user manual
Contents
1. This allows either the Current readings i e the retained thresholds see Section 5 3 or the thresholds stored in one of the audiometer s internal memory locations see Section 5 4 to be transferred to Audibase To select an internal memory location un check the Current readings box and enter the required memory location numbers 1 to 12 Click on OK and the selected data will be transferred to Audibase The PC850 window will then close Remember to save the data in Audibase to retain it in the database refer to the Audibase operating manual Note that the manual test method described above will transfer only thresholds stored in the audiometer The results of any partial automatic test will be discarded Thus if an automatic test has been completed but with errors the Mixed Test mode should be used to insert manual readings into the incomplete automatic test see Section 4 3 8 4 4 Options Available to Set up amp Control an Automatic Test The Options menu selection at the top of the PC850 window opens a dialogue box which provides access to a number of options as follows Frequencies Computer test i 250 Hz f 2of3 Start with familiarization M S500 Hz i 3of5 W Omit repeat frequency y Tone response Patient details Wf pe 1165 Ha On error repeat once e Full 2 KHz C Reference 2 KHz and then pause test C None d KHz E KHz COM Password o KHz i 2345 kW Co2. retry the frequency that was being tested when the TALKOVER key was pressed Retry or skip the frequency that was being tested and move on to the next frequency Ignore 4 3 5 Computer Testing Use the audiometer controls to clear any current test readings retained thresholds Refer to Section 5 2 2 Click the Computer test icon the icon will then be highlighted aN Alternatively use the Test gt Computer drop down menu selection at the top of the PC850 window To run a Computer test click the Run selected test icon E and confirm the operation by clicking Yes in the Run Test dialogue box The Computer test will run according to the test options selected see Section 4 4 with the test status indicated at the bottom left of the PC850 window In Computer mode the time available for the patient to respond is from the point the tone is presented to the beginning of the next presented tone approximately 2 3 seconds maximum If a response is made within this time period a random delay is then added to the time until the next tone is presented The test will proceed and conclude as described in Section 4 3 4 Remember to save the data in Audibase to retain it in the database or Cancel Insert Edit if the data is to be discarded refer to the Audibase operating manual 4 3 6 Bekesy Testing Use the audiometer controls to clear any current test readings retained thresholds Refe
3. 30 dip in Uy for 30 dip in Uy for 25 cycles 25 cycles lt 5 Uz lt 5 Ur gt 95 dip in Uy for gt 95 dip in Uy for 5 sec 5 sec Power frequency Power frequency magnetic fields should be 50 60 Hz magnetic at levels characteristic of a typical location in field a typical commercial or hospital environment IEC 61000 4 8 NOTE U is the a c mains voltage prior to the application of the test level OMO015 9 Amplivox PC850 Operating Manual Page 27 Guidance and manufacturer s declaration electromagnetic immunity 2 The Amplivox PC850 Audiometer is intended for use in the electromagnetic environment specified below The customer or user of the PC850 Audiometer should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the PC850 Audiometer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 2 VP IEC 61000 4 6 150kHz to 150kHz to 8O0MHz 80MHz Radiated RF d 1 2VP 80MHz to 800MHz IEC 61000 4 3 d 2 3VP 800MHz to 2 5GHz where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer and d is the recommended separation distance
4. press and hold the response switch when a series of pulses are heard and release when the pulses are no longer heard 4 3 3 Initiating a Test Before starting an automatic test It is important to clear any current test readings from the audiometer typically these would be retained thresholds from a previous manual test see Section 5 3 Refer to Section 5 2 2 for details of clearing a test If this is not done then dealing with any error conditions could become problematic Start the Audibase application and with reference to the user manual either establish a new a patient or access and display details of an existing patient Use the left mouse button to click on the Test icon in the Audibase toolbar S Page 8 OM015 9 Amplivox PC850 Operating Manual Alternatively use the Test gt Launch Test drop down menu selection at the top of the Audibase window A new window will open for the PC850 software and the most recent audiogram stored in Audibase for the patient is transferred and displayed in the PC850 window as previous data ra Amplivox PC850 Database for t or x File Test View Options Pause About Die S M Px E A CA E CI II II IC A A pow oe oe NC fe fos CA CI CI a ee To J ees ee 1K 1K5 2K 3K 4K 6K 8K dBHL 250 500 1K 1K5 2K 3K 4K 6K 8K 10 4 3 4 Running a Test The test type previously used is remembered and the following dialogue box will be displayed Audib
5. 5 The audiometer is supplied with PC based software including the Amplivox Audibase application which enables automatic testing to be conducted via the PC with the transfer of audiometric test results for storage and analysis You must use the designated USB cable which is supplied with this option 3 Using the Audiometer General 3 1 Switching the Audiometer On and Off Press and briefly hold the ON switch situated on the back panel No warm up time is required To switch off press and hold the MENU key followed by the YES RIGHT key and then release both 3 2 Testing the Patient Response Switch Press the patient response switch and the indicator labelled RESPONSE above and to the right of the display will illuminate 3 3 Testing the Talkover Function To communicate with the patient hold down the TALKOVER key to route the operator s voice from the front panel microphone to the headset the level is adjusted with the SIGNAL 4 keys 3 4 Audiometry preparation and ambient conditions Refer to the various audiometric standards and other relevant publications for guidance on audiometric testing Audiometric testing should always be performed in quiet conditions e g a quiet room or an acoustic booth The optional Audiocups can provide an additional level of isolation from ambient noise For further explanation on permissible ambient noise levels please refer to the standard 1506189 3 5 Test system arrangement The schemati
6. Audiometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the PC850 Audiometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PC850 Audiometer as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 2 3 P 0 01 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people OMO015 9 Amplivox PC850 Operating Manual Page 29 Appendix 2 Use with Non medical Electrical Equipment Any person who connects external equipment to signal input signal output or other connectors has created a medical electrical system and is therefore respons
7. bin symbol with black bar underneath or e have been replaced with new Amplivox products on a like for like basis please contact our WEEE Compliance Scheme B2B Compliance using the details below B2B Compliance will be able to provide further information on how to recycle your waste electrical units and answer any queries you may have B2B Compliance Tel 44 0 1691 676 124 Option 2 Email operations b2bcompliance org uk Page 26 OMO015 9 Amplivox PC850 Operating Manual Appendix 1 EMC Guidance amp Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic emissions The Amplivox PC850 Audiometer is intended for use in the electromagnetic environment specified below The cl EE or user of PC850 Audiometer should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance RF emissions Group 1 The PC850 Audiometer uses RF energy only for its internal function w ial Therefore its RF emissions are very low and are not likely to cause CISPR 11 interference in nearby electronic equipment RF emissions Class A The PC850 Audiometer is suitable for use in all establishments other than domestic and those directly connected to the public low CISPR 11 voltage power supply network that supplies buildings used for IEC 61000 3 2 Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Guidance and manufacturer s declaration electrom
8. disconnect device and therefore the audiometer should be positioned such that easy access to the mains adapter is possible lf a replacement mains adapter is required please contact Amplivox or your Amplivox distributor 2 4 Audiometer Connections All the relevant accessory terminals and connections are labelled to ensure correct identification and connection as follows ll an Ll Code E ima e LEFT 6 3mm jack Blue way O ee I diagnostic use only below ere eee fees Type B diagnostic use only below 2 5mm power NI Mains AC DC Adapter NS jack AA RESPONSE 6 3mm jack Patient Response Switch The relevant part numbers are indicated in Section 13 Note regarding the RJ12 amp 6 pin mini DIN sockets These are restricted sockets for service and repair use only No user access is permitted For connected parts marked only connect the accessories supplied with the instrument or supplied by Amplivox or an Amplivox distributor These parts have been tested for use with the Amplivox PC850 Audiometer for compliance with the standards IEC 60601 1 and IEC 60601 1 2 The use of accessories other than those specified may compromise compliance with these standards For other sockets refer to Appendix 2 2 5 Connection to a Computer Refer to Appendix 2 for important information regarding the connection of non medical electrical equipment to medical electrical equipment OMO015 9 Amplivox PC850 Operating Manual Page
9. edit button on the Audibase toolbar i When data is saved in Audibase a further dialogue box appears similar to that shown below This displays the hearing level categorisation and provides an opportunity for the operator to enter a recall period for the patient Categorization i f Enter recall period 2 Wears x Cancel Enter the appropriate recall period from the drop down options and click on OK to confirm saving of the data Clicking on Cancel will cancel the save operation and discard the data Users should remain aware that it is possible to modify audiometric test results transferred into Audibase as long as they have not been saved Refer to the Audibase manual for details 4 3 4 2 Changing the Test Type or Other Options lf an alternative test is required or if the configuration options are to be modified click No which will close the dialogue box and allow alternative options to be selected Refer to Sections 4 3 5 to 4 3 9 and Section 4 4 as appropriate for additional guidance 4 3 4 3 Using the Talkover Function lf the TALKOVER key is pressed while an automatic test is in progress the test will be paused with a dialogue box displayed as below Page 10 OMO015 9 Amplivox PC850 Operating Manual Test Paused O Stop test retry frequency or continue After any necessary instruction is given to the patient and the TALKOVER key is released the operator can choose to stop the test Abort
10. number see Section 13 Handle the audiometric headset and other accessories with care For parts that are in direct contact with the patient it is recommended that replacement parts are used or the parts are subjected to a standard disinfecting procedure between patients This includes physically cleaning and use of a recognised disinfectant The specific manufacturer s instructions should be followed for use of this disinfecting agent to provide an appropriate level of cleanliness Clean the ear cushions including those on the Audiocups if used with a recognised disinfectant e g a Mediswab Important note During the cleaning process do not allow moisture to enter the earphone 9 3 Mains adapter maintenance Before use check the mains AC adapter for signs of wear and or damage If you find any replace the adapter immediately by contacting Amplivox or your Amplivox distributor Refer to Section 13 for approved part numbers DO NOT USE ANY OTHER TYPE OF MAINS ADAPTER WITH THIS INSTRUMENT See Section 2 3 10 Instrument Storage and Transportation This instrument can be stored or transported within the following environmental parameters Temperature 20 C to 70 C Humidity 10 to 90 non condensing Atmospheric Pressure 500 hPa to 1060 hPa Page 24 OMO015 9 Amplivox PC850 Operating Manual 11 Calibration and Repair of the Instrument Amplivox recommends that this audiometer should be calibrated on an annual bas
11. on screen Use the SIGNAL 11 keys to select a location numbered 1 12 and then press the YES key Release the MENU key once confirmation appears on the display 5 6 Data transfer to Amplivox Audibase Refer to the Audibase operating manual to transfer test results to a PC with the Amplivox Audibase software installed Page 20 OMO015 9 Amplivox PC850 Operating Manual 5 7 Suggested Sequence of Operation and Test Procedure The following notes are for guidance only Refer also to ISO 8253 Audiometric Test Methods for further guidance 5 7 1 Pre test 1 Switch the audiometer on 2 Perform a listening check 3 Decide whether to use the Threshold Retention Function and or an audiogram card to record the thresholds 4 Prepare the test environment amp patient see Sections 3 4 to 3 6 5 If the patient response switch is not being used give instructions to the patient to acknowledge any tone presented by raising or lowering the finger 6 If the patient response switch is in use give instructions to the patient to acknowledge any tone presented as follows As soon as you hear the tone press the switch When you no longer hear the tone release the switch 7 Fit the headset to the patient Select the better hearing ear according to the patient by pressing either the LEFT or RIGHT key and start the familiarisation session 5 7 2 Familiarisation 1 Present the tone 30dB at 1kHz for between 1 and 2 seconds If there
