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GSi PELLO User Manual Download Page 2

Title: GSI Pello™ Audiometer User Manual

Copyright © 2018 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
Grason-Stadler. The information in this publication is proprietary to Grason-Stadler.

Compliance

The CE 0123 mark identifies compliance with the Medical Device Directive 93/42/EEC. Grason-
Stadler is an ISO 13485 certified corporation.

Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1,
5500 Middelfart
Denmark

0123

Grason-Stadler
10395 West 70

th

Street

Eden Prairie MN 55344 USA

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Summary of Contents for PELLO

Page 1: ...andard 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 GSI Pello User Manual o part...

Page 2: ...tten permission of Grason Stadler The information in this publication is proprietary to Grason Stadler Compliance The CE 0123 mark identifies compliance with the Medical Device Directive 93 42 EEC Gra...

Page 3: ...g 15 Warning Explosion 15 Warning Line Voltage Brownout and Interruptions 15 Warning Connections 15 Warning Battery Safety 15 Warning General 15 Shutdown Procedure 15 Recycling Disposal 15 Regulatory...

Page 4: ...rols 37 Scorer Timer 37 Monitoring 37 Test Type Buttons 37 Function Buttons 38 Chapter 5 Test Type Displays 39 Monitor 39 Tone Test Type Audiogram 41 Tone Test Type Status 45 Speech Test Type Status 4...

Page 5: ...and Noise 63 Distortion and Frequency Shift 63 Speech Level Check 64 Internal Controls Check 64 Bone Vibrator Check 64 Masking Level Check 64 Talk Forward Check 64 Cleaning the System 64 Cleaning and...

Page 6: ...103 Bone Vibrators Pure Tone RETFL 104 Bone Vibrators ANSI Speech RETSPL 105 Bone Vibrators IEC Speech RETSPL 105 Bone Vibrators Pure Tone max HL 106 Bone Vibrators NB noise effective masking level 10...

Page 7: ...sic audiometric testing as well as detailed evaluations to assist in diagnosis of audiologic pathologies Careful handling of instrument transducers and testing performed by a properly trained instrume...

Page 8: ...ISO 389 1 Reference Equivalent Threshold SPLS for Pure Tones and Supra Aural Earphones 5 ISO 389 2 Reference Equivalent Threshold SPLS for Pure Tones and Insert Earphones 6 ISO 389 3 Reference Equiva...

Page 9: ...presentation of the signal at the maximum dB HL to exceed 10 minutes The buildup of increased temperature can cause harm to the earphones This caution label refers the user to the accompanying litera...

Page 10: ...t results of the ABLB and Tone Decay are not recorded directly on the report This message indicates that the results should be documented in the comments The startup configuration for this test type i...

Page 11: ...y oxygen enriched environment such as a hyperbaric chamber oxygen tent etc Periodically have a service technician perform electrical safety checks on the unit in order to maintain continued compliance...

Page 12: ...m ambient noise is highly recommended so that hearing threshold values may be obtained If a separate examination sound room is used it is considered sufficiently quiet for the purposes of these tests...

Page 13: ...or PH51 Cushion dB IP30 inserts dB DD450 dB HDA 300 dB 125 3 33 5 14 5 12 5 160 4 200 5 250 5 34 5 16 12 7 315 5 400 6 500 7 34 5 22 5 9 4 630 9 750 800 11 1000 15 35 0 28 5 12 8 1250 18 1500 1600 21...

Page 14: ...th other testing as deemed appropriate given their professional skills Incorrect use could lead to wrong results The maximum sound levels over 100 dB HL that can be generated by the system can cause s...

Page 15: ...al System and is therefore responsible for the system to comply with the requirements If in doubt contact qualified medical technician or your local representative A Separation Device isolation device...

Page 16: ...tput to the transducers will be muted Warning Connections Do not switch on any system power until all cables have been properly connected and verified See this manual which accompanies all deliveries...

Page 17: ...ic A S Audiometer Alle 1 5500 Middelfart Denmark Within the European Union it is illegal to dispose of electric and electronic items in unsorted municipal waste Electric and electronic waste may conta...

Page 18: ...ent Classified by Intertek Testing Services NA Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 Classified under the Medical Device Directive 93 42 EEC...

Page 19: ...No Symbol Description 15 Patient response switch 16 Follow Instructions for Use 17 China RoHS compliance...

