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Regulatory Symbols

No.

Symbol

IEC Pub.

Description

980 & 60601-1

Serial Number

980 & 60601-1

Date of Manufacture

980 & 60601-1

Manufacturer

980 & 60601-1

Caution, Consult Accompanying
Documents

980 & 60601-1

Return to Authorized Representative,
Special Disposal Required

980 & 60601-1

Reference Number

60601-1

B Patient Applied Part According to
IEC60601-1

980 & 60601-1

Consult Operating Instructions

60601-1

Keep Dry

60601-1

Transport and Storage Temperature
range

Logo

EC REP

980 & 60601-1

EU Authorized Representative

ISO 7010-

M002&60601-

Where Appropriate

REF

Содержание CORTITM

Страница 1: ...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 in...

Страница 2: ...served 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 Co...

Страница 3: ...Recycling Disposal 11 Regulatory Symbols 12 Introduction 13 How Does the Corti Device Work 14 What are DPOAEs 14 What Are TEOAEs 15 What Do Otoacoustic Emission Results Tell Us 15 What Frequency Range...

Страница 4: ...ts 27 Deleting Results 28 Printing to a Thermal Printer 28 Connecting to the Corti Data Manager 29 Understanding Printed Results 30 Understanding the DPOAE Printout 30 Understanding the TEOAE Printout...

Страница 5: ...Reset Protocol 42 Save Protocol 42 Cleaning and Maintenance 43 Cleaning and Disinfection 43 Maintenance 44 Probe tube Replacement 44 Troubleshooting 45 Appendix A Specifications 47 Appendix B Flowchar...

Страница 6: ...n 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 Ele...

Страница 7: ...s of short duration IEC 60645 6 2010 Electroacoustics Audiometric Equipment Part 6 Instruments for the measurement of otoacoustic emissions ISO 14971 2007 Application of Risk Management to Medical Dev...

Страница 8: ...into the ear canal Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process Available evidence suggests that otoacoustic emiss...

Страница 9: ...ler facility If field service is requested there will be no charge for labor or material however there will be a charge for travel expense at the service center s current rate NOTE Changes in the prod...

Страница 10: ...en the 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...

Страница 11: ...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 poten...

Страница 12: ...itional tests can be performed Power Low The battery charge level is too low for operation The user must charge the battery before additional tests can be performed Printer Error Indicates a problem w...

Страница 13: ...of illumination of the indicator provides a means of identifying the status of the charging function...

Страница 14: ...se 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 anesthetic gases Do NOT use the Cort...

Страница 15: ...by hearing healthcare professionals i e ENT doctors audiologists and or technicians neonatal nurses and school nurses who have been trained by a hearing healthcare professional Cautions General If the...

Страница 16: ...he instrument from the supply mains by removing the micro USB cable from the connector as shown in Figure 2 on page 15 Warning Explosion This system is not explosion proof Do not use in the presence o...

Страница 17: ...vices 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 electr...

Страница 18: ...Documents 980 60601 1 Return to Authorized Representative Special Disposal Required 980 60601 1 Reference Number 60601 1 B Patient Applied Part According to IEC60601 1 980 60601 1 Consult Operating In...

Страница 19: ...Performance Only those products bearing the UL Classification Mark for the U S and Canada should be considered as being covered by UL s Classification and Follow Up Service and meeting the appropriate...

Страница 20: ...pad of the device allow the user to control testing and printing and to reset test protocols The Probe houses the speaker and microphone which produce test stimuli and measure the sound pressure level...

Страница 21: ...wed to override other indications that hearing is not normal A full audiologic evaluation should be administered if concerns about hearing sensitivity persist A REFER test result should not be assumed...

Страница 22: ...correlates to normal hearing However a passing result using this instrument is not an indication that the full auditory system is normal Thus a PASS result should not be allowed to override other indi...

Страница 23: ...mmunication to the Corti Data Manager Charging and connection to the PC can also be conducted directly from the Corti unit The remainder of this manual assumes that charging and communication to the P...

