Robotics Vero Safety Technical Inspection; Sti - Safety Technical Inspection Requirements - Brainlab ROBOTICS VERO Hardware User's Manual

ROBOTICS VERO SAFETY TECHNICAL INSPECTION

3 ROBOTICS VERO SAFETY
TECHNICAL INSPECTION
3.1

STI - Safety Technical Inspection Requirements

Scope and Interval
The device shall be subjected to regular quality assurance inspection, at least once a year, based
on the requirements of IEC 62353 (IEC 62353 / Medical Electrical Equipment - Recurrent Test
And Test After Repair Of Medical Electrical Equipment).
For a detailed list of mandatory Safety Technical Inspections. requirements refer to the current
version of 'Technical Leaflet -STI Robotics Vero'.
Safety Inspection Record
All tests performed during the safety technical inspection shall be documented comprehensively.
Inspections by Brainlab Personnel
If a service contract has been purchased, a Brainlab support specialist will carry out the Safety
Technical Inspection as part of the annual PMI.
If you do not have a service contract, contact Brainlab support to arrange the inspection for a set
fee.
Suitability of Inspection Personnel
The safety technical inspection must be performed by authorized qualified personnel who:
• Are qualified for carrying out safety inspections on electrical medical equipment.
• Are familiar with the product safety information and product instructions, and has read and
understood the user guides.
• Are up-to-date with current local regulations regarding industrial and non-industrial accident
prevention.
• Inform Brainlab immediately in writing if the equipment is deemed unsafe
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 45