Operation Manual for Audiometer PDD-401 0197 PISTON Ltd. 1121 Budapest Pihenő út 1. C pavilon v.3.080
Table of Content TABLE OF CONTENT...1 QUICK PREVIEW...3 INSTALLATION...3 DAILY ROUTINE...4 ICON DESCRIPTIONS...5 SCREEN...7 INTRODUCTION...9 INSTALLATION AND CONFIGURATION...11 INSTALLATION OF PDD-401 AUDIOMETER...12 MINIMUM PC CONFIGURATION...12 SOFTWARE INSTALLATION...13 CONFIGURING THE AUDIOMETER...13 AUDIOMETER CALIBRATION...14 AUDIOMETER...17 SELECTION OF MEASURING METHOD...17 Measuring mode...17 Signal type...18 ASCENDING ALGORITHM...19 DESCENDING ALGORITHM...20 CONFIGURATION OF AUTOMATIC SEQUENCE...21 First ear to be examined...21 Type of iteration...22 Test frequencies...22 Number of trials...22 Criteria of acceptance...22 Allowed tolerance...23 Error messages...23 Set default values...23 MANUAL MODE...23 ASCENDING ALGORITHM...24 DESCENDING ALGORITHM...25 AUTOMATIC SEQUENCE...25 POSSIBLE ERROR MESSAGES...26 MEASUREMENT STORAGE...27 COMMENT...27 EXPORTING DATA TO AN EXCEL WORKBOOK...27 REPORT...29 Table of Content - 1
REPORT PREVIEW...29 REPORT PRINT...29 REPORT CONTENTS...29 MAINTENANCE...31 DISINFECTING COMPREHENSIVE TABLE...31 POSSIBLE PROBLEMS AND SOLUTIONS...33 AUDIOMETER...33 MISCELLANEOUS...34 TECHNICAL SPECIFICATIONS...37 GUARANTEE...37 LIMITED LIABILITY...37 SAFETY PRECAUTIONS...37 ENVIRONMENTAL CONDITIONS...38 ELECTRICAL SAFETY...38 ELECTRICAL DATA...39 MECHANICAL DATA...39 GENERAL VALUES...39 GUARANTEED VALUES...39 ACCESSORIES...40 2 - Table of Content
Quick preview Installation Connecting the Device (see: 12 page) Software installation (see: Users Manual of Database) Start panel* (see: Users Manual of Database) Location of database (see: Users Manual of Database) Physicians data* (see: Users Manual of Database) Data of Institution* (see: Users Manual of Database) Configuration of the Device (see: 13 page) Creation and selection of database (see: Users Manual of Database) * Marked items can be used only in Database version Quick preview - 3
Daily Routine Run the program Open Database* (see: Users Manual of Database) Enter to the Database* (see: Users Manual of Database) Yes New patient No Retrieval from Database * (see: Users Manual of Database) Algorithm selection (see: 16 page) Signal selection (see: 17 pagel) Measurement (see: 22-24 page) Comment* (see: 25 page) Print results (see: 27 page) Save results (see: 25 page) No Finished? Yes Close patients window* Exit Program * - Marked items can be used only in Database version 4 - Quick preview
Icon descriptions Audiometer Print Exit Microphone Manual mode Ascending algorithm Descending algorithm Automatic sequence Continuous sound Single Pulse sound Icon descriptions - 5
Continuous Pulse sound Saving the examination Comment Sending data to an Excel workbook View current and previous comments Step back in print preview Step forward in print preview Full page view in print preview Two page view in print preview Exit from print preview 6 - Icon descriptions
Screen Icon descriptions - 7
Screen 8 - Icon descriptions
Introduction The PDD-401 is an IBM/PC based screening audiometer for air conductive 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 offers 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: Manual mode Ascending algorithm Descending algorithm Automatic sequence Continuous signal Impulse signal Continuous interrupted signal Introduction - 9
10 - Introduction
Installation and configuration The safety precautions in this chapter must be followed! The Piston Ltd. or its authorised distributors or their authorised staff may only install the Audiometer system. The above mentioned companies only accept liability for their installations. Before operating the Audiometer system, the user has to make sure that the computer and monitor to be used as medical electronic device has license issued by local authorities or the user declares full responsibility for safety. The installation should be done in a way that the patient was at least 1.5m distance from all the devices, which are in direct electronic contact with the PC. In case of faulty equipment, design modification or any other reason the devices in the system (computer, monitor, printer) may only be exchanged, if the new device(s) has the same safety class as the original device, and the sign mentioned above is also applied to the new device(s). The user has to be instructed about the safety precautions by the person performing the installation. This instruction also includes the review of this chapter. The user certifies the performance of this instruction in writing. Installation and configuration - 11
Installation of PDD-401 audiometer Connect the audiometer to a free USB port of the IBM/PC Connect the patient feed back switch to the audiometer Connect the headphone set to the audiometer. Minimum PC configuration The following minimum configuration is required to run the program: Intel or AMD processor 1 GHz 256 MB RAM Colour monitor with 800x600 resolution and 256 colour and VGA video card 30 MB free space on the hard disk drive Windows compatible printer Mouse One free USB port Windowx XP Professional or Home operational system 12 - Installation and configuration
