MADSEN Tymp-Screen Middle-Ear Screener Operation Manual Rev 03

Although the information in this document has been thoroughly checked, no liability is assumed by GN Otometrics for any discrepancies. The information in this Operation Manual is subject to change without notice. Copyright © 2003, GN Otometrics, Copenhagen, Denmark. GN Otometrics A/S 2 Dybendalsvaenget, P.O. Box 119 DK-2630 Taastrup, Denmark. Phone: +45 72 111 555 Fax: +45 45 72 111 548 E-mail: [email protected] www.gnotometrics.com Technical Support: Please contact your local supplier.

Tymp-Screen Operation Manual

Contents 1. 1.1 1.2 1.3 1.4 2. 2.1 2.2 2.3 2.4 2.5 3. 3.1 4. 4.1 4.2 5. 5.1 6. 6.1 6.2 6.3 6.4 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 8. 9. 10. 10.1 11. 12. 13.

Introduction to Tymp-Screen ...3 Standards...3 Safety...3 Annual calibration...4 Unpacking ...4 Operating Tymp-Screen ...5 Before testing ...5 Tympanometry ...7 Reflex...10 Transmitter/printer ...12 Changing batteries ...13 Cleaning and Maintenance ...15 Eartips ...15 Testing and Calibration ...17 Testing Tymp. performance with the test cavity ...17 Testing reflex performance with the test cavity...18 Tymp-Screen Technical Specifications ...19 EMC aspects...20 Introduction to the MP 10 Tymp Printer ...21 Unpacking ...21 Symbols...22 Manufacturer’s responsibility ...22 Max. non-destructive voltages at input and output sockets ...23 Operating the MP 10 Tymp Printer ...24 Front panel functions...24 Rear panel connections...25 Changing batteries ...26 Mounting IR receiver ...27 Positioning the MP 10 printer...27 Inserting paper...28 Printing out test results ...29 Explanation of printout ...29 Cleaning and Maintenance ...31 Optional Languages...32 MP 10 Technical Specifications ...33 EMC ASPECTS ...33 Accessories for Tymp-Screen and MP 10...34 Adapter PS 50 ...35 Packing Instructions...36

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Tymp-Screen/MP 10 Printer Operation Manual

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Tymp-Screen/MP 10 Printer Operation Manual

1. Introduction to Tymp-Screen As the name indicates, the Tymp-Screen is a portable battery-operated middle-ear screener designed for quick and precise measurement of the basic functions of the middle ear. The instrument is capable of making immittance measurements in the auditory meatus covering the range from +200 daPa to -300 daPa (range of the normal middle-ear pressure). Furthermore the Tymp-Screen is capable of measuring stapedius reflexes in the frequency range from 500 Hz to 4000 Hz. The instrument is very simple to use as there are only four function buttons. The actual measuring is controlled by a built-in microprocessor. If desired, test results shown on the display can be transmitted via a built-in infrared transmitter for printout on the optional MP 10 Tymp printer (range up to 8 meters from the Tymp-Screen). The MP 10 printer is strongly recommended as the printout is easy to understand and serves as good documentation. The infrared transmitter saves you the trouble of wiring, etc. The printer has built-in batteries, and can be transported and used independently of any connection to the mains. It can also be powered by the optional PS 50 power adapter. The MP 10 printer can easily be set up to print text out in different languages – please refer to section 9.

1.1

Standards The Tymp-Screen complies with the following standard: EN 61027 Type 2 The Tymp-Screen and this manual are CE-marked according to the Medical Devices Directive 93/42/EEC.

The Tymp-Screen is marked with this symbol to indicate compliance with Type B requirements of EN 60601-1.

1.2

Safety This Operation Manual contains information and warnings which must be followed to ensure the safe performance of the Tymp-Screen and MP 10 printer. Local government rules and regulations, if applicable, should also be followed at all times. Special note should be made of the following: The MP 10 printer is marked with this symbol when it is important that the user refers to associated warnings given in this manual. Please pay special attention to these warnings. The Tymp-Screen and MP 10 printer have been designed and tested in accordance with EN 60601-1 “Safety of Medical Electrical Equipment”.

