B-K Medical Pro Focus 2202, User Manual

Page: 27 / 356

General and Safety Information 27
Prudent Use
Exposure
level
•
Scan patients only when clinical reasons make it necessary.
•
Keep exposure time as short as possible.
•
Be careful to prepare the patient correctly so that you get the best possible
image.
• Start scanning at a low acoustic output level (see “Thermal and Mechanical
Indices” on page 28) and increase the level only as much as necessary to obtain
a satisfactory image.
• If you switch from an application requiring high acoustic output levels (see
“Functions Affecting Acoustic Output” on page 29), to one that requires lower
levels (fetal scanning, for example), be sure to reset the levels before you scan.
(For example, start in B-mode.)
•
Take into account all the types of tissue that may be affected. For example, when
scanning a breast, it may be appropriate to monitor the TI in bone rather than in
soft tissue because the ribs will be subjected to ultrasound.
Training
requirements
Acoustic output data for transducers used with the scanner are given on a CD
(BZ2100) that accompanies this user guide. The uncertainty level for each parameter
measured is listed in the user guide for each transducer. For definitions of the
parameters, refer to the Food and Drug Administration (FDA) Guide [7] as well as
EN 60601-2-37 [3] and AIUM/NEMA standards [8,9].
In North America, the FDA requires all ultrasound equipment to be cleared before it
is marketed in the United States.
The routes (or tracks) available for clearance by the FDA are well-defined. Track 3
is for diagnostic ultrasound systems that follow the Output Display Standard. Under
Track 3, acoustic output will not be evaluated on an application-specific basis, but
the maximum derated Spatial Peak–Temporal Average Intensity (I
SPTA
) must be
≤
720mW/cm
2
, the maximum Mechanical Index (MI) must be
≤
1.9, and the
maximum Thermal Index (TI) must be
≤
6. All B-K Medical transducers for use with
the Pro Focus 2202 Ultrasound Scanner are Track 3.
WARNING Always keep the exposure level (the acoustic output level and the
exposure time) as low as possible.
WARNING Before attempting to use B-K Medical equipment, you should be trained in
ultrasonography or be under the supervision of someone who is trained in
ultrasonography. You should also be thoroughly familiar with the safe operation of your
ultrasound system and should always use the transducer best suited to the
examination.