Technical Specifications - Interacoustics MT10 Instructions D'utilisation

5. Technical Specifications

"The technical specifications provided here cover the general aspects of the instrument. The MT10
Tympanometer is classified as a Class II a device under Annex IX (Section 1) of the EU Medical
Devices Directive. It is intended fortransient use as a screening tympanometer instrument
Tympanometry
Instrument type
Analysis performed
Probe tone levels and accuracy
Pressure levels and accuracy
Ear volume measurement range
and accuracy
Sweep speed
Pressure limits (safety cutout)
Number of samples stored
Optional:
Reflex measurements
Measurement modes
Reflex tone levels and accuracy
Reflex measurement range and
accuracy
Number of reflex levels
Reflex analysis
Pressure used for reflex
measurement
Reflex level cut-off
Reflex threshold detection
Reflex tone duration
Number of records stored in Patient
Database
Data storage
Data held
Display mode
Real Time Clock
Time stamps
Backup power supply
Languages
Operating languages
Printing
Supported printer
Interface
Information printed
MT10 Instruction for Use - English
Date: 2012-05-01
Screening tympanometer
Compliance peak level (in ml). Pressure of same; Gradient (in daPa);
Ear Canal Volume (ECV) @ 200 daPa.
226Hz +/-2%; 85dB SPL +/-2dB over range 0.2ml to 5 ml.
+200daPa to -400 daPa +/-10daPa or +/-10% (whichever is larger) over
range.
0.2ml to 5ml +/-0.1ml or +/-5% (whichever is larger) over entire range.
Typically 200-300daPa/sec; dependant on ear&cavity volume.
+600 to -800daPa
100 per tympanogram
Ipsilateral optional
500Hz, 1kHz, 2kHz, 4kHz
Frequency +/-2%, configurable over range 70dB to 100dB HL (4kHz
restricted to 95dBHL) +/-2dB, referenced to 2ml calibration volume;
Compensates for measured ear volume.
0.01ml to 0.5ml +/-0.01ml configurable in 0.01ml steps.
Four: 100dB with 5dB or 10dB steps;
95dB, 90dB or 85dB with 5dB steps.
Reflex pass/fail at each level tested;
Maximum amplitude of each reflex (seen on printed report and PC report);
Pressure at which reflex was performed.
Pressure at Tympanogram peak, or 0daPa (Always and Prompt Before
Each Test modes)
Optionally, Auto-stop when reflex found.
Configurable 0.01-0.50ml in 0.01ml increments.
0.6 seconds.
30
Any recording can be stored once the tympanogram is viewed. Patient
Initials (A-Z, 0-9, "-") must be entered before storage.
Patient Initials, Tympanogram and Reflex graphs and analysis for Left Ear
and/or Right Ear, Time and Date of recording, which ears were tested,
whether or not the record has been printed and /or sent to a PC,
parameters printed and/or sent to a PC, parameters used for analysis,
128 bit Globally Unique Idenfitier (GUID).
Records listed in reverse chronological order (latest first), with indication
of date stored as described above.
Time and date stamp applied to all recordings, and to the last calibration
date.
>30 days without main batteries fitted.
English, German or French
Sanibel MPTII.
Infra-red, IrDA hardware, 9600 baud.
Space for patient and clinician's details, Tympanogram analysis
parameters, Tympanogram, Reflex analysis parameters, Reflex graph,
Serial Number of device, Last and Next Due Calibration dates.
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