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Welch Allyn MicroTymp® 4 Tympanometer User Manual

DIR 80024157 Ver A

Page 44

QUIPMENT CLASSIFICATION

The Welch Allyn MicroTymp 4 Tympanometer is classified as a Class IIa device under Annex IX
(Section 1) of the EU Medical Devices Directive.

Type of protection against electric shock

Internally Powered

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

UDIOMETRIC

TANDARDS

The Welch Allyn MicroTymp 4 Tympanometer is designed to meet or exceed the Aural
Impedance/Admittance Instrument Standard Requirements - Type 2 listed below.

ANSI S3.39 Specification for Instruments to measure Aural Acoustic Impedance and Admittance
(Aural Acoustic Immittance)

IEC 60645-5 Electroacoustics - Audiometric Equipment – Instruments for the measurement of
aural acoustic impedance/admittance

ISO 389-2 Reference Equivalent Threshold SPLS for Pure Tones and Insert Earphones

Содержание MICROTYMP 4

Страница 1: ...4341 State Street Road Skaneateles Falls NY 13153 www welchallyn com WELCH ALLYN MICROTYMP 4 HAND HELD PORTABLE TYMPANOMETER USER MANUAL...

Страница 2: ...product in accordance with the instructions cautions warnings or statement of intended use published in this manual For information about any Welch Allyn product contact Welch Allyn Technical Support...

Страница 3: ...cautions ix Electromagnetic compatibility EMC considerations x Warranty xi Recycling Disposal xi Introduction 1 Indication for Use 1 Intended Use 1 Contraindications 2 Description and Operating Princi...

Страница 4: ...tions 9 Configuration 10 Test sequence 12 Ear seal check 12 Reflex levels 12 Reflex frequencies 12 Reflex selection 12 Reflex threshold 12 Reflex auto stop 12 Reflex polarity 13 Reflex filter 13 Set T...

Страница 5: ...t records 26 Delete records 27 Print records 27 Performing Daily Checks 28 Routine Maintenance 30 Cleaning the MicroTymp 4 30 Eartip and Probe 30 Calibration and Repair of the Instrument 31 Error Mess...

Страница 6: ...Allyn MicroTymp 4 Tympanometer User Manual DIR 80024157 Ver A Page iv Electromagnetic Compatibility 45 Electrical Safety EMC and Associated Standards 45 Appendix Use with Non medical Electrical Equipm...

Страница 7: ...ndard audiology texts for the theory and application of the screening tests provided by this instrument MANUAL CONVENTIONS Throughout this manual the following meaning of warnings cautions and notices...

Страница 8: ...ymbol for SERIAL NUMBER Regulatory Product Identifier RPI number Welch Allyn Part Number Return to Authorized Representative Special disposal required Symbol for European Representative Symbol for Man...

Страница 9: ...iption This side up Follow Instructions for Use Consult the operating instructions directions for use A copy of the operating manual is available on this website www welchallyn com mt4 A printed copy...

Страница 10: ...ge current and patient auxiliary current The applied part is the ear tip Definition The output from the mains AC adapter is Direct Current Definition Class II equipment equipment in which protection a...

Страница 11: ...safety and IEC 60601 1 2 for EMC the tympanometer 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...

Страница 12: ...e influenced by significant changes in elevation and pressure See Daily Check section for more information Do not attempt to open modify or service the instrument Return the instrument to the manufact...

Страница 13: ...hese parts are only guaranteed against faulty materials or manufacture THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHA...

Страница 14: ...utomatic detection of stapedial reflexes Up to 32 dual ear patient tests can be stored in non volatile memory Configurable settings for user preferences held in non volatile memory Printout of data to...

Страница 15: ...robe contains one microphone two receivers and an air channel One of the receivers is used for probe tone signal The second receiver is used for the acoustic reflex stimulus signal The microphone meas...

Страница 16: ...tes a reflex and the change in admittance at that level when the stimulus is applied is displayed as a plot against time The acoustic reflex is measured at the static ear canal pressure that produces...

Страница 17: ...original shipping carton Please check the contents of the shipping carton against the delivery note to make sure that all items ordered have been included If anything is missing please contact the di...

Страница 18: ...tput lead from the adapter into the power socket on the rear of the instrument cradle Switch on the mains supply the indicator on the adapter will illuminate green The mains adapter is the mains disco...

