GSI Audera Reference Guide

Title:

GSI Audera Reference Manual

Date:

November, 2004

Copyright © 2003 VIASYS Healthcare, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of VIASYS Healthcare, Inc. The informa
tion in this publication is proprietary to VIASYS Healthcare, Inc. Part number:

2001
0100

Printing history:

May, 2002 July, 2003 August, 2003 November, 2003 November, 2004

First printing Second printing Third printing Fourth printing Fifth printing

Rev 1.0 Rev 2.0 Rev 3.0 Rev 4.0 Rev 5.0

Compliance The CE0344 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-Stadler is an ISO 9001-certified corporation.

.

DCO
0290 DCO 2001
0033

Additional copies

Additional copies of this manual or other GSI literature may be obtained from: VIASYS Healthcare, Inc. P.O. Box 44994 Madison, WI, USA 53744
4994

Attention

The information in this document is subject to change without notice. VIASYS Healthcare, Inc. makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. VIASYS assumes no responsibility for any errors that may appear in this document. VIASYS makes no commitment to update nor to keep current the information contained in this document.

Trademar ks ademarks

Microsoft, MS, Windows, Window XP and Windows NT are registered trademarks of Microsoft Corporation. Pentium is a trademark of Intel Corporation. Audera is a trademark of Grason
Stadler.

©2004 VIASYS Healthcare, Inc. Printed in USA

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GSI Audera

System warranty

VIASYS Healthcare, Inc warrants that each product we sell you shall conform to its product specifications as defined in the user documentation. If the product does not function as warranted during the warranty period, we will repair or replace it without charge. If in our judgment we are unable to do so, you may return it to us and we will refund your money.

Warranty period

The warranty period is stated in the product user documentation. If you install the product, the warranty period begins on the date of invoice. If we install the product, the warranty period begins on the date of installation but will begin no later than 30 days from the date of invoice. The warranty period for products sold outside the U.S.A. and Canada is 12 months from the date of installation or 14 months from the date of shipment, whichever is less.

Limit of warranty

Misuse, accident, modification, unsuitable physical or operating environment, improper maintenance, or damage caused by a product for which we are not respon
sible may void the warranty. Certain components may have separate warranty periods as stated in the product user documentation. Consumables are not covered under warranty. THIS WARRANTY REPLACES ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ANY OTHER OBLIGA
TIONS OR LIABILITIES ON THE PART OF VIASYS HEALTHCARE, INC. WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE OR OTHERWISE. VIASYS SHALL NOT BE LIABLE FOR AND DISCLAIMS ALL CONSEQUEN
TIAL, INCIDENTAL AND CONTINGENT DAMAGES.

Items not covered by warranty

We do not warrant uninterrupted or error
free operation of a product. We provide certain non
VIASYS products on an “as is” basis. Non
VIASYS manufacturers or suppliers may provide their own warranties to you. Separate software warranty is provided with software user documentation.

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Software warranty

VIASYS Healthcare Inc. warrants that the physical media (e.g. CDs), shall be free of malfunction in labor and materials for a period of ninety (90) days from the invoice date. If the physical media containing the software is defective, VIASYS will replace it without charge. This is your sole remedy for product malfunctions. In no event will VIASYS’ liability exceed the price paid for the software, regardless of the form of the claim. VIASYS does not warrant that the software will operate uninterrupted or error
free. VIASYS HEALTHCARE INC. MAKES NO OTHER WARRANTIES, EITHER EXPRESSED OR IMPLIED, WITH RESPECT TO THIS SOFTWARE, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. VIASYS MAKES NO WARRANTY, EITHER EXPRESSED OR IM
PLIED, WITH RESPECT TO THE QUALITY OR PERFORMANCE OF THIS SOFTWARE. VIASYS SHALL NOT BE LIABLE FOR CONSEQUENTIAL, INCI
DENTAL OR CONTINGENT DAMAGES. Some states do not allow the exclusion or limitation of implied warranties or limitation of liability for incidental or consequential damages, so the above limita
tion or exclusion may not apply to you.