Page 20: ...onfiguration Application Config App allows the selection of the desired symbol set The symbol sets are shown in the following table For symbols that are not specified in the reference documents for sp...

Page 21: ...ralia China Hong Kong UK R L L R R L L R R L L R R L L R R L L R AC or or NR or or AC masked NR BC NR BC masked NR BC Forehead NR BC Forehead masked NR SF NR SF masked NR SF Aided NR SF Cochlear NR MC...

Page 22: ...er that offers seamless data transfer to a computer In the event of a network failure or computer lock up the examiner will not lose patient data or the ability to test The stand alone configuration i...

Page 23: ...at a proper claim can be made Be certain to save all packing material so that the claim adjuster can inspect it as well As soon as the carrier has completed the inspection notify a Grason Stadler repr...

Page 24: ...te DVD Software User Manuals 8504768 GSI Pello DVD Bundle Config App User Manuals 8503125 GSI Pello User Manual Hard copy 8505749 Pello Carrying Case 8503180 Touch screen PC for use with GSI AMTAS Pel...

Page 25: ...Automated Audiometry Pediatric Noise Remote Keyboard ABLB TEN Test SISI Tone Decay 8508410 GSI AMTAS Speech Plus Upgrade Kit Automated Audiometry Quick SIN BKB SIN AutoScore Play AZ Bio 8508411 GSI A...

Page 26: ...t IEC 14 R2 USB Computer Connection USB B style connector R3 LAN Connections Ethernet Connection RJ45 Currently not supported R4 USB Connectors USB A style plugs R5 FF Speaker RCA Connections Output 2...

Page 27: ...25 mV and 5 mV for a 0 dB reading on a VU indicator the input impedance is 3 200 ohm R11 Ext A and B 3 5 mm stereo jack Input jacks for optional digital music player or CD player input NOTE External...

Page 28: ...ts It is possible to connect external devices such as mouse keyboard or external printer to be used with the audiometer Additionally a memory stick may be inserted into a USB port for updating softwar...

Page 29: ...the Medical Device Directive 93 42 EEC as a Class IIa device Caution consult accompanying documents Conforms to European Medical Device Directive 93 42 EEC Manufacture Date year and month will be inse...

Page 30: ...is indicates that the power switch is in the on position Stimulus Intensity Level s Test Mic Input A and Input B Level Controls Talk Forward To calibrate the test signal for the test microphone or the...

Page 31: ...ched If the dB HL limit is reached in Channel 2 before Channel 1 the Channel 2 dB HL display will temporarily flash and remain at this level Tracking remains on When the Channel 1 dB returns to a leve...

Page 32: ...ble If PDF is the selected printer a memory stick or USB drive must be inserted into a USB ports on the Pello prior to printing test results Print Messages Printing A status bar will indicate the prin...

Page 33: ...Printer Output Formats Standard...

Page 34: ...Additional Printer Output Formats High Frequency License The printout formats are shown in the following figures...

Page 35: ...down bandwidth of a 1 3 octave at a minimum and octave at a maximum Speech Noise The Speech Noise pushbutton selects speech noise that is calibrated in effective masking level and contains a spectrum...

Page 36: ...termine the routing for the stimulus to the output transducer selected for Channel 1 and Channel 2 Left Right delivers the stimuli from Channel 1 to both the left and right transducers Both the Channe...

Page 37: ...n is in the on position indicated by the presence of the light bar Channel 2 stimulus is presented When the Interrupt button is in the off position no Channel 2 stimulus is presented Frequency Up Down...

Page 38: ...nnel 1 CH 1 Channel 2 CH 2 Talkback Controls The Monitor Headset allows the operator to listen to the stimuli as they are presented and to listen to the patient s comments through the talk back system...

Page 39: ...The selection loads the appropriate symbol and calibration for bone conduction testing This selection will be active throughout the current session When a new session is started the symbol scheme wil...

Page 40: ...rs if examiners have been entered The examiner list may be entered from the Config App Test Type Information Under the title bar test specific information will be displayed On the left and right side...

Page 41: ...and the result is then displayed Interlock When interlock is active a padlock icon will appear Tracking When tracking is selected a railroad track icon will appear Data Transfer When there is an acti...

Page 42: ...st type Pure Tone will be displayed On the right side of the title bar the Examiners will be displayed if an examiners list has been created An underline on any item on the display indicates that a se...

