3.1.14 3.1.15 3.1.16 3.1.17

Main Menu Items... 20 Electronic Help ... 21 Viewing Historic Sessions ... 21 Protocol Selection ... 21 Temporary Setup ... 21 Rearrange Curves ... 21 Group Waveforms ... 21 Reporting ... 21 Printing ... 22 Display A-B Curves ... 22 Display Contra Curve ... 22 Talk Forward ... 22 Single Curve Display ... 22 Split Screen Display ... 23 Save & New ... 23 Save & Exit ... 23 Stimulus Rate Selection ... 23

3.1.18 3.1.19 3.1.20 3.1.21 3.1.22 3.1.23 3.1.24 3.1.25 3.1.26 3.1.27 3.1.28 3.1.29 3.1.30 3.1.31 3.1.32 3.1.33 3.1.34

3.2

The Edit Tab ... 27 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9 3.2.10 3.2.11 3.2.12 3.2.13 3.2.14 3.2.15 3.2.16 3.2.17 3.2.18 3.2.19

3.3

Frequency Selection ... 24 Stimulus Window... 24 Manual Stimulation Window ... 24 Status Window ... 24 Waveform Reproducibility ... 24 Start / Stop ... 25 Pause ... 25 Next Intensity ... 25 Fmp & Residual Noise Graph ... 25 Extending the Number of Sweeps/Averages ... 26 Raw EEG ... 26 Advanced EEG ... 26 Display Gain ... 27 Recording Window ... 27 Selecting a waveform ... 27 Moving an Individual Curve ... 27 Display Differential Curves ... 27 Monitoring Rejection ... 28 Placing Waveform Markers ... 28 Deleting Waveform Markers ... 29 Suggest waveform markers ... 29 Normative latency data ... 30 Deleting individual curves ... 30 Enlarge/Diminish Individual Curves... 30 Hiding Individual Curves ... 30 Fixate Individual Curves /Comparing to a Historic Session ... 31 Merging Curves (Creating a Summed Curve) ... 31 Adding Curves ... 31 Differential Ipsi minus Contra (Ipsi-Contra) Curve ... 32 Differential A minus B (A-B (N)) Curve ... 32 Changing Display Filtering ... 32 Recorded Curve Conditions ... 33 Adding Comments to a Curve ... 33 Using the Cursor ... 33 Signal to Noise Ratio Calculation (3:1)... 34 CR, RA & INC Waveform Markers ... 34

The Latency Tab ... 35 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5

Latency Values ... 35 Interlatency Values... 35 Latency Graph ... 36 Disabling Desktop Composition (EPx5 software only) ... 36 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 3.6.2

3.7

Making an ABR Threshold recording ... 40 3.7.1 3.7.2 3.7.3 3.7.4

3.8

Elektrode montage ... 40 ABR threshold stimuli ... 40 Editing of ABR threshold recordings ... 41 Interpretation and use of ABR threshold results ... 41

Making a Neuro Latency recording ... 42 3.8.1 3.8.2

3.9

Impedance Check ... 39 Transducers ... 39

Elektrode montage ... 42 Editing of Neuro Latency recordings ... 42

Making an eABR recording ... 44 3.9.1 3.9.2

Two suggested eABR Electrode Montages ... 44 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 3.12.2 3.12.3

Example of Electrode montage AMLR ... 49 Available AMLR stimuli ... 49 Example of AMLR recording ... 50

3.13 Making a ALR recording / Cortical ERA ... 51 3.13.1 3.13.2 3.13.3 3.13.4

Example of electrode montage for an ALR threshold recording ... 51 Stimuli ... 51 Interpretation of the ALR result ... 52 Electrophysiological Threshold Estimation and Infant Hearing Instrument Fitting ... 52

3.14 Making a P300/MMN recording ... 53 3.14.1 3.14.2 3.14.3

Example of electrode montage for P300/MMN ... 53 Available P300/MMN stimuli ... 53 Summary of parameters for P300 and MMN ... 54