Software copyright protection

This software is protected by state, U.S. and international copyright treaty provi
sions. These copyright provisions apply to your use of this software regardless of whether or not you agree to the following terms. Under law, copyright infringers may be liable for actual damages sustained by the copyright owner and for punitive damages of up to $100,000 per infringement. Unauthorized copying of computer software, and attempts to do so, are also criminal violations, with penalties that may exceed $100,000 in fines and 10 years in prison. 1. Unless restricted by an agreement with VIASYS, you are permitted to: a. Use this software on only one computer and by one user at a time. b. Make one copy of this software, provided that: (i) the copy is created as an essential step in the utilization of this software in conjunction with your machine and that it is used in no other manner, or (ii) that the copy is for archival purposes only and that all archival copies are destroyed in the event that your continued possession of this software should cease to be rightful. c. Sell this software, and any archival copy, only as part of the sale of all of your rights in this software, except that adaptations so prepared may be transferred only with the authorization of VIASYS. 2. You are not permitted to: a. Make copies of this software or documentation except as described above. b. Alter, modify or adapt this software or documentation except as described above. c. Distribute, lease, rent or sublicense this software or documentation.

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GSI Audera product and its components will perform reliably only when operated and Customer responsibility This maintained in accordance with the instructions contained in this manual, accompa
nying labels, and/or inserts. A defective product should not be used. Parts which may be broken or missing or are plainly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from VIASYS. The responsibility of VIASYS for a malfunctioning product is limited by the warranty set forth in this manual. Should repair or replacement of this product become necessary after the warranty period, the customer should seek advice from GSI Technical Suppport. prior to such repair or replacement. If this product is in need of repair it should not be used until all repairs have been made and the unit is functioning properly and ready for use. The owner of this product has sole responsibility for any malfunction resulting from improper use or mainte
nance, or repair by anyone other than VIASYS, and from any malfunction caused by parts that are damaged or modified by anyone other than VIASYS.

Regulatory standards

GSI Audera systems meet the following safety standards set by domestic and international regulatory agencies for Medical Electrical Equipment. • UL 2601
1
American Standards for Medical Electrical Equipment General Requirements • CAN/CSAC 22.2 No. 601.1
M90 Canadian General Requirements for Medical Electrical Equipment • IEC/EN 60601
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International Standards for Medical Electrical Equipment General Requirements • IEC/EN60601
2
40 Particular Requirements for the safety of Electromyographs and Evoked Response Equipment

! CAUTION FederallawintheU.S.A.andCanadarestrictsthesale,distributionoruseofthis productto,byorontheorderofalicensedmedicalpractitioner.

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GSI A uder erence Guide Auder uderaa Ref Reference Chapter 1

Introduction

About GSI Audera Protective classification Intended operator User interface Output devices Identifying the GSI Audera software version number Requirements Input requirements System Requirements PC Recommendations System Checklist Menu bar commands Entering commands Using the keyboard Pulldown Menus Shortcut keys Using the mouse Toolbar Buttons Safety summary Precautions Safety precautions

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GSI Audera

Chapter 2

Connecting the GSI Auder uderaa System

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Tools Required Check the voltage setting
Laptop system GSI Audera Base Laptop Computer Check the voltage settings
115V Desktop system Isolation transformer Computer GSI Audera Base Monitor Check the voltage settings
230V Desktop system Isolation transformer Computer GSI Audera Base Monitor Changing the computer's line voltage setting Cabling a Laptop system Cable the components Attaching an OAE probe Cable the components Connect the power cables Cabling a Desktop system Cable the components Connect the power cables
115V Desktop systems Connect the power cables
230V Desktop systems Switching the system on and off Laptop system Desktop system

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Installing the GSI Audera Software Licensing the GSI Audera Software Compatible operating systems

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Chapter 3

The Main Windo w Window

GSI Audera Main Screen 1. Menu Bar Database Options Options > Main Options Options > Select Your Entry Screen Color Options > Examiner Names Help Options> Assign Calibration Information Options > Earprobe Check Help Menu > About GSI Audera Help > Contacting GSI GSI Audera Patient Database general information Help > View Manual The GSI Audera database contains the following features: 2. Patient Selection 3. Patient List and Session Information 4. Application Buttons New Patient Edit Patient Search for an existing patient To perform a search: Deleting a patient, session, or test Deleting a Patient Deleting a Session Deleting an AEP, CAEP, ASSR or DPOAE Test Database > Import Patient Record Database > Export Patient Record Database > Copy Sessions From... To backup your database To restore a database To Restore a database from the Default backup file: To restore a database from the Default Archive file: To restore a database from a CD: Windows XP To archive a database To copy archived files to CD The Help Menu About Audera Contacting GSI View Manual