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Tymp-Screen/MP 10 Printer Operation Manual

To ensure safe performance, the Tymp-Screen and MP 10 printer must be correctly installed and the following safety requirements must be complied with. Only the original power adapter supplied with the MP 10 Tymp printer must be used. This must be fitted with an approved 3-pole mains (line) plug, which has a protective earth conductor. A personal computer (PC) is connected to the MP 10 Tymp printer via an RS232C serial data port which is marked with this symbol to indicate compliance as follows: “The use of accessory equipment not complying with the equivalent safety requirements of this equipment, may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: -

use of accessory in the patient vicinity evidence that the safety certification of the accessory has been performed in accordance to the appropriate EN 60601-1 and/or EN 60601-1-1 harmonized national standard.”

The infrared beam on the Tymp-Screen must never be pointed in the direction of eyes or eye damage may occur. Do not use the Tymp-Screen/MP 10 in the presence of flammable anaesthetics. No parts, accessories, batteries or eartips may be eaten, burnt or in any way used for purposes other than tympanometry. Disassembly may present electrical shock hazards. Batteries must never be recharged or replaced with any other size or type.

1.3

Annual calibration It is recommended that calibration of headset and transducers be carried out once a year. In addition, we recommend calibration if the equipment has suffered any potential damage.

1.4

Unpacking When you have received and unpacked your new Tymp-Screen, you should check that the following parts are included in the package: 1) 2) 3) 4) 5)

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1 x Tymp-Screen 4 x 10 eartips (sizes 2-5) 4 x 1.5 v batteries 1 x 1 & 4 cc test cavity 1 x Operation Manual

Tymp-Screen/MP 10 Printer Operation Manual

2. Operating Tymp-Screen 2.1

Before testing The Tymp-Screen is a battery-operated instrument – please refer to §2.5 on Changing Batteries (Figs. 13, 14, 15). A diagram of Tymp-Screen can be found on page 2. Numbers in parentheses below refer to numbers on the diagram. The tympanic membrane should always be visually inspected before a tympanometric measurement is made. This is because even small pressure variations may damage a thin tympanic membrane.

2.1.1.1 2.1.1.2

2.1.1.3

Before testing, select a suitably sized eartip (size 2-5) and mount on the probe tip (2), see Fig. 1. For hygienic reasons, eartips should be sterilised or discarded after use. EARTIPS. PLACING OF PROBE IN THE EAR.

Fig. 1. Mounting an eartip. START MEASURING. The Tymp-Screen is now ready for use. Gently place the eartip/probe is gently placed in the ear of the patient and press into the auditory meatus, as shown in Fig. 2.

Fig. 2. Probe inserted into the auditory meatus. By pressing one of the start buttons, (4) or (5), either a tymp or reflex measurement is initiated. The actual measurement is performed automatically by the built-in microprocessor. The start button must be held down during the whole course of the measurement and must not be released until the results are shown on the display (3). Prior to the actual measurement the microprocessor checks the measuring conditions, i.e. whether the eartip seals the auditory meatus and whether the measuring volume (0.3 cc - 4.5 cc) is correct. Various drawings and symbols on the display (illustrated below) indicate whether the probe is correctly placed.

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Tymp-Screen/MP 10 Printer Operation Manual

2.1.1.4

Fig. 3 shows that the probe is either entirely out of the ear or that the probe does not seal properly in the auditory meatus, i.e. that the measured volume is higher than 4.5 cc. Carefully correct the position of the probe in the auditory meatus until the symbol shown in Fig. 5 appears. BEFORE MEASURING IS STARTED.

Fig. 3. Probe out of ear.

Fig. 4 shows that the probe is blocked (volume < 0.3 cc) either due to clogging (ear wax) or because the probe is pressed against the wall of the auditory meatus so that the hole in the eartip is blocked. Carefully correct the position of the probe in the auditory meatus until the symbol shown in Fig. 5 appears.

Fig. 4. Probe blocked. If the eartip is blocked by ear wax, it must be cleaned or replaced. See §3 Cleaning and Maintenance.

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Tymp-Screen/MP 10 Printer Operation Manual

2.1.1.5 2.1.1.6

2.2

Fig. 5. Correctly placed probe. MEASURING. Fig. 5 shows that the probe is correctly placed and that the volume in the auditory meatus is within the permitted range (0.3 cc - 4.5 cc). INTERPRETATION OF READINGS.