Page 43: ...down list of options for selection Frequency Window This window will display the test frequency When a patient response switch is used a gray bar will appear below the frequency when the patient depr...

Page 44: ...the menu displays the current date and time Signal Menu The signal menu displays a sub menu with the choices of signal type Steady Indicates a steady pure tone signal FM Applies a frequency modulation...

Page 45: ...or the test type are presented If a high frequency is included in the frequency list and the test range is Standard only the standard frequencies are presented Ch2 Tone Selecting Ch2 Tone enables a pu...

Page 46: ...Status Display The Status table display for the Tone Test Type displays the data in a tabular format The columns indicate the frequency dB HL level and the effective masking level dB EM The display co...

Page 47: ...entered will be displayed In the center of the title bar the test type Speech will be displayed On the right side of the title bar the examiner name if entered will be displayed An underline on any it...

Page 48: ...ntage The lower part indicates the current word being presented If a patient response switch is used a gray bar will appear below the current word when the patient depresses the button NOTE When using...

Page 49: ...word on the list is presented the next page will be displayed Using the navigation buttons on the instrument you can move to the next page by pressing the down or right navigation key on the last word...

Page 50: ...tiple favorite word lists are designated storing a test result will automatically advance to the next word list in favorites NOTE In Manual mode highlight the desired word and press the presentation b...

Page 51: ...pure tone air conduction audiogram of the test ear in place of half of the Speech test Results table This button acts as a toggle to display the audiogram or speech results table Speech Test Status Di...

Page 52: ...dialog also contains the option to record the patient test reliability Selecting the Reliability button from the comments dialog displays the options for reliability The options for the reliability la...

Page 53: ...plotted on the Speech Audiogram will be which indicates the stimulus was presented to both ears Navigation Menu The Navigation menu has the same functionality and selections as the Speech Status displ...

Page 54: ...ical shock can alter their operating characteristics or change the output levels which may require that the transducers be replaced CAUTION It is recommended that all parts that come into direct conta...

Page 55: ...m is aimed directly at the opening into the ear canal Adjust the headband for a tight fit If the cushions are not tight to the ears the test result will be false especially at lower frequencies WARNIN...

Page 56: ...ded speech testing For manual presentation Utilize the navigation menu or external mouse to select the test type and the word list Select Word Nav and use the navigation buttons to highlight word stim...

Page 57: ...f the subject responds repeat at 40 dB If the subject responds again this is the start point NOTE Discomfort of the patient could lead to inaccurate results The operator is to evaluate the environment...

Page 58: ...iate to familiarize the patient with the entire spondee word list Using live voice or recorded speech internal Wav files or external file played through a digital device present the standardized spond...

Page 59: ...0dB above the pure tone threshold in the better ear Set the Ch2 level to 10dB below the pure tone threshold in the suspect ear Press the present button If the patient indicates they heard the tone thi...

Page 60: ...the USB flash drive into the computer and ensure the computer is connected to the Pello via USB cable The Pello should be powered on Follow the on screen installation prompts to load the Config App to...

Page 61: ...settings and the information for 2 speakers if used may also be defined in this section Please see the Pello Config App manual for further information Printout Tab Report preferences are determined b...

Page 62: ...on the transducer being used GSI Instrument Services Description GSI Instrument Services allows electronic transmission of test parameter information from the Pello to an external computer with a sin...

Page 63: ...addition of comments into a report The report data is saved in a PDF or other format that may be saved to the local PC a remote location or attached with electronic medical data records EMR GSI Suite...

Page 64: ...transducer on your head Activate both Interrupt buttons Bend the cord next to the plug at both ends of each earphone Listen for an intermittent signal abrupt changes in the signal level or a scratchy...

Page 65: ...the calibration should be verified Masking Level Check Select the Tone test type Ensure the stimulus is narrow band noise on Channel 2 Activate the Channel 2 Interrupt button and listen for a smooth e...

Page 66: ...by an application of EPA registered hospital disinfectant Do not use any abrasive cleaners Use of a non alcohol based disinfectant is recommended for larger areas and headphones Non alcohol based pro...

Page 67: ...iogram range 8 kHz 20 kHz The High Frequency Range display does not have the data calculations for the PTA or SII Full audiogram range 125 Hz 20 kHz NOTE The High Frequency license option is required...