3.15 System Performance / Loop Back (LBK15) Testing ... 55 4

Operating Instructions VEMP ... 57 4.1

Preamplifier Setup ... 58

4.2

VEMP Monitor ... 58

4.3

VEMP Waveform Markers ... 58

4.4

Calculating the VEMP Asymmetry Ratio (VEMP Partner) ... 59

4.5

VEMP Scaling ... 59

4.6

Making a cVEMP recording ... 60 4.6.1 4.6.2 4.6.3 4.6.4 4.6.5

4.7

Making a oVEMP recording ... 63 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5

5

Electrode Montage for oVEMP ... 63 Stimuli for oVEMP ... 63 Procedure ... 63 Edit oVEMP results ... 64 Example of oVEMP result ... 64

Research module... 65 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5

6

Electrode Montage for cVEMP ... 60 Stimuli for cVEMP ... 60 Procedure ... 61 Edit cVEMP results ... 61 Example of cVEMP result ... 62

Logging of each sweep for a late ”replay” ... 65 Exporting the averaged curve &/or Full session ... 66 Exporting the session (all curves) ... 67 Exporting waveform when offline ... 67 Importing wavefiles for stimuli ... 67

Operating Instructions TEOAE25 ... 71 6.1

Using the TEOAE25 module ... 71

6.2 6.3

OAE Probe Tips ... 71 Mounting & Dismounting the Probe Tip ... 72 6.3.1 6.3.2

6.4 6.5

Handling and selection of ear tips ... 73 The TEOAE25 Test Screen ... 74 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.5.8 6.5.9 6.5.10 6.5.11 6.5.12 6.5.13

6.6

Main Menu Items... 74 Electronic Help ... 75 Viewing Historic Sessions ... 75 Protocol Selection ... 75 Temporary Setup ... 75 Reporting ... 75 Printing ... 75 Display A-B Curves ... 75 Save & Exit ... 76 Status ... 76 Rejection Level ... 76 Obtained Records ... 76 Ear Selection ... 76

Making a TEOAE recording ... 77 6.6.1 6.6.2 6.6.3 6.6.4 6.6.5 6.6.6 6.6.7

7

Mounting the Probe Tip ... 72 Dismounting the Neonatal Probe Tip ... 72

Probe Check ... 77 Start, Stop & Pause... 77 Probe Check Graph ... 77 Stimulus Graph ... 77 TEOAE Response Graph ... 78 Pass & Refer Labels ... 78 Response Waveform Graph... 79

Operating Instructions DPOAE20 ... 81 7.1

Using the DPOAE20 module ... 81

7.2

OAE Probe Tips ... 81

7.3

Mounting & Dismounting the Probe Tip ... 82 7.3.1 7.3.2

7.4 7.5

Handling and selection of ear tips ... 83 The DPOAE20 Test Screen ... 84 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.5.6 7.5.7 7.5.8 7.5.9 7.5.10 7.5.11 7.5.12 7.5.13 7.5.14

7.6

Mounting the Probe Tip ... 82 Dismounting the Neonatal Probe Tip ... 82

Main Menu Items... 84 Electronic Help ... 85 Viewing Historic Sessions ... 85 Protocol Selection ... 85 Temporary Setup ... 85 Reporting ... 85 Printing ... 85 Save & Exit ... 85 Save & New ... 86 Status Window ... 86 Stimuli Window ... 86 Obtained Records ... 86 Rejection Level dB SPL ... 87 Ear Selection ... 87

Making a DPOAE recording ... 88 7.6.1 7.6.2 7.6.3 7.6.4 7.6.5 7.6.6

Probe Check ... 88 Start, Stop, Pause & Next ... 88 Probe Check Graph ... 88 Level Graph ... 88 DPOAE Graph ... 89 DP- Response Graph ... 90

7.6.7

7.7

DPOAE Technical Specifications ... 91 7.7.1 7.7.2

8

Standards... 91 DPOAE20 Specifications ... 91

Operating Instructions ABRIS ... 93 8.1

Using the ABRIS module ... 93

8.2

Mounting Electrodes ... 93

8.3

Impedance Check ... 94

8.4

Loop Back (LBK15) Testing ... 94

8.5

ABRIS Test Screen ... 95 8.5.1 8.5.2 8.5.3 8.5.4 8.5.5 8.5.6 8.5.7 8.5.8 8.5.9 8.5.10