Audiometer calibration Software installation Connect the audiometer to a free USB port of the PC. The Windows XP recognizes the new USB device and asks for the driver. Insert the system CD to the CD drive and the Windows XP finds the appropriate drivers. In some cases a messages may appear which has to be neglected. Run the SETUP.EXE from the system CD/Programs/32 bit Configuring the audiometer In case of a Database version select from the [Database] menu the [Settings] sub-menu and the [Audiometer configuration ] item. In the case of Module version select from [Audiometer] menu the [Settings] sub-menu and [Audiometer configuration ] item. The following will appear on the screen: Select the Communication port from the rolling down list: USB port you have connected the audiometer. Then press the [Check] button. If everything is correct, press the [OK] button. Pressing the [Cancel] button exits without saving the changes. Installation and configuration - 13
Audiometer calibration In a case of Database version, the correctional values have to be entered, based on the calibration report, which included to the equipment. From the [Database] menu select the [Settings] sub-menu, and the [Audiometer calibrating ] item. In a case of Module version select from [Audiometer] menu the [Settings] submenu and the [Audiometer calibrating ] item. The following will appear on the screen: We are not responsible for any incorrect measurements, if the correct values based on the calibration report have not been entered here. Prior to enter the calibration values selects the type of SPL standard. The following options are provided: IEC 645-1 For Europe and USA SABS 0154 For South Africa To return to the original factory settings push the [Default settings] button. Enter values from the Average Measured SPL row of the calibration table to the [Measured SPL] column. If the user s internal regulations do not prescribe in a different way, audiometers should be re-calibrated annually. 14 - Installation and configuration
Calibration procedure should be done by a validated sound pressure meter. After calibration enter correction values into to the table of [Audiometer calibration]. Push the [OK] button to validate changes or the [Cancel] button to abandon changes. If any change occurred to the values the following message appears: Do you want to save modifications? If everything is correct, press the [OK] button. Pressing the [Cancel] button exits without saving the changes. Installation and configuration - 15
16 - Installation and configuration
Audiometer The patient s hearing threshold can be determined at different frequencies with the audiometer. The program knows all the standard frequencies. The sound pressure may be selected from 10 db to +110 db. Start the audiometer by pressing the on the screen: audiometer button. The following will appear Selection of measuring method Prior to measurement select the method: Measurement mode Signal type Measuring mode The system provides the following modes: Manual mode Manual mode Ascending iteration Descending iteration Automatic sequence User gives the sound pressure and frequency. Audiometer - 17
Selection of measuring method 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. 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. Automatic sequence According to the pre set sequence both ears are tested fully automatically. Signal type Continuos Impulse Interrupted The system provides the following types of signal Continuos Impulse Interrupted The signal is generated continuously. The continuos signal is available only in Manual mode. The signal is generated for 1-2 second intervals. The Impulse signal is available for all modes. The signal generated continuously but interrupted regularly. The interrupted signal is available only in Manual mode. 18 - Audiometer
Ascending algorithm Set starting sound pressure Frequency selection Signal is heard? No Sound pressure increased by 10dB Yes Sound pressure decreased by 20dB Yes Signal is heard? No Sound pressure increased by 5dB No No Signal is heard? Yes Signal is heard? Yes Record the sound level Sound pressure decreased by 10dB No Does the number of equivalent sound levels reach the desired quntity? No Does the number of trials reach the prescribed quanity? Igen Yes Finished The hearing level is defined Invalid There are not enough equivalent hearing levels! Audiometer - 19
Descending algorithm Set starting sound pressure Select frequency Signal is heard? No Sound pressure increased by 10dB Yes Sound pressure decreased by 5dB Yes Signal is heard? No Record previous sound pressure No Does the nuber of equivalent hearing levels reach the desired quantity? No Does the number of trials reach the desired quantity? Yes Finished The hearing level is defined Yes Invalid There are not enough equivalent hearing levels! 20 - Audiometer
