User Guide Supplement
170 Pages
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M-Turbo Ultrasound System
User Guide Supplement P13286-01
Manufactured by SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201
SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801
Caution:
United States federal law restricts this device to sale by or on the order of a physician.
M-Turbo, SonoSite, and the SonoSite logo are registered trademarks or trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. The SonoSite product(s) referenced in this document may be covered by one or more of the following U.S. patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, 7449640, 7534211, 7549961, 7588541, 7591786, 7604596, D456509, D461895, D509900, D538432, D544962, D558351, D559390, D591423, D592750, D592760, and by the following counterpart foreign patents: AU727381, AU730822, CA2372158, CA2373065, CN ZL 97113678.5, CN ZL 98106133.8, CN ZL 98108973.9, CN ZL 200830007734.8, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, FR0815793, FR0875203, FR0881492, FR1175713, FR1180970, GB0875203, GB0881492, GB1175713, GB1180970, GB1180971, IT0815793, IT0881492, IT1175713, KR528102, KR532359, NO326202, NO326814, NZ542968, RCD000897368-0001, SP0815793, SP0881492. Patents pending.
P13286-01 11/2009 Copyright 2009 by SonoSite, Inc. All rights reserved. Printed in the USA.
ii
English
M-Turbo Ultrasound System User Guide Supplement P13286-01
Deutsch Español
Introduction ...1 Imaging ...1 Measurements and calculations ...2 Troubleshooting and maintenance ...3 Specifications ...4 Safety ...4
Introduction
Imaging
Français
This supplement to the M-Turbo Ultrasound System User Guide describes the availability of the L38xi/10-5 MHz transducer on the M-Turbo® ultrasound system.
2D imaging Italiano
2D options Guide
Português
Turns guidelines on and off. Guidelines are for needle guidance, are an optional feature, and depend on transducer type. For transducers with a single-angle or multi-angle bracket, the touchpad moves the depth cursor. If the transducer uses a multi-angle bracket, select Guide and then select the angle: A, B, or C. To exit angle selection, select Back. To clear the guides, do either of the following: • Select the angle again (A, B, or C). • Exit angle selection and press Guide. See also the needle guide’s user documentation.
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Imaging modes and exams available by transducer Imaging modes and exams available by transducer Imaging Mode Transducer
Exam Type1
L38xi
2D M Mode2
CPD3
Color3
PW
CW
Bre
3
3
3
3
-
IMT
3
3
3
3
-
Msk
3
3
3
3
-
Nrv
3
3
3
3
-
SmP
3
3
3
3
-
Vas
3
3
3
3
-
Ven
3
3
3
3
-
1. Exam type abbreviations: Bre = Breast, IMT = Intima Media Thickness, Msk = Musculoskeletal, Nrv = Nerve, SmP = Small Parts, Vas = Vascular, Ven = Venous. 2. The optimization settings for 2D are Res, Gen, and Pen. 3. The optimization settings for CPD and Color are low, medium, and high (flow sensitivity) with a range of PRF settings for Color depending on the setting selected.
Measurements and calculations Calculations for L38xi transducer
2
Exam Type
Calculations
Exam Type
Calculations
Bre
Volume
Nrv
Volume
IMT
IMT Percent Reduction
SmP
Percent Reduction Small Parts Volume
Msk
Percent Reduction Volume
Vas
Percent Reducton Vascular Volume Volume Flow
English
Troubleshooting and maintenance Cleaning and disinfecting transducers
Deutsch
To disinfect the transducer, use the immersion method or the wipe method. Follow the instructions on the disinfectant label. For more information about cleaning and disinfecting the L38xi transducer, refer to the ultrasound system user guide. The following table lists disinfectants that have been tested by SonoSite. See the SonoSite website for updated cleaning and disinfectant information: www.sonosite.com.
Español
The table does not have the following regulatory information for disinfectants:
Français
• EPA Registration • FDA 510(k) clearance (liquid sterilant, high level disinfectant) • CE approval Prior to use, confirm that the regulatory status of the disinfectant is appropriate for your jurisdiction and use. .
Table 1: Cleaner and Disinfectant Compatibility with SonoSite Standard Transducers Cleaner or Disinfectant
L38xi
Cleaner or Disinfectant
L38xi
Airkem A-33®
3
Ethyl Alcohol
3
PerCept RTU Wipes™
3
Anioxyde 1000
:
Hydrogen Peroxide (3%)
3
Steranios 20%
:
Asepti-HB
3
Isopropyl Alcohol (100%)
:
Super Sani-Cloth®
:
CaviWipes™
3
Rely+On™ PeraSafe™
:
T-Spray™
3
Cidex® OPA
3*
Sani-Cloth® HB
3
T-Spray II™
3*
Coverage™ Spray
3
Sani-Cloth® Plus
:
Tristel Solo
3
Echo Clean Lingettes
:
Sporicidin®
:
Virex® II 256
3
Endosporine
3
Madacide 1
3
Virex® TB
3
Envirocide®
3
Metricide OPA Plus
3
Virox® 5 RTU Wipes
3
L38xi Italiano
Cleaner or Disinfectant
Português
3 - Acceptable for use with system 3* - Cleaner or disinfectant has been tested by SonoSite for disinfection effectiveness on SonoSite transducers. : - Not Acceptable (Do not use)
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Specifications Transducers L38xi/10-5 MHz (5.5 ft/1.7 m)
Safety Guidelines for reducing MI and TI Table 2: MI Transducer
Depth
L38xi
↑
↓ Decrease or lower setting of parameter to reduce MI. ↑ Increase or raise setting of parameter to reduce MI.
