Intended Use; Using The System - Brainlab EXACTRAC INFRARED MONITORING Clinical User Manual

1.4

Intended Use

1.4.1

Using the System

Indications for Use This submission describes a system that is intended to be used to place patients at the isocenter of
a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The ExacTrac system
uses optical tracking of infrared reflecting markers as the method of locating the position of the pa-
tient. The ExacTrac system consists of infrared cameras, computer workstation, reflective markers
and calibrations tools.
Careful Hardware
Handling
Operator Profile
Symbols on
Hardware
Components
Plausibility Review
Clinical User Guide Rev. 1.1, ExacTrac Infrared Monitoring Ver. 1.0
System components and accessory instrumentation comprise precise mechanical
parts. Handle them carefully.
Only trained medical personnel may operate system components and accessory in-
strumentation.
ExacTrac system components and accessory devices may only be operated by trained
medical personnel.
Symbol Explanation
Class I Type B equipment according to IEC 60601-1
s
Attention! Consult accompanying documents
Before patient treatment, review the plausibility of all information input to and output
from the system.
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