User`s Manual - Piston Medical
Contents
1. Audiometry Malfunction Diagnose Fixing No signal in headsets Connection problem Check the connection of the headset Communication prob Reconnect the device to the PC lem The signal of the Connection problem Check the connection of the hand hand switch is not switch detected by the soft ware Communication prob Reconnect the device to the PC lem Piston Audiometry 14 THE PROGRAM S MAIN FUNCTIONS Patient database The software is able to store any number of the patients and any number of the test Automatic safety backup The software makes automatic safety backups according to the user de finable intervals Available tests The air conductive hearing level of the patient can be determined by the audiometer Test modes The following test modes are available e Manual e Semi automatic ascending iteration according to Hughson Westlake protocol e Semi automatic descending iteration e Programmable automatic sequence Manual mode Frequency and the sound level is set by the user manually Piston Audiometry 15 The program s main functions Ascending iteration In the ascending iteration the sound level is raised from the unheard level to the level when the patient indicates that the sound is heard already Set starting sound pressure Frequency selection Signal is heard Sound pressure increased by 10dB Sound pressure decreased by 20dB Si2. Configuration of automatic sequence Store results Piston Audiometry 21 User interface Report editor g Print preview for audiometry sa Print selected measurement results Um m Store a report as PDF document or image X Close Report editor Piston Audiometry 22 User interface User interface The mainframe software provides control of pulmonary function tests Zero button 2008 12 18 10 25 07 Abaffy Tiborn B3kg 168cm S5 ves PRE EME 12 18 1541 Device selector S amp 125 250 500 15000000 1500 2000 3000 4900 6000 soep Menu JOBB Patient data EM 7 e Navigator Frequency selector PRE POST Audiogram Sound pressure Ear selector 500 6 05 5 08 Signal type selector Test mode Results Device selector The device selector indicates the connected devices Select the device to be used from the drop down list Menu The program s general main menu which contains the grouped basic functions Patient data Contains the most important measurement data for the patient selected from the database Piston Audiometry 23 User interface Navigator Controls that group the basic phases of daily routine Frequency selector Selection of frequency of the generated signal PRE POST PRE POST comparison can be compiled of the actually measured tests and of the retrieved tests from database Audiogram Graphic presentation of the heari
3. All previous measurements can be reloaded so reports can be printed at anytime Viewing previous measurements To reload previous measurements e Select the patient e Select the visit by date e If you only wish to view the results of certain measurement mode select the one from the list e Select required measurements If you wish to see all measurement results of a selected visit click the Otw rz button If only certain measurements are important click them while holding the CTRL button down After selection click on the Otw rz button If you wish to include further measurements to the report click the Baza danych pacjent w button to reopen the Patient database Select further measurements and click the Dodaj pomiar button to in clude them to the report WARNING You can only simultaneously load eight measurements of the same mode For this reason the Zaladuj wszystko button is not always avail able Piston Audiometry 34 Baza danych pacjent w PRE POST evaluation To load the data for all previous visits check the Wszystkie pomiary checkbox This displays a patient s all previous measurements sorted according to the following e Date e Measurement mode Measurement results quality Select the results of at least two identical measurement mode for exam ple two FVC measurements Load the data as mentioned earlier PRE POST measurements are detailed in the PRE POST secti
4. 04 A tan s t s az al bbi tev kenys gekre rv nyes Audiom terek l gz sdiagnosztikai berendez sek s kapcsol d sz jcsutora valamint bakt rium sz r k gy rt sa s forgalmaz sa A tan s tott ter lettel s az MSZ EN ISO 13485 2004 szabv ny k vetelm nyeinek alkalmazhat s g val kapcsolatban tov bbi inform ci a szervezettel val konzult ci tj n nyerhet A tan s tv ny 2011 december 21 t l 2014 december 20 ig rv nyes sikeres fel lvizsg latok eset n Meg j t audit esed kes legk s bb 2014 december 13 ig Kiad s 1 Tan s tva 2011 december 21 t l Ei Tohl Andr s MIR TAN S T ZENISO 13485 SGS Hungaria Kft Systems amp Services Certification born 1531 Pf 25 Sir ly u 4 1124 Budapest yHungary t 36 13093340 36 13093333 www sgs com Oldalsz m 1 1 EE k 9 a t rv nybe tk z s jogi elj r st vonhat maga ut n Piston Audiometry 52 Certificates of Quality Management System HU11 6221 sz m tan s tv ny ford t sa Tan s tjuk hogy a z Piston Kft 1033 Budapest Sz l kert u 4 b ir ny t si rendszer t audit ltuk s az megfelel az al bbi szabv ny k vetelm nyeinek ISO 9001 2008 A tan sit s az al bbi tev kenys gekre rv nyes Audiom terek l gz sdiagnosztikai berendez sek s kapcsol d sz jcsutora valamint bakt rium sz r k gy rt sa s forgalmaz sa A tan s tott ter lett
5. AL DATA Warranty The device complies with the effective Technical Specifications The manufacturer guarantees the product according to the terms of the Installation Delivery protocol The warranty does not cover post delivery careless shipping unprofes sional storage violent damaging abnormal operation unprofessional op eration inefficient protection against external effects natural disasters or not following the contents of the User Manual Check package condition after delivery If packaging is damaged notify the carrier and Piston Ltd or its representative Limited liability Piston Ltd and its carriers according to the valid laws do not accept any responsibility for any individual unforeseeable direct or indirect dam ages including loss of business profit interruption of business activity loss of business data or any other damages due to financial loss result ing from the use or non usefulness of the product Safety instructions To avoid possible damages and accidents please pay attention to the fol lowing safety instructions e Make sure the mains voltage is the same as that on the product label Make sure the connection cable is not damaged Take care of your device according to the maintenance section Only use the device according to the manual Do not use any accessories not recommended for the device Store the device in a dry place Keep the cable away from heat source sharp objects r
