AUDIOMETER SIBELMED AS5
Contents
1. 2 Plug power connection in base N 19 and in its electric supply of 220V 50Hz other options on request 3 Connect air conduction earphones bone conduction vibrator and patient s response connection to their corresponding bases 9 13 14 15 and 16 in accordance with the colours code des cribed in section 1 3 2 4 Drive switch N 1 to I ON position It will light up and fig suononajsum Instructions Sibelmed AUDIOMETER AS5 User Manual 18 1 4 1 will be displayed on the screen ASS BUDIOMETER SIBELMED eB DC 1888 Fig 1 4 1 sure that when pressing SE AL SIGNAL 9 5 key you can hear the tone on the right earphone 5 Set the block of audiometric graphs in the place intended for them N 2 1 6 AUDIOMETRIC TESTS In this handbook the mechanics to carry out some basic au diometric explorations are explained These mechanics can be adapted to those criterions the specialist think more suitable Apart from these tests there exist other tests or variations of them which are not included here The procedures for these ca ses will be determined by the specialist It is advisable for those who are not very acquainted with these techniques to consult publications in the matter WARNING TRANSDUCER CALIBRATION BEWARE IN OWN TEAM IF USING A NO TRANSDUCER CALIBRATION TESTING DO NOT BE THAT AUDIOMETRIC VALID VA TRANSDUCER EACH LABEL WITH AUDIOMETER SE2. DO NOT use damaged accessories NEVER immerse any part of the equipment in liquid THIS COULD CAUSE AN ELECTRICAL DISCHARGE Sibelmed AUDIOMETER AS5 User Manual 7 To ensure vital safety features under the EN 60601 1 standard only equipment compliant with the electrical safety standards in force may be connected to this device To connect AS 5 to a non medical device with ground conductor you must install an additional ground conductor to the non medical device DO NOT use multiple mains sockets unless they comply with EN 60601 1 They can degrade electrical safety RISK OF EXPLOSION DO NOT use this equipment in the presence of anaesthetics or flammable gases THIS COULD CAUSE AN EXPLOSION INTERFERENCE RISK This is an electronic product so high frequency emissions can interfere with the correct use For this reason the products which can generate interferences radios cellular phones etc should be kept apart The portable or mobile radiofrequency devices can affect the normal functioning of the electronic medical devices This is a medical electronic device and as such it needs special precautions regarding the electromagnetic compatibility EMC and it should be installed and setup according to the EMC in formation attached See Appendix 1 ELECTROMAGNETIC COMPATIBILITY The use of transducers accessories and cables different to the ones specified here except the transducers and cables sold by the manufactur
3. RIAL NUMBER HAS BEEN WITH CALIBRATION MATCHING CHECK BEFORE USING THE TRANSDUCER HEADSET Vi brator Sibelmed 7 AUDIOMETER AS5 User Manual 19 1 6 1 PROCEDURE FOR DETERMINATION OF HEA RING THRESHOLD LEVELS THROUGH AIR CONDUCTION WITHOUT MASKING NOISE The SIBELMED AS5 audiometer has the following frequencies and tone levels for air conduction HZ 250 500 1000 2000 3000 4000 6000 8000 Max dB HTL 90 105 105 105 105 105 90 80 M n dB HTL 10 10 10 10 10 10 10 10 The place where the audiometry is going to be carried out has to be quiet It must not disturb the reception of minimum intensity tones generated by the audiometer It is absolutly necessary for the patient to be calm confortably sat and rested so that he can pay maximum attention to the test It is also advisable for the patient not to see the operator handling the audiometer during the examination The aim of this test is to determine the minimum hearing levels the patient can listen to hearing threshold level HTL The test is carried out by applying pure tones to each ear Hearing thres hold determination can be carried out by testing all the tones with one ear and then with the other or else testing successi vely each tone with one ear and then with the other For threshold determination you can proceed according the fo llowing steps or similar ones always in accordance with the specialist s criterions 1 Explain the patient what the examin
4. m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 800 MHz the separation distance for the higher frequency applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absortion and reflection from structures objects and people
5. mis function etc which might result from a defective maintenance by people not working directly in SIBEL S A 5 3 CORRECTIVE MAINTENANCE The corrective maintenance consist on fixing the equipment which it has been put out of service for bad operation or bad use In case of detecting a system break down which it does not permit a normal use disconnect the equipment from the mains power and contact the correspondent technical service specifi ying as detailed as possible the anomaly detected If the equipment needs a corrective maintenance it will be con venient also to perform the preventive maintenance described in the paragraph 5 2 2 OBJECTIVE CHECKUP This requirement must be specified to the technical service that fix the equipment since possible misfunctions can produce di sadjustments not easily to find without a checkup and calibra tion Sibelmed 7 AUDIOMETER AS5 User Manual Guidance and manufacturer s declaration electromagnetic emissions AS 5 AUDIOMETER is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment Guidance AS 5 uses RF energy only for its internal function The RF Radiated emissions Group 1 refore its RF emissions are very low and are not likely CISPR 11 EN 55011 Class B to cause any interference in nearby elec
