Welch Allyn MicroTymp 3 Handle Directions For Use Manual Download Page 11

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Directions for use

Introduction

tificatio

symbols

Meets essential requirements of European
Medical Device Directive 93/42/EEC

74227

Complies with applicable U.S. and
Canadian medical safety standards

Class I equipment, Type BF
(Handle)

European regulatory manager

Class I equipment, Type B
(Printer/Charger)

0297

Miscella

s symbols

Reorder number

Manufacturer

Serial number

REF

Summary of Contents for MicroTymp 3 Handle

Page 1: ...MicroTymp 3 portable tympanometric instrument Directions for use...

Page 2: ...oftware may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and o...

Page 3: ...est 17 Obtaining a tympanogram 17 Select a probe tip 17 Start a test 17 Store and display data 20 Erase memory contents 20 Change the default frequency 20 3 Understanding the LCD messages 23 Company i...

Page 4: ...panogram section 42 Data section 43 Interpretive messages section 43 Select printout formats 44 Change from manual to automatic printout 45 Change printout format 45 Printer function messages 47 Print...

Page 5: ...environment 65 Storage environment 65 Battery 65 Probe tips 65 Printer paper 66 Printer Chargers 66 Operating ranges 66 Equivalent units and symbols 66 Standards compliance 67 Disposal of non contami...

Page 6: ...vi Contents Welch Allyn MicroTymp3 portable tympanometric instrument...

Page 7: ...this manual to or on the order of a licensed physician Using this device s 226 Hz and 1000 Hz tympanometry settings you can quickly and easily obtain objective results supporting diagnosis of otitis m...

Page 8: ...t 0297 IEC TYPE 3 Skaneateles Falls NY USA US Pat 5 383 097 ANSI TYPE 4 Patent Pending C US 74227 23650 REF ON CTS ON OFF 1 2 3 4 ON CTS ON OFF 1 2 3 4 72910 REF Lithium Ion Liquid Crystal Display LCD...

Page 9: ...box POWER indicator CHARGE indicator FEED button PRINT button Paper slot Paper access cover Charging well for MicroTymp 2 or 3 Card holder with 1000 Hz screening results cards IEC power cord receptacl...

Page 10: ...bols POWER indicator FEED button CHARGE indicator PRINT button TEST button RIGHT memory button Gradient width adult LEFT memory button Gradient width child Switch options ON OFF symbol TEST R GR A L C...

Page 11: ...opean Medical Device Directive 93 42 EEC 74227 Complies with applicable U S and Canadian medical safety standards Class I equipment Type BF Handle European regulatory manager Class I equipment Type B...

Page 12: ...1 1 if additional devices are connected to the MicroTymp Handle WARNING Improper handling or disposal of the battery can lead to heat generation smoke bursting or fire WARNING Do not disassemble modif...

Page 13: ...e that the Printer Charger is receiving power Set up the handle Install the rechargeable battery in the handle as follows 1 Unscrew the battery cover in a counterclockwise direction using the 1 Philli...

Page 14: ...battery lightly to compress the contact and lower the battery into the compartment 4 Replace the cover by inserting the tip end under the front cover lowering the opposite end and replacing the screw...

Page 15: ...place the Handle with battery installed into the Printer Charger charging well with the LCD and buttons facing you 2 Leave the Handle in the well for a minimum of 16 hours to achieve a full charge Yo...

Page 16: ...16 Introduction Welch Allyn MicroTymp3 portable tympanometric instrument...

Page 17: ...nto the probe making sure that the tip is fully seated Start a test 1 Pick up the handle and press any button The Welch Allyn screen will display Note Tips are not intended to be deeply inserted into...

Page 18: ...gently back to straighten the child s ear canal or up and back for adults See the image on the left below 6 While maintaining tension on the pinna press the tip firmly against the ear canal opening Se...

Page 19: ...t movement causes a leak beyond 300 daPa in 1000 Hz mode the test will be stopped but the data will be saved Note Because of changes in air pressure during a test the subject will feel slight pressure...

Page 20: ...y contents in two ways By storing a new test The device automatically erases the previous test when you store a new test By pressing either the Left or Right memory button for more than three seconds...

Page 21: ...below 5 Replace the cover by inserting the tip end under the front cover lowering the opposite end and replacing the screw 6 Tighten the screw in a clockwise direction To avoid stripping the screw th...

Page 22: ...22 Completing a test Welch Allyn MicroTymp3 portable tympanometric instrument...

Page 23: ...ate the unit s frequency options You can toggle between frequencies by simultaneously pressing both the Right memory and Left memory buttons Press to confirm selected frequency and to exit frequency c...

Page 24: ...large canal 2 5 cc Possible solutions Reposition the probe tip Perform otoscopy to check for perforated membrane or patent tympanostomy tubes Test The TEST message indicates that the test has started...

Page 25: ...e tip is clogged with cerumen Possible solutions Reposition the probe tip Perform otoscopy to check for occlusion Remove cerumen from probe tip Leak The test cannot proceed since desired pressures wit...

