Technical Specifications; Risk-Relevant Performance Features Of Clinical Functions; Compliance; Guidelines With Which The System Is Compliant - Zeiss VISULAS green Manual

Documentation set
VISULAS green
000000-2096-101-DokS-GB-181218

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:
UMDNS No.

11.2.4 RoHS Conformity

The product is compliant to RoHS according to directive
2011/65/EU.

11.1 Risk-relevant performance features of clinical functions

IIb
17-446 (VISULAS green)
11 Technical specifications
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