Page 68: ...equency Test Procedure High frequency testing above 8000 Hz may be completed by using the Range Selection button on the Navigation Menu to select the high frequency range 8 000 to 20 000 Hz or the ful...

Page 69: ...r pushbuttons may be used to start pause stop and clear the timer The timer is displayed in the test area of the screen The timer may be set to stop at 1 2 3 or 4 minutes The timer may be paused and r...

Page 70: ...ase requires mouse Prt Sc Print Signal Types Two additional signal types are added to the Signal Menu with Special Test license Ped Noise Pediatric noise a steeply filtered noise providing a frequency...

Page 71: ...scribed screens The Navigation Menu has a single option for the dB Step in addition to the comment icon Test results should be noted in the comments Test Procedure Alternate Binaural Loudness Balance...

Page 72: ...f followed by Channel 2 at 400 msec on 400 msec off Keeping the level fixed in the reference ear vary the hearing level of the tone presented to the test ear Record the level at which the patient judg...

Page 73: ...of the display has the common elements found on all the previously described screens The center section displays the results of the testing Using the Correct Incorrect score buttons obtain a percenta...

Page 74: ...uditory disorders not in the cochlea or normal hearing equals Negative SISI Presentation Level Set the attenuator to 20 dB SL re the pure tone threshold for the test frequency Test Instructions You wi...

Page 75: ...esence of ipsilateral continuous background noise and a 2 dB final step size is used to measure thresholds The test was designed for detecting the presence of cochlear dead regions and defining their...

Page 76: ...ion Level If the hearing loss is 60 dB or less start the TEN noise level at 70 dB If the hearing loss is 70 dB or greater start the TEN level 10 dB higher than the threshold If the TEN is reported to...

Page 77: ...d when the patient presses the response button or may be started manually from the Correct Start button on front panel When the patient response button is released it pauses the timer and when pressed...

Page 78: ...ase the hand switch only when the tone becomes inaudible Test Procedure Select Tone Decay from the More Tests Menu Present the continuous tone at the selected hearing level When the patient responds b...

Page 79: ...behavior of the Auto Play option The auto play option may be defined to do one of the following wait for a score score as correct incorrect or no score when the time expires Scorer Timer The Correct...

Page 80: ...1 and 2 Output sections that are similar to what has been described for the speech displays Scoring Window There are two scoring windows in the middle of the top section of the display The scoring win...

Page 81: ...igation Menu to highlight the sentence and pressing the present button When a sentence is being presented the background will be highlighted yellow The sentences are scored by pressing the correct or...

Page 82: ...esearch 2001 Killion et al 2004 was designed to provide a quick estimate of SNR Loss and is appropriate for use with most adults The sentences used in the QuickSIN are at approximately a high school l...

Page 83: ...y become louder making it difficult to understand the woman s voice but please guess and repeat as much of each sentence as possible Test Procedure Select BKB SIN from the More Tests Menu Select the p...

Page 84: ...nel 1 and 2 Output sections that are similar to what has been described for the speech displays Scoring Window There are two scoring windows in the middle of the top section of the display The scoring...

Page 85: ...imes If more sentences are on the list than can be displayed additional pages are used This is indicated in the top right area of the sentence list title bar There are up down arrows that allow moveme...

Page 86: ...Channel 2 to 70 dB HL For PTA of 50 dB HL or greater set the attenuators to a level that is judged to be loud but okay The sound should be perceived as loud but not uncomfortably loud Test Instructio...

Page 87: ...tes or recipients The word lists are located in the Word Lists menu under CD name in the Speech Test Type screen Each CD contains 15 lists of 20 sentences each Test Procedure Select the desired list f...

Page 88: ...o 120 dB HL High Frequency 20 dBHLto 100dB HL DD450 Bone Conduction B81 10 dBHLto 90dBHL mastoid 10 dBHLto80dBHL forehead 10dB tolerance SoundField 10 dBHLto90dBHL amplified speakers 10 dB HL to 102 d...

Page 89: ...ms at 32 Ohm 1 5Vrms at 8 Ohm load 60 20 000Hz 3dB Free Field Power Amplifier and Speakers With an input of 7 Vrms Amplifier and loudspeakers must be able to create a sound pressure level of 100 dB at...

Page 90: ...idity 10 to 95 non condensing Ambient Pressure Range 98 kPa to 104 kPa Background Sound Level 35 dB A Storage Temperature 0 C to 50 C 32 F to 122 F Transport Temperature 20 C to 50 C 4 F to 122 F Qual...