Tympanometry If the Tymp. start button (4) was activated (see §2.1), and the display indicates that the probe is correctly placed (see Fig. 5), the instrument now automatically starts measuring. NOTE: it is important that the instrument be kept completely still as vibrations may influence the reading. During the measurement (approx. 3 sec.), Fig. 5 is shown on the display. As soon as the measurement has been completed, the results (compliance/ tympanogram) are displayed in the form of a curve (see Fig. 6).

Fig. 6. Example of a tymp curve.

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Tymp-Screen/MP 10 Printer Operation Manual

The Tymp. button (4) can now be released without the curve on the display disappearing. The Tymp-Screen can be removed from the ear and the reading can be transmitted for printing if desired (see §2.4 Transmitter/Printer). After approx. 90 sec. the instrument automatically switches OFF. Fig. 6 shows the curve for the compliance/tympanogram. The curve is produced by measuring the acoustic impedance of the auditory meatus at various pressure values from +200 daPa to 300 daPa. The volume at +200 daPa is designated as the base volume. This value is deducted from the values measured at other pressures to calculate the curve on the display. The numbers 1 to 4 on Fig. 6 are explained below: 1) Here the size of the base volume is indicated by the height of the column.The number in the top right-hand corner indicates the full-scale value of base volume (5 cc). 2) Here the degree of compliance is indicated by the height of the column. The number in the top left-hand corner indicates the full-scale value and is either 1 cc or 2 cc - according to the compliance of the ear. 3) The small mark under the graph indicates where on the pressure axis maximum compliance has been achieved. 4) This is the actual curve which shows the ear's compliance as a function of pressure (the horizontal axis on the display).

2.2.1.1

It may happen that the instrument is not able to build up sufficient pressure in the patient's auditory meatus, and thus not be able to perform a tymp. test. If this case, the symbol in Fig. 7 is shown indicating that air is leaking out – either the probe/eartip does not fit tightly or the patient's tympanic membrane is perforated. Release the tymp.button (4), wait until the display clears and repeat the test – you may try using another sized eartip. ERRORS DURING MEASURING.

Fig.7. Probe not tight - measurement interrupted.

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Tymp-Screen/MP 10 Printer Operation Manual

2.2.1.2

To help you interpret test results, Fig. 8 shows four typical compliance readings. TYPICAL CURVES.

a.

b.

c.

d.

Fig. 8. Examples of compliance readings.

Fig. 8a:

- Compliance peak at 0 daPa - normal ear with normal tympanic membrane mobility - normal Eustachian function

Fig. 8b:

- Compliance peak at -175 daPa - tympanic membrane retracted due to negative pressure in the middle ear - poor Eustachian tube function - normal tympanic membrane mobility

Fig. 8c:

- No compliance peak - reduced mobility of tympanic membrane - tympanic membrane perhaps perforated (large base volume) - impacted cerumen/blocked ear (small base volume) - otitis media - ossicular fixation (otosclerosis)

Fig. 8d:

- Very high compliance - "normal" flaccid tympanic membrane - high degree of tympanic membrane mobility - ossicular discontinuity - Incus Luxation

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Tymp-Screen/MP 10 Printer Operation Manual

2.3

Reflex If the reflex button (5) is activated, the instrument automatically starts the test. During the actual measuring, it is very important that the instrument be kept completely still as vibrations may influence the reading. During the measurement (approx. 8 sec.), Fig. 5 is shown on the display (blinking). As soon as the measurement has been completed, the results (the reflex columns) are displayed in the form of a bar chart (see Fig. 9).

Fig.9. Example of reflex measurement. The reflex button (5) can now be released without the bar chart on the display disappearing. The Tymp-Screen can be removed from the ear and the reading can be transmitted for printing if desired (see §2.4 Transmitter/Printer). After approx. 90 sec. the instrument automatically switches OFF. Fig. 9 shows a bar chart for the patients' reflexes. The bar chart is produced by first measuring the acoustic impedance in silence (unstimulated) and then measuring the acoustic impedance at the same time as a pure tone of 95 dB HL (stimulated) is presented in the patients' ear. The pure tone causes the stapedius muscle to contract, thereby measuring the stiffness of the ossicular chain and changing the acoustic impedance. The difference between the stimulated volume and the unstimulated volume is defined as the 'stapedius reflex' and the size of this is represented by the height of the column in the display. Please observe that the Tymp-Screen performs all reflex measurements at 0 daPa – which is not always the same as the middle-ear pressure!

