Recurrent Test Requirements; Overview - Brainlab CURVE System And Technical User Manual

Recurrent Test Requirements

10.2 Recurrent Test Requirements
10.2.1

Overview

Interval
The recurrent test should be performed once annually.
For sustained safety of the equipment, a yearly electrical safety test according to IEC 62353
is required.
NOTE: Local regulations and requirements that vary from this standard take precedent.
Alternatively, the test can be performed according to IEC 60601-1.
Scope
The test must include all the items specified on the safety inspection form. In addition to the safety
inspection form, the safety inspection also comprises the further inspections described under the
Maintenance.
In addition, Brainlab service personnel or authorized partners shall regularly clean air intake filters
and exchange the battery when necessary.
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 Support
• 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.
Related Links
10.2.3 Safety Inspection Form - Recurrent Tests on page 148
12.1.3 Further Inspections on page 187
146 System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2