Probe Acoustic Output Specifications - Bard Site-Rite 6 Instructions For Use Manual

32
Site~Rite * 6 Ultrasound System
12.3

Probe Acoustic Output Specifications

REF Number
9770001
9772002
**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.
I spta.X
Operating (X denotes statisti-
Mode cally determined
maximum)
49.003 mW/cm 2
B
2
24.5 mW/cm
B
MI X
FDA I spta.3 (X denotes
Published statistically
Values determined
maximum)
Peripheral Vessel
< 720 mW/cm 2
Cardiac
.885
< 430 mW/cm 2
Fetal Imaging & Other**
< 94 mW/cm 2
Peripheral Vessel
< 720 mW/cm 2
Cardiac
.993
< 430 mW/cm 2
Fetal Imaging & Other**
< 94 mW/cm 2
FDA MI
Published Values
Peripheral Vessel
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
< 1.9
Peripheral Vessel
< 1.9
Cardiac
< 1.9
Fetal Imaging & Other**
< 1.9