Brainlab VectorVision, Руководство пользователя системы

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76 System User Guide Rev. 1.6 VectorVision
Using VectorVision sky in an iMRI Environment
5.6.3 Disclaimer
Intended Use The VectorVision sky system is intended for use in an MR environment.
Excluded
Responsibility Brainlab is not responsible for:
• Patient/operator safety
• MR compatibility
• MR safety
• Clinical compatibility of any non-Brainlab device, regardless of its origin, that is introduced into
the MR environment
• Assessment of the proper clinical function of any device that was not manufactured by Brainlab.
The manufacturer of the device and/or clinical engineering must make arrangements to test
their device in the MR environment.
MR Environment
and New Devices Before introducing any hardware part or device into the MR environment, regardless of its origin,
have the device inspected by qualified hospital personnel.
Verify the MR compatibility of the device and its clinical operation in the magnetic field before it is
used during an intervention.
The use of any device for animal or human procedures must comply with any applicable governmen-
tal or local institute safety and animal/human committees requirements.
Customer
Responsibility The customer is responsible for having appropriate and valid architectural features and procedures
(screening) incorporated to ensure safe operations of the iMRI environment.
This is especially important with regard to magnetizable materials and electro-magnetically sensitive
electronic devices preventing from entering the MR environment. Such devices can be implanted
metal plates, pacemakers, tools, carts, oxygen tanks, etc.
Reference to FDA Regarding MR safety, refer to the FDA web page.
At the time this manual was written the current link was:
http://www.fda.gov/cdrh/safety/mrisafety.html