Intended Use - Brainlab ExacTrac Planning Manual

GENERAL INFORMATION
1.3

Intended Use

Indications for Use
ExacTrac is intended for placing patients at an accurately defined point within the treatment beam
of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Treatment
includes lesions, tumors and conditions anywhere in the body where radiation therapy is
indicated. ExacTrac is also used for monitoring the patient position during treatment.
Intended User
The intended users of ExacTrac are medical staff having received dedicated training for this
application, such as:
Title
Radiation Therapist
Radiation Oncologist/Physician
Medical Physicist/Physicist
(This classification depends on country-specific requirements/regulations and might vary from the
classifications above.)
Only trained medical staff may operate system components and accessory
instrumentation.
Known Contra-Indications
To prevent injury to patients wearing pacemakers, contact the pacemaker manufacturer
regarding possible hazards resulting from radiation exposure before commencing patient
treatment.
Place of Use
The application is to be used in the treatment room.
Careful Hardware Handling
System components and accessory instrumentation comprise precise mechanical parts.
Handle them carefully.
Only trained medical personnel may operate system components and accessory
instrumentation.
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from
the system.
No modification of this equipment is allowed.
Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x
Education Actions
Education, training Main workflow
Physician with MD Fusion approval, patient initialization
PhD in medical phys- System Quality Assurance, data
ics handling
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