Configuration of Automatic sequence The system provides full automatic test of both ears for this the parameters of automatic sequence should be specified. In the case of Database version select from the [Database] menu the [Setup] submenu and [Configuration of automatic sequence ] item. In the case of Modular version select from the [Audiometer] menu the [Setup] submenu and [Configuration of automatic sequence ] item. The following window appears: The following parameters should be set for specifying the automatic sequence: First ear to be examined Type of iteration Test frequencies Number of trials Criteria of acceptance Allowed tolerance First ear to be examined To select the first ear to be examined click at the appropriate radio switch: Right Left Audiometer - 21
Configuration of Automatic sequence Type of iteration To select the type of iteration click at the appropriate radio switch: Ascending Descending Test frequencies The frequencies to be included in to the automatic sequence can be specified arbitrary. Selection of test frequencies Click at the desired frequency in the [Frequency] window and push the [>>] add button. The selected frequency appears in the [Tests] window at the lower position. The frequency in the very first position is the Basic frequency. The hearing level at the Basic frequency is measured twice during the automatic sequence and called as the Control frequency. Modifying the sequence of frequencies Click at frequency to be moved and push any of the [ ] [ ] positioning buttons. The Basic frequency can t be moved or replaced. The Basic frequency can be deleted in this case the next frequency becomes the Basic frequency. Deleting a frequency Click at the frequency to be deleted and push the [Delete] button. Number of trials Number of trials at the same frequency should be specified. The default value is 5. Criteria of acceptance The number of equivalent hearing levels at the same frequency should be specified. Obviously this number can not be higher than the number of trials. The default value is 3. 22 - Audiometer
Manual mode Allowed tolerance The tolerance between the hearing levels at the Basic and Control frequency should be specified. The default value is 5dB. Error messages If the Basic frequency repeated more than once the following message appears: The Basic frequency can be repeated only once! If not the Basic frequency is repeated the following message appears: Only the Basic frequency can be repeated! If the Basic frequency not repeated the following message appears: The Basic frequency should be repeated! Set default values To return to the original factory settings push the [Default values] button. To save modifications push the [OK] button or to abandon modifications push the [Cancel] button. Manual mode To select the Manual mode click at the icon. Select the ear and set the sound pressure and frequency. The measuring goes on till clicking at the icon. Audiometer - 23
Ascending algorithm The audiometer can be controlled from the keyboard as well with the following keys: Keys used during preparation of test [ ] Cursor key increases sound pressure [ ] Cursor key decreases sound pressure [DEL] Selects the Right ear [PAGE DOWN] Selects the Left ear Keys used during test [ ] Cursor key increases sound pressure [ ] Cursor key decreases sound pressure [ ] Cursor key decreases frequency [ ]Cursor key increases frequency [END] Generates signal in pulse mode [SPACE] Equivalent to the patients feedback switch [ESC] Interrupts the test Ascending algorithm To select the Ascending algorithm click at the icon. Select the ear and set the sound pressure and frequency. The hearing level is determined automatically. The process can be aborted at any moment by clicking at the icon. The audiometer can be controlled from the keyboard as well with the following keys: Keys used during preparation of test [ ] Cursor key increases sound pressure [ ] Cursor key decreases sound pressure [DEL] Selects the Right ear [PAGE DOWN] Selects the Left ear 24 - Audiometer
Descending algorithm Keys used during test [SPACE] Equivalent to the patients feedback switch [ESC] Interrupts the test Descending algorithm To select the Descending algorithm click at the icon. Select the ear and set the sound pressure and frequency. The hearing level is determined automatically. The process can be aborted at any moment by clicking at the icon. The audiometer can be controlled from the keyboard as well with the following keys: Keys used during preparation of test [ ] Cursor key increases sound pressure [ ] Cursor key decreases sound pressure [DEL] Selects the Right ear [PAGE DOWN] Selects the Left ear Keys used during test [SPACE] Equivalent to the patients feedback switch [ESC] Interrupts the test Automatic sequence To select the Automatic sequence click at the icon. Select the starting sound pressure and click at the icon. The measuring of the hearing levels is done automatically. The process can be interrupted at any moment by clicking at the icon. The audiometer can be controlled from the keyboard as well with the following keys: Audiometer - 25
