Instructions for Use. Oscilla TSM400 Screening Tympanometer. Specifications are subject to change without notice ID: 6795 / ver.

Transcription

1 Instructions for Use Oscilla TSM400 Screening Tympanometer Specifications are subject to change without notice

2 Contents General description... 3 Installation... 4 Device overview... 5 Rear panel... 5 Tympanometry mode... 6 Tympanometer display buttons... 7 Basic tympanometry operation... 8 Tympanometer settings... 9 Probe calibration Oscilla AudioConsole Connecting to AudioConsole for the first time Tympanometry in AudioConsole Technical specifications Warning and safety notices Maintenance & calibration Cleaning Shipping recommendations Disposal Symbols EMC Responsibility of the manufacturer Manufacturer

3 General description Oscilla TSM400 is a screening tympanometer. The device features ipsi- and contralateral reflex testing. The device can be connected to a PC for use with Oscilla AudioConsole software. Intended use Measuring acoustic impedance/admittance in the human external acoustic meatus using a stated probe tone or other probe signals. User profile The intended users are trained professionals, healthcare personnel, clinicians and ENT doctors with audiological experience. Contraindications Low-frequency tympanometry is not recommended for infants younger than 7. Testing should not be performed on patients with the following symptoms without a medical doctor s approval: Recent stapedectomy or other middle ear surgery Ear discharge (otorrhea) Acute external auditory canal trauma Discomfort e.g. severe otitis externa Occlusion of the external auditory canal Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when high intensity stimuli are used. Visual inspection for obvious structural abnormalities of the external ear structure and positioning as well as the external ear canal should be performed before testing. 3

4 Installation Powering the device Use only the power supply specified in the Technical specifications section. The power supply is a part of the device. The operator is qualified to perform the installation. 1. Connect the mains plug of the external power supply to a mains outlet. 2. Connect the output cord to the power supply socket of the device. 3. Switch on the mains outlet. 4. Switch on the device using the switch marked and. The device displays information regarding firmware version, serial number and latest calibration date. 4

5 Device overview Rear panel Power supply The power supply is connected to the device using the socket marked Power supply. Power switch The device is turned on by switching the power switch to The device is turned off by switching the power switch to USB PC-connection for use with Oscilla AudioConsole. Probe The probe is connected to the device using the air and jack sockets marked Probe. Contralateral headset The contralateral headset is connected to the device using the socket marked Contralateral headset. 5

6 Tympanometry mode This is the main tympanometry screen: Middle ear pressure The pressure with the highest measured compliance. Ear volume Volume of the ear canal. Compliance Peak value of the compliance curve. Tymp width Span of the compliance curve. Onscreen assistant Visual guidance for selected test type Status Indicator Ready Blocked Leak Tymp Reflex Remove The device is ready. Probe tip is blocked maybe due to misalignment of the probe in the ear. The air seal between the probe and the ear is not tight. Test is in progress. Reflex test is in progress. Test is finished and the probe can be removed. 6

7 Tympanogram Shows the graph of the middle ear compliance as a function of pressure. - x-axis Pressure in dekapascal (dapa). - x-axis Compliance in equivalent volume of air in millilitres (ml). Reflex test Shows the ear s reflex response to the five test frequencies. - x-axis Reflex frequency. - x-axis Compliance. Reflex detection Compliance curves with peaks greater than 0.05 ml are marked by: - A blue checkmark indicates a detected reflex for the left ear. - A red checkmark indicates a detected reflex for the right ear. - The number represent the db hearing level for the transmitted stimulus. Tympanometer display buttons Use the buttons below and on the right hand side of the display are used for operation and configuration. Probe Select the left or the right ear. Reflex Select reflex test: - Ipsilateral reflex test - Contralateral reflex test - Both ipsilateral and contralateral reflex test - Reflex test off. View Select to view measurement: - Ipsilateral measurement - Contralateral measurement - Both ipsilateral- and contralateral measurement - Measurements off. Current ID Browse through saved measurements and available storage slots. Print Print the current tympanogram on the internal printer. 7

8 Settings Enter the setup menu of the device. Refer to section Tympanometer settings for further information Calibration Enter probe calibration. Refer to section Probe calibration for further information. 2/1 Press and hold this button to access more functions: Print combined audiogram and tympanogram Print audiogram and tympanogram on a single printout. Delete Delete the current measurement Basic tympanometry operation 1. Select the ear to test using the Probe button. 2. Select the reflex test type using the Reflex button. 3. Select a new ID for the test using the Current ID buttons, if necessary. 4. Insert the probe into the patient s ear. The test starts automatically. 5. Keep the probe in a steady horizontal position and hold it still as even slight movements can affect the test results. 6. Test results will be updated on the display in real time. Should an air leak or blockage 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. Remove the probe and start a new test if the messages Blocked or Leak message continues to display. 7. The test is completed when the Status indicator displays the message Remove. Remove the probe. 8. Use the Probe button to select the patient s other ear and repeat the test. 9. The measurements are stored in the specific ID. Print the measurement using the Print button. 8