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Tymp-Screen/MP 10 Printer Operation Manual

The Tymp-Screen performs reflex measurements for 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz pure tones, and the results are plotted simultaneously on the display, starting from left with the lowest frequency (see Fig. 9). 1)

This is the full scale value for the actual measurement. Results may be displayed on either a 0.25 cc or 0.50 cc scale depending on the size of the strongest reflex.

2)

Here the magnitude of each reflex is displayed (left to right, for 500, 1000, 2000 and 4000 Hz, respectively).

To help you interpret reflex measurement results, Fig. 10 shows four typical reflex readings.

a.

b.

c.

d.

Fig. 10. Examples of reflex readings.

Fig. 10a:

- Equal moderate reflexes - normal ear with a normal reflex threshold for all 4 frequencies

Fig. 10b:

- One single reflex - probably the result of unsteady operation of the Tymp-Screen - repeat the measurement, and try to keep the Tymp-Screen very steady

Fig. 10-c :

- Very large reflexes - normal ear with a low reflex threshold for all 4 frequencies

Fig. 10d:

- Very small or absent reflexes - maybe very high reflex thresholds - maybe otosclerosis - maybe otitis media - inability to contract the stapedius muscle - the small reflexes seen at 500, 1000 and 4000 Hz could also be the result of unsteady operation - very great negative pressure in middle ear

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Tymp-Screen/MP 10 Printer Operation Manual

2.4

Transmitter/printer Test results can be printed out on the optional MP 10 Tymp printer using the infrared transmitter built into Tymp-Screen. Depending on whether you have tested the right or left ear, simply press the red (for right) or blue (for left) transmitter button (6) and at the same time point the probe tip of the instrument at the printer. When pressing one of the two transmitter buttons, the symbol shown in Fig. 11 appears on the display of the Tymp-Screen, indicating that transmission is being made to the printer.

Fig. 11. Curve is transmitted to printer. If the printer is switched on, it will now give a short beep indicating that the curve was transmitted correctly. If there is no beep, the printer was not able to receive the data correctly. Possible causes: •

The printer could not "see" the Tymp-Screen (the transmission is performed by infrared light in the same way as a TV’s remote control).

•

The distance to the printer was too great (more than 8 meters).

•

The probe tip was not pointing at the printer.

Try moving closer to the printer or moving into the "visual field" of the printer, and then transmit again. Transmission can only be made while the test results (compliance or reflex) are shown in the display, and not after the instrument has automatically switched OFF (after 90 seconds). The printer has a built-in memory with storage capacity for 4 measurements. If the printer responds with one long beep, it means that the internal storage is full and that data cannot be received until the next printout starts. In this case, just wait until the next printout starts and then transmit again. NB: Every time you transmit, the elapsed time before the instrument automatically switches OFF is reset, and you have another 90 seconds before losing your data. WARNING: The infrared beam must not be pointed at eyes or eye damage may occur.

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Tymp-Screen/MP 10 Printer Operation Manual

2.5

Changing batteries The Tymp-Screen has built-in battery control. If the battery symbol shown in Fig. 12 appears on the display, the batteries have run down and must therefore be changed.

Fig. 12. Change batteries. Old batteries should be removed immediately to avoid leakage. For the same reason, it is recommended that the batteries be removed when the instrument is not in use for an extended period of time (e.g. prior to holidays). To change batteries: 1.

Roll the three black rubber rings (7) OFF the instrument (see Fig. 13).

Fig. 13. Opening the Tymp-Screen. 2.

Turn the Tymp-Screen upside down, i.e. with the display facing the table. Carefully take off the rear casing, and electronic parts, pump and batteries can be seen - see Fig. 14.

Fig. 14. Open Tymp-Screen.

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Tymp-Screen/MP 10 Printer Operation Manual

3.

Gently remove the battery container from the battery chamber and separate it from the instrument by detaching the battery clip. Replace all 4 Penlite batteries with new ones (see Fig. 15).

4.

Ensure that the batteries are inserted with the correct polarity! Refer to the + and – symbols inside the battery container.

5.

Reattach the clip onto the battery container (it fits only one way), and then replace the container in the battery chamber (see Fig. 14).

Fig. 15. Changing batteries. 6.