Possible error messages Keys used during preparation of test [ ] Cursor key increases sound pressure [ ] Cursor key decreases sound pressure Keys used during test [SPACE] Equivalent to the patients feedback switch [ESC] Interrupts the test When difference of hearing levels at the Basic frequency and the Control frequency is higher than the allowed tolerance the whole measurement should be done again. If the difference is considerable lower during the repeated test means that the patient has learned the test and the whole test should be done again. If the difference is higher during the repeated test reason should be revealed. Possible reasons: Possible error messages The headset is shifted from the ideal position The patient does not understand the procedure There are several reasons for an invalid measurement: The number of equivalent hearing levels is lower than requested The hearing level at the Control frequency is lower than at the Basic frequency and minus the allowed tolerance The hearing level at the Control frequency is higher than at the Basic frequency and plus the allowed tolerance The sound pressure cannot be decreased anymore! The sound pressure cannot be increased anymore! The measurement was stopped. With the exception of the last one, these error messages do not happen in manual mode (see Possible problems and solutions section). 26 - Audiometer
Measurement storage This feature available only at the database version of the program. To store the measurement, press the button. Comment This feature available only at the database version of the program. Pressing the for the measurement. button opens a comment window Exporting data to an Excel workbook It is possible to send the measurement results to an Excel worksheet, by pressing the following on the screen: button. This will display the This function is only available if Excel is running and a worksheet is open. The column and row identifiers have to be entered (R and C) according to the current version of the Excel. Enter the number of the first cell to export the data. A name may be entered for worksheet, or if left blank the data will be exported to the current worksheet. Audiometer - 27
Exporting data to an Excel workbook 28 - Audiometer
Report Report preview The examination results created during the measurement may be printed. In case of Database version select [Print preview] item from the [Database] menu. In case of Module version select [Print preview] item from the [Audiometer] menu. Report print To start printing, press the window will appear on the screen: print button. The following Report contents The header always appears in the report and contains the following: Name of the physician performing the measurement Name and address of the institution Print data and time Patient s name, identification, date of birth and antropometric data Report - 29
Report contents Logo on / off Comment The following items are optional. It is possible to turn off the logo in the header. If You would like Your own logo, You have to make a 640 * 480 pixels with 256 colour BMP picture and save it as logo.bmp if it is black and white, or logoclr.bmp if it is colour. This file must be located in the program directory. This feature available only at the database version of the program. Prints the patient comment. It is possible to include only part of the comment in the diagnosis. The following steps describe how to accomplish this: Select measurement to be printed Open the comment window (see the Comment chapter) Enter the comment Select block of the comment You would like to see in the diagnosis (see the Comment chapter) Press print button Place a checkmark in front of the comment, if it is not already there Finally, press the [OK] button. Report language It is possible to select the language of report, which can be different from the language of the main program. 30 - Report
Maintenance This chapter describes how to clean and disinfect parts of the audiometer, which are in direct contact with the patients. The headset and the patient s feedback switch are in direct contact with the patients. We propose using formaldehyde free, alcohol based solvent to spray the surface of those parts. Use solvents only, which are compatible with electronic devices. During cleaning and disinfecting follow the regulations 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 disifecting material Patient s feedback switch Unbreakable Polystyrene Incidur spray Headset Unbreakable Polystyrene Incidur spray PVC pillow Case Unbreakable Polystyrene Incidur spray Maintenance - 31
Disinfecting comprehensive table 32 - Maintenance
Possible problems and solutions Audiometer The number of equivalent hearing levels is lower than requested Patient could not reach the desired number of equivalent hearing levels during the possible trials. The hearing level at the Control frequency is lower than at the Basic frequency and minus the allowed tolerance Probably the patient has learned the procedure, in this case it is advisable to repeat the whole test. The hearing level at the Control frequency is higher than at the Basic frequency plus the allowed tolerance Probably the patient does not understand the procedure or the headset shifted out of original position, in this case it is advisable to repeat the whole test. The sound pressure cannot be decreased anymore! When the sound pressure is as low as 10dB and the patient still hears the signal. Probably the patient pushes the feedback switch randomly. The audiometer went wrong. The sound pressure cannot be increased anymore! When the sound pressure is as high as +110dB and the patient still does not hear the signal. Probably the patient is totally deaf. The audiometer went wrong. The measurement was stopped. The measurement is interrupted by the operator Possible problems and solutions - 33