6. B PistoriXP program files 10 6 MB User s manual 40 3 MB v English 15 6 MB v Deutsch 10 2 MB v Maavar 145MB Y Current selection requires at least 1 548 8 MB of disk space Bak Nec Cancel te Setup PistonXP Select Start Menu Folder Where should Setup place the program s shortcuts Setup will create the program s shortcuts in the following Start Menu folder To continue click Next If you would like to select a different folder click Browse Pion Medos lt Back Next gt Cancel Installation Carefully read the License Agreement click I accept the agreement and click Next If you do not accept the agreement exit the installation You can specify the install destination Click Next You can select which part of the program to install experienced users Click Next You can enter the name the program appears under in the Start menu experienced users Click Next Piston Audiometry 10 1e Setup PistonXP Select Additional Tasks Which additional tasks should be performed Select the additional tasks you would like Setup to perform while installing PistoniXP then click Next Additional icons v Create a desktop icon Setup PistonXP Ready to Install Setup is now ready to begin installing PistorXP on your computer Click Install to continue with the installation or clic
7. E POST e Click on a button in the Podglad wydruku section to view the print preview e After making the necessary settings click the Print button During printing graph display is similar to on screen display Complete curve or only the representative curve section e One or more graphs Piston Audiometry 40 Measurements Export report into graphical formats This feature provides export of the printed report into the commonly used graphical formats Exported reports can be stored and for example sent as an attachment to an e mail Supported formats e PDF Adobe Acrobat document e GIF picture e JPEG picture e BMP Windows Bitmap picture e EMF and WMF vector graphics Settings The Export function is in the Report edition window e Click on the Drukuj button at the main menu Contents and the format of the exported report are fully identical to the printed version More information can be found in the chapter Printing on page 39 Export procedure Prior to printing and exporting results of measurements have to be stored in order to provide reliable traceability e Click on the Drukuj button at the main menu e Select graphs tables and text fields to be exported e Select the language of the report e Select the type of the report PRE POST e For previewing the report click on any button at the Podgl d wy druku section e After setting click on the Przechowaj button Exported graphs are fully ide
8. Filling a form User may select a form from the preinstalled templates Click on the LINK button in the main menu to open the Im port Export window Click on the HTML button to open the Raport indywidualny window Select the desired template from the a Szablony list Click on the Wybierz button and the form is automatically filled out Piston Audiometry 42 CALIBRATION Calibration procedure of the audiometer depends on the serial number of the device Devices from the newer series don t need manual calibration because correction Sound Pressure Levels are stored in the device Device with serial number of the interval 401 U 2004 001 to 401 U 2008 118 needs entering the Sound Pressure Levels for all frequencies manually Calibration sheet is included to the set of the audiometer Please refer to the following paragraph Select the Audiometer group in the Ustawienie Opcje Urzadzenia menu Institute setup Audiometer S jJ Frequency SPL predicted SPL measured Standard 125 115 0 1115 0 IEC 645 1 e a me i 250 5 5 CN ee zi Como 500 81 5 Aw Spirometer f 1 82 Doctors 750 77 5 ray A m Calibration Syringe 770 Layout 6 5 Plethysmograph SS 1 Right Left Diffusion j 80 0 ae l 1 4 735 Nebulizer i 55 Rhinomanometer T 3 0 1 i in le films 0 lax ms 0 Ld Operation M 9 fal 0 5000 M a 0 5000 Timing 2 Display Automatic Mod
9. Perform the installation from the included CD The most up to date version is available from our website http www pistonmedical com In the Downloads Software section Type the name of a program Folder document or Internet resource and Windows will open it For you Open OK Cancel al Browse Look in E Administrator i borland eJ pzdhxx EjuserData Install E Administrator s Documents 3 Application Data 4 contacts 89 cookies desktop Favorites Local Settings My Computer oF My Recent Documents 3 NetHood j PrintHood s SendTo e Start Menu Templates My Documents amp My Network Places File name Su LocalDisk P Files of type Programs Cancel Select Setup Language ta Select the language to use during the installation English v Setup PistonXP welcome to the PistonXP Setup Wizard This will install PistoriXP on your computer It is recommended that you close all other applications before continuing Click Next to continue or Cancel to exit Setup Click on the Start menu and se lect Run Click on the Browse button and select the install program When installing from the CD select the CD drive Find the pxp setup exe file in the Programs folder Click OK The install program starts Select the preferred language for the setup and the installed software Click OK A welcome screen app
10. Piston User s Manual Supported devices PDD 401 Audiometer Piston Ltd 1033 Budapest Sz l kert u 4 b Rev 1 02 1 9 19 December 21 2011 TABLE OF CONTENTS Introduction conso ED REPREHENE URGERE Pep Eolo Eb ba 4 Introduction a us mien ac a th ano nn ne ee CRRA RN ee ee ha scs utc a t UTR Cr 4 General Moti AMO Mis n e oett eie re oe iere eter bce RERA AE 5 ESITE n CO i EPRE atit n unti stt ien Ln Unt pud t ii aiat iie 6 Electric shock protection 2c cats cede teet ttt te eiat te ett 6 Minimum PE configurat OH ua ees ene eee rater ctt tuta ie re t eet 7 Installation of PDD 401 audiometer esee 8 Sobbwaredmnstallab OI neenon eeclesie lle dados etin E 9 Maintenance us 13 Device mantenaoe uocat euet en ut pun NE E EE E E UM ME 13 Disinfecting comprehensive table ccc ete e nee ee ete rene Ga ee ee 13 vci n TI C 14 PossibIc problems cestestesttie stetit tentent tette tetendit 14 The program s main fUNCTIONS ccsccsscsscsecssssescssssescsssssccsescssssesseessesseass 15 PALIT data Das eem NERIS NENNEN INN ERENNNEQEN TR NRE SN RR ERNNR sete REEERENE ER ER SIN NRI EE 15 Automatc safety backuper einne eiae a aar atacado donde 15 JA valable TESTS annen a a a aai 15 TeSt MOIES ten An A EE OO LE 15 User interfac c i n a R R 19 evo P a a ez z ez deze z t ze stee 19 MUS OR TERI AG etse tecptec eee eee eena asea aeia aE aa 23 SL n OIE REEE EEEE EAA EA TE
11. TEE AE AEE AAAA 25 Dane HS Ly EC Ge e e eR a e R R oc eu E E E 25 E yA E coL C E E E cR N Clo Cla Ca cei cet 25 TERN TJ aii HP Om 26 Patient identification FODIIQU equite ecu alata lt puedes 26 COrapIiSebtBES Coco ee eoe RA Spr HRS ERN NPR ANN NER eats eee deeded NN EARN REN RAN NER NES 26 MS VAC SS MNEENUPDN HE N 28 Baza danych pacjent w A eere eee Lect eese ee eene eee eene ene nete eate eae enata 31 User interface Overview ed dtes ede eed e duoc dada Coo dua cua 3l D ta Mput FOUBI eee e N NON O ER ERE ERE TR RAE RERR CARRE 32 Patients personaldataim cs ouo veas eoa qae ede P eec ede de MR RD 33 Finding a patient m tlie datab ase utet etie idet etes 33 Viewing previous HIeas re melissa tnt ttn oe ttis 34 Comment teld TOt patiems eee ee e CERERI ENSE R SERE NIN ERN NER ANNE AERE RNER 35 Measurements dinis ita hio ntis ht ni nti ntn nt ntt his 36 General measurement process daily routine eene 36 Patient sSele S IOTE oue Mac cdi editt eec Cun Ru eure Come Cau ale nudus 37 PUG AALS sie m 37 MegsureHieHis Gia Ca oo CC a Cas tet C LC qd 38 Piston Audiometry 2 SOLO ei otasiosbusbs isi nonin cialis deti eeetuto aiu se sine iro eee i ede tede dos 39 POND c TD ees 39 Export report mto graphical formats od eee ee eee eee 41 Intertace t rintormatton Systems dae ed e due a 41 Calibration sessssssssssszsss s s s s s s s se ss t
