Bard 9770000, Инструкция по эксплуатации, Страница: 34 / 44

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Site~Rite* 6 Ultrasound System
12.3
Probe Acoustic Output Specifications
**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
and UD-3, 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 requirements
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* 6 Ultrasound System acoustic output parameters
fall well below all FDA thresholds for adverse biological effects, any given ultrasound
procedure should be performed 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.
REF Number
Operating
Mode
Ispta.X
(X denotes statisti-
cally determined
maximum)
FDA Ispta.3
Published
Values
MI X
(X denotes
statistically
determined
maximum)
FDA MI
Published Values
9770001 B 49.003 mW/cm
2
Peripheral Vessel
< 720 mW/cm2
Cardiac
< 430 mW/cm
2
Fetal Imaging & Other**
< 94 mW/cm
2
.885
Peripheral Vessel
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
< 1.9
9772002 B
24.5 mW/cm
2
Peripheral Vessel
< 720 mW/cm2
Cardiac
< 430 mW/cm
2
Fetal Imaging & Other**
< 94 mW/cm
2
.993
Peripheral Vessel
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
< 1.9