MADSEN Capella Cochlear Emissions Analyzer User Manual Rev 11

Copyright notice No part of this Manual or program may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written consent of GN Otometrics A/S. Copyright© 2011, GN Otometrics A/S Printed in Denmark by GN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest product information available at the time of publication. GN Otometrics A/S reserves the right to make changes at any time without notice. Version release date 8. September 2011 Technical support Please contact your supplier.

FM template version: 01-02-2010

Contents

1

Introduction

1.1

Applications of Capella ... 6 1.1.1

Spontaneous Otoacoustic Emissions ... 6

1.1.2

Evoked Otoacoustic Emissions... 6

1.2

The NOAH fitting platform... 8

1.3

About this manual... 9

1.4

System requirements... 9

1.5

Software installation... 10

1.6

Starting up the system ... 10

2

The Capella Hardware

2.1

Safety ... 11

2.2

2.1.1

Symbols ... 11

2.1.2

Safety precautions... 12

Installing the Capella hardware ... 12 2.2.1 2.2.2

Storage and shipment... 13

2.2.3

Inspection ... 13

2.2.4 2.3

Unpacking Capella ... 12

2.2.3.1

Equipment supplied... 14

2.2.3.2

Optional accessories ... 14

Installation... 14

Care and maintenance ... 15 2.3.1

Probe... 15

2.3.2

Eartips ... 17

2.3.3

2.3.2.1

Disposal ... 17

2.3.2.2

Portable use ... 17

Hardware platform ... 18

2.4

Fuse replacement ... 18

2.5

Equipment failure ... 19

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Contents

2.6

Capella - User Manual

Battery powered version... 19 2.6.1

Battery replacement ... 19

2.6.2

Battery operation... 20

2.6.3

Battery life ... 20

2.7

Service and repair... 21

2.8

Start-up ... 21

2.9

Calibration ... 22

3

General Description

3.1

Technical specifications... 24 3.1.1

Distortion-Product Otoacoustic Emissions (DPOAE)... 24

3.1.2

Transiently Evoked Otoacoustic Emissions (TEOAE)... 24

3.1.3

Spontaneous Otoacoustic Emissions (SOAE)... 25

3.1.4

Echo-Screen ... 25

3.1.5

Tympanometry (immittance measurements) ... 26

3.1.6

Power Supply... 27

3.1.7

Patient Safety ... 27

3.1.8

Operating Environment... 27

3.1.9

Storage & Shipment Environment ... 27

3.1.10 EMC ... 27 3.1.11 Dimensions and Weight... 28 3.2

Manufacturer... 28

3.3

Starting up the system ... 28

4

Operation

4.1

Probe fit ... 29

4.2

ECHO-SCREEN ... 30

4.3

TEOAE ... 31

4.4

DPOAE: DP-gram ... 32

4.5

DPOAE: Input/Output... 35

4.6

SOAE... 36

4.7

Tympanometry ... 37

4.8

Importing old Celesta files... 38

4.9

Comments ... 38

4.10 User configuration ... 38 4.11 Auto sequence... 39 4.12 Compare... 40 4.13 Printing measurement results and comments ... 41

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CAPELLA Cochlear Emissions Analyzer

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User Manual

Introduction The CAPELLA Cochlear Emissions Analyzer is the most recent addition to the comprehensive line of audio diagnostic instrumentation from GN Otometrics. Capella is a PC-based system which runs under Microsoft® Windows™, either together with the NOAH/PAX software platform, or as a self-contained program. In addition to the main unit containing the hardware, Capella consists of separate software modules, this documentation and accessories. Capella evaluates both of the two broad classes of emissions, Spontaneous and Evoked, and two of the evoked emission types, Transient and Distortion Product. Two separate modes are incorporated for Transient emissions, Echo-Screen for rapid neo-natal and infant screening, and TEOAE for clinical and diagnostic testing of all patients. Tests include amplitude and input/output determinations of Evoked emissions, as well as spectral averages of Spontaneous emissions. A Tympanometry module is included for identifying hearing problems arising in the middle ear. CAPELLA Cochlear Emissions Analyzer is operated by an IBM or compatible personal computer via the built-in RS232C connection, and offers the following unique features:

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Windows-based software running under NOAH or PAX.

•

Small, lightweight combination probe tip.

•

Separate Echo-Screen probe especially suited to infants and new-born babies.

•

Each probe is individually calibrated for maximum probe measurement accuracy.

•

Mounting options for probe assembly: shoulder harness, standard sized headband or children´s headband.

•

Significantly reduced noise floor for threshold detection and Input/Output tests.

•

Screening Tympanometry module.