12. Ustawienie Opcje Wy wietlacz Zawarto arkusza pacjenta V bas database Audiometry Title Last name First name T Identifying data I i cA Print Sex Second name Mother s name Female LINK tal Exit d 2007 08 02 v __ __ __ Postal code City w v p Street Phone Accessibility v Mobile E Mail Body mass index fH Weight f kg Body Mass Index Age 58 years List of empty fields b j 1 R Click on the items i List of incomplete fields anne ee eg rar ip nom information about the cieli name required data ec Control panel 5 g X Cancel we eee c Identifying data Group of data essentially identifying the patient Name date of birth so cial security number sex etc Accessibility Patient s accessibility Address phone numbers e mail address Body mass index calculated value The patient s current body weight index square of the height of the pa tient in meter divided by body weight List of incomplete fields A list of fields that either have to be completed and are still empty or that have been filled out incorrectly Control panel Basic database operations new patient modification store Musisz zamkn baz danych pacjenta aby zachowa zmiany Piston Audiometry 32 Baza danych pacjent w Patient s personal data The program can store an arbitrary number of patients Pink fields indicate fields that have to b
13. de can be viewed anytime in the Historia list The currently entered comment is not lost when viewing a previous or another measurement modes com ments To display the comment select the measurement mode you would like to edit from the list To store curves marked Visible and Questionable press the Przechowaj button Successful data storage returns a feedback PRE POST The system can print two types of reports e Normal report Three measurements results simultaneously e PRE POST report Two measurements results simultaneously and their difference in absolute and percentage format Customized reports The printed report has the following parts e Header Piston Audiometry 39 Measurements e Parameter table e Graphs e Comment The header is the only fixed part of the header the other three may be turned on and off arbitrarily only the desired parts make it into the re port Highlight rows To highlight odd rows at colour or grayscale printing select the Zaznacz nieparzyste wiersze checkbox Simplified report To print only the best measurements of all modes select the Tylko na jlepszy pomiar checkbox Printing Before printing measurement results have to be stored so the printed re ports can be followed up e Click the Drukuj icon in the main menu e Select the graphs tables and manual diagnosis you would like to print e Select the report language e Select the report type normal or PR
14. e completed New patient To enter a new patient press the Nowy pacjent button Complete the fields and make sure that two patients cannot have the same identifier To store the patient press the Zapisa button You will receive feedback about the success of data storage If you do not wish to save the data press the Anulowa button Modify data Select the patient to modify Click on the Modyfikuj button After modification press the Zapisa button You will receive feedback about the success of data storage If you do not wish to save the modified data press the Anulowa but ton About deleting To preserve consistency and for future searches it is not possible to de lete from the database All diagnosis has traces in the database Finding a patient in the database The top section of the patient database window is the search block You can search based on several criteria When those criteria change the program automatically lists the patients meeting the updated criteria Normal search Search only based on the patient s family and surname Enter the patient s name or part of it Piston Audiometry 33 Baza danych pacjent w Detailed search Click the Szczeg owe wyszukiwanie button You can refine the search criteria in the window e patient s sex e date of birth with interval address or part of it e doctor e identifier social security number Viewing previous measurements
15. e setup Mod d Count of trials fa step 1 10 1 ag Maintenance 4 E ml oe 5 Humber of equivalent hearing levels E step 1 3 vul Ld Prediction USB Audiometer disconnected Select the desired SPL correction option from the Standard rolling down e EC 645 1 Most accepted standard e SABS 0154 Standard for South African Republic To return the original settings push the DomysInie button Enter into the SPL mierzone column values from the Calibration sheet Average Measured SPL Please pay special attention during entering the correction values because these values strongly influent the accuracy of the device We don t take any responsibility of the consequences of the faulty en tered SPL correction values If there is no other regulation in the Quality Management System of the user it is advisable to validate the audiometer annually Validation can be done only by a calibrated sound pressure meter Piston Audiometry 43 Calibration The periodic validation and recalibration of the audiometer has to be done in the similar way as it was done during the very first installation To save modifications push the Wykonano button or to cancel modifi cation push the Odrzu button Piston Audiometry 44 MEASUREMENT Goal of the measurement The air conductive hearing level at different frequencies can be deter mined by the device wen Demo Patie
16. ears just click Next Piston Audiometry 9 18 Setup PistonXP License Agreement Please read the following important information before continuing Please read the following License Agreement You must accept the terms of this agreement before continuing with the installation LICENSZ SZERZ D S PistonXP v gfelhaszn l i licensz szerz d s FONTOS MEGJEGYZ S A TERM K TELEP T S VEL EGY B HARMADIK F LT L M S GY RT T L SZ RMAZ SZOFTVERTERMEKEK IS TELEP T SRE KER LNEK MELYEK SAJ T V GFELHASZN L I LICENSZ SZERZ D SSEL RENDELKEZNEK A FELHASZN L A PROGRAM TELEPITESEVEL A HARMADIK F LT L SZ RMAZ SZOFTVERTERM KEK EIS SZERZ D S T IS ELFOGADJA EZEN SZOFTVERTERMEKEK AZ AL BBIAK 9 accept the agreement O I do not accept the agreement 18 Setup PistonXP Select Destination Location Where should PistoriXP be installed a Setup will install PistoriXP into the following folder To continue click Next If you would like to select a different folder click Browse At least 105 9 MB of free disk space is required 18 Setup PistonXP Select Components Which components should be installed Select the components you want to install clear the components you do not want to install Click Next when you are ready to continue Full installation v V Oracle XE 14944MB Database server 1494 4 MB Client components only 77 2 MB USB drivers 0 8 M
