bk ultrasound bk3500, Руководство пользователя

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bk3500 User Guide (16-01410-EN-04) Safety Information 45
Acoustic output data for transducers used with the system are given in the Technical
Data (BZ2100) that accompanies this user guide. The uncertainty level for each
parameter is also listed. For definitions of the parameters, refer to the Food and Drug
Administration (FDA) Guide as well as EN 60601-2-37
(Particular requirements for
the safety of ultrasonic medical diagnostic and monitoring equipment) and
AIUM/NEMA standards.
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 BK transducers for use with the
bk3500 Ultrasound System are Track 3.
Monitor Display
The Mechanical Index (MI) and Thermal Index (TI) can be viewed in all imaging
modes.
Thermal and Mechanical Indices
The MI and TI indices are intended to allow users to implement the ALARA (As
Low As Reasonably Achievable) principle using an indicator related to a potential
bioeffect.
The MI can be adjusted by using the MI image parameter button and the touch screen
dial:
Figure 3-3. The MI image parameter button.
Appropriate
transducer
WARNING AO-w2
To avoid tissue damage, always use the transducer best suited to the examination.