Related Manuals for Welch Allyn MICROTYMP 4
Summary of Contents for Welch Allyn MICROTYMP 4
- Page 1 ® M ® 4 ELCH LLYN ICRO ORTABLE YMPANOMETER ANUAL 4341 State Street Road, Skaneateles Falls, NY 13153 www.welchallyn.com...
- Page 2 Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, or for any illegal or improper use of the product, that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual.
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Page 3: Table Of Contents
Welch Allyn MicroTymp® 4 Tympanometer User Manual TABLE OF CONTENTS TABLE OF CONTENTS ............................... i Preface ................................... v Manual Conventions ................................v Regulatory Symbols ................................vi Device Symbols ................................. viii Important Safety Instructions ............................. ix Precautions ..................................ix Electromagnetic compatibility (EMC) considerations ......................x Warranty ..................................... - Page 4 Welch Allyn MicroTymp® 4 Tympanometer User Manual Handset……… ..................................7 Handset LED Indicators ............................... 8 Handset probe ..................................8 Printer………..................................8 Operation and Configuration ............................9 Start-up and menu displays ..............................9 Main Menu Options ............................... 9 Configuration ..................................10 Test sequence ................................
- Page 5 Welch Allyn MicroTymp® 4 Tympanometer User Manual Ear tips…................................... 15 Performing a test ................................16 Ear seal check ................................... 18 Error messages ................................. 22 Saving Results in the Database ............................. 23 Data entry ..................................23 Database full ..................................24 Sending the Results to a Printer ............................
- Page 6 Welch Allyn MicroTymp® 4 Tympanometer User Manual Electromagnetic Compatibility ............................45 Electrical Safety, EMC and Associated Standards ......................45 Appendix - Use with Non-medical Electrical Equipment....................46 DIR 80024157 Ver A Page iv...
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Page 7: Preface
Welch Allyn MicroTymp® 4 Tympanometer User Manual REFACE This user manual provides information about the Welch Allyn MicroTymp 4 tympanometer. This manual is intended for technically qualified personnel. Please note: This User Manual is not intended as a training manual for tympanometry. The reader should consult standard audiology texts for the theory and application of the screening tests provided by this instrument. -
Page 8: Regulatory Symbols
Welch Allyn MicroTymp® 4 Tympanometer User Manual EGULATORY YMBOLS Symbol Description Conforms to European Medical Device Directive 93/42/EEC Symbol for "SERIAL NUMBER" Regulatory Product Identifier (RPI) number Welch Allyn Part Number Return to Authorized Representative, Special disposal required Symbol for “European Representative”... - Page 9 Welch Allyn MicroTymp® 4 Tympanometer User Manual Symbol Description 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 of the operating instructions can be ordered from...
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Page 10: Device Symbols
Welch Allyn MicroTymp® 4 Tympanometer User Manual EVICE YMBOLS The following symbols appear on the tympanometer, the instrument cradle or the mains adapter: Definition: Consult operating instructions. Definition: Type B applied part – an applied part providing protection against electric shock, particularly regarding allowable patient leakage current and patient auxiliary current. -
Page 11: Important Safety Instructions
AFETY NSTRUCTIONS WARNING The Welch Allyn MicroTymp 4 instrument must be used only by medical professionals including, but not limited to, Physicians, Physician Assistants, Nurse Practitioners, Nurses, Audiologists and Medical Technologists knowledgeable in the theory and application of the screening tests provided by this instrument. It is intended for transient use as a screening and diagnostic tool;... -
Page 12: Electromagnetic Compatibility (Emc) Considerations
Welch Allyn MicroTymp® 4 Tympanometer User Manual Do not immerse the unit in any fluids. See the Routine Maintenance Section of this manual for the proper cleaning procedure for the instrument and its accessories and the function of single- use parts. -
Page 13: Warranty
Welch Allyn MicroTymp® 4 Tympanometer User Manual ARRANTY We, Welch Allyn, warrant that this product is free from defects in material and workmanship and, when properly installed and used, will perform in accordance with applicable specifications. If within one year after original shipment, it is found not to meet this standard; it will be repaired,... -
Page 14: Introduction
NDICATION FOR The Welch Allyn MicroTymp 4 is intended to be used for the measurement of acoustic impedance/admittance within the human external ear canal. These measures are useful in the evaluation, identification, documentation and diagnosis of ear disorders. The device is intended to be used on patients of any age. -
Page 15: Contraindications
DMITTANCE MEASUREMENT The MicroTymp 4 measures the admittance of 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. - Page 16 The MicroTymp 4 can measure an acoustic reflex at any combination of 500Hz, 1000Hz, 2000Hz and 4000Hz. The maximum level for the reflex stimulus may be preset, along with the step size in dB between the three preceding lower levels of stimulus.