17. el s az ISO 9001 2008 szabv ny k vetelm nyeinek alkalmazhat s g val kapcsolatban tov bbi inform ci a szervezettel val konzult ci tj n nyerhet A tan s tv ny 2011 december 21 t l 2014 december 20 ig rv nyes sikeres fel lvizsg latok eset n Meg j t audit esed kes legk s bb 2014 december 13 ig Kiad s 1 Tan s tva 2011 december 21 t l E Y UKAS MANAGEMENT SYSTEMS SGS United Kingdom Ltd Systems amp Services Certification 005 Rossmore Business Park Ellesmere Port Cheshire CH65 3EN UK t 444 0 151 350 6666 f 144 0 151 350 6600 www gs com Oldalsz m 1 1 ll SG C g nk ezt a dokumentumot a Tan sit si Szolg ltat s ltal nos Szerz d si Felt tele szerint ll totta ki A szab lyzat teljes sz vege megtal lhat a www sgs comterms and conditions htm webcimen amely k l n s figyeimet szentel a K dokumentum ff m dos t s tartalmi vagy kin zetbeli v ltoztat s hamisitasnak min s l teh t t rv nybe tk z s jogi elj r st vonhat maga ut n Piston Audiometry 53 APPENDIX I Format of the patient identification field The format of the patient identification filed can be any free text or some predefined format according to a special mask If this mask is defined the ID field is compulsory to fill during adding a new patient Otherwise the field can be left empty If a character appears in the mask optional characters are
18. gnal is heard Yes Sound pressure increased by 5dB Signal is heard Signal is heard Record the sound level Sound pressure decreased by 10dB Does the number of equivalent sound levels reach the desired quntity Does the number of trials reach the prescribed quanity Igen Yes Invalid There are not enough equivalent hearing levels Finished The hearing level is defined Piston Audiometry 16 The program s main functions Descending iteration In the descending iteration the sound level is decreased from the well heard level to the level when the patient indicates that the sound is not heard yet Set starting sound pressure Select frequency Signal is heard Sound pressure increased by 10dB Sound pressure decreased by 5dB Signal is heard Yes Record previous sound pressure Does the number of trials reach the desired quantity Does the nuber of equivalent hearing levels reach the desired quantity Yes Invalid There are not enough equivalent hearing levels Yes Finished The hearing level is defined Piston Audiometry 17 The program s main functions Automatic sequence The automatic test sequence can be compiled and stored by the operator and the hearing test will be performed according to the previously com piled sequence Piston Audiometry 18 Icons L amen m e x LS belt USER INTERFACE Mai
19. ic character in this position but doesn t require it The character permits a numeric character or a plus or minus sign in this position but doesn t require it ee The character is used to separate hours minutes and seconds in times If the character that separates hours minutes and seconds is different in the regional settings of the Control Panel utility on your computer system that character is used instead The character is used to separate months days and years in dates If the character that separates months days and years is different in the regional settings of the Control Panel utility on your computer system that character is used instead Piston Audiometry 54
20. into a Peltor noise protecting case with 40 dB attenuation Noise protecting case Type Peltor OPTIME II Hand switch Robust hand switch for the patient s feed back Piston Audiometry 5 INSTALLATION Electric shock protection The safety precautions in this chapter must be followed Only Piston Ltd as manufacturer or its authorized distributor s person nel or the distributor s representatives may install the lung diagnostics device The above mentioned companies only accept responsibility for systems installed by them Before installing the lung diagnostics devices the personnel must make sure the computer the monitor and the printer installed as medical elec tronic devices comply with the standards for the given country or the user declares concerning this with responsibility Minimum EC 1 5m SE Information exchange with the computer goes through USB connection For low leakage current relating to medical devices standards this con nection is optically isolated inside the device Before shipping we check the device s leakage current The operator has the opportunity to have the leakage current checked periodically if he she finds it necessary The system must be installed so the examined person is at least 1 5m away from those devices that are electrically connected to the computer equipment Parts of the system computer monitor and printer can only be replaced in case of failure modification or for a
21. ion Unsuccessful iteration Successful KONTROL test A Unsuccessful KONTROL test difference between the BAZA and the KONTROL tests exceeds the allowed tolerance Unsuccessful KONTROL test any of the BAZA and or the KONTROL test was unsuccessful Piston Audiometry 47 PRE post The PRE POST measurement The system supports measurement comparison previous measurements may be compared against measurements made later e Select the patient e Select and load the PRE or previous measurements e Measure the current POST values with the patient e Select the two measurement to be compared e Print the PRE POST report Retrieve measurement Perform the steps in the Baza danych pacjent w page 2 section Open the database e Select the patient e Select one or more measurements e Load the measurement results Max 8 measurements may be displayed simultaneously so if you loaded 6 measurements you can perform 2 more measurements Notice The program also makes it possible to print the PRE POST report from the actually performed measurements Report compilation Printing Procedure of the compilation of PRE POST report e Select two measurements from the PRE POST list e Upon selection the result table will be refreshed automatically Printing is identical to the regular report automatically a PRE POST re port will be printed out Piston Audiometry 48 TECHNIC
22. je Wy wietlacz menu item Schemat graficzny You can select the graph color settings e Ciemne tlo jasne wykresy e Jasne tlo ciemne wykresy e Tak jak na wydruku white background Raster The grid may be enabled or disabled on the graph Piston Audiometry 26 Setup Pokaz krzywe It can be selected for several same type measurements e The diagrams appear in one coordinate system e Allthe diagrams appear in different coordinate systems Piston Audiometry 27 Devices Setup Some of the parameters may seriously influence the accuracy of the measurements These parameters are only shown on the user s screens and these can t be modified These parameters can be modified in the PistonXP ini file but only by a trained person Audiometer Select the Audiometer group in the Ustawienie Opcje Urzadzenia menu Calibration Values of the Calibration Sheet for the older series can be entered in this window For more detailed information please refer to the Calibration chapter page 43 Ustawienie czasu The waiting period prior to signal generation can be specified The waiting period is randomly set between the minimal and maximal values Automatyczna konfiguracja Fix poczatkowego ci nienia akustycznego The initial sound pressure for the automatic iterations If this option is set this initial sound pressure will be valid instead of the value specified in the measuring window Wzrost ci nienia aku
