OSCILLA TSM-300 Instruction Manual

ID: 1588 / ver. 205

Table of contents

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

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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5.2 Transmitting the test data to a PC

Test data can be transmitted to a PC running Inmedico’s AudioConsole program, or other programs that is able to read the transmitted format. This is done simply by pressing the right arrow key, while the key is set to TRANSMIT mode. After a short moment the test should appear in the AudioConsole program.

5.3 Identification key

The serial port is also used for transmitting an identification key to the PC. This happens automatically when the device is turned on. It tells the PC program that a tympanometer is present so it can switch to tympanometer mode. Note that this key is not transmitted if the serial port is set up to be used to print through.

5.4 Printing the test results

Printing a test is also started by pressing the right arrow key, but the key’s mode should be set to PRINT. To

make printout work successfully, the device will have to be set up to the correct type of printer. This is done in the printer setup menu.

5.5 Setting the printer type

The tympanometer supports 4 printer types. To change the printer type, enter the menu and go into the “Printer type” item and:

Select MATRIX if the printer is an Epson compatible printer. Select IBM PRO if the printer is an IBM PRO or compatible printer. Select THERMO if the printer is a Kyosha thermo printer. This setting may work with other small printers too. Select HP if the printer supports PCL-2 to PCL-5, language.

Some printers may emulate other printers. For example, many laser printers other than HP will work with the HP setting, because they use the same language. Also, some inkjet printers will work with MATRIX or IBM PRO setting. Other inkjets, like HP DeskJet printers, will usually work with the HP setting.

The printer’s manual should provide information about what language the printer uses, or which other printers it

can emulate. If this information is not available, you can just try out the different printer type settings and see if it works. It does not harm anything to select the wrong type.

Clear data

Clear all data

Printer setup

Printer type

MATRIX

Reflex setup

Printer Port

THERMO

Calib cavity

Carriage return

IBM PRO

Right key

Printer margin

Tymp sweeps

Note that printers designed specially for Windows or require bidirectional communication will not work when connected directly to the tympanometer. But it is perfectly possible to connect them to a PC running the AudioConsole program, and transmit the tympanogram data to the PC and print them out from there.

5.6 Printer port

The tympanometer can use both serial and parallel printers. Only a few uses serial port, so normally the port used for printout should be set to parallel. An example of a serial printer is the small portable Kyosha thermo

Printer setup

Printer type

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printer. Note than when the serial port is selected for printout, the tympanometer will not transmit its identification key at start up.

Clear data

Clear all data

Printer setup

Printer type

Reflex setup

Calib cavity

Carriage return

Serial

Right key

Printer margin

Tymp sweeps

5.7 Printer margin

The left margin of the printout can be adjusted in the setup. This allows the printout to be shifted to the right, to give space for holes for inserting in a ring binder. Just be sure not to set it too wide, it may cause clipping of the right side of the printout. The “Test printer” item will print out a test image with the selected margin. To leave the menu, press MENU.

Clear data

Clear all data

Printer setup

Printer type

Reflex setup

Printer Port

Calib cavity

Carriage return

Right key

Tymp sweeps

Test printer

5.8 Turning carriage return on and off

Carriage return is used to force a carriage return command to the printer. If the printer does not advance the paper, the carriage return should be set to on. This setting has no effect when printer type is set to HP.

Clear data

Clear all data

Printer setup

Printer type

Reflex setup

Printer Port

Calib cavity

Carriage return

Right key

Printer margin

Off

Tymp sweeps

Printer setup

Printer Port

Parallel

Printer setup

Printer margin

Printer Margin 0

Printer setup

Carriage return

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5.9 Solving printer troubles

When a printout is started with the right arrow key, a message is shown on the display, telling which printer type and what port is used for the printout. If the parallel port is used, and the printer is not working for some reason, you may get a “Printer error:” message after a while. If this happens, check that the printer has not run out of paper, that it is turned on, that it is ‘online’, that the printer cable is connected etc. The error message is removed by pressing the right arrow key again.

If the printer does print, but the printout is wrong, it is most likely that some of the settings in the tympanometer need to be changed. The printout may be wrong in some different ways. If there is no recognizable graphics present, but only strange letters and characters, it is most likely because a wrong printer type has been selected. If you do see the graphics, but there are regular horizontal blank lines in it, try to disable the Carriage return function in the printer setup menu. This may also happen if an IBM Pro Printer is selected in the setup, and an Epson compatible printer is used, or vice versa. If the printer just advances the paper without printing anything, it may help to enable Carriage return in the printer menu.

When using a serial printer like the Kyosha thermo printer and it prints strange characters, again it may be because a wrong printer type is selected. But it may also be because the Right key mode is set to TRANSMIT, and thereby send test data intended for a PC to the printer.

6. Disabling reflex frequencies

If it is desired not to measure stapedius reflex at all the 5 available frequencies, some of them can be disabled. Press the MENU key, select the “Reflex setup” item and press the right arrow key. Now you can enable and disable the individual frequencies by pressing the right arrow key. If the bottom item “On/Off” is disabled, the whole reflex test is disabled and will be skipped over when a test is performed.

Clear data

Clear all data

Printer setup

500 Hz

Calib cavity

1000 Hz

Right key

2000 Hz

Tymp sweeps

3000 Hz

4000 Hz

On/Off

When returning to the main screen, the frequencies that have been disabled will be shown with a line over the frequency number to indicate they will not be used.