Page 91: ...ithin 5 dB at 125 6 000 8 000 and 12 000 Hz in the earphones the GSI Pello should be scheduled for immediate maintenance It is not possible to select a dB HL value outside the limits for a particular...

Page 92: ...1 12 11 14 10 5 6000 Hz 20 5 16 13 5 16 17 21 6300 Hz 19 21 13 5 21 17 5 21 5 8000 Hz 12 15 5 13 15 5 17 5 23 9000 Hz 19 27 5 10000 Hz 22 18 11200 Hz 23 22 12000 Hz 17 5 11 0 12500 Hz 27 5 27 14000 Hz...

Page 93: ...ise Non linear 6 7 5 7 5 7 5 5 5 2 White noise in speech 21 22 5 22 5 22 5 21 5 17 DD45 GF GC PTB DTU report 2009 2010 TDH50 GF GC ANSI S3 6 2010 HDA200 GF GC ANSI S3 6 2010 and ISO 389 8 2004 HDA300...

Page 94: ...5 4 5 2 3 3 5 1 Speech noise Non linear 6 7 5 7 5 7 5 5 5 2 White noise in speech 22 5 22 5 22 5 22 5 22 5 22 5 DD45 GF GC PTB DTU report 2009 2010 TDH50 GF GC ANSI S3 6 2010 HDA200 GF GC ANSI S3 6 2...

Page 95: ...120 120 Tone 800 Hz 120 120 120 120 120 120 Tone 1000 Hz 120 120 120 120 120 120 Tone 1250 Hz 120 120 120 120 110 120 Tone 1500 Hz 120 120 120 120 115 120 Tone 1600 Hz 120 120 120 120 115 120 Tone 200...

Page 96: ...800 Hz 11 5 13 5 13 5 13 5 11 9 NB 1000 Hz 12 13 5 13 5 13 5 11 5 8 NB 1250 Hz 13 13 5 13 5 13 5 12 8 5 NB 1500 Hz 14 13 5 13 5 13 5 11 5 9 NB 1600 Hz 14 14 14 5 14 11 5 8 5 NB 2000 Hz 14 15 17 15 10...

Page 97: ...110 105 105 100 105 NB 1000 Hz 110 110 105 105 100 105 NB 1250 Hz 110 110 105 105 95 105 NB 1500 Hz 110 110 105 105 100 105 NB 1600 Hz 110 110 105 105 100 105 NB 2000 Hz 110 110 100 100 100 105 NB 250...

Page 98: ...85 80 95 Speech noise Non linear 115 115 110 110 105 120 White noise in speech 95 95 95 95 90 100 Earphones IEC Speech max HL Transducer DD45 DD45 TDH50 TDH50 HDA200 DD450 HDA300 Impedance 10 10 60 60...

Page 99: ...5 1250 Hz 2 2 8 5 8 5 1500 Hz 2 2 9 5 9 5 1600 Hz 2 2 9 5 9 5 2000 Hz 3 3 11 5 11 5 2500 Hz 5 5 13 5 13 5 3000 Hz 3 5 3 5 13 13 3150 Hz 4 4 13 13 4000 Hz 5 5 5 5 15 15 5000 Hz 5 5 18 5 18 5 6000 Hz 2...

Page 100: ...ot linear level 1 kHz RETSPL ANSI S3 6 2010 DD45 TDH50 HDA200 HDA300 and EAR 3A IP30 B71 B81 12 5 dB 1 kHz RETSPL ANSI S3 6 2010 no weighting Insert Earphones IEC Speech RETSPL Transducer EAR3A IP30 E...

Page 101: ...115 115 115 115 115 115 115 115 Tone 800 Hz 115 115 115 115 115 115 115 115 Tone 1000 Hz 120 120 120 120 120 120 120 120 Tone 1250 Hz 120 120 120 120 120 120 120 120 Tone 1500 Hz 120 120 120 120 120 1...

Page 102: ...0 Hz 9 9 12 5 12 5 NB 750 Hz 7 7 11 11 NB 800 Hz 6 5 6 5 10 5 10 5 NB 1000 Hz 6 6 11 5 11 5 NB 1250 Hz 8 8 14 5 14 5 NB 1500 Hz 8 8 15 5 15 5 NB 1600 Hz 8 8 15 5 15 5 NB 2000 Hz 9 9 17 5 17 5 NB 2500...

