Technical Specifications - Interacoustics Titan IMP440 Setup & Installation

3 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
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:
Setup and Installation Manual
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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