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Summary of Contents for GSi CORTITM
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Page 1: User Manual
GSI CORTI ™ User ManUal Part number D-0103241 rev D Setting The Clinical Standard www.grason-stadler.com Grason-Stadler, 10395 West 70th Street, Eden Prairie, Minnesota 55344 800-700-2282 • 952-278-4402 • fax 952-278-4401 • e-mail info@grason-stadler.com... - Page 2 Copyright © 2013 Grason-Stadler. 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 GSI. The information in this publication is proprietary to GSI.
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Page 3: Table Of Contents
Table of Contents Standards Compliance ............................1 Indications for Use ..............................2 Warranty ..................................3 Warnings, Cautions, and Errors ........................... 4 Status/Error Messages ............................... 6 Customer Responsibility ............................8 Safety Precautions ..............................9 Cautions - General ..............................9 Warning - Electric Shock Hazards .......................... 10 Warning - In Case of Emergency .......................... - Page 4 Turning On the Instrument ............................21 Control Panel ................................21 Main Menu ................................22 Selecting the Test Protocol ............................22 Starting a Test ................................. 22 AutoStart Probe Check ............................23 Test Phase ................................23 SNR Bar Graph View .............................. 24 Value Graph View ..............................
- Page 5 Advanced Options for the DPOAE Diagnostic Unit ..................37 Instructions for Customizing a Test Protocol ......................37 Selecting the Level of Primary Tones ........................38 Setting the Averaging Time ............................ 38 Setting the PASS SNR Level ..........................38 Setting the Number of Frequencies for PASS ......................39 Reset Protocol .................................
- Page 6 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the GSI Corti ..................................57 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ..............58 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ..............59...
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Page 7: Standards Compliance
Standards Compliance Issue Standard Date Title ANSI/ASA 3.6 2010 Specification for Audiometers Medical Electrical Equipment – General Requirements for Basic IEC 60601-1 2005 Safety and Essential Performance, Ed. 3 IEC 60645-1 2004 Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers IEC 60645-3 2007... -
Page 8: Indications For Use
Indications For Use Intended Use: The GSI Corti is a test instrument that measures otoacoustic emissions in infants, children, and adults. Indications for Use: The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). -
Page 9: Warranty
Warranty We, Grason-Stadler, warrant that this product is free from defects in material and workmanship and, when properly installed and used, will perform in accordance with applicable specifications. If within one year after original shipment, it is found not to meet this standard; it will be repaired, or at our option, replaced at no charge except for transportation costs, when returned to an authorized Grason-Stadler facility. -
Page 10: Warnings, Cautions, And Errors
Corti power supply and an AC outlet. No modifications of the equipment are allowed by anyone other than a qualified GSI representative. Modification of the equipment could be hazardous. The Corti product has been verified by an independent laboratory to conform to international standards for EMC (electromagnetic emissions and immunity). - Page 11 Instruments which bear the Underwriters Laboratories, Inc. label should be interconnected with accessories that have the proper electrical compatibility and are listed as meeting the requirements of the UL Medical and Dental Equipment Standard. Connection of accessories not meeting these requirements may result in electrical leakage currents in excess of those allowed by the standard and present a potential electrical shock hazard to the person being tested.
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Page 12: Status/Error Messages
Status/Error Messages Display Messages: Attach Probe No probe is detected at the start of a test. Device not The printer is not responding to queries from the instrument. Responding BT Device Not The paired wireless device cannot be detected. The device may be Found turned off or too far away. - Page 13 of illumination of the indicator provides a means of identifying the status of the charging function.
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Page 14: Customer Responsibility
GSI. This product should not be used in the presence of fluid that can come into contact with any of the electronic components or wiring. -
Page 15: Safety Precautions
CAUTION proper functioning in accordance with GSI published specifications. Use only the disposable eartips designed for use with this instrument. Never insert the probe tube into the ear canal without affixing an eartip. -
Page 16: Warning - Electric Shock Hazards
Warning - Battery Safety This instrument contains a rechargeable lithium- WARNING ion battery. The battery is not user replaceable and must be returned to an authorized GSI service location for repair. Warning - General Proper use of this device depends on careful... -
Page 17: Recycling/Disposal
Follow all your respective local laws and regulations for the proper disposal of batteries and any other parts of this system. Below is the contact address for proper return or disposal of electronic wastes relating to GSI products in Europe and other localities. Grason-Stadler (GSI) 10395 West 70... -
Page 18: Regulatory Symbols
Regulatory Symbols Symbol IEC Pub. Description 980 & 60601-1 Serial Number 980 & 60601-1 Date of Manufacture 980 & 60601-1 Manufacturer Caution, Consult Accompanying 980 & 60601-1 Documents Return to Authorized Representative, 980 & 60601-1 Special Disposal Required 980 & 60601-1 Reference Number B Patient Applied Part According to 60601-1... - Page 19 Symbol IEC Pub. Description CAN/CSA- C22.2 No. 60601-1 (2008) Only those products bearing the UL (Medical Classification Mark for the U.S. and Electrical Canada should be considered as being Equipment - covered by UL's Classification and Follow-Up Service and meeting the Part 1: General appropriate U.S.
