Related Manuals for Inventis TIMPANI
Summary of Contents for Inventis TIMPANI
- Page 1 ANDHELD YMPANOMETER CREENING UDIOMETER IMPANI ULTILANGUAGE ANUAL Document title: IM1P-User Manual Revision: Date: 30/06/2022...
- Page 3 YMPANOMETER IMPANI ANUAL...
- Page 4 Internal inspection of the instrument must be entrusted entirely to approved technicians. Copyright: Inventis S.r.l. is the owner of the copyright on this manual. It is forbidden to copy, reproduce or alter the manual, in its entirety or in part, without the express written authorization of Inventis S.r.l.
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Page 5: Table Of Contents
Summary Foreword....................... v Chapter 1 Introduction ................. 1 User Manual .................. 1 Operator responsibilities .............. 1 Intended use ................... 2 Indications for use and end users ..........2 Main features ................. 2 Use cases ..................3 Warnings and Precautions ............3 Disposal .................. - Page 6 Chapter 6 Patient management ..............23 Commands ................... 23 Create new patient ..............24 View patient data ................ 24 Chapter 7 Settings ..................27 Setup menu .................. 27 User-settable parameters ............27 License menu ................29 Chapter 8 Docking station ................. 31 Chapter 9 Interface with PC ..............
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Page 7: Foreword
The Inventis company has always considered the use of its devices in conjunction with computers to be a factor of key importance. Installing the Maestro software... -
Page 9: Chapter 1 Introduction
Defective or faulty parts must only be replaced with original spare parts supplied by Inventis and all repairs must be carried out exclusively by Inventis or by staff authorized by Inventis. No parts of the device must be modified or replaced without authorization from Inventis. -
Page 10: Intended Use
AIN FEATURES The Timpani is a portable device that can be used to conduct middle ear screening tests simply, swiftly and accurately. Available with a range of optional licenses, the device is able to meet the needs of private medical practices, clinics and hospitals alike. -
Page 11: Use Cases
These tests must be conducted in a particularly quiet environment in order to avoid artifacts. The Timpani tympanometer is intended for use by persons who have a detailed knowledge of the procedures associated with the tests supported by the instrument; the operator must therefore be either an audiometrist (or a technician having the requisite levels of audiological knowledge) or a medical practitioner in possession of specific skills (ENT or audiology specialist). - Page 12 The Timpani is a medical device: if connected to a computer (or any external device) located within the "patient area" (as defined in IEC 60601-1-1), this likewise must be a medical device, or protected by an isolating transformer, in order to ensure that the combination of computer (external device) + tympanometer is in compliance with IEC 60601-1-1.
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Page 13: Disposal
ONFORMITY The Timpani tympanometer is a class II device, in accordance with Annex IX of the medical devices directive 93/42/EEC as amended and supplemented by directive 2007/47/EC. Inventis is a company certified to ISO 13485. - Page 14 characters 6-7: year of manufacture ("20" denotes 2020) characters 8-13: pro serial number Catalog code Name and address of manufacturer. Medical Device Device with applied parts, Type B (IEC 60601-1) The device emits radio frequency Mark indicating conformity with Council Directive 93/42/EEC concerning medical devices (as amended and expanded by Directive 2007/47/EC) –...
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Page 15: Chapter 2 Installation And Use
Should the instrument or any of its parts or accessories appear to be damaged or defective, contact the dealer or Inventis service. Keep the packaging materials, in case the instrument should need to be sent to the dealer or to Inventis for any reason. ASIC CONFIGURATION ACCESSORIES... -
Page 16: Precautions
Brushes for cleaning the probe RECAUTIONS Installation of the Timpani tympanometer is easy but needs to be done carefully: incorrect installation could lead to safety issues while using the system. Like any other electrical or electronic device, the tympanometer will emit electromagnetic waves. -
Page 17: Connections
ONNECTIONS The Timpani can be connected either to a PC for recharging and transferring test data, or to the power adapter supplied. Use only the USB cable supplied with the product. If the optional docking station is available, the power adapter only can be connected, or the PC only, or both;... - Page 18 Button Function Perform Tympanometry Perform Tympanometry and then the Acoustic Reflex test Perform Audiometry Perform Automatic Audiometry Save the current session to the patient memory (see Chapter 6) Delete the current session Print the current session to the thermal printer (if configured and available) Indication Information...
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Page 19: Chapter 3 Tympanometry
Chapter 3 Tympanometry HE SCREEN 3.1.1 Common commands The following commands at the top of the touchscreen are common to all types of exams available. Button Function Return to the main screen Select the ear to test (in the example the right ear was chosen) Delete the current test 3.1.2... - Page 20 Button Function Probe tone selection Force the tympanometry to start. The first step is to select the most suitable earpiece for the patient being examined. The probe, with the selected earpiece attached, is then introduced into the auditory canal of the patient and inserted deep enough to ensure a pressure- tight fit.
