Interacoustics Titan - 5 General Technical Specification; 5.1 Titan Hardware - Technical Specifications

Titan Instructions for Use - EN Page 91
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:
IEC 60601-1, Internally powered, Type B and BF applied parts
EMC:
IEC 60601-1-2
Impedance:
IEC 60645-5/ANSI S3.39, Type 1
Test Signal:
IEC 60645-1/ANSI S3.6 , IEC 60645-3
OAE:
IEC 60645-6 2009, Type 2 Otoacoustic emissions
ABR:
IEC 60645-7 2009, Type 2
Cradle
Safety:
Power
Mains voltages and
frequencies:
Consumption:
IEC 60601-1, Class II
Astrodyne ASA30M-0301 or UE24WCP
100 – 240 VAC, 47 – 63 Hz
0.8 – 0.4 A
Battery
Use only:
NP120 or CGA103450
Operation environment
Temperature:
15 – 35 °C
Relative Humidity:
30 – 90%
Ambient Pressure:
98kPa – 104kPa
Warm-up Time:
1 minute
Transport & Storage Storage Temperature:
Transport Temperature:
Rel. Humidity:
0°C – 50°C
-20 – 50 °C
10 – 95%
Impedance Measuring System
Probe tone
Frequency:
Level:
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)
Air pressure
Control:
Indicator:
Range:
Pressure limitation:
Pressure change rate:
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.
Compliance Range:
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.
Test types Tympanometry
Automatic, where the start and stop pressure can be user-
programmed in the setup function.
Manual control of all functions.
Eustachian tube function 1 –
Non perforated eardrum
Williams test
Eustachian tube function 2 –
Perforated eardrum
Toynbee test
Eustachian tube function 3 –
Patulous Eustachian tube
Continuous sensitive impedance measurement for 30 up to 150 s.
Indicators Graphical display
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.
Memory Tympanometry:
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.
There is no deviation between static and dynamic mode.