SIBELMED W-50
Contents
1. FOWLER z OWLER TES e Window showing graph of intensities e Window for e Selection of masking election of frequency 125 Hz to 8000 Hz e Notes window Sibelmed SIBELMED W 50 Software Manual TONE DECAY TEST Y SOFTWARE W 50 MANUAL Databa MED AVDIOMETR Setup Options 2 Bim 6 ga TONE DECAY ann 55 e Window showing graph of Intensity v Frequency e Window for e Selection of conduction Air Bone Free e Notes window 0S M 2 1a1deyo Chapter 2 Audiometry Software W 50 Sibelmed 7 SIBELMED W 50 Software Manual 56 LUSCHER TEST MED ALIDIOMETRY SOFTWARE w 50 MANUAL Database _ SIBEL 30000000001 Garcia P rez Juan E Ex em a e Window showing table of intensities for each frequency e Window for e Selection of ear e Selection of intensities 0 2 dB to 5 dB e Notes window Sibelmed 7 SIBELMED W 50 Software Manual 57 PURE TONE HF AUDIOMETRY 0 Ministry of Labour and Social Affars b Hearing Loss w zi Saves the test in the dotabase e Window showing graph of Intensity v Frequency LF for the right ear e Window showing graph of Intensity v Frequency HF for the right ear e Window showing graph of Intensity v Frequency LF for2. an kaa SR wns 61 ABOUT THE SOFTWARE a da a a kad aa kl kabab pa e pake vant a 61 MATIN MENU ki ka n e 61 GO TO THE SIBEL SEITE icr kn ra mas a atak ape OUR nn ki n Rr En 61 3 AUDIOMETRY ot een kk aie 63 INTRODUCTION ei s ei tre bo ekite pad po kak ko dete 64 TYPES OF AUDIOME TRY zak av ne pot e k alin pi aa ko pyan ank 67 PURE TONE THRESHOLD AUDIOMETRY as cn kata ten tet in tb 64 PURE TONE SUPRATHRESHOLD 65 SPEECH AUDIOMETRY OR LOGOAUDIOMETRY 66 APPLICATIONS OF AUDIOMETRY xx a ER ma m xa 67 DIAGNOSES nM xt T 68 4 TECHNICAL 5 65 69 SOFTWARE COMPATIBILITY AND COMPUTER REQUIREMENTS 70 PARAMETERS n a kaa ROO IRA CR TOO LEE ER DU 71 PERSONALISING THE PROGRAM renean nnn rn son sa pannan 71 DATABASE 71 Xp Bri pP 72 5 MAINTENANCE nnani rnini 73 6 MODIFICATIONS 1 75 APPENDIX1 COMPLIANCE WITH ORGANIC LAW ON DATA PROTECTION ane
3. Rana Esa Ra 77 APPENDIX 2 DIAGNOSIS 85 Sibelmed 7 STBELMED W 50 Software Manual DECLARATION OF CONFORMITY The SIBELMED W 50 Audiometry Software has been developed for use with SIBELMED brand audiometers by SIBEL S A s R D amp I department in accordance with the Sibel S A Quality Manual and therefore in accordance with the ISO 13485 quality standard as well as the European Medical Device Directive 93 42 EEC Under this directive it is regarded as a class IIa product 4 0318 PRODUCT CONFORMS WITH 93 42 EEC Medical Devices Directive Class II a Revised Approved Date 2012 05 Date 2012 05 Jos Maria Plana Carlos Recio Technical Director Sales Director yo Declaration of Conformity Sibe med 7 SIBELMED W 50 Software Manual L 6 pe ey Sibelmed 7 SIBELMED W 50 Software Manual 1 INSTRUCTIONS FOR USE AND INSTALLATION 15 pue asp 40 SUONINJASUT T 1o3deu Sibelmed 7 SIBELMED W 50 Software Manual 8 INTRODUCTION SIBELMED W 50 is software for viewing storage transfer analysis and entry of audiometric tests for use under the Microsoft Windows environment SIBELMED W 50 Audiometry Software has been developed for use with SIBELMED brand audiometers by SIBEL S A s R D amp I department in accordance with the Sibel S A Quality Man
4. 16 PRINTER SETUP AND REQUIREMENTS ern st tr n n n 17 2 W 50 AUDIOMETRY SOFTWARE 19 INTRODUCTION er pk penk kn a ke 20 ABOUT THE 5 HELP sais kiss sisie ski afe sal 21 MAIN MENU inr aya iua t ENEE kana kan kana Gau dd 22 CONFIGURATION MENU n ere rr ex e 23 SELECT PRINTER RTI PIS RUE e te Feat e 24 LINKS I 25 OTHER eT 26 REPORT HEADER 5 259 2 26 PARAMETERS AND 26 FINISH dire 27 OPTIONS MENU a 29 pi poWicc 29 EXPLORE DATABASE echa Oe p pe poun eis ERU knn E Ee ae rne 30 ORE px EU DIG I eA TUER EEA 39 s1u91uo5 Contents Sibelmed 7 SIBELMED W 50 Software Manual 4 DATABASE MAINTENANCE setae sos Feet 41 AUDIOMETRY eben a t box ein ino 47 IMPORT TESTS beat rated an nat Ak teni ava a ai PS FUE aU dra ant 60 HELP MENU kore pw kana Ite ice ket ea kok ann pik cee kola Are ii ra Rer nien 61 ABOUT THE HELP SYSTEM sitt aou
5. oo 125 195 35 6 265 61 9 335 130 200 37 5 270 63 8 340 gt 205 39 4 275 65 6 345 412 67 5 43 1 69 3 45 0 EN 712 46 9 2 73 1 1 Sibelmed 7 SIBELMED W 50 Software Manual 89 2 COUNCIL DIAGNOSIS The percentage of hearing loss is determined from the pure tone audiogram in accordance with the second formula of the Council of Physical Therapy A percentage of the hearing loss in each ear is taken at the 500 1000 2000 and 4000 Hz frequencies as a function of their importance specifically 15 at 500 4000 Hz 30 at 1000 Hz and 40 at 2000 Hz A 0 hearing loss corresponds to normal and a 100 hearing loss to cofosis By reference to a table published by the institution you can find the percentage hearing loss for each frequency and the level of intensity A Monoaural hearing loss 1 The hearing thresholds of each ear are determined at frequencies of 500 1000 2000 and 4000 Hz and added 2 The corresponding percentage of hearing loss for each frequency and intensity is found in Table 2 3 The loss values for the four frequencies are added giving the 9o of hearing loss of the ear under study Example Right ear RE 500 1000 2000 4000 dB of loss 15 10 5 10 loss 0 5 0 3 0 0 1 Sum 0 5 0 3 0 0 1 0 9 9 o Hearing loss RE 0 9 dB Average RE 40 4 10 0 dB Left ear LE 500 1000 2000 4000 dB of loss 35 30 40 50 105
6. Degree of Class name Characteristics Sal A 16 Normal Both ears are within normal limits worse ear with no Gil Fult in quiet Fonver sations 16 30 Close to normal Has Gil Fult with quiet one of the Fonversatio ns but nothing more ears C 31 45 Slight Auditory Has Gil Fulties in normal Fonver better ear Loss sations but not if people speak up 46 60 Serious Has Gil Fulties even when people better ear Auditory speak up Loss 61 90 Serious Can only hear a conversation using better ear Auditory a hearing aid Loss 91 99 Profound Cannot hear a conversation even better ear Auditory with a hearing aid Loss G gt 100 Totally deaf in Can hear no sound at all better ear bothears TABLE 5 Sibelmed 7 SIBELMED W 50 Software Manual 97 6 KLOCKHOOF DIAGNOSIS Modified by the Lavoro Clinic of Milan For this test the 500 1000 2000 and 4000 frequencies are investigated and the criteria set out in Table 6 are applied 1 If the threshold is not higher than 25 dB at any frequency the diagnosis is Normal 2 If the threshold at the 4000 frequency is below 55 dB and below 25 dB in the other frequencies the diagnosis is Slight Acoustic Trauma No conversational loss 3 If the threshold at the 4000 frequency is above 55 dB and below 25 dB in the other frequencies the diagnosis is Advanced Acoustic Trauma No conversational loss 4 If there are 1 or more frequencies below 25 dB at le
7. Reinstalls the program e Remove Completely removes the software but retains the database in the folder in which the program was installed COMPUTER SETUP AND REQUIREMENTS The setup of the computer must be carried out in accordance with its Instruction Manual The computer used must comply with the minimum requirements set out below Minimum Recommended Hard disk 1 Gb 20 Gb or larger Graphics card 800 x 600 800 x 600 or better Monitor 15 17 Operating system Windows 98 2000 XP or Vista Backup unit Recommended Sibelmed SIBELMED W 50 Software Manual 17 It is advisable to select large fonts under the operating system big letter fonts size option for easier viewing of the program This option can be found under display properties See the manual for the computer s operating system PRINTER SET UP AND REQUIREMENTS The setup of the printer should be carried out in accordance with its Instruction Manual The printer used should comply with the minimum requirements set out below Windows compatible printer 160 PPP resolution 5 pages per minute Compliance with standards applicable to printers 3 S E a gt a k Q A pue asp 40 1a1deyj Sibel med SIBELMED W 50 Software Manual 2 AUDIOMETRY SOFTWARE W 50 0S M asemyos Sibelmed SIBELMED W 50 Softwar
8. SIBELMED W 50 Software Manual 84 Transmission of data The software supports the transmission of files containing patient data via the Internet If this functionality is used the user must configure their e mail server so that the data is encrypted before transmission and is therefore converted into unreadable form to guard against any unauthorised access Sibelmed 7 SIBELMED W 50 Software Manual APPENDIX 2 DIAGNOSIS 85 sisoubelq APPENDIX 2 Diagnosis Sibelmed 7 SIBELMED W 50 Software Manual 86 1 MINISTRY DIAGNOSIS The percentage of hearing loss is determined by the pure tone audiogram and according to the evaluation criteria for discapacity due to hearing deficiency as established by the Spanish Ministry of Labour and Social Affairs in OSB No 22 of January 26 2000 A Monoaural hearing loss 1 The hearing thresholds of each ear are determined at frequencies of 500 1000 2000 and 3000 Hz and added NOTE If one of the central frequencies is missing 1000 or 2000 and an adjacent frequency is selected the audiometer uses this frequency to calculate the diagnosis and includes this modification in the report 2 The corresponding hearing loss is found in Table 1 3 If the hearing threshold is 25 dB or lower this is not considered as loss of hearing Example Right ear RE 500 1000 2000 3000 dB of loss 15 10 5 10 Sum 15410 45410 40 9 o Hearing loss RE 0 0 dB A