•

Echo-Screen baby screening module.

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1.1

CAPELLA Cochlear Emissions Analyzer

Applications of Capella CAPELLA Cochlear Emissions Analyzer is designed to measure the low-amplitude audio frequencies transmitted from the cochlea through the middle ear to the external ear canal and known as otoacoustic emissions. Otoacoustic emissions (OAE's) were first identified at the Royal National TNE Hospital, London, and have been shown to be the result of an active mechanical process in the cochlea. This process enhances the sound-induced motion of cochlear structures and increases the sensitivity and frequency selectivity of the ear. OAE's are typically classified into two broad classes based on the type of acoustic stimulation that evokes them, as described below.

1.1.1

Spontaneous Otoacoustic Emissions Spontaneous Otoacoustic Emissions (SOAE's) are low-level narrowband signals measured in the absence of deliberate acoustic stimulation. They occur in only about one half of normal-hearing ears, and at only a few frequencies for ears in which they do occur. Consequently, they are thought to have limited clinical utility although they may have research implications.

1.1.2

Evoked Otoacoustic Emissions Evoked emissions, which occur in nearly all normal-hearing ears, are further divided into three sub-types according to the nature of the acoustic stimulus used to elicit them. Transient Evoked Otoacoustic Emissions (TEOAE's) occur in response to brief acoustic signals (clicks, tone bursts, etc.). It has been suggested that they may be particularly well-suited to detection of cochlear disorders, especially in screening applications. Stimulus-Frequency Otoacoustic Emissions (SFOAE's) are elicited by swept pure tone signals and show characteristics similar to those of transient emissions. However, because their detection is more complicated and time-consuming than the measurement of TEOAE's, they have not yet been incorporated into clinical tests. Distortion Product Otoacoustic Emissions (DPOAE's or DP's) are evoked by two simultaneously presented pure tones of different frequencies. They represent the ear's nonlinear response to the stimulus tones, and consist of new frequencies not present in the eliciting stimuli. Although DPOAE's are somewhat more complex to elicit and analyze than TEOAE's, they may have greater clinical utility for some applications. Capella currently measures Spontaneous, Transient, and Distortion Product Otoacoustic Emissions, using synchronous time averaging (where applicable), correlation techniques and FFT frequency analy-

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sis to measure emissions whose sound pressure level is below that of extraneous and body sounds and (where applicable) the evoking stimuli. Echo-Screen uses statistical analysis to perform rapid measurement and classification of Transient Otoacoustic Emissions. Capella also incorporates a Tympanometry module to diagnose or eliminate middle ear disorders as a cause of hearing loss or potential hearing problems identified by OAE measurement. This module records the changes in the immittance of the middle ear associated with changing static pressure in the ear canal. This pressure is swept through a predetermined range by means of a digitally driven pump. The measurement techniques employed in Capella have several distinct advantages over more traditional audiologic tests:

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1.

Objectivity No behavioural response is required from the patient.

2.

Time-efficiency Some tests can be accomplished in less than a minute for both ears.

3.

Non-invasiveness No electrodes are required. No discomfort to the patient. Signal delivery and OAE response measurement are achieved using a small probe held in place by a soft, disposable eartip.

4.

Sensitivity to cochlear function Useful in the differential diagnosis of cochlear and retrococh-

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lear disorders. Capable of distinguishing sensory (cochlear) hearing loss from neural hearing loss in site-of-lesion testing. 5.

Sensitivity to disorders of the middle ear and Eustachian tube

CAPELLA Cochlear Emissions Analyzer is intended for the following applications: •

Hearing screening -Difficult-to-test patients, including infants -Industrial (occupational hearing loss) -Schools and itinerant patients -Geriatric patients

•

Clinical evaluation -Differential diagnosis (middle ear versus cochlear versus retrocochlear) -Monitoring: progressive hearing loss, ototoxicity, noiseinduced hearing loss

•

Research

Measured properties of cochlear function include signal detection threshold and response amplitude, frequency content, and growth. • • •

Outer hair cells (OHC) Basilar membrane Efferent innervation

Capella complies with the following international standards:

1.2

•

Patient Safety: Complies with EN 60601-1.

•

Immittance testing: Comparative tympanometry according to EN 61027 and ANSI S3.39.

The NOAH fitting platform The Capella OAE application module may be integrated with HIMSA's NOAH program for fitting hearing instruments. NOAH uses a common software platform and central database to integrate hearing instrument fitting systems, test equipment, and office management software systems. NOAH integrates client records, audiological data and the dedicated fitting modules from various hearing instrument manufacturers. Digitally programmable hearing instruments using different technologies and different programming devices are available from a number of manufacturers. NOAH provides a common software

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platform for fitting different brands of programmable hearing instruments. Alternatively, Capella can also run under PAX, HIMSA's new software standard for ENT professionals. Please read the NOAH or PAX User's Guide for detailed instructions on how to install and run these programs.

