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AmpliVox PC850, Operating Manual

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AmpliVox PC850 Operating Manual Download Page 5

 

 

 

 

 

 

 

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D-0116493-B (OM015) 

– PC850 Operating Manual

                                                            

 

1.

 

INTRODUCTION 

1.1.

 

THANK YOU 

Thank  you  for  purchasing  the  Amplivox  PC850  audiometer,  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.

 

This operating manual applies  to the  PC850 in combination  with  Audibase  Software Version 5.5.  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.

 

INTENDED APPLICATIONS 

This instrument is designed for use by trained personnel only, such as audiologists, ENT surgeons, doctors, 
general practitioners, hearing aid dispensers, child health professionals and hearing healthcare professionals 
with  a  similar  level  of  education.  It  is  not  recommended  to  utilize  the  equipment  without  the  necessary 
knowledge and training.  

 

1.3.

 

CONTRADICTIONS 

Always visually inspect the outer ear and the external auditory canal for abnormalities before testing. Testing 
should not be performed on patients in the following items is applicable.  

1.  The presence of other sensitivity to loud sounds may contraindicate testing when high intensity stimuli 

are used. 

2.  Recent outer ear surgery. 

 

1.4.

 

STANDARD AND OPTIONAL COMPONENTS 

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.com

).  The  required  fitting 

instructions are supplied with each part. 

STANDARD COMPONENTS 

PC850 Audiometer 

8510385 

Patient Response Switch 

8011155 

Audiometric headset & leads (DD45) 

8509615 

Approved mains adapter UES12LCP 

8512734 

HBA audiometric headband 

8010882 

Cable USB A to USB B (2.0 m) 

8011241 

USB 

stick 

with 

Software 

and 

Operating Manuals 

 

Carrying case  

8004674 

Calibration certificate 

 

 

 

 

 

Summary of Contents for PC850

Page 1: ...PC850 Operating Manual ...

Page 2: ... Audibase version 5 5 onwards This product is manufactured by Amplivox Ltd 10393 West 70th Street Eden Prairie MN 55344 United States Amplivox Ltd 3800 Parkside Solihull Parkway Birmingham Business Park Birmingham West Midlands B37 7YG United Kingdom www amplivox com For all enquiries please contact us under Tel 888 941 4208 Fax 952 903 4100 info amplivox us Tel 44 0 1865 880846 hello amplivox com...

Page 3: ...Electromagnetic compatibility EMC 11 3 3 6 Explosion hazards 11 3 3 7 Measuring Security 11 3 3 8 Miscellaneous 11 3 3 9 Use of equipment after transport and storage 12 3 4 CONNECTIONS 12 4 USING THE PC850 COMPUTER CONTROLLED 14 4 1 GENERAL 14 4 2 SWITCHING THE AUDIOMETER ON AND OFF 14 4 3 USING THE TALKOVER FUNCTION 14 4 4 STARTING THE SOFTWARE 14 4 5 AVAILABLE TEST MODES 15 4 5 1 Manual Test 15 ...

Page 4: ... 27 7 1 NO INSTRUMENT CONNECTED 27 7 2 WRONG PASSWORD 27 7 3 NO RESPONSE FROM PATIENT 27 7 4 CONTINUAL RESPONSE FROM PATIENT 28 7 5 NO RESULTS 28 7 6 ERRORS IN TEST SEQUENCE 28 7 7 INCONSISTENCY IN 1KHZ REPEAT TEST 29 7 8 USB LEAD DISCONNECTED 29 7 9 ACCIDENTAL CLOSURE OF PC850 PROGRAM 30 8 ROUTINE MAINTENANCE 31 8 1 GENERAL MAINTENANCE PROCEDURES 31 8 2 AUDIOMETER MAINTENANCE 31 8 3 HEADSET MAINT...

Page 5: ... as audiologists ENT surgeons doctors general practitioners hearing aid dispensers child health professionals and hearing healthcare professionals with a similar level of education It is not recommended to utilize the equipment without the necessary knowledge and training 1 3 CONTRADICTIONS Always visually inspect the outer ear and the external auditory canal for abnormalities before testing Testi...

Page 6: ... 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 com The required fitting instructions are supplied with each part 1 5 WARNINGS Throughout this manual the following...