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Page 21: Settings
ETTINGS For more details on the settings available, see Chapter 7. ESULTS On completion of the tympanometry test sequence, the relative screen will display the tympanogram obtained and the relative numerical results. Indication Information Tympanometry. unit measurement of the vertical axis (acoustic admittance) is expressed in: ml (equivalent volume of air), with 226 Hz probe tone... - Page 22 Compliance: Amplitude tympanogram peak measured against ECV. The unit of measurement reflects that of the tympanogram. Gradient of the tympanogram: width of the tympanogram at 50% of the compliance value (only for the 226 Hz probe tone) If the test has not been able to determine one or more of the above values, a double dash "--"...
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Page 23: Chapter 4 Tympanometry And Acoustic Reflex Testing
Chapter 4 Tympanometry and acoustic reflex testing HE SCREEN After pressing the relative button on the main screen, the instrument will be ready to perform the Tympanometry test and then the Reflex test in sequence. 4.1.1 Common commands For commands common to all tests, see section 3.1.1. 4.1.2 Execution of the Tympanometry test For the settings and execution of the tympanometry test see section 4.1.2. -
Page 24: Settings
Button Function Start the Acoustic Reflex test. During the test, the reflex curve obtained with a given stimulus signal is displayed in real time. The test finishes when the instrument has analyzed all frequencies at which measurement of the acoustic reflex was programmed. ETTINGS For more details on Acoustic Reflex settings see Chapter 7. - Page 25 Indication Information Reflex performance. The green segment indicates the duration of the stimulus. Reflex frequency, reflex level, pressure at which the reflex search was performed.
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Page 27: Chapter 5 Audiometry
Chapter 5 Audiometry HE SCREEN Depending on the selection, the instrument starts the audiometry test manually or automatically. Before proceeding with the test, have the patient wear the chosen transducers, checking, from the info screen accessible from the setup menu, that the transducers are those duly calibrated. - Page 28 5.1.2 Manual audiometry Button Function Save the current point Increase/decrease Level and Frequency Send the stimulus Indication Information Stimulus level Stimulus frequency. If valid data are associated with the current frequency, this is highlighted in the color representing the side.
- Page 29 5.1.3 Auto threshold (automatic audiometry) Button Function Start the test Suspend the test Stop the test Auto Threshold pure tone audiometry allows the operator to establish the hearing threshold for different frequencies by way of an automatic procedure. The method applied is the Hughson-Westlake technique, modified by Martin, which provides a modified and abbreviated version of the method indicated in the ISO 8253-1 standard for determining the VA threshold without masking.
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Page 30: Settings
The automatic test includes an initial familiarization phase, to train the patient on the threshold determination procedure, and this is followed by the actual test at all enabled frequencies. Stimulation takes place for a duration of 1.7 seconds and is then followed by a pause of random duration lasting between 1.7 and 2.5 seconds. -
Page 31: Chapter 6 Patient Management
Patient management The Patient Management screen allows adding (or editing) patients and updating saved tests. The first time you access the Patient Management screen, Timpani asks you to enter a PIN to prevent unauthorized access. You can choose to enter your PIN or disable data protection. -
Page 32: Create New Patient
REATE NEW PATIENT To enter the patient's personal details, press the relevant item and fill in the fields using the keypad. The ID field contains a unique code that is assigned automatically by the system at the time of creation and cannot be changed. IEW PATIENT DATA To access the stored details, touch the name or code of the desired patient. - Page 33 Button Function Return to the list of patients Side of the test saved Delete the current patient Print the tests of the current patient...
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Page 35: Chapter 7 Settings
Chapter 7 Settings ETUP MENU The Settings screen allows the user to change the Timpani parameters. Icon Function Return to the main screen Access the info screen with device serial number, calibrated transducers, firmware version and other useful information for support SETTABLE PARAMETERS General configuration parameters for the device are listed below. - Page 36 7.2.2 Date and time menu Access the menu used to set the date, time and format. 7.2.3 Data security Access the menu used to change the PIN and enable/disable it. 7.2.4 Automatic test repetition Enables/disables the possibility of repeating the test, re-inserting the probe in the ear (without having to manually delete the previous test).