23. k Back if you want to review or change any settings Destination location c Program Files x86 PistonXxP Setup type Full installation Selected components Microsoft SQL Server 2000 Desktop Engine Borland Database Engine 5 11 Program Files Start Menu folder Piston Medical ie Setup PistonXP Installing Please wait while Setup installs Piston lt P on your computer Extracting files c Program Files PistonP PistonXP exe n Cancel ie Setup PistonXP Installing Please wait while Setup installs Piston lt P on your computer Install Oracle XE Database Server This can take several minutes Installation You can select whether a PistonXP icon should be created on the desktop experienced users Click Next An install summary window appears and if all settings are acceptable Click Install The install process begins Please wait until it finishes installing the software After installing the software external components will be installed also The installation of the Oracle XE Database Server Client runs in background and the process can take several minutes Please wait until it finishes installing the software Piston Audiometry 11 ia Setup PistonXP Installing Please wait while Setup installs PistoriXP on your computer Installing FTDI LISB Driver m Setup PistonXP Completing the PistonXP Setup Wizard Setup has finished installing Pisto
24. le for all measurement modes Interrupted The continuous signal is interrupted and attenuated by 20 dB This signal type is available only at Manual mode Measurement modes Manual mode Sound pressure and frequency can be set freely Select Manual mode Select signal type Set the desired sound pressure Select ear Set frequency Piston Audiometry 46 Measurement Tip If you click with the mouse at any point of the audiogram signal whit the selected frequency and sound pressure will be generated right away Rosnaco mode During Rosnaco mode a week inaudible signal generated and the sound pressure level is incremented till the moment the patient indicates that the signal is audible already Select Rosnaco mode Set the initial sound pressure Select ear Set frequency Malejaco mode During Malejaco mode a strong surely audible signal generated and the sound level decreased till the moment the patient indicates that the signal is inaudible already Select Malejaco mode Set the initial sound pressure Select ear Set frequency Automatic sequence Automatic sequence provides full automatic hearing level determination for both ears For configuration of Automatic sequence please refer to the Automatyczna konfiguracja sekwencji chapter page 29 To start the measurement push the AUTO MODE button Evaluations of the results During Automatic sequence an icon is shown after each step Successful iterat
25. n window Open patient database Open comment opinion editor Open lung function test sub menus Health Level Seven HL7 and GDT import and export functions Open report editor printing Exit the program Main window Audiometry Audiometry User s Manual Patient database Clear patient quick search fields Enter new patient Modify patient data Store entered modified data Cancel changes Piston Audiometry 19 User interface ip Load all measurements from the selected meeting s Ud Load selected measurements I i ri Health Level Seven HL7 import and export functions Settings Set institute data P9 Doctor records iD j 7 Devices settings connected to the PC Program operation related settings Display graphs and other program parts Maintenance safety backup related settings Reference value calculating algorithms List of parameters to be displayed Service panels Enter new doctor Modify doctor s data Store entered modified data Cancel changes Accept changes and close Options panel s Er Er ki X O Piston Audiometry 20 User interface Measurement windows Audiometry Test of left ear Test of right ear Turn on microphone Muting Manual mode Ascending mode Descending mode SBP 0S See o o m Impulse signal Continuous interrupted signal Continuous signal Start automatic sequence sat C
26. ndow Doctor Dr Semmelweis Ign c x Cy Sep Help 2007 08 02 12 33 02 T V Quick search Wb fp HD ace eS Detailed search Patient database e Fist name Postal address Born Mother s name Weight Height iD Sri p 1121 Budapest Fihen steet UG 1969 07 20 E T8 1599804 M ohn 2092 Budakeszi Erkel Ferenc ca Th 1981 07 28 F cy Katalin 5 We 057964815 Patient list y 1 2006 05 05 Aata Cre 16 100 ooon Em teem S NN E3 Exit Details NC 426 FVC 417 Details Control panel Visits Measurements Jve 2007 07 31 13275 0 Plethysmograph RESISTANGE 2007 07 31 13262 0 Piethysmograph _JoFFusion 2007 07 31 1331 0 0 Plethysmograph 26 44 Tico Load Measurement se lection Quick search Helps find a patient Patient list A list of patients meeting the search criteria Details Displays the selected patient s most important parameters for the selected measurement Control panel Basic database operations enter new patient modify patient data store Visits Dates of previous visits Measurements A list of measurements for the selected date or measurement type Load Control buttons to display the selected measurements Measurement selection Measurements may be listed according to measurement type as well Piston Audiometry 31 Baza danych pacjent w Data input form Content of the Data input form can be set in the menu
27. ng level Sound pressure The sound pressure can be entered by numbers or by the vertically slid ing control Ear selector The left or right ear can be selected for the tests Signal type selector For selection of the sound signal type Test mode For selection of the tests mode Results The result table shows the values of the actual and previous tests and the difference of them Piston Audiometry 24 CJ Institute 29 os Doctors a za Devices 2 Fae Aye Calibration Syringe 70 1 Layout Plethysmograph Right Left Diffusion 7 Nebulizer 3 Rhinomanometer mmm 1 Operation Min lo dms 0 5000 Max o ms 0 5000 Ead pi I r5 Display 250 5 5 5 500 815 Default Spirometer 1 SETUP The Ustawienie Opcje menu item allows customization of the system Settings that can be changed during measurement are also available in the Ustawienie tab of the measurement windows Program settings appear grouped on the left side setup ae a Frequency SPL predicted SPL measured Standard 425 115 0 115 0 HEC 645 1 v 750 775 65 Timing Automatic Mode setup Count of trials s 3 step 1 10 KEL Humber of equivalent hearing levels Al step 1 3 ad Ivi USB Audiometer disconnected Dane instytucji You can enter the following information at the Ustawienie Opcje Dane instytucji menu item Institute name Site address Mailing address Ph