6. need any special technical skill except the proper knowledge of the functions and manipulation of the equipment It can be performed by the same user The operations to be ca rried out are described below 5 1 1 CLEANING THE AUDIOMETER The audiometer can be wiped smoothly with a dry or sligthly water moistened cloth and then dried You must pay attention to no liquid go into the audiometer or its connectors Don t use abrasive or solvent substances 5 1 2 CLEANING THE ACCESORIES The cleaning method described before is also applied to the ac cesories Sibelmed AUDIOMETER AS5 User Manual 37 In the case of the air way headphone cushions they can be cleaned better if they are put out the headphone and washed with water and soap and dried perfectly before mounting in the headphone WARNING The bone way vibrator is a fragile device Little hits can break it So it is recommended to handle with care 5 2 PREVENTIVE MAINTENANCE The preventive maintenance consist on all those technical ac tions that keep the equipment in a good condition Some different actions can be performed but standart rules like ISO 8253 1 are suggested Sibel suggests at least to follow the next procedures 5 2 1 ROUTINE CHECKUP AND SUBJECTIVE TESTS This routine checkup will be performed once per week 1st Verify all the connections are connected and all the cables and connectors are in good condition 2nd Check subjectively that the audiom
7. AUDIOMETER SIBELMED AS5 USER MANUAL S belmed 7 520 500 MU2 e Rev 2 02 e 2013 06 Sibelmed 7 AUDIOMETER AS5 User Manual CONTENTS DECLARATION OF CONFORMITY SAFETY 1 OPERATING INSTRUCTIONS INTRODUCTION PRELIMINARY OBSERVATIONS AS 5 AUDIOMETER MODELS CONTROLS INDICATORS AND CONNECTORS INSTALLATION AND START UP AUDIOMETRIC TESTS TECHNICAL SPECIFICATIONS CONFIGURATION ACCORDING TO MODELS FREQUENCIESANDLEVELS MASKING NOISE TRANSDUCERS GENERAL INFORMATION APPLICABLE STANDARDS SIMBOLOGY USEFUL LIFE FUNCTIONAL DESCRIPTION GENERATOR AND TONES CONTROL MASKING SIGNAL FUNCTION SELECTOR AND CONDUCTION PATHS PROCESSOR PATIENT S RESPONSE KEYBOARD AND SCREEN POWERSUPPLY 4 AUDIOMETRIC TECHNIQUE 5 PRESERVATION PREVENTIVE AND CORRECTIVE MAINTENANCE 5 1 PRESERVATION 5 2 PREVENTIVE MAINTENANCE 5 3 CORRECTIVE MAINTENANCE 6 MODIFICATIONS APPENDIX 1 ELECTROMAGNETIC COMPATIBILITY pa pd pd pd pd pd 2 gt NNNNNNNN Lo WY La La W CO HR 5 Sibel med AUDIOMETER 55 User Manual e a C edi Revised Approved Date 2013 06 Date 2013 06 d Jos Maria Plana Carlos Recio Director T cnico Director Comercial PRODUCTO CONFORME 93 42 CEE Directiva de Productos Sanitarios Clase II a SIBEL S A Rossell 500 08026 Barcelona Espa a Tel 93 436 0008 Fax 93 436 16 11 Co
8. AUDIOMETER MODELS The set of SIBELMED AS5 audiometers is available in four ver sions with the following differences between them AS5 AOM With air conduction bone conduction and masking noise AS5 AO Without masking noise 5 Without bone conduction AS5 A Without masking noise and bone conduction The table below shows each model s built in features as stan dard Shadedo and other items which can be included as optio nal White You can upgrade to a higher model by adding the relevant features at any time All you need to do is contact the SIBEL S A Sales Department or your distributor Sibelmed AUDIOMETER AS5 User Manual 11 RELACI N DE CONTENIDO PACKING LIST P gina 1 de 1 AUDIOMETRO AS5 AS5 AUDIOMETER 520 SD8 D10 REV 4 00 201204 MODELOS MODELS DESCRIPCI N DESCRIPTION EIENEN ARE ASE AUDIONETER AVISO PACIENTE PATIENT SWITCH EGO AURICULARES VIA AEREA EARPHONE SET E ROJO RED PEN AZUL BLUE PEN RED 2m MAINS PLUG CABLE 2m CODE NC we a enese eme a c a Em 1 Bl eum a TT Wr li Hd JE E STANDARD OPCIONAL OPTIONAL DISPONIBLE AYAZ ARE rain T ODA LAS DU E D EREA T RARER AAA a l ia GALLO RO IN UH LUE PALA O PATA A Oe E PO IO
9. CEERLY AMT Be GINE RA PECERA TIRA POR COR EPI A ULL DO DO NON TARDA ART POCO OUR PCO 14 APE CUH IE ee OL PO AMT PAESE APTA FILI EDU AA OA ATEO Sibelmed AUDIOMETER AS5 User Manual 12 MANUFACTURER S RESPONSIBILITIES SIBEL S A guarantees the safety reliability and proper functio ning of this equipment provided that e The location where the equipment is installed complies with the UNE IEC requirements for electrical installations with an earth connection and such other standards as may apply e Repairs maintenance and modifications whether within the warranty period or otherwise are carried out by SIBEL S A te chnical staff e The equipment is used by qualified staff and in accordance with the recommendations in this Instruction Manual WARNING In accordance with the various standards we recommend testing and calibrating the electromedical equipment pe riodically in order to guarantee reliable operation of the functions and patient user and environmental safety In addition to the necessary routine maintenance of the AS 5 audiometer we recommend calibrating the transducers and performing a general check of the safety systems adjustments functions etc at least once every twelve months ISO 8253 1 This should also be done whenever there is reason to suspect that t