9. W 50 Software Manual 77 Sa APPENDIX 1 COMPLIANCE WITH THE DATA PROTECTION ACT DIRECTIVE 95 46 EC U01 99 01g uo MET 2 YUM T XIGNAddV APPENDIX 1 Compliance with Organic Law on Data Protection Sibelmed 7 SIBELMED W 50 Software Manual 78 COMPLIANCE WITH THE FOR DATA PROTECTION ACT DIRECTIVE 95 46 EC This section aims to facilitate the compliance of current legislation referring to data protection by the user with the use of this software Consult your local translation of the 95 46 EC directive A brief description of the key points of this legislation is set out and an explanation given of the action which should be taken with the SIBELMED W 50 Audiometry Software and or operating system in order to comply with the requirements of the abovementioned law IMPORTANT WARNING According to current legislation the software user is solely responsible for the storage and treatment of their patient data in accordance with the law Observance of the recommendations included in this section does in no case guarantee the full adaptation of user activity to the standards relating to data protection Requirements which specifically affect the use of the SIBELMED W 50 Audiometry Software Identification and Authentication The processes of identifying and authenticating users to use the SIBELMED W 50 Audiometry Software are carried out by the PC s operating system For this reas
10. Weber RESULTS Council of Physical Therapy LE act act Hearing Loss ES 0S M 2 z 1a1deyo Sibelmed 7 SIBELMED W 50 Software Manual 48 This window enables the user to view the results obtained on carrying out an audiometric test using the AC50 audiometer select AC5O in the Setup Links window SIBELSOUND 400 audiometer select SSOUND 400 in the Setup Links windows or manually enter the data obtained on carrying out an audiometric test using another audiometer select MANUAL ENTRY in the Setup Links window The following options are available from the menu SETUP MENU See the Topic MAIN MENU SETUP MENU OPTIONS MENU TESTS Allows selection of the required audiometric test Pure Tone Audiometry Logoaudiometry Sisi Jerger Fowler Tone Decay L scher or Weber NEW PATIENT Allows selection of a patient in the database or creation of a new one To do this enter the patient reference Patient Selection x Reference Surname Qo Sibelmed SIBELMED W 50 Software Manual 49 SAVE IN THE DATABASE Saves the test in the database COMPARE Selects a test against which to make a comparison Previous test Other test in the latter case a window appears for selection of a test from the list of tests for the patient On selecting a test for comparison it is displayed superimp
11. above the underlined word the cursor changing to a hand clicking the left mouse button causes the relevant help to be displayed Chapter 2 Audiometry Software W 50 Sibelmed SIBELMED W 50 Software Manual 27 MAIN MENU This window shows the main options available from the SIBELMED W 50 Audiometry Software with the corresponding sub options SIBELMED AUDIOMETRY SOFTWARE W 50 SIBELSOUND 400 Database SIBEL aj x Setup Options Help SETUP e Select Printer e Links e Other e Utilities only when the SIBELSOUND 400 audiometer is selected in the setup Links menu e Exit Sibelmed 7 SIBELMED W 50 Software Manual 23 OPTIONS MENU e Database e Audiometry e Import tests HELP MENU e About Help e About the Software e Main menu e Go to the SIBEL website Using each of these options provides access to the relevant information There are also five icons for rapid access to some of the menus which correspond to Explore database Audiometry Load data Help and Finish A description of each of the functions which can be carried out by the SIBELMED W 50 software is set out below SETUP MENU The SIBELMED W 50 Audiometry Software is a versatile program supporting a variety of functional options Some of these may not be relevant to some users Therefore once the process of Installation and Activation has been completed it needs to be customised to the needs of each user Accor
12. is calculated by subtracting the corresponding correction value for presbycusia in Table 3 from the hearing loss at a frequency of 4000 Hz The frequency of 4000 Hz is evaluated considering loss due to age and gender 2 Acoustic trauma is classified on an increasing scale of A B C D E from lower to higher hearing capacity according to Table 4 Example Patient Male 50 years old Right ear RE 4000 dB of loss 30 Left ear LE 4000 dB of loss 40 Applying correction ELI Right ear 30 20 10 dB Grade B Normal good Left ear 40 20 20 dB Grade C Normal Table for ELI calculation Correction for presbycusia at 4000 Hz dB Classification of acoustic traumas sisoubelq APPENDIX 2 Diagnosis Sibelmed 7 SIBELMED W 50 Software Manual 94 CORRECTION FOR PRESBYACUSIA AT 4 000 Hz Db FOR CALCULATION OF THE ELI INDEX TABLE 3 ELI SCALE C orrected Audiometric Loss Degree of ELI amp ODWL FDWLon dB 23 29 0D Suspicion of deafness 230 Clear indication of deafness TABLE 4 Sibelmed 7 lt W 50 Software Manual 95 5 SAL INDEX The SAL Index Speech Average Loss evaluates the conversational frequencies 500 1000 and 2000 Hz and is defined as the arithmetic mean of hearing loss in decibels of these frequencies It establishes a classification by degrees A B C D E F G from SAL A both ears are within normal limits to SA G complete deafness Once
13. recorded material APPLICATIONS OF AUDIOMETRY The main applications of audiometry are 1 Obtaining a diagnosis To provide a diagnosis of hearing loss in a patient in one or both ears To do this we calculate the percentage hearing loss the global bilateral percentage hearing loss and the average dB hearing loss To evaluate distortions in the sensation of sound using suprathreshold pure tone tests To determine the threshold of intelligibility by means of speech audiometry or logoaudiometry 2 To evaluate incapacity or invalidity 3 Public Health Sibelmed 7 SIBELMED W 50 Software Manual 68 e Epidemiological prevalence studies e Environmental effects studies e Occupational studies DIAGNOSES The SIBELMED W 50 software calculates and prints the following diagnoses 1 MINISTRY DIAGNOSIS ACCORDING TO THE MINISTRY OF LABOUR AND SOCIAL AFFAIRS OSB No 22 January 26 2000 2 DIAGNOSIS OF THE COUNCIL OF PHYSICAL THERAPY 3 DIAGNOSIS OF THE MEXICAN INSTITUTE OF SOCIAL SECURITY 4 ELI Early Loss Index 5 SAL INDEX Speech Average Loss 6 KLOCKHOFF DIAGNOSIS Modified by the Lavoro Clinic of Milan The parameters for each diagnosis and the calculation method of each are described in APPENDIX 2 of this manual n UY EE PENES n Sibelmed SIBELMED W 50 Software Manual 69 a 4 TECHNICAL SPECIFICATIONS BLIUYIAL p 193d eu Chapter 4 Technical Specifications
14. showing symbols for identification of conduction and masking e Results window Hearing loss Average dB Bilateral loss e Notes window M Z 05 Chapter 2 Audiometry Software W 50 5 SIBELMED W 50 Software Manual 52 SPEECH AUDIOMETRY xj 5 AuOLOMETRY SOFTWARE W 5 Setup Bd din EE SPEECH AUDIOMETRY MANUAL Database VSIBEL Ref 0000006001 Garcia P rez Juan Yo Correct 00 to previous menu e Window showing graph of Correct detections v Intensity e Window for e Selection of conduction Air Free e Selection of masking e Notes window S be imed SIBELMED W 50 Software Manual 53 SISI JERGER TEST Setup SIE MED AUDEOME TRY SOFTWARE W SO MANUAL Database SIDIL Ref 0000000001 Garcia P rez Mian comparison options e Window showing graph of Correct Detections v Frequency for the right ear e Window showing graph of Correct Detections v Frequency for the left ear e Window for ear selection e Notes window 0S M 2 z 4 Chapter 2 Audiometry Software W 50 Sibe med 7 SIBELMED W 50 Software Manual 54 FOWLER TEST SIBELMED AUDIOMETRY SOFTWARE 50 MANUAL Database SIBEL Ref 0000000001 Garcia P rez Juan
15. the left ear e Window showing graph of Intensity v Frequency HF for the left ear e Central window with e Selection of conduction Air LF and Air HF e Selection of masking Access to diagnoses e Legend showing symbols for identification of conduction and masking e Results window Hearing loss Average dB Bilateral loss e Notes window Sibelmed 7 SIBELMED W 50 Software Manual 58 MANUAL ENTRY Select this option from Setup Links on the main window On accessing the tests window Options Audiometry you can enter data manually from an audiometric test carried out with another audiometer To do this you must 1 Select new patient icon or Options menu New patient 2 Enter the latter s reference can be new or an existing reference if the patient has already been registered in the database 3 Enter the required data in the patient and test cards 4 Select the relevant test from the drop down menu at the top of the window or from the Options menu Tests 5 Depending on the test various options are available with regard to the application of signal and masking see description of test windows above Select the required options 6 Enter the data obtained moving the cursor to the graph point corresponding to the result then clicking the left mouse button and repeating for all data These points are joined creating a graph of the test Once all the data has been entered you may e Enter notes by double cli
