User Guide
32 Pages
Preview
Page 1
Copyright notice © 2016, 2017 Inmedico A/S. All rights reserved. Oscilla® is a registered trademark of Inmedico A/S in the U.S.A. and/or other countries. Version release date 2017-10-31 (167384) Technical support Please contact your supplier.
2
Inmedico A/S - T830/T840
User Guide
Table of Contents 1
Overview _______________________________________________________________________ 4
2
Intended use ____________________________________________________________________ 5
3
Unpacking ______________________________________________________________________ 6
4
Installation _____________________________________________________________________ 6
5
The probe and the contralateral phone _______________________________________________ 8
6
Tympanometry testing using the device ______________________________________________ 11
7
Testing using the Oscilla® AudioConsole software ______________________________________ 17
8
Tympanometry testing using AudioConsole ___________________________________________ 17
9
Device setup using AudioConsole ___________________________________________________ 18
10 Service, cleaning and calibration____________________________________________________ 18 11 Technical specifications __________________________________________________________ 22 12 Standards and warnings __________________________________________________________ 28 13 Other references ________________________________________________________________ 31 14 Manufacturer __________________________________________________________________ 31
Inmedico A/S - T830/T840
3
User Guide
1
Overview This User Guide describes the Oscilla® T830/T840 tympanometer.
T830/T840 tympanometer T830/T840 is a screening tympanometer for conducting middle ear measurements on patients.
T830/T840 is an auditory impedance tester that is intended for changing the air pressure in the external auditory canal and measuring and graphing the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. T830/T840 uses technologies which are highly effective for diagnostic and screening purposes. Tympanometry and acoustic reflex measurements measure the mechanical response of the middle ear and form a basis for evaluating whether the related physiological structures are functioning correctly or not.
Operating the device You can operate the device either as a stand-alone unit using the front panel buttons and display, or from the Oscilla® AudioConsole PC software.
Note • If you are controlling the device from the Oscilla® AudioConsole PC software, see the Oscilla® AudioConsole User Manual.
Note • Oscilla® AudioConsole PC software is an optional accessory, which requires a license key. If you wish to use AudioConsole, please contact your distributor.
Probes The device supports the following probes: •
The test probe
•
A contralateral phone or insert phone (T840 only)
Supported tests The device supports the following tests: •
Tympanometry
•
Ipsi- and contralateral reflex (contralateral: T840 only)
T830/T840 - Oscilla® AudioConsole interfacing The device is designed to operate with the Oscilla® AudioConsole PC software. From AudioConsole you can perform tests, monitor test results, store data, and print reports.
4
Inmedico A/S - T830/T840
User Guide
Printing test results The device can be connected to a printer (optional accessory) for printing test results. When the device is used in connection with AudioConsole, test results can be printed either on the printer connected to the device, or from the AudioConsole software.
2
Intended use Measuring acoustic impedance/admittance in the human external acoustic meatus using a stated probe tone or other probe signals. Users:
Audiologists, ENTs and other health care professionals with knowledge of immittance measurements.
Use:
Screening tympanometry and reflex measurements.
Patient population:
Children (from 6 months of age) and adults.
Contraindications
Warning • If the patient is troubled by the test, stop the test. The test is interrupted immediately. Already measured results are kept.
Warning • Look into the ear canal. It is strongly recommended that you perform an otoscopy to assess the status of the outer ear before you insert the probe. If the ear canal is blocked, this may affect the result of the test. Clean the ear canal if needed. Make sure that there is no residual fluid in the patient's ear after cleaning or wax removal.
Warning • Testing should not be performed on patients displaying the following symptoms without the approval of a medical doctor:
•
If there is discharge in the ear
•
If the patient recently has undergone middle ear surgery
•
If the ear canal is occluded
•
If the patient suffers from acute trauma
•
If the patient experiences severe discomfort
•
If the patient displays symptoms of tinnitus or hyperacusis, in which case using excessively loud acoustic stimuli for acoustic reflex measurements should be avoided.