28. nie robbbebo ebbe bobb poko ehe re bb Febo EVER VENE NEN 54 Format of the patient identification field sane ttr 54 Piston Audiometry 3 INTRODUCTION Introduction The PDD 401 is an IBM PC based screening audiometer for air conduc tive testing the hearing system There are two versions of the program one is the modular version and the other one is with database management The modular version can be called from the host system In this case the host system has its own database management The database version has an integrated database management system The PDD 401 makes easy to measure the hearing level It is well suited for screening and following up changes in hearing level Thanks to the IBM PC base it is easy to handle but at the same time of fers a lot of features During measurement the hearing level is shown in real time Results can be printed out even in colours The PDD 401 screening audiometer provides the following modes and services Continuous signal Impulse signal Continuous interrupted signal Manual mode Ascending algorithm Descending algorithm Automatic sequence Piston Audiometry 4 Introduction General information Information on the main components of the audiometer Portable device Connecting to a laptop PC full portability is provided even in battery mode The audiometer takes power supply only from the USB port of the PC Headset Type Telephonics TDH 39 Speakers built
29. nt 73kg 177cm 28 ves PRE 2010 01 08 v POST 2010 01 08 v esses A 8 28 8007 750 DU 80 72000 3000 aoon 600 890 30 de Li kata 31 T T ES Kil p s o qun 6 0k 80k 40 10 40 10 0 10 15 POST Do 0B 5 0 5 40 40 5 5 15 2 PRE 20 10 0 lt 5 40 40 5 SOP PSO OSS S pe SLIGO eles Reference values The system displays the Statistical Distribution of hearing thresholds as function of age according to the NF EN ISO 7029 2000 standard Meaning of the curves There is a percentage value at the right side of all curves which shows the ratio of the population which has better hearing ability For example 75 means that 4 of the population have a better hearing ability Piston Audiometry 45 Measurement Process of measurement Measurement modes e Manual mode e Ascending iteration e Descending iteration e Automatic sequence Signal types e Continuous e Impulse e Interrupted When the selected signal is generated and the signal is audible for patient the patient has to push the hand switch If there is a proper feedback the actual sound level is stored for that fre quency Signal types Continuous Signal is generated continuously This signal type is available only at Manual mode Impulse The signal generated only once for adjustable time typically 1 2 sec onds This signal type is availab
30. ntical to the graphs shown on the screen e Full curve or only the important part e One or more graphs Interface to information systems Interface to frame systems Our system provides communication according to the more commonly used protocols e Health Level Seven HL7 USA e Ger te Daten Trager GDT Germany These protocols provide exchange of the patient data and measured re sults between the lung diagnostics equipment and the frame systems Piston Audiometry 41 Measurements These protocols are predefined by the System administrator consequently can not be modified by the user Receiving the request for tests Click on the LINK button in the main menu and open the Im port Export window According to your frame system type click one of the HL7 or GDT buttons in the Import section in order to receive a Request for tests If a Request for test is available the system automatically acquires it and lists all the requested tests Exporting Click on the LINK button in the main menu and open the Im port Export window According to your frame system type click one of the HL7 or GDT buttons in the Export section The system automatically exports the re sults of the tests Filling special forms The system provides filling customer defined forms Templates of the forms can be compiled in any ASCII format HTML XML CSV etc Compilation of the form is the competence of the System administrator
31. ny other reason if the part to be installed has the same electric shock protection conditions as the original one The personnel installing the device will train the operator concerning op eration electric shock protection This training includes the contents of this section The operator verifies the training in official written form Piston Audiometry 6 Minimum PC configuration Installation The operation of the audiometric system requires a personal computer with the following minimum configuration Description Minimum Recommended Operating system Windows XP Processor for 600 MHz Intel Celeron Pentium 3 Core 2 PDD 301 family family AMD K96 Athlon Duron family Processor for 1 GHz Intel Celeron Pentium 4 Core 2 PDT 111 family family AMD K6 Athlon Duron family Screen resolution 1024x768 1280x1024 Printer Windows compatible Colour Internet connection For software updates Piston Audiometry 7 Installation Installation of PDD 401 audiometer The hearing test should be performed in an environment where the back ground noise level doesn t exceed the 18 dB sound pressure according to the 1 1th paragraph of the ISO 8253 1 1989 standard Connect the Audiometer to a free USB port of the IBM PC Connect the patient feedback switch to the Audi ometer Connect the headphone set to the Audiometer Piston Audiometry 8 Software installation Installation
32. on Page 48 Comment field for patients Comments may be entered about the patients even for every visit All comments are stored separately in the database and may be retrieved in dividually To enter a comment Open the Patient database e Selected the desired patient Click the Diagnoza button to open the text editor window Select the Pacjent operating mode from the list Enter the comment Press the Przechowaj button to store the comment Previous diagnosis All previous comments about the patient may be retrieved from the Historia list The currently entered text is not lost when viewing a previous diagnosis To display the currently entered text again select the Pacjent option from the list of operating modes again Piston Audiometry 35 MEASUREMENTS General measurement process daily routine Start of the program Calibration if necessary page 64 Enrolment into the data base New patient page 61 Retrieve from the database page 59 Reload previous tests if necessary page 62 Test mode selection page 7 1 Setting initial sound pressure page 70 Ear selection page 70 Frequency selection page 72 No Is the test ready Comment entry page 75 Store test results page 75 Print report page 76 No End of service Exit from the program Piston Audiometry 36 Measurements Patient selection Before
33. one number Fax num ber Web page E mail address This data appears in the header of the printed report Lekarze The doctor s data can be entered at the Ustawienie Opcje Lekarze menu item New doctor Press the Nowy lekarz button to enter data for a new doctor Complete the fields Make sure that two doctors cannot have the same identifier Press the Zapisa button to store the entered data Piston Audiometry 25 Setup Modify data Select the doctor from the Nazwisko lekarza drop down list whose data you would like to modify Click the Modyfikuj button Change the desired fields When done press the Zapisa button You will see feedback about the success of the data storage If you do not wish to store the entered data press the Odrzu button About deleting To preserve consistency and for future searches it is not possible to de lete from the database All diagnosis has traces in the database Language selection You can select the program s language in the Ustawienie Opcje Zadanie menu item All supported languages are displayed in English and in the specific lan guage as well Select the language you would like to use Patient identification format You can enter the patient identification format in the Ustawienie Opcje Zadanie menu item Format descriptions may be found in the Appendix I page 54 section Graph settings Graph displays may be set in the Ustawienie Opc