16. 041 2008 EN 980 2008 EN ISO 14971 2009 USEFUL LIFE 7 tears Sibelmed 7 SIBELMED W 50 Software Manual 73 rn 5 MAINTENANCE lt 193deu 5 Sibelmed 7 SIBELMED W 50 Software Manual 74 The SIBELMED W 50 Audiometry Software does not require specific maintenance beyond what any computer program that manages data would require e Make a backup copy of the program in case the original becomes damaged e Make regular backup copies of the Databases used so they can be restored in the event of loss of information from the computer In the event of any problem doubt suggestion etc you may have before during or after using the software we recommend you follow the steps below ist Use the program s Help system 2nd Refer to the SIBELMED W 50 Audiometry Software s Instruction Manual 3rd Contact SIBEL S A s Aftersales Service SIBEL S A Rossell 500 08026 Barcelona Domestic Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00 07 e mail export sibelmed com Technical serv Tel 34 93 433 54 50 e mail sat sibelmed com Fax 34 93 436 16 11 Website www sibelmed com Sibelmed 7 SIBELMED W 50 Software Manual 25 MODIFICACIONES v Audi metro Clinico ra Caracteristicas 6 MODIFICATIONS 9 1o3deu Chapter 6 Modifications Sibe med 7 SIBELMED W 50 Software Manual Sibelmed 7 SIBELMED
17. 5 3 7 54 12 98 0 Sum 3 7 5 4 12 9 8 0 30 0 Hearing loss LE 30 09 o dB Average LE 155 4 38 7 dB sisouBeiq APPENDIX 2 Diagnosis Sibelmed 7 SIBELMED W 50 Software Manual 90 Binaural hearing loss Binaural hearing loss is calculated by multiplying the loss of the best ear by seven and adding the loss of the worst ear and then dividing the total by eight Binaural hearing loss in 9o 7 loss in best ear loss in worst ear 8 Example Binaural hearing loss 7x0 9 30 0 8 4 5 C Categories of Hearing Loss The COUNCIL diagnosis does not establish categories of hearing loss However the same categories as for the MINISTRY diagnosis have been adopted Council of Physical Therapy 2nd Formula To arrive at the index both ears need to be tested Sibelmed 7 SIBELMED W 50 Software Manual 91 TABLE FOR THE CALCULATION OF PERCENTAGE HEARING LOSS ACCORDING TO THE COUNCIL OF PHYSICAL THERAPY in dB 5 es es ho zi 29 19 s 177 ss fpe rs uz ma ss ss fiso sz 97 e us ns mss m fues ma ss 146 ue fos mz 149 TABLE 2 sisouBeig APPENDIX 2 Diagnosis Sibelmed 7 SIBELMED W 50 Software Manual 92 3 DIAGNOSIS OF THE MEXICAN INSTITUTE OF SOCIAL SECURITY The percentage of hearing loss is determined from the pure tone audiogram in accordance with the Mexican Social Securi
18. AM This option allows you to enter the required data to get the activation code and send them bay e mail to SIBEL S A or to your distributor You can acquire the software with theRegistro option from the SOFTWARE VALIDATION dialeg box or the Utilities Purchasing the Program option from the setup menu 5 SIBELMED W 50 Software Manual 15 UNINSTALLING THE AUDIOMETRY SOFTWARE 1 Place the CD ROM in the CD DVD drive 2 If the CD DVD drive has autoplay enabled installation will start automatically If not run the file Setup exe on the software CD 3 The following window appears from which you can choose one of the following options AUDIOMETRY SOFTWARE SIBELMED W50 Welcome Modify repair or remove the program T S Welcome to the AUDIOMETR SOFTWARE W50 Setup Maintenance program This program lets Sibelr ned you modify the current installation Click one of the options below Modify Select new program features to add or select currently installed Features to remove Repair fa Reinstall all program features installed by the previous setup 0 gt Remove E Remove all installed Features 7 5 1 b GROU Sibelmed 7 SIBELMED W 50 Software Manual 16 e Modify Allows uninstallation by modules This option is not recommended as you might lose the database if a backup copy has not been made Use the option Remove to carry out the uninstall e Repair
19. Database If this happens and the file selected does actually correspond to a Database the latter must Sibelmed 7 SIBELMED W 50 Software Manual 45 be recreated with the same name and in the same location This can be done by selecting the Create Database option from Options menu Database Database Maintenance The existing data WILL NOT BE LOST On confirming the selected database the PASSWORD is requested Provide the same password as entered when the database was created CREATE DATABASE Creates a database Enter the path and the name of the database On confirming the name a password is requested The password must be entered a second time to confirm it Create Database x Database Path jDSIBEL w Database name Noname QO G DELETE DATABASE On selecting the delete database option the window lists the database or databases available and the user selects the one they wish to delete On confirming the database to be deleted the corresponding PASSWORD is requested Provide the same password as entered when the database was created When a database is deleted not only are the patient records eliminated but also corresponding graphs parameters and any other information recorded It is very important to use a password which can be easily remembered Sibelmed 7 SIBELMED W 50 Software Manual 46 If the password is forgotten contact the SIBEL S A Aftersales Service who will explain the proces
20. E SOFTWARE This window shows the version of the program and also information about SIBEL S A for reference purposes MAIN MENU This window offers access to an explanation of the various options in the main menu GO TO THE SIBEL WEBSITE Accesses the SIBEL website on the Internet Chapter 2 Audiometry Software W 50 Sibe med 7 SIBELMED W 50 Software Manual Sibelmed 7 SIBELMED W 50 Software Manual 63 n 3 AUDIOMETRY 1a1dey Sibelmed 7 SIBELMED W 50 Software Manual 64 INTRODUCTION The purpose of audiometry is to chart changes in hearing in response to acoustic stimuli The ear comprises two groups of anatomical structures e The Transmission System middle and outer ear which transmit vibrations to the inner ear e The Perception System which constitutes the sensory organ proper inner ear with cochlea nervous pathways and higher auditory centres TYPES OF AUDIOMETRY There are three types of audiometry PURE TONE THRESHOLD AUDIOMETRY This involves determining the minimum hearing thresholds for different frequencies by air conduction and bone conduction Itis considered that the hearing threshold is the sound level at which under specific conditions a person achieves a response rate of 50 correct detections over a series of repeated trials Air conduction involves transmission of sound via the outer and middle ear to the inner ear Bone conduction involves transmi
21. LMED W 50 software work properly To install the Driver follow these steps 1 Start up the audiometer consult the corresponding user manual 2 Insert the W 50 Installation CD into the computer Windows 98 2000 XP and Vista 3 Connect the audiometer to the computer with the USB cable consult the corresponding user manual As it is the first time that the equipment is connected to the computer the Windows New Hardware Detected screen will appear with the name of the equipment that you have connected Select Next 4 A screen will appear that allows you to select between two options First Find best controller for your device Second Show a list of all controllers in a location Select the Second and click on Next D Now a screen will appear which allows you to select between Show Hardware or Show Compatible Hardware Select Show all Hardware and click the Use Disk button 6 1f your operating system is Windows 98 select the file D13Test in the directory D Driver W98 of the audiometry CD For others Sibelmed 7 SIBELMED W 50 Software Manual 12 operating systems Windows 2000 Windows XP select the file Sibelusb of the directory D Driver W2K_WXP_WVISTAx32 Press OK 7 Click on Next and Finish The Driver will now install itself Windows Vista 3 Connect the audiometer to the computer with the USB cable consult the corresponding user manual As it is the first time that the equi
