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                                                             50 

D-0126050 rev 1 -  

270+ Operating Manual                                                            

 

Guidance and manufacturer’s declaration – electromagnetic immunity (2) 

The  Model  270+  Audiometer  is  intended  for  use  in  the  electromagnetic  environment  specified  below.  The 
customer or user of the Model

 

270+ Audiometer should assure that it is used in such an environment. 

Immunity test

 

IEC 60601 

test level

 

Compliance 

level

 

Electromagnetic environment 

– guidance

 

 

 

 

 

 

 

 

 

 

 

 

Conducted RF 

IEC 61000-4-6 

 

 

Radiated RF 

IEC 61000-4-3 

 

 

 

 

 

 

 

 

 

 

 

3 Vrms 

150kHz to 
80MHz 

 
 
3 V/m 

80MHz to 
2.5GHz 

 

 

 

 

 

 

 

 

 

 

 

3 Vrms 

 
 
 
 

3 V/m 

Portable  and  mobile  RF  communications  equipment 
should be used no closer to any part of the Model 270+ 
Audiometer,  including  cables,  than  the  recommended 
separation  distance  calculated  from  the  equation 
applicable to the frequency of the transmitter. 

Recommended separation distance 

d = 1.2√P 

d = 1.2√P 80MHz to 800MHz 

d = 2.3√P 800MHz to 2.5GHz 

where  P  is  the  maximum  output  power  rating  of  the 
transmitter  in  Watts  (W)  according  to  the  transmitter 
manufacturer  and  d  is  the  recommended  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

 

 

Interference  may  occur  in  the  vicinity  of  equipment 
marked with the following symbol: 

 

 

 

 

NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. 

 

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption 
and reflection from structures, objects and people. 

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and 
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted 
theoretically with accuracy. To assess the 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 Model 270+ Audiometer is used exceeds the applicable RF compliance level above, the Model 270+ 
Audiometer  should  be  observed  to  verify  normal  operation.  If  abnormal  performance  is  observed, 
additional measures may be necessary, such as re-orienting or relocating the Model 270+ Audiometer. 

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

Содержание 270+

Страница 1: ...270 Operating Manual...

Страница 2: ...ured by Amplivox Ltd 3800 Parkside Solihull Parkway Birmingham Business Park Birmingham West Midlands B37 7YG www amplivox com For all enquiries please contact us under Amplivox Ltd 10393 West 70th St...

Страница 3: ...Operation 12 2 4 CONNECTIONS 12 2 5 CONTROLS AND INDICATORS BASE UNIT 13 2 6 LIGHT INDICATORS 14 2 7 HARDWARE INSTALLATION 14 2 8 THE SANIBEL MPT II PRINTER 15 2 8 1 Installing the sanibel MPT II Pri...

Страница 4: ...Masking Intelligence 29 4 8 4 3 Manual Masking 29 4 8 5 Automatic testing Pure tone audiometry 30 4 8 6 Automatic testing with masking Pure tone audiometry 30 4 8 7 Freefield presenting Tone Testing...

Страница 5: ...STICS 46 7 EMC GUIDANCE MANUFACTURER S DECLARATION 47 8 APPENDIX A FREE FIELD CALIBRATION PROCEDURE 52 8 1 GENERAL 52 8 2 ASSURANCE OF CALIBRATION 52 8 3 EXTERNAL LOUDSPEAKER 52 8 4 CALIBRATION SET UP...

Страница 6: ...ipment without the necessary knowledge and training The audiometer is capable of undertaking both air and bone conduction tests with or without masking and has many additional features such as the fac...

Страница 7: ...8011512 OPTIONAL ACCESSORIES Masking monitor earpiece 2 8507921 Audiocups add on noise reducing earphone enclosures 1 8010855 Microphone and monitor headset 8507435 Foam Eartips for Insert Phones stan...

Страница 8: ...bol Explanation Refer to instruction manual Definition Type B applied part an applied part providing protection against electric shock particularly regarding allowable patient leakage current and pati...

Страница 9: ...ack Patient talkback microphone 6 35 mm jack Line Out for external amplifier 3 5 mm jack 2 3 SAFETY INSTRUCTIONS 2 3 1 GENERAL The following safety precautions must be observed at all times General sa...

Страница 10: ...he equipment are allowed by anyone other than a qualified Amplivox Ltd representative Modification of the equipment could be hazardous Amplivox Ltd will make available on request component part lists...

Страница 11: ...the safety requirements stated in the general standard IEC 60601 1 edition 3 1 clause 16 Any equipment not complying with the leakage current requirements in IEC 60601 1 must be kept outside the pati...