9 Tympanometer settings Press the settings button to enter the settings menu: Exit Exit the menu / Return to previous menu Browse Browse through the menu. Enter Enter menu Information Information about model name, firmware version, device serial number and date of latest calibration. Adjust Adjust setting Confirm Confirm changes Each menu is described in the following sections: 9

10 Reflex levels Use the buttons to adjust: - Hearing level for ipsilateral reflex stimuli - Hearing level for contralateral reflex stimuli - Reflex sensitivity. Refer to section Technical specifications for the range of reflex levels. The reflex sensitivity can be adjusted within the range of 0 20 where: - 0 is the least sensitive is the most sensitive. Time and date Use the buttons to edit: - Time and date Printer settings Use the button to select or deselect: - Information to be included on printouts. 10

11 Language Use the button to select: - Language of the device Probe calibration Daily calibration is recommended. To perform the calibration, press the calibration button to enter the calibration tool: Exit Exit the calibration tool Restart Restart the calibration tool to step 1 Check Show the volume measurement in real time. Next Proceed to next step in the calibration tool. Probe calibration process 1. Place the probe in the 0.5 ml cavity and hold it steady. Press Next 2. Place the probe in the 2.0 ml cavity and hold it steady. Press Next. 3. Place the probe in the 5.0 ml cavity and hold it steady. Press Next 4. Check if the calibration is correct by placing the probe in the cavities and verify whether the measured value match the current cavity. 5. Press Finish to save and close the calibration. If the device detects and error during the calibration, press Restart and perform the calibration again. 11

12 Changing the eartip The eartips are for single use only and must be replaced for each new patient. The eartip is changed in two simple steps: 1. Remove the eartip from the probe head by pulling: 2. Place a new eartip on the probe head: Oscilla AudioConsole The device can be connected to a PC using Oscilla AudioConsole. AudioConsole allows to carry out audiometric measurements using the PC, save patient data in the AudioConsole patient database, generate customised PDF reports, and export data to most patient journaling systems. Connecting to AudioConsole for the first time 1. Install the AudioConsole software on your PC. 2. Connect the device to the computer using a USB cable. Windows will automatically detect and install the device. Wait until the automatic installation is finished. 3. Launch AudioConsole. 4. Enter the AudioConsole license key, when prompted. 5. Once the license key has been accepted, the device will show up in the Instrument manager in the lower left corner of AudioConsole. The following sections describe specific features for the device in AudioConsole. Refer to the AudioConsole User Manual for a general introduction to Oscilla AudioConsole. 12

13 Tympanometry in AudioConsole PC Screen Status indicator Shows the status of the test. Probe Select ear. Reflex Select ipsi- or contralateral reflex test. Onscreen assistant Guidance for selected test type. Probe frequency Shows test frequency Print Print the tympanogram on internal printer. Settings Open setting menu on the device. Delete Delete current tympanogram. Calibration Enter probe calibration tool on the device. Refer to section Probe calibration for information. 13

14 Import Import measurements from the device. Save Save the current tympanogram. TSM500 screen Settings Open setting menu on the device. Save measurement Save the measurement in AudioConsole. Refer to section Tympanometry mode for further information on the tympanometry mode screen. 14

15 Technical specifications Device compliance Tympanometer IEC :2004, Type 2 ANSI S (R2012), Type 2 Electrical safety EMC IEC :2005, Class II, Type B applied parts, IPX0 IEC :2007, Class A Tympanometer performance Measuring system Probe signal Pure tone frequency: 226 Hz ± 2 % Measurement range 0 cm cm 3 Total harmonic distortion: < 3 % Level: 85 db SPL ± 3 db Accuracy of measurement Pressure range Accuracy of relative pressure indicator ± 5 % or ± 0.1 cm 3, whichever is greater -300 dapa 200 dapa ± 10 dapa or 15 %, whichever is greater Rate of pressure change 200 dapa/s ± 15 % Ipsilateral- and contralateral stimulation Pure tone signals 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz and 4000 Hz ± 3 % Pure tone harmonic distortion: TDH-39P: <2.5 % Probe: <5 % Probe-type level range 500 Hz 4000 Hz: 80 db 110 db HL, 5 db/step Probe-type accuracy 500 Hz 2000 Hz: ± 5 db 3000 Hz 4000 Hz: + 5/-10 db TDH-39P level range 500 Hz 4000 Hz: 80 db 110 db HL, 5 db/step TDH-39P accuracy 500 Hz 4000 Hz: ± 3 db Stimulus presentation control On-off and Signal-to-noise ratio A weighted SPL in off-position Rise and fall time 70 db < 25 db < 100 ms RETSPL values RETSPL in accordance with ISO 389-2:1997 and ANSI S Frequency [Hz] IEC supra-aural phone type Ref.: 20 µpa [db] Acoustic coupler (IEC 126) Ref.: 20 µpa [db]