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Page 37: License Menu
Frequency selection: selection of stimulus frequencies in the range 125 Hz – 8 kHz. The value 1kHz cannot be unselected. Default value: all frequencies enabled. Stimulus mode: sets the stimulation mode, allowing the user to choose between continuous stimulation or pulsed 1 Hz stimulation. Default value: continuous. -
Page 39: Chapter 8 Docking Station
Plug the docking station into a power socket using the power adapter supplied by Inventis and to the computer using the cable supplied (USB cable with A / mini B connectors). The two USB ports on the back of the instrument are interchangeable;... -
Page 41: Chapter 9 Interface With Pc
Timpani tympanometer in conjunction with a computer. ONNECTION TO Connect the Timpani tympanometer to a USB port of the computer using the cable provided (USB cable with A / mini B connectors) or plug it into the docking station (which in turn is connected to the computer via the USB cable provided). -
Page 43: Chapter 10 Maintenance
Chapter 10 Maintenance The Timpani tympanometer does not require any special periodic maintenance other than calibration and normal cleaning, both of which are described in this chapter. The instrument must be switched off before commencing any kind of cleaning operation. -
Page 44: Maintenance Of Transducers
Also, check that the calibration interval has not expired: the date is shown on the info screen accessible from the setup menu. Calibration must be entrusted to technicians approved by Inventis. The operation should be performed at least once every 12 months, and whenever a transducer is replaced. -
Page 45: Cleaning The Probe
The earpieces of the probe and the insert earphones are made of biocompatible material and must be used once only, then discarded in compliance with current waste disposal regulations. Earpieces are not sterile. Reusing unsterilized earpieces can cause ear infections. To avoid damaging the DD45 headphones, do not press them against a flat surface. -
Page 46: Cleaning The Instrument
In the event of the probe being broken or malfunctioning, contact an Inventis service technician. The replacement of the probe must be entrusted exclusively to Inventis or to a service technician authorized by Inventis. If the probe is replaced, it must be calibrated before being used with the instrument. -
Page 47: Replacing The Battery
Technical specifications even when fully recharged, it may be that the battery is damaged or spent. Purchase a new battery from an Inventis-approved dealer; proceed to replace the existing battery from the instrument as described below: Switch off the instrument and disconnect it from the USB cable;... -
Page 49: Appendix A Technical Specifications
Appendix A Technical specifications AVAILABLE TESTS Tympanometry (226Hz and optional 1000Hz), Acoustic Reflexes (optional), Manual tonal audiometry (optional), Automatic tonal audiometry. CALIBRATION 12 months TYMPANOMETRY 226HZ Probe tone With AGC Frequency and intensity 226 Hz ± 1%; 85 ± 1.5 dB SPL Measurement range 0.2 to 8.0 ml... - Page 50 Test pressure Automatic Tympanogram peak pressure Peak pressure less gradient (width of pressure curve at half peak height) Atmospheric pressure AUDIOMETRY – audiometry license required Stimulus Pure tone Attenuator step 5 dB Method of presentation Continuous, Pulsed (cadence: 1Hz) Frequency accuracy 0.1% Intensity accuracy ±3 dB between 125Hz and 4kHz;...
- Page 51 Freq. DD45 ER-3C [Hz] [dB] [dB] 33.5 34.5 34.5 1000 15.0 35.0 1500 2000 26.0 33.0 3000 4000 32.0 39.5 6000 8000 24.0 43.5 (*) With MX41\AR or PN 51 cushions PATIENT MANAGEMENT Maximum number of patients Details memorized Patient details (first name, last name, date of birth, gender), test date and time, Tympanogram (RH + LH), reflex tracing (RH + LH), audiometric thresholds (RH + LH) PHYSICAL SPECIFICATIONS...
- Page 52 TÜV SÜD Product Service GmbH, Ridlerstrasse 65, D-80339 Műnchen Notified body number 0123 Upon request, Inventis will make available circuit diagrams, parts lists, descriptions, calibration instructions or other information that may assist service personnel in repairing parts of the device that Inventis has deemed repairable by staff.
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Page 53: Appendix B Troubleshooting
Holes of probe tip blocked inside Transducer not connected Check that the transducer is properly connected properly No signal from a transducer Contact Inventis service department Transducer damaged or dealer Unable to Problems with USB Check the USB connection between establish a direct connection... - Page 54 Touch the screen or press the power Instrument in stand-by button The display remains blank (LED on) Contact Inventis service department Display damaged or dealer Change the USB cable (USB A – USB cable damaged mini B standard) Contact Inventis service department...
- Page 55 Problem Possible cause Solution Restart the instrument; if the message: Fatal internal error problem persists, contact the “Serious error” Inventis service department...
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Page 57: Appendix C Electromagnetic Compatibility
Cables, transducers and accessories The cables, transducers and accessories for which Inventis declares compliance with IEC 60601-1-2 standard are those supplied with the device, in particular: Medical grade USB power adapter... - Page 58 Manufacturer's indications and declaration - electromagnetic emissions The Timpani is designed for use in an electromagnetic environment as specified below. The user of the Timpani must ensure that the instrument is operated in ambient conditions as close as possible to these.
- Page 59 If the field strength measured at the point where the Timpani is in use exceeds the applicable RF level of compliance indicated above, check the operation of the instrument closely, to ensure that its performance levels meet the required standards. If abnormalities are observed, then additional measures may be necessary, such as changing the directional position or the location of the Timpani.
- Page 60 Manufacturer's indications and declaration - electromagnetic immunity Function requiring verification to Pass/fail acceptance criteria exclude unacceptable risks Sound generator operating correctly No unwanted sound from transducers exceeding 80 dB; lockup or restart of the device is acceptable Tympanometry on test cavity, conducted Flat tympanometry curve, ECV indication equivalent to nominal correctly in normal operating conditions value of cavity +/- 0.1ml...
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