Bard Site-Rite IV, Руководство пользователя

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0 Site~Rite* IV Ultrasound System Operator’s Manual
Chapter 10: Technical Specifications
10.4 Site~Rite
*
IV Ultrasound System Standards Information
The Site~Rite IV Ultrasound System is designed to comply with applicable sections of the following
International Standards:
- IEC 60601- 1
- IEC 60601- 1- 2 - EN 55011: 2000 Class A
- IEC 60601- 2- 37 - IEC 68- 2- 1 - IEC 68- 2- 2
- IEC 68- 2- 13
NEMA Standard Publications “Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equiptment” UD- 2
NEMA Standard Publications “Standard for Real-Time Display of Thermal and Machanical
Acoustic Output Indices on Diagnostic Ultrasound Equiptment” UD- 3
10.5 Site~Rite
*
IV Ultrasound System Disposal Information
To return the Site~Rite 5 System for end of life recycling, please contact your nearest Bard sales or distribu-
tor office in the country of purchase.
Warning: Always properly dispose of dead battery packs in accordance with local regulations.
Improper disposal may present an enviromental hazard.
10.6 Site~Rite
*
IV Probe Acoustic Output Specifications
Caution:
Any given Ultrasound Procedure should be performed using the principle of ALARA
(As Low As Reasonably Achievable). The Site~Rite IV System holds the acoustic output
of the device constant. The licensed medical practitioner should limit the time of patient
exposure to ultrasonic radiation using the principle of ALARA.
Description
of Probe
I
spta
X
(X denotes
statistically
determined
maximum)
Operating
Mode
FDA I
spta
.3
Published
Values
MI X
(X denotes
statistically
determined
maximum)
FDA MI
Published
Values
7.5MHz
Probe
9.0MHz
Probe
B
B
0.31mW/cm2
1.22mW/cm2
Peripheral Vessel <
720mW/cm2
Cardiac <
430mW/cm2
Fetal Imaging and
other* <
94mW/cm2
0.18
0.38
Peripheral
Vessel <
1.9
Cardiac <
1.9
Fetal Imaging
and other* <
1.9
*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 requirements of the September 30, 1997
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers [3].