10. Devices DOCUMENTATION AND INFORMATION e EN 1041 2008 Information supplied by the manufacturer of medical devices e EN 15223 1 2012 Graphical symbols for use in labeling in me dical devices 2 Related to the manufacturer QUALITY e EN ISO 13485 2012 Quality management systems Require ments for regulatory purposes e EN ISO 9001 2008 quality management Requirements e EN ISO 14971 2012 Risk management in medical equipment WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of WAEE 2002 96 CE Directive 3 To be satisfied by the user AUDIOMETRY e EN ISO 8253 1 1998 Fundamental liminal audiometry of pure tones in air and bone conduction e EN ISO 8253 2 1998 Free field audiometry with test signals of pure tones and narrow bands noise e EN ISO 8253 3 1998 Vocal audiometry e EN 26189 1991 Tonal liminal audiometry for air conduction hearing preservation suonona4jsug Instructions Sibelmed AUDIOMETER AS5 User Manual 28 DATA PROTECTION e Compliance with LOPD and 95 46 CE Directive WASTE e RD 208 2005 Electrical and electronic equipment and waste management Transposition of WAEE 2002 96 CE Directive Sibelmed 7 AUDIOMETER AS5 User Manual 29 2 7 SIMBOLOGY SN SERIAL NUMBER uad MANUFACTURER The date of manufacture name and address of manufacturer 4 TEMPERATURE LIMITATION HUMIDITY LIMITATION ES PREASURE LIMITATION A APPLICABLE PART B CAUTION e em
11. From 10 to 40 C Relative humidity less than 85 no condensation Power 220 V 50 Hz 15 VA Size 324 x 246 x 95 mm Weight 3 Kg approx 2 6 APPLICABLE STANDARDS 1 Related to the al Product MEDICAL DEVICE e 93 42CEE Directive RD 1591 2009 suononajsum Instructions Sibelmed AUDIOMETER AS5 User Manual ELECTRICAL SAFETY e EN 60601 1 2006 Seg medical equipment Class type B EMC e EN 60601 1 2 2007 EMC in medical equipment Not vital sup port See APPENDIX 1 ELECTROMAGNETIC COMPATIBI LITY AUDIOMETERS e EN 60645 1 2001 Pure tone audiometers e ANSI S3 6 2004 Specifications for audiometers Only models with speech audiometry option Only models with High Frequency option CALIBRATION e EN ISO 389 1 2001 Air conduction calibration supra aural e EN ISO 389 3 1999 Bone conduction calibration e ANSI S3 6 2004 Specifications for audiometers Only models with Free field option USABILITY AND APTITUDE FOR USE e EN 60601 1 6 2010 General requirements for safety Part 1 6 Collateral standard Usability e EN 62366 2008 Application of engineering skills to use medi cal devices VIBRATION AND TEMPERATURE e Series EN 60721 1995 Classification of environmental condi tions e Series EN 60068 1999 Environmental testing Sibelmed 7 AUDIOMETER AS5 User Manual 27 BIOCOMPATIBILITY e ISO 10993 1 2009 Biological evaluation of medical devices Part 1 SOFTWARE e EN 62304 2006 Software for Medical
12. OR AND dB TONES SELECTOR Once calibrated the tone signal goes through five attenuation stages of 5 10 20 40 and 40 dB They provide a control in 5dB jumps from 10 up to 105 dB The stage selection is carried out through the processor by means of electronic conmutators 3 1 3 SE AL SIGNAL KEY The output of the last stage of the attenuator is connected to a silencer circuit This by means of LDR photoelectric cells blocks the way of the tone signal whenever the SENAL SIGNAL key is not pressed down The grade of attenuation of this system is superior to 80 dB On pressing the SENAL SIGNAL key this circuit is defused and the tone freely moves on to the function selector 3 2 MASKING NOISE The masking noise is white noise wide band type This is ge nerated from an aleatory sequence of rectangular pulses that covers the audible tone spectrum This signal is controlled by the processor both for generation and for processor attenuator control The masking signal attenuator consists of four attenuation sta ges of 5 10 20 and 20 dB With them masking levels between 30 and 80 dB are selected Once the signal has been shaped and calibrated apply the function selector 3 3 FUNCTION SELECTOR AND CONDUCTION PATHS 3 3 1 FUNCTION SELECTOR Pure tone and masking noise should be applied at the inputs of an electronic conmuter controlled by the processor The mis sion of this device is to send each one of these signals t
13. Vibrator for bone conduction N 23 Patient s response connection VA Hz 187 WE N serie 8 7 1 ig 17 16 15 14 13 Fig 1 3 3 Sibelmed AUDIOMETER AS5 User Manual 17 1 5 INSTALLATION AND START UP This handbook is applicable to the SIBELMED AS5 AOM audio meter For AS5 A AS5 AM and AS5 AO models will applicable the same except the sections of this handbook which do not correspond In accordance with the type of protection against electrical dis charges established in standard EN 60601 1 the AS 5 audio meter is categorised as CLASS I equipment In order to be brought into operation the SIBELMED AS5 au diometer requires a 220 V 50Hz network wire other options on request together with its corresponding earth terminal The required ambient conditions are e Storage temperature 5 to 70 C e Ambient temperature between 5 and 40 C e Relative humidity less than 85 no condensation Be careful of keeping the unit away from sprinkling water or any other liquid Also do not cover this unit with any object that may prevent proper ventilation while operating It is advisable to install the audiometer within a soundproof room for audiometric tests If this is not possible the unit should be installed in so quiet a room that test results get not distorted The operations order to get the audiometer ready to work is as follows 1 Turn general switch N 1 to 0 OFF position