Inmedico A/S - T830/T840
5
User Guide
2.1
Typographical conventions The use of Warning, Caution and Note To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses precautionary statements as follows:
Warning • Indicates that there is a risk of death or serious injury to the user or patient.
Caution • Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note • Indicates that you should take special notice.
3
4
Unpacking 1.
Unpack the device carefully. When you unpack the device and accessories, it is a good idea to keep the packing material in which they were delivered. If you need to send the device in for service, the original packing material will protect against damage during transport, etc.
2.
Visually inspect the equipment for possible damage. If damage has occurred, do not put the device into operation. Contact your local distributor for assistance.
3.
Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is incomplete, contact your local distributor.
Installation To ensure safe performance of the device, make sure that the device is correctly installed and that the requirements listed as warning notes are complied with. See Warning notes ► 29.
Location
Caution • Storage or transportation at temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage to the device.
Testing is facilitated by a moderately quiet room. A sound cabin or sound treated room is not necessary.
6
Inmedico A/S - T830/T840
User Guide
Probe We recommend that you carry out a probe check daily to verify that the system measures correctly.
Powering •
See Powering the device ► 7.
Oscilla® AudioConsole For a general introduction to Oscilla® AudioConsole, please see the Oscilla® AudioConsole User Manual (operator setup, database management, reports and data import/export).
4.1
The connection panel T830/T840 On/Off switch PC/USB connection Printer cable connection External power supply Contralateral phone (T840 only) F. Probe air supply connection G. Probe A. B. C. D. E.
4.2
Powering the device The device is powered through an external power supply connected directly to the mains outlet.
Caution • Use only the power supply specified in Technical specifications ► 22.
Connecting the external power supply to the device 1.
Connect the plug end of the external power supply cable to the external power supply socket on the back of the device.
Connecting the external power supply to the mains supply 1.
Connect the mains plug of the external power supply directly to an AC mains outlet.
2.
If applicable, switch on the mains supply.
Switching the device on and off 1.
To switch on the device, press the On/Off button on the back of the device. –
2.
The display lights up.
To switch off the device, press the On/Off button. If needed, switch off the mains supply and disconnect the power supply from the mains outlet.
Inmedico A/S - T830/T840
7
User Guide
4.3
Connecting to the PC To connect the device to the PC, you must install Oscilla® AudioConsole on the PC. For instructions on installing AudioConsole, see the AudioConsole User Manual.
Caution • Use only the USB cable supplied with the device.
1. Connect the supplied USB cable from the USB socket on the back of the device to a USB socket on the PC. The AudioConsole Windows automatically detects and installs the device.
When the device has been installed, AudioConsole detects the device and prompts you to enter the license key. When the license key has been registered, the device is shown in the Instrument Manager in the lower left corner of the AudioConsole screen.
4.4
Connecting the printer 1. Connect the supplied printer cable from the printer socket on the back of the device to the socket on the printer.
5
The probe and the contralateral phone Warning • Inspect the patient's ear. Look into the ear canal. It is strongly recommended that you perform an otoscopy to assess the status of the outer ear before you insert the probe. If the ear canal is blocked, this may affect the result of the test. Clean the ear canal if needed. Make sure that there is no residual fluid in the patient's ear after cleaning or ear wax removal.
Warning • The eartip can be used for both ears. If you suspect infection in one ear, use a clean eartip and probe tip before you continue testing on the other ear.
Hygienic precautions •
Be sure to follow any established infection control procedures for the setting in which you are working.
•
Always use clean eartips.
Warning • To prevent cross-infection, use new eartips when you test the next client.
8
Inmedico A/S - T830/T840
User Guide
5.1
The probe A. B. C. D. E.
Probe tip Probe body Eartips (example) Air connection plug Probe connection plug
Connecting the probe 1.
To connect the probe, insert the probe plug and the air connection plug into the probe socket and air supply socket on the connection panel.