Страница 12: ...nent damage to the instrument and its accessories Do not place the instrument next to a heat source of any kind Great care should be exercised when handling transducers as rough handling for example d...

Страница 13: ...th electronic circuit protection In case of overload the adapter will shut down When the fault is cleared the adapter will operate as normal However the input to the mains adapter is protected with a...

Страница 14: ...601 1 and IEC 60601 1 2 The use of accessories other than those specified may compromise compliance with these standards 2 5 CONTROLS AND INDICATORS BASE UNIT The 270 consists of an LCD screen three b...

Страница 15: ...to activate talkover and talkback 12 Present Present test stimulus 13 Store Save measured point 2 6 LIGHT INDICATORS The indicators on the 270 show the status of the selected ear and test mode LIGHT L...

Страница 16: ...wer ON or OFF One short beep will be heard at power ON two short beeps at power OFF The green power indicator will be lit if the printer is powered by battery 2 8 3 USING THE PRINTER Printer self test...

Страница 17: ...r hearing or if not specified differently on the right ear The BSA British Society of Audiology recommends starting the test at 1000 Hz to then next measure the higher frequencies When done with the h...

Страница 18: ...ents into the transducer 2 Do not drop and avoid other undue impact to this device If the instrument is dropped or in any other way damaged return it to the manufacturer for repair and or calibration...

Страница 19: ...the power button when switching on An additional display will allow the selection of English F1 or Deutsch F2 After selecting a language the start up screen will show 4 5 SYSTEM INFORMATION The syste...

Страница 20: ...se this to talk to the patient the internal or an external headset can be used Please note It is not possible to use both an external and an internal microphone at the same time The used microphone ne...

Страница 21: ...el and frequency In order to clear the screen display select CLEAR Use the F1 to F4 to either clear the current shown test result F1 or to store the data by choosing a reference number using F3 and co...

Страница 22: ...tton again to leave the menu without changes 4 6 6 2 CONTINUOUS PRESENT AND PULSE In the tone audiometry module select F1 to choose between present pulse continuous and continuous pulse Select NORMAL...

Страница 23: ...bone conduction Selecting F3 will utilise the connected loudspeakers to present the signal via FREEFIELD Select CANCEL F4 or the OUTPUT button again to leave the menu without changes 4 6 10 AUTO AUTO...

Страница 24: ...ness Balance ABLB Short Increment Sensitivity Index SISI Master Hearing Aid MHA Hearing Loss Simulation HLS Decay Test Carhart Test Select the NEXT F2 or the Channel 1 rotary control to move through t...

Страница 25: ...th the latest changes stored ITEM DESCRIPTION DEFAULT Present Time Select the time that a stimulus can sound when the PRESENT key is pressed either continuously while the present button is pressed or...

Страница 26: ...no No Store on Automatically stores a threshold if the responses made for two out of three test signals are at the same hearing level 3 out of 5 Frequencies Choose the test frequencies which shall be...

Страница 27: ...4 PRINT The Sanibel MPT II is the designated thermal printer to be used with the 270 Learn more about the MPT II printer in chapter 2 8 When using the printer ensure it is switched on and ready to pr...

Страница 28: ...quency in this example masking is off 5 Stored Test Level Left Ear Test Level stored for Left Ear or Loaded Test Level from previous Test 6 Stored Test Level Right Ear Test Level stored for Right Ear...

Страница 29: ...he patient response switch the LED above the display labeled with RESPONSE will illuminate Store the obtained threshold for the selected frequency by pressing the store button The stored threshold wil...

Страница 30: ...tive However the masking level is judged to be too high It is recommended to decrease the masking intensity until the v disappears 4 8 4 3 MANUAL MASKING When the masking channel is active the LED rin...

Страница 31: ...in one attempt and no inconsistent answer is given in between To pause an automatic test select F4 From here the test can be continued F3 the current tested frequency can be skipped or the sequence c...

Страница 32: ...air conduction test signals sinusoid warble pulsed test signal via a loudspeaker Select the OUTPUT button to find your FFIELD option and confirm the output by pressing softkey F3 Please note When two...

Страница 33: ...er line in e g CD or external Mic eMic for presenting the speech signals Use F2 to change between the two 6 Monitor Level above shows the current monitor level 7 Gain Level above shows the current gai...

Страница 34: ...ine input is intended for connection to audio playback devices that are able to output signals where the line level voltage amplitude is around 0 707Vrms Using other types of output i e headphone sock...

Страница 35: ...hoose the preferred option of manual or tracked masking As soon as masking is active the light ring around the Channel 2 rotary control is illuminated and speech weighted masking is now routed to the...

Страница 36: ...l illuminate To start the sequence adjust the test tone in the poorer ear to be presented at 10 to 20dB above the indicated threshold and the test tone in the better ear to be 20dB above threshold The...