1.3

About this manual The Windows-based application software of Capella is so userfriendly that we are convinced that you will find operation of Capella a very straightforward process. The simplicity of the screen layouts together with online Help make the program very easy to use. This manual describes Capella’s hardware and accessories, and also includes an Operation Guide to the application software. Familiarity with Windows is assumed. Note: Program diskette is located at the back of this manual!

1.4

System requirements Recommended IBM® or IBM compatible PC with the following: 32 MB RAM Microsoft Windows 95 or 98 Pentium processor VGA graphics adapter Mouse Color printer 1 free COM port PC noise level under 35 dB (A)

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1.5

CAPELLA Cochlear Emissions Analyzer

Software installation The Capella software is supplied on the diskette(s) enclosed in a plastic pocket at the back of this User Manual. To install Capella on your PC, proceed as follows:

1.6

1.

Insert the diskette (or diskette #1 if there are more than one) into your diskette drive.

2.

Use the Windows Run function to locate and run Setup on the diskette.

3.

Windows will now start the Installation program. Just follow the on-screen instructions.

4.

By default, the program will install Capella under the path for NOAH.

5.

If you are not using NOAH, you may specify another path. The Capella software is represented by a NOAH icon. You can simplify start up by creating a short cut to Capella on the Windows desktop.

Starting up the system If Capella is running under NOAH, first access NOAH´s Client Module. On the toolbar, only the first icon (Client Module) and the last icon (Help) are active until a client has been selected - all the others are greyed (inactive). Before proceeding to any of the application modules, it is first necessary to access the Client Module, and then to either select an existing client or to add a client to the database. You are referred to the NOAH or PAX User's Guide for detailed navigation instructions. After having selected or added a client, click on the Selection of Measurement Module icon which opens the NOAH/PAX Measurement Selection Screen. Double-click on the Capella button. The Capella software will now be loaded, and the program will start by trying to connect with the Capella hardware platform - see next chapter. If not running NOAH, start Capella by double-clicking on the NOAH icon in the directory where you have installed Capella, or on the Windows desktop if you have made a short cut.

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2

The Capella Hardware

2.1

Safety

2.1.1

Symbols This User Manual contains information and warnings which must be followed to ensure the safe performance of the CAPELLA Cochlear Emissions Analyzer. Local government rules and regulations, if applicable, should also be followed at all times. Special note should be made of the following: The Capella carries this symbol when it is important that the user refer to associated warnings in this guide. The Capella and this manual are CE-marked according to the Medical Devices Directive 93/42/EEC. Classified with respect to electrical shock, fire, mechanical and other specified hazards in accordance with UL2601-1 and CAN/CSA-C22.2 NO 601.1-90 Capella is marked with this symbol to indicate compliance with Type B requirements of EN 60601-1. This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional.

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2.1.2

CAPELLA Cochlear Emissions Analyzer

Safety precautions Capella has been designed and tested in compliance with EN 606011 "Safety of Medical Electrical Equipment". To ensure safe performance, Capella must be correctly installed and the following safety requirements must be complied with. Only the original power cable supplied with Capella must be used. This must be fitted with an approved 3-pole mains (line) plug, which has a protective earth conductor. Capella should only be connected to an AC power supply which has a protective earth conductor in accordance with EN requirements. Caution: Grounding continuity should be checked periodically. Avoid using extension cables. The increased length of the cable may increase the resistance of the protective earth conductor beyond an acceptable level. When assembling an electro-medical system, the person carrying out the assembly must take into account that other connected equipment which does not live up to the same safety requirements as this product may lead to a reduction in the overall safety level of the system. When selecting accessories connected to the RS232 socket, the following points must be considered: •

Use of connected equipment in a patient environment.

•

Evidence that connected equipment has been tested in accordance with EN60601-1 and/or EN 60601-1-1.

2.2

Installing the Capella hardware

2.2.1

Unpacking Capella Capella is shipped in its own custom-made carton together with this User Manual, a Packing Specification and standard accessories. Please keep and store this carton in case you need to return the instrument to your supplier or to the factory for service or repair. If the shipping carton is visibly damaged upon delivery, ask the carrier's agent to be present when the instrument is unpacked. If the instrument is damaged or fails to operate, please notify the carrier and your supplier immediately. Your supplier will arrange for the repair

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or replacement of the instrument prior to settlement of any claim against the carrier. Please refer to the Packing Specification sheet enclosed with the instrument to ensure that all accessories are complete and intact.