22. SIBELMED W 50 AUDIOMETRY SOFTWARE USER MANUAL Sibelmed 520 660 MU2 e REV 2 00 e 2012 05 Sibelmed Sibelmned SIBELMED W 50 Software Manual SIBEL S A Rossell 500 08026 Barcelona Domestic Sales Tel 93 436 00 08 e mail comercial sibelmed com International Sales Tel 34 93 436 00 07 e mail export sibelmed com Technical serv Tel 34 93 433 54 50 e mail sat sibelmed com Fax 34 93 436 16 11 Website www sibelmed com Sibelmed 7 SIBELMED W 50 Software Manual 3 CONTENTS DECLARATION OF CONFORMITY 5 1 INSTRUCTIONS FOR USE AND INSTALLATION 7 INTRODUCTION kw netu urere i RI uie 8 INTRODUCTORY INFORMATION 5 inanis c ipa nao euren konn a sesa 8 MANUFACTURER S RESPONSIBILITIES rea inn nn nennen 9 INSTALLATION SETTING UP AND 5 9 INSTALLING THE AUDIOMETRY SOFTWARE 9 USB INSTALLATION DRIVER ennt rre nere ep 11 SETTING UP FERME HUI 12 ACTIVATION CODE 13 ACQUIRING THE PROGRAM V ek cotta Ko tk a e a 14 UNINSTALLING THE AUDIOMETRY 15 COMPUTER SETUP AND REQUIREMENTS
23. Sibelmed 7 SIBELMED W 50 Software Manual 70 SOFTWARE COMPATIBILITY AND COMPUTER REQUIREMENTS Minimum Recommended Hard Disk 1GB 20 GB or more Graphic Card 800 x 600 800 x 600 or more Monitor 15 17 Port RS232 USB 2 0 Other requirements Operating System Windows 98 2000 XP or Windows Vista Backup unity Recommended Sibelmed 7 SIBELMED W 50 Software Manual 71 PARAMETERS Hearing Loss Yo Average Loss dB Bilateral Loss Yo Diagnosis Minitry of Labour Social Affairs Diagnosis Council of Physical Therapy Diagnosis Mexican Social Security Institute Diagnosis Eli index Diagnosis Sal index Diagnosis Klockhoff index PERSONALISING THE PROGRAM Software Configuration by the user at the level of Type of printer Parameters and other Language Databases Communication links with the software DATABASE Capability of working with different Databases Storage of tests Registration deletion and changes to patient cards Quick search of the database by Record Reference Surname e Printing reports from the database e Importing Exporting tests Chapter 4 Technical Specifications Sibelmed 7 SIBELMED W 50 Software Manual 72 STANDARDS Threshold pure tone audiometry in accordance with EN ISO 8253 1 Audiogram in accordance with recommendations in EN 26189 1991 1506189 1983 Speech audiometry in accordance with UNE EN ISO 8253 2 EN 62304 2006 2008 EN 62366 2008 EN 1
24. WARE From this moment the firmware update process must be repeated OPTIONS MENU DATABASE The SIBELMED W 50 Audiometry Software can be used with various databases in accordance with the user s needs This option provides access to the data structures set up when configuring the system and is therefore for storage and management of information generated when carrying out audiometric tests For this purpose the following sub options are provided Sibelmed 7 SIBELMED W 50 Software Manual 30 EXPLORE DATABASE x Day Month Year Time Reference 0000000001 27 Date 20 oz 2004 09 40 Name mn Surname Garda P rez Height cm 174 weight za 23 1 Normal weight Reason Origin Technician Notes go From this window you can see the relationships between the patients in the database and their respective tests and in turn have access to the following options from the menu e Setup e Database e Options e Window e Help There are icons provided for rapid access to Load Tests Load Export tests in CSV format EXP Import tests in CSV format IMP Test data Print Report Print Preview Help and Exit RET Sibelmed 7 SIBELMED W 50 Software Manual 31 e SETUP See the Topic MAIN MENU SETUP MENU DATABASE PATIENT CARD See the Topic MAIN MENU OPTIONS MENU DATABASE PATIENT CARD TEST CARD The test card shows the following da
25. ast one gt 25 dB the diagnosis is Slight hypoacusia by noise Conversational loss 5 If all the frequencies are affected but none is above 55 dB the diagnosis is Moderate hypoacusia by noise Conversational loss 6 If all the frequencies are affected and one or more are above 55 dB the diagnosis is Advanced hypoacusia by noise Conversational loss Diagram modified by the Lavoro Clinic of Milan sisouBeiq iagnosis APPENDIX 2 D Sibelmed 7 SIBELMED W 50 Software Manual KLOCKHOFF CLASSIFICATION NORMAL The threshold does not exceed 25 dB at any frequency The threshold at the 4000 frequen cy is below 55 dB and below 25 dB ISOLATED i in the other frequencies ACOUSTIC No conversatio TRAUMA nal loss The threshold at the 4000 frequen ADVANCED is above 55 dB and below 25 dB at the other frequencies 2ne or more frequencies are not LIGHT affected are below 25 dB GLOBAL ACOUSTIC Conversational MODERATE All frequencies are affected above TRAUMA loss 25 dB but none is above 55 dB All frequencies are affected above ADVANCED 25 dB and one above 55 dB OTHER LOSS not due to exposure to sound TABLE 6
26. ation on the latter refer to the relevant Instruction Manual for the device The options provided are CHANGE PASSWORD Changes the password for a database The system requests the new password and confirmation of the latter Chapter 2 Audiometry Software W 50 Sibelmed 7 SIBELMED W 50 Software Manual 42 x Enter new password EE amp CONVERT DATABASE Allows the format of old databases created with the Audiometry Software under DOS to be changed to the current format for SIBELMED W 50 Audiometry Software On using this option the following window appears Buscar en gt ex E3 iDBPARAM DBF Z PACIENTE DBF PRUIEBAS DBF Nombre DBPARAM DBF Tipo Ficheros DBase dbf Cancelar Sibelmed SIBELMED W 50 Software Manual 43 Options for Existing Patient patient is already in the Database Indicate the option you require 1 Add the tests to the Existing Patient 2 Replace the existing patient adding the tests 3 Do not convert this patient or their tests 4 Use new reference Data for Existing Patient Reference 21433870 Date of Birth 171 1961 Patient 1 ASENSI CASTELLO ANTONIO Data for New Patient Reference 21433870 Date of Birth 17 1 1961 Patient TOMAS ASENSI ANTONIO Lise the same option For all patients QO 0 This shows the data for the new patie
27. bf data files insert find delete etc In any event the log and access control file must be kept for a minimum period of two years Sibelmed 7 SIBELMED W 50 Software Manual 83 Below all actions registered on the log file are listed Opening db file Closing a db file Selecting a db Creating a db Creating a db file Deleting a db e Deleting a db file Re indexing a db file Compacting a db file e Changing password Finding a record e Adding a record Marking a record Recovering a record Changing a record Deleting a record Exporting a record Importing a record Other important points Printing documents When paper reports containing patient data are stored it is necessary for these documents to be stored securely such that only authorised personnel have access to them Further in the event that the user decides to dispose of the printed documents it is necessary to ensure their effective physical destruction to avoid unauthorised access to the data Exporting tests The software allows tests to be exported only if the user is identified and authorised to read the database Once a test has been exported to a file the user of the software is responsible for the security of that file and its subsequent deletion u0I329304d uo MET BIUBIJdWODJ XIaN3ddV APPENDIX 1 Compliance with Organic Law on Data Protection Sibelmed 7
28. cking on the notes window e Save the test to the database icon or Options menu Save in the database Sibelmed 7 SIBELMED W 50 Software Manual 59 e Print a report of the test icon or Options menu Print Report e Compare with other tests icon or Options menu Compare e Delete a point right click above the point 0S M 9848n3Jos z 1a1deyo Sibelmed SIBELMED W 50 Software Manual 60 IMPORTS TESTS IMPORT TESTS Loads test data stored in the audiometer Select the required tests by clicking on each one individually or select all of them using the Select button to unselect a test click on it or click the Unselect button Click the OK button to import the selected tests The bar at the foot of the window indicates that the import process is in progress At the end of the process it indicates that the data import is complete At this point the tests have been saved in the database Click Cancel to return to the previous window without loading data Database C SIBEL 50 BDSIBEL SIBEL 1 Data Import Mo of Tests 1 Mo Reference Type P2 Date Time 0000000001 AUDIQ ACSO 0 0 0 0 20 07 2004 09 40 Sibelmed 7 SIBELMED W 50 Software Manual 61 DELETE TESTS ON THE DEVICE Deletes tests stored in the audiometer HELP MENU ABOUT THE HELP SYSTEM This window explains the Help system incorporated in the SIBELMED W 50 Audiometry Software ABOUT TH
