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Operation Manual PILOT TEST

 

 

 

8504660

 Rev. 

3

 

6 

06/11/2019 

 

2.2  Regulatory Symbols 

The following Table 1 gives an explanation of the symbols used on the device itself, 
on the packaging and the accompanying documents including the Operation Manual. 

Table 1 Regulatory Symbols 

REGULATORY SYMBOLS

 

SYMBOL 

DESCRIPTION 

 

 

 

 

 

Serial number 

 

Date of manufacture  

 

Manufacturer 

 

Caution, consult accompanying documents 

 

Warning, consult accompanying documents 

 

Return to authorized representative, special disposal required 

  

Reference number 

 

Patient applied part type B according to IEC 60601-1 

 

Refer to instruction manual (mandatory) 

 

Keep away from rain 

 

Transport and storage temperature range 

 

Transport and storage humidity limitations 

 

Voltage transformer 

 

Conforms to European Medical Device Directive 93/42/EEC  

 

ETL listed mark 

 

Logo 

 

 

 

Содержание PILOT TEST

Страница 1: ...Operation Manual PILOT TEST...

Страница 2: ......

Страница 3: ...ibility EMC 9 3 Warranty Maintenance and After Sales Service 10 3 1 Warranty 10 3 2 Maintenance 10 3 3 Cleaning and Disinfection Recommendations 10 3 4 Components and Replacement Parts 11 3 5 Recyclin...

Страница 4: ...biz Internet www maico biz Copyright 2019 MAICO Diagnostics All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permi...

Страница 5: ...iliar with the operation and functions of the PILOT TEST If you have questions or suggestions for further improvements please do not hesitate to contact MAICO 1 2 Intended Use and Indications for Use...

Страница 6: ...ld levels can be determined by presenting pure tone test signals to the child with the included headphones air conduction AC The purpose of AC audiometry is to establish the hearing sensitivity at var...

Страница 7: ...y information as well as maintenance and cleaning recommendations READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this manual All images and screensho...

Страница 8: ...PTION Serial number Date of manufacture Manufacturer Caution consult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Referen...

Страница 9: ...y worn distorted or contaminated should be replaced immediately with clean genuine replacement parts manufactured by or available from MAICO NOTE Customer responsibility includes proper maintenance an...

Страница 10: ...to be conducted when a defected headphone is replaced Uncalibrated devices may lead to faulty measurements and sometimes even damage the hearing of the examinee 2 7 Electrical Safety and Measuring Sec...

Страница 11: ...If such use is necessary this device and the other equipment should be observed to verify that they are operating normally Please also refer to EMC consideration in Section 6 5 Use of accessories tran...

Страница 12: ...manufacturer In the event of repair during the guarantee period please enclose evidence of purchase with the device 3 2 Maintenance In order to ensure that the device works properly it has to be check...

Страница 13: ...t fluids have contacted the system components or accessories the unit should not be used until deemed safe by a MAICO certified service technician Do not use hard or pointed objects on the device or i...

Страница 14: ...with a crossed out wheeled bin Within the limits of Article 9 of DIRECTIVE 2002 96 EC on waste electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additional distri...

Страница 15: ...mediately to report the shortage If any component appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appears to be d...

Страница 16: ...ard English PILOT TEST Picture Board Spanish PILOT TEST Laminated Chart English PILOT TEST Laminated Chart Spanish Headphones DD45 with HB7 Headband DD65 V2 Applied parts according to IEC 60601 1 Sele...

Страница 17: ...eadphones L Left Blue 4 2 3 Storage When the PILOT TEST is not in use store in a location where it will be safe from damage to the display acoustic transducers and cables Store according to the recomm...

Страница 18: ...for audiometric equipment 5 1 2 Where to Setup The PILOT TEST should be operated in a quiet room so that the audiometric examinations are not influenced by outside noises Ambient sound pressure levels...

Страница 19: ...ating Instructions Start Stop Start Stop of PILOT TEST Enter Store response during test Pause Temporily stop PILOT TEST Audiometer Starts Tone Audiometry Forward PILOT TEST Next word Audiometry Pulse...

Страница 20: ...ord Group The prerecorded list of test words that are played There are 4 test groups available for selection 4 Status of the test being performed Options include Test Stopped No Group is being played...

Страница 21: ...child for pictures to be selected Place the headphones on red side on the right ear blue side on the left ear and make sure that they are secure Adjust the headband of the headphones so that the trans...

Страница 22: ...ure board and the tester marks the response See Section 5 2 5 on scoring results The test will automatically go to the next sentence and the volume level decreases to 45 dB HL Continue to mark the ans...

Страница 23: ...the child for further audiometric examination The child has passed when both ears have been tested and pass criteria met Protocol recommendation The above is an example screening protocol Users are t...