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7

GSI Audera

Appendix

Appendix A: A Guide to Minimizing Extraneous Noise Electrical and electromagnetic interference Other problematic areas Minimizing Interference Appendix B: Additional Information Typical international symbols Typical symbols on GSI systems Typical GSI labels Appendix C C:: Preventive maintenance Safe installation and use Appendix D: European Authorized Representative Service manuals for your system Appendix E: Cleaning, disinfection and sterilization of parts in contact with the patient GSI electrodes Cleaning Sterilizing Approved electrodes Mains operated equipment with additional power supply Primary batteries Replacement of fuses and other parts Restricted environmental conditions for operation, transport and storage Protective packaging measures

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Introduction Chapter 1

Introduction This chapter contains general informa
tion concerning your GSI Audera system. Make sure to read and understand the Safety Summary and Precautions located at the end of this chapter before applying power to and using the system.

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GSI Audera Blank Page

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Introduction

About GSI A uder Auder uderaa

The GSI Audera system provides all the functionality you need to perform the following auditory exams: • Auditory Steady State Evoked Response • Auditory Evoked Potential • Cortical Evoked Potentials • Distortion Product Otoacoustic Emissions • Spontaneous Otoacoustic Emissions

Protective classification

This system is intended for continuous operation and has a protective classification of Class I, Type BF and Type B applied parts, ordinary equipment, not suitable for use in the presence of flammable anesthetics.

Intended operator

The system is intended as an aid for users trained and skilled in audiology

User interface

• A pointing device (mouse, touchpad, or track
ball) • Standard Windows™ toolbars with customized icons • Keyboard short cuts

Output devices

• Windows
supported printers

Identifying the GSI A uder are vversion ersion nnumber umber Auder uderaa softw software To locate which version of the software is loaded on your system, 1. Open the Audera application 2. From the Menu Bar, click on Help 3. Click on About Audera The software version number is displayed on the About Audera window.

Requirements

The GSI Audera package requires a GSI Audera hardware platform in order to operate.

Input requirements

System Power: 115W, excluding printer Frequency Range: 50
60Hz AC Voltage/Current: 100V
120V/11.5A
9.6A/250V 220V
240V/5.3A
4.8A/250V Fuse: 5x20mm 100V
120V: T10AL 220V
240V: T5AL

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GSI Audera

System Requirements

Before attempting to assemble or use the GSI Audera system, please ensure you have the following items of hardware and software:

PC Recommendations

A notebook or desktop PC compatible computer system with: • Windows XP (Professional) • 1.4 GHz Celeron or above processor • 256 MB Ram • 20 GB hard disk available • 3.5 inch, 1.4 MB diskette drive • CD R/W drive for additional storage • 2 USB connector • Displays should use a resolution of 1024*768 pixels (or higher). Interlaced video display modes should not be used. Non
interlaced modes and a high refresh rate are far superior and provide easier viewing of the displayed results and less eyestrain. • Notebook PCs: Active matrix color TFT LCD screens are required. Passive technologies such as dual scan color STN screens are NOT acceptable. • This program makes use of color when printing, but color printers are not essential. Differently colored sections can still be differentiated when using black and white printers.

System Checklist

The full set of GSI Audera System components as shipped, comprising: • • • • •

GSI Audera software with activation code GSI Audera unit with USB cable Power cable for GSI Audera unit GSI Audera Reference Manual Loop back cable

Other accessories will be shipped depending on the configuration of the system and licensed software packages purchased. Systems ordered with AEP or ASSR software packages will include: • • • •

One set of GSI Tip
50 insert phones with disposable ear tips Frequency response chart for the supplied earphones GSI Audera amplifier with amplifier cable Electrode starter kit

Systems ordered with DPOAE software will include: • • • •

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OAE probe with calibration CD Serialized test cavity for calibration of probe Ear tip starter kit Probe mounting kit

Introduction

Menu bar commands

When you are directed to make selections from a pull down menu in this guide, it will be shown using this convention: Xxxxx > Yyyyy Yyyyy. For example, if you are to select Main Options from the Options pull down menu, it will be shown as: 1. From the Menu Bar, click on Options > Main Options Options. This means, click on Options from the Menu Bar and then click on Main Options from the pull down menu.

Entering commands Using the keyboard

You can often use either the keyboard or the mouse to enter commands to your program. The keyboard can be used to control the majority of the GSI Audera application, but you will need to use the mouse at times.