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Page 17: Installation
Please retain the carton and packaging as the tympanometer will need calibrating on an annual basis and should be returned to the distributor or Welch Allyn in its 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. -
Page 18: Initial Set Up
OWER SUPPLY The Welch Allyn MicroTymp 4 tympanometer is designed for continuous operation and is powered by a rechargeable Nickel-Metal Hydride (NiMH) battery-pack which is fitted in the instrument. If the instrument is placed onto its cradle the battery within it will be charged. -
Page 19: Cradle Led Indicators
For connected parts marked * only connect the parts or accessories supplied with the instrument or supplied by Welch Allyn or a Welch Allyn distributor. 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. -
Page 20: Handset
On/Off Button Press the On/Off key momentarily to turn the Welch Allyn MicroTymp 4 on (refer to the diagram above). No warm-up time is required, although a short diagnostic routine will run for a few seconds. During this time the internal pump will operate. To switch off, again press and hold the On/Off key for a few seconds. -
Page 21: Handset Led Indicators
Welch Allyn MicroTymp® 4 Tympanometer User Manual When not located in the cradle and not performing a test the Welch Allyn MicroTymp 4 will switch off automatically if no key is pressed for 90 seconds. This time may be extended to 180 seconds in the CONFIGURATION menu. -
Page 22: Operation And Configuration
TART UP AND MENU DISPLAYS When the Welch Allyn MicroTymp 4 is turned on, the start-up screen is shown while 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 item in the menu. -
Page 23: Configuration
Welch Allyn MicroTymp® 4 Tympanometer User Manual Press the down ▼ navigation keys to scroll through the menu until CONFIGURATION is highlighted and then press the right navigation key ► to select. ONFIGURATION The configuration menu contains 17 items with the values and defaults indicated in the table below. - Page 24 Welch Allyn MicroTymp® 4 Tympanometer User Manual Reflex Polarity Up or Down Down Reflex Filter 2 Hz or 1.5 Hz 2 Hz Reload Defaults Yes or No (Reflex Settings) Configuration Item Value Options Default Value (System Settings) Set Time/Date Date and time formatted selections Date currently set –...
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Page 25: Test Sequence
STOP By default, the reflex test at each frequency will stop at the lowest level of stimulus that produces a response. By setting REFLEX AUTO-STOP to NO the MicroTymp 4 will test for a reflex at all Page 12 DIR 80024157 Ver A... -
Page 26: Reflex Polarity
OWER ELAY The Welch Allyn MicroTymp 4 will switch off automatically if no key is pressed for a specified duration. Use the ▲ and ▼ 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. -
Page 27: Department
Press the ► key to confirm and save the selection or the ◄ key to cancel. ANGUAGE The Welch Allyn MicroTymp 4 supports multiple languages. To set the operating language (English, German, French, Spanish, Portuguese or Italian) use the ▲ and ▼ keys to select the language. -
Page 28: Data Collection
Welch Allyn MicroTymp® 4 Tympanometer User Manual OLLECTION WARNING Ensure that the appropriate settings have been made before carrying out a test. See the information below and the CONFIGURATION options in the previous section. RIOR TO TESTING AND MBIENT CONDITIONS... -
Page 29: Performing A Test
Welch Allyn MicroTymp® 4 Tympanometer User Manual ERFORMING A TEST Testing should be conducted in a quiet environment such as a private examination room. No specific action is required by the patient during the automatic test. However, the patient must be advised to remain still and avoid speaking or swallowing while the probe is applied to the ear. - Page 30 Welch Allyn MicroTymp® 4 Tympanometer User Manual 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 Cancel TESTING LEFT EAR...