29. dingly the system becomes personalised to each user making it simpler to operate and to understand how it works Sibelmed 7 SIBELMED W 50 Software Manual 24 The various options that can be personalised from the configuration menu are set out below SELECT PRINTER This option is for configuring a page for printing size origin orientation and indicates the printer selected by the operating system as well as the available printers If the required printer is not listed it must be added in the normal way for the operating system Refer to the Manual for the Operating System Configurar impresi n 2141 Impresora Nombre Propiedades Estado Listo Tipo Snaalt 6 Printer Ubicaci n SNAGIT6 Comentario Papel Orientaci n Tama o Jaa 1 Vertical Origen Selecci n autom tica 1 f Horizontal Red Cancelar Sibelmed SIBELMED W 50 Software Manual 25 LINKS From this window you can select e The equipment AC50 SIBELSOUND 400 or manual entry e The device Audiometer or Disk The Disk option includes some standard recorded tests so that the software can be tried out without the need to carry out a test e The serial port for communication between the equipment and computer If USB comunications are used only SIBELSOUND 400 this parameter doesn t take any effect x Device AUDIOMETER C DISK Equipment ssoumaoo AUDIOME Serial Port c
30. e Manual 20 INTRODUCTION The SIBELMED W 50 Audiometry Software operates under the Microsoft Windows environment and provides as its main features Management of various patient databases Download of data from audiometric tests carried out with the AC50 or SIBELSOUND 400 audiometers Manual entry of data from audiometric tests carried out with other audiometers Viewing of the individual audiometric tests Obtaining diagnoses Printing of test reports Version 520 66A 8 03 Date 17 07 2008 SIBEL S A Cf Rossell 500 08026 Barcelona Spain 1 gt Tel 34 93 4360009 Fax 34 93 4361611 Email sat sibelmed es Sibelmed SIBELMED W 50 AUDIOMETRY SOFTWARE Sibelmed 7 SIBELMED W 50 Software Manual 21 ABOUT THE ON SCREEN HELP The help incorporated into the SIBELMED W 50 Audiometric Software is structured based on the MICROSOFT Windows system and shows the user how to make appropriate use of the program s various options The Instruction Manual provides in some cases a more detailed explanation concerning technical specifications or other aspects In general each window contains a Help menu where you can find an explanation of the various options available The help feature is marked on each window with an icon text or both In some sections of text you will find words or phrases which link to further help for a more detailed explanation To do this place the cursor
31. e selected tests The bar at the foot of the window indicates that the import process is in progress At the end of the process it indicates that the data import is complete At this point the tests have been saved in the database EXPORT TESTS BY EMAIL Allows tests to be sent by email To do this you must 1 Mark the tests you wish to email 2 Select the Export tests by email option from the Options menu The email system installed in the PC then opens displaying a new draft message with an attachment called TESTS containing the data for the selected tests 3 Enter the destination email address and any message text 4 Click Send to send the email TEST DATA Opens the tests window to view graphs parameters diagnoses etc relating to the selected test Sibelmed 7 SIBELMED W 50 Software Manual 36 PRINT REPORT Prints a report of the selected test PRINT PREVIEW Opens a window showing a preview of the report so you can check it is the report you want and is correctly formatted before printing The following options are available Report prints the report Forward Back moves forwards backwards within the report so that all pages can be previewed Zoom Out In allows to decrease increase the dimensions of preview of the last Help displays Help in relation to the print preview function Return returns to the previous window e WINDOW SELECT For selection of a patient or test Where the Patien
32. ent file DELETE deletes the patient together with the corresponding tests UNDELETE removes the deletion marker from a patient who has been marked for deletion Double clicking on a patient opens their file On clicking the right button of the mouse above a test a menu appears with the following options DATA accesses the test s data card DELETE deletes the test Sibelmed 7 SIBELMED W 50 Software Manual 39 UNDELETE removes the deletion marker from test which has been marked for deletion GRAPH opens the test window REPORT prints the relevant test Double clicking on a test opens the test window PATIENT CARD This window provides access to the card for any patient saved in the database and enables their various tests to be viewed along with their key parameters Patient s Card Database SIBEL 1 Options Index Record yi T 2 Deleted Day Montt Year Date of Birth 10 fio 1980 27 Mame Juan Job Reference T Surname Garc a P rez Man Womar Address City Postcode Country Po Telephone Po Telephone Po Notes Patient Tests 20 07 2004 09 40 AUDIOMETR Y 002 20 07 2004 09 42 AUDIOMETR Y QQQUF 44 Sibelmed 7 SIBELMED W 50 Software Manual 40 The fields associated with each card are NOTE The patient data are fictitious Field Type No characters Index A N Reference A N 8 Date of Birth N 8 dd mm y
33. ftware Manual 66 e If they detect between 20 and 60 of the instances the test is inconclusive e If they detect more than 60 of the instances the test is positive FOWLER TEST This tests the balance between the left and right ears This involves comparing at the same frequency the equality of the level of sound intensity between the two ears This is aimed more at predominantly unilateral deafness the two ears must not be identical TONE DECAY TEST This involves exposing the patient to a pure tone at 5 dB above the hearing threshold and observing whether it is perceived clearly for 60 seconds Normally it would be perceived throughout this period If not the level is increased in 5 dB steps until it can again be heard and again successively until the patient confirms they can hear the sound for one minute LUSCHER TEST This involves distinguishing variations in the modulation of the signal For the ear to perceive an increase or decrease in physical intensity as a change in subjective intensity sonority the physical intensity must change by more than a certain value This small change in physical intensity which the ear can perceive is called the differential threshold SPEECH AUDIOMETRY Speech audiometry essentially consists of determining the threshold of intelligibility the patient hears and understands words Sibelmed 7 SIBELMED W 50 Software Manual 67 pronounced using a list of words spoken live or via
34. gram you must enter the key found on the label of the CD as indicated in the instruction manual 2nd If the program is in DEMO mode you may use it for the remaining period indicated 3rd If you wish to purchase it click the Register button and send the data to the distributor or to SIBEL S A so that they can supply you with the activation key for the program After this period some program functions will be disabled j e pm This screen allows ti activate the software by means of the activation code if the Activar Producto options selected It also allows to ask for the activation code if the Registro Options selected When the specified evaluation period is finished some software functions are desactivated The following warning message is shown iii ATENCION x iEl per odo de evaluaci n ha finalizado Sibelmed 7 SIBELMED W 50 Software Manual 14 To activate the program you must connect the SIBELSOUND 400 audiometer by means of the USB or RS232 wire Following select the options Utilities Activation Code from the Configuration menu o select the Activar Producto option from the SOFTWARE VALIDATION dialog box the following dialog box is shown ACTIYATION CODE X Cade Hm Qe 9 Enter the activation code provided when the software was purchased From then onwards you are free to use the Sibelmed W50 Software without restriction ACQUIRING THE PROGR
35. he Security tab From this tab you can select both the users who may have access and the corresponding permissions full control read modification write etc for each user File audit We recommend the activation of the log file audit in order to record on the security event viewer the actions performed upon it To activate this option you must first enable the audit of this file At this level you must specify the users depending on the users who access the SIBELW50 HOME MBdsibel directory and types of access to be audited The log file audit can be activated from the Security tab of the file Properties Using the Advanced button you can access the Audit tab From here simply add the users and the type of access to be audited Note that if all actions are audited via the log file the security events viewer will have a large number of entries which will make it difficult to monitor instances of unauthorised access The next step is to activate the audit of access to objects via local security configuration To do so access the Administrative Tools icon from the Control Panel From there select Local Security Policy and then Local Policies from the policies tree You must then use Audit Object Access Both correct and incorrect accesses can be enabled Finally other files must be audited for example the password files lt SIBELW50_HOME gt Bdsibel NAME_DB gt PW TXT if access to the NAME_DB database by other users has n