14. ains power quality should be that of a Surge typical commercial or hospital environ ment 2 kV common 2 kV EN IEC 61000 4 5 mode mode 524 Mains power quality should be that of a Voltage dips short in 5 96 Ut lt 5 000 typical commercial or hospital environ terruptions and volta gt 95 dip in Ut gt 95 dip inUt ment If the user of the AS 5 requires ge variations on power for 0 5 cycle for 0 5 cycle continued operation during power mains supply input lines interruptions it is recommended that the 40 Ut 40 Ut AS 5 be powered from an uninterruptible DTE power supply or a battery EN IEC 61000 4 11 60 96 dip in Ut 60 dip in Ut for 5 cycles for 5 cycles 70 Ut 70 Ut 30 dip in Ut for 25 cycles 95 Ut gt 5 dip in Ut for 5 seconds 30 dip in Ut for 25 cycles 95 Ut 75 in Ut for 5 seconds Power frequency 50 60 Hz magnetic field EN IEC 61000 4 8 3 A m 3 A m El campo magn tico en la sala debe ser suficientemente bajo para asegurar la realizaci n del test NOTE Ut is the a c mains voltage prior to application of the test level Sibelmed 7 AUDIOMETER AS5 User Manual Guidance and manufacturer s declaration electromagnetic immunity AS 5 AUDIOMETER is intended for use in the electromagnetic environment specified below The costumer or the user of AS 5 should assure that it is
15. ation is about and tell him her to press the response connection every time he she hears the tone and to keep it pressed down as long as he she hears it Next put the air conduction earphones on the patient s head according to the following instructions Right ear Red left ear Blue Make sure the masking noi se is not being applied The digits corresponding to the masking noise level should be displayed along with two dashes This suononajsum Instructions Sibelmed AUDIOMETER AS5 User Manual warns you that this signal is disconnected Fig 1 5 1 66 C 1008 Fig 1 5 1 2 Examine the ear the patient considers to be the best and start examination with 1000 Hz frequency and then 2000 4000 8000 500 and 250 Hz Frequencies of 3000 and 6000 Hz are optional 3 In order to determine the hearing threshold level of each frequency press SENAL SIGNAL key for one two or three se conds sending a sufficiently high level 60 dB for example so that the patient can distinctively identify it At the same time the two digits on the screen corresponding to the pure tone signal application will light up Then the patient should press the response push button and the dB value of the tone signal being applied will flash on the screen Fig 1 5 2 en 1m Fig 1 5 2 If the patient presses the push button when the operator is not pressing down the SENAL SIGNAL N 5 key Fig 1 5 3 is di
16. d while the intended ear is being nullified Therefore we leave to the specialist s cri terion to decide the following When is masking necessary How to determine its initial intensity How to determine the threshold of tone with masking etc 2 TECHNICAL SPECIFICATIONS 2 1 CONFIGURATION ACCORDING TO MODELS AS5 A AS5 AM AS5 AO AS5 AOM AIR CONDUCTION YES YES YES YES BONE CONDUCTION NO NO YES YES CONTINUOUS TONE YES YES YES YES PULSETONE YES YES YES YES MASKINGNOISE NO YES NO YES TDH39 EARPHONES YES YES YES YES B71 or B72 BONE VIBRATOR NO NO YES YES SIGNAL INDICATOR YES YES YES YES PATIENT SRESPONSE YES YES YES YES LCDSCREEN YES YES YES YES Sibelmed AUDIOMETER AS5 User Manual 25 2 2 FREQUENCIES AND LEVELS Frequency Hz 250 500 1000 2000 3000 4000 6000 8000 Max Pure Tone AC dB HTL 90 105 105 105 105 105 90 80 Max Pure Tone BC dBHTL 40 50 50 50 50 50 Min AC BC dB HTL 10 10 10 10 10 10 10 10 Level increments 5 dB Frequencyaccuracy 2 Levelsaccuracy 3dB Calibration Regulations ISO 389 ANSI 3 26 1981 2 3 MASKING NOISE Type of signal White noise of wide band Level range from 30 to 80 dB SPL Level increments 5 dB 2 4 TRANSDUCERS Air conduction Earphones type TDH 39 pair Bone Conduction Bone vibrator type B71 or B72 2 5 GENERAL INFORMATION Functions control Tactile membrane keyboard Data presentation LCD screen Store temperature From 0 to 60 C Operating temperature
17. easing the frequency applied to the patient N 9 Hz Y Key for decreasing the frequency applied to the patient N 10 ir Key for increasing the pure tone level dB applied to the pa tient N 11 TONO TONE Y Key for decreasing the pure tone level dB applied to the pa tient N 12 LCD alphanumerical screen of 16 x 1 Fig 1 3 2 Sibelmed 7 AUDIOMETER AS5 User Manual 15 abcdefghijkilmnop abc dB level corresponding to pure tone d Free ef Indicates that the pure tone is applied to the patient g Corresponds to F1 R Right L Left and B Bone h Corresponds to F2 C Continuous and P Pulse Free jklm Frequency selected in Hz n Free op dB level corresponding to masking noise 1 4 2 REAR PANEL Fig 1 3 3 N 13 I L Blue Base for the connection of the left earphone of air conduction N 14 D R Red Base for the connection of the right earphone of air conduction N 15 0 B Yellow Base for the connection of the bone vibrator N 16 PAC PAT White Base for the connection of the patient s response push button NO 17 Features plate NO 18 General fuse holders with slow fuses of 5x20 0 2 A N 19 Base for the connection of power and ground cable N 20 Base for the connection of the additional protection N 21 suonon4jsug Instructions Sibelmed 7 AUDIOMETER AS5 User Manual 16 Set of air conduction earphones N 22