Страница 24: ...ion indicates the charging function is in process Fast blink illumination indicates a fault condition in which the user would be directed by the user manual to return the instrument for service During...

Страница 25: ...l Use only the eartips approved for use with the instrument The eartips are disposable and must be replaced after each patient After selecting an eartip push it onto the probe tube until it is flush a...

Страница 26: ...he 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 pl...

Страница 27: ...reen Figure 9 The yellow TEST light will appear briefly just above the display The green READY light will remain on indicating the instrument is ready for use A Flash Screen will appear briefly indica...

Страница 28: ...for customizing protocols on the Diagnostic units can be found in the sections Advanced Options for DPOAE Diagnostic Unit on page 35 or Advanced Options for TEOAE Diagnostic Unit on page 38 NOTE The d...

Страница 29: ...tube check that the probe connector is fully seated in the socket and try again NOTE To test children with PE tubes the Probe Check needs to be disabled This is accomplished by first inserting the pr...

Страница 30: ...e absolute emission levels at each DP test frequency or TE frequency band The shaded area is the Expanded Boys Town Norms template See page 23 for a description of the template Refer to pages 33 and 3...

Страница 31: ...own in Table A1 from Gorga M P Neely S T Ohlrich B Hoover B Redner J and Peters J 1997 From laboratory to clinic a large scale study of distortion product otoacoustic emissions in ears with normal hea...

Страница 32: ...rotocols the test will pause when noise levels exceed the noise rejection limit Pause is indicated when the Noise Test and Ready lights turn on simultaneously Testing will automatically resume when no...

Страница 33: ...efault mode When operating in the Save 250 mode the Corti will save up to 250 tests There are two options in the Save 250 mode 1 The Corti will automatically number each test from 1 to 250 2 The Corti...

Страница 34: ...data will be deleted Data can be deleted using the Clear function in the System Menu page 32 Data can be deleted in the Corti from the Data Manager when the device is connected to the Data Manager ca...

Страница 35: ...e Micro USB of the cable into the port found at the base of the Corti instrument see Figure 2 For the PC to Corti Cradle connection plug the USB A of the cable into a computer USB port and the USB B c...

Страница 36: ...e signal to noise ratio SNR DP level minus the noise floor in dB 14 A P to the right of the SNR if pass criteria were met for that frequency 15 The Value or SNR graph as selected on the Corti 16 MIN i...

Страница 37: ...s are rounded up to the nearest integer and are shown as DP 6 NF 0 and SNR 6 This can result in what appears to be an error with regard to the pass criterion If the pass criterion is 6 dB while the ac...

Страница 38: ...lay 15 If the time and date are correct press the UP key to escape back to the main menu Changing the Date Time If either the date or time is incorrect press the CHANGE key to access the menu to chang...

Страница 39: ...ith the Corti unit e g thermal printer Follow the above instructions to access the menu in Display 18 then select DISCOVER to initiate discovery of available wireless devices The Corti will search for...

Страница 40: ...ess NEXT Save Mode Storing Test Results The Corti unit automatically stores only the most recent test result for each ear L R Display 23 but has the capacity to store 250 individual tests The number o...

Страница 41: ...teria including the minimum SNR and the number of passing frequencies for overall test Pass The Corti is set with this feature turned OFF when it is shipped from the factory To change the mode to Mini...

Страница 42: ...e Language setting Display 28 allows the user to select among several languages To change the language press the CHANGE keys until the desired language is shown Press the NEXT to exit this menu Reset...

Страница 43: ...ol To enter the DPOAE Menu 1 Press CHANGE at the main menu Display 1 2 Using the CHANGE buttons select the DPOAE protocol you want to customize the DP 4s protocol is not customizable 3 Press SETUP at...

Страница 44: ...ys to select an option and the NEXT key to exit Display 31 NOTE Longer averaging times help to reduce the noise floor which can improve the likelihood of obtaining a passing result particularly with a...

