Inventis TIMPANI User Manual
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Inventis TIMPANI User Manual

Tympanometer
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YMPANOMETER
T
IMPANI
U
M
SER
ANUAL

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Summary of Contents for Inventis TIMPANI

  • Page 1 YMPANOMETER IMPANI ANUAL...
  • Page 3 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..

  • Page 5: Table Of Contents

    Summary Foreword ....................vii Chapter 1 Introduction ................9 User Manual ................... 9 Operator responsibilities ............... 9 Intended use ..................10 Main features ..................10 Use cases ....................11 Warnings and Precautions ..............11 Disposal ....................13 Conformity ................... 13 Symbols on labels .................
  • Page 6 Chapter 6 Settings ..................35 Settings window ..................35 General user-settable parameters ............36 Chapter 7 Interface with PC ..............37 Connection to PC ................. 37 Chapter 8 Maintenance ................39 Periodic checks ..................39 Maintenance of Transducers ............... 41 Cleaning the probe ................

  • Page 7: Foreword

    Bear in mind also that Inventis has developed a complete line of audiology devices: in addition to middle ear analyzers, the company's product line includes a range of audiometers, REM and HIT hearing aid fitting devices, a wireless video otoscope, and much more.

  • Page 9: Chapter 1 Introduction

    When defective or failed parts must be renewed, accept only original replacement parts supplied by Inventis s.r.l. Any repairs must be entrusted exclusively to Inventis or to service technicians approved 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

    SE CASES The Timpani can be used to conduct automatic tympanometry tests at low frequency (226 Hz) and at high frequency (1000 Hz, only with optional 1000 Hz tympanometry license) and ipsilateral acoustic reflex tests (only with full reflex and 1000 Hz-only reflex licences).
  • 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 EN 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 EN standard 60601-1-1.

  • 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.

  • Page 14: Symbols On Labels

    Inventis s.r.l. is a company certified to ISO 13485. YMBOLS ON LABELS Warning: the use of this instrument calls for certain precautions; to ensure safe use, consult the accompanying documentation. Refer to the instructions for use. Refer to the manual for information.
  • Page 15 The product is subject to the requirements of Directive 2012/19/EU on waste electrical and electronic equipment (WEEE). In the event of this product being sold and/or scrapped, it must not be disposed of as ordinary household or industrial waste, but collected separately.

  • Page 17: 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.

  • Page 18: Parts And Accessories

    Parts and accessories supplied with the product or available to order are listed in the following tables. Tympanometer pack Tympanometer Pack of assorted earpieces and brush thread for cleaning Inventis Software Suite USB cable Medical grade USB multi socket power adapter Carry case Tympanometer user manual...

  • Page 19: 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.

  • Page 20: Power-Up And Main Screen

    The main screen shows the buttons for selection of the main tests supported by the Timpani, depending on the specific licenses that are activated. The lower part of the main screen shows the icons that can be selected to print, delete and save tests conducted during the current session.
  • Page 21 to the patient database. In addition, if the thermal printer is available and correctly configured, the print icon allows the user to access the print menu. All screens of the software utility show the time at the top left, and the charge status of the battery at the top right.

  • Page 23: Chapter 3 Tympanometry

    Chapter 3 Tympanometry OW THE TEST IS CONDUCTED The first step is to select the most suitable earpiece for the patient being examined. The probe, with the selected earpiece attached, is introduced into the auditory canal of the patient and inserted deep enough to ensure a pressure-tight fit.
  • Page 24 Once the tympanometry function is under way, besides indicating the status of the probe, the screen will also display a progress bar showing how far the test has advanced. The instrument carries out a pressurized scan, and if a pressure-tight closure is properly ensured, displays the completed tympanometry: in the event of pressure losses being detected, the instrument will repeat the pressurized scan up to three times before generating an alert to indicate that there is a problem.

  • Page 25: Test Results

    EST RESULTS On completion of the tympanometry test sequence, the relative screen will display the data acquired by the instrument and the relative numerical results. The results of the test consist in a graph — the tympanogram — and, shown above the graph, measurements of the typical parameters.

  • Page 26: 1000 Hz Tympanometry

    1000 H Z TYMPANOMETRY To conduct a test with 1000 Hz probe tone, in the case of Timpani appliances with a 1000 Hz tympanometry license, the user must select the relative button on the tympanometry screen. The graphic interface is almost identical to that of the 226 Hz tympanometry test window.
  • Page 27 The parameters and test results are the same as for low frequency tympanometry.

  • Page 29: Chapter 4 Tympanometry And Acoustic Reflex Testing

    Chapter 4 Tympanometry and acoustic reflex testing This chapter describes the possibility of performing tympanometry tests and acoustic reflex tests in sequence, given activation of the reflex license (full reflex license or 1000 Hz-only reflex license). To run the tympanometry and acoustic reflex test sequence, simply press the relative button on the main screen: first, a tympanometry test will be conducted as described in the previous chapter, and when this has been completed, the acoustic reflex test will start automatically.

  • Page 30: Acoustic Reflex Test Window

    For more details on the setup menu, refer to Chapter 6. COUSTIC EFLEX EST WINDOW As in the case of the tympanometry test, if the requisite conditions are detected, the test will begin automatically; alternatively, the start of the test can be forced by pressing the Start acoustic reflex button.

