Test Requirements; Overview - Brainlab Buzz 2.0 System And Technical User Manual

Test Requirements

5.2 Test Requirements
5.2.1

Overview

Interval
The recurrent test should be performed once annually or if the equipment is repaired or modified.
The recurrent test is mandatory for medical electrical equipment and when creating a medical
electrical system according to IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1,
respectively.
Repeat this test any time the medical electrical equipment or 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 the equipment, a yearly electrical safety test according to IEC 62353 is
required. For an ME SYSTEM or permanently installed equipment, an electrical safety test
according to IEC 60601-1 may be required.
NOTE: Local regulations, national deviations and requirements that vary from these standards
take precedent.
Scope
The test must include all the items specified in the safety inspection form as well as in this
chapter.
Each piece of equipment of the ME SYSTEM that has its own connection to mains supply, or
which can be connected/disconnected from mains supply without the use of a tool, must be tested
individually. Additionally, the ME SYSTEM must be tested as a whole to avoid that an aging
component causes unacceptable values.
If items of ME EQUIPMENT that are combined into an ME SYSTEM by functional connections
cannot be tested separately for technical reasons, test the complete ME SYSTEM.
In addition, Brainlab support or authorized partners shall regularly clean air intake filters and
exchange the battery when necessary.
Inspections by Non-Brainlab Personnel
Only qualified, trained and skilled personnel are allowed to perform electrical safety tests.
Qualification shall include training on the subject, test equipment, knowledge, experience and
acquaintance with the relevant technologies, standards and local regulations. Personnel
assessing the safety must be able to recognize possible consequences and risks arising from
non-conforming equipment.
Brainlab must be informed immediately in writing if 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
Safety Inspection on page 79
Testing Overview on page 67
66 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0