18. er as spare parts could adversely affect patient safety cause a malfunction of the equipment and or produce an increase of the emissions or a decrease in the device immunity A19jes Safety Sibelmed AUDIOMETER AS5 User Manual 8 DISPOSAL OF ELECTRICAL OR ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION mmm This symbol on the product indicates that it must not be disposed of as part of domestic waste Rather if it is to be disposed of it is the user s responsibility to take it to a designated recycling point for electrical and electronic devices The separate collection and recycling of different kinds of waste at the point of disposal helps to preserve natural resources and to ensure that recycling will safeguard health and the environment If you require further information about where to take products of this type for recycling contact your local authority the local domestic waste disposal service or the distributor from whom you purchased the product Sibelmed 7 AUDIOMETER AS5 User Manual 9 1 OPERATING INSTRUCTIONS 1 1 INTRODUCTION The SIBELMED AS5 audiometer is a compact unit based on a tone generator a white noise generator optional a set of air conduction earphones a bone conduction vibrator optional and a liquid crystal alphanumerical screen The whole system is controlled by a microprocessor that provides a reliable quick and simple way to carry out an audiometry The SIBELMED AS5 a
19. eter air way and bone way output are equal in bothchannels and in all frequencies To do this apply a level of 10 or 15 dB just it can be heard Of course the person that performs the test should have a good hearing 3rd Check with a level of 60 dB in air way and 40 dB in bone way that no distortion nor noise nor parasitic signal can be heard testing at all frequencies 4th Check that the signal key turns on off properly 5th Check that the atenuator levels performs their function without noise or interferences 6th Check that the headphone and vibrator strips are correct suonsn 13SuT Instructions Sibelmed AUDIOMETER AS5 User Manual 5 2 2 OBJECTIVE CHECKUP This checkup consists on a general and technical verification of the safety adjustment functions calibrations that configure the device The calibration is made with artificial mastoid and ear according to the standards that are applied to THIS CHECKUP MUST BE MADE ANNUALLY and following the Verification and Adjustment procedure of the SIBELMED AS5 owned by the manufacturer This kind of operations should be made by qualified technical personnel of the maintenance de partment of the center supplier or manufacturer In any case SIBEL S A as manufacturer must authorize and allow by writing at least during the warranty period to the technical service to perform this maintenace In any case SI BEL S A will not admit any responsability for any damage
20. he equipment is malfunctioning These checks should be carried out by the maufacturer or by qualified technical staff authorised by SIBEL S A in accordance with the manufacturer s SIBEL S A Proce dures for Verification and Adjustment Sibelmed 7 AUDIOMETER AS5 User Manual 13 1 4 CONTROLS INDICATORS AND CONNECTORS 1 4 1 GENERAL AND LATERAL PANEL Fig 1 3 1 N9 1 0 General switch OFF 0 ON 1 2 Block of audiometric graphs for noting down sound pressure levels as well as patient s name address etc N ENMASC MASK dir Key for increasing the dB level of the masking noise N 4 ENMASC MASK WY Key for decreasing the dB level of the masking noise Fig 1 3 1 suononajsum Instructions Sibelmed AUDIOMETER AS5 User Manual 14 NO 5 SE AL SIGNAL On being pressed down this key sends the tone signal to the patient s earphones or bone vibrator N 6 F2 Function key for selecting the form of applying the tone to the patient C Continuous Tone P Pulse Tone The corresponding letter is displayed on the LCD screen above F2 NO 7 F1 Function key for selecting the way of applying the tone to the patient D R Derecha Right The screen displays R I L Izquierda Left The screen displays L O B Osea Bone The screen displays B The corresponding letter is displayed on the screen above 1 function NO 8 Hz Key for incr
21. i EARTH mmm DISPOSAL OF ELECTRICAL OR ELECTRONIC DEVICES BY DOMESTIC USERS IN THE EUROPEAN UNION suononajsum Instructions Sibelmed AUDIOMETER AS5 User Manual 2 8 USEFUL LIFE 7 years 3 FUNCTIONAL DESCRIPTION The audiometer as it is well known consists of the following parts Low frequency oscillator Attenuator for tone level control Air conduction earphones and bone vibrator if it has one Switch for sending at will generated sound Next a more detailed description of the audiometer SIBELMED AS5 is provided See Block Diagram 3 1 GENERATOR AND TONES CONTROL 3 1 1 TONES GENERATOR AND FREQUENCIES SELECTOR The tones generator comprised in this audiometer is a sine Wien bridge oscillator It uses an operational amplifier selfrregulated in amplitude by a field effect transistor FET Frequencies generated by this oscillator are 250 500 1000 2000 3000 4000 6000 and 8000 Hz They are selected through the keyboard through an electronic conmutator contro lled by the processor The tones generator output is applied to an adjustment stage Each frequency is calibrated at the manufature process or at every periodical check up by means of an artificial ear for the air conduction earphones and an artificial mastoid for the bone vibrator These calibration levels are carried out in dB HTL Hea ring Threshold Level according to regulations Sibelmed 7 AUDIOMETER AS5 User Manual 31 3 1 2 ATTENUAT
