Manuel-Technique-Oto..
Contents
1. Otowave 102 Service Manual v 3 Page 17 Measurement modes Ipsilateral Reflex tone levels and accuracy 500 1000 2000 and 4000 Hz 0 1 configurable up to 100 dB HL 2 dB referenced to 2 ml calibration volume Reflex measurement range and accuracy 0 01 ml 0 5 ml 0 01 ml relative accuracy Number of reflex levels 4 in 5 dB or 10 dB steps Reflex analysis Reflex pass fail at each level tested maximum amplitude of each reflex seen on printed report amp PC report pressure at which reflex was performed Pressure used for reflex measurement Pressure at Tympanogram peak or 0 daPa Always and Prompt Before Each Test modes Reflex level cut off Optionally Auto stop when reflex found Reflex threshold detection Configurable 0 01 0 50 ml in 0 01 ml increments Reflex tone duration 1 15S Number of records stored in Patient Database 30 Data storage Any recording can be stored once the tympanogram is viewed Patient Initials A Z 0 9 must be entered before storage Data held Patient Initials Tympanogram and Reflex graphs and analysis for Left Ear and or Right Ear Time and Date of recording which ears were tested whether or not the record has been printed and or sent to a PC parameters used for analysis 128 bit Globally Unique Identifier GUID Display mode Records listed in reverse chronological2. 1 kV differential mode 2 kV common mode Not applicable Not applicable Otowave 102 Service Manual v 3 Page 23 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in U for 0 5 cycle 40 Ur 60 dip in U for 5 cycles 70 Ur 30 dip in Us for 25 cycles lt 5 Ur gt 95 dip in U for 5 sec Not applicable Not applicable Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to the application of the test level Page 24 Otowave 102 Service Manual v 3 Guidance and manufacturer s declaration electromagnetic immunity 2 The Otowave 102 Tympanometer is intended for use in the electromagnetic environment specified below The customer or user of the Otowave 102 Tympanometer should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated RF IEC 61000 4 3 3 V m 80MHz to 2 5GHz 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Otowave 102 Tympanometer including cables
3. 5 Set the sound level meter to display SPL in dB with a third octave filter centred at a frequency of 250Hz Insert the Otowave probe into the 2 ml coupler 6 Select PROBE TONE from the calibration menu Select 226 Hz Select SET TONE LEVEL Press gt to show the ADJUST LEVEL screen Otowave 102 Service Manual v 3 Page 9 5 3 5 4 Use the Up and Down keys on the Otowave to adjust the level shown on the meter to 85 dB 1 dB When the level is correct press and hold Save to store the calibration setting Calibrating the reflex tone levels 1 Set the sound meter to display SPL in dB with a third octave filter centred at the frequency of interest in this case 500 Hz for Otowave102 4 2 Select REFLEX TONE from the calibration menu Select 500Hz Press Next to display the set level screen Use the UP and DOWN keys to adjust the SPL shown on the meter to between 85 0dB and 86 0dB When the level is correct press Save to store the calibration setting 3 Carry out steps 1 and 2 for the 1 KHz tone Otowave 102 1 and 102 4 Adjust the SPL to between 79 5dB and 80 5dB 4 Carry out steps 1 and 2 for the 2 KHz tone Otowave 102 4 only Adjust the SPL to between 82 5dB and 83 5dB 5 Carry out steps 1 and 2 for the 4 KHz tone Otowave 102 4 only Adjust the SPL to between 85 0dB and 86 0dB Calibrating the pressure sensors 1 Connect the instrument to the pressure meter syrin
4. 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 Otowave 102 Service Manual v 3 Page 27
5. Otowave 102 Service Manual v 3 9 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 T517 Probe tip T518 Sealing Washer T018 Test Chamber Volume 0 5 and 1 ml T10 Ear Tip Set T101 Ear Tip Otowave 6mm T102 Ear Tip Otowave 7mm T103 Ear Tip Otowave 8mm T104 Ear Tip Otowave 9 5mm T105 Ear Tip Otowave 11mm T106 Ear Tip Otowave 12 5mm T107 Ear Tip Otowave 14mm T108 Ear Tip Otowave 16mm T109 Ear Tip Otowave 18mm B132 Carrying case MANOW Amplivox Otowave Operating Manual A091 Thermal Printer c01 Thermal Printer rolls 20metres T91 ACTIiSYS Infrared USB adapter T003 Amplivox NOAH Impedance module T004 Amplivox NOAH Impedance module IrDA PC port Otowave 102 Service Manual v 3 Page 21 10 EMC Guidance amp Manufacturer s Declaration Guidance and manufacturer s declaration electromagnetic emissions environment The Otowave 102 Tympanometer is intended for use in the electromagnetic environment specified below The customer or user of the Otowave 102 Tympanometer should assure that it is used in such an Emissions test Compliance Electromagnetic environment guidance RF emissions Gro
