Bard Site-Rite 6 - Probe Acoustic Output Data

32
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
I
spta.X
(X denotes statisti-
cally determined
maximum)
FDA I
spta.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/cm
2
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/cm
2
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