22. is of very low tension and it feeds the suononajsum Instructions Sibelmed 7 AUDIOMETER AS5 User Manual 34 whole system The voltage provided by the transformer goes through filtering and stabilization circuits These prevent the audiometer opera tion fom being afected by possible flutters in the supply network 35 7 AUDIOMETER AS5 User Manual Instructions 501234244 DAM 123 2 4 SSv OBLIMOLIW 5 13615 301237135 ONINSWH SLND S1iln2Wi2 wita SO WHY Instructions Sibelmed AUDIOMETER AS5 User Manual 36 4 AUDIOMETRIC TECHNIQUE The audiometric technique is so wide due to the high number of modalities that exist To do a description of each one would be a complex task and it doesn t the purpose of this manual Therefore for those specialist that want a complementary in formation they can consult the different bibliographies that are published about this topic 5 PRESERVATION The AS 5 audiometer requires as every equipment and spe cially due to its medical application a preservation or mainte nance first pointed to the sefety of the patient operator and environment second to insure the reability and accuracy of the functions which it has been developed for Therefore a serie of routines must be performed 5 1 PRESERVATION Preservation is the action directed to maintain the equipment in a correct operating condition The person that has to perform it doesn t
23. l or not 8 In some cases and this is left to the specialist s criterion it is preferable to use pulse rather than continuous tone This option is selected through key N 6 1 6 2 DETERMINATION PROCEDURE FOR HEARING THRESHOLD LEVELS THROUGH BONE CONDUCTION WITHOUT MASKING NOISE The audiometer SIBELMED in its AS5 AO and AS5 AOM versions also permits studying the patient s bone conduction The frequencies and levels applicable with this unit are following Hz 250 500 1000 2000 3000 4000 M x dB 40 50 50 50 50 50 M n dB 10 10 10 10 10 10 The examination consists of determining the hearing threshold levels when pure tones through bone conduction are provided For that purpose select letter B Bone through key N 7 in the corresponding digit on the screen Fig 1 5 6 Sibelmed AUDIOMETER AS5 User Manual 23 y 48 __0 1000 Fig 1 5 6 The investigation of the threshold of bone conduction is more delicate to carry out and to interpret For this reason you have to be very careful when carrying it out The correct position of the vibrator is very important in order to carry out determinations through the bone conduction Place it on the mastoid Apply a tone a few decibels above the thres hold indicating the patient to move it along the mastoid until the zone where he can hear it loudest Make sure the vibrator is perfectly coupled to the mastoid and it does not touch the ear in order to avoid cartilaginou
24. o the suonona4jsug Instructions Sibelmed AUDIOMETER AS5 User Manual corresponding paths that have been previously selected by the keyboard The electronic conmuter output can send the pure tone signal to the right earphone to the left earphone or to the bone vibrator and the masking noise either to the right or left earphone 3 3 2 CONDUCTION PATHS The SIBELMED AS5 audiometer as it has been said before has Air Conduction and Bone Conduction optional Three power amplifiers feed the right left earphones and bone vibrator 3 4 PROCESSOR The processor consists of a set of electronic devices that store conduct receive and send out information In outline it has the following parts ROM resident control program of 8Kb 1Kb 1000 bytes RAM memory of 2Kb Central Process Unit CPU Comunication Controls 3 4 1 PROGRAM It is in charge of conducting all the orders sent to it from the keyboard so as to carry out the audiometric examination co rrectly The control program is utterly developed in assembling langua ge assuring by that a high control speed The memory where the program is recorded is ROM type Read Only Memory 3 4 2 RAM MEMORY The data storage capacity is of 2 Kb A RAM memory is used Random Access Memory in order to keep the data and stage Sibelmed 7 AUDIOMETER AS5 User Manual 33 where the audiometer is 3 4 3 C P U It is the device that conducts and carries
25. out instruction compri sed in the program MOS 6502 technology is used with a clock frequency of MHz 3 4 4 CONTROLLERS They are in charge of the data exchange between the keyboard screen patient warning and selector on the one hand and CPU on the other 3 5 PATIENT RESPONSE KEYBOARD AND SCREEN El SIBELMED AS5 audiometer has a circuit driven by a push button for the patient to give warning when he hears the applied tones This system has been developed in such a way that it makes possible for the operator to detect whether the patient is sending a false warning The operator controls the audiometer through a nine key tactile membrane keyboard This system is silent reliable and easy to handle In this way noises coming from rotary conmuters both mechanical and electrical are avoided The audiometer operating state all the time is displayed on the LCD liquid crystal screen This makes possible a clear and quick view of levels frequency path etc that are being applied or are to be applied to the patient The screen has 16 large and distinctive alphanumerical digits 3 6 POWER SUPPLY As the audiometer is an electronic unit it requires an electric source to operate This is taken from a 220V 50Hz network other voltages or and frequencies are available In order to guarantee the safety of patient operator and their environment the network voltage is applied to a transformer in a highly iso lated fashion The output
