Technical Specifications - Interacoustics Titan Gebrauchsanweisung

1.13 Technical Specifications

Medical CE-mark:
Standards:
Cradle
Operation
environment:
Storing/handling:
Transport:
Impedance Measuring System
Probe tone:
Air pressure:
Compliance:
Test types:
Indicators:
Memory:
There is no deviation between static and dynamic mode.
Titan Instruction for Use - English
Date: 2011-06-06
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
Safety:
EMC:
Impedance:
Test Signal:
OAE:
ABR:
Safety:
Power
Mains voltages and
frequencies:
Consumption:
Temperature:
Rel. Humidity:
Temperature:
Rel. Humidity:
Frequency:
Level:
Control:
Indicator:
Range:
Pressure limitation:
Pressure change rate:
Range:
Tympanometry
Eustachian tube function 1
– Non perforated eardrum
Eustachian tube function 2
– Perforated eardrum
Eustachian tube function 3
– Patulous Eustachian
tube
Graphical display
Tympanometry:
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
100 – 240 VAC, 47 – 63 Hz
0.8 – 0.4 A
15 – 35 C
30 – 90%
Temperatures below 0C and above 50C may cause
permanent damage to the instrument and its accessories.
-20 – 50 C
10 – 95%
226 Hz, 678 Hz, 800 Hz, 1000 Hz
69 dB HL with AGC, assuring constant level at different ear
canal volumes.
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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