Eclipse Instructions for Use Rev D Sept 2022

Copyright© Interacoustics A/S: All rights reserved. Information in this document is proprietary to Interacoustics A/S. The information in this document is subject to change without notice. No part of this document may be reproduced or transmitted in any form or by any means without a prior written permission of Interacoustics A/S.

TABLE OF CONTENTS 1

Introduction... 1 1.1 About this manual... 1 1.2 Indications for use ... 2

1.3 1.4 1.5 2

3

Intended operator ... 2 Patient population ... 2 Contraindications ... 3

Product description... 4 Warnings ... 5 Malfunction ... 7

Unpacking and installation ... 9 2.1 Unpacking and inspection ... 9 2.2 Markings ... 10 2.3 Hardware installation ... 11 Grounding the patient bed/chair ... 12 Eclipse back panel ... 13 Eclipse front panel... 13 Preamplifier buttons ... 14

2.4

Software installation ... 14

2.5 2.6

Reader station ... 18 License ... 18

2.7

Starting up from OtoAccess® Database ... 19

2.8

Starting up from Noah (ASSR or IA OAE suite only) ... 20

To know before you start installation ... 14 Minimum PC requirements... 14 What you will need: ... 15 Software installation ... 15 Driver installation... 16 Restoring factory default settings in the software ... 16 Installing a language pack... 16 Eclipse serial number ... 18 DSP serial number & license key ... 18 Module setup in OtoAccess® Database... 19

Operating instructions EP15/EP25 ... 21 3.1 The record tab ... 22 Main menu items ... 22 Electronic help ... 23 Viewing historic sessions ... 23 Protocol selection ... 23 Temporary setup ... 23 Rearrange curves... 23 Group waveforms ... 23 Reporting ... 23 Printing ... 24 Display A-B curves ... 24 Display contra curve... 24 Talk forward ... 24 Single curve display ... 24 Split screen display ... 25 Save & New ... 26 Save & Exit ... 26 Stimulus rate selection ... 26 Frequency selection ... 26 Stimulus window ... 26 Manual stimulation window ... 27 Status window ... 27 Waveform reproducibility... 27

Start / Stop ... 27 Pause ... 28 Next intensity ... 28 Fmp & residual noise graph ... 28 Extending the number of sweeps/averages ... 28 Raw EEG ... 29 Advanced EEG ... 29 Hide stimulus artefact... 30 Display gain ... 31 Recording window ... 31 Selecting a waveform ... 31 Moving an individual curve ... 31 Display differential curves ... 31 Adding a note to the waveform ... 32 Monitoring rejection ... 33 Placing waveform markers ... 34 Deleting waveform markers ... 34 Suggest waveform markers ... 34 Normative latency data ... 35 Deleting individual curves ... 35 Enlarge/diminish individual curves ... 35 Hiding individual curves ... 36 Fixate individual curves /comparing to a historic session ... 36 Merging curves (creating a summed curve) ... 36 Adding curves ... 37 Differential Ipsi minus contra (Ipsi-Contra) curve ... 37 Differential A minus B (A-B (N)) curve... 38 Changing display filtering ... 38 Recorded curve conditions... 38 Adding comments to a curve... 39 Using the cursor ... 39 Signal to noise ratio calculation (3:1) ... 39 CR, RA & INC waveform markers ... 40

3.2

The latency tab ... 41

3.3 3.4 3.5

Windows® 7, 8 & 10 fails to launch Help ... 43 PC shortcuts ... 44 Patient preparation prior to testing ... 45

3.6

Making an ABR threshold recording ... 46

3.7

Making a neuro latency recording ... 48

3.8

Making an eABR recording ... 50

3.9

Making an ECochG recording ... 52

Latency values ... 41 Interlatency values ... 41 Latency graph ... 42 Disabling desktop composition (EPx5 software only) ... 42 Display of the peak to trough markers (SN10 marker) (EPx5 software only) ... 43

Impedance check ... 45 Transducers ... 45 Electrode montage ... 46 ABR threshold stimuli ... 46 Editing of ABR threshold recordings ... 47 Interpretation and use of ABR threshold results ... 47 Electrode montage ... 48 Editing of neuro latency recordings ... 48 Two suggested eABR electrode montages ... 50 Editing an eABR recording ... 50 Electrical threshold estimation for cochlear implant fitting ... 51 ECochG electrode montages ... 52 Editing an ECochG recording ... 53

3.10 Making an CM recording ... 54

Patient preparation ... 54 CM electrode montage ... 54 Stimuli for CM recordings ... 54

