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Titan Instructions for Use - EN
5 General Technical Specification
Titan Hardware – Technical Specifications
Medical CE-mark
The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical
Device Directive 93/42/EEC.
Approval of the quality system is made by TÜV – identification no0123
Standards
Safety:
EMC:
Impedance:
Test Signal:
OAE:
ABR:
Cradle
Safety:
Power
Mains voltages and
frequencies:
Consumption:
Battery
Use only:
Operation environment
Temperature:
Relative Humidity:
Ambient Pressure:
Warm-up Time:
Transport & Storage
Storage Temperature:
Transport Temperature:
Rel. Humidity:
Impedance Measuring System
Probe tone
Frequency:
Level:
Air pressure
Control:
Indicator:
Range:
Pressure limitation:
Pressure change rate:
Compliance
Range:
Test types
Tympanometry
Eustachian tube function 1 –
Non perforated eardrum
Eustachian tube function 2 –
Perforated eardrum
Eustachian tube function 3 –
Patulous Eustachian tube
Indicators
Graphical display
Memory
Tympanometry:
There is no deviation between static and dynamic mode.
IEC 60601-1, Internally powered, Type B and BF applied parts
IEC 60601-1-2
IEC 60645-5/ANSI S3.39, Type 1
IEC 60645-1/ANSI S3.6 , IEC 60645-3
IEC 60645-6 2009, Type 2 Otoacoustic emissions
IEC 60645-7 2009, Type 2
IEC 60601-1, Class II
Astrodyne ASA30M-0301 or UE24WCP
100 – 240 VAC, 47 – 63 Hz
0.8 – 0.4 A
NP120 or CGA103450
15 – 35 °C
30 – 90%
98kPa – 104kPa
1 minute
0°C – 50°C
-20 – 50 °C
10 – 95%
Classic tympanometry: 226 Hz, 678 Hz, 800 Hz, 1000 Hz; pure
tones; AGC controlled to protect for loud probe tone stimuli in small
ear canals.
WBT: 226 Hz – 8000 Hz broadband stimulus, 21.5/sec.
226 Hz: 85 dB SPL (≈ 69 dB HL)
WBT: 96 dB peSPL (infant) / 100 dB peSPL (adult). (100 dB peSPL
≈ 65 dB nHL)
Automatic.
Measured value is displayed on the graphical display.
-600 to +300 daPa.
-750 daPa and +550 daPa.
Minimum, medium, maximum or automatic with minimum speed at
compliance peak. Selectable in the setup.
0.1 to 8.0 ml at 226 Hz probe tone (Ear volume: 0.1 to 8.0 ml) and 0.1
to 15 mmho at 678, 800 and 1000 Hz probe tone.
Automatic, where the start and stop pressure can be user-
programmed in the setup function.
Manual control of all functions.
Williams test
Toynbee test
Continuous sensitive impedance measurement for 30 up to 150 s.
Compliance is indicated as ml and pressure as daPa. In PC
controlled mode admittance, susceptance and conductance can be
printed.
Stimulus level is indicated as dB Hearing Level.
1 curve per ear per tympanometry test. 3 curves per ear per
Eustachian tube function test. And theoretically an infinite number of
tests per protocol.
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