Страница 24: ...anguage options that are programmed into the device Press the arrow key until the language you wish to select is highlighted and press Enter Select the Menu key to exit and return to the test screen 5...

Страница 25: ...the screen e g 30 dB Table Hearing level is displayed within the right lower box 3 Tone Touch the Tone bar to present the signal When a signal is presented to the child the Stimulus box is in black Si...

Страница 26: ...a tone is heard at least 50 of the time The test normally starts at 1000 Hz on the better ear A procedure of down 10 dB when heard up 5 dB when not heard is typically utilized to establish a threshold...

Страница 27: ...ne frequency This provides a reliability check to the response If child does not meet this criteria record Refer and continue testing When one ear is completed select the other ear L R key and start t...

Страница 28: ...key as defined on the screen If a printer is not connected and powered on at time of accessing the Delete Print screen the Print and Print Delete will not be shown Figure 11 Figure 10 Figure 11 5 4 2...

Страница 29: ...diogram Figure 13 or table format Figure 14 dependent on the settings made Figure 13 Figure 14 PILOT TEST results are shown in short table view Figure 15 or a table with Pictures Figure 16 dependent o...

Страница 30: ...ection Press the Enter key to choose a submenu or to select a new setting Press the Menu key again to exit the sub menu and save the new settings After leaving the User menu you will return to the tes...

Страница 31: ...es can be set between 1 s and 20 s Default length is 3 s Print Size Selection is between Short where only numerical data will print or with Pictures where the test word picture is shown A checkmark is...

Страница 32: ...er Tone is interrupted stopped when the Tone key is touched Frequency change after saving When On the next frequency is selected upon storing the result If this function is switched Off the next frequ...

Страница 33: ...st i e 8 kHz or lowest 125 Hz test frequency device returns to 1 kHz automatically When set to Off it will continue to next highest lowest frequency Level increase This function sets the direction of...

Страница 34: ...correct date and time of the device for printing of tests Figure 28 Move to the available field with the arrow keys To make a change use the arrow keys Date Set the current date Date format Select th...

Страница 35: ...cord plugged in correctly in the power connector Is the wall outlet working No sound from headphone Disturbed connection Is the headphone cable plugged in correctly to the socket Is the lead loose or...

Страница 36: ...ormation About Specifications The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once per year MAICO Diagnostics puts diagrams a...

Страница 37: ...ght 1 3 kg 2 9 lbs Dimensions 305 mm x 260 mm x 65 mm 12 01 in x 10 24 in x 2 56 in Display TFT LCD Panel 5 0 in Active size 110 88 mm x 62 83 mm 4 37 in x 2 30 in User interface Push button Language...

Страница 38: ...0 0 N 0 5 N Tone Audiometry Inputs Pure tone Outputs Left Right Free Field only for conditioning Accuracy Frequency 2 Level 3 dB Tone Stimuli Headphone intensity 10 dB HL to 100 dB HL with exception o...

Страница 39: ...in x 2 41 in Weight 475 8 g 17 8 oz without paper roll Paper Continuous paper Paper Width 80 mm Paper Thickness 0 053 mm to 0 100 mm Paper Roller Diameter 50 mm To be printed on paper roll Printing t...

Страница 40: ...OR PIN 1 PIN 2 PIN 3 Mains DC socket Rated current international 250 V 2 5 A L Live G Ground N Neutral Phone L 6 3 mm Mono Ground Signal Phone R Free Field Patient Response Monitor 3 5 mm Stereo Groun...

Страница 41: ...2018 AAU Report 2018 DD45 DD65 V2 Frequency Hz Tone RETSPL dB re 20 Pa Tone Max Level Sound Attenua tion dB ISO 4869 1 Tone RETSPL dB re 20 Pa Tone Max Level dB HL Sound Attenua tion dB ISO 4869 1 12...

Страница 42: ...ST Install and operate the PILOT TEST according to the EMC information presented in this Section The PILOT TEST has been tested for EMC emissions and immunity as a standalone device Do not use the PIL...

Страница 43: ...is intended for use in the electromagnetic environment specified below The customer or the user of the PILOT TEST should assure that it is used in such an environment Immunity Test IEC 60601 Test lev...

Страница 44: ...ded separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Inte...

Страница 45: ...e are cleaned Cushions of the headphone are undamaged Test subject PILOT TEST carried out with test person correct answer x wrong answer na no answer Level dB HL Word from Group 1 Test person s answer...

Страница 46: ...Operation Manual PILOT TEST 8504660 Rev 3 44 06 11 2019 6 6 2 Checklist for subjective Audiometer Testing...

Страница 47: ...ecifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail sales maico biz Internet www maico b...

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