8.6

Main Menu Items... 95 Viewing Historic Sessions ... 96 Save & Exit ... 96 Printing ... 96 Electronic Help ... 96 Reporting ... 96 View EEG or Noise Bar ... 96 Stimulus Window... 96 Test Status Window ... 97 Ear ... 97

Making an ABRIS recording ... 98 8.6.1 8.6.2 8.6.3 8.6.4 8.6.5 8.6.6 8.6.7

9

2f1-f2 Graph ... 90

Starting & Pausing a Test ... 98 EEG Graph ... 98 EEG Noise Bar ... 98 AEP Waveform ... 98 Remarks Box ... 98 Status Bar ... 99 ABRIS Response Curve... 99

8.7

PC Shortcuts ... 99

8.8

Technical Specifications ABRIS ... 100

8.9

Detachable Parts ... 101

Operating Instructions ASSR ... 103 9.1

Using the ASSR module ... 103

9.2

Preparations prior to the ASSR Test ... 104

9.3

Preparations prior to Testing ... 104 9.3.1 9.3.2 9.3.3

Preparation of the Skin... 104 Placement of Electrodes ... 104 Impedance Check ... 104

9.4

Mounting Electrodes ... 106

9.5

Impedance Check ... 106

9.6

System Performance / Loop Back (LBK15) Testing ... 106

9.7

The ASSR Tab ... 107 9.7.1 9.7.2 9.7.3 9.7.4 9.7.5 9.7.6 9.7.7 9.7.8

Main Menu Items... 107 Protocol Selection ... 107 Temporary Setup ... 108 Reporting ... 108 Printing ... 108 Save & Exit ... 108 Viewing Historic Sessions ... 108 Stimulus Window... 108

9.7.9 9.7.10

9.8

Making an ASSR recording ... 109 9.8.1 9.8.2 9.8.3 9.8.4 9.8.5 9.8.6 9.8.7 9.8.8

9.9

Total Session Status Window ... 109 Stimulus Rate ... 109 Start & Stop ... 109 Pause ... 109 Raw EEG Graphs... 109 Test Frequency Graph ... 110 ASSR Table ... 111 Extending the Test Time ... 111 Adjusting the Stimulus Intensity ... 111 Stopping a Test Frequency/Intensity ... 112

The Audiogram Tab ... 113 9.9.1 9.9.2

Estimated Audiogram ... 113 Selected Correction Factor ... 114

9.10 PC Shortcuts ... 115 10 Maintenance ... 117 10.1 General Maintenance Procedures ... 117 10.2 How to clean Interacoustics Products ... 117 10.3 Cleaning the OAE Probe Tip ... 118 10.4 Concerning Repair ... 119 10.5 Warranty ... 120 11 Technical Specifications ... 121 11.1 Technical Specifications - Eclipse Hardware ... 121 11.2 Technical Specifications EP15/EP25/VEMP ... 122 11.2.1

peSPL to nHL Correction Values ... 124

11.3 Technical Specifications TEOAE25 ... 125 11.4 Technical Specifications DPOAE20 ... 126 11.5 Technical Specifications ABRIS ... 127 11.6 Technical Specifications ASSR ... 128 11.7 Electromagnetic Compatibility (EMC) ... 129 11.8 Eclipse Software Module Overview... 132 11.8.1 11.8.2 11.8.3 11.8.4 11.8.5

EP15/EP25/VEMP Modules ... 132 TEOAE25 Module ... 132 DPOAE20 Module ... 133 ABRIS Module ... 133 ASSR Module ... 133

Eclipse Instructions for Use - EN

Page 1

1 Introduction 1.1

About this Manual

This manual is valid for the Eclipse EP15/25 v4.4, DPOAE20 v1.03.1, TEOAE25 v3.04.2, ABRIS v1.06.1, VEMP v4.3 and ASSR v 1.2.4. The product is manufactured by: Interacoustics A/S Drejervaenget 8 DK 5610 Assens Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] Web: www.interacoustics.com It is the purpose of this manual to provide users of Interacoustics EP15, EP25, VEMP, TEOAE25, DPOAE20, ABRIS 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 - EN

