DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
Page
57
of
61
Neither the DYSIS device nor the DYSISmap are diagnosis aids, and even more so, as colposcopy that they are
used for is not intended to provide a direct diagnosis of a patient’s condition.
In conclusion, use of DYSIS Ultra 2.0 Digital Colposcope does not depend on essential performance.
24.
Technical Description
General Information:
•
Product Name: DYSIS Ultra 2.0 Digital Colposcope
•
EC Product Class: Class IIa, FDA Product Class II
Mechanical:
•
Monitor Arm (ARMD) - 5 degrees of freedom (X, Y, Z, tilt and yaw)
•
Imaging Head Arm (ARMO)
–
5 degrees of freedom (X, Y, Z, tilt and yaw)
•
Main Stand with 6 axis wheelbase (BASE)
PC Unit and Monitor:
•
DYSIS proprietary software running on Linux operating system
•
Motherboard: 8
th
Generation core i3 CPU; on-board GPU
•
RAM: 8GB, HDD: 1 Tb, SSD: 256Gb
•
1 x USB port
•
1 x HDMI port
•
1 x Ethernet port
•
Monitor -
15”
touchscreen monitor Full HD 1920x1080P pixels max resolution @ 60Hz
Imaging Head Unit:
•
CMOS sensor
•
Resolution: 2802 x 2100 pixels, >20 frames per second,20-line pairs per mm resolution
•
Digital interface: USB3
DYSIS Ultra 2.0 Digital Colposcope Power/Operation:
•
Frequency: 50/60Hz
•
Rated Input Voltage: 100-240VAC
•
Rated Output: 12VDC
•
Start Up Time to Operation < 1 min
•
Operational Footprint Length, Width, Height (cm): 125 x 70 x 165
•
Idle Footprint - Length, Width, Height (cm): 70 x 70 x 165
•
DYSIS Ultra 2.0 Product Weight: 69 Kg (Plus packaging 80 Kg)
•
Packaging dimensions - Length, Width, Height (cm): 83 x 83 x 143
Each DYSIS Ultra 2.0 Digital Colposcope system is accompanied by:
•
DYSIS acetic acid applicator
•
DYSIS declaration of conformity, EUR
•
DYSIS Ultra 2.0 Digital Colposcope quick reference guide
•
DYSIS calibration card
•
DYSIS calibration jig