Remount the rear casing, and roll the three rubber rings (7) onto the instrument so that they fit into the grooves.

To check the new batteries, you can activate one of the start buttons (4) or (5), after which the display should indicate "probe out of ear" (Fig. 3).

Warning: Replace batteries only with correct size and type, i.e. 1.5 Volt Penlite - AA - LR6 Mignon etc.). Do not use rechargeable batteries!

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Tymp-Screen/MP 10 Printer Operation Manual

3. Cleaning and Maintenance Because they are in contact with your patients, care should be taken to ensure that the probe tip and eartips are kept clean. The instrument itself may only be cleaned with ordinary household alcohol and not with any other kind of detergents. Wet a piece of cloth with some alcohol, clean the instrument carefully (without force) and wipe with a dry cloth. Over time the probe tip (2) may become blocked by ear wax. This prevents correct measurement and, in extreme cases, the symbol "blocked probe" is shown on the display (Fig. 4). In this case, unscrew the front part of the probe tip, and clean the actual probe opening with alcohol and a cotton swab (see Fig. 16). The metal tubes may in some cases also become blocked. If it is not possible to clean them properly with a needle, the instrument must be sent to your local Madsen distributor for cleaning and recalibration.

Fig. 16. Cleaning the probe tip.

Note that the instrument must be stored in a dry and frost-free place since mechanical parts and batteries cannot tolerate damp and frost over a longer period of time.

3.1

Eartips Tymp-Screen’s eartips are designed to fit over the end of the probe and permit a tight seal in the subject's external ear canal. Eartips should be used on only one subject, after which they should be sanitized: 1. Wash in warm soapy water or other suitable solution. 2. Rinse thoroughly.

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Tymp-Screen/MP 10 Printer Operation Manual

3. Dry by standing upright on toweling overnight. Eartips have a limited life, and should be discarded when they appear dry and cracked or when it is no longer possible to achieve a reliable seal with the subject's ear. To prolong eartip life, do not use alcohol or similar agents for cleaning. 3.1.1.1 Disposal There are no special requirements for disposal of the rubber eartips, i.e. they may be discarded in any regular waste bin. 3.1.1.2 Portable Use The Tymp-Screen is a fully portable system, but the optional carrying case is recommended for safe transportation. Before packing the system, ensure that the probe assembly, eartips, etc., are not loose in the case.

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Tymp-Screen/MP 10 Printer Operation Manual

4. Testing and Calibration We recommend that your Tymp-Screen be tested and calibrated once a year by your local distributor – every precision measuring instrument is only as precise as what it is calibrated for. As time goes by, ageing takes place which may cause the instrument to become uncalibrated. The instrument is calibrated and adjusted to observe the strict demands we make on our medical equipment and, unless it is exposed to stress, etc., it must not be calibrated other than at the recommended annual inspection. However, it is possible to test whether the volume/reflex circuit of the instrument is functioning correctly. This is done by performing a measurement in the supplied test cavity.

4.1

Testing Tymp. performance with the test cavity A compliance measurement is made without using an eartip: just insert the probe tip into one of the two holes in the test cavity and press the Tymp. Start button (see drawing below).

The reading displayed depends on which end of the test cavity you have used. If you have used the 1 cc hole, the base volume should show 1 cc ± 0.1 cc. If you have used the 4 cc hole, the base volume should show 4 cc ± 0.2 cc (see Fig. 17). Furthermore, the curve should be almost flat since the test cavity has no compliance:

Fig. 17. Test in 4 cc test cavity.

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Tymp-Screen/MP 10 Printer Operation Manual

In some cases, the "leak" symbol (Fig. 7) appears in the display. This may be caused by a poor seal between the probe tip and the test cavity or there may be a problem with the probe system. If you suspect that the probe system of your Tymp-Screen is leaking, please contact your local Madsen distributor for a complete check-up and recalibration.

4.2

Testing reflex performance with the test cavity A reflex measurement is made without using an eartip: just insert the probe tip into one of the two holes in the "test cavity" and press the Reflex start button. The reading displayed should not depend on which end of the "test cavity" you have used. The resulting bar chart (see Fig. 18) must be almost flat since the test cavity has no reflexes.

Fig. 18. Reflex test measurement in 1 cc or 4 cc. If the results of your tests do not match those above, you should contact your local distributor to have your instrument calibrated and checked.

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