12. 0 window will then close Remember to save the data in Audibase to retain it in the database refer to the Audibase operating manual Note that any automatic test thresholds recorded will always be transferred even if a threshold has been manually entered on the audiometer at that frequency Only manual thresholds entered at frequencies where there is no automatic test threshold are transferred to Audibase Note also that if the previous test results on the audiometer the retained thresholds were not cleared then any retained thresholds at frequencies where an automatic test was not carried out e g for frequencies that were deselected for an automatic test would also be transferred into Audibase This is why it is essential to clear the retained thresholds before carrying out an automatic test 4 3 9 Manual Testing This assumes that a set of audiometric thresholds has already been established by using the audiometer in manual test mode see Section 5 Click the Select upload manual test icon the icon will then be highlighted ud Alternatively use the Test gt Manual drop down menu selection at the top of the PC850 window To transfer a set of manual thresholds to Audibase click the Run selected test icon E OMO015 9 Amplivox PC850 Operating Manual Page 13 and confirm the operation by clicking Yes in the Run Test dialogue box A further dialogue box will open Stored audiogram number cos
13. 048 Audiocup headband cover A023 Headband standard headphone A026 Earphone cushion A032 Earphones DD45 A030 Headset lead B128 Carrying case A091 7 Approved mains adapter within EU A091 6 Approved mains adapter rest of world A085 Patient response switch A051 Audiogram cards pack of 50 MANPC850 Amplivox PC850 operating manual OM015 F07 USB Cable 1 8m OM015 9 Amplivox PC850 Operating Manual Page 25 Accessories marked require calibration with the specific audiometer to be used Do not attempt to use these accessories until the audiometer has been calibrated to match their characteristics shipping documentation will reference the stock number quoted above and images of the parts alongside the relevant stock number are available on the Amplivox website www amplivox ltd uk The required fitting instructions are supplied with each part 14 Disposal Information Amplivox Limited is fully compliant with the WEEE Waste Electrical and Electronic Equipment Regulations Our PRN Producer Registration Number is WEE GA0116XU and we are registered with the approved WEEE Compliance Scheme B2B Compliance approval number WEE MP3338PT SCH The main purpose of the WEEE Regulations is to encourage the segregation of waste electrical items from the general waste stream and into reuse recovery and recycling routes Therefore for any waste electrical units purchased from Amplivox that either e bear the crossed out wheeled
14. Amplivox PC850 Automatic Audiometer Operating Manual Audibase Software Version 5 4 Applies from serial number 22966 onwards Amplivox Ltd 29 30 Station Approach Kidlington Oxford OX5 1JD UK Tel 44 0 1865 842411 Fax 44 0 1865 841853 sales amplivox td uk www amplivox td uk Contents 1 Introduction 1 1 Intended Applications 1 2 Unpacking 1 3 Warranty Card UK Customers Only 1 4 Standard Contents 1 5 Optional Accessories 2 Important Safety Instructions 2 1 Precautions 2 2 Electromagnetic Compatibility EMC Considerations 2 3 Mains Supply Operation 2 4 Audiometer Connections 2 5 Connection to a Computer 3 Using the Audiometer General 3 1 Switching the Audiometer On and Off 3 2 Testing the Patient Response Switch 3 3 Testing the Talkover Function 3 4 Audiometry preparation and ambient conditions 4 Using the Audiometer Automatic Testing 4 1 Introduction 4 2 Test Types Available 4 3 Performing a Test 4 4 Options Available to Set up amp Control an Automatic Test 4 5 Error Handling amp Troubleshooting 5 Using the Audiometer Manual Testing 5 1 Audiometer display 5 2 Audiometer controls 5 3 Threshold Retention Function 5 4 Saving audiograms in internal memory 5 5 Loading audiograms from internal memory 5 6 Data transfer to Amplivox Audibase 5 7 Suggested Sequence of Operation and Test Procedure 6 Specification 6 1 Output data 6 2 Physical Data 6 3 Equipment classification 7 Symbols 8 Tech
15. D x 68mm H Weight 0 7kg approx Safety IEC 60601 1 plus UL CSA amp EN deviations EMC IEC 60601 1 2 CE mark To the EU Medical Device Directive 6 3 Equipment classification Type of protection against electric shock Powered via SELV Classll mains adapter Degree of protection against electric shock Type B applied part Degree of protection against ingress of water Not protected Mode of operation Continuous operation Equipment mobility Portable The Model PC850 Audiometer is classified as a Class lla device under Annex IX of the EU Medical Devices Directive It is intended for use as a screening audiometer instrument Page 22 OMO015 9 Amplivox PC850 Operating Manual 7 Symbols The following symbols appear on the audiometer or mains adapter auxiliary current associated cables Definition Refer to instruction manual mandatory Definition Type B applied part an applied part providing protection against electric shock particularly regarding allowable patient leakage current and patient The applied parts are the left amp right earphones patient response switch and the DC ZZZ Petinition The output from the mains AC adapter is Direct Current Definition Class Il equipment equipment in which protection against electric 8 Technical Information Audiometer Audiometer type Transducers Types and reference levels Static headband force Sound attenuation characteristics shock does no
16. PC850 used with the medically approved mains adapter Mains Outlet Medical Mains Adapter Page 30 OMO015 9 Amplivox PC850 Operating Manual Diagram 2 PC850 used with the medically approved mains adapter and PC Mains Outlet Medical Mains Adapter PC850 Audiometer Mains Outlet S 3 a y PC Power Supply PC via USB Socket OMO015 9 Amplivox PC850 Operating Manual Page 31