Страница 19: ...r These parts have been tested for use with the Welch Allyn MicroTymp 4 tympanometer for compliance with the standards IEC 60601 1 and IEC 60601 1 2 The use of accessories other than those specified m...

Страница 20: ...internal pump will operate To switch off again press and hold the On Off key for a few seconds Press the up and down navigation keys to scroll through the menus or set values Press the right navigatio...

Страница 21: ...rted Slow flash Off Taking a measurement HANDSET PROBE The probe tip must be fitted with a new ear tip before it is presented to a patient s ear canal The ear tip must be fitted completely to the prob...

Страница 22: ...internal tests are performed and the pump is initialized When the start up sequence is complete the MAIN MENU is displayed The LCD display shows the first 3 menu items with the highlight on the first...

Страница 23: ...memory after the unit is turned off Configuration Item Sweep Settings Value Options Default Value Test Sequence Both L R Both R L Both R L Ear Seal Check Standard or Extended Standard Reload Defaults...

Страница 24: ...YY and HH MM SS Date currently set Power Off Delay 90 or 180 seconds 90 seconds LCD Contrast Change using Up Down keys Mid range Report Cal Dates Print or Hide Print Date Format DD MM YY or MM DD YY...

Страница 25: ...set between 85dBHL 100dBHL with a step size of 5dB plus the option for 10dB step size at 100dBHL Press the key to confirm the selection or the key to cancel REFLEX FREQUENCIES Use the key to scroll th...

Страница 26: ...keys to change this duration between 90 and 180 seconds and press the key to confirm and save the selection or the key to cancel LCD CONTRAST Use the and keys to change the contrast of the LCD screen...

Страница 27: ...press and briefly hold the key to cancel RELOAD DEFAULTS The settings for the device may be returned to the factory defaults The Sweep Reflex or System settings may be returned separately to the fact...

Страница 28: ...contraindications are present The latter would include obstruction of the external ear canal due to excessive wax and or hairs both of which would need to be removed Tympanometric and reflex testing...

Страница 29: ...be advised to remain still and avoid speaking or swallowing while the probe is applied to the ear A typical tympanogram measurement and reflex test is carried out as follows From the MAIN MENU select...

Страница 30: ...DIR 80024157 Ver A Page 17 TESTING LEFT EAR INSERT PROBE Cancel Place the ear tip into the ear canal to obtain a seal and the following messages will be displayed TESTING LEFT EAR Equalizing Pressure...

Страница 31: ...using the eartips to create a seal the alternative EXTENDED option may be helpful This checks that a range of pressures will be available before starting a test by means of a visual indication of the...

Страница 32: ...and other reflex test options may be changed in the CONFIGURATION menu Before starting the reflex test the ear canal pressure will be set to the value that gave the peak admittance during the tympano...

Страница 33: ...test was carried out the results will now be displayed The display shows The frequency of the reflex stimulus if a reflex was found otherwise X The lowest level of tone dBHL at which a reflex was foun...

Страница 34: ...will be saved in the last test memory The results will remain available until a new test is started even if the MicroTymp 4 is turned off If both ears were chosen for test the entire sequence will no...

Страница 35: ...will be erased as soon as a new test is started Test results should be saved to the internal database or printed to ensure that data is not lost ERROR MESSAGES The following error messages may be seen...

Страница 36: ...o used as the reference for the patient s name on the printed record and for data transferred to a computer The identifier would typically be the patient s initials and as the tympanometer uses a comb...

Страница 37: ...atabase is full when attempting to save a test MEMORY IS FULL MANAGE RECORDS OVERWRITE OLDEST Back Select Selecting MANAGE RECORDS will display the DATA MANAGEMENT menu which provides options for prin...

Страница 38: ...automatically although reference should be made to the appropriate guidance notes below Connect the printer to the MicroTymp 4 cradle using the supplied cable With the device located in the cradle pri...

Страница 39: ...NAGEMENT LIST RECORDS DELETE RECORDS PRINT RECORDS Back Select LIST RECORDS is used to work with the record of an individual test All other options operate on groups of records LIST RECORDS LIST RECOR...

Страница 40: ...ROCESS RECORD menu will be displayed This accesses the following functions View the selected record Print the selected record Delete the selected record DELETE RECORDS DELETE RECORDS allows a group of...