34. ough surfaces and check the cable s good condition Do not expose the device to direct sunlight or strong light more than 1500 lux Do not use the device in a highly dusty environment Do not use the device in a highly vibrating environment e Take care to ensure the current environmental conditions The device complies with the contents of the detailed standards in the Hiba A hivatkoz si forr s nem tal lhat section Hiba A k nyvjelz nem l tezik page Piston Audiometry 49 Technical data Shipping conditions Air temperature eoe LL ette tied eon 30 C 60 C Relative DUmidilys us une eae RPA 10 100 Atmospheric Dressufe ioa aca eese 500 1060 mbar Storage conditions AIP ie mperature u a aee ioo ened deceased 0 C 50 C Relative Dimildity eoe ee taie 10 85 Atmospheric pressure etcetera ati 500 1060 mbar Operating conditions Aar ie mperatire zoe oed oU dude disant 10 C 40 C Relative Dusniditys uo tei dde 30 75 Atmospheric pressure uaa 700 1060 mbar Informing values Expected lifetime DEVICES a A ati ati LAU ASR E Mo ME E 8 years Electrical data The connected computer s and printer s electrical data is found in the re spective manufacturer provided specifications The following values apply only to the Piston Ltd manufactured devices PDD 401 Audiometer PC SCOMNECUON ensen ieee esztet USB 1 1 POW OT i deett ut uus Does not require external powe
35. r Maximal supply current eicere teer ertet 360mA Piston Audiometry 50 Technical data Mechanical data PDD 401 Audiometer SE uu nee eee ee ee ed L150 W 82 H45 mm Weight including headset 2 ee ee el 960 g TIC ACS CE nei oor wat tte deett t TDH 39 Noise attenuation of protecting case oo eee eeeeeeseeteeteeeee 40 dB Expected lifetime of the device isi cae 5 years SLED OE SOUNC pressdreus odo ood ol als 5 dB Frequencies omes erase 125Hz 250Hz 500Hz 750Hz 1kHz Iu enmtom eei sala tat 1 5kHz 2kHz 3kHz 4kHz 6kHz SkHz Sound pressure level sooo deu 10dB HL 110dBHL Guaranteed values PDD 401 Audiometer Total harmonic distortion eii ee ite te teens lt 1 Acburdcy OL Ireque Hey s duties 1 List of accessories Included accessories The current Shipping contract contains the list of accessories included in the purchase price Optionally purchased accessories The following information must be provided when ordering accessories and disposables e Description e Type e Part number Device type and serial number for which the accessories are used Piston Audiometry 51 Certificates of Quality Management System CERTIFICATES OF QUALITY MANAGEMENT SYSTEM SGS Tan s tv ny HU11 6220 Tan sitjuk hogy a z Piston Kft 1033 Budapest Sz l kert u 4 b ir ny t si rendszer t audit ltuk s az megfelel az al bbi szabv ny k vetelm nyeinek MSZ EN ISO 13485 20
36. represented in the text as leading blanks If a character is not present optional characters are represented in the text as trailing blanks If a gt character appears in the mask all characters that follow are in upper case until the end of the mask or until a character is encountered If a character appears in the mask all characters that follow are in lower case until the end of the mask or until a gt character is encountered lt gt If these two characters appear together in a mask no case checking is done and the data is formatted with the case the user uses to enter the data The character that follows a character is a literal character Use this char acter to use any of the mask special characters as a literal in the data The L character requires an alphabetic character only in this position For the US this is A Z a z The 1 character permits only an alphabetic character in this position but doesn t require it The A character requires an alphanumeric character only in this position For the US this is A Z a z 0 9 The a character permits an alphanumeric character in this position but doesn t require it The C character requires an arbitrary character in this position The c character permits an arbitrary character in this position but doesn t require it The 0 character requires a numeric character only in this position The 9 character permits a numer
37. riXP on your computer The application may be launched by selecting the installed icons Click Finish to exit Setup Installation Finally USB Drivers are being installed Please wait until it finishes installing the software A window indicates the end of the installation Click Finish to close the install wizard This concludes installation Start the program The program automatically detects the connected devices Piston Audiometry 12 Device maintenance MAINTENANCE The audiometer doesn t request any special maintenance Parts which are getting in direct contact with the patient like headset and the hand switch should be disinfected after every use For disinfection the mentioned parts a formaldehyde free detergent should be used which is recommended for electronic devices Always follow instructions of the manufacturer Disinfecting comprehensive table In the table below we comprehend which parts of the audiometer should be cleaned and disinfected and some sample materials are given for use Of course always follow the regulations of the cleaning and disinfecting materials Name Material Cleaning and disinfect ing material Patient s feedback Unbreakable Polystyrene Incidur spray switch Headset Unbreakable Polystyrene Incidur spray PVC pillow Case Unbreakable Polystyrene Incidur spray Piston Audiometry 13 TROUBLESHOOTING Possible problems
38. ses tes szsz ss HARE E el Ee 43 Measurement P 45 G alofthe Tae AS UE HODIE e eei e eite eie eoe e eee VE SEEN TE ER RE REID 45 Reference values oe Hu oae ue dius 45 Process of measurement ssssssseseseeeeeee eene nenne ener eterne nnne nnns 46 ibus dado MR CP 46 Measurement modes e A A A E A 46 PRE POS Vwissessaseiicaiisasiviieeivieneinsiea vies VEON OVERES RE SIERE Eeoae Sees s AER 48 The PRE POST measurement chicc ich ich ichiahiohteledadeind caletaleteletnetahdotedois 48 Retrieve quedsute 18 IE gee ere iO eC deu ut Hsc 48 Report COMIN AUOD e Sur EA e CER EN SEEN RRC 48 BENE ene iven venetus ien loas idea uda celi ee ELM C cd ace 48 Technical d ata mee 49 EN ATE ANU EY MR RN RN RR RUNE UR TU TON UN 49 Limited liabil e eee ote teret te ee e 49 Safety InStFUCHODS s s szesz encontre ecc ara dc cua cal lap aea aaeanoa ian 49 Informing values euet teet ite eoi tere eee 50 Electrical data PCR 50 PID AO P AMO MIG len e E E A AER 50 Mechanical data uae etat Glad dala li f faf feet fot al ld 51 Guaranteed values oaicetettetteletetteiebdee etie tst toe fs 51 List of accessories ccccscsccessccesscccesseceeseccesscecesseecessecesseecesseccessecesssecessesessaees 51 Certificates of Quality Management System eere eese eere e ene 52 EC Declaration of Conformity Hiba A k nyvjelz nem l tezik Appendix L 5er orent ie Qe hene et npe