17. agnetic immunity 1 The Amplivox PC850 Audiometer is intended for use in the electromagnetic environment specified below The customer or user of the PC850 Audiometer should assure that it is used in such an environment Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic Discharge ESD tile If floors are covered with synthetic 8 kV air 8 kV air material the relative humidity should be at IEC 61000 4 2 least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a transient burst supply lines supply lines typical commercial or hospital environment IEC 61000 4 4 1 kV for input output 1 kV for lines input output lines Surge 1 kV differential 1 kV differential Mains power quality should be that of a mode mode typical commercial or hospital environment IEC 61000 4 5 2 kV common mode 2 kV common mode Voltage dips short lt 5 Uy lt 5 Uy Mains power quality should be that of a interruptions and gt 95 dip in Uy for gt 95 dip in Uy for typical commercial or hospital environment voltage variations on 0 5 cycle 0 5 cycle If the user of the PC850 Audiometer requires power supply input continued operation during power mains lines 40 Ur 40 Ur interruptions it is recommended that the 60 dip in Uy for5 60 dip in Uy for PC850 Audiometer be powered from an IEC 61000 4 1 1 cycles 5 cycles uninterruptible power supply or a battery 70 Ur 70 U7
18. arding EMC and needs to be installed and put into service according to the EMC information provided in Appendix 1 This provides guidance on the electromagnetic environment in which to operate the instrument Portable and mobile radio frequency RF communications equipment can affect medical electrical equipment The instrument should not be used adjacent to or stacked with other equipment if this is necessary the instrument should be observed to verify normal operation 2 3 Mains Supply Operation The audiometer is designed for continuous operation and is powered by a mains adapter which is supplied and specified as part of the equipment If a replacement is required please contact your Amplivox distributor All other connections must be made before connecting the output lead from the adapter into the POWER input socket on the back of the audiometer Switch on the mains supply the indicator on the adapter and the POWER indicator on the audiometer will both illuminate green showing that the instrument is ready for use Page 4 OMO015 9 Amplivox PC850 Operating Manual The output from mains adapter is fitted with electronic circuit protection In case of overload the adapter will shut down and the indicator will be extinguished When the fault is cleared the adapter will operate as normal The input is to the mains adapter is protected with a non replaceable fuse If this fails the adapter will not operate The mains adapter is the mains
19. ase Run Test 4 3 4 1 Running the Previous Test Type To run the same type of test with the same options as previously used simply click Yes and the test will commence as previously run refer to Sections 4 3 5 to 4 3 9 The Run selected test icon will change to that shown below Assuming that an automatic test is in use the serial number of the connected audiometer is shown at the bottom right of the PC850 window and the status message Running test is displayed at the bottom left Additionally the message Linked is shown on the display of the audiometer OMO015 9 Amplivox PC850 Operating Manual Page 9 To view the traces of the presented tones select the Show test detail icon Eg Alternatively use the View gt Detail drop down menu option To view the audiogram thresholds select the Show Audiogram icon Alternatively use the View gt Audiogram drop down menu option If thresholds are established at all of the selected test frequencies then these thresholds will automatically be transferred back to Audibase the PC850 software will close and the Audibase screen displayed Refer to Section 4 5 for dealing with errors Remember to save the data in Audibase to store it in the database refer to the Audibase operating manual If the data is not to be stored then the Edit gt Cancel Insert Edit menu option in Audibase is used to discard it or click the cancel insert
20. c diagram below shows a typical example of the use of audiometric test equipment The audiometer is located on the desk of a seated operator as shown Computer Patient wearing headset Operator Headset lead Audiometer Response switch amp lead Page 6 OMO015 9 Amplivox PC850 Operating Manual The patient is seated in front of the desk facing away from the operator The patient wears a headset see Section 3 6 and responds to test stimuli by use of a hand held switch which is also connected to the instrument 3 6 Headset The headset must be fitted by a qualified person to ensure a proper seal and a comfortable fit The leads from the headset are connected to the instrument and the headset is then fitted to the patient 4 Using the Audiometer Automatic Testing 4 1 Introduction Before the PC850 can be used as an automatic audiometer the operating software and the Audibase application must be installed and registered on the connected PC Refer to the relevant section of the Audibase operating manual for details of this operation On start up the display will show the following default setting SIGNAL dBHL FREQUENCY Hz 30dB 1kHz lt gt lt gt This indicates that the audiometer is now ready to be used for automatic testing which is initiated by Audibase and controlled by the PC850 software 4 2 Test Types Available 4 2 1 Computer Test This is a method of automatic audiometry based on the Hughson and Westlake metho
21. d and undertaken automatically by the instrument The level is increased in 5dB steps until a response is obtained from the patient and decreased in 10 dB steps until no response occurs The process is repeated until depending upon the criteria selected for recording a threshold see Section 4 4 the instrument will record a threshold at that particular frequency The PC850 then continues to the next test frequency and so on to complete the test on both ears When completed the test data is transferred to Audibase 4 2 2 Bekesy Test This is a method of automatic audiometry devised by Von Bekesy 1947 using pure tone stimuli to track auditory thresholds This application is known as discrete frequency Bekesy testing and the principle behind the test is that the patient adjusts the presented level according to his hearing threshold The decibel level decreases when the patient presses the response switch upon hearing the presented tone Conversely when the patient can no longer hear the presented tone he will release the response switch therefore allowing the level to increase until the presented tone is heard again The level changes are in 2 5dB steps OMO015 9 Amplivox PC850 Operating Manual Page 7 When a number of these peaks and valleys have been consistently performed the PC850 will calculate an average to the nearest dB and display this as the hearing threshold for that particular frequency The PC850 then continues to the next test