Page 7: ...arting the test at 1000 Hz to then next measure the higher frequencies When done with the high frequencies 1000 Hz shall be retested and to then continue with the lower frequencies When done with the air conduction the bone conduction is being assessed In cases of unsymmetrical hearing it might be required to mask the air and bone conduction in order to prevent hearing the test tone on the opposit...

Page 8: ...proper seal and comfortable fit The leads from the headset are connected to the instrument and the headset is then fitted to the patient Patient Instructions The patient is given the following instructions Press and then release the response switch when a tone is heard In the case of Manual or Computer testing As soon as you hear the tone press and release the response switch In the case of Bekesy...

Page 9: ...f a licensed medical professional 3 2 MARKINGS The following markings can be found Symbol Explanation Type B applied parts According to IEC 60601 1 Patient applied parts that are not conductive and can be immediately released from the patient Refer to instruction manual WEEE EU directive This symbol indicates that when the end user wishes to discard this product it must be sent to separate collect...

Page 10: ...ofessionals i e ENT doctors audiologists nurses or technicians who have been trained in the proper use of the device 3 3 2 CAUTIONS GENERAL If the system is not functioning properly do not operate it until all necessary repairs are made and the unit is tested and calibrated for proper functioning in accordance with Amplivox s specifications Do not drop or in any other way cause undue impact to thi...

Page 11: ...t is recommended that the instrument be operated within an ambient temperature range of 15 C 59 F to 35 C 95 F and in relative humidity between 30 and 90 non condensing Do not use the device in the presence of fluid that can come into contact with any of the electronic components or wiring Should the user suspect fluids have contacted the system components or accessories the unit should not be use...

Page 12: ...to the appendix regarding EMC 3 3 6 EXPLOSION HAZARDS Risk of explosion Do not use in the presence of flammable anesthetics or other gases Do NOT use in the presence of flammable gaseous mixtures Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases Do NOT use the PC850 in a highly oxygen enriched environment such as a h...

Page 13: ...ORAGE Please make sure that the instrument is functioning correctly before use If the instrument has been stored in a cold environment even for short period of time please allow the instrument to become acclimatized This can take long time depending on the conditions such as environmental humidity You can reduce the condensation by storing the instrument in its original packaging If the instrument...

Page 14: ... 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 Please note 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 606...

Page 15: ...ff press the switch marked again or press and hold the MENU key followed by the YES RIGHT key and then release both 4 3 USING THE TALKOVER FUNCTION If the TALKOVER key is pressed while an automatic test is in progress the test will be paused with a dialogue box displayed as below After any necessary instruction is given to the patient and the TALKOVER key is released the operator can choose to sto...

Page 16: ...ndow The test type last used is remembered if this was a manual test the procedures may be followed if this was an automatic test the following dialogue box will be displayed 4 5 AVAILABLE TEST MODES 4 5 1 MANUAL TEST 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 retain...

Page 17: ...C850 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 frequency and so on to complete the test on both ears 4 5 4 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 usef...

Page 18: ...Additionally the message Linked is shown on the display of the audiometer To view the traces of the presented tones select the Show test detail icon Alternatively use the View Detail drop down menu option To view the audiogram thresholds select the Show Audiogram icon Alternatively use the View Audiogram drop down menu option If thresholds are established at all of the selected test frequencies th...

Page 19: ...anual 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 and confirm the operation by clicking Yes in the Run Test dialogue box A further dialogue box will open This allows either the Current readings i e the retained thresholds or the thresholds stored in one of the audiometer s internal memory locations to b...

Page 20: ...and the Response icon will change to light green when a patient response is made To view the traces of the presented tones select the Show test detail button Alternatively use the View Detail drop down menu option To view the audiogram thresholds select the Show Audiogram button Alternatively use the View Audiogram drop down menu option The order of frequencies tested assuming that all frequencies...

Page 21: ...C850 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 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 11 SINGLE FREQ...

Page 22: ...by clicking Yes in the Run Test dialogue box A further dialogue box will open In this case leave Current readings selected click on OK and the combined data will be transferred to Audibase when the PC850 window is closed 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 transferr...

Page 23: ... to the indicated ear On start up the audiometer defaults to the left ear 5 4 AUDIOMETER CONTROLS 5 4 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 MENU SELECT The use of these keys is described below 5 4 2 MENU Press and hold MENU to access the following options Use the MENU...