Example of a CM recording... 54 Interpretation of the CM result... 54

3.11 Making a AMLR recording ... 55

Example of electrode montage AMLR... 55 Available AMLR stimuli ... 55 Example of AMLR recording ... 56

3.12 Making a ALR recording / cortical ERA ... 57

Example of electrode montage for an ALR threshold recording ... 57 Stimuli ... 57 Interpretation of the ALR result ... 58 Electrophysiological threshold estimation and infant hearing instrument fitting... 58

3.13 Making a P300/MMN recording... 59

Example of electrode montage for P300/MMN ... 59 Available P300/MMN stimuli ... 59 Summary of parameters for P300 and MMN... 60

3.14 System performance / loop back (LBK15) testing... 61 4

Operating instructions VEMP ... 63 4.1 Preamplifier setup ... 64 4.2 VEMP monitor ... 64 4.3 VEMP waveform markers ... 64 4.4 Calculating the VEMP asymmetry ratio (VEMP partner) ... 65 4.5 VEMP scaling ... 65 4.6 Making a cVEMP recording ... 66

4.7

Electrode montage for cVEMP ... 66 Stimuli for cVEMP ... 66 Default collection parameters ... 67 Procedure ... 67 Edit cVEMP results ... 67 Example of cVEMP result ... 68

Making a oVEMP recording ... 69

Electrode montage for oVEMP... 69 Stimuli for oVEMP ... 69 Default collection parameters ... 69 Procedure ... 70 Edit oVEMP results ... 70 Example of oVEMP result ... 70

5

Research module... 71

6

Operating instructions IA OAE suite ... 77 6.1 Handling and selection of ear tips ... 78 6.2 Daily system checks for OAE devices... 79

Logging of each sweep for a later ”replay” ... 71 Exporting the averaged curve &/or full session ... 72 Exporting the session (all curves) ... 74 Exporting waveform when offline ... 74 Importing WAV files for stimuli ... 74

Probe integrity test ... 79 Real-Ear Check ... 80

7

The IA OAE suite ... 81 7.1 PC power configuration ... 81 7.2 Compatible devices ... 81

7.3 7.4

Starting from OtoAccess® Database ... 81 Starting from Noah 4 ... 81 Simulation mode ... 81 Crash report ... 82

Using the menu ... 83 Using the DPOAE module ... 84

Preparing for the test... 84

8

9

Elements in the DPOAE module ... 86

7.5

Using the TEOAE module ... 92

7.6

Using the Print Wizard ... 100

Preparing for the test... 92 Element in the TEOAE module ... 94

Operating instructions ABRIS ... 103 8.1 Using the ABRIS module ... 103 8.2 Mounting electrodes ... 103 8.3 Impedance check ... 104 8.4 Loop back (LBK15) testing ... 104 8.5 ABRIS test screen ... 105 Main menu items ... 105 Viewing historic sessions ... 106 Save & exit ... 106 Printing ... 106 Electronic help ... 106 Reporting ... 106 View EEG or noise bar ... 106 Stimulus window ... 106 Test status window... 107 Ear ... 107

8.6

Making an ABRIS recording ... 108

8.7

PC shortcuts ... 110

Starting & pausing a test ... 108 EEG graph ... 108 EEG noise bar... 108 AEP waveform ... 108 Remarks box ... 109 Status bar... 109 ABRIS response curve ... 109

Operating instructions ASSR ... 111 9.1 Using the ASSR module ... 111 9.2 Preparations prior to the ASSR test ... 112 9.3 Preparations prior to testing ... 112 Preparation of the Skin... 112 Placement of electrodes... 112 Impedance check ... 112

9.4 9.5 9.6 9.7

Mounting electrodes ... 114 Impedance check ... 114 System performance / loop back (LBK15) testing... 114 The ASSR tab ... 115

9.8

Making an ASSR recording ... 118

Main menu items ... 115 Protocol selection ... 115 Temporary setup ... 116 Reporting ... 116 Printing ... 116 Save & exit ... 116 Viewing historic sessions ... 116 Stimulus window ... 117 Total session status window ... 117 Stimulus rate ... 117 Start & stop ... 118 Pause ... 118 Raw EEG graphs ... 118 Test frequency graph ... 118 ASSR table ... 119 Extending the test time... 120 Adjusting the stimulus intensity ... 120 Stopping a test frequency/intensity ... 121

