Brainlab KICK 2, System And Technical User Manual

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User Supposed Roles
Medical Technician
Trained Brainlab employees
Brainlab trained service personnel
Recurrent Test Requirements
Inspections by Non-Brainlab Personnel
Only trained and skilled personnel (in the following named as "medical technician") 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.
• Places system out of operation and marks it as such.
Use Environment
The system is only for use indoors, in a hospital operating room under the following environmental
conditions:
Specification Operating Conditions
Temperature 10 °C (50 °F) to 30 °C (86 °F)
Humidity 30% to 75% non-condensing
Altitude/Pressure
The device can be operated up to 3,000 m above sea level.
NOTE: This equals a range from 700 hPa to 1060 hPa air pressure.
Patient Population
The patient population depends on the application software. For details please refer to the
respective application software documentation.
Expected Service Life
The Monitor Cart and Camera Cart provides an expected service life of eight years. The EM
Tracking Unit provides an expected service life of five years.
Careful Handling of Hardware
The device is a highly sensitive medical device. Handle it with care.
Using the System
14 System and Technical User Guide Rev. 1.0 Kick 2 Navigation Station Ver. 1.1