Technical Specifications - Interacoustics AT235 Instructions For Use Manual

AT235 Instructions for Use - EN

5 Technical Specifications

General
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
PC control: USB:
Thermal printer Type: MPT-III
(Optional):
UE60
Power supply
Dimensions H x W x L
AT235 Weight
Impedance Measuring System
Probe tone: Frequency:
Level:
Air pressure: Control:
Indicator:
Range:
Pressure limitation:
Pump Speed:
Compliance: Range:
Test types: Tympanometry
Eustachian tube function 1
- Non perforated eardrum
Eustachain tube function 2
- Perforated eardrum
Eustachian tube function 3
- Patulous Eustachian tube
Reflex Functions
IEC 60601-1, Class I, Type B applied parts
IEC 60601-1-2
IEC 60645-5 (2004)/ANSI S3.39 (2012), Type 1
IEC60645-1 (2012)/ANSI S3.6 (2010), 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.
Input/output for computer communication.
Data can be sent to and saved on the PC and stored
in OtoAccess™ (Diagnostic Suite sync module is
required).
Thermal MPT-III printer with recording paper in rolls.
Print on command via USB
Use only specified power supply unit UE60 type
Input: 100-240VAC 50-60Hz, 1.5 A
Output: 24.0 VDC
29 x 38 x 7,5 cm
2.5 kg
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.
Automatic, Fast 300 daPa/s, Medium 200 daPa/s,
Slow 100 daPa/s, Very slow 50 daPa/s.
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.
Williams test
Toynbee test
Continuous sensitive impedance measurement
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