22. delivery note that all the accessories ordered have been included with your audiometer If anything is missing please contact Amplivox Customer Support on 44 0 1865 842411 email sales amplivox td uk If you have purchased from a distributor you should contact them directly Please retain the shipping carton and packing materials as the audiometer will need calibrating on an annual basis and should be returned to Amplivox in its original shipping carton 1 3 Warranty Card UK Customers Only Please complete the enclosed warranty registration card and return it to Amplivox This will enable us to register your purchase to deal with any enquiries you have and assist us in providing you with technical support 1 4 Standard Contents Amplivox PC850 Audiometer Audiometric headset amp leads Patient response switch USB cable to connect to PC Mains adaptor see 2 3 Operating manual 4 guide Calibration certificate Carrying case Software installation disk Password certificate 1 5 Optional Accessories Audiogram cards Spare USB cable Audiocups noise reducing earphone enclosures 2 Important Safety Instructions The Amplivox PC850 audiometer must be used only by practitioners qualified to perform audiometric tests It is intended for use as a screening tool OMO015 9 Amplivox PC850 Operating Manual Page 3 2 1 Precautions READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT To comply with the standards IEC 60601 1 fo
23. frequency and so on to complete the test on both ears 4 2 3 Single Frequency Test The PC850 provides the facility to repeat a test at a specified single frequency and add the results into the overall audiogram result This feature is useful for situations where one particular frequency has proved problematic 4 2 4 Mixed mode Test insert manual readings This allows manual testing of any frequencies when an automatic test has been unable to determine a threshold The combined results are then transferred to Audibase 4 2 5 Manual Test upload manual readings While not strictly an automatic test this allows the operator to use the PC850 software to transfer to Audibase the results of a previous manual test These could be either the retained thresholds see Section 5 3 or the thresholds stored in one of the internal memory locations of the audiometer see Section 5 4 The audiometric data is transferred to Audibase in the same way as that for an automatic test 4 3 Performing a Test 4 3 1 Preparation Refer to the various audiometric standards and other relevant publications for guidance on audiometric testing and the information in Section 3 for preparing the audiometer 4 3 2 Instructions to the Patient The patient is typically given the following instructions Inthe case of Manual or Computer testing press and then release the response switch when a tone is heard Inthe case of Bekesy testing
24. frequency that was being tested and move on to the next frequency Ignore 4 5 4 Continual Response from Patient If the patient holds the response switch on continuously it will not be possible to record a hearing threshold and the following dialogue box will be displayed Threshold not found i Stop test retry frequency or continue E Retry Ignore The operator can choose to stop the test Abort retry the frequency Retry or skip the frequency that was being tested and move on to the next frequency Ignore 4 5 5 No Results If no results are available to transfer to Audibase the following dialogue box will be displayed Page 16 OMO015 9 Amplivox PC850 Operating Manual This could be because the PC850 window was closed before any thresholds could be recorded the test was aborted or some other problem has occurred with the test sequence Click OK to close the box and then use the Edit gt Cancel Insert Edit option to cancel the operation A further test may then be launched from Audibase 4 5 6 Errors in Test Sequence lf one or more thresholds cannot be recorded the following dialogue box is displayed at the end of the test fest Finished Test sequence complete with errors Click OK and consider the options described in Sections 4 3 7 to 4 3 9 to complete the test regime 4 5 7 Inconsistency in 1kHz Repeat Test lf the repeat frequency option is enabled for a Compute
25. ible for the system complying with the requirements of clause 16 of IEC 60601 1 2005 General requirements for basic safety and essential performance lf connections are made to standard equipment such as printers and computers special precautions must be taken in order to maintain medical safety The following notes are provided for guidance in making such connections to ensure that the general requirements of clause 16 of IEC 60601 1 2005 are met The following signal inputs and outputs on the Amplivox PC850 audiometer are electrically isolated to the requirements of IEC 60601 1 in order to reduce any potential hazard associated with the use of mains powered equipment connected to these inputs and outputs Socket Label Socket Type Typical Connection USB USB Connector Type B External equipment intended for connection to signal input signal output or other connectors shall comply with the relevant IEC or international standards e g IEC 60950 CISPR 22 amp CISPR 24 for IT equipment and the IEC 60601 series for medical electrical equipment Equipment not complying with IEC 60601 shall be kept outside the patient environment as defined in IEC 60601 1 2005 at least 1 5m from the patient The operator must not touch the connected equipment and the patient at the same time as this would result in an unacceptable hazard Refer to Diagrams 1 amp 2 below for typical configurations of connected peripheral equipment Diagram 1
26. in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range i Interference may occur in the vicinity of equipment marked with the following symbol e NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the PC850 Audiometer is used exceeds the applicable RF compliance level above the PC850 Audiometer should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the PC850 Audiometer Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 28 OM015 9 Amplivox PC850 Operating Manual Recommended separation distances between portable and mobile RF communications equipment and the PC850 Audiometer The Amplivox PC850