39. starting the measurement it is necessary to enter patient data using one of the following methods Enter new patient e Search for patient already in the database Preparations Device Connection Make sure that the device you wish to use is connected to the computer If not connect the device as detailed in the Installation 6 page section Selection The Audiometer might be selected from the Device selection list If there are no other devices the Audiometer is selected automatically Parts in direct contact with the patient It is advisable to disinfect both the headset and the hand switch after each patient see chapter Maintenance page 13 Environment The hearing test should be performed in an environment where the back ground noise level doesn t exceed the 18 dB sound pressure according to the 11th paragraph of the ISO 8253 1 1989 standard Patient Recommended body position e Sitting on a chair e Straight back e Level head Directions The hearing level test requires co operation from the patient so it is nec essary to inform and prepare the patient for the test e Let know the patient about the goal and process of the test e Pay attention the proper adjustment and setting of the headset e Teach the patient how to use the hand switch It is advisable to monitor the proper operation of the hand switch on the screen Se lect any frequency and sound level and by pushing the hand switch observe the hand swi
40. stycznego w stanie pocz tkowym rosn co i malej co The initial value of the increasing sound pressure for the coarse determi nation of hearing level during automatic iterations Spadek ci nienia akustycznego w stanie pocz tkowym rosn co The initial value of the decreasing sound pressure for the coarse determi nation of hearing level during automatic iterations Liczba pr b Number of repeated trials for Rosn co and Malej co iterations to deter mine the hearing level Liczba r wnowa nych prog w s uchu During Rosn co and Malej co iterations the hearing level is determined repeatedly The iteration declared to be successful when the number of equal hearing levels reaches the value specified here Piston Audiometry 28 Setup Automatyczna konfiguracja sekwencji Select the Audiometer group in Ustawienie Opcje Urzadzenia menu Click ont he Inne button Or Click on the Konfiguruj button at the Audiometer test window Audiometer automatic sequence setup Available Composed test frequencies First observed ear 12 5 OnRight 250 gt Left 500 2 750 Type of iteration 1000 Ascending 1500 CONTROL z 2000 Descending 3000 4000 CONTROL and BASE frequency 6000 1000 Hz 8000 Automatic Mode setup Fix initial sound pressure 0 100 Incrase of sound pressure in initial state Asc and Desc y 4 10 30 Decrase of sound pressure in initial state Ascending al 10 30 Co
41. tandard for South African Republic To return the original settings push the DomysInie button Enter into the SPL mierzone column values from the Calibration sheet Average Measured SPL Please pay special attention during entering the correction values because these values strongly influent the accuracy of the device We don t take any responsibility of the consequences of the faulty en tered SPL correction values Piston Audiometry 38 Measurements If there is no other regulation in the Quality Management System of the user it is advisable to validate the audiometer annually Validation can be done only by a calibrated sound pressure meter The periodic validation and recalibration of the audiometer has to be done in the similar way as it was done during the very first installation To save modifications push the Wykonano button or to cancel modifi cation push the Odrzu button Measurement chapter page 43 Enter comment A separate comment may be entered for all measurement modes All comments are stored separately in the database e Click on the Diagnoza icon to open Kreator diagnozy e Select the measurement mode or the Patient mode from the list to which you would like to add a comment e Enter the comment e Press the Przechowaj button to store the comment in the database at tached to the measurement Previous comments Store Printing Previously created comments for the given measurement mo
42. tch state icon Piston Audiometry 37 Measurements Measurements Detailed description of the hearing test can be found in the Calibration procedure of the audiometer depends on the serial number of the device Devices from the newer series don t need manual calibration because correction Sound Pressure Levels are stored in the device Device with serial number of the interval 401 U 2004 001 to 401 U 2008 118 needs entering the Sound Pressure Levels for all frequencies manually Calibration sheet is included to the set of the audiometer Please refer to the following paragraph Select the Audiometer group in the Ustawienie Opcje Urzadzenia menu Institute setup l wdiomeer 0 0 0 0 0 JJ 29 Frequency SPL predicted SPL measured Standard Doctors eis i 3 125 115 0 115 0 Hi IEC 645 1 v B z Devices 250 5 5 500 181 5 Default Aw Spirometer 1 750 7 5 2 ERE 2 Aye Calibration Syringe 770 Layout 6 5 Plethysmograph Right Left Diffusion F lap L Nebulizer Rhinomanometer mm Timing 1 gt Operation Min lo ia ms 0 5000 Max lo al ms 0 5000 M 6 ivi Automatic Mode setup Count of trials i3 lel step 1 10 Clone Humber of equivalent hearing levels 2 s step 1 3 vol USB Audiometer disconnected Select the desired SPL correction option from the Standard rolling down e EC 645 1 Most accepted standard e SABS 0154 S
43. unt of trials 4 1 10 Humber of equivalent hearing levels fal 1 5 Allowed difference between BASIC and CONTROL measurement E 0 100 Po raz pierwszy badane ucho Here you can select which ear to be tested first Rodzaj iteracji Here you can select which type of iteration to be used Rosnaco or Malejaco Setting of automatic sequence can be done here as well For more information refer to the Automatyczna konfiguracja chapter page 28 Akceptowana r nica mi dzy pomiarem BA ZA a KONTROL A KONTROL test can be included into the automatic sequence The frequency of the KONTROL test equals to the frequency of the BAZA test Piston Audiometry 29 Setup After the KONTROL test the software compares the hearing level value of the very first BAZA test The difference of these two tests can t ex ceed the specified value of this field Compilation of Automatic Test Sequence Drag the desired frequency from the Dostepne czestotliwosci list and drop into the Test zlozony list For insertion the button can be used as well The undesired frequencies can be dropped back to the Dostepne czestot liwo ci list or can be deleted with the X button The compiled list of frequencies can be modified with mouse or the A and Y buttons Connection of an audiometer device will be detected within 2 seconds Piston Audiometry 30 BAZA DANYCH pacuentow User interface overview Main wi
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