26. radio broadcast and TV broadcast cannot be predicted theo retically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electro magnetic site survey should be considered If the measured field strength in the location in which AS 5 is used exceeds the applicable RF compliance level above AS 5 should be observed to verify normal operation Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m suononajsum Instructions Sibelmed 7 AUDIOMETER AS5 User Manual Recommended separation distances between portable and mobile RF communications equipment and AS 5 AUDIOMETER AS 5 AUDIOMETER is intended for use in an electronic environment in which radiated RF disturbances are controlled The costumer or the user of AS 5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and AS 5 as recommended below according to the maximum output power of the communications equipment aE ane Separation distance according to frequency of transmitter mitter m From 150 kHz to 80 From 80 MHz to 800 From 800 MHz to 2 5 MHz MHz GHz 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters
27. rreo electr nico sibel sibelmed com WEB www sibelmed com SERVICIO POSTVENTA Tel 93 433 54 50 Fax 93 436 16 11 Correo electr nico sat sibelmed com Sibelmed 7 AUDIOMETER AS5 User Manual 5 SAFETY SPECIAL PRECAUTIONS The AS 5 audiometer has been designed to have the maximum safety All the operation instructions should be read before starting the device Otherwise lesions to the user or patient and damage to the device and or accessories may happen INTENDED USE The audiometer generates a series of acoustic and vibrational stimuli and calculates a series of parameters relating to human audiometry The audiometer is intended for use by medical staff only under the supervision and instruction of a doctor The audiometer is not intended for use outdoors nor in conditions or with energy sources other than as set out in this manual DO NOT use transducers headphones for air bone conduction loudspeakers that have not been calibrated with the audio meter THAT COULD INVALIDATE THE AUDIOMETRIC TEST PERFORMED THE ROLE OF THE PATIENT IN THE USE OF THE AUDIOMETER The audiometry tests require the cooperation of the patient The patient must press a button to communicate the detection of a stimulus The doctor must evaluate the patient s ability to carry out the audiometry tests Special care must be taken with children the elderly and the handicapped LIMITATIONS OF USE CONTRAINDICATIONS The interpre
28. s played on the screen for an instant 4 When a well defined reply is obtained progressively diminish the tone level through key N 11 in 10 dB jumps once you have cancelled the pure tone signal key No 5 without being pressed When you reach the level at which the patient is uncertain about his reply go down 10dB further and initiate the ascent throught key N 10 in 5dB jumps until the patient answers again Then go down again in 5dB jumps until the patient cannot hear anything Fig 1 5 3 Sibelmed 7 AUDIOMETER AS5 User Manual 21 5 Usually dB level identified by the patient 100 of the times is taken as hearing threshold level Fig 1 5 4 IMPORTANT On noting down the levels on the graph take into account that ne gative decibels in the graph mean loss of audibility Therefore if the patient is applied 10 dB screen write 10dB on the graph and coversely Fig 1 5 4 6 As hearing thresholds are being found they should be noted down according to the normalized notation and colours code as the graph shows Finally they should be joined together by a line for each ear Fig 1 5 5 suononajsug Instructions Sibelmed 7 AUDIOMETER AS5 User Manual TEE Fig 1 5 5 7 In those cases you think hearing is normal either in one or both ears carry out the test in all frequencies at a tone level of 10dB This will determine in short while whether hearing is norma
29. s conduction In threshold examination through boneconduction without mas king the opposite ear should be absolutely free that is to say without the earphones on because their occlusive effect may disturb the test results Hearing threshold determination through bone conduction should be carried out as described in section 1 5 1 DETERMINATION PROCEDURE FOR HEARING THRESHOLD LEVELS THROUGH AIR CONDUCTION WITHOUT MASKING NOISE 1 6 3 DETERMINATION PROCEDURE FOR HEARING THRESHOLD LEVELS THROUGH AIR CONDUCTION OR BONE CONDUCTION WITH MASKING NOISE The SIBELMED AS5 AM audiometer makes possible to study the hearing thresholds of air conduction with masking noise and the AS5 AOM the thresholds of air and bone conduction with masking noise The type of masking noise used by these audiometers is as fo llows White Noise of Wide Band Range from 30 to 80 dB SPL Sound Pressure Level 5 dB level increases suononajsum Instructions Sibelmed AUDIOMETER AS5 User Manual 24 The earphone presenting the masking signal is the opposite to the one sent by the air conduction For example if the pure tone signal is sent through the right earphone the masking signal can be sent through the left one or conversely When the exploration is carried out through bone conduction the masking always turns up though the right earphone The masking technique requires skilful handling It must not interfere with the ear that is being examine