6. general practitioners hearing aid dispensers and child health professionals The instrument performs two types of measurement Tympanometry is used to measure the compliance of the tympanic membrane and middle ear at a fixed frequency over a range of pressures Reflex tests are used to measure stapedial reflexes The Otowave measures ipsilateral reflexes and when selected reflex measurement is automatically carried out after a tympanogram is taken 1 2 Features e Automatic measurement of ear canal volume tympanic compliance peak placement of the peak and the gradient e Automatic detection of stapedial reflexes e Up to 30 dual ear patient tests can be stored in non volatile memory e Configurable settings for user preferences held in non volatile memory e Printout via an infrared link to a thermal printer e Transfer to Windows XP via an infrared IrDA link for storage and display using NOAH 1 3 Standard contents Amplivox Otowave 102 tympanometer 4x 1 5V AA Batteries UK only Test cavity Set of disposable ear tips Carrying case Operating manual Calibration certificate Warranty card Otowave 102 Service Manual v 3 Page 3 1 4 Optional accessories Portable thermal printer Amplivox NOAH3 impedance module Infra red USB Adapter Additional sets of ear tips Additional rolls of thermal printer paper 2 Principles of Operation 2 1 Compliance measurement The Otowave measures the compliance o
7. the batteries immediately see section 5 1 Powering down The Otowave is turning off because the batteries are spent Replace the batteries PUMP ERROR Cannot determine pump direction If problem persists contact Amplivox Pump fault If the fault persists contact your Amplivox service centre PUMP ERROR If problem persists contact Amplivox Measurement timed out This occurs when the ear seal check is set to THOROUGH if i The pump failed to achieve the starting pressure within 4 seconds This may be because the probe was moved in the ear ii The pressure failed to reach 400 daPa within 12 seconds Retry the test If the problem persists contact your Amplivox service centre WARNING DEVICE UNCALIBRATED One or more default values require recalibration before further tests are performed This message should never normally be seen If it persists contact your Amplivox service centre WARNING DEFAULTS RELOADED Default configuration settings reloaded Check before making new tests This message should never be seen Check all the CONFIGURATION settings before taking any measurements If the error persists contact your Amplivox service centre ERROR Transfer failed No device found ERROR Transfer failed Link was unreliable The Otowave was unable to send data to the computer See section 8 for details Page 16 Otowave 102 Service Manual v 3 W
8. Amplivox Otowave 102 Hand Held Portable Tympanometer Service Manual Firmware versions up to 1 67 Oeterrerr Amplivox Ltd 29 30 Station Approach Kidlington Oxford OXON OX5 1JD UNITED KINGDOM Tel 44 0 1865 842411 Fax 44 0 1865 841853 sales amplivox td uk www amplivox ltd uk CONTENTS Introduction MAE eee een ee ee 3 Intended applications ccccccecceeeeessececeeeeeeeeetseeeeeeeeeeesseseeeeeeeenees 3 F ature iw inin teeta enti deat ead ivie gia eedevee aides 3 Optional accessories cceccececeeeeeceeeeeeeeeeeeeeeeeeeeeeeeeeteteeeeeseneeeteees 3 Principles Of Operation ccccccccccssssseneeeeeeessssseeeeeeeeeeeesssssseeeeees 4 Compliance measurement cccceeceeeeeeeeeeeeeeeeeeeseeeeeeeeeesneeeeeees 4 Tympanogram cceeeeeseeeeeeeeeeeeeeeeeeaeeaeeaaaaaaaaeeaaeeaeeeeeeeeeeeeeeeeeeeees 4 Stapedial reflex measureMent cccccceeeeceeeeeeeeeeeeeeeeeeeeeeeeneeeetees 4 Notes on using the Otowave ccscccceeeeeeesssseneeeeeeeeeeeeeesssseneaees 5 Installing amp replacing batteries ccccccccceeeeeeeeeeeeeeeceeeesteeeeenaees 5 The proberen a aa aa Eea a EAA EAA E EEE EAA EE EE EEEE EAEE 5 Communicating with a printer cccccceeeeeeeeeeeeeeeeeeeeeeeseeeeteeaees 6 Communicating with a Computer ccceeeeeeeeeceeeeeeeeeeeeeeteeeeetaees 6 Sevicing the Otowave cccccceeseeeeeeeeeeeeeeseeeeeeseneeeseeaeeeeeesneeeeesn