27. is Please contact Amplivox or the designated distributor for details of calibration services Refer to ISO 8253 1 for additional guidance The instrument should be returned to the manufacturer for service amp repair There are no user serviceable parts within it When packing the instrument for shipping please use the original shipping carton and packing materials Ensure that the headset leads are not wrapped around the headband of the headset 12 Guarantee All Amplivox instruments are guaranteed against faulty materials and manufacture The instrument will be repaired free of charge for a period of one year from the date of despatch if returned carriage paid to the Amplivox service department Return carriage is free of charge for customers in the UK and chargeable for overseas customers Important Note The following exceptions apply Earphones may go out of calibration due to rough handling or impact dropping The life of the leads is also dependent upon conditions of use These parts are only guaranteed against faulty materials or manufacture 13 Ordering Consumables and Accessories To order consumables additional accessories and to replace detachable parts that have been damaged please contact Amplivox for current prices and delivery charges The items available are listed below Stock No Description A022 Audiocups noise reducing earphone enclosures AC1042 Audiocup ear cushion AC1047 Audiocup headband AC1
28. is no response at 30dB increase the attenuation level in 10dB steps until the patient responds 2 When the patient responds wait for 1 to 2 seconds and present the tone again at the same level however if the patient does respond at 30dB reduce the signal level in 10dB steps repeating the presentation until there is no response then increase the signal level in 5dB steps until the patient responds wait 1 to 2 seconds and present the tone again at the same level 3 If the responses are consistent with the pattern of tone presentation proceed to Section 5 7 3 and start measuring the patient s hearing thresholds if not repeat the familiarisation 5 7 3 Test 1 Use the Clear test option see Section 5 2 2 to clear any thresholds 2 Present the first test tone at 30dB at 1kHz 3 If the patient responds reduce the signal level in 10dB steps repeating the presentation until there is no response then increase the signal level in 5dB steps until the patient responds 4 If the patient does not respond increase the signal level in 5dB steps until there is a response and then continue with step 4 5 Repeat the test by reducing the signal level in 10dB steps until the patient no longer responds Then increase the signal level in 5dB steps until a response occurs and note this level 6 Repeat step 4 until the patient responds three out of a maximum of five times at the same signal level This indicates the patient s hearing threshold le
29. lour display W Colour print W Beep on finish Frequencies which allows the operator to add or delete specific frequencies to or from the test regime note that 1kHz is always included Computer test which provides controls to allow the selection of either 2 out of 3 or 3 out of 5 consistent responses to generate a valid threshold afamiliarisation run prior to the test aretest of the first frequency to be omitted including this function can prove useful in correlating test results see also Section 4 5 7 Page 14 OMO015 9 Amplivox PC850 Operating Manual Tone response which provides controls to determine the action to be taken on error the number of times a frequency is repeated 0 1 2 or 3 times if an error in testing occurs for example if there is no response from the patient and then the action to be taken if the error continues skip the frequency stop the test or pause the test Patient details which may be ignored when used with Audibase COM which may be ignored for instruments with serial numbers covered by this user guide Colour display which may be selected to display the audiogram in colour Colour print which may be ignored when used with Audibase Beep on finish which sounds an audible warning on the PC at the end of the test Password which allows the user to input a valid password for the connected audiometer 4 5 Error Handling amp Troubleshooting 4 5 1 No Instru
30. ment Connected If no audiometer has been connected when a test is requested from Audibase a dialogue box similar to that shown below will be displayed Communication Erro Instrument not found Error 2 type 9 Check e That the PC850 audiometer is switched on e That the PC850 audiometer is connected to the computer e That the PC850 software has been installed correctly Click OK to close the box and then use the Edit gt Cancel Insert Edit option to cancel the operation Audibase functions may then be continued 4 5 2 Incorrect Password lf the password of the connected audiometer does not match that displayed in the Options dialogue box in the PC850 window the following message is displayed Click OK open the Options dialogue box and enter the correct password Once this is done testing may proceed OMO015 9 Amplivox PC850 Operating Manual Page 15 4 5 3 No Response from Patient lf the patient does not operate the response switch and the maximum output level is reached the following dialogue box will be displayed No patient response Check e That the earphones and response button are correctly plugged in That the audiometer is presenting a tone That the Patient Response Switch is working correctly That the patient understands the test and that they understand how to respond to the tones presented The operator can choose to stop the test Abort retry the frequency Retry or skip the
31. nical Information 9 Routine Maintenance 9 1 Audiometer maintenance 9 2 Transducer maintenance 9 3 Mains adapter maintenance 10 Instrument Storage and Transportation 11 Calibration and Repair of the Instrument 12 Guarantee 13 Ordering Consumables and Accessories 14 Disposal Information Appendix 1 EMC Guidance amp Manufacturer s Declaration Appendix 2 Use with Non medical Electrical Equipment COW 0 Y Y Y acu B BO oon oS Oo 25 25 25 26 27 30 Page 2 OMO015 9 Amplivox PC850 Operating Manual 1 Introduction 1 1 Intended Applications Thank you for purchasing an Amplivox audiometer The Amplivox PC850 is an air conduction screening audiometer that is designed for use by audiologists and occupational health practitioners Its primary use is as an automatic audiometer interfacing to and launched from the Amplivox Audibase PC software However it may also be used as a standalone manual audiometer that can save the results of up to 12 tests These tests may then be transferred to Audibase at a later stage Audibase allows electronic storage of audiometric test records on a PC application of audiogram categorisation schemes printing of audiograms and data exchange with other PC applications The audiometer is not intended for use to determine the full extent and scope of a patient s hearing deficiency 1 2 Unpacking Open the shipping carton and carefully remove all the equipment Check against the