36. he Cancel button to return to the previous window without saving the data Guardar en le TMP vi cRAFOD1 CSV PRUEBAS CSV Nombre RUEBAS CSV Tipo Fichero Impartaci n E portaci n csv Cancelar IMPORTING TESTS IN CSV FORMAT Allows tests saved in CSV format to be imported To do this you must 1 Click the IMP icon or select the Import tests in CSV format from the Options menu The Open window then appears Audiometry Software W 50 r2 er Chapt Sibelmed 7 SIBELMED W 50 Software Manual 34 Buscar en vi E E GraFoo1 csy PRUEBAS CSV Tipo Fichero Importaci n E xportaci n Cancelar 2 Find the folder containing the file to import and select the file Click the Cancel button to return to the previous screen without importing data or D Click the Open button to proceed with the data import The Data Import window appears showing the tests contained in the selected file Data Import Database C SIBEL W50 BDSIBEL SIBEL No of Tests 1 Mo Reference Type P1 P2 Date Time 0000000001 AUDIO ACSO 0 0 0 0 20 07 2004 09 40 Sibelmed 7 SIBELMED W 50 Software Manual 35 4 Select the required tests by clicking on the relevant test or select all of them using the Select All button to unselect click on the relevant test or click the Unselect button 5 Click the OK button to import th
37. ing them aware of their obligations in relation to the handling of personal data It is also advisable to enable the security audit feature in order to record valid and erroneous accesses on the system Access setup and control File permissions The next step is to set up the access levels to the files which form the databases by reference to the users which have been set up The root of the databases is found in the folder lt SIBELW50_HOME gt Badsibel Within it there is a subfolder for the database also the log file W50 log One possible configuration is to provide full access to the SIBELW50 HOME Bdsibel directory to all users or at least to the users of the application and to restrict access to each of the subdirectories to their respective users In any event the owner must always have read and write access for their subdirectory and the files that make up the subdirectory The other users may for example have access to that database totally denied Note that in this situation the users may only access their database via the application At the level of the log 5 SIBELMED W 50 Software Manual 81 file W50 log it would be advisable for the users to only have write access so that the application could record accesses to the various databases Permissions can be applied from Windows Explorer itself Simply access the Properties of the directory or file on which you wish to establish permissions and select t
38. nt and the existing patient and offers the choice of the following options 1 Add the tests to the existing patient The patient data is not changed the only change is the addition of the new tests 2 Replace the existing patient adding the tests The patient data is changed but not the existing tests The new tests are added Make no change to this patient or their tests the conversion is not carried out 4 Use a new reference a new reference is created for the new patient In this event the new reference must be entered To apply the same choice for all patients use the tick box located towards the lower part of the window Sibelmed 7 SIBELMED W 50 Software Manual 44 SELECT DATABASE Allows a database to be selected To do this enter the path where it is located and select the database by name Database Selection Database Path BDSIBEL Database name SIBEL w 9 The path could be relative e g BDSIBEL BASE or absolute e g C BDSIBEL BASE Network drives can also be used provided they are shared and have been given the necessary reading and writing permissions WARNING If in any doubt consult the system administrator The path can be selected using the drop down menu or entered using the keyboard On selecting a path the available Databases are listed in the lower drop down DATABASE NAME On selecting a Database the following error message may be displayed Not a
39. om S be imed SIBELMED W 50 Software Manual 26 OTHER From this menu option you have access to REPORT HEADER A three line header can be inserted in printed reports with data chosen by the user For example Name of centre name of doctor address etc Report header 13 P 2a O amp Q This header remains in force until modified PARAMETERS AND OTHER This window is for selection of e The type of diagnosis for the pure tone audiometry test Ministry of Labour ans Social Affairs Council of Physical Therapy Mexican Social Security Institute Eli Index Sal Index and Klockhoff Index e The parameters which we wish to view in the pure tone audiometry test e The language for the application Sibelmed SIBELMED W 50 Software Manual 27 SETUP OTHER 2 x Diagnoses Parameters 3 IPS Ministry of Labour and Social Affairs V Hearing Loss Council of Physical Therapy e verage dBs Mexican Social Security Institute Bilateral Loss 95 Eli Index Sal Index Language Klockhoff Index Engish 9 9 Q To finisch the program and return to Windows use the exit option UTILITIES This option is only available if the SIBELSOUND 400 audiometer and the device Audiometer are selected in the Setup Links menu The following options are shown Update Flash Pu
40. on only Windows Operating Systems which allow these processes to be carried out in a secure way are valid that is Windows NT 4 Windows 2000 Windows XP and Windows Vista with the NTFS file system The Windows 9x systems are not valid neither is the FAT file system Sibelmed 7 lt W 50 Software Manual 79 PC administrator must create unique and personalised username for each user and activate user authentication The operating system encrypts the passwords Access control The Operating System must be set up to control the access to data i e permit or deny access to data Likewise the PC administrator must set up user account locking in order to block repeated attempts to gain unauthorised access Consult the operating system s manual for help with setting up access controls Access register Accesses to the different databases are stored on the one access register file Security copies backup and recovery The user must at least once a week make back up copies of all data in order to guarantee full recovery of data in the case of a computer system failure In the case of the SIBELMED W 50 Audiometry Software full recoverability of all the data in all the databases can be guaranteed by saving the whole of the BDSIBEL folder which is in the application folder This back up copy must be stored at all times in a different place to where the equipment on which the software is used is located Config
41. osed Comparison Options 4 Compare with previous test 002 20 07 2004 09 42 Pure Tone PRINT REPORT Prints a report based on the current test PRINT PREVIEW See the Topic MAIN MENU OPTIONS MENU DATABASE EXPLORE DATABASE Sibelmed 7 SIBELMED W 50 Software Manual 50 ORGANISE WINDOWS This option allows the user to make proportionate changes to those windows which have been selected The user can adjust the window sizes using the mouse and dragging any of the sides or vertices of a window HELP MENU See the Topic MAIN MENU HELP MENU The following options are also available from the icons at the top of the window New Patient Save to database Compare Print Report Print Preview Help and Exit Test selection can also be carried out using the drop down menu at the top of the window Depending on the selected test the following windows appear Sibelmed 7 SIBELMED W 50 Software Manual 51 PURE TONE THRESHOLD AUDIOMETRY 210802 Setup Options Help i 9 Fone RESULTS Council of Physical Therapy Hearing Loss e Window showing graph of Intensity v Frequency for the right ear e Window showing graph of Intensity v Frequency for the left ear e Central window for e Selection of route Air Bone Free e Selection of masking e Weber Test Access to diagnosis e Legend
42. ot been completely restricted uo YUM BIUBIJdWODJ XIaN3ddV APPENDIX 1 Compliance with Organic Law on Data Protection Sibelmed 7 SIBELMED W 50 Software Manual 82 Description of the access log Access to the various databases is recorded in one log file W50 log in the BDSIBEL folder of the directory where the application is installed by default SIBEL w50 and from now on lt SIBELW50_HOME gt Basibel This file is created the first time that the application is launched and cannot be deactivated The system administrator is responsible for the maintenance of the size of this file and the preparation of a monthly report where the periodic reviews carried out are analysed and any problems detected are reported The log file saves for each access e User Time and date of access Database accessed Action carried out on the database e Type of access authorised or denied File path of database accessed Reference of the record accessed The format for each entry is as follows USER YYYYMMDD HH MM SS BASE ACTION ACCESS PATH REFERENCE The database comprises a directory and two data files paciente dbf and pruebas dbf as well as auxiliary files indexes etc The actions to be recorded are divided into Action on the actual database itself open close delete etc e Action on the records stored in the paciente dbf and pruebas d