9. ITHDRAW PROBE The probe has been moved during measurement Re insert the probe to repeat the test Volume outside range WITHDRAW PROBE The ear canal volume is above the 5ml This message also occurs when the probe is not properly inserted into the ear Blocked probe WITHDRAW PROBE The ear canal volume is below 0 1ml This message also occurs when the probe tip is blocked Check that the probe is correctly inserted into the ear Check that the probe is not blocked PLEASE REINSERT PROBE The seal was lost Reinsert the probe to repeat the test 8 Technical Specification 8 1 Performance Tympanometry Instrument type Meatus compensated tympanometer Analysis performed Compliance peak level in ml Pressure of same Gradient in daPa Ear Canal Volume ECV 200 daPa Probe tone levels accuracy 226 Hz 0 1 85 dB 2 dB over range 0 2 ml 5 ml Pressure levels accuracy 200 daPa to 400 daPa 10 daPa over entire range Atmospheric compensation applied at power up Ear volume measurement range and accuracy 0 2 ml 5 ml 0 1 ml or 10 over entire range whichever is greater Sweep speed Approx 3 s for tympanogram equating to approx 200 daPa s Software pump pressure limits 400 to 600 daPa Hardware pressure limits 600 to 800 daPa Number of samples stored 100 per tympanogram Reflex measurements
10. NEW TEST SELECT EAR Choose which ear s to test and start the test A tympanogram is taken followed by reflex measurements if selected On screen messages amp LEDs indicate Page 12 Otowave 102 Service Manual v 3 progress Graphical displays are shown automatically at the end VIEW THE LAST TEST SELECT EAR Recall the last stored test for the selected ear Shows the tympanogram and reflex responses if available Also allows the last test to be printed sent to a PC or saved in the internal database DAILY CHECK Shows the volume in ml measured by the probe DATA MANAGEMENT LIST RECORDS Lists the test results stored in the internal database Allows individual records to be viewed printed sent to a PC or deleted DELETE RECORDS Delete stored records Select ALL PRINTED RECORDS Delete all records that have been printed ALL SENT RECORDS Delete all records that have been sent to a PC ALL RECORDS Delete all records PRINT RECORDS Print stored records Select UNPRINTED RECORDS Print all records not previously printed ALL RECORDS Print all records SEND RECORDS TO PC Transfer records to a PC Select UNSENT RECORDS Send all records not previously sent ALL RECORDS Send all records CONFIGURATION TODAY S DATE Set the internal clock date and time Otow
11. ave 102 Service Manual v 3 Page 13 REFLEX SELECTION Select when reflexes will be measured ALWAYS MEASURE Reflexes are always measured NEVER MEASURE Reflexes are never measured ONLY IF PEAK FOUND Reflexes will be measured only if the Otowave detects a peak on the tympanogram PROMPT TO MEASURE The user is asked whether to perform a reflex at the start of each test REFLEX LEVELS Select the maximum tone level to be used for the reflex test Set to 85 90 95 or 100 dB SPL You can then set the interval between levels during the test to 5 dB or 10 dB REFLEX FREQUENCIES Choose to perform the reflex test at a 1KHz only or at 500 1000 2000 and 4000 Hz REFLEX Select the change in compliance THRESHOLD that determines that a reflex has been detected Adjustable in 0 01 ml steps from 0 01 to 0 5 ml Default 0 03 ml REFLEX AUTO If selected reflex measurement at STOP each frequency stops as soon as a reflex is found Default YES REFLEX FILTER Select either 2 Hz or 1 5 Hz The lower value smoothes the plot more BATTERY TYPE Select Alkaline or NiMH This effects the battery state display and low battery warning Page 14 Otowave 102 Service Manual v 3 POWER OFF DELAY The time before the unit turns off automatically if no key is pressed Select 90 or 180 seconds LCD CONTRAST Change the display c
12. dical connectors allow the syringe and the Otowave to be connected 3 A calibrated sound pressure level meter with a 2 ml acoustic coupler to IEC126 The meter must be capable of displaying dB SPL for the standard third octave bands A standard Amplivox 9 5mm ear tip pale Page 8 Otowave 102 Service Manual v 3 5 2 blue may be used to provide a means of connection the Otowave to the coupler as illustrated below 4 Test cavities with capacities of 0 2ml 1ml and 5ml These are obtainable from Amplivox Ltd The 1ml test cavity supplied with the Otowave may be used for calibration Calibrating the probe tone level 1 You will need the serial number of the instrument This is shown on a label inside the battery compartment It can also be found by selecting SYSTEM INFORMATION from the main menu 2 Hold down the UP and LEFT keys and turn on the Otowave Keep the keys held down while the instrument powers up 3 Scroll to the end of the main menu and select the TYMP CALIBRATION option 4 Enter the calibration code for the instrument This may be obtained from Amplivox Ltd To enter the code select the number you wish to enter and then press and hold the gt key When all four digits have been entered press and hold the gt key again and the calibration menu will be shown To delete a digit press and hold the lt key When all digits have been deleted pressing and holding the lt key will return you to the main menu