Страница 45: ...PASS to 5 when only 4 frequencies are being tested would result in every test being labeled as a REFER NOTE To disable the PASS REFER indication set the number of frequencies for pass to 0 Press the C...

Страница 46: ...ing a Test Protocol To enter the TEOAE Menu 1 Press CHANGE at the main menu Display 1 2 Using the CHANGE buttons select the TEOAE protocol you want to customize the TE 64s protocol is not customizable...

Страница 47: ...considered a PASS at that frequency The limits for the PASS SNR are 3 dB to 10 dB Pressing the LEFT or RIGHT arrow keys will increase or decrease the requirement This requirement is used in combinati...

Страница 48: ...e instrument settings or the settings of any other protocol Save Protocol Once all of the settings have been selected for the protocol these settings can be saved by selecting the SAVE keys Display 0...

Страница 49: ...low level disinfection is appropriate for this type of instrument This may not conform to the infection control guidelines of the user s facility The disinfection materials and procedures applied in t...

Страница 50: ...ation date Have an authorized service technician perform electrical safety checks on the unit in order to maintain continued compliance to IEC and UL 60601 1 Probe tube Replacement Probe tubes are dis...

Страница 51: ...t print Check the printer status Turn the thermal printer on wake from sleep mode by pressing the power button If the printer doesn t turn on plug in the power supply to charge the battery Be sure the...

Страница 52: ...probe and retry the test Replace the probe tube Contact GSI for service if problem persists across several patients Fit Error Too Low For a DP test the level of the calibration tone is too low User s...

Страница 53: ...nstrument Weight 6 4 oz 180 gm User Interface OLED Display to provide user information and progress of measurement 4 button keypad to control instrument functions Connectors Communications Integrated...

Страница 54: ...Appendix B Flowcharts Flowchart Measurement To Start Press DOWN arrow for 1 second Press UP arrow to return to Main Menu...

Страница 55: ...Flowchart Setup Menus Press and hold DOWN arrow for three seconds to enter next menu Clock Menu System Menu DP Settings TE Settings...

Страница 56: ...mately 31 Hz The NF estimate is obtained by averaging the power in the 4 closest 2 bins to the DP bin FOR TEOAE The calibration phase automatically measures the peak pressure obtained from a sequence...

Страница 57: ...ally that the SNR will be greater than 6 dB approximately 7 times out of 100 This is not a limitation of the instrument but a fundamental property of the method used to estimate the SNR in all emissio...

Страница 58: ...t hearing loss to 1 or less Note By the binomial distribution two of three frequencies at 8 4 dB or three of six frequencies at 7 dB should also ensure less than 1 probability of passing a moderately...

Страница 59: ...d TEOAE measurements in background noise and babble as high as 55 to 65 dB SPL A weighted Briefly explained use of available memory in the Corti processor permits a post hoc statistical analysis that...

Страница 60: ...e of Frequ encies F2 Frequency L1 L2 Averaging Time Pass SNR Passing Freq for Test Pass DP 4s 4 2 0 3 0 4 0 5 0 kHz 65 55 4 sec 6 dB 3 DP 2 0 5 0 4 2 0 3 0 4 0 5 0 kHz 65 55 4 sec 6 dB 3 DP 1 5 6 0 6...

Страница 61: ...ed not customizable DP Screener DP 2s DP 4s TE Screener TE 32s TE 64s DP and TE Screener Combo DP 2s DP 4s TE 32s TE 64s DPOAE Screening Default Protocols Protocol Name of Frequ encies F2 Frequency L1...

Страница 62: ...netic Compatibility 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...

Страница 63: ...ch radiated RF disturbances are controlled The customer or the user of the GSI Corti can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF com...

Страница 64: ...erential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial hospital or residential environment Voltage Dips Short Interruptions a...

Страница 65: ...xed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked Note...

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