Page 103: ...NB 800 Hz 110 105 110 105 110 105 110 105 NB 1000 Hz 110 105 110 105 110 105 110 105 NB 1250 Hz 110 105 110 105 110 105 110 105 NB 1500 Hz 110 105 110 105 110 105 110 105 NB 1600 Hz 110 105 110 105 1...

Page 104: ...10 105 105 105 105 105 Speech noise Speech noise Equ FF Speech noise Non linear 100 100 100 100 100 100 100 100 White noise in speech 95 95 95 95 85 85 85 85 Insert Earphones IEC Speech max HL Transdu...

Page 105: ...9 1000 Hz 42 5 51 42 5 51 1250 Hz 39 49 39 49 1500 Hz 36 5 47 5 36 5 47 5 1600 Hz 35 5 46 5 35 5 46 5 2000 Hz 31 42 5 31 42 5 2500 Hz 29 5 41 5 29 5 41 5 3000 Hz 30 42 30 42 3150 Hz 31 42 5 31 42 5 40...

Page 106: ...t linear level 1 kHz RETSPL ANSI S3 6 2010 DD45 TDH50 HDA200 HDA300 and EAR 3A IP30 B71 B81 12 5 dB 1 kHz RETSPL ANSI S3 6 2010 no weighting Bone Vibrators IEC Speech RETSPL Transducer B71 B71 B81 B81...

Page 107: ...5 75 60 Tone 750 Hz 70 55 75 60 Tone 800 Hz 70 55 75 60 Tone 1000 Hz 75 65 85 75 Tone 1250 Hz 75 65 90 80 Tone 1500 Hz 80 60 90 80 Tone 1600 Hz 80 60 90 75 Tone 2000 Hz 80 60 90 75 Tone 2500 Hz 75 60...

Page 108: ...5 53 5 66 5 NB 800 Hz 52 64 52 64 NB 1000 Hz 48 5 57 48 5 57 NB 1250 Hz 45 55 45 55 NB 1500 Hz 42 5 53 5 42 5 53 5 NB 1600 Hz 41 5 52 5 41 5 52 5 NB 2000 Hz 37 48 5 37 48 5 NB 2500 Hz 35 5 47 5 35 5 4...

Page 109: ...50 NB 750 Hz 60 45 65 50 NB 800 Hz 60 45 65 50 NB 1000 Hz 60 50 70 60 NB 1250 Hz 65 55 75 60 NB 1500 Hz 65 50 75 60 NB 1600 Hz 65 50 75 60 NB 2000 Hz 65 50 70 55 NB 2500 Hz 65 50 65 50 NB 3000 Hz 60 4...

Page 110: ...eech noise Speech noise Equ FF Speech noise Non linear 50 40 50 40 White noise in speech 50 40 60 50 Bone Vibrators IEC Speech max HL Transducer B71 B71 B81 B81 Impedance 50 50 10 10 Coupler Mastoid F...

Page 111: ...95 95 110 750 2 4 1 1 2 6 100 100 110 1000 2 4 1 6 3 1 100 100 110 1500 2 4 1 1 2 6 100 100 110 2000 1 3 4 3 3 3 100 100 115 3000 5 8 10 8 8 3 105 105 115 4000 5 4 9 4 4 9 105 105 115 6000 4 3 3 2 5...

Page 112: ...Insert x 2 Bone Ground Signal Talkback Patient Response Ground DC Bias Signal Ext CD Ground CD2 CD1 Talk Forward Ground DC Bias Signal Monitor Ground Right Left FF x 2 Ground Signal USB A x 4 Host US...

Page 113: ...is instrument and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than those specified or provided by the manufacturer...

Page 114: ...1 1 2 Medical Electrical Equipment Part 1 Electromagnetic Compatibility Requirements and Tests Guidance and Manufacturer s Declaration Electromagnetic Emissions The GSI Pello is intended for use in th...

Page 115: ...he maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not a...

Page 116: ...er Frequency 50 60 Hz IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note UT is the...

Page 117: ...electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Pello is used exceeds the appl...

Page 118: ...ld Audiometry Guidelines Available from www asha org policy Margolis R H and Morgan D E 2004 Automated Pure Tone Audiometry An Analysis of Capacity Need and Benefit American Journal of Audiology Vol 1...

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