16 Warm-up time < 10 minutes Earphone sound attenuation Device specifications Applied parts Frequency [Hz] TDH-39P with MX41/AR [db] Contralateral headset and ear tip Transducers TDH-39 Static force 4.5 N ±0.5 N Power supply GlobTek model GTM , Compliance: IEC :2015+A1:2012 Input: VAC, Hz, 0.6 A ±10% Output: 12 VDC, 2.08 A, <25 W Protection class: Class II PC connection Data storage USB 200 measurements Environmental conditions for operation Mode of operation Continuous operation Ambient temperature Relative humidity Ambient pressure 15 C to 35 C (59 F to 95 F) 30 % RH 90 % RH (non-condensing) 700 hpa to 1060 hpa Environmental conditions for storage & transport Ambient temperature Relative humidity Ambient pressure -20 C to 60 C (-4 F to 140 F) 90% or less (non-condensing) 700 hpa to 1060 hpa Physical characteristics Dimensions 315 mm x 180 mm x 55 mm (12.4 in x 7 in x 2.1 in ) 16

17 Accessories & detachable parts Included in package Optional parts Probe Contralateral headset Eartip box Power supply Calibration cavities Carrying bag USB cable AudioConsole software Paper for internal printer (item no ) Warning and safety notices Warning No modifications of the device nor accessories are allowed. Safety notices Place the device at least 1 meter from the patient. Always use accessories supplied by the manufacturer. Maintenance & calibration It is recommended to have the device calibrated every other year by Inmedico A/S or a technician authorised by Inmedico A/S. Contact your Oscilla distributor for further information regarding calibration. Cleaning The patient responder, patient headset, probe and contralateral headset need to be cleaned on a regular basis for hygienic reasons. The parts can be cleaned with disinfecting wipes or a cloth wrung in lukewarm water with soap or dishwashing liquid. Disconnect the parts from the device before cleaning. Ensure that they are dry before re-connecting. Shipping recommendations The device should be packed in a manner, which prevents it from being damaged during transportation. For example, the device can be packed in bubble wrap and shipped in an ordinary cardboard box or similar. Disposal According to Directive 2012/19/EU (WEEE) and local regulations, the device including accessories can be disposed of as normal electronic waste. 17

18 Symbols Manufacturer Serial number Catalogue/product number Caution Follow instruction for use Consult instruction for use Type B applied part Direct current Medical device according to Medical Device Directive 93/42/EEC. Humidity limitation Atmospheric pressure limitation Temperature limit The device must be recycled or disposed of in a proper manner in accordance with the WEEE Directive 2012/19/EU. 18

19 EMC TSM400 is an electro-medical device and is therefore subject to special safety precautions. For this reason, the installation and operating instructions provided in this document must be followed closely. Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of TSM400. Guidance and manufacturer s declaration electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Class A Not applicable Not applicable The device is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the device or shielding the location. Guidance and manufacturer s declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC ± 6 kv contact ± 8 kv air ± 6 kv contact ± 8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Electrical fast transient/burst IEC ± 2 kv for power supply lines ± 1 kv for input/output lines ± 2 kv for power supply lines ± 1 kv for input/output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC Voltage dips, short interruptions and voltage variations on power supply input lines IEC Power frequency (50/60 Hz) magnetic field IEC ± 1 kv differential mode ± 2 kv common mode <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycle 70 % UT (30 % dip in UT) for 25 cycle <5 % UT (>95 % dip in UT) for 5 sec 3 A/m 3 A/m ± 1 kv differential mode ± 2 kv common mode <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycle 70 % UT (30 % dip in UT) for 25 cycle <5 % UT (>95 % dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power source or battery. Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment. Conducted RF IEC Radiated RF IEC Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz 3 Vrms 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 19

20 Recommended separation distance d = 1.17 P d = 1.17 P 80 MHz to 800 MHz d = 2.33 P 800 MHz to 2.5 MHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol: Note: UT is the AC mains voltage prior to application of the test level. At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people a b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 20

21 Responsibility of the manufacturer The manufacturer is only responsible for the safety, reliability and performance of the device if: All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the device manufacturer or by personnel authorized by the manufacturer. The electrical installation, to which the device is connected, complies with EN/IEC requirements. The device is used in accordance with the instructions for use. The manufacturer reserves the right to waive all responsibility for the operating safety, reliability and performance of devices serviced or repaired by unauthorised parties. Service manual may be supplied upon request. Manufacturer Inmedico A/S Johann Gutenbergs Vej 3 DK-8200 Aarhus N Denmark support@oscillahearing.com 21