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Page 20: Introduction
Introduction The purpose of the Corti test system is to provide rapid measurement and documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies. How Does the Corti Device Work? The system consists of the instrument, probe, printer, single-use eartips Probe Connector replaceable probe tubes and other... -
Page 21: What Are Teoaes
Corti device provides an estimate of outer hair cell function over a wide range of frequencies. What Are TEOAEs? Transient Evoked Otoacoustic Emissions (TEOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a series of wideband clicks. -
Page 22: Sensitivity And Specificity
Sensitivity and Specificity Sensitivity and specificity of this type of device are based on the test characteristics defined by the user, and may vary depending on environmental and operating conditions. The presence of otoacoustic emissions suggests normal outer hair cell function, which in turn correlates to normal hearing. -
Page 23: Setup
(1) Calibration Certificate (Part Number 8104432) If any of these parts are missing, contact your special equipment distributor or GSI. We recommend that you save the shipping box and packing materials in case you need to store or ship the system. -
Page 24: Installing The Probe
Insert the Probe’s HDMI connector firmly into the socket on the top of the Corti (Figure 3). The plug will fit in only one direction. The GSI wave logo will align with the instrument control panel. NOTE: Misalignment of the plug and socket can cause damage. The plug and socket should be visually inspected prior to each installation of the remote probe. -
Page 25: Attaching Probe Tube
Corti cradle. Placing the probe into the holder will help to protect the probe head. Make sure the probe holder is towards the end of the probe cable at the GSI wave logo / HDMI connector end. Gently push the probe Figure 7... - Page 26 cable into the probe holder at the point of the probe head. Refer to Figure 7 for an example of the probe in the probe holder when the Corti is resting on a table. Refer to Figure 8 for example of the probe in the probe holder when placed in a Corti cradle.
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Page 27: Operating Instructions
Operating Instructions Preparing the Patient for Testing Otoscopic examination of the patient’s ear canals should be performed prior to testing. Excessive cerumen or vernix in the ear canals may interfere with the test and give invalid or incomplete results. Patients with excessive cerumen, debris, or foreign bodies in the ear canals should be referred to an audiologist or physician for removal of the blockage prior to testing. -
Page 28: Main Menu
Main Menu Selected Protocol Battery Status Date & Time Number of Stored Tests Start Right Start Left Ear Test Ear Test Display 1 Change Protocol and Settings Selecting the Test Protocol The currently selected protocol is shown on the Main Menu (Display 1). -
Page 29: Autostart Probe Check
AutoStart Probe Check After the test ear is selected, the AutoStart Probe Check will begin automatically. The Probe Check display shows a cone, larger at the left and tapering toward the right, representing the ear canal volume from very large (blue area) to very small (orange area). The vertical white bar indicates the measured ear canal volume and probe fit stability: Blue (Display 4) = The ear canal volume is too large for the... -
Page 30: Snr Bar Graph View
test frequency or TE test band. The Value graph view shows the absolute emission and noise levels for each DP test frequency or TE test band. SNR Bar Graph View Display shows the SNR bar graph view. These are the signal-to- noise ratio (SNR) test results which are displayed as the emissions and noise floor are measured. -
Page 31: Test Technique
When the test result is “NOISY,” “NO SEAL,” or “FIT ERR,” the tester should reposition the probe, selecting a different size eartip if necessary, and retest. To review the results, push the DOWN arrow key to return to the bar graph (Display 8). After reviewing the results, again push the DOWN arrow key to return to the Results display (Display 11 or Display 12 or the up arrow to return to the Main Menu... -
Page 32: Noise Sources
asleep. A pacifier may be used to calm the infant; however, sucking will add noise to the test and decrease the likelihood of a passing result. Pull gently down and back on the pinna to straighten out the ear canal. Gently place the probe tube into the infant’s ear canal. When testing children and adults, pull gently up and back on the outer ear during insertion to straighten the ear canal and ensure proper placement. -
Page 33: Managing Results
Managing Results Users have the option of printing to the optional thermal printer, transferring results to the GSI Data Manager database or utilizing Auto Print. Specific options will vary depending on the configuration of the system purchased. Saving Results The Corti instrument automatically saves the results of completed tests in the non-volatile memory (meaning tests are saved even if the battery is temporarily discharged). -
Page 34: Deleting Results
Deleting Results The Corti holds data in non-volatile memory. The data stays in the memory even after data is printed or downloaded to the Corti Data Manager. Data can be deleted through a few methods, depending on the Save mode. Save L/R Mode: ... -
Page 35: Connecting To The Corti Data Manager
The Corti will search for the paired printer showing Display 14 while searching. When the printer is found, all test results stored in memory will print out automatically. The Corti instrument will power off when printing is complete. NOTE: All printed test results are marked for deletion, but will Display 14 continue to be stored in memory until a new test is started at which time all tests in the memory will be erased. -
Page 36: Understanding Printed Results