Страница 37: ...th cochlear impairment It is necessary to have an audiogram done before the SISI test can be performed When SISI is selected in the SPECIAL menu SISI will be shown in the ear selected Both ears will b...

Страница 38: ...ing MHA you will be taken to the Speech Module to start the hearing aid simulation Select F3 to change the filter settings and to present different hearing losses to the subject Use softkey F2 to chan...

Страница 39: ...return to the Tone Audiometry Screen 4 10 6 PERFORMING DECAY The Decay Test also known as the Carhart Test is used in subjects with sensitivity loss to measure fatigue It is necessary to have an audi...

Страница 40: ...mputer and subsequently viewed annotated printed This software is supplied on a USB stick which includes this operating manual Refer to the installation operating instructions provided with NOAH Audil...

Страница 41: ...detergent or similar Always disconnect the mains power adaptor during the cleaning process and be careful that no fluid enters the inside of the instrument or accessories 5 After each patient examinat...

Страница 42: ...your Amplivox distributor requesting the relevant part number Handle the audiometric headset bone vibrator headset and other accessories with care For parts that are in direct contact with the patien...

Страница 43: ...Amplivox Ltd is only considered to be responsible for the validity of the CE marking effects on safety reliability and performance of the equipment if assembly operations extensions readjustments modi...

Страница 44: ...incidental indirect or consequential damages in connection with the purchase or use of any Amplivox Ltd product This shall apply solely to the original purchaser This warranty shall not apply to any...

Страница 45: ...F to 95 F Operating humidity 30 to 90 RH non condensing Operating atmospheric pressure 700 hPa to 1060 hPa Transport storage temperature 20 C to 70 C 4 F to 94 F Transport and storage humidity 10 to...

Страница 46: ...Insert Masking Earpiece Calibration method With 2cc coupler compliant with IEC 126 Test Signals Frequency AC 0 125 8 kHz BC 0 25 8 kHz Frequency accuracy 1 Distortion 2 Output level range AC 10dBHL t...

Страница 47: ...trical Voltage requirement at 0dB input level setting to zero meter 1 20Vrms at 1kHz Output level 90dBSPL at 1kHz for attenuator setting of 70dBHL with level meter at 0dB 6 5 MAXIMUM HEARING LEVELS PR...

Страница 48: ...sducers and cables can be found in this appendix Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches t...

Страница 49: ...Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic immunity 1 The Model 270 Audiometer is intended for use in the electromagnetic en...

Страница 50: ...dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the Model 270 Audiometer requires continued opera...

Страница 51: ...om fixed 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...

Страница 52: ...ommunications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d...

Страница 53: ...ration which would then need to be repeated when warble tone testing is required 8 2 ASSURANCE OF CALIBRATION It must be emphasised that it is the responsibility of the equipment operator to ensure th...

Страница 54: ...set the output to 70dBHL and adjust the external amplifier to give a reading of 90dBSPL as measured by the SLM at the reference point The response should then be checked to be within the following li...

Страница 55: ...ble tones The audiometer will now output at 70dBHL from the Left channel As reference for the calibration of warble tone sound pressure levels the values from ISO 389 7 Table 1 are used binaural on ax...

Страница 56: ...the F2 softkey and the display will change to indicate the option to adjust the competing noise calibration level the legend Sp Mask is used to indicate this 3 Without changing the setting on the ext...

Страница 57: ...to reduce any potential hazard associated with the use of mains powered equipment connected to these inputs and outputs SOCKET LABEL SOCKET TYPE TYPICAL CONNECTION DATA 6 pin mini DIN Printer LINE IN...

Страница 58: ...57 D 0126050 rev 1 270 Operating Manual Diagram 1 270 used with the medically approved mains adapter Mains Outlet Medical Mains Adapter Model 270 Audiometer...

Страница 59: ...rev 1 270 Operating Manual Diagram 2 270 used with the medically approved mains adapter and printer Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet Printer Power Supply Printer vi...

Страница 60: ...0126050 rev 1 270 Operating Manual Diagram 3 270 used with the medically approved mains adapter and PC Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet PC Power Supply PC via USB s...

Страница 61: ...0126050 rev 1 270 Operating Manual Diagram 4 270 used with the medically approved mains adapter and CD Tape player Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet CD tape MP3 Pla...

Страница 62: ...1 D 0126050 rev 1 270 Operating Manual Diagram 5 270 used with the medically approved mains adapter and external amplifier Mains Outlet Medical Mains Adapter Model 270 Audiometer Mains Outlet Amplifie...

Страница 63: ...v 1 270 Operating Manual Copyright 2020 Amplivox Ltd 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 o...

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