Page 24: ... the range keep the key pressed FREQUENCY Press the key to select a lower frequency and the 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 5 THRESHOLD RETENTION FUNCTION This function allows the thresholds determined for each ear and each frequency to be ...

Page 25: ...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 patient 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...

Page 26: ...ps until a response occurs and note this level 6 Repeat step 5 until the patient responds three out of a maximum of five times at the same signal level This indicates the patient s hearing threshold level 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 Proce...

Page 27: ... 2 out of 3 or 3 out of 5 consistent responses to generate a valid threshold o a familiarisation run prior to the test o a retest of the first frequency to be omitted including this function can prove useful in correlating test results Tone response which provides controls to determine the action to be taken on error o the number of times a frequency is repeated 0 1 2 or 3 times if an error in tes...

Page 28: ...ation Audibase functions may then be continued 7 2 WRONG PASSWORD If this error message is seen the audiometer is being used with a version of Audibase older than Version 5 5 Please refer to the documentation supplied with the previous version 7 3 NO RESPONSE FROM PATIENT If the patient does not operate the response switch and the maximum output level is reached the following dialogue box will be ...

Page 29: ...sted and move on to the next frequency Ignore 7 5 NO RESULTS If no results are available to transfer to Audibase the following dialogue box will be displayed 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 Cancel Insert Edit option...

Page 30: ...at 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 7 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 button...

Page 31: ...he controls If possible attempt to switch off the audiometer Then remove the power from the audiometer for several seconds The PC850 may then be reconnected and Audibase started as usual 7 9 ACCIDENTAL CLOSURE OF PC850 PROGRAM If 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 It will be necessary to switch t...

Page 32: ...he instrument or accessories 5 After each patient examination ensure that there has been no contamination to the parts touching the patient General precautions must be observed in order to avoid cross contamination of disease from one patient to another Water should be used for frequent cleaning but in the case of severe contamination it may be necessary to use a disinfectant Before cleaning alway...

Page 33: ...e over time We recommend that you keep theses replacement parts available 8 5 REPAIR Amplivox Ltd is only considered to be responsible for the validity of the CE marking effects on safety reliability and performance of the equipment if assembly operations extensions readjustments modifications or repairs are carried out by authorized persons a 1 year service interval is maintained the electrical i...

Page 34: ...r This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Amplivox Ltd shall not be responsible for any loss arising in connection with the purchase or use of any Amplivox Ltd product that has been repaired by anyone other than an authorized Amplivox Ltd service representative altered in any way so as in Amplivox Ltd opinion t...

Page 35: ... note The following exceptions apply The 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 ...

Page 36: ...5N Sound attenuation characteristics ISO8253 1 Table 3 9 2 INPUT OUTPUT DATA Outputs Left Right earphone Frequency range 250Hz 8kHz Frequency accuracy 1 Distortion 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 ...

Page 37: ...000 Attenuation dB 5 7 15 25 31 23 9 5 ENVIRONMENTAL Operating temperature 15oC to 35oC Storage transport temperature 20oC to 70oC Humidity operating 30 to 90 non condensing Humidity storage transport 10 to 90 non condensing Atmospheric Pressure operating 700hPa to 1060hPa Atmospheric Pressure storage transport 500hPa to 1060hPa ...

Page 38: ...ransducers and cables can be found in this appendix Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of this instrument including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result NOTICE ESSENTIAL PERFORMANCE for this instrument...

Page 39: ...stablishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic immunity 1 The PC850 Audiometer is intended for use in the electro...

Page 40: ... for 0 5 cycle 0 UT 100 dip in UT for 1 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 500ms 0 UT 100 dip in UT for 5 sec Mains power quality should be that of a typical commercial or hospital environment If the user of the PC850 Audiometer requires continued operation during power mains interruptions it is recommended that the PC850 Audiometer be powered from an uninterruptible powe...

Page 41: ... m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is aff...

Page 42: ... d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 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 manufactu...

Page 43: ...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 Computer 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 60...

Page 44: ...43 D 0116493 B OM015 PC850 Operating Manual Diagram 1 PC850 used with the medically approved mains adapter Mains Outlet Medical Mains Adapter PC850 Audiometer ...

Page 45: ...44 D 0116493 B OM015 PC850 Operating Manual ...

Page 46: ...M015 PC850 Operating Manual Copyright 2019 Amplivox Ltd All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Amplivox Ltd ...

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