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M-Turbo User Guide Supplement and Errata P05496-01 Oct 2010
User Guide Supplement and Errata
254 Pages
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M-Turbo Ultrasound System User Guide Supplement and Errata P05496-01 This user guide supplement and errata provides additional information about using the M-Turbo® ultrasound system.
Supplement To calculate Cardiac Output automatically WARNING:
To avoid an incorrect diagnosis: • Do not use automatic Cardiac Output calculations as the sole diagnostic criteria. Use them only in conjunction with other clinical information and patient history. • Do not use automatic Cardiac Output calculations in neonatal patients. To avoid inaccurate velocity measurements if you use PW Doppler, make sure that Angle Correction is set to zero.
The system can maintain the accuracy of automatic Cardiac Ouput measurements only if the flow rate is 1 L/min or greater.
Errata Patient report If you transfer or export an exam from the M-Turbo® ultrasound system, the following measurements do not appear in the exported patient report. If you need to record them, save the report as an image (press the SAVE key) before transferring or exporting, or write them manually into the patient record. • GYN exam: Follicle • Cardiac exam: Automatically calculated CO values (CO, SV, CI, SI, VTI, Vmax, Vmean, PGmax, PGmean, LVOT D, LVOT area)
Language selection If you need to change the Language selection on the Presets setup page, make sure to first archive, transfer, or export all saved patient data you want to keep. The system may not correctly maintain the saved patient information after the Language selection is changed.
SonoSite, Inc.
SonoSite Ltd
21919 30th Drive SE Bothell, WA 98021 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201
Alexander House 40A Wilbury Way Hitchin, Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801
11/2009 Copyright 2009 by SonoSite, Inc. All rights reserved.
P05496-01
*P05496-01* 16
M-Turbo Ultrasound System S Series Ultrasound System
0086
User Guide Supplement P13895-03
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, S Series, SonoMBe, SonoSite, and the SonoSite logo are registered (in some jurisdictions) and unregistered trademarks owned by SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. The SonoSite ultrasound system(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, 7643040, 7686766, 7694814, 7727153, 7740586, 7804970, 7809400, 7819807, 7841575, 7849250, 7867168, 7883276, D456509, D461895, D509900, D538432, D544962, D558351, D559390, D591423, D592750, D592760, D625014, D625015, and by the following counterpart foreign patents: AU727381, AU730822, CA2372152, 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, DE60 2004 23 816.3-08, FR0815793, FR0875203, FR0881492, FR1175713, FR1180970, FR1589878, GB0875203, GB0881492, GB1175713, GB1180970, GB1180971, GB1589878, IT0815793, IT0881492, IT1175713, IT1589878, KR528102, KR532359, NO326202, NO326814, NZ542968, RCD000897368-0001, SP0815793, SP0881492, SP1589878. Patents pending.
P13895-03 03/2011 Copyright 2011 by SonoSite, Inc. All rights reserved. Printed in the USA.
ii
English
M-Turbo Ultrasound System S Series Ultrasound System User Guide Supplement P13895-03
Deutsch
Introduction ...1 Imaging ...1 Safety ...4
Español
Introduction This user guide supplement does the following:
Français
• Updates acoustic output information for the M-Turbo® ultrasound system and S Series™ ultrasound system • Describes SonoMBe™ multi-beam imaging, enhanced (MBe), available on the following transducers: • C60x/5-2 MHz • HFL38x/13-6 MHz
Italiano
• HFL50x/15-6 MHz • L25x/13-6 MHz • L38xi/10-5 MHz
Português
Imaging 2D imaging WARNING:
To avoid incorrect needle placement when MBe is on: • Using movement and fluid injection, verify the needle-tip location and trajectory. MBe enhances linear structures within a selected angle range on the ultrasound plane. Linear structures outside the selected angle range or the ultrasound plane-such as a bent needle-may be less apparent. • Note that linear structures are enhanced only in an outlined portion of the image. The area outside the outline remains unchanged. (See Figure 2.) • Note that the beam divergence of a curved array transducer may prevent a segment of the needle shaft from showing in the image. (See Figure 3.) The needle tip may not show.
