Regulatory Information - Brainlab ROBOTICS VERO Hardware User's Manual

REGULATORY INFORMATION

4 REGULATORY
INFORMATION
4.1 Regulatory Information
Compliances
Robotics Vero is compliant to the requirements of:
• IEC 60601-1, Medical electrical equipment - General requirements for basic safety and
essential performance*
• IEC 60601-1-1, Medical electrical equipment - Part 1-1: General requirements for safety -
Collateral standard: Safety requirements for medical electrical systems
• IEC 60601-1-2, Medical electrical equipment - Collateral standard: Electromagnetic
compatibility - Requirements and tests
• IEC 60601-1-4, Medical electrical equipment - Collateral Standard: Programmable electrical
medical systems
• IEC 60601-1-6, Medical electrical equipment - Collateral standard: Usability
• IEC 60601-2-1, Medical electrical equipment - Particular requirements for the basic safety and
essential performance of electron accelerators in the range 1 MeV to 50 MeV
• R&TTE Directive 1999/5/EC - EN 300 328
Robotics Vero is classified as Type B applied part with internal power source (IEC 60601-1,
Medical electrical equipment - General requirements for safety). Connection to mains supply by
Class-II power supply.
* 2nd edition (1998 / +A1 / +A2) and 3rd edition (2005-12 / +C1 / +C2)
Brainlab assumes responsibility for the correct installation of the device Robotics Vero and its
sub-components according IEC 60601-1. This includes compliance with leakage-currents as
specified herein for the device (applied part).
By integrating Robotics Vero into the linear accelerator system a medical electrical system is
created the responsibility of which lies in the area of authority of the operator of the system.
Corresponding acceptance testing for the medical electrical system according to IEC 60601-1-1
shall be carried out by the operator of the system before clinical use. In request to compliance to
other regional standards please contact your Brainlab sales partner
Warranty
Warranties do not apply to products that have been damaged by abuse, accident, misuse,
misapplication, improper re-installation, or inadequate packaging for return shipment.
Warranties do not apply to products that have been modified or replaced without written
authorization by Brainlab.
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