4.4 Electrical Safety Test - Medical Electrical System
Interval
The test is mandatory when creating a medical electrical system according to IEC 60601-1 or IEC
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.
For sustained safety of each piece of equipment and the combination thereof, a yearly
electrical safety test is required.
Scope
The test must include all the items specified on the safety inspection form (see from page 58). In
addition to the safety inspection form, the safety inspection also comprises the further inspections
described starting on page 81.
Inspections by Non-Brainlab Personnel
Only trained and skilled personnel are allowed to perform electrical safety tests.
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
understood the user guides.
• Is up-to-date with current local regulations regarding industrial and non-industrial accident
prevention.
• Informs Brainlab immediately in writing if the equipment is deemed unsafe.
Inspections by Brainlab Personnel
• If a suitably qualified person is not available at the customer site, Brainlab support will perform
this inspection for a set fee.
• If you require a Brainlab support specialist, contact Brainlab support.
Electrical Safety Test - Medical Electrical System
56 Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2
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