30. tation of the tests and the derived treatments should A19jes Safety Sibelmed AUDIOMETER AS5 User Manual 6 be performed by a doctor The medical staff must evaluate any symptoms presented by the patient before any audiometric tests are carried out The suitability of audiometric testing is the responsibility of the medical staff The audiometer should not be used when it is likely that the validity of the results could be compromised by external factors Take care NOT to place the equipment where it could be splas hed by water or other liquids or cover it with objects that prevent air from circulating around it while it is running The device should NOT be used stacked or adjacent to other equipment All accessories and spare parts etc must be originals and are to be requested from the manufacturer or authorized distributor in order to ensure the safety of the patient and the correct working order of the spirometer and the safety of the patient Thus this may increase the emissions or decrease its immunity The equipment must be stored and used within the temperatu re pressure and humidity ranges specified in this manual ELECTRICAL RISKS DO NOT remove the device or accessories cover Servicing and repair of the apparatus must only be carried out by trained personnel Contact with the voltage inside the system can cause serious injury DO NOT use the equipment if the power cable is in poor condition or cracked
31. tronic equip inci AS 5 uses RF energy only for its internal function The RF Conducted emissions Group 1 refore its RF emissions are very low and are not likely CISPR 11 EN 55011 Clase B interference in nearby electronic equip Harmonic emissions Class A EN IEC 61000 3 2 Voltage fluctuations Flicker emissions Yes EN IEC 61000 3 2 suononajsug Instructions Sibelmed 7 AUDIOMETER AS5 User Manual Guidance and manufacturer s declaration electromagnetic immunity AS 5 AUDIOMETER is intended for use in the electromagnetic environment specified below The costumer or the user of AS 5 should assure that it is used in such an environment Immunity test EN IEC 60601 test level Compliance level Electromagnetic environment Guidance Electrostatic discharge ESD EN IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or cera mic tile If floors are covered with synthe tic material the relative humidity should be at least 30 96 Electrical fast transient burst EN IEC 61000 4 4 2 kV for power supply lines X1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environ ment The input output line cables are shorter than 3 meters long 1 kV differential 1 kV differential M
32. udiometer has been entirely developed in Spain The most advanced technology used in other medical instruments as well as the experience acquired from making audiometers for more than ten years has been applied to this audiometer Its functional line and the fact of having eliminated many of the electromechanical components the majority of au diometers currently have makes of the SIBELMED AS5 audio meter a lasting working instrument The SIBELMED AS5 audiometer has been developed following standard criteria from the National Institutions U N E as well as from the Internatinal Institutions 1 E C etc 1 2 PRELIMINARY OBSERVATIONS Use this manual is intended for all models and options that can make up the audiometer AS 5 Therefore in each case shall apply only those options or model functions that are available This audiometer is built with professional components solid sta te under strict quality controls However accidents can happen in the transportation or storage of equipment so it is advisable to make an initial review of their status prior to installation as well as accessories to complement it WARNING IF ANY DAMAGE DETECTED IN THE PACKAGE IMMEDIA TELY CONTACT THE AGENCY OF TRANSPORTATION AND YOUR DEALER PRIOR TO INSTALL DO NOT PULL suononajsum Instructions Sibelmed 7 AUDIOMETER AS5 User Manual 10 Do not pull any packaging bag etc until it is fully verified both as running accessories 1 3 AS 5
33. used in such an environment EN IEC 60601 Compliance Immunity test test level level Electromagnetic environment guidance Portable and mobile RF communications equi pment should be used no closer to any part of AS 5 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 38 pae 80 MHZ a 800 MHZ RF conducida 3 Vrms 3 Vrms LE EN IEC 61000 4 6 150KHz a 80 MHz d 38 pae 80 MHZ a 800 MHZ RF radiada 3 Vrms 3 V m EN IEC 61000 4 3 80 MHz a 800 MHz d ES 80 MHZ a 800 MHZ where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recom mended 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 equip ment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorp tion and reflection from structures objects and people 4 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM
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