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Page 31: Ear Seal Check
Welch Allyn MicroTymp® 4 Tympanometer User Manual AR SEAL CHECK The type of ear seal check employed at the start of a test may be set in the CONFIGURATION menu. The default STANDARD option is adequate for most circumstances, and this checks that an adequate pressure can be created in the ear canal before starting the test. - Page 32 Welch Allyn MicroTymp® 4 Tympanometer User Manual Taking a tympanogram takes about 3 seconds. It is important not to move the probe and to ask the patient to remain very still during the test. When the tympanogram is complete the instrument will perform the reflex test(s), if selected.
- Page 33 ▲ and ▼ keys to view the results for the other frequencies. If the MicroTymp 4 was set to test for a reflex at all levels of the stimulus (see Reflex Autostop) press ► to view an additional display following the reflex graphs. This shows a summary of the levels and frequencies at which a reflex was detected.
- Page 34 Welch Allyn MicroTymp® 4 Tympanometer User Manual REFLEX SUMMARY Press ◄ to return and view the tympanogram, reflex results or to repeat the test. When satisfied with the results press ►.
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Page 35: Error Messages
MAIN MENU (Return to the main menu) The results of the last test performed remain available even if the MicroTymp 4 has been turned off. To view these results select VIEW THE LAST TEST from the main menu. After selecting the required ear the tympanogram will be displayed. -
Page 36: Saving Results In The Database
Welch Allyn MicroTymp® 4 Tympanometer User Manual AVING ESULTS IN THE ATABASE To save the results of a test select SAVE RESULTS from the PROCESS RESULTS menu that is displayed on completion of a test. This option can also be accessed by selecting VIEW THE LAST TEST from the main menu and scrolling through the results using the ►... -
Page 37: Database Full
Welch Allyn MicroTymp® 4 Tympanometer User Manual To cancel saving the last test: Delete any characters that have been entered. Press and hold the ◄ key. ATABASE FULL A warning will be displayed if the database is full when attempting to save a test:... -
Page 38: Sending The Results To A Printer
ESULTS TO A RINTER The MPT-II printer is available as an option for use with the MicroTymp 4. Printing is by a cable connecting the printer to the instrument cradle. Before attempting to print ensure the printer is fully charged, switched on, loaded with paper and ready to print. If the MicroTymp 4 is in the cradle the data will be sent via the connecting cable. -
Page 39: Data Management
Welch Allyn MicroTymp® 4 Tympanometer User Manual ANAGEMENT Up to 32 patient records can be stored in the database of the Welch Allyn MicroTymp 4. Records can be listed, viewed, deleted, printed or sent to a computer using the DATA MANAGEMENT option of the main menu. -
Page 40: Delete Records
Welch Allyn MicroTymp® 4 Tympanometer User Manual Each entry shows: Three-letter patient identifier entered when the test was stored; Date and time of the test Whether the test has been printed ( Whether the test has been sent to a computer ( ) ... -
Page 41: Performing Daily Checks
Welch Allyn MicroTymp® 4 Tympanometer User Manual ERFORMING AILY HECKS The operation of the MicroTymp 4 should be checked daily using the 4 in 1 test cavity assembly supplied with the instrument. Select the DAILY CHECK option in the main menu: DAILY CHECK... - Page 42 However, it will affect the ECV and Test Cavity values. If the MicroTymp 4 is being used at an elevation greater than 1,000 ft, when new, and after each recalibration, perform a Daily Check on all 4 test cavity volumes (0.2ml, 0.5ml, 2ml & 5ml).
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Page 43: Routine Maintenance
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 service. Use a soft damp cloth and mild detergent to clean the instrument panel and case when required. -
Page 44: Calibration And Repair Of The Instrument
After replacing the tip, a Daily Check should be carried out. ALIBRATION AND EPAIR OF THE NSTRUMENT Welch Allyn recommends that the MicroTymp 4 is calibrated annually. Please contact your Welch Allyn distributor for details. Page 31 DIR 80024157 Ver A... - Page 45 Welch Allyn MicroTymp® 4 Tympanometer User Manual WARNING The instrument should be returned 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 materials.