9.9

ASSR masking calculator... 121

The audiogram tab ... 123

Estimated audiogram symbols ... 123 Audiometric symbols in NOAH or OtoAccess® Database... 124 Estimated audiogram ... 126 AC and BC in the same audiogram ... 127 No response ... 127 Selected correction factor ... 128 PC shortcuts ... 128

10 Maintenance ... 129 10.1 General maintenance procedures ... 129 10.2 How to clean Interacoustics products ... 130 10.3 Cleaning the OAE probe tip ... 130 10.4 Concerning repair ... 132 10.5 Warranty ... 132 11 Technical specifications ... 133 11.1 Technical specifications - Eclipse hardware ... 133 11.2 Technical specifications EP15/EP25/VEMP ... 134 peSPL to nHL correction values ... 136

11.3 Technical specifications TEOAE ... 137 11.4 Technical specifications DPOAE... 138 11.5 Technical specifications ABRIS ... 139 11.6 Technical specifications ASSR ... 140 11.7 Electromagnetic compatibility (EMC) ... 141 11.8 Eclipse software module overview ... 145

EP15/EP25/VEMP modules ... 145 EP15/EP25/VEMP module stimulus maximum intensity ... 146 TEOAE module ... 147 DPOAE module ... 147 ABRIS module ... 147 ASSR module ... 148

1 Introduction 1.1 About this manual

This manual is valid from software version EP15/25 v4.6, IA OAE suite 1.2, ABRIS v1.06.1, VEMP v4.6 and ASSR v 1.2.8. The product is manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middelfart Denmark Tel.: +45 6371 3555 Fax: +45 6371 3522 E-mail: [email protected] Web: www.interacoustics.com The purpose of this manual is to provide adequate information for the users to carry out test procedures in a consistent and efficient manner with Eclipse instrument which includes EP15, EP25, TEOAE, DPOAE, ABRIS, VEMP, and ASSR modules. 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.

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1.2 Indications for use 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. cVEMP & oVEMP The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse VEMP includes children from 8 years and up. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure. TEOAE The Eclipse TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Eclipse TEOAE includes all ages. DPOAE The Eclipse DPOAE 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 DPOAE includes all ages. 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. 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.

Intended operator General for Eclipse System and all modules, 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.

Patient population The patient target population includes all ages for all modules, with the exception of VEMP testing, which is from the age of 8 years and up.

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Contraindications Contraindications to place the stimuli transducer in/on a patient’s ear include a discharging ear, acute external auditory canal trauma, discomfort (e.g. severe otitis externa) or occlusion of the external auditory canal. Testing should not be performed on patients with such symptoms without a medical doctor’s approval. Testing VEMP, patients with neck, muscular and cervical injury problems should not perform the VEMP test. Furthermore patient with conductive hearing loss, patients whose sternocleidomastoid muscle is too difficult to locate. For oVEMP testing, total blindness and patients with exenteration (removal of the eye and extraocular muscles) should not be tested.

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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® Database: • Early, middle and late latency evoked potential testing (EP15/25) • Vestibular evoked myogenic potential testing (VEMP) • Transient Evoked Otoacoustic Emissions (TEOAE) • Distortion Product Otoacoustic Emissions (DPOAE) • Auditory Brainstem Response Infant Screening (ABRIS) • Auditory Steady-State Response testing (ASSR) The system consists of the following included parts: EP15/EP25/VEMP/ASSR/ABRIS Eclipse EPA Preamplifier1 EPA4 cable collector USB cable Power cable LBK15 (only EP15,EP25, VEMP) IP30 inserts phone including eartips 3A, 3B Neonatal Insert Ear tips 4.0 mm, 3.5 mm Pediatric starter kit (EarTips) Eartip adaptor and Tubekit. ETB Standard surface Electrode Cables with Buttons ETSE tab surface electrode kit. Jumper Cable 125mm. NuPrep gel 4oz/114g tube (SPG15) Gauze Swabs PEG15 Pregel foam snap electrodes (25 pcs) 1 Disposable Snap electrodes1. Disposable tab electrodes1. Bridge & Implant Cleaners (Proxysoft) Alcohol Pads EP15/25/VEMP software Instructions for Use Manual on USB Additional Information Manual on USB

DPOAE Eclipse OAE Probe complete1 Power cable USB cable IA OAE Suite software Ear Tip1 Assortment Box Cleaning tool Probe tips1 Instructions for Use on USB Additional Information Manual on USB TEOAE Eclipse OAE Probe complete1 Power Cable Country specific USB connection cable IA OAE Suite software Assortment Box with ear tips1 for OAE Cleaning tool Probe tips1 Instructions for Use Manual on USB Additional Information Manual on USB

EP25: ECochG Starter Kit including cable, gel and 2 TM electrodes1 Optional parts: OtoAccess® Database Tranducers as headphone DD45s and bone conductor B81 are also available. Refer to the current Sanibel Disposables & Accessories brochure (www.interacoustics.com) or contact your local distributor.

