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Note: The US FDA guidance document "Information for Manufacturers Seeking Market Clearance
of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008 classifies
intravascular ultrasound within the application(s) "Fetal Imaging & Other" to determine the
maximum allowable acoustic output energy. The catheter is not intended for fetal imaging.
ACOUSTIC OUTPUT
Global Maximum Value
p
r.3
W
0
f
c
z
sp
Associated
x-6
Beam
Acoustic
Dimensions
Parameters
y-6
PD
PRF
Az.
EDS 5F/6F
Elev.
Operating
No operator controls affecting
Control
acoustic output
Conditions
All intensities and total power have uncertainty of +35.6% to -27.3%.
All pressure values have uncertainty of +17.8% to -13.7%
All center frequency values have uncertainty of + 7.78% to – 7.78%.
Term
Definition
MI
Mechanical Index, defined as MI = p
I
Derated Intensity, Spatial Peak Temporal Average
SPTA.3
I
Derated Intensity, Spatial Peak Pulse Average
SPPA.3
Derated Peak Negative Pressure at a location of the maximum
p
derated pulse intensity integral
r.3
W
Total Power
0
Center frequency
f
c
z
Distance in the z axis direction where the measurements were taken
sp
x-6 and
–6 dB dimensions for In Plane (azimuth) and Out of Plane (elevation)
y-6
at the x-y plane where z
is obtained
sp
PD
Pulse duration
PRF
Pulse repetition frequency
EDS
Entrance dimensions of scanning for azimuth and elevation to a plane
Note: Since the iLab
System is identical with respect to the ultrasound generator, the acoustic
™
output values provided above also apply to the iLab System with MDU5 PLUS.
ACOUSTIC OUTPUT – COMPLIANCE TO IEC 60601-2-37
Prudent-Use Statement
It is the responsibility of the system operator to understand the risk of the acoustic outputs
generated by the Imaging System and its associated imaging catheters. It is also the operator's
responsibility to act appropriately to mitigate such risks. To that end, Boston Scientific Corporation
has reported Mechanical and/or Thermal Indices that may exceed the requirements of
IEC 60601-2-37.
Please note that the Mechanical Index (MI) displayed on the system's screen has not been corrected
for finite amplitude effects.
Imaging Catheter Information
Acoustic Power Output varies between different models of imaging catheters. Each imaging
catheter supplied by Boston Scientific Corporation is supplied with Directions for Use (DFUs) that
include statements and tables specifying their acoustic power outputs.
IEC requirements for measurements and definition of terms may be found in IEC 60601-2-37 –
"Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment."
Where Mechanical and/or Thermal Indices are reported, the MI/TI is displayed on the lower right of
the IVUS image next to the imaging catheter identification.
Black (K) ∆E ≤5.0
I
MI
SPTA.3
(mW/cm
2
)
0.390
3.426
(MPa)
1.697
(mW)
0.021
(MHz)
54.29
54.29
(cm)
0.086
(cm)
(cm)
(µsec)
0.029
(Hz)
7680
(cm)
0.267/0.303
(cm)
0.053
TERMINOLOGY
/(f
1/2
)
r.3
c
Index Label
Maximum index value
I
SPPA.3
(W/cm
2
)
160.251
0.021
54.29
Associated Acoustic
Parameters
0.086
0.0392
0.0371
0.029
7680
Other Information
Operating control
Units
conditions
n/a
All intensities and total power have uncertainty of +35.6% to -27.3%
All pressure values have uncertainty of +17.8% to -13.7%
mW/cm
2
All center frequency values have uncertainty of + 7.78% to – 7.78%
W/cm
2
Term
Definition
MPa
MI
Mechanical Index, defined as MI =
mW
MHz
C
1 MPa MHz
MI
cm
Attenuated peak-rarefactional acoustic pressure
p
r,α
cm
f
Acoustic working frequency
awf
P
Output power
µs
TIS-Scan
Soft tissue thermal index
Hz
z
Distance from the source to a specified point
cm
A
–12 dB output beam area
aprt
t
Pulse duration
d
Pulse repetition rate
prr
p
Peak-rarefactional acoustic pressure
r
I
Attenuated pulse-average intensity
pa,α
I
Pulse-intensity integral
pi
I
Attenuated pulse-intensity integral
pi,α
WARRANTY
Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and
manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not
expressly set forth herein, whether express or implied by operation of law or otherwise, including,
but not limited to, any implied warranties of merchantability or fitness for a particular purpose.
Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the
patient, diagnosis, treatment, surgical procedures and other matters beyond BSC's control directly
affect the instrument and the results obtained from its use. BSC's obligation under this warranty is
limited to the repair or replacement of this instrument and BSC shall not be liable for any incidental or
consequential loss, damage or expense directly or indirectly arising from the use of this instrument.
BSC neither assumes, nor authorizes any other person to assume for it, any other or additional
liability or responsibility in connection with this instrument. BSC assumes no liability with respect
to instruments reused, reprocessed or resterilized and makes no warranties, express or implied,
including but not limited to merchantability or fitness for a particular purpose, with respect to such
instruments.
4
ACOUSTIC OUTPUT REPORTING TABLE
(In accordance with IEC 60601-2-37)
p
(MPa)
r,α
P
(mW)
min. of [P
(z
),
(mW)
α
s
I
(z
)]
ta,α
s
z
(cm)
s
z
(cm)
bp
z
(cm)
b
z at max. I
(cm)
pi,α
d
(z
)
(cm)
eq
b
f
(MHz)
awf
X (cm)
Dim of A
aprt
Y (cm)
t
(µsec)
d
prr
(Hz)
p
at max. I
(MPa)
r
pi
d
at max. I
(cm)
eq
pi
I
, at max. MI
(W/cm
2
)
160.251
pa.3
There are no user controls that affect the catheter values provided
in this table.
TERMINOLOGY
p
f
-1/2
r,α
awf
C
MI
-1/2
MI
TIS-Scan
0.390
0.008
1.697
0.021
0.086
54.29
54.29
0.0628
0.0594
0.029
7680
1.95
Units
n/a
n/a
MPa
MHz
mW
n/a
cm
cm
2
µs
Hz
MPa
W/cm
2
J/m
2
J/m
2
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