1.2

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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 VEMP The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for use in the electrophysiological evaluation and documentation of vestibular and related disorders using Vestibular Evoked Myogenic Potentials. The target population for Eclipse VEMP 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 ABRIS The Eclipse ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Eclipse ABRIS is newborns. 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 - EN

1.3

Page 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)  Vestibular evoked myogenic potential testing (VEMP)  Transient Evoked Otoacoustic Emissions (TEOAE25)  Distortion Product Otoacoustic Emissions (DPOAE20)  Auditory Brainstem Response Infant Screening (ABRIS)  Auditory Steady-State Response testing (ASSR) The system consists of the following included parts: EP15/EP25/VEMP 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/VEMP 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/TEOAE25 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

ABRIS 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/ 114 g tube (SPG15) Gauze Swabs PEG15 Pregel foam snap electrodes ( 25 pcs) Alcohol Pads Ten20 Electrode Paste 8oz/228 g jar ABRIS software OtoAccess™ software Instructions for Use Manual on CD Additional Information Manual on CD

ASSR 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 - EN

1.4

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Warnings

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.

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.

Eclipse Instructions for Use - EN

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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 - EN

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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 and ABRIS 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 - EN

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2 Unpacking 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 - EN

2.3

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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.

Refer to instruction manual. or

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 - EN

2.4

Page 9

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 - EN

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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 - EN

2.4.2

Eclipse Back Panel

Position: 1 2 3 4 5 6

Symbol: Power Mains 50-60 Hz Aux Out Preamp. Pat. Resp. Trigger In/Out

7 8 9 10 11 12 13 14 15

Talk Back Talk Forward OAE Left Right Bone USB/PC DC

2.4.3

Position: 1

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Function: Turns power on/off Plug for mains cable For future use Plug for Preamplifier Plug for patient response button Connector for trigger input/output E.g. eABR (cochlear implant) testing etc. Connector for talk back microphone Connector for talk forward microphone Plug for the eight pin OAE probe Plug for left headphone/insert Plug for right headphone/insert Plug for bone conductor Plug for USB cable to connect to PC Plug for power supply for an optical USB Connection for equipotentiality

Eclipse Front Panel

Symbol: Power indication

Function: Power on – blue light. Power off - no light.

Eclipse Instructions for Use - EN

2.4.4

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Preamplifier Buttons

The preamplifier is used for the ABRIS, EP15, EP25, VEMP and ASSR modules. For further instruction on how to use, please read the module chapter. Position: 1 2

Symbol: Dial Button

3 4

LED Button

2.5 2.5.1

Function: Dial used to determine surface electrode impedance. Press button (Imp.) to select impedance mode. Button flashes with a blue light when in this mode. Green or Red lights indicate the electrode impedance. Press button (-20dB) to reduce the gain for relevant tests. Blue button light remains stable.

Software installation 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/VEMP 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.

Eclipse Instructions for Use - EN

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Supported Operating Systems  Microsoft Windows® 7 32-bit and 64-bit.  Microsoft Windows® 8 32-bit and 64-bit. Windows® is a registered trademark of Microsoft Corporation in the United States and other countries. Important: make sure you have the latest service packs and critical updates installed for the version of Windows® that you are running.

2.5.3 1. 2. 3. 4.

What you will need: TM

OtoAccess software CD Eclipse module software CD USB Cable Eclipse hardware

Install the OtoAccess™ program from the enclosed CD. The Eclipse module software runs within the TM OtoAccess (and/or Noah 4 in the case of the Eclipse ASSR module). Ensure that the database is installed prior to the Eclipse software installation. Follow the manufacturer’s installation instructions provided to install the relevant database. Insert the installation CD and follow the on-screen steps to install the Eclipse module 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 CD. Double click the “setup.exe” file to initiate the installation.

2.5.4

EPx5 Software Installation Prompts

During installation of the EPx5 software, the following prompts will appear. 1. Leave all items checked and press continue to install all the factory default protocols, settings and latency data.

2. Accept installation of latency data.