Miscellaneous Error while opening the diagnosis file! The program could not store the measurement results. The storage device is either full or damaged. The LOGO is not a bitmap file. The logo has to be an unpacked Windows Bitmap file. The file passed as 'Old?' may be damaged. The opened unit is damaged. It is possible that the measurement has to be deleted from the database. The program requires 256 or more colours! The program cannot be fully enjoyed in 16 colours. Change Windows to a higher colour level. Frame error experienced by the serial port. It is possible, that incorrect baud rate has been set. Contact the device distributor. Invalid or unsupported serial device identification. Contact the device distributor. Unsupported serial device baud rate. Incorrect baud rate has been set in the Ini file. Contact the device distributor. Invalid byte size. Contact the device distributor. Incorrect default parameter. Contact the device distributor. 34 - Possible problems and solutions
Miscellaneous The function cannot reserve the buffers. Exit from other applications and try again. If the program still does not work, decrease the receiver buffer size in the Ini file. Contact the device distributor. 'LOGO' file not found. The Logo.bmp file is missing. Miscellaneous In a case of malfunction switch of the audiometer and if there is no risk of electric hazard after a little while turn it on again. Possible problems and solutions - 35
Miscellaneous 36 - Possible problems and solutions
Technical specifications Guarantee Limited liability Safety precautions The audiometer complies with the actual Technical Data. The manufacturer assumes responsibility according to the conditions of actual Installation report or other Purchase documents. The guarantee does not cover malfunctions which happen due to the careless transport or handling not sufficient protection against harmful environmental effects and not following the regulations of the Users Manual. The Piston Ltd. and its distributors do not take any responsibility even to the slightest extent in the case of individual, unforeseeable, direct or indirect losses, for cancellation of profit, for interruption of activity, for losing information, for any financial losses, which may be derived from the usage or not usage of the device. Please take into consideration the following precautions to avoid damages: The mains voltage should be equivalent to the voltage indicated on the label of the device Electrical cables should be intact Regularly make maintenance according to Users Manual Use the device only for original functions Use spare parts only from the original manufacturer During replacing spare parts follow the regulations of Users Manual Keep the device in a dry place Technical specifications - 37
Environmental conditions Keep the device far from intensive source of heat Keep the device away from oil, sharp items, rough surfaces Do not expose the device to the intensive sunshine or artificial light brighter than 1500 lux Do not use the device in polluted environment Do not use the device in shocking environment Regularly inspect the pillows of the headsets. Never use broken or cracked pillows. Environmental conditions Electrical safety The device complies with the EN 60601-1:1997 standard. Transport conditions: Ambient temperature:... -30 C - +60 C Relative humidity:...10% - 100% Ambient pressure:...500 1060 mbar Storage conditions: Ambient temperature:...0 C - +50 C Relative humidity:...10% - 85% Ambient pressure:...500 1060 mbar Service conditions: Ambient temperature:... +10 C - +35 C Relative humidity:...30% - 75% Ambient pressure:...700 1060 mbar The device complies with the following standards: EN 60601-1:1997, EN 60601-1-1:1998, EN 50081-1:1992, EN 50082-1:1992 Safety class I. Environmental protection IP20 Patient safety B 38 - Technical specifications
Electrical data With this symbol the B type patient circuit is labelled which complies with the EN 60601-1;1997 standard, especially with the leakage current. Electrical data Mechanical data General values Guaranteed values The electrical data of the applied PC and printer are available in their Users manual. Audiometer (PDD 401): Current consumption from the USB port:...max. 190 ma Audiometer interface unit (PDD-401): Width:... 82 mm Depth:... 150 mm Height:... 45 mm Weight:...960 g Earphones:...TDH 39 Attenuation of headset:... 40 db Expected lifetime:...5 év Step of sound pressure:... 5 db Frequencies:... 125Hz, 250Hz, 500Hz, 750Hz, 1kHz 1,5kHz, 2kHz, 3kHz, 4kHz, 6kHz, 8kHz Volume range:... -10dB HL, +110dB HL Total harmonic distortion:... < 1% Frequency accuracy:... ±1% Technical specifications - 39
Accessories Accessories included: Name Type Quantity Audiometer interface PDD-401 1 unit System software 1 set Headset HE-2000 1 set Feedback switch HE-3000 1 set Serial cable (1,5 m) 9 pole extension 1 piece Users manual Audiometer 1 volume Database 1 volume 40 - Technical specifications