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Page 46: Error Messages & Fault Conditions
Recharge the batteries before performing tests Other than after the specified power off delay, the Powering down MicroTymp 4 may turn off because the internal batteries are spent. To replace the batteries, contact your Welch Allyn service center. AIRFLOW ERROR. - Page 47 Welch Allyn MicroTymp® 4 Tympanometer User Manual problem persists, contact Welch Allyn “WARNING! DEVICE UNCALIBRATED. This message should never normally be seen. If it One or more default values require persists, contact your Welch Allyn service center. recalibration before further tests are performed WARNING! DEFAULTS RELOADED.
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Page 48: Ordering Consumables And Accessories
CCESSORIES To order consumables, additional accessories and to replace detachable parts that have been damaged, please contact Welch Allyn or your Welch Allyn distributor for current prices and delivery charges. Some of the items available are listed below: Part Number... -
Page 49: Appendix - Menu Summary
Welch Allyn MicroTymp® 4 Tympanometer User Manual 39422-10-025 39422-10-100 10 mm mushroom style disposable ear tips 39422-11-025 39422-11-100 11 mm mushroom style disposable ear tips 39422-12-025 39422-12-100 12 mm mushroom style disposable ear tips 39422-13-025 39422-13-100 13 mm mushroom style disposable ear tips... - Page 50 Welch Allyn MicroTymp® 4 Tympanometer User Manual progress. Graphical displays are shown automatically at the end. Select the test order for a both-ear test - CONFIGURATION TEST SEQUENCE left then right or right then left. (SWEEP SETTINGS) EAR SEAL CHECK Select STANDARD or EXTENDED.
- Page 51 Welch Allyn MicroTymp® 4 Tympanometer User Manual Use the UP/DOWN arrow keys to change LCD CONTRAST the display contrast. Select PRINT CAL. DATES or HIDE REPORT CAL. DATES CAL.DATES SET DATE FORMAT Select DD/MM/YY or MM/DD/YY HOSPITAL NAME Allows the Hospital name to be entered (this will appear at the top of the print out).
- Page 52 Welch Allyn MicroTymp® 4 Tympanometer User Manual 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 computer. ALL RECORDS – Delete all records PRINT RECORDS Print stored records.
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Page 53: Appendix - Technical Specification
Welch Allyn MicroTymp® 4 Tympanometer User Manual PPENDIX ECHNICAL PECIFICATION Tympanometry Instrument type Meatus compensated tympanometer Admittance peak level (in ml); Pressure of same; Analysis performed Gradient (in daPa); Ear Canal Volume (ECV) @ 200 daPa Probe tone levels and accuracy 226Hz +/- 2%;... - Page 54 Welch Allyn MicroTymp® 4 Tympanometer User Manual Number of reflex levels (see Acoustic Four: 100dB with 5dB or 10 dB steps; 95dB, 90dB Reflex Measurement) or 85dB with 5 dB steps Reflex pass/fail at each level tested; maximum Reflex analysis amplitude of each reflex (seen on printed report &...
- Page 55 Welch Allyn MicroTymp® 4 Tympanometer User Manual Languages Operating Languages English, German, French, Spanish, Portuguese or Italian Printing Supported printer MPT-II Interface Wired connection to cradle Information printed Space for patient & clinician’s details, Tympanogram analysis parameters, Tympanogram, Reflex analysis parameters, Reflex...
- Page 56 Welch Allyn MicroTymp® 4 Tympanometer User Manual Physical Display 128 x 64 pixels / 8 lines of 21 characters Dimensions 230mm (L) x 115mm (W) x 70mm (H) Total Weight (handset and cradle) 650g Environmental Operating temperature range C to +35...
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Page 57: Equipment Classification
Welch Allyn MicroTymp® 4 Tympanometer User Manual 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... -
Page 58: Appendix - Emc Guidance & Manufacturer's Declaration
EMC Tables available at www.welchallyn.com/emc-mt4. The Welch Allyn MicroTymp 4 has been tested for EMC emissions and immunity as a standalone instrument. Do not use the device adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. - Page 59 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 Welch Allyn at the address given on the front of this user manual if advice is required regarding the use of peripheral equipment.