Using the probe •
Fitting the eartip on the probe ► 9
•
Cleaning the probe and probe tip ► 19
Warning • Always fit an eartip on the probe before inserting it into the ear of the patient.
Warning • The eartip can be used for both ears. If you suspect infection in one ear, use a clean eartip and probe tip before you continue testing on the other ear.
5.2
Fitting the eartip on the probe 1.
Firmly push and twist the eartip onto the probe tip, until it rests firmly against the base of the probe tip.
Removing the eartip •
To remove the eartip, grasp the stem of the eartip and pull the eartip straight off the probe tip.
Inmedico A/S - T830/T840
9
User Guide
5.3
Fitting the probe in the patient's ear 1.
Look into the ear canal. It is strongly recommended that you perform an otoscopy to assess the status of the outer ear before you insert the probe.
2.
If the ear canal is blocked, this may affect the result of the test. Clean the ear canal if needed.
Caution • The probe can be damaged if fluids enter the probe.
Warning • Never place the probe tip in the ear canal of a new patient without using a clean eartip.
Warning • The eartip can be used for both ears. If you suspect infection in one ear, use a clean eartip and probe tip before you continue testing on the other ear.
Caution • Always use a suitably sized eartip. Using a probe with an unsuitably sized eartip or applying excessive force may cause unnecessary discomfort to the patient.
Procedure 1.
Fit the eartip on the probe.
2.
To stabilize the probe and to avoid blocking the probe against the ear canal of the patient, grasp the pinna and gently pull the pinna back and slightly away from the patient's head. –
For adults: pull the pinna upwards and back.
–
For infants and children: pull the pinna downwards and back.
3.
Insert the probe in the patient's ear canal while twisting the probe gently.
4.
Make sure that the eartip fits well. This will minimize the risk of blocking the probe tip against the ear canal wall.
Probe status and leakage The status indicator in the lower left corner of the device screen, or, if applicable, on the AudioConsole screen, will show the status of the probe.
5.4
Text
Description
Blocked
Indicates that probe tip is blocked (this may be caused by incorrect positioning of the probe in the ear).
Leak
Indicates that the air seal between the probe and the ear is not tight.
The contralateral phone (T840 only) If you wish to test for the contralateral reflex, use the contralateral phone to present the stimulus to the non-probe ear.
10
Inmedico A/S - T830/T840
User Guide
Connecting the contralateral phone 1.
To connect the phone, insert the plug end into the contralateral phone socket on the connection panel. Push the plug firmly into the socket until it locks into the socket.
Disconnecting the contralateral phone •
To disconnect the contralateral phone, take hold of the reinforced sleeve of the plug and pull firmly until the plug is disconnected.
Insert phone
Caution • Never insert the contralateral phone into the patient's ear without first inspecting the patient's ear canal.
Warning • The eartip can be used for both ears. If you suspect infection in one ear, use a clean eartip and probe tip before you continue testing on the other ear.
Warning • Do not use the contralateral insert phone in an ear with discharge. Use a supra-aural phone instead.
Warning • To prevent cross-infection, use new eartips when you test the next client.
Fitting a foam tip on the insert phone 1.
Fit a suitably sized foam eartip on the contralateral insert phone.
2.
Before inserting the eartip in the patient's ear, compress the foam eartip to make it smaller. Insert the eartip in the patient's ear until the outer surface of the eartip is flush with the ear canal entrance. The eartip will expand in the ear canal within a few seconds.
Supra-aural phone 1.
Fit the supra-aural phone on the patient's head so that the center of the phone is directed towards the entrance of the ear canal.
Caution • Some ear canals may collapse and prevent the stimulus from entering the ear. In such cases either use the insert phone or follow local recommendations.
6
Tympanometry testing using the device The main screen The tympanometry main screen is shown on the display when you start up the device.