1 Applied part according to IEC60601-1

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1.4 Warnings

Throughout this manual the following meaning of warnings, cautions and notices are used:

The WARNING label identifies conditions or practices that may present danger to the patient and/or user.

The CAUTION label identifies conditions or practices that could result in damage to the equipment.

NOTICE

NOTICE is used to address practices not related to personal injury.

For the US only: Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a licensed medical practitioner.

Read these instructions carefully and completely before using the product

1. This equipment is intended to be connected to other equipment thus forming a Medical Electrical System. External equipment intended for connection to signal input, signal output or other connectors must comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601series for medical electrical equipment. In addition, all such combinations – Medical Electrical Systems – must comply with the safety requirements stated in the general standard IEC 60601-1, (edition 3.1), clause 16. Any equipment not complying with the leakage current requirements in IEC 60601-1 must be kept outside the patient environment i.e. at least 1.5m from the patient support or must be supplied via a separation transformer to reduce the leakage currents. Any person who connects external equipment to signal input, signal output or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with these requirements. If in doubt, contact a qualified medical technician or your local representative. When the instrument is connected to a PC, or other similar items, beware of not touching the PC and patient simultaneously. 2. A Separation Device (isolation device) is needed to isolate the equipment located outside the patient environment from the equipment located inside the patient environment. In particular such a Separation Device is required when a network connection is made. The requirement for the Separation Device is defined in IEC 60601-1 clause 16. 3. To avoid the risk of electric shock, this equipment must only be connected to supply mains with a protective earth. 4. Do not use any additional multiple socket-outlet or extension cord. For safe setup please refer to section 2.3 5. No modification of this equipment is allowed without the authorization of Interacoustics. Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information. This will assist service personnel to repair, the parts of this audiometer that are designated by the Interacoustics service personnel as repairable. 6. For maximum electrical safety, turn off the power to a mains- powered instrument when it is left unused.

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7. The instrument is not protected against ingress of water or other liquids. If any spillage occurs, check the instrument carefully before use or return for service. 8. No part of the equipment can be serviced or maintained while in use with the patient. 9. Do not use the equipment if it is showing visible signs of damage.

1. Never insert, or in any way use, the insert headset without a new clean and non-defective test tip. Always make sure that the foam or ear-tip is mounted correctly. Ear tips and foam are for single use only. 2. The instrument is not intended for use in environments exposed to fluid spills. 3. The instrument is not intended for use in oxygen rich environments or for use in conjunction with flammable agents. 4. Check calibration if any parts of the equipment are exposed to shock or rough handling. 5. Components marked for “single use” are intended for a single patient during a single procedure, and there is a risk of contamination if the component is re-used. 6. Do not switch the power on/off for the Eclipse device while a patient is connected. 7. The specifications for the device are valid if the device is operated within the environmental limits. 8. 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. 9. 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. 10. Use only sound stimulation intensities that will be acceptable to the patient. 11. 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. Please refer to cleaning section 12. 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.

NOTICE

1. To prevent system faults take appropriate precautions to avoid PC viruses and similar. 2. Use only transducers calibrated with the actual instrument. To identify a valid calibration, the serial number for the instrument will be marked on the transducer. 3. 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 monitored to ensure that there is no mutual disturbance. Please also refer to EMC considerations in section 11.7 4. Use of accessories, transducers and cables other than specified, with the exception of transducers and cables sold by Interacoustics or representatives, may result in increased emission or decreased immunity of the equipment. For a list of accessories, transducers and cables that fulfil the requirements please refer to section 1.3 5. Within the European Union, it is illegal to dispose of electric and electronic items in 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 wheeled bin symbol, 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. 6. Outside the European Union, local regulations should be followed when disposing of the product after end of life. 7. 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).

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1.5 Malfunction

In the event of a product malfunction, it is important to protect patients, users, and other persons against harm. Therefore, if the product has caused, or potentially could cause such harm, it must be quarantined immediately.

