OSCILLA TSM-300 Instruction Manual

ID: 1588 / ver. 205
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ID: 1588 / ver. 205
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1. GENERAL DESCRIPTION .............................................................................................................................................. 3
1.1 FRONT PANEL DESCRIPTION ............................................................................................................................................. 3
1.2 BACK PANEL DESCRIPTION .............................................................................................................................................. 4
2. OPERATION ...................................................................................................................................................................... 4
2.1 SETTING UP THE TSM-300 .............................................................................................................................................. 4
2.2 TAKING A MEASURE ........................................................................................................................................................ 4
2.3 READING THE DISPLAY .................................................................................................................................................... 5
3. USING THE MENUS ......................................................................................................................................................... 6
4. THE MEMORY .................................................................................................................................................................. 6
4.1 CLEARING A MEMORY LOCATION .................................................................................................................................... 7
4.2 CLEARING THE ENTIRE MEMORY ..................................................................................................................................... 7
5. USING THE PRINT OR TRANSMIT FUNCTION ........................................................................................................ 7
6. DISABLING REFLEX FREQUENCIES ....................................................................................................................... 10
7. CALIBRATING THE PROBE ........................................................................................................................................ 11
8. CHOOSING NUMBER OF TYMPANOGRAM SWEEPS .......................................................................................... 12
9. HOW TO CLEAN THE PROBE ..................................................................................................................................... 13
10. OPERATION OF THE TSM-300 .................................................................................................................................. 14
TECHNICAL SPECIFICATIONS ...................................................................................................................................... 15
WARNING AND SAFETY NOTICES ............................................................................................................................... 16
MAINTENANCE & CALIBRATION ......................................................................................................................................... 16
CLEANING ........................................................................................................................................................................... 16
SHIPPING RECOMMENDATIONS ............................................................................................................................................ 16
DISPOSAL ............................................................................................................................................................................ 16
SYMBOLS ............................................................................................................................................................................. 17
EMC ....................................................................................................................................................................................... 18
RESPONSIBILITY OF THE MANUFACTURER ........................................................................................................... 20
MANUFACTURER .............................................................................................................................................................. 20
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1. General description
The OSCILLA® TSM-300 is designed for tympanometric screening. This screening is divided into two different tests. First, a tympanogram is recorded, which measures the mobility of the tympanic membrane and middle ear. Second, an ipsilateral acoustic reflex test is recorded, which measures the contraction of the stapedius muscle in response to loud sounds.
The test results are displayed on a graphic LCD display while they are recorded. When the test is completed it is stored in the memory. Tests may be printed out using an external printer connected to the tympanometer, or transmitted to a PC through a serial cable. TSM-300 may store results from 20 tests.
For configuring and calibrating the device, there is a menu system with various functions. These are setup options, calibration and clearing memory. In the daily use it is not necessary to use the menu system, the functions for daily use are linked directly to dedicated keys, to make them easy accessible.
1.1 Front panel description
Display – Show actual measurements, menus and messages.
Left button – Change between left and right ear.
Up / Down buttons – Change of ID number, for saving of tympanogram and reflex.
Right button – Print a measurement or transmit data to PC.
Menu button – Activate menu screen on the device.
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1.2 Back panel description
PROBE – Connectors for the probe’s combined jack and air plug.
SERIAL – Serial RS232 port for data transfer to a PC or printout on a serial printer.
PRINTER – Connector for parallel printer.
ON/OFF – Switches the device ON / OFF.
POWER – Connector for power supply.
2. Operation
This section describes how to set up and use the tympanometer.
2.1 Setting up the TSM-300
Setting up the tympanometer is quite easy and quick.
Place the tympanometer on a table and connect the probe’s combined air and jack plug to the back of the
device, where the label “PROBE” is printed.
Connect the mains adapter’s cable to the socket marked “POWER” and insert the adapter in a mains outlet and switch on the mains.