Страница 41: ...n the main menu DAILY CHECK INSERT PROBE Cancel Wait until INSERT PROBE is displayed Insert the probe without an ear tip into the hole at the 2ml end of the test cavity Make sure that the probe is pus...

Страница 42: ...ment Slight weather related barometric pressure changes will usually yield volume readouts with 0 1 ml of the expected cavity value but barometric pressure changes due to elevation can be more signifi...

Страница 43: ...he accuracy of all operating functions CAUTION The device is not heat resistant Do not autoclave The MicroTymp 4 is a precision instrument Handle it carefully to ensure its continued accuracy and serv...

Страница 44: ...base of the probe tip This should be examined and replaced if it is damaged Do not remove the nut securing the boss to the body of the instrument CAUTION The sealing washer should be replaced when the...

Страница 45: ...turned to the Welch Allyn distributor for service and repair There are no user serviceable parts within it When packing the instrument for shipping please use the original shipping carton and packing...

Страница 46: ...emove it and clean or replace it If the problem persists contact your Welch Allyn service center AIRFLOW ERROR Unknown pump fault Restart the unit If problem persists contact Welch Allyn WARNING CALIB...

Страница 47: ...k all the CONFIGURATION settings before taking any measurements If the error persists contact your Welch Allyn service center WITHDRAW PROBE The probe has been moved during measurement Re insert the p...

Страница 48: ...OBE TIP STARTER KIT 93730 MICROTYMP 4 PROBE FLOSS CLEANING KIT 93740 MICROTYMP 4 PROBE TIP AND GASKET KIT 93750 MICROTYMP 4 TEST CAVITY 93760 MICROTYMP 4 CARRY CASE 93790 X MICROTYMP 4 DFU QUICK START...

Страница 49: ...style disposable ear tips 39422 15 025 39422 15 100 15 mm mushroom style disposable ear tips 39422 19 025 39422 19 100 19 mm mushroom style disposable ear tips APPENDIX MENU SUMMARY Default values ar...

Страница 50: ...e used for the reflex test Default is 95dBHL with 5dB steps REFLEX FREQUENCIES Selectable from 500 1000 2000 and 4000 Hz REFLEX SELECTION ALWAYS MEASURE NEVER MEASURE ONLY IF PEAK FOUND PROMPT TO MEAS...

Страница 51: ...S The options in this group are reset to their default values SELECT LANGUAGE Select ENGLISH GERMAN FRENCH SPANISH PORTUGUESE or ITALIAN for operating language CONFIGURATION RELOAD DEFAULTS All config...

Страница 52: ...ALL SENT RECORDS Delete all records that have been sent to a computer ALL RECORDS Delete all records PRINT RECORDS Print stored records Select UNPRINTED RECORDS Print all records not previously print...

Страница 53: ...ver is larger over range Ear volume measurement range and accuracy 0 2ml to 5ml 0 1ml or 5 whichever is larger over entire range Sweep speed Typically 200daPa sec dependent on ear cavity volume Pressu...

Страница 54: ...0 6 seconds Data Management Number of records stored in Patient Database 32 Data storage Any recording can be stored once the tympanogram is viewed Patient Initials A Z 0 9 must be entered before sto...

Страница 55: ...ysis parameters Tympanogram Reflex analysis parameters Reflex graph Serial Number of device Last and Next Due Calibration dates Interface to computer Interface USB Version 1 1 Information sent Patient...

Страница 56: ...0 RH non condensing Operating atmospheric pressure range 980 to 1040 mb Transport and storage temperature range 5oC to 40oC Transport and storage humidity range 30 to 90 RH non condensing Transport an...

Страница 57: ...gress of water Not protected Mode of operation Continuous operation Equipment mobility Portable AUDIOMETRIC STANDARDS The Welch Allyn MicroTymp 4 Tympanometer is designed to meet or exceed the Aural I...

Страница 58: ...cing parts sold by Welch Allyn as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the device Anyone connecting additional equipment is responsible...

Страница 59: ...Welch Allyn MicroTymp 4 tympanometer are electrically isolated to the requirements of IEC 60601 1 Socket Label Socket Type Typical Connection USB USB connector Type B Computer RJ6 socket Supplied prin...

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