13. ees 8 Callibprationicscriccsccsceccctee cee sacbecatededesouspsbesctedsdeci cpaveniejagectecdess nczecetsted 8 Equipment required ties 21 c Acad ati ee see et ene eet eee 8 Calibrating the probe tone level cccceececeeeeceeeeeeeeeeeesseeeeeeees 9 Calibrating the reflex tone levels ccccccccceeeeeeeeeeeeeeeeeeeteeeetees 10 Calibrating the pressure SCNSOSS cccceceeeeeeeeeeeeeeeeeeeeeteeeeeees 10 Volume Calibration ccececccceeeeeeessseeceeeeeeeeeeeeestseeeeeeeeeeestsseeeaeees 11 Set the calibration dates ccccecccceeeeeeeeeeeceeeeeeeeeeeeeeeseeeeeseeeeees 12 Men SUMM APY iccciectocvccesdecseseilecwedecceseecniceceedeeceavennseccvereessnuesnuedeve 12 Maim menti ch asset A ose Satria a a tne etic 12 Sub Menu Selections ccccesesceceeeeeceeeeeeeeeeeeeeeeeeeseeeceeeesneeeees 12 Error MOSSAGCS s EAE 15 Technical Specification ccccccsecceeeeseeeeeeseeeeeeeeeeeeeeseeeeeeeeeenees 17 Performance ssrin aiee ii ai 17 Equipment classification ccccccccccccsssssseeeeeeeessesseeeeeeesssesnaaeees 20 Aan 0a E ce AA A AE E E 20 Ordering Consumables and Accessories ccceeeteeeeeeeeeeeees 21 EMC Guidance amp Manufacturer s Declaration ccesss 22 Otowave 102 Service Manual v 3 Page 1 Page 2 Otowave 102 Service Manual v 3 1 Introduction 1 1 Intended applications The Amplivox Otowave is designed for use by audiologists
14. ert the probe firmly into the 1 ml calibration cavity Make sure the probe is square to the cavity Press gt to start the calibration measurement After a short while the Insert probe into 5ml cavity message is displayed 4 Insert the probe firmly into the 5 ml calibration cavity Make sure the probe is square to the cavity Press gt to start the calibration measurement Otowave 102 Service Manual v 3 Page 11 5 6 After a short while the display returns to the calibration menu 5 The volume calibration can be confirmed by selecting DAILY CHECK from the main menu and verifying that the calibration cavities are measured correctly Errors are usually a result of the probe not being inserted into the test cavity correctly and can usually be cleared by repeating the volume calibration Set the calibration dates 1 Select SET CAL DATE from the calibration menu This sets the last calibration date to the current date and the next calibration date one year a head 2 If you want a calibration interval other than one year select NEXT CAL DATE from the calibration menu You can then set the next calibration date manually 6 Menu summary Default values are shown in bold 6 1 Main menu Menu Sub menu MAIN MENU NEW TEST VIEW THE LAST TEST DAILY CHECK DATA MANAGEMENT CONFIGURATION SYSTEM INFORMATION 6 2 Sub Menu selections Sub menu Option Choices Description
15. f the tympanic membrane and middle ear by playing a continuous 226Hz tone into the ear canal at a level calibrated to give 85dB SPL into a 2ml cavity The sound level this produces in the ear canal is measured using a microphone and the compliance calculated from the result In line with normal audiometric practice compliance is displayed as an equivalent volume of air in ml 2 2 Tympanogram To record the tympanogram the compliance is measured while the air pressure in the ear canal is varied from 200daPa to 400daPa by means of a small pump The compliance peaks when the air pressure is the same on both sides of the tympanic membrane The changing compliance with pressure is displayed as a graph 2 3 Stapedial reflex measurement Using the same principle it is also possible to establish whether a Stapedial reflex is present In this case the 226Hz tone is used to measure the compliance of the ear while a tone at a different frequency is presented Where the reflex is elicited the stapedial muscles respond causing the tympanic membrane to become stiffer More probe tone sound energy is reflected back into the ear and the measured ear volume as determined from the microphone signal appears to get smaller This change in volume is shown as a plot of compliance in ml against time The stapedial reflex is measured at the static ear canal pressure that produces the maximum membrane compliance so reflex measurements are taken after the tym