2.2.2

Storage and shipment See Section 3.1.9, ‘Storage & Shipment Environment” on page 27 for specification of storage and shipment environment. To protect the instrument and accessories during storage or shipment, always use the best packaging available. If it becomes necessary to return the instrument to your supplier or to the factory for service or repair, please use the original shipping cartons, as recommended above. All products returned to GN Otometrics or its representatives must be shipped prepaid and insured, or you must assume the risk of loss or damage in transit. When shipping Capella, please remember to: 1.

Seal the shipping container securely.

2.

Mark the container FRAGILE to ensure careful handling.

3.

Refer to the instrument by make, model, and serial number in any correspondence.

4.

Specify the problem and your preferred return shipping address and arrangements.

Always store Capella in a clean, dry environment, and never leave the power on when the instrument is in an enclosed container!

2.2.3

Inspection Capella is a modular system which may be assembled from accessories chosen to meet the needs of different countries and practices.

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The following lists are for general guidance and purposes of identification. 2.2.3.1

Equipment supplied Capella Instrument 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Hardware platform Probe Assembly, including preamplifier Probe Eartip Assortment Shoulder Harness (standard) or Headband (optional) Capella application module (software) RS232C Serial Interface Cable Probe Connector Cable Power Cord Capella User Manual including program diskette Calibration Adaptors Fuse Kits

Note: Program diskette is located at the back of this manual! 2.2.3.2

Optional accessories Echo-Screen probe Eartip box with 2cc cavity Carrying Case Inkjet, or laser printer Children´s Headband M.E. Coupler B & K Calibrator 8m Serial Interface Cable Service Manual

2.2.4

Installation Locate Capella in a well-ventilated room away from all liquids and sources of heat (see Section 3.1.8, ‘Operating Environment” on page 27 for detailed specifications of operating environment). Test-

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ing will be facilitated by a moderately quiet room, although a soundtreated booth is not necessary. Note: Capella is NOT suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Connect the Probe Connector Cable and personal computer (PC) to their respective ports on the Connection Panel at the back of Capella. Before connecting the power cord, please make sure that the voltage from the electrical outlet matches the voltage shown on the identification label stuck over the power inlet. Caution! Operating at the wrong voltage may blow the fuses! Plug one end of the supplied power cord into the power inlet on the back of Capella (see Fig. 1 below) and plug the other end directly into a three-wire, protective ground, AC power outlet.

Headset

Data Interface 100-240V 50/60Hz 55VA

T1A L/250V

1

2

Figure 1 For more information about installation, set up the Capella software on your PC (Section 3.3, ‘Starting up the system” on page 28) and then refer to the section on "Installation" in the on-line help.

2.3

Care and maintenance The probe, headset and parts are in constant contact with your patients so care should be taken to ensure that they are kept clean.

2.3.1

Probe Proper treatment of the Capella combination probe is important. It contains delicate transducers, precisely calibrated to work with your

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instrument. It should not be dropped, brought in contact with liquids, or otherwise maltreated. However, the probe tip should be inspected periodically for foreign matter at the end of the tip. To clear cerumen, vernix and other debris from the tip, follow the instructions below:

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1.

Brush the probe every time after use with the cleaning tool supplied. If cerumen or vernix is pushed up inside the probe housing, the probe will be damaged. Brush in a direction away from the probe housing, towards the tip of the probe.

2.

The probe should never be placed directly in water or other cleaning liquids. Liquids seeping into the housing will damage the probe.

3.

When fitting a new eartip to the probe, ensure it is pushed all the way to the probe casing, so there is no gap between the eartip and the casing. The top should be flush with the end of the probe tip.

4.

Caution! Do not allow the probe body, which contains the acoustic transducers, to come in contact with any liquids.

5.

The probe cannot be dismantled - this is not necessary for cleaning if the care instructions are followed.

6.

Do not fit the probe by holding on to the cable as you could damage the pin connector by doing this.

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Probe body

Probe tip Eartip

Probe cable

2.3.2

Eartips Capella eartips are designed to fit over the end of the probe and permit a tight seal in the patient's external ear canal. Please see the instructions on the eartip assortment box for proper attachment on the probe tip. Use a new eartip for every patient. Select an appropriately sized eartip for the patient’s ear canal - the eartip should fit snugly. Use only the eartips supplied with this probe. Eartips should be used on only one patient. The eartips are in direct contact with your patients, and you should therefore observe strict hygienic precautions to prevent passing infections from one patient to another. It is therefore recommended that you use only disposable eartips. Most eartips are disposable, and should not be cleaned or re-used. Always throw away disposable eartips after use on a patient.

