Bard Site-Rite 5, Инструкция по эксплуатации, Страница: 35 / 40

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Site~Rite*­5 Ultrasound System
**Abdominal, Intraoperative, Pediatric, Small Organ (breast, thyroid, testes, etc.), Neonatal Cephalic, Adult Cephalic.
All measurements were conducted in accordance with the measurement procedures of the NEMA Standard Publications UD-2 [1]
and UD-3 [2], and following the calibration procedures given in Appendices B, C, D and E of the 1985 FDA 510(k) Guide, and Part
A, Sections III-IV, and Appendices A, B, C and D of the 1989 FDA 510(k) Guide, and the Track 1 and Track 3 reporting require-
ments of the September 30, 1997 Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Transducers
Caution
: The adverse biological effects of ultrasound on tissue appear to be threshold effects. When
tissue is repeatedly exposed to ultrasound, with intervals in between, there will likely be no
cumulative biological effect. If however a certain threshold has been passed biological
effects may occur. While the Site~Rite 5 acoustic output parameters fall well below all FDA
thresholds for adverse biological effects, any given Ultrasound Procedure should be per-
formed using the principle of ALARA (As Low As Reasonably Achievable). The licensed
medical practitioner should limit the time of patient exposure to ultrasonic radiation using
the principle of ALARA.
The system meets the output display standard for mechanical index (MI). A real time display of the MI
is located in the upper left hand corner of the screen. The MI is displayed in increments of .1 with an ac-
curacy of +/- .09. This index is modified as the system focus is changed with the "CM" button on the front
panel. For more in-depth information concerning what the MI values mean see the following reference:
- Duck F.A., The Meaning of Thermal Index (TI) and Mechanical Index (MI) values, BMUS Bulletin, Nov. 1997, p. 36-40.
9.
­­­Probe­Specifications
L-VA : Linear Vascular Access Probe
Frequency: 5 -10 MHz
Elevation Focus: 1.8 cm
Maximum Scan Depth: 6.0 cm
Scan Width: 1.9 cm
Lateral Foci:
Image Depth Focal Depth
1.5 cm 0.6 cm
3.0 cm 1.5 cm
4.5 cm 3.0 cm
6.0 cm 5.0 cm