GE Vscan Air User Manual

Important safety considerations
Vscan Air – User Manual 2-17
Direction GP092020-1EN Rev 18
Essential Performance
The essential performance of the Vscan Air CL is:
•
The ability to display physio
logical images as input for
d
iagnosis by qualified and trained healthcare professionals.
•
The ability to display quantified data as input for diagnosi
s
by
qualified and trained healthcare professionals.
•
The display of ultrasound indices as aid for safe use of the
Vscan Air CL.
Acoustic output
Definition of the acoustic output parameters
Thermal Index
TI is an estimate of the temperature increase of soft tissue or
bone. There are three thermal index categories:
•
TIS: Soft tissue thermal index. The main TI category. Us
ed
for
applications that do not image bone.
•
TIB: Bone thermal index (bone located in a focal region)
.
Used
for fetal application.
•
TIC: Cranial bone thermal index (bone located close to the
surface). Used for transcranial application.
Reference to calculation of TI can be found in:
•
EN/IEC 60601-2-37. Medical electrical equipmen
t.
Par
t 2-37: Requirements for the safety of ultrasonic me
dical
d
iagnostic and monitoring equipment
•
EN/IEC62359: Test methods for the determination
of
th
ermal and mechanical indices related to medica
l
d
iagnostic ultrasound fields.
Mechanical Index
MI is the estimated likelihood of tissue damage due to cavitation.
The absolute maximum limit of the MI is 1.9 as set by the FDA
guidance of June 27, 2019 for diagnostic ultrasound systems
and transducers.

GE Vscan Air Specifications

General

Brand	GE
Model	Vscan Air
Category	Medical Equipment
Language	English