Brainlab VECTORVISION Series Technical User Manual page 154

Electrical Safety Test - Medical Electrical System
11.5 Electrical Safety Test - Medical Electrical System
11.5.1 Overview
The test is mandatory when creating a medical electrical system according to IEC 60601-1 or IEC
Interval
60601-1-1 respectively.
Repeat this test any time the medical electrical system setup is changed, e.g., after repair of one or
all combined equipment or after the exchange of equipment components like cables.
The test must include all the items specified on the safety inspection form (see from page 156).
Scope
Inspections by
Non-Brainlab
Personnel
The test must be performed by a qualified engineer who:
• Is qualified to carry out safety inspections on electrical medical equipment.
• Is familiar with the product safety information and product instructions, and has read and under-
• Is up-to-date with current local regulations regarding industrial and non-industrial accident pre-
• Informs Brainlab immediately in writing if the equipment is deemed unsafe.
• If a suitably qualified person is not available at the customer site, Brainlab support will perform
Inspections by
Brainlab Personnel
• If you require a Brainlab support specialist, contact Brainlab support.
154
For sustained safety of each piece of equipment and the combination thereof, a yearly
electrical safety test according to IEC 62353 is required.
Only trained and skilled personnel are allowed to perform electrical safety tests.
stood the user guides.
vention.
this inspection for a fee.
Technical User Guide Rev. 2.7 VectorVision & Kolibri