Reflex setup

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7. Calibrating the probe

Clear data

Clear all data

Printer setup

Reflex setup

Calib cavity

0.5 ml

Right key

2.0 ml

Tymp sweeps

5.0 ml

Store

You should adjust your tympanometer before use, to the actual atmospheric pressure by means of the enclosed calibration cavity chamber set. The calibration is very easy and takes only a short while.

1. Enter the Calib cavity item from the main menu.

2. Put the probe tip with ear tip into the hole of the test cavity labelled 0.5 ml and then press Right key.

3. Press the Down key to select 2.0 ml.

4. Put the probe tip with ear tip into the hole of the test cavity labelled 2.0 ml and then press Right key.

5. Press the Down key to select 5.0 ml.

6. Put the probe tip with ear tip into the hole of the test cavity labelled 5.0 ml and then press Right key.

7. Press the Down key to select Store, and then press Right key. If successful calibration is done, the text “OK, Calibrations stored” is displayed.

To return to the main screen press Left key twice.

ATTENTION:

If the error message "ERROR, REDO CALIBRATION" appears when activating Store, please check if the openings of the calibration chamber and the probe tip are clean and re-calibrate the probe. Be sure to use the correct cavity volumes. If the error message appears again, the probe or the instrument is probably defective. Contact your service to get help.

Calib cavity

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8. Choosing number of tympanogram sweeps

When a tympanogram is recorded, the device sweeps the pressure between negative and positive. This is done a number of times before it stops. This number can be set to a value between 1 and 10 in the main menu, under the menu item “Tymp sweeps”.

Clear data

Clear all data

Printer setup

Reflex setup

Calib cavity

Right key

Tymp sweeps

If you want a quick test without repeatedly sweeping and graph redrawing, set the value to 1. The device will then build up a negative pressure, take one sweep from negative to positive, and stop. If you want to watch a more dynamic live picture of the tympanic membrane’s behaviour, set the number to a higher value. The device will then sweep the selected number of times before ending the measure.

Tymp sweeps

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9. How to clean the probe

If the probe becomes clogged in the hole at the tip, clean it using the following procedure.

Probe head

To remove the ear tip, hold firmly but carefully on the probe head and then remove the old ear tip and replace it with the new one.

If there is ear wax or other things in the probe head, then the probe can be dismounted for better cleaning. Please do as shown in the next figures.

Probes handle Probe head

To remove the probe head, hold firmly but carefully on the probe handle and then gently pull the probe head off.

Be careful not to bend the small metal pipe. If anything is stuck inside the metal pipe be careful not to push it further in when removing it. The probe head can be cleaned in lukewarm water and soap.

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10. Operation of the TSM-300

When recording a tympanogram it is done in a slightly different manner than usual. Normally only one sweep of pressure change is used, usually from negative to positive. The TSM-300 uses a few cycles of pressure change in both directions. While these cycles are running, it will simultaneously display the tympanogram in real time on

the display. This produces a ‘live’ picture that may be useful in some situations. It also assists in positioning the

probe correctly in the ear. It is possible to change the number of sweep cycles the device performs before it accepts the measurement. This is done in the main menu under “Tymp sweeps”.

Another difference is that the 226Hz measuring tone is kept at a constant signal level instead of changing the level during a measure. Often a feedback system is used to adjust the sound level dynamically so it tracks the ear canal volume and kept at 85dB independently of the volume. This system’s tracking control signal is then used to determine the volume. In the TSM-300 such a system is not used, the measuring tone is instead calibrated to give 85dB in a 2cc cavity. When a smaller or larger cavity is applied, the sound level measured by the probe’s microphone changes, and this change is used directly to determine the volume.

The reflex test is, like the tympanogram, displayed live while it is recorded. This gives a good chance of observing if noise from unintended movements of the probe occurs, because the noise will show up instantly on the live graph during a test.

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Technical specifications

Standards: EN 60601-1: 1996

EN 60601-1-2:2001 EN 60645-5:2005

Classification: Group 1, class A EN 60601-1-2:2002 Medical CE- mark: Inmedico A/S is approved for medical CE marking, by DGM.

Identification number 0543 Tympanometer: Test frequency: 226 Hz Tolerance frequency: ± 1% Test Level: 85dB SPL in 2ml ± 3dB Pressure: +200 to -300 daPa Volume range: 0.1 to 6.0 ml Reflex measurements: Test frequencies: 500 Hz, 1 kHz, 2 kHz, 3 kHz, 4 kHz ± 2% Test method: ipsilateral Test Level: 105dB SPL in 2ml ± 3dB Supply: 230 VAC / 12 VDC ±10 % Dimension: 225 mm x 180 mm x 55 mm Weight: Approx. 1000 g Warm-up time: < 10 minutes. Operating temperature: +15 to +35 degree C. Humidity: 30 % to 90 % Surroundings pressure: 98 to 104 kPa Calibration cavities: 0.5 ml, 2.0 ml and 5.0 ml, the volume tolerances shall be ± 2 % or 0.05 cm3,

whichever is greater.

Included parts: 1 PSU, 1 user manual, 1 calibration certificate, 1 calibration cavity set and 1 probe

with 6 sizes of tips.

Accessories: Carrying bag, thermo printer.