16. ge arrangement 2 Select PRESSURE LEVELS from the calibration menu The Set pressure to 400 daPa message is displayed 3 Slowly pull back the syringe plunger until the pressure meter reads 400 daPa 0 05 daPa The pressure reading should be stable between these limits If the pressure falls there is a problem with the instrument that must be investigated Press gt to save the pressure calibration setting Page 10 Otowave 102 Service Manual v 3 The Set pressure to 200 daPa message is displayed 4 Push the syringe plunger slowly in until the pressure meter reads 200 daPa 0 05daPa The pressure reading should be stable between these limits If the pressure falls there is a problem with the instrument that must be investigated Press gt to save the pressure calibration setting The Expose to atmosphere message is displayed 5 Disconnect the instrument from the pressure meter Press gt to save the calibration setting 5 5 Volume calibration 1 Select PROBE TONE from the calibration menu Select 226 Hz Select VOLUME CALIBRATION Press gt start the calibration sequence The Insert probe into 0 2 ml cavity message is displayed 2 Insert the probe firmly into the 0 2ml calibration cavity Make sure the probe is square to the cavity Press gt to start the calibration measurement After a short time the Insert probe into 1ml cavity message is displayed 3 Ins
17. obe boss A small seal will be found in the base of the probe tip This should be examined and replaced if it is damaged When replacing the tip ensure that the seal is correctly inserted with its flat aligned with the flat on the probe tip Push the probe tip over the boss and replace the nose cone Make sure that the nose cone is screwed home firmly but do not over tighten Do not use any tools to tighten the nose cone 3 3 Communicating with a printer The designated thermal printer is supplied correctly configured for communication with the Otowave If for any reason you need to change the configuration instructions are given in the printer manual Option 4 RS232 Baud Rate Setting Number 4 2400 baud The Otowave sends data to the printer through the small window to the right of the probe The data is received through the window in the front of the printer below the on off switch The Otowave should be placed on the desk 10 20cm in front of the printer with the two communication windows in line and pointing directly at each other Both units must be out of direct sunlight for good communication The infra red link must not be broken once printing has started If the printer or Otowave are moved or something comes between them the printed results will be corrupted If this happens press lt to cancel printing and turn the printer off Turn the printer on again and restart printing 3 4 Communicating with a computer The Otowa
18. ontrast 0 14 Default 8 EAR SEAL CHECK Select QUICK or THOROUGH See section 5 3 REPORT CAL DATES Select PRINT CAL DATES or HIDE CAL DATES HOSPITAL NAME Allows the Hospital name to be entered and appear at the top of the print out DEPARTMENT Allows the Department name to be entered and appear at the top of the print out RELOAD DEFAULTS The options above are reset to their default values SYSTEM INFORMATION Shows Battery voltage Software version Date calibrated Next calibration date Number of stored records Current date and time 7 Error messages Message Meaning Action PROBE NOT CLEAR Please ensure the probe is not blocked or obstructed Examine the probe tip for blockages If necessary take it off and clean or replace it see PUMP ERROR Unknown pump fault Restart the unit If problem persists contact Amplivox section 5 3 If the problem persists contact your Amplivox service centre WARNING CALIBRATION EXPIRED Recalibration needed before further tests are performed The current date is later than the next calibration date Check that the clock is set to the correct date If so arrange for the instrument to be recalibrated Tests can still be performed Otowave 102 Service Manual v 3 Page 15 WARNING BATTERIES LOW Replace batteries before performing new tests Replace