Both harmful and harmless malfunctions, related to the product itself or to its use, must immediately be reported to the distributor where the product was acquired. Please remember to include as many details as possible e.g. the type of harm, serial number of the product, software version, connected accessories and any other relevant information. In case of death or serious incident in relation to the use of the device, the incident must immediately be reported to Interacoustics and the local national competent authority.

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2 Unpacking and installation 2.1 Unpacking and inspection Check for damage

When the instrument is received, ensure that you have received all the components on the shipping checklist. All the components should be checked visually for scratches and missing parts before use. All the contents of the shipment have to be checked for their mechanical and electrical functioning. If the equipment is found faulty, please contact your local distributor immediately. Keep the shipping materials for the carrier’s inspection and insurance claim. Keep carton for future shipment The instrument comes with shipping cartons, which are specifically designed for the components. It is recommended to keep the cartons for future shipments in case of any need for return or service. Reporting and returning procedure Any missing part or malfunction or any damaged components (due to shipment) should be reported immediately to the supplier/local distributor along with the invoice, serial number and a detailed report of the issue. For any on-site service-related information, please contact your local distributor. If the system / components are to be returned for service, please fill all the details related to product issues in the ‘Return Report’, which is attached to this manual. It is very important that you describe all the known facts about the issue in the return report, as this will help the engineer to understand and solve the problem to your satisfaction. Your local distributor holds the responsibility for coordinating any service/return procedure and related formalities. Storage If you need to store the instrument for a period, please ensure that it is stored under the conditions specified in the section for technical specifications.

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2.2 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. Follow Instructions for Use

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.

Medical Device

Year of manufacture.

Manufacturer

Serial number

REF

Reference number

Do not reuse

I

On (Power: connection to the mains).

O

Off (Power: disconnection from the mains).

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Equipotentiality is used to ground metal parts, e.g. the frame underneath a patient bed. This will reduce the noise pick up by patient. Use the Equipotentiality cable which is included in the Eclipse shipment. Keep dry

Transport and storage temperature range

Transport and storage humidity limitations

Transport and storage atmospheric pressure limitations ETL CL ASSIFIED

4005727

ETL listing mark

C o n fo rms to ANSI/AAM I ES6 0 6 0 1 -1 :2 0 0 5 /A1 :2 C erti fi ed to C AN/C SA-C 2 2 .2 No . 6 0 6 0 1 -1 :2 0

Company Logo NOTE. The instrument label is located on the backside of the Eclipse Hardware.

2.3 Hardware installation

When connecting the Eclipse to the mains supply and to a computer, the following warnings must be observed:

1. All contact between the conductive parts of electrodes or their connectors, including the neutral electrode and other conductive parts including earth must be avoided. Contact your local distributor to purchase an optical USB isolator if required.

2. Avoid any mixing of cables ex. USB cables/power cord etc. mixed up with the electrode/Preamplifier cable used for the EP system. The following diagrams indicate how to ensure that the Eclipse is installed correctly and patient safety is maintained.

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Eclipse having device ID number 8507420 has built in medical safety, at Eclipse power supply socket, the USB socket and Trigger in/out socket. You do not need to connect additional safety transformer to maintain patient safety and may risk more noise as often safety transformers has poor or no connection to ground. Eclipse fulfills the IEC 60601-1:2012 safety. Fig.1: Eclipse is powered from mains and is connected with a standard USB cable to a laptop PC running on battery or mains.

Fig.2: Eclipse is powered from mains and is connected to a computer via USB cable. The computer can be attached to other devices and still maintain patient safety.

Please consult with a medical device safety specialist if in doubt. The separable mains plug is used to safely disconnect mains from the device. Do not place the instrument in a position where it is difficult to disconnect the mains plug.

Grounding the patient bed/chair 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.

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Eclipse back panel

Position: 1 2 3

Symbol: Power Mains

4 5

USB/PC Trigger In/Out

6 7

Talk Forward OAE

8 9 10 11 12

Patient Resp. Bone Right Left Preamp.

Function: Turns power on/off Plug for mains cable, 100-240V~ 50-60 Hz Connection for equipotentiality, please refer to the chapter markings. Plug for USB cable to connect to PC Connector for trigger input/output E.g. eABR (cochlear implant) testing etc. Connector for talk forward microphone Plug for the OAE probe. Note the OAE probe is dedicated to one Eclipse only! Calibration is stored on the Eclipse. Plug for patient response button Plug for bone conductor Plug for right headphone/insert earphone Plug for left headphone/ insert earphone Plug for Preamplifier

Eclipse front panel

Position: 1

Symbol: Power indication

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

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