32. or 5 6 Once a threshold has been determined press the selected ear key once again and the level will be stored and displayed in a similar way to that shown below To review the retained thresholds use the FREQUENCY lt gt keys to select the required frequency The threshold values for the left and right ears are shown on the lower line of the display as illustrated below SIGNAL dBHL FREQUENCY Hz 30dB 4kHz This display shows 20 10 thresholds at 4kHz Thresholds retained Left ear 20dBHL Right ear 10dBHL To clear the Threshold Retention memory press and hold the MENU key use the FREQUENCY lt gt keys to select Clear test No Press YES and then release the MENU key 5 4 Saving audiograms in internal memory The user may save up to 12 audiograms referenced by number in the internal memory of the audiometer To save the current set of audiogram thresholds the retained values described in Section 5 3 press and hold the MENU key and then press MENU SELECT repeatedly until Save Audiogram to 1 appears on screen Use the SIGNAL 11 keys to select a location numbered 1 12 and then press the YES key Release the MENU key once confirmation appears on the display Note that the Save process will overwrite any records that exist in the selected memory location 5 5 Loading audiograms from internal memory Press and hold the MENU key and then press MENU SELECT repeatedly until Load Audiogram No 1 appears
33. plivox PC850 Operating Manual 5 2 Audiometer controls 5 2 1 Multifunction Keys several keys on the audiometer have different functions depending on the actual mode of operation These are MENU OFF LEFT NO RIGHT YES and FREQUENCY gt MENU SELECT The use of these keys is described below 5 2 2 MENU Press and hold MENU to access the following options Use the MENU SELECT keys to step through the available options and then the NO YES or SIGNAL Uf keys to select an action or modify a setting Release of the MENU key then initiates the action or saves the modified setting and returns to the default display Menu Option Description Switch off As described in Section 3 1 Clear test Press YES and release MENU to clear the Threshold Retention Function results from the previous test Save audiogram to 1 Use the SIGNAL 11 keys to select the required storage location and press the YES key to save the audiogram then release MENU Load audiogram no 1 Use the SIGNAL 1 keys to select the required storage location and press the YES key to load the audiogram then release MENU Contrast Adjust contrast using the SIGNAL 1 keys then release MENU 5 2 3 Description of Function of Other Keys 20dB This enables tone levels to be presented with up to 20dB higher output in manual test mode press the key and then use SIGNAL 1 to access the extra 20dB in 5dB steps an indicator above the key illuminates green to show that the func
34. r safety and IEC 60601 1 2 for EMC the audiometer is designed to be used only with the medically approved mains adapter supplied which is specified as part of the equipment Do not use any other type of mains adapter with this instrument Refer to Section 13 for the stock number of the adapter The audiometer is for indoor use only and should be used only as described in this manual The transducers supplied with the audiometer are specifically calibrated with it if these transducers are changed calibration will be required Do not immerse the unit in any fluids See Section 9 of this manual for the proper cleaning procedure for the instrument and its accessories Do not use the instrument in an oxygen rich environment or in the presence of a flammable anaesthetic mixture or other flammable agents Do not drop or otherwise impact this instrument If the instrument is dropped or damaged return it to the manufacturer for repair and or calibration Do not use the instrument if any damage is suspected The instrument must be stored and used within the specified temperature pressure and humidity ranges see Sections 8 and 10 Do not attempt to open modify or service the instrument Return the instrument to the manufacturer or distributor for all repair and servicing requirements Opening the instrument will void the warranty 2 2 Electromagnetic Compatibility EMC Considerations Medical electrical equipment needs special precautions reg
35. r test see Section 4 4 an additional test at 1kHz is carried out at the end of the test and compared with the original test result at this frequency lf the two results differ by 10dB or less then the second result is recorded as the threshold at 1kHz and the test continues lf the two results differ by more than 10dB the following dialogue box is displayed No correlation on repeat e Stop test retry frequency or continue The operator can choose to stop the test Abort retry the repeat frequency Retry or skip the repeat frequency and continue the test Ignore If the Ignore option is selected the second result is recorded as the threshold at 1kHz 4 5 8 USB Lead Disconnected If the cable connecting the PC850 to the PC becomes disconnected any automatic test running will cease It may take the audiometer a few moments before the test stops It may be possible to select control buttons and menus options in the PC850 window on the PC but these will have no effect Reconnecting the USB lead will also have no effect Depending on the task in process when disconnection occurred one or more error messages may be displayed for example OMO015 9 Amplivox PC850 Operating Manual Page 17 No patient response 2 Stop test retry frequency or continue If possible use the File gt Exit drop down menu selection at the top of the PC850 window This should close the PC850 window and return to Audibase Fur
36. r to Section 5 2 2 Click the Bekesy test icon the icon will then be highlighted pa OMO015 9 Amplivox PC850 Operating Manual Page 11 Alternatively use the Test gt Bekesy drop down menu selection at the top of the PC850 window To run a Bekesy test click the Run selected test icon E and confirm the operation by clicking Yes in the Run Test dialogue box The Bekesy test will run according to the test options selected see Section 4 4 with the test status indicated at the bottom left of the PC850 window The time available for the patient to respond in Bekesy mode is from the point the tone is presented until the point when the next tone in the sequence is presented The test will proceed and conclude as described in Section 4 3 4 Remember to save the data in Audibase to retain it in the database or Cancel Insert Edit if the data is to be discarded refer to the Audibase operating manual 4 3 7 Single Frequency Testing This option allows an automatic test at a single frequency to be repeated for example if the full automatic test has been unable to record a threshold Use the Test gt One freq test drop down menu selection at the top of the PC850 window to select the single frequency from those available for testing An automatic test at that frequency will be performed and the test will proceed and conclude as described in Section 4 3 4 Remember to save the data in Audiba