2.3.2.1

Disposal There are no special requirements for disposal of the rubber eartips, i.e. they may be discarded in any regular waste bin.

2.3.2.2

Portable use Capella is a fully portable system, but the optional carrying case is recommended for safe transportation. Before packing the system,

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ensure that the probe assemblies, eartips, etc., are not loose in the case. Note: Eartips for Capella and Madsen´s Zodiac 901 Middle-Ear Analyzer are interchangeable.

2.3.3

Hardware platform Capella requires no preventative maintenance. However, it is recommended that the following guidelines be observed: The instrument should be kept clean and as free of dust as possible: •

Remove dust using a soft cloth or brush.

•

To clean, use a soft, slightly damp cloth with a small amount of mild detergent on it. Do not allow any moisture inside the instrument or probe.

Caution! Chemical agents containing ammonia or alcohol will damage the cabinet. Avoid exposing the instrument to direct sunlight, and keep it wellventilated at all times to prevent overheating.

2.4

Fuse replacement Two identical fuses are located in the connection panel between the power inlet and the on/off switch. To replace a fuse, please proceed as follows. 1.

Disconnect Capella from mains/line power supply.

2.

The black plastic fuse holder may be extracted from the fuse compartment using a small screwdriver to press back the clip in the middle left of the holder.

3.

When loose, extract the holder and change fuses - refer to the fuse specifications marked above the on/off switch.

Warning! When replacing the fuses there is a risk of fire. For continued protec-

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tion against fire hazard, replace fuses with the same type and rating only. 4.

2.5

Replace the fuse holder by pushing it firmly into place - an audible click can be heard (the holder cannot be replaced back to front).

Equipment failure If you believe the correct function or operating safety of Capella is impaired in any way, disconnect it from the power supply and secure it against further use. Caution: Under no circumstances remove the Hardware Platform's cover! Contact your local representative that supplied Capella.

2.6

Battery powered version The optional battery powered version of Capella utilizes a rechargeable Ni-MH battery pack. The battery pack is located inside the Capella cabinet, and is NOT to be accessed by unauthorized personnel. If you experience any problems with recharging the battery pack, or operation on battery power only, please contact your local supplier.

2.6.1

Battery replacement For authorized personnel only: 1.

Disconnect Capella from AC power source.

2.

Unscrew the 4 screws which secure the cabinet to the baseplate.

3.

Replace the battery pack with a new one, type HHR-380A/ L2x3 (7.2V, 3800mAh).

4.

Dispose of the battery pack by sending it to an authorized NiMH battery destruction facility.

Do not attempt to disassemble the battery pack. Do not incinerate the battery pack, or expose to fire.

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2.6.2

CAPELLA Cochlear Emissions Analyzer

Battery operation When connected to an AC power source, the battery version of Capella will automatically recharge the battery pack, whether Capella is powered on or off. When powered on, the Power LED (see Figure 3) will light continuously green, and the AC/Charge LED will light as follows: Yellow = charging Green = fully charged If the battery is allowed to become exhausted, the AC/Charge LED will not indicate charging until about five minutes after AC power has been applied. When not connected to an AC power source, the Power LED will light green when Capella is powered on, and the AC/Charge LED will not light. Capella cannot be operated if the battery pack is dead, not even when connected to the mains (line). Note: In order to disengage the battery pack of Capella completely from an AC power source, it is not sufficient to power the instrument off. The power cable must be detached from the power source.

2.6.3

Battery life When fully charged, Capella can operate for approximately 5 to 7 hours of constant use, up to 22 to 24 hours´ "typical" usage, and up to 38 hours´ stand-by, i.e. powered on, but not in use. The life of the rechargeable battery pack depends on too many variables to be estimated, but you are advised to follow the normal rules for maximizing battery life: avoid constant recharging when not in use, and completely exhaust the batteries periodically (once every 6 months). A memory effect will occur when a user repeatedly recharges the battery before it is fully drained. For example, if you use the battery for 20 minutes at a time and then recharge it, the battery will tend to "remember" that it needs to operate only 20 minutes per charge. As a result, during the charging process, the declining battery will receive only a portion of its charge capacity. The declining battery will also exhibit some characteristics of a fully charged battery. For example, during charging, the battery temperature will rise, prompting the system to stop charging. The memory effect also has a direct impact on the battery's life span. Ni-MH batteries have a typical life (charge/drain cycles) of up to 800 cycles. If the battery is used an average of 30 minutes per cycle, you can expect a total life of 400 hours. If you use the battery 6 hours per

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