Printer; Cart; Acoustic Output; Acoustic Output Definition - Whale PE-12-025 User Manual

Portable ultrasound diagnostic scanner
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Acoustic Output

2.6.2

Printer

Digital Graphic Printer (Printer A)
Model: UPD897
Input: 100-240V~ 50/60Hz 1.5-0.8A
Video Copy Processor (Printer B)
Model: P93C
Input: 100-240V~ 50/60Hz 0.8A
2.6.3

Cart

Input Rated: 100-240V~, 50/60 Hz
2.7
Acoustic Output
2.7.1

Acoustic Output Definition

Mechanical Index (MI)
MI is the estimated likelihood of tissue damage due to cavitation. The abso-
lute maximum limit of the MI is 1.9 as set by the FDA 510(k) guidance of
1997.
Thermal Index (TI)
TI is an estimate of the temperature increase of soft tissue or bone. There are
three thermal index categories:
Rev 1.00
Connect the power supply of the printer to the respective power recep-
tacle on the Cart. Do not power the printer from other power supply
WARNING
sources.
TIS: soft tissue thermal index. The main TI category. Used for applica-
tions that doesn't image bone.
TIC: cranial bone thermal index (bone located close to the surface).
Used for transcranial application.
TIB: bone thermal index (bone located in a focal region). Used for fetal
application.
Chapter 2 - Safety
19

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