Inmedico A/S - T830/T840
11
User Guide
T830
A. B. C. D. E.
T840
Online values Status indicator Softbutton selections Tympanogram Reflex table
A. On-line values
Middle ear pressure
Shows the pressure with the highest measured compliance.
Ear volume
Shows the volume of the section between the ear tip and the eardrum in ml.
Compliance
Shows the value of the compliance from the tympanogram in ml.
Tymp width
Shows the value that sums up the curve characteristics in one number.
B. Status indicator The status indicator can display a number of messages:
12
Ready
Indicates that the device is ready for testing.
Blocked
Indicates that probe tip is blocked (this may be caused by incorrect positioning 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.
Inmedico A/S - T830/T840
User Guide
B. Status indicator
Reflex
Indicates that a reflex test is in process.
Remove
Indicates that a test is finished and the probe can be removed from the ear.
C. Softbutton selections Press the softbutton to toggle the selections shown above the button.
D. Tympanogram The tympanogram shows the graph of the middle ear compliance as a function of pressure. •
The X-scale represents the pressure in daPa.
•
The Y-scale represents the compliance in equivalent volume of air in ml.
E. Reflex table The reflex table shows the ear’s reflex response to the five test tones.
6.1
•
The X-scale shows the progress of the deflection curve.
•
The Y-scale indicates if a change in compliance greater than 0.05 ml is detected and a reflex is considered present.
Softbutton functions Softbuttons below the screen
Probe: Left or Probe: Right Press this button to select the ear on which you wish to perform the test: Left or Right.
Stim: Ipsi or Stim: Contra or Stim: Ipsi/Contra (Stim: Contra or Stim: Ipsi/Contra - T840 only) Press this button to select ipsilateral or contralateral reflex testing, or both. You can also deselect reflex testing.
View: Ipsi, View: Contra or View: Both (View: Contra and View: Both - T840 only) Press this button to select whether to show ipsilateral, contralateral or both measurements on the display.
Current ID Press this button to browse between saved measurements and available storage slots in the integrated memory. You can save up to 200 measurements. Measurement IDs are numbered from 1 to 200. If the memory is full, you can use the Oscilla®AudioConsole software, if available, for storing more measurements.
Inmedico A/S - T830/T840
13
User Guide
Softbuttons on the right-hand side of the screen
Print Press this button to print the active measurement.
Settings Press this button to enter the Settings menu. See section for an introduction to the setup and configuration of the device. To exit the Settings menu, press the Home softbutton.
Calibration Press this button to calibrate the probe. For this, you will need the calibration cavities supplied with your device. When you activate calibration mode, the calibration guide is shown on the display. Follow the steps shown to calibrate the probe.
2/1 - Shift Press and hold this button to access more functions in the right hand side menu.
Delete Press this button to delete the current measurement.
6.2
Setting up tympanometry testing 1.
Press the Settings button to enter the Tympanometer settings menu. In the Tympanometer settings menu, you can adjust and configure a number of settings.
2.
14
Use the up/down arrow buttons to navigate, and press the Enter softbutton to select.
Inmedico A/S - T830/T840
User Guide
Reflex levels If needed, adjust the reflex stimulus tones for ipsilateral and contralateral reflex tests and set the reflex sensitivity (T830 supports 500 to 3000 Hz). –
Reflex levels Use the -/+ buttons to adjust the reflex levels from 80 to 110 dB HL.
–
Reflex sensitivity Use the -/+ buttons to adjust the reflex sensitivity from 10 to 200 microliters. 10 is the least sensitive, 200 is the most sensitive. Default: 30 microliters.
Tympanometer test (T840 only):
Normal mode
If needed, choose between Normal mode and Extended mode.
In Extended mode, the graph is scaled to allow for showing higher curves.
Extended mode
Time and date If needed, adjust the time and date settings of the device. Use the arrow buttons to navigate, and the -/+ buttons to adjust the time settings.
Inmedico A/S - T830/T840
15
User Guide
Printer settings Select/deselect details to be included on printouts. Use the arrow buttons to navigate, and the checkmark button to select/deselect the details.
