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EyeSeeCam vHIT Instructions for Use – EN

6 Technical information

Medical CE-mark:
Standards:
Operating environment
Transport & Storage
PC Interface
USB supply
Camera
Goggle
Weight
Calibration
Sample rate
Head tracking sensor
Gain
Data Analysis
System Requirements:
PC Hardware
PC Software
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 no. 0123
Safety:
EMC:
Temperature:
Relative Humidity:
Ambient Pressure:
Storage Temperature:
Transport
Temperature:
Relative Humidity:
USB 2.0
5VDC ±0.25VDC
Monocular camera, interchangeable between left
and right eye
Molded, flexible frame with snug fit, cleanable
silicone contact areas. Fits pediatric and adult
faces.
Goggle: 40g
Camera: 32g
Combined weight: 72g
Goggle mounted laser with 5-point calibration
220 Hz
Inertial Measurement Unit (IMU) gyroscope with 6
degrees of freedom
Instantaneous gain at 40, 60 and 80 ms –
equivalent to scleral search coil method.
Velocity Regression Plot, Gain Plot
Intel Core i3 processor 2.53 GHz or better
Minimum 8 GB RAM
One USB 2.0 port available
Windows®10 (32-bit or 64-bit)
Windows®8 (32-bit or 64-bit) Professional
Windows®7 (32-bit or 64-bit) Professional
IEC 60601-1, Class II, Type B, applied parts
IEC 60601-1-2
15 - 35 °C
30 – 90%
98 kPa – 104 kPa
0 - 50 °C
-20 - 50 °C
10 – 95%
Page 45

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