43. pment is connected to the computer the Windows New Hardware Detected screen will appear with the name of the equipment that you have connected Select Next 4 A screen where you will be able to read Insert the disc came with your device will appear select I don t have the disc Show me other options 5 Now a screen will appear that allows you to select between two options select Browse my computer for driver software 6 If your operating system is a Windows Vista 32 bits version select the directory D Driver W2K WXP WVISTAx32 of the audiometry CD For Windows Vista 64 bits select the directory D Driver WVistax64 Press OK 7 Click on Next and Finish The Driver will now install itself START UP Reboot the PC and launch the program by clicking on the W 50 icon under All Programs gt SIBEL from the Start menu or double clicking on the W50 short cut on the desktop Press OK on the ABOUT screen to access the MAIN WINDOW Sibelmed SIBELMED W 50 Software Manual 13 ACTIVATION CODE This option is to activate the program once when it s used with SibelSound 400 audiometer the trial period has expired program in DEMO mode During this period of 30 days the program notifies the number of days remaining before the end of the above mentioned period by means of the following dialog box SOFTWARE WARNING Only 30 days use remaining 1st IF you have purchased this pro
44. rchasing the program see the topic ACQUIRING THE PROGRAM Activating the program see the topic ACTIVATION CODE UPDATE FLASH The SIBELSOUND 400 audiometer of SIBEL S A has a firmware updating and maintenance process Sibelmed 7 SIBELMED W 50 Software Manual 28 Before starting the update process check that the device is ON and connected to the computer If you are using serial communications check if the selected port in Setup Links menu is correct To update the version of the firmware the Setup Utilities Update Flash option must be selected From the SSOUND 400 Update dialog box enter the key supplied with the audiometer click the SEND button and verify the evolution of the loading process in the screen x FIRMWARE Program S400FLAS Evamine Bios 54008105 mime Tr 2 o WARNING DON T CANCEL THE LOAD PROCESS WHEN IT HAS STARTED Finally a transmission correct message will appear So the new firmware runs smoothly you must leave the loading screen turn off the audiometer and turn it on again From now on the device will work perfectly with the new firmware version Sibelmed SIBELMED W 50 Software Manual 29 If there was error during the load process it s possible to restart the firmware update You must leave the loading screen turn off the device and turn it on again A screen with the following text will be shown in the audiometer ACT FIRMWARE UPDATE FIRM
45. s to follow Delete Database Database Path Database name SIBEL COMPACT DATABASE This option is used to permanently delete records marked for deletion by the user and reorganise the remaining records in the database This option can be used as often as the user wishes but may take some time to carry out depending on the volume of data stored REINDEX RECORDS Allows a database to be reorganised whenever any problem with it is encountered This option can be used as often as the user wishes but may take some time to carry out depending on the volume of data stored SHOW DELETED RECORDS When a Database record is deleted it remains hidden but is not Sibelmed 7 SIBELMED W 50 Software Manual 47 permanently deleted unless the compact database option is used You can use this option at any time to see the records marked for deletion AUDIOMETRY In this section we describe the various windows and functions which are specific to audiometry The various audiometric tests and the procedure to carry them out are described in Chapter 3 EN SIBELMED AUDIOMETRY SOFTWARE W 50 MANUAL Database SIBEL There is no patient ioj x Setup Options Help gt B kii gt AUDIOMETRY 125250 500 2K 4K ar 125250 500 2K 4K 7 7 7 Bone 3 F Field Masking Bone 7
46. ssion of sound to the inner ear principally via mechanical vibration of the cranial bones Sibelmed 7 SIBELMED W 50 Software Manual 65 WEBER TEST For this test all frequencies between 250 and 8000 Hz must be investigated at 15 dB above the subject s frontal bone threshold The vibrator is applied frontally held in place with a headband not by hand as the latter might allow variation pressure which could lead to error A note is made of which side the patient perceives the sound to be coming from This test is fundamental in clinical audiometry its physiopathological significance is considered subsequently for purposes of diagnosing deafness PURE TONE HF It consists of realizing a pure tone audiometry in a range of frequencies extended up to 20 000 Hz Unlike the classic pure tone audiometry hearing thresholds are only inspected by air conduction PURE TONE SUPRATHRESHOLD AUDIOMETRY These tests are for evaluation of distortions in the sensation of sound due to disorders in the perception System These tests include SISI JERGER TEST This involves having the patient hear a continuous pure sound at 20 dB above the threshold for two minutes Every 5 seconds the intensity of the sound increases by 1 dB for 2 10 sec The patient must signal the occurrence of this brief change in intensity every time they perceive it e If they detect less than 20 of the instances the test is negative Sibelmed 7 SIBELMED W 50 So
47. ta concerning the patient on a read only basis Reference Age in years Name Surname BMI Body Mass Index And other items may be entered such as Date and time the test was carried out Height in cm between 100 and 215 cm Weight in Kg between 15 and 135 kg Reason for carrying out the test Origin or centre department doctor etc from where patient was referred Technician who carried out the test Notes on the test Sibelmed 7 SIBELMED W 50 Software Manual 32 Test Data B x Day Month Year Time Reference 0000000001 27 Date 20 07 2004 09 40 ke Name Juan Surname Garc a P rez Height cm 174 Weight 7o 23 1 Normal weight Reason Origin Technician Notes Q DATABASE MAINTENANCE See the Topic MAIN MENU OPTIONS MENU DATABASE MAINTENANCE OPTIONS IMPORT TESTS See the Topic MAIN MENU OPTIONS MENU IMPORTS TESTS IMPORT TESTS EXPORT TESTS IN CSV FORMAT Allows tests to be exported in CSV format To do this you must 1 Mark the tests you wish to export 2 Click on the EXP icon or select the option Export tests in Sibelmed 7 SIBELMED W 50 Software Manual 33 CSV format from the Options menu The Save As window then appears 3 Enter the name of the file and the folder to which you wish the data to be saved 4 a Click the Save button to save the data At this point the file is created or D Click t
48. this value has been obtained Table 5 of the SAL Index is used to present the evaluation To arrive at the index both ears need to be tested Clinical recommendations have led us to change the text of the SAL Index Table of the Protocol for Specific Health Surveillance Interterritorial Council of the Spanish National Health System according to the following Grade C changes from Slightly worse to Slight Hearing Impairment Grade D changes from Seriously worse to Significant Hearing Impairment Grade E changes from Severely worse to Serious Hearing Impairment Grade F changes from Extremely worse to Severe Hearing Impairment Grade F covers 91 to 99 dB and Grade G applied to 100 dB onwards There are some situations not covered by the evaluation table particularly where impairment is too asymmetric one ear within the normal range but the other however displays serious acoustic trauma This occurs when the best ear presents a drop of lt 16 dB and the worst ear presents gt 30 dB In such cases the following text is displayed Detected deafness too asymmetric to be evaluated using the SAL table sisouBeiq iagnosis APPENDIX 2 D Sibelmed 7 SIBELMED W 50 Software Manual 96 As well as the SAL Index we obtain Monoaural hearing Loss and Binaural or Bilateral Hearing Loss as described in the MINISTRY diagnosis TABLE FOR EVALUATION AND INTERPRETATION OF SAL INDEX