Language (T840 only) If needed, change the language setting of the device. Use the arrow buttons navigate, and the checkmark button to select the language.
6.3
Performing a tympanometric measurement See Fitting the eartip on the probe ► 9 and Fitting the probe in the patient's ear ► 10. 1.
If needed, press the Probe softbutton to select the ear you wish to test first.
2.
When the status indicator displays the Ready message, insert the probe into the patient’s ear.
3.
When you have inserted the probe in the patient’s ear, the test starts automatically. Test results are shown on the display while the test is running.
4.
Make sure that the eartip fits well. This will minimize the risk of blocking the probe tip against the ear canal wall. A flat tympanogram together with an abnormally small ear canal volume indicates that the probe is blocked. A measurement will not autostart if the ear canal volume reading is too low.
5.
Make sure that you keep the probe in a steady horizontal position, and as still as possible. Even slight movements can affect the test results.
6.
Any leakage will interrupt the test. The status indicator on the screen will indicate if there is a leak. If an air leak or blockage should occur, the status indicator will alert you by displaying the message Leak or Blocked. If either of these messages is displayed, adjust the position of the probe slightly to continue the test. If the message Leak or Blocked reappears, remove the probe from the patient’s ear and start a new test.
7.
16
The status indicator shows when the test is completed by displaying the message Remove.
Inmedico A/S - T830/T840
User Guide
8.
7
If needed, press the Probe softbutton to select the other ear and repeat the test.
Testing using the Oscilla® AudioConsole software With AudioConsole you can carry out measurements from the PC, save patient data in the AudioConsole patient database, generate customized PDF reports, and export data to most patient management systems. For a general introduction to AudioConsole please see the AudioConsole User Manual, where you will find descriptions for operator setup, database management, reports and data import/export. The following sections provide you with a basic description of how to operate the device from AudioConsole.
8
•
Connecting to the PC ► 8
•
Tympanometry testing using AudioConsole ► 17
Tympanometry testing using AudioConsole Note • The safety intensity level cannot be exceeded in screening mode.
1.
Launch AudioConsole and select or create operator and patient from the operator and patient databases.
2.
Click the New Impedance Session button.
3.
Select the ear you wish to test.
4.
Select the reflex test type.
5.
Insert the probe in the patient’s ear.
6.
The status indicator on the screen indicates when the test is complete, and when you can remove the probe. Measurements are shown on the screen.
7.
Click the Save button to save the measurements.
Inmedico A/S - T830/T840
17
User Guide
Indicators, buttons and functions Probe frequency indication. Print out the tympanogram on the built-in device printer.
Open the Tympanometer settings menu on the device.
Delete the currently selected measurement.
Calibrate the device using the calibration cavities.
Import measurements from the device.
9
Device setup using AudioConsole To set up the device for tympanometry testing, see Setting up tympanometry testing ► 14.
10
Service, cleaning and calibration Warning • Under no circumstances disassemble T830/T840. Contact your supplier. Parts inside T830/T840 must only be checked or serviced by authorized personnel.
Warning • For the sake of safety and in order not to void the warranty, service and repair of electro-medical equipment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective device.
10.1
Cleaning the device Caution • Make sure that you comply with local infection control regulations.
18
Inmedico A/S - T830/T840
User Guide
Caution • Use only the cleaning agents prescribed for cleaning the device.
See Recommended cleaning agents ► 19.
Frequency We recommend that you set up a schedule for cleaning the device and accessories such as probes and/or earphones.
Prerequisites •
Before cleaning, switch off T830/T840 and disconnect it from any external power source.
•
If needed, unplug the contralateral phone from the device.
Cleaning the probe tip See Cleaning the probe and probe tip ► 19.
Disposal There are no special requirements for the disposal of disposable articles such as eartips, i.e. they can be discarded according to local regulations.