19. order latest first with indication of data stored as described above Real Time Clock Time stamps Time and date stamp applied to all recordings and to the last calibration date Backup power supply gt 30 days without main batteries fitted Page 18 Otowave 102 Service Manual v 3 Printing Supported printer MCP8830 Interface Infra red IrDA hardware 9600 baud Information printed Space for patient amp clinician s details Tympanogram analysis parameters Tympanogram Reflex analysis parameters Reflex graph Serial Number of device Last and Next Due Calibration dates Serial Interface to PC Interface OBEX Object Exchange service running on top of IrDA stack Auto selects rate between 9600 115200 baud Serial Interface to PC Information sent Patient header full left and right ear data Power Supply Battery Types 4 Alkaline AA Cells or 4 NiMH rechargeable NiMH batteries which must be of greater than 2 3 Ah capacity Warm up period None at room temperature Number of recordings from one set of cells Approx 200 Alkaline or 100 NiMH Auto power off delay 90 or 180 S Idle current 90 mA Current while testing 270 mA Physical Display 128 x 64 pixels 8 lines of 21 characters Dimensions 190mm long x 80mm wide x 40mm high excluding probe 210mm long including probe Weight withou
20. panogram is measured when the peak compliance Page 4 Otowave 102 Service Manual v 3 pressure has been established The reflex stimulus sound pressure level SPL is increased in steps until the change in compliance exceeds a predetermined threshold The change in compliance at that level when the stimulus is applied is displayed as a plot against time 3 Notes on using the Otowave 3 1 Installing amp replacing batteries The Otowave may be powered from Alkaline AA LR6 batteries e g Duracell MN1500 or rechargeable Nickel Metal Hydride NiMH batteries Four batteries are required If the Otowave is to be used infrequently we recommend alkaline cells are fitted NiMH batteries have a high self discharge rate and are likely to need recharging if left unused for several weeks You must set which type of cell is fitted in the CONFIGURATION menu By default this is set to ALKALINE To change the setting select CONFIGURATION from the main menu and scroll to BATTERY TYPE as described later in this manual Removing the batteries does not affect the configuration the contents of the database the calibration settings or the results of the last test 3 2 The probe Otowave 102 Service Manual v 3 Page 5 The small holes through the Otowave probe tip must be kept clear If these become blocked a warning message will be displayed The tip should be replaced To remove the tip unscrew the nose cone and pull the tip off the pr
21. t batteries 285 g Weight with batteries 380 g Environmental Operating temperature range 10 C to 40 C Operating humidity range 10 90 RH non condensing Otowave 102 Service Manual v 3 Page 19 Operating atmospheric pressure 980 1040 mb range Storage temperature range 40 Cto 70C Storage humidity range 10 90 RH non condensing Storage atmospheric pressure 900 1100 mb range Standards conformance Safety EN60601 1 1990 EMC EN60601 1 2 1993 Performance EN60645 5 2005 Type 2 Tympanometer CE mark To the Medical Device Directive 8 2 Equipment classification Type of protection against electric shock Internally Powered Degree of protection against electric shock Type BF applied part Degree of protection against ingress of water Not protected Mode of operation Equipment mobility Continuous operation Portable The Otowave 102 Tympanometer is classified as a Class lla device under Annex IX Section 1 of the Medical Devices Directive It is intended for transient use as a screening tympanometer instrument 8 3 Symbols Definition Type BF equipment equipment providing a regarding allowable LEAKAGE current and reliability of the particular degree of protection against shock particularly protective earth connection if present Definition Attention consult accompanying documents Page 20
22. t was saved If you get a Device not found message while trying to send data check the following e The Otowave is pointing directly at the computers infra red receiver from no more than 20cm away e The computer has its IrDA software properly installed and the interface enabled e If the computer has been in Hibernate mode the IrDA interface is not always re enabled Try restarting your computer e The IrDA adapter on your computer is compatible with the Otowave Turn the Otowave off and on again before trying to send the data again If communication is lost while sending the data you will get a Link was unreliable message Press lt to cancel sending the data and start the operation