Visionix EyeRefract - Conformity to Directives and Standards

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Visionix EyeRefract User Guide
86
Appendices
Operating system
Windows 8
Output
RS232
1
USB2.0
7 internal, 4 external for maintenance
Internal as follows:
2 for SH cameras
2 for VISU cameras
1 for communications with the heads
1 for the printer
1 for charging the tablet
External for connecting a keyboard, mouse, or
USB dongle
VGA
1 (For maintenance)
LAN
1 (For communication with other devices and
for maintenance)
Electrical
Power source/consumption
100-240 Vac, 50/60 Hz
Controller voltage
24VDC 6.3A
7. 2 Conformity to Directives and Standards
The Eye Refract complies with CE medical device directive 93/42/EC, amended by
2007/47/EC, and is in class 2 (rule 10).
IEC60601-1 (2005) and A1 (2012): Medical electrical equipment - Part 1: General
requirements for basic safety and essential electrical safety performance.
IEC60601-1-2 (2007): Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility – Requirements and tests.
Lifetime of the product: 7 years
First CE marking: 2015-12
User manual publication date: 14-March-2022