49. ts window is active on selecting a patient all that patient s tests are also selected UNSELECT Unselects the selected patient or tests Where the Patients window is active on unselecting a patient all that patient s tests are also unselected Sibelmed 7 SIBELMED W 50 Software Manual 37 SELECT ALL Where the Patients window is active all patients are selected together with all the tests If the Tests window for a patient is active all the tests for the selected patient are selected UNSELECT ALL Where the Patients window is active all patients are unselected together with all the tests If the Tests window for a patient is active all the tests for the selected patient are unselected CASCADE Superimposes all the Patients and corresponding Tests subwindows in a cascade arrangement TILE HORIZONTAL Arranges all the Patients and corresponding Tests subwindows above and below each other TILE VERTICAL Arranges all the Patients and corresponding Tests subwindows side by side REFRESH Refreshes the information in the windows Sibelmed 7 SIBELMED W 50 Software Manual 38 SORT BY Sorts the list of patients by criterion selected record number Surname or reference SHOW DELETED RECORDS Shows those records marked for deletion e HELP See the Topic MAIN MENU HELP MENU On clicking the right button of the mouse above a patient a menu appears with the following options DATA provides access to the pati
50. ty Institute A Monoaural hearing loss 1 The hearing thresholds of each ear are determined at frequencies of 500 1000 2000 and 3000 Hz and added 2 The four values of each ear are added and the average is calculated 3 The result is then multiplied by 0 8 Fletcher Index Example Right ear RE 500 1000 2000 3000 dB of loss 15 10 5 10 Average 15 10 5 10 4 10 dB Hearing Loss RE 10 x 0 8 8 dB Average RE 40 4 10 0 dB Left ear LE 500 1000 2000 3000 dB of loss 35 30 40 50 Average 35 30 40 50 4 38 7 Hearing Loss LE 38 7 x 0 8 3190 dB Average LE 155 4 38 7 dB B Binaural hearing loss Binaural hearing loss is calculated by multiplying the loss of the best ear by seven and adding the loss of the worst ear and then dividing the total by eight Sibelmed 7 lt W 50 Software Manual 93 Binaural hearing loss in 9o 7 loss in best ear loss in worst ear 8 Example Binaural hearing loss 9o 7x8 31 0 8 10 9 Yo C Categories of Hearing Loss The MEXICAN diagnosis does not establish categories of hearing loss However the same categories as for the MINISTRY diagnosis have been adopted 4 ELI The ELI Early Loss Index is calculated from a frequency of 4000 Hz and following the tables of the Protocol for Specific Health Surveillance Interterritorial Council of the Spanish National Health System following the steps below 1 The ELI
51. ual and therefore in accordance with the ISO 13485 quality standard as well as the European Medical Device Directive 93 42 EEC Under this directive it is regarded as a class IIa product INTRODUCTORY INFORMATION This product is manufactured under strict quality control However accidents can occur during the transport or storage of the equipment It is therefore advisable to carry out an initial check on its condition and that of the accompanying accessories before installation The SIBELMED W 50 Audiometry Software comprises CODE QUANT DESCRIPTION 520 660 001 1 SIBELMED W 50 Audiometry Software 520 690 001 1 W 50 Communication software 520 660 MU1 1 Instruction manual 5 SIBELMED W 50 Software Manual 9 MANUFACTURER S RESPONSIBILITIES SIBEL S A guarantees the safety reliability and proper functioning of this equipment provided that e The computer in which the software is installed complies with the IEC UNE electrical installation requirements for medical products 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 technical staff e The software is used by qualified staff following the recommendations for use in accordance with the Instruction Manual INSTALLATION SETTING UP AND REQUIREMENTS INSTALLING THE AUDIOMETRY SOFTWARE WARNING If installing the software under the Windo
52. uration of the Operating System On a Windows operating system level NT 2000 XP and Vista and for NTFS partitions it is possible to restrict the access to the various databases using the file system s security features Generally speaking control of access to databases involves the following uo BIUBIJdWODJ APPENDIX 1 Compliance with Organic Law on Data Protection Sibelmed 7 SIBELMED W 50 Software Manual 80 Configuration of Identification Authentication Each user that accesses the system must have a unique username and password whether a local user or a network user connecting to a domain The passwords must be changed periodically as often as desired and while a series of passwords may remain valid they are stored in encrypted form Users may be added from the Users and Passwords icon on the Control Panel Using the Advanced Administration button on the Advanced Options tab you can access the Local Users and Groups setup In the Users section new users can be created or existing properties modified The access level of users can be set up in user properties on the Users tab of the Users and Passwords icon We recommend that users are not given Administrator access level In any event the Administrator is responsible for ensuring that users use their username appropriately in accordance with technical requirements and documentation as well as mak
53. verage RE 40 4 10 0 dB Left ear LE 500 1000 2000 3000 dB of loss 35 30 40 50 Sum 35 30 40 50 155 Hearing loss 20 6 dB Average LE 155 4 38 7 Sibelmed 7 lt W 50 Software Manual 87 B Binaural or Bilateral hearing loss Binaural hearing loss is calculated by multiplying the loss of the best ear by five and adding the loss of the worst ear and then dividing the total by six Binaural hearing loss in 5x loss in best ear loss in worst ear 6 Example Binaural hearing loss 5x0 0 20 6 6 3 4 C Categories of Hearing Loss The MINISTRY diagnosis does not establish categories of hearing loss However professional clinical recommendations have led us to include the following categories depending on the hearing loss in each ear CATEGORIES HEARING LOSS NORMAL 0 to 10 SLIGHT HYPOACUSIA 11 to 30 MODERATE HYPOACUSIA 31 to 609 o SEVERE HYPOACUSIA 61 to 100 Conversion of the estimated hearing level in percentage of monoaural hearing loss sisouBeig APPENDIX 2 Diagnosis Sibelmed 7 SIBELMED W 50 Software Manual 88 TABLE FOR THE CALCULATION OF PERCENTAGE HEARING LOSS ACCORDING TO THE MINISTRY OF LABOUR AND SOCIAL AFFAIRS OFFICIAL GAZETTE 26 JANUARY 2000 dshl dshl dshl dshl 1055 dB loss dB loss dB loss m pem perm p 105 175 28 1 245 54 4 315 80 6 110 A 180 30 0 250 56 2 320
54. ws NT 4 Windows 2000 Windows XP or Windows Vista operating systems the user must have Administrator privileges for the program to install correctly In case of doubt consult the system Administrator or Windows Help Sibe med 7 SIBELMED W 50 Software Manual 10 To install the Software on the hard disk of the PC proceed as follows 1 Place the CD_ROM in the CD DVD drive 2 If the CD DVD drive has autoplay enabled installation will start automatically If not run the file Setup exe on the software CD 3 When setup starts the following window appears offering the choice of install language Elegir idioma de instalaci n Seleccione uno de los idiomas siguientes instalaci n 4 Choose the folder where the program is to be installed the program group name By default the program is installed in the folder SIBEL W50 AUDIOMETRY RE SIBELMED W50 TS Setup will install W50 in the Following Folder Sibelmed To install to this folder click Next To install to a different Folder click Browse and select another Folder gt Jestination Folder 5 I b c GROUP Cancel Sibelmed 7 SIBELMED W 50 Software Manual 11 5 Once the installation is finalised the SIBEL program group is created and a short cut is added to the desktop USB INSTALLATION DRIVER A driver needs to be installed on the computer in order to USB communications between SIBELSOUND 400 and SIBE
55. yyy Name A N 20 Surnames A N 35 Job Sex A N 25 Address City A N 46 Postcode A N 28 Country A N 5 Telephone 1 A N 10 A N 10 Telephone 2 A N 10 Notes1 A N 74 Notes2 A N 74 A N Alphanumeric field Numeric field On clicking Options a drop down appears with the following options REGISTER Registers a new patient A dialog box appears for entry of the new reference number The program warns if the reference has already been used for another patient DELETE Deletes a patient and all that patient s tests UNDELETE Undeletes the deleted records To use this function you need to access the Options menu from the main window and Sibelmed 7 SIBELMED W 50 Software Manual 41 select Database Maintenance and then activate the Show deleted records option FIND Finds the file for the required patient You can search by reference surname or record number EXPORT Opens the export window EXIT Returns to the previous window The find and test data options are also available from the icons in the lower part of the window You can also use the slow tab keys advance one record ata time or the fast tab keys move by 10 records at a time to navigate through the database to find the required card The card shows the number of records in the database and the number of the selected record DATABASE MAINTENANCE This Maintenance option refers only to the database on the computer not the one in the audiometer For inform
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