Understanding Printed Results Results from the Corti can be transferred to Corti Data Manager or Auto Print for a full page printout or to a portable thermal printer. The following information is included on printouts. Understanding the DPOAE Printout The following information is provided for each test: 1) The time and date of the test, based on the setting of the internal clock;... -
Page 37: Rounding Results
Rounding Results The user needs to be aware that the SNR and single PASS criterion on the Corti are calculated from the full internal precision of the instrument, and not from the values shown in the printout for the emission (DP/TE) and noise floor (NF) estimates. This approach is used to preserve the full precision of the test results, but can result in some apparent errors in the printout due to the effects of rounding. -
Page 38: Clock Settings
Clock Settings When the Corti test instrument is first used, the correct date and time may need to be set on its internal clock. The clock should be set prior to testing, as changing it after tests are saved will not change the date on the printout. -
Page 39: Instrument Settings
Instrument Settings The Corti instrument allows the user to change many of the instrument's settings or functions. These settings include wireless Device Pairing, Clearing Test Results, Auto Shutdown Time, Minimum Amplitude Value, Save Mode, DPOAE Norms On/Off, Clock Mode, Language, and Reset to Default Settings. To access the menus to change these functions, press CHANGE at the main menu (Display 1) and then press ... -
Page 40: Clearing Test Results
Clearing Test Results The Test Results Clear menu (Display 21) allows the user to clear the test results stored in the unit without printing them. Select the LEFT or RIGHT arrow key to clear the results and select Yes or No to verify clearing or to cancel. To advance to the next menu without clearing the results, press NEXT. -
Page 41: Minimum Amplitude
the Corti list for instances when a patient is being tested but the patient name was not transferred to the Corti. NOTE: When using the 250 test mode for numbered tests, it is important to keep a record of the test number for each patient. When 245 tests have been saved, the user will be warned that the memory is almost full. -
Page 42: Language
Norms The Norms setting (Display 27) allows the user to display the Expanded Boys Town Norms template on the Value Graph for eligible DPOAE protocols. The norms template has no effect on the overall test results and is for display purposes only. ______________________________________________________ NOTE: The template will display when target L1 and L2 levels are 65 and 55 dB SPL respectively. -
Page 43: Advanced Options For The Dpoae Diagnostic Unit
Advanced Options for the DPOAE Diagnostic Unit The Advanced Options menus permit modification of the test parameters and pass criterion for the customizable protocols on the DP Diagnostic unit. Changes to the protocol should be made only by qualified personnel, usually the administrator. If you are not familiar with the use of these variables, do not attempt to change the protocols. -
Page 44: Selecting The Level Of Primary Tones
Selecting the Level of Primary Tones The intensity of the primary tones (L1, L2) may be changed to any level between 40 dB SPL and 70 dB SPL. The level L1 (Display 30) will change in 1 dB increments by pushing the LEFT or RIGHT arrow keys and press NEXT to move to the L2 screen. -
Page 45: Setting The Number Of Frequencies For Pass
Setting the Number of Frequencies for PASS The number of frequencies required for determining a PASS can be set from 0 to 12 depending on the protocol selected. If the setting is on 0, then no indication of PASS/REFER will be made. This setting is used in conjunction with the PASS SNR (Display 32) to set the criteria for the overall test PASS/REFER indication. -
Page 46: Advanced Options For The Teoae Diagnostic Unit
Advanced Options for the TEOAE Diagnostic Unit The Advanced Options menu permits modification of the test stimuli and measurement values for the Custom Protocols of the TE Diagnostic unit. Changes to the protocol should be made only by qualified personnel, usually the administrator. If you are not familiar with the use of these variables, do not attempt to change the protocols. -
Page 47: Selecting The Averaging Time
Selecting the Averaging Time The Averaging Time can be changed to one of four settings. The Averaging Time will have a significant impact on the time required to perform the test and on the signal-to-noise ratio (SNR). An 8 second average would produce a test in about 8 seconds. A 64 second average would produce a test in about 64 seconds. -
Page 48: Reset Protocol
Reset Protocol Selecting the RESET arrow key in the Reset Protocol menu (Display ) will return the selected protocol settings to their original factory settings. Press the NEXT key to exit. NOTE: This does not affect the instrument settings or the settings of any other protocol. -
Page 49: Cleaning And Maintenance
Cleaning and Maintenance Cleaning and Disinfection Use a new eartip for each patient. Eartips are for single patient use only. The probe tube, which does not make direct contact with the patient, should be replaced if there is any sign of contamination or if the test will not progress past the AutoStart phase. -
Page 50: Maintenance
GSI. Equipment is not user repairable. Repairs and battery replacement must be performed by a qualified service representative only. -
Page 51: Troubleshooting
Check that the instrument will start in your own ear with the proper eartip for testing yourself. If the test will not start or if the AutoStart tones sound unusual, replace the probe tube. Contact GSI for service if the problem persists across several patients. The results will not Check the printer status. - Page 52 User should refit the probe and retry the test. Replace the probe tube. Contact GSI for service if problem persists across several patients. Fit Error For a DP test, the level of the calibration tone is too high. User Too High should refit the probe and retry the test.