again Otowave 102 Service Manual v 3 Page 7 If you see any other messages while sending data turn the Otowave off and then on again Try sending the data again If the problem persists contact your Amplivox service centre 4 Servicing the Otowave The Otowave 102 has no user serviceable parts inside and should be returned to Amplivox for repair 5 Calibration 5 1 Equipment required To carry out calibration of the Otowave 102 you will require the following 1 Acalibrated pressure meter capable of showing air pressure in the range 400daPa to 200 daPa 2 Ameans of applying a known pressure to the Otowave probe We recommend a 2ml syringe connected to the pressure meter with a T piece as shown below Standard me
23. than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP 80MHz to 800MHz 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 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 Otowave 102 Service Manual v 3 Page 25 Guidance and manufacturer s declaration electromagnetic immunity 2 Interference may occur in the vicinity of equipment marked with the following symbol A 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 a 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 Oto
24. up 1 The Otowave 102 Tympanometer uses RF CISPR 11 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause interference in nearby electronic equipment Bi Ginissions Class B The Otowave 102 Tympanometer is suitable for CISPR 11 use in all establishments Harmonic emissions Not including domestic applicable establishments and those l IEC 61000 3 2 directly connected to the public low voltage power supply Sa aa Not network that supplies buildings smissione applicable used for domestic purposes IEC 61000 3 3 Page 22 Otowave 102 Service Manual v 3 Guidance and manufacturer s declaration electromagnetic immunity 1 The Otowave 102 Tympanometer is intended for use in the electromagnetic environment specified below The customer or user of the Otowave 102 Tympanometer should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable Not applicable Surge IEC 61000 4 5
25. ve can send test results to a computer via an infra red link for inclusion in a NOAH database or for use by other applications If your computer does not have an infra red port you will need a suitable infra red adapter The Otowave has been tested with the Actysis ACT IR2000U USB adapter and we recommend that you use this device This may be purchased from Amplivox Page 6 Otowave 102 Service Manual v 3 Please refer to the operating manual for your Amplivox Otowave module for NOAH to ensure that all necessary software is correctly installed on your computer The Otowave sends test results to a computer through the small window to the right of the probe The Otowave should be placed on the desk 10 20cm from the computers infra red receiver and pointing directly at it The receiver and the Otowave must be out of direct sunlight to ensure good communication The transmitted results are placed in a folder called Amplivox By default this is placed on the current users desktop If the folder already exists subsequent data will be saved in folders called Copy 1 of Amplivox Copy 2 of Amplivox and so on Each test is stored in a separate file within the folder Files are named thus nnn_DDMMYYYY_HHMM APX where nnn is the identifier entered when you stored the test in the tympanometer see section 6 or xxx if no identifier is available DDMMYYYY is the date the measurement was saved and HHMM is the time the measuremen
26. wave 102 Tympanometer is used exceeds the applicable RF compliance level above the Otowave 102 Tympanometer should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Otowave 102 Tympanometer over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 26 Otowave 102 Service Manual v 3 Recommended separation distances between portable and mobile RF communications equipment and the Otowave 102 Tympanometer The Otowave 102 Tympanometer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Otowave 102 Tympanometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Otowave 102 Tympanometer as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter Separation distance according to frequency of transmitter m 150 kHz to 80 80MHzto800 800 MHzto 2 5 WwW MHz MHz GHz d 1 2VP d 1 2 P 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 23 10 3 8 3 8 73 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres
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