Page 26: ...essure is reached at 1000 Hz the PASS REFER or RETEST results will be displayed Right store Left store Test results have been stored in the designated memory location Immediately following this messag...

Page 27: ...emoved See Chapter 6 Maintenance and troubleshooting for instructions on removing and recharging the battery Range error The RANGE ERROR message indicates that a large pressure change occurred during...

Page 28: ...the Handle Appropriate charges will apply each time your tympanometer is calibrated Needs service The NEEDS SVC message appears when something has caused the tympanometer to fail an internal test The...

Page 29: ...See Service information Data Transfer When the DATA XFER message displays the device has made the data connection to the Printer Charger Any 226 Hz data stored in the Handle is now available for prin...

Page 30: ...30 Understanding the LCD messages Welch Allyn MicroTymp3 portable tympanometric instrument...

Page 31: ...a measure of the width of the tympanogram reported in decapascals daPa at 50 of static admittance Peak Ya or the tympanometric peak Given appropriate normative values tympanometric gradient is a good...

Page 32: ...elines for Screening for Hearing Impairments and Middle Ear Disorders 1990 400 200 0 200 2 0 5 0 1 0 1 GR A GR C PRESSURE daPa Ya mmho 200 Vea cc Normal static admittance and TPP Adults Normal static...

Page 33: ...usion Tympanosclerosis 400 200 0 200 2 0 5 0 1 0 1 1 5 PRESSURE daPa Ya mmho Vea 200 RIGHT EAR R Note Low Peak Ya of the middle ear is produced by space occupying lesions in various ways A lesion that...

Page 34: ...ar fixation and otosclerosis High admittance tympanograms Tympanogram with high Peak Ya Conditions which cause tympanograms with increased peak height high Peak Ya Tympanic membrane abnormalities Ossi...

Page 35: ...negative pressure is normal Negative middle ear pressure often accompanies a cold or allergies or can be a result of eustachian tube dysfunction Negative middle ear pressure is not usually associated...

Page 36: ...ear effusion Flat tympanogram with increased ear canal volume Conditions which cause flat graph and increased ear canal volume Patent tympanostomy tube Perforated tympanic membrane 400 200 0 200 2 0...

Page 37: ...appropriate age based frequency is to use 1000 Hz tympanometry for infants below four months of age 226 Hz for infants above six months of age and both frequencies for infants four to six months of a...

Page 38: ...Audiol 14 383 392 2003 Interpreting 1000 Hz results Pass A normal tympanogram will yield a PASS result The displayed numerical value represents the compensated admittance Condition which causes a PASS...

Page 39: ...e test is indicative of abnormal middle ear function most commonly middle ear effusion Retest Note You may choose to retest the patient to confirm a REFER result 400 200 0 200 2 0 5 0 1 0 1 GR A GR C...

Page 40: ...2 cc Adjustment for 0 5 cc Adjustment for 1 0 cc Adjustment for 1 5 cc Adjustment for 2 0 cc Adjustment for 2 4 cc 1200 ft 366 m 0 0 cc 0 0 cc 0 0 cc 0 0 cc 0 0 cc 0 0 cc 0 ft 0 m 0 0 cc 0 0 cc 0 0 cc...

Page 41: ...Removing the Handle from the well causes the data to be removed from the Printer Charger memory Ty m p 3 M ic ro Po rta ble Ty mp an om et ric Ins tru me nt 400 200 0 200 2 0 5 0 1 0 1 GR A GR C PRES...

Page 42: ...ections tympanogram data and interpretive messages Following is a detailed account of the information presented in each of these sections For instructions on changing the format of the printout see pa...

Page 43: ...patent tympanostomy tube Perforations can be present when Vea is normal If the numeric values are greater or less than the 90th percentile of the normative data for a child or an adult an asterisk ap...

Page 44: ...t Normal Tympanogram The computer scans the list of messages and prints the first message that applies The hierarchy is arranged so that the most clinically important message is displayed first Select...

Page 45: ...begin automatically once the Handle is placed in the well and data transfer is complete Manual Print Depress the OFF portion of the switch to select this option This causes the printout to begin only...

Page 46: ...essages Depress the OFF portion of the switch to select this option This causes the messages which interpret the tympanograms to be included on the printout OFF 1 2 3 4 1 2 3 4 OFF Tympanogram only De...

Page 47: ...LOW BATT messaged does not appear The Handle is not functioning properly Call your nearest Welch Allyn service location distributor or factory representative No Data Nothing in Memory Both right and...

Page 48: ...48 Printing 226 Hz results Welch Allyn MicroTymp3 portable tympanometric instrument...

Page 49: ...dle as follows 1 Allow the Handle to power down 2 Unscrew the battery cover in a counterclockwise direction using the 1 Phillips head screwdriver provided Save the screw 3 Remove the battery cover by...

Page 50: ...attery against the contact in the holder Push the battery lightly to compress the contact and lower the battery into the compartment 6 Replace the cover by inserting the tip end under the front cover...