Table 3: TI (TIS, TIC, TIB) CPD Settings Transducer
L38xi
Box Height
Box Depth
PRF
Depth
Optimize
↑
↑
-
-
-
-
↓ Decrease or lower setting of parameter to reduce TI. ↑ Increase or raise setting of parameter to reduce TI.
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PW Settings
Box Width
↓ (Sample volume zone or size)
English
Transducer surface temperature rise Table 4: Transducer Surface Temperature Rise, External Use (°C) L38xi
Still air
12.5
Simulated Use
8.8
Deutsch
Test
Output display Español
Table 5: Modes in Which a TI or MI Is ≥ 1.0 CPD/ Color
PW Doppler
CW Doppler
MI
Yes
Yes
Yes
NA
TIC, TIB, or TIS
No
Yes
Yes
NA
Index
L38xi
Français
2D/ M Mode
Transducer
Italiano Português
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Acoustic output tables Table 6: Transducer Model: L38xi/10-5
Operating Mode: 2D TIS
Index Label
Associated Acoustic Parameter
Global Maximum Index Value pr.3
Other Information
(MPa)
1.5 3.54
Non-scan Scan
Aaprt≤1
Aaprt>1
(a)
-
-
#
-
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
deq@Pllmax
(cm)
Dim of Aaprt
Focal Length IPA.3@MImax
Operating Control Conditions
M.I.
TIB
Control 1: Exam Type Control 2: Optimization Control 3: Depth Control 4: MB
Non-scan
TIC
-
(b)
-
#
-
1.0
- 5.76
# # #
- - -
- - -
- - -
# # #
0.146 7551 4.32 -
FLx (cm)
#
-
-
#
FLy (cm)
#
-
-
#
2
(W/cm )
776 Any Gen/Pen 2.0 cm On/Off
(a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. #No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.
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Operating Mode: M Mode TIS
Index Label
Associated Acoustic Parameter
Aaprt≤1
Aaprt>1
-
(a)
-
-
#
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
(cm)
Focal Length IPA.3@MImax
(b)
37.1
#
0.9
1.0
0.49 5.76
- - -
# # #
- - -
5.20 1.86 0.40
# # #
0.146 1600 4.32 0.49
FLx (cm)
-
#
-
#
FLy (cm)
-
#
-
#
2
(W/cm )
776 Any Gen
Any Pen
4.7 cm
7.3-9.0 cm
Português
Control 1: Exam Type Control 2: Optimization Control 3: Depth
1.2
Italiano
deq@Pllmax
TIC
Français
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
Non-scan
Español
Other Information
1.5 3.54
Non-scan Scan
W0
Dim of Aaprt
Operating Control Conditions
(MPa)
TIB
Deutsch
Global Maximum Index Value pr.3
M.I.
English
Table 7: Transducer Model: L38xi/10-5
(a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. #No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.
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Table 8: Transducer Model: L38xi/10-5
Operating Mode: CPD/Color TIS
Index Label
Associated Acoustic Parameter
Global Maximum Index Value pr.3
Other Information
(MPa)
1.5 3.30
Non-scan Scan
Aaprt≤1
Aaprt>1
1.1
-
-
47.5
-
W0
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
deq@Pllmax
(cm)
Dim of Aaprt
Focal Length IPA.3@MImax
Operating Control Conditions
M.I.
TIB Non-scan
TIC
-
(b)
-
#
- - -
# # #
0.8 4.82
4.82 0.66 0.40
- - -
- - -
0.544 2885 3.79 -
FLx (cm)
1.86
-
-
#
FLy (cm)
1.50
-
-
#
2
(W/cm )
Control 1: Mode Control 2: Exam Type Control 3: 2D Optimization/Depth Control 4: Color Optimization/PRF Control 5: Color Box Position/Size
605 CVD/CPD CVD Any Bre Any/2.0- Any/3.8 2.5 cm cm Low/ Any/Any 1323 Any/ Any/Any Default
(a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. #No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.
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Operating Mode: PW Doppler TIS
Index Label
Associated Acoustic Parameter
Aaprt≤1
Aaprt>1
-
2.6
-
-
114.5
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
(cm)
Focal Length IPA.3@MImax
3.7
(b)
114.5
#
0.8
1.19
0.49 4.88
- - -
4.79 1.86 0.40
- - -
4.79 1.86 0.40
# # #
1.22 1008 2.97 0.45
FLx (cm)
-
5.54
-
#
FLy (cm)
-
1.50
-
#
2
(W/cm )
342 Bre/Vas 1 mm 1008 Zone 1
Bre/Vas 1 mm 10417 Zone 7
Bre/Vas 1 mm 10417 Zone 7
Português
Control 1: Exam Type Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position
Italiano
deq@Pllmax
TIC
Français
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
Non-scan
Español
Other Information
1.1 2.56
Non-scan Scan
W0
Dim of Aaprt
Operating Control Conditions
(MPa)
TIB
Deutsch
Global Maximum Index Value pr.3
M.I.
English
Table 9: Transducer Model: L38xi/10-5
(a) This index is not required for this operating mode; value is <1. (b) This transducer is not intended for transcranial or neonatal cephalic uses. #No data are reported for this operating condition since the global maximum index value is not reported for the reason listed. (Reference Global Maximum Index Value line.) - Data are not applicable for this transducer/mode.
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P13286-01
*P13286-01*