10.1.1
Recommended cleaning agents Caution • Use only the cleaning agents prescribed for cleaning the device.
For cleaning the device, we recommend that you only use non-alcohol-based disinfectant wipes (e.g. Audio wipe) or a cloth dampened lightly with a recommended cleaning agent to ensure proper infection control and maximum lifetime of the device. The following chemical solutions are recommended:
Cabinet surface and probe •
Non-alcohol-based disinfectant wipes (e.g. Audio wipe)
•
Lukewarm water with a mild detergent
Caution • If plastic parts are soaked in a cleaning agent they will deteriorate.
10.1.2
Cleaning the probe and probe tip Although the probes are designed to be easily cleaned, care should be taken to make sure that they last a long time.
Note • Check the sound channels in the probe tip every time you have used the probe. Even small amounts of cerumen or vernix can block the sound channels. Clean the sound channels if needed.
Note • Accurate testing is only guaranteed if you use the eartips approved specifically for the device.
Inmedico A/S - T830/T840
19
User Guide
Ear canal debris blocking the probe tubes can lead to abnormally large ear canal volume readings, leak messages, and other odd results.
Warning • Fit a new probe tip on the probe if you have been testing on an infected ear canal.
Cleaning the probe •
Wipe the probe with a disinfectant wipe, such as Audio-wipes, between patients.
•
Wipe the cable with a disinfectant wipe, such as Audio-wipes.
•
Wipe the probe home with a disinfectant wipe, such as Audio-wipes.
•
Alternatively, use a damp, non-flocculent cloth with a small amount of mild detergent.
Cleaning the probe tip
Note • Always comply with local hygienic standards for disinfection.
A. Probe body B. Probe tip
1.
To remove the probe tip, hold the probe by the probe body and carefully pull off the probe tip.
Caution • Even the slightest amount of moisture may dissolve any residual cerumen and thus contaminate the sensitive parts in the body of the probe.
Caution • Be careful not to push or bend the small metal pipe on the probe.
2.
Check to see if the sound channels of the probe tip are blocked.
Caution • Never clean the sound channels in the probe body, as this may cause damage to the probe.
10.1.3
3.
Clean the probe tip in lukewarm water with a mild detergent.
4.
Dry the probe tip thoroughly.
5.
Carefully fit the probe tip back on the probe.
The test cavities If a test cavity becomes contaminated, do not use it. Dispose of it and replace it with a new one.
20
Inmedico A/S - T830/T840
User Guide
10.1.4
Replacing the internal battery Caution • Replacing the battery should only be performed by an authorized technician.
Caution • Using another type of battery may present a risk of fire or explosion.
•
10.2
Replace the internal battery only with a non-rechargeable lithium/manganese dioxide battery typeCR 2032.
Calibration The device and the probe are delivered fully calibrated. •
The device is calibrated from the factory in dB SPL or dB HL using the stated reference equivalent thresholds. dB HL are related to sound pressure levels. See RETSPL Table in the section Technical specifications ► 22.
Daily calibration The probe should be calibrated daily. See Daily calibration ► 21.
Note • If the test environment changes, for instance if there is a change in humidity or if you are going to test at a different altitude, make a daily calibration to verify that the system measures correctly.
Annual calibration •
The device and probe(s) must be calibrated every year by an authorized service department.
Warning • Local government rules and regulations, if applicable, should be followed at all times.
10.3
Daily calibration To make sure that the probe is functioning correctly, it is recommended that you perform a daily calibration at the start of each day. The probe is checked for occlusion and leakage.
Caution • Always clean and disinfect the probe tip before you insert it into a test cavity.
Note • If the test environment changes, for instance if there is an increase in humidity or if you are going to test at a different altitude, make a daily calibration to verify that the system measures correctly.
1.
Make sure that the probe tip has been cleaned and disinfected, before you place it in the test cavity. This is to make sure that the probe tip does not influence the probe test, and that the test cavity is not contaminated.
Inmedico A/S - T830/T840
21