Page 51: ...or off site situations where there may not be a need to print but there is a need for continuous operation A fully drained battery should be recharged overnight 16 hours Note The unit will not power...

Page 52: ...o printing can occur 1 Remove the paper access cover by pulling up on the front edge Lithium ion battery Must be recycled or disposed of properly Note Use only an appropriate heat sensitive paper or t...

Page 53: ...slot under the pinch roller making sure that the paper is centered 6 Return the paper lever to its original position and press the FEED button to advance several inches of paper beyond the pinch roll...

Page 54: ...harger by wiping it with a cloth that has been lightly dampened with 70 Isopropyl alcohol Make sure liquid does not seep into either the printer area or the charging well Clean the probe tips After ea...

Page 55: ...e the probe tip against the 0 5 cc cavity as if it were an ear Hold the handle and MicroTest Cavity carefully to prevent movement Depress the TEST button and test the cavity as you would an ear 3 Stor...

Page 56: ...against the 0 5 cc cavity as if it were an ear Hold the handle and MicroTest Cavity carefully to prevent movement Depress the TEST button and test the cavity as you would an ear 3 Store the informati...

Page 57: ...rotection circuit was not reset Place the Handle in the Printer Charger for a minimum of 10 seconds to reset the battery protection circuit Too much artifact on LCD Too much movement during test See p...

Page 58: ...light printing Repeat the test pattern to confirm any suspected printing problems If paper advances but nothing prints out check to be sure the paper is inserted properly see page 52 2 Software Versio...

Page 59: ...ult in a flat tympanogram Lateral ossicular fixation Lateral ossicular fixation may result from tympanosclerosis a complication of chronic otitis media that may involve the eardrum malleus incus and o...

Page 60: ...r disruption Disruption of the ossicular chain can range from partial interruption to complete absence of the ossicles These conditions result from the erosive effects of chronic infection trauma and...

Page 61: ...egion for service options Calibration Welch Allyn recommends that the Handle be calibrated annually Arrangements may be made by returning the registration card or by contacting Welch Allyn s Technical...

Page 62: ...eturn the instrument directly to Welch Allyn or an authorized distributor or representative Ground shipping charge to return a defective device to the nearest Welch Allyn center is included This warra...

Page 63: ...2 in 24 4 cm 9 70 in 24 6 cm 4 82 in 12 2 cm POWER CHARGE FEED PRINT TEST 400 200 0 200 2 0 5 0 1 0 1 GR A GR C PRESSURE daPa Ya mmho 200 Vea cc MicroTymp 3 Portable Tympanometric Instrument 0297 IEC...

Page 64: ...p Rate 400 daPa sec average during data acquisition period applies only at sea level Range 200 to 400 daPa Display resolution 20 daPa Accuracy 15 or 10 daPa whichever is greater Compensation Auto zero...

Page 65: ...mAh capacity All specifications are met over a battery voltage range of 3 1V to 4 2V Probe tips Five color coded sizes Extra Small Small Medium Large Extra Large Note No warm up period is required if...

Page 66: ...oustic Admittance mmho 10 8m3 Pa s Air Pressure daPa Air Pressure daPa 1 daPa 1 02 mmH2O Equivalent Volume Ve 200 Vea Pressure on LCD printout Relative Pressure ps Pressure on LCD printout pressure da...

Page 67: ...epublic of Ireland Tel 353 46 28122 Fax 353 46 28536 Disposal of non contaminated electrical and electronic equipment Directive 2002 96 EC WEEE Do not dispose of this product as unsorted municipal was...

Page 68: ...tomer or user of the MicroTymp3 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The MicroTymp3 uses RF...

Page 69: ...pital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment...

Page 70: ...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 w...

Page 71: ...m Rated Max Output Power of Transmitter W 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 33 0 01 0 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785 1 1 1667 1 1667 2 3333 10...

Page 72: ...72 Specifications Welch Allyn MicroTymp3 portable tympanometric instrument...

Page 73: ...be Tips Four of the selected size in a bag Box with two sets of tips MicroTymp 2 and 3 Paper Spindle for Paper Card Holder 2 0 cc 0 5 cc MicroT est CA VITY 72910 REF Lithium Ion 72910 3 7 V Lithium io...

Page 74: ...Canada Japan U S 761076 4 230 V United Kingdom 761076 6 230 V Australia New Zealand 761076 2 230 V Europe TEST 400 200 0 200 2 0 5 0 1 0 1 GR A GR C PRESSURE daPa Ya mmho 200 Vea cc MicroTymp 3 Porta...

Page 75: ...tympanic membrane also called cholesteatoma lateral ossicular fixation Fixation of the malleus and or incus frequently caused by tympanosclerosis a complication of chronic otitis media middle ear eff...

Page 76: ...aPa at 50 of static admittance Peak Ya or the tympanometric peak tympanometric peak pressure The location of the tympanometric peak on the pressure axis TPP is reported in decapascals daPa tympanometr...

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