Switch on the device at the switch next to the POWER socket. The tympanometer will start with a brief start up screen on the display. Then the main screen appears and the device is ready for use.
To ensure correct measurement, you should calibrate the device now, using the calibration cavity chamber set.
See section “7. Calibrating the probe”.
2.2 Taking a measure
Before taking a test on a patient, mount a new rubber ear tip on the probe that fits the patient’s ear size. Ensure the patient’s ear canal is clean and not clogged by ear wax. Also remove any hair or other objects that can prevent an air tight seal between the probe tip and the auditory canal.
Choose on the TSM-300 which ear to test, left or right. (Use left arrow key to change with). Choose the desired ID location to save the measured data. (Use up / down keys to change with). Place the probe’s tip in the patient’s auditory canal and press gently. The probe must follow the auditory canal in
a line, to obtain the best performance.
The tympanometer will start automatically, and begin running the pump and draw the tympanogram. This is drawn in real time while the test runs. Keep an eye on the message in the upper right corner of the display. It
should say “TYMP” for a few seconds while measuring. If it says “LEAK” or “BLOCKED”, adjust the probe position slightly. If you have trouble with constantly getting a “LEAK” message, try to remove the probe and let
the pump return to its starting position, then insert the probe again. The pump position is displayed in the lower right corner as a little vertical bar marked “PUMP”.
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When the tympanogram is completed, the values in the right box are updated, and the pump seeks to the point of maximum compliance. Then the reflex test is carried out. Be sure to keep the probe very still while this is running, even small movements will add noise to the reflex graph.
After the reflex test, a “REMOVE” message is shown, and the probe can be removed. The test result is now stored in the memory at the selected ID position.
2.3 Reading the display
After having carried out a measurement you can see the results on the display. The picture below shows a typical measurement of a normally functioning ear.
The picture is divided into three main sections. The tympanogram is shown in the upper section, the reflex test in the lower, and to the right there is a box with four values obtained from the tympanogram.
Tympanogram: The tympanogram shows the graph of the middle ear compliance, as a function of pressure. The X-scale is the pressure, given in deka Pascal (daPa). This is nearly the same as millimetres of water (mmH2O), as 1.02 mmH2O is approx. 1.0 daPa. The Y-scale is the compliance given in equivalent volume of air, in millilitres. Inside the tympanogram frame is a box. If the peak of the measured graph is inside this box, the ear condition can be considered normal.
Reflex test: This shows the ear’s reflex response to the 5 test tones. Stimulus tones of 105 dB SPL at 500, 1000, 2000, 3000 and 4000 Hz are presented as short bursts. If a change in compliance greater than 0.05 ml is detected, a reflex is considered present. Because this is an extremely small compliance change, any movement of the probe during the test may produce an artefact (false response). If the tympanometric results display any abnormal findings, the results of the acoustic reflex testing may be inconclusive and should be interpreted with care. Theoretically, a compliance peak is necessary to observe a reflex at peak pressure.
Measurement box: In the box to the right, the numerical measurements are displayed:
MID EAR PRESS indicates the pressure with the highest measured compliance (in the example 0 daPa). EAR VOLUME indicates the volume of the section between the ear tip and the eardrum in ml (example 1.87 ml). COMPLIANCE indicates the value of the compliance from the tympanogram, in ml (example 0.97 ml). TYMP WIDTH is the width of the peak at half the peak height, related to -200daPa (example 46 daPa).
In addition to the three main sections, the following other items appear: Status indicator:
In the top right corner, the status indictor is shown. This tells you what state the device is in. The message can be one of the following:
READY indicates that the instrument is ready for testing. BLOCKED indicates that probe tip is blocked. This may be caused by misalignment of the probe in the ear. LEAK indicates that the air seal between the probe and the ear is not tight. TYMP indicates that the tympanometric test is in process. REFLEX indicates that the reflex test is in process. REMOVE indicates that the test is finished and the probe can be removed.