Pulldown Menus

You can execute commands from the menus located at the top of the screen by holding down the Alt key and then typing the underlined letter in the menu name (e.g., File). Then, when the menu appears, you can choose the required option typing the underlined letter in the desired option (e.g., Open). Alternatively, you can use the Up/Down Arrow keys to select a menu item and then press the Enter key.

Shortcut keys

A set of special shortcuts is provided for efficient keyboard control which allows you to execute specific commands quickly.

Using the mouse

The mouse allows you to control virtually the entire GSI Audera application. You must, however, use the keyboard to enter alphanumerics.

Toolbar Buttons

Within the GSI Audera test applications, standard toolbar buttons allow access to Delete specific commands (Delete Delete, Hide Hide, etc.).

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GSI Audera

Safety summary

This section describes the types of safety symbols used in this guide and lists the Warnings and Cautions found in this manual.

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

! CAUTION The CAUTION label identifies conditions or practices that could damage the equipment or lose data. The Note label helps identify areas of possible confusion and avoid potential problems during system operation.

IMPORTANT!! Please read and follow all WARNINGS, CAUTIONS and NOTES provided in this guide. To avoid the possibility of injury, damage to your system or lost data, observe these safety precautions during system operation.

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Introduction

Precautions Safety precautions

! WARNING

The following safety precautions must be observed at all times. FAILURE TO OBSERVE THESE REQUIREMENTS COULD RESULT IN SERIOUS INJURY OR DEATH. This device should only be used by hearing health care professionals such as, an audiologist, otolaryngolgist, researcher or a technician under the direct supervision by the fore mentioned specialists. Users should use their professional skills when interpreting the results and this should be done in conjunction with other testing as deemed appropriate given their professional skills. This device is rated “Type BF”. This means the device is not insulated sufficiently to be considered totally isolated electrically and dangerous leakage currents can occur. In particular: a) The earphone connector at the transducer box has an air gap small enough to allow the possibility of a mains powered cable in close contact or in direct contact to leak current into the unit and the earphones via the earphone cable. b) The GSI Audera amplifier could leak current to the electrodes connected to the patient if a mains powered cable comes in close contact or in direct contact with the metallic parts on the GSI Audera amplifier such as the electrode test inputs. c) The OAE probe could leak current to the eartip connected to the patient if a mains power cable comes in close contact or in direct contect with OAE probe parts. Users should take the necessary precautions for environments or situations that require “Type BF or Type CF” protection. Contact your hospital’s Bio
medical engineering department or call GSI for clarification as required. The GSI Audera amplifier must only be used with electrodes and leads designed to suit its connectors. These leads are designed to avoid accidental conduction of dangerous voltages to the patient. Ensure that the earth connection at the mains electrical power outlet is properly earthed. Standard clinical precautions must be taken when testing sedated or anaesthetised patients. Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anaesthetic gases. Discuss with your anaesthetist. Installation of third party software packages can affect the functionality of the software and may cause malfunctions. Do not use extension cords for the Isolation Box. Extension cords can cause ground integrity and impedance problems. When used simultaneously with high frequency surgical equipment, burns may occur at the site of any recording or stimulating electrode.

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GSI Audera

! WARNING

Advise patients with implanted electronic devices not to be subjected to electrical stimulation unless specialist medical opinions have first been obtained. Electrodes of inadequate size or unsuitable application could provoke skin reactions or burns. These electrodes contain an adhesive that maintains the electrode skin position and contact during electrical stimulation. The maximum sound levels that can be generated by the system can cause serious injury to the ear. Before attaching the earphones to the patient, ensure that: a) the system is running. b) the hearing levels in the test set to be used are appropriate. c) you have checked the sound produced by the system yourself by slowly bringing the earphone emitting the generated tone to your own ear. In addition to electrical safety considerations, poorly earthed mains power outlets are likely to cause inaccurate test results due to the introduction of electrical interference from the mains. As a safety precaution, at time of delivery the system output default limit is set to 90 dB SPL. To present stimuli at higher levels, the default setting may be in
creased to a maximum of 130 dB SPL. See Options > Main Options > Artificial Audio Level Limit.

!

This Warning symbol indicates a stimulus level of 95 dB SPL or greater can now be delivered.