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Page 53: Appendix A: Specifications
Appendix A: Specifications PROBE SPECIFICATIONS Measurement Type: Distortion Product Otoacoustic Emissions (DPOAE) Transient Evoked Otoacoustic Emissions (TEOAE) Frequency Range: DPOAE: 1.5 to 12 kHz TEOAE: 0.7 to 4 kHz Stimulus Intensity Range: DPOAE: 40 to 70 dB SPL TEOAE: 83 dB SPL peak equivalent (±3 dB) Microphone System Noise: -20 dB SPL @ 2 kHz (1 Hz bandwidth) / -13 dB SPL @ 1 kHz (1 Hz bandwidth) Dimensions and Weight: Length: 40 in. -
Page 54: Appendix B: Flowcharts
Appendix B: Flowcharts Flowchart - Measurement To Start: Press DOWN arrow for 1 second Press UP arrow to return to Main Menu... -
Page 55: Flowchart - Setup Menus
Flowchart – Setup Menus Press and hold DOWN arrow for three seconds to enter next menu System Menu DP Settings TE Settings Clock Menu... -
Page 56: Appendix C: Test Sequence
Appendix C: Test Sequence A complete test sequence consists of an AutoStart, calibration, and test phase. The AutoStart phase determines when the calibration phase should proceed, while the calibration phase calibrates the level of the tones that will be applied during the actual test phase. Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts. -
Page 57: Comment About Variations In The Snr Estimate
Comment about Variations in the SNR Estimate The user needs to be aware that the SNR estimate has an inherent statistical variation due to the effects of random noise, especially when no emission is actually present. If a test is performed with the instrument’s probe placed in a test cavity, it can be shown theoretically that the SNR will be greater than 6 dB approximately 7 times out of 100. -
Page 58: Appendix D: Pass/Refer Criteria
Appendix D: Pass/Refer Criteria Pass/Refer Criteria for DPOAE The decision that a DPOAE exists is based on detecting a signal whose level is significantly above the background noise level. This requires a statistical decision, since the random noise level in the DPOAE filter channel can be expected to exceed the average of the random noise levels in the four adjacent filter channels —... -
Page 59: Pass/Refer Criteria For Teoae
Pass/Refer Criteria for TEOAE The same basic principles that underlie DPOAE Pass/Fail criteria underlie TEOAE Pass/Fail criteria. In the case of transients, requiring SNR of 4 dB at any three out of the six test frequencies drops the probability of passing an ear with a significant hearing loss to less than 1%. NOTE: The SNR limits for transients are lower than the corresponding limits for distortion products primarily because the traditional noise calculation used in TEOAE measurements (and in the Corti instrument) gives a 3 dB lower SNR than the calculation used for DPOAEs. -
Page 60: Appendix E: Configurations And Test Protocols
Appendix E: Configurations and Test Protocols GSI Corti Diagnostic Configurations Configuration Protocols Included DP Diagnostic: DP 4s (default - not customizable) DP 2.0-5.0 DP 1.5-6.0 DP 1.6-8.0 DP 1.5-12 TE Diagnostic: TE 64s (default - not customizable) TE 1.5-4.0 TE 0.7-4.0... - Page 61 "PASS" do not have a factory provided pass criteria. Users may establish a custom pass criterion based on normative data collected in their own clinics or information available by literature review. GSI Corti Screening Configurations Configuration Protocols Included (not customizable) DP Screener: DP 2s...
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Page 62: Appendix F: Emc Compatibility
The GSI Corti has been tested for EMC emissions and immunity as a standalone instrument. Do not use the GSI Corti adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. -
Page 63: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The GSI Corti is intended for use in the electromagnetic environment specified below. The customer or the user of the GSI Corti should assure that it is used in such an environment. Emissions Test... -
Page 64: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The GSI Corti is intended for use in the electromagnetic environment specified below. The customer or the user of the Corti should assure that it is used in such an environment. Immunity Test... -
Page 65: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The GSI Corti is intended for use in the electromagnetic environment specified below. The customer or the user of the Corti should assure that it is used in such an environment. Immunity Test...
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