37. se to retain it in the database or Cancel Insert Edit if the data is to be discarded refer to the Audibase operating manual 4 3 8 Mixed mode Testing This allows manual readings to be inserted at frequencies at which an automatic test has been unable to establish a threshold In these circumstances the automatic test would finish with the following dialogue box displayed Test Finished Test sequence complete with errors Click OK and note the frequencies at which thresholds were not established Return to the audiometer and use it to manually determine thresholds at these frequencies refer to Section 5 It will be easier to do this if any previous displayed results the retained thresholds have been cleared see Section 5 2 2 Page 12 OMO015 9 Amplivox PC850 Operating Manual When the required manual test results have been established on the audiometer click the Select insert manual readings icon the icon will then be highlighted e Alternatively use the Test gt Mixed drop down menu selection at the top of the PC850 window To transfer the combined thresholds to Audibase click the Run selected test icon and confirm the operation by clicking Yes in the Run Test dialogue box A further dialogue box will open Stored audiogram number cos In this case leave Current readings selected click on OK and the combined data will be transferred to Audibase The PC85
38. t rely on BASIC INSULATION only but in which additional safety precautions such as DOUBLE INSULATION or REINFORCED INSULATION are provided there being no provision for protective earthing or reliance upon installation conditions Type 4 IEC 60645 1 2001 Type 4 ANSI S3 6 2004 DD45 ISO 389 1 Table 2 Headphones 4 5N IS08253 1 Table 3 Earphone Sound Attenuation Characteristics Frequency Hz 8000 Environmental Operating temperature Operating humidity Atmospheric pressure Input Output Power input Patient response input Left amp Right outputs USB Maximum voltage at any output OMO015 9 Amplivox PC850 Operating Manual 15 C to 35 C 30 to 90 non condensing 700 hPa to 1060 hPa 2 5mm barrel type socket 6 3mm Jack socket 6 3mm Jack socket Type B socket 12V peak Page 23 9 Routine Maintenance 9 1 Audiometer maintenance The Amplivox PC850 audiometer is a precision instrument Handle it carefully in order to ensure its continued accuracy and service When cleaning the instrument first disconnect it from the mains supply Use a soft cloth and mild detergent to clean the instrument panel when required Refer to ISO 8253 1 for additional guidance 9 2 Transducer maintenance Before use check the transducer cables and connectors for signs of wear and or damage If you find any please replace the item immediately by contacting Amplivox or your Amplivox distributor requesting the relevant part
39. ther error messages may appear for example If possible use the use the Edit gt Cancel Insert Edit option in Audibase to discard any data and then close Audibase Depending on the task in process when disconnection occurred the audiometer may lock up and not respond to the controls If possible attempt to switch off the audiometer as described in Section 3 2 Then remove the power from the audiometer for several seconds The PC850 may then be reconnected and Audibase started as usual 4 5 9 Accidental Closure of PC850 Program lf the PC850 program is closed while an automatic test is running the test will end and the No results message will be displayed in Audibase see Section 4 5 5 It will be necessary to switch the audiometer off and on see Section 3 2 Clear any test results and re start the test 5 Using the Audiometer Manual Testing Manual testing with the audiometer in standalone mode may be carried out with or without the connection to the PC If an automatic test has been launched by Audibase then manual testing is not possible until this has concluded 5 1 Audiometer display On start up the display will show the following default setting SIGNAL dBHL FREQUENCY Hz 30dB 1kHz lt gt lt gt This indicates that when the PRESENT key is pressed a tone will be presented at 30dBHL at a frequency of 1kHz to the indicated ear On start up the audiometer defaults to the left ear Page 18 OMO015 9 Am
40. tion is active TALK OVER Hold this key to interrupt the test and route the operator s voice from the front panel microphone to the headset the level is adjusted with the SIGNAL 7 keys LEFT Press once to select the left ear the indicator above the key illuminates green if the left ear is already selected press again to store the displayed signal value as a threshold see Section 5 3 RIGHT Press once to select the right ear the indicator above the key illuminates green if the right ear is already selected press again to store the displayed signal value as a threshold see Section 5 3 SIGNAL Press the Uf keys to decrease or increase the level of the tone presented in 5dB steps to scroll through the range keep the key pressed OMO015 9 Amplivox PC850 Operating Manual Page 19 FREQUENCY Press the key to select a lower frequency and the gt key to select a higher frequency PRESENT Press to present the displayed test signal to the patient The PRESENT indicator above the display will be illuminated green during tone presentation 5 3 Threshold Retention Function This function allows the thresholds determined for each ear and each frequency to be stored and displayed for reference The operator can then review the results at the end of the test and record them on an audiogram card transfer them into the internal memory see Section 5 4 or transfer the results into the Amplivox Audibase application see Sections 4 3 9
41. vel for that frequency Either mark the threshold on an audiogram card or press the appropriate ear key once to activate the Threshold Retention Function and save the threshold level on screen 7 Proceed to the next test frequency It is common practice to test the frequencies in the following order 1k 2k 3k 4k 6k 8k and 500 Hz 8 Repeat steps 2 to 8 for the other ear OMO015 9 Amplivox PC850 Operating Manual Page 21 5 7 4 Post test 1 Use the Threshold Retention Function to review the results See 5 3 2 If required do one or more of the following Record the results on an audiogram card or Save the results to the internal memory Section 5 4 or Transfer the results to a computer Sections 4 3 9 or 5 6 Refer to Section 5 2 2 to clear the thresholds at the end of a test and if required switch off the audiometer 6 Specification 6 1 Output data Outputs Left amp Right earphone Frequency range 250Hz 8kHz see Section 6 2 Frequency accuracy lt 1 Distortion lt 2 Output level range 10dBHL min 100dBHL max all frequencies Output level accuracy Within 3dB Output level step size 5dB Output transducer AC DD45 earphones supplied Tone present Single tone Communication Integral talk over facility USB interface Interface to PC PC850 amp Audibase software 6 2 Physical Data Display 2 lines of 24 characters Mains power 100 240Vac 50 60Hz 0 4A Dimensions 2 0mm W x 175mm
Download Pdf Manuals
Related Search