At high stimulus levels (>100 dB peSPL) the electrode leads should be placed away from the earphone transducer boxes and cables, or artifacts may result. The earphones supplied use plastic tubes to ameliorate the possibility of electrical interference with the electrode leads. Separate the Insert earphones and the electrode leads, in order to minimize the possibility of electrical coupling. Bone conductors are especially vulnerable to producing artefacts. Only a level of 55 dB is required with a bone conductor to produce an artefact that would require a level of 100 dB using earphones. This is compounded by placing the bone conductor close to the electrode on the mastoid. The following common deficiencies will adversely affect testing: a) Using blocked earphones b) Using earphones designated and calibrated for one channel with the other channel, when that channel is using another earphone calibration file c) Using incorrect calibration files for the earphones in use d) Using an OAE probe without its corresponding calibration file loaded For optimal ASSR results, the patient should be asleep. The GSI Audera System unit is designed for 50 Ohm earphones only. Some Insert earphones are 10 or 300 Ohms, and are not suitable for use with our system. This warning also applies to bone conduction oscillators and other types of headphones. The speaker is 8 ohms. The tubes on the TIP
50 insert earphones should never be changed in length, as this affects the acoustics of the earphones.

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Introduction

! CAUTION

The Audera System is designed to operate in an air
conditioned environment. The maximum temperature at which the system should be used is 300 Celsius. The unit should be placed in a position that allows adequate ventilation. Avoid placing it in the proximity of other equipment that may also produce heat. Operation at temperatures above 300 Celsius could damage the GSI Audera System. Do not stack any item of equipment on top of the GSI Audera System Unit (other than a laptop computer when appropriate). The modulation frequencies need to be selected carefully when making your own ASSR test sets. Avoid modulation frequencies that have a fundamental or harmonic relationship to the frequency used in your country’s mains power supply (50 or 60 Hz), and its harmonics. Using these frequencies can give erroneous results as the power supply’s voltage could be imposed on them. Other frequencies such as the refresh frequencies used by computer monitors (typically 60 to 100 Hz) can also cause erroneous results. Refer to the manual supplied with your computer monitor if in doubt. Proper use of this software depends on careful reading of all instructions and labels. Federal law in the U.S.A. and Canada restricts the sale, distribution or use of this device to, by or on the order of a licensed medical practitioner. Do not attempt to reinstall the software without consulting a qualified GSI Service Representative first. You can destroy all your data. Follow the steps provided only under the direction of a qualified Service Representative. Follow the Shutdown sequence described in your system's User manual to turn off the system to ensure the integrity of your data files. Use this device in humidity controlled medical use rooms with an anticipated humid
ity range of 20 to 80%. All nonmedical equipment connected to this device, such as printers, must comply with IEC 950 and/or appropriate European Directives. Connect all nonmedical equipment to the GSI Isolated Power Supply. Turn OFF system power before cleaning. Prevent detergent solution or cold steril
ization agents from seeping into the electronics of the instrument. Be especially careful around controls, connectors and panel edges. Do not use abrasives. If the system is not functioning properly, do not operate it until all necessary repairs are made and unit is tested for proper functioning in accordance with GSI published specifications. It is recommended that all repairs be performed by a qualified service representative only. Do not disconnect or reconnect the amplifier cable with system power on. You may damage the amplifier.

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GSI Audera

! CAUTION

Inspect the power cord often for fraying or other damage. Do not operate the apparatus with a damaged power cord or plug. The AC power outlets on the iso
power box are intended for use with GSI approved components only. Use of any other equipment may result in damage to the power unit. Follow all safety standards set by your place of employment. Do not over tighten the connector securing screws. The customer is responsible for maintaining all system software in a safe, secure location. IMPORTANT! Do not attempt any procedures requiring specialized test equipment or access to the interior of the instrument. Switch off all power to the system before attempting any service and maintenance. Approved Electrodes: Use only GSI approved/supplied electrodes and transducers. See your GSI Distributor. Use of non
approved electrodes or transducers might adversely affect the function of your system. The USB cable and connectors are delicate. Be careful not to kink or sharply bend the cable. It should not be coiled to a diameter less the 15 cm. Do not use excessive force or use force delivered at an angle when unplugging the amplifier or probe connectors. Damage to the amplifier cable, probe, or connectors is not covered by warranty. The repetition rate needs to be selected carefully when making your own Test Set: • Avoid repetition rates that have a fundamental or harmonic relationship to the frequency used in your country’s main power supply (50 or 60 hz) and it harmon
ics. Using these rates can give erroneous results as the power supply’s voltage could impose on them. • Other rates such as the refresh rates used by computer monitors (typically 60
100 hz) can also cause erroneous results. Refer to the manual supplied with your computer if in doubt.

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