  • Page 31: Chapter 5 Patient Management

    Patient management This chapter describes the functionality of saving acquired test data to the non-volatile memory of the Timpani instrument, and associating the information with a specific patient. To access the patient management window, all the user needs to do is scroll the display toward the left and then press the Patient management button.

  • Page 32: View Patient List

    IEW PATIENT LIST To display the list of patients stored in the Timpani memory, simply go to the patient management page. Scrolling the display up and down, the user can view the entire list, which shows the essential information associated with each patient: unique ID code and first/last names (if specified at the moment when the patient identity was created).
  • Page 33 icon on the main screen and select the patient in question from the list, or alternatively, create a new patient and associate the data with the new name or ID code.

  • Page 35: Chapter 6 Settings

    Chapter 6 Settings The Timpani tympanometer has a number of configuration parameters that can be changed in the settings window. This chapter describes the general parameters available, and how to change them. ETTINGS WINDOW To access the settings window, all the user needs to do is scroll the display toward the left and then press the Settings button.

  • Page 36: General User-Settable Parameters

    Also displayed in the settings window is an info icon, which can be selected to view the serial number of the instrument, together with the firmware version and the relative date. ENERAL USER SETTABLE PARAMETERS General configuration parameters that can be set by the user are listed below.

  • Page 37: Chapter 7 Interface With Pc

    ONNECTION TO The Timpani tympanometer is connected to a USB port of the computer using the cable provided (conventional USB cable with A / mini B connectors) or plugged into the charging base (which in turn is connected to the computer via USB).

  • Page 39: Chapter 8 Maintenance

    Chapter 8 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 performance and safety of the instrument will be assured as long as the recommendations for care and maintenance indicated here are correctly observed.
  • Page 40 It is essential to make certain that the calibration interval has not expired: an alert will be generated by the device to indicate when calibration is due. Calibration must be entrusted to technicians approved by Inventis srl. The operation should be performed at least once every 12...

  • Page 41: Maintenance Of Transducers

    AINTENANCE OF RANSDUCERS Do not use liquids or sprays to clean the tympanometer. Do not allow dust to collect on the transducers. Also: The cushions of headphones are made of biocompatible material but are not sterile: before being used on a new patient, these items must be sanitized by wiping the surfaces with a proprietary hypoallergenic disinfectant, following the maker's instructions.
  • Page 42 First, the screw collar must be loosened and removed so that the tip of the probe can be separated from the main body. The three channels in the tip of the probe can be cleaned using thin nylon threads. Insert the thread into each of the channels in turn, from the base, and push through until it can be pulled out from the top.

  • Page 43: 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 44: Repairs And Technical Assistance

    All accessories mentioned in the manual are designed especially for use with this instrument. Only accessories supplied by Inventis should be connected to the tympanometer. EPAIRS AND TECHNICAL ASSISTANCE Before contacting the service department, make certain that all the possible solutions Troubleshooting appendix have been tried.

  • Page 45: Appendice A Technical Specifications

    Appendix A Technical Specifications 226Hz tympanometry specifications Probe tone With AGC Frequency and intensity 226 Hz ± 1%; 85 ± 1.5 dB SPL Measurement range and 0.2 to 8.0 ml accuracy ± 0.1 ml or ± 5% (whichever is greater) Representation Meatus-compensated Influence of ambient...
  • Page 46 Calibration Duration of calibration: 12 months Calibration reference: IPSI: EN ISO 389-2 Acoustic couplers For probe: IEC 60318-5 Reference equivalent Frequency IPSI RetSPL threshold levels [Hz] [dB SPL] 1000 1500 2000 3000 4000 6000 8000 Patient management Number of patients storable Details memorized Patient details (first name, last name, date of birth, gender) Date and time of test...
  • Page 47 Medical USB type, responding to EN 60601-1 standard output 5Vdc min 1.4A input 100-240Vac 50/60Hz, 0.3-0.15A Interface with computer Connection: USB (no driver needed) Compatible software Inventis Maestro suite products Bluetooth interface for printer Bluetooth v4.2 – dual mode Module type Frequency 2402 - 2480 GHz...
  • Page 48 Notified body number 0123...

  • Page 49: Appendice B Troubleshooting

    Transducer not Connect the transducer to the correct connected to correct output output No signal from a transducer Contact Inventis service department or Transducer damaged dealer Problems with USB Check the USB connection between connection instrument and computer Connection between...
  • Page 50 Instrument not Check the positioning of the instrument positioned correctly in Check that the contacts are clean charging base Replace the battery - Contact Inventis Battery damaged service department or dealer Contact the Inventis technical service A test cannot be...

  • Page 51: Appendice 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:...
  • Page 52 30 cm (12 inches) to any part of the Timpani, including cables specified by the maker. If this advice is ignored, the performance of the instrument may suffer.
  • Page 53 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 54 Manufacturer's indications and declaration - electromagnetic immunity 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 55 RF transmitters, it may be necessary to conduct an electromagnetic survey on site. 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.

  • Page 57: Appendice D Bibliography

    Appendix D Bibliography Cynthia G. Flower and Janet E. Shank, Tympanometry, Handbook of Clinical Audiology, 175-202, Katz J. Editor, Williams & Wilkins (2002). Stanley A. Gelfand, The Acoustic Reflex, Handbook of Clinical Audiology, 205-229, Katz J. Editor, Williams & Wilkins (2002). Jackie L.

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