Specifications; At235 Technical Specifications - Interacoustics AT235 Instructions For Use Manual

AT235 Instructions for Use - EN

5 Specifications

5.1 AT235 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:
Audiometer:
Operation Temperature:
environment:
Relative Humidity:
Ambient Pressure:
Warm-up Time:
Transport & Storage: Storage Temperature:
Transport Temperature:
Rel. Humidity:
Internal Battery
Impedance Measuring System
Probe tone: Frequency:
Level:
Air pressure: Control:
Indicator:
Range:
Pressure limitation:
Compliance: Range:
Test types: Tympanometry
IEC 60601-1, Class I, Type B applied parts
IEC 60601-1-2
IEC 60645-5/ANSI S3.39, Type 1
IEC60645-1/ANSI S3.6, Type 4
15 – 35 °C
30 – 90%
98kPa – 104kPa
1 minute
0°C – 50°C
-20 – 50 °C
10 – 95%
CR2032 3V, 230mAh, Li. Not serviceable by user.
226 Hz, 678 Hz, 800 Hz, 1000 Hz; pure tones; ±1%
85 dB SPL (≈ 69 dB HL) ±1.5 dB
Automatic.
Measured value is displayed on the graphical display.
-600 to +400 daPa. ±5%
-750 daPa and +550 daPa.
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. All ±5%
Automatic, where the start and stop pressure can be
user-programmed in the setup function.
Manual control of all functions.
Page 45