Zeiss VISULAS green, Manual

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Documentation set 11 Technical specifications
VISULAS green 11.1 Risk-relevant performance features of clinical functions
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11 Technical specifications
11.1 Risk-relevant performance features of clinical
functions
• No undesired laser shot and no parameter change in "Treat"
step (READY mode)
• No power deviation of more than 20 % without warning
message and no power deviation of more than 50 % without
error message in active shooting mode
• Accurate positioning of laser beam
• Possibility to stop laser emission in hazardous situations
• Protective means to limit laser radiation in viewing optics
11.2 Compliance
This declaration shall be rendered invalid if changes are made to
the device without the manufacturer’s authorization.
11.2.1 Guidelines with which the system is compliant
The system complies with EU Medical Device Directive 93/42/EEC:
Class II b
It is marked with
11.2.2 The device fulfills the requirements of the following
standards
• IEC 60601-2-22
11.2.3 System classification
The system is classified as follows:
Device class according to MDD: IIb
UMDNS No. 17-446 (VISULAS green)
11.2.4 RoHS Conformity
The product is compliant to RoHS according to directive
2011/65/EU.