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Key related texts at the bottom of the picture: Above the left key, the word LEFT or RIGHT indicates the chosen ear at the moment. Above the up and down keys, the ID number for storing data is shown. Above the right key, the word PRINT or TRANSMIT is shown. This indicates if a press on the key will print out the test, or transmit it to a PC.
Pump indicator: In the lower right corner a pump indicator is shown. This follows the physical pump that delivers the pressure during the tympanogram measurement. The pump has a limited travel range, and it may happen that it runs all the way to the limits and is unable to deliver more air. This will cause the “LEAK” message to appear. If this happens repeatedly during a test, remove the probe and wait for the indicator to return to the starting position.
3. Using the menus
To use the menu system, press the MENU key. This enters the main menu, and the arrow keys are now used to control the menu.
Left button – Used to go back in the menu, or adjust a setting
Down button – Moves the menu selection bar down
Up button – Moves the menu selection bar up
Right button – Used to enter the selected menu, or adjust or activate the selected menu item
Menu button – Used to enter or leave menu
4. The memory
The tympanometer has a built in memory for 20 complete tests. Each test is stored under an identification number from 1 to 20. A stored test includes all data seen on the display, both the graphic and numeric data for the tympanogram and the reflex test graph. These data are stored for both ears.
After taking a test, it is stored under the currently selected ID number and the currently selected ear. The ID number is displayed in the bottom of the screen, above the up and down arrow keys. These two keys are used to select the ID number. The selected ear is displayed above the left arrow key, and this key is used to toggle between left and right ear. When a new ID is selected, or the ear is changed, the data from the new location is recalled to the display. If a test is performed, the stored data is overwritten with the new test data.
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4.1 Clearing a memory location
Clear data
Normally it is not necessary to clear the memory, because a new test is overwriting old data. But if it is desired to clear an ID location, for example because you only want to measure one ear, and therefore wants to have the other ear cleared, it can be done inside the menu. Press the MENU button, select the Clear data item and press and hold down the right arrow key for one second. After this time the selected ID location is cleared. This takes a few seconds and ends with a brief “Done” message. The ID location that is cleared is the one that is selected in the main screen.
Clear all data
Printer setup
Reflex setup
Calib cavity
Right key
Tymp sweeps
4.2 Clearing the entire memory
Clear data
If you want to erase all the tests stored, enter the menu and select the Clear all data menu item and hold the right arrow key for one second. This erases all the ID locations while displaying the ID number of the location currently being erased, ending with a “Done” message. This takes about a minute to complete.
Clear all data
Printer setup
Reflex setup
Calib cavity
Right key
Tymp sweeps
5. Using the PRINT or TRANSMIT function
Clear data
Clear all data
The tests stored in the memory can be exported in two ways. They may be printed out on a printer connected directly to the tympanometer, or they may be transmitted to a connected PC. This is done by pressing the right arrow key. To chose if it should be the PRINT or the TRANSMIT function that is activated when the key is pressed, go into the menu and select the “Right key” item at the bottom of the menu. Then toggle between the two functions with the right arrow key. When you leave the menu, the chosen function is shown above the
Printer setup
Reflex setup
Calib cavity
Serial transmission
Tymp sweeps
Print
5.1 Connecting a printer or PC
Before data can be printed or transmitted, the correct cable must be connected. A printer can be connected
either to the parallel port marked “PRINTER”, or the serial port of the tympanometer, depending on the printer
type. Most printers use the parallel port, but a few uses the serial port, for example the small Kyosha thermo printer. Turn off the tympanometer and the printer and attach the printer cable to the printer and the tympanometer.
A computer is always connected to serial port. The cable used is a “null-modem” cable. It should be connected between the serial port on the tympanometer and the serial port on the computer. Some computers do not have a serial port. In this case, a USB-to-serial converter can be used to add a serial port to it.
Clear data
Clear all data
Right key
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