1
2D controls MBe
Turns on SonoMBe imaging, which enhances linear structures within a selected angle range and can facilitate needle guidance during catheter placement and nerve-block procedures. A three- or four-sided outline indicates the affected area. (See Figure 2.) For curved array transducers, MBe can help identify the direction of the needle, although only segments of the needle shaft may show in the image. (See Figure 3.) Use movement and fluid injection to help verify the needle-tip location. Use a 17-gauge to 25-gauge needle (recommended). Enhancement results can depend on the type and brand of needle used. For more information, consult the medical literature on needle visibility in ultrasound-guided procedures. You can angle the needle up to 50° from the transducer surface. (See Figure 1.) Beyond 50°, the needle may be less enhanced. (MBe has little or no benefit to out-of-plane procedures. MBe is intended for in-plane procedures only.) Avoid setting the gain too high, as unnecessarily high gain can cause artifacts in the image. Also, respiratory and cardiac movement in the image may cause bright pulsating artifacts. When MBe is on, additional controls are available: • L/R Flip flips the affected area (the outline) horizontally on the image. For reorienting the entire image, use the orientation control
.
• Shallow, Medium, or Steep sets the outline’s sloped edge, which is indicated by a dotted line. • Linear transducer: Use whichever setting provides best perpendicularity to the dotted line. Within the affected area, the more perpendicular that a linear structure is to the dotted line, the more it is enhanced. Similarly, the less perpendicular (and more parallel) that a linear structure is to the dotted line, the less it is enhanced. • Curved array transducer: For a linear structure angled 30° or less from the transducer surface, use Shallow for best enhancement. For a linear structure angled 30-40°, use Medium. For a linear structure angled 40° or greater, use Steep. In M-Turbo, the current selection is highlighted green. In S Series, the control key of the current selection is outlined. • Off turns off MBe. Temporarily turning off MBe can help you identify artifacts and other structures not of interest.
2
English
• Back returns to the previous screen. If MBe is on, MBe is highlighted green and MBe appears in the mode data area. Pressing MBe again redisplays the MBe controls.
Deutsch
Available in Breast, Musculoskeletal, Nerve, Small Parts, Vascular (L25x only), and Venous (L25x only) exams and in full-screen imaging only. If MBe is on, the MB control is unavailable. Tip: (M-Turbo) If you use MBe frequently, use a shortcut key to turn on the MBe control. For instructions to program a shortcut key, see A & B Key, Footswitch setup in the user guide.
Español
2
1
0 - 50° Français
Figure 1: For best results, angle the needle only up to 50° from the transducer surface: 1 Needle
2 Transducer
Italiano Português
2 1 3
4
Figure 2: Image with MBe on (linear transducer) 1 Needle 2 Outlined area affected by MBe
3 Dotted line 4 Unenhanced area
3
1
3 2
Figure 3: With a curved array transducer, only segments of the needle shaft may show: 1 Upper needle shaft 2 Needle tip
3 Unshown segment of needle shaft (unshown segment or segments depend on specific image)
Safety Output display Table 1: TI or MI ≥ 1.0 CPD/ Color
PW Doppler
CW Doppler
MI
Yes
Yes
Yes
-
TIC, TIB, or TIS
No
Yes
Yes
-
MI
Yes
Yes
Yes
-
TIC, TIB, or TIS
No
No
Yes
-
MI
Yes
No
No
-
TIC, TIB, or TIS
No
No
Yes
-
Index
HFL38x
HFL50x
L25x
4
2D/ M Mode
Transducer Model
Table 2: Transducer Model: HFL38x/13-6
Operating Mode: 2D TIS
Aaprt>1
(a)
-
-
#
-
(mW)
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
[email protected] (cm)
fc
(MHz)
deq@Pllmax
(cm)
Control 2: Optimization Control 3: Depth Control 4: MBe
(b)
-
#
- - 5.33
#
-
-
-
#
# #
- -
- -
- -
# #
0.525 2450 3.19 -
FLx (cm)
#
-
-
#
FLy (cm)
#
-
-
#
-
-
-
-
-
- - -
- - -
- - -
- - -
- - -
2
(W/cm )
325.3 Nrv/Bre/ SmP/Msk Any 3.3 cm On
Português
Control 1: Exam Type
-
Italiano
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
IPA.3@MImax
TIC
1.2
deq(zsp)
Focal Length
Non-scan
Français
Other Information
1.1 2.56
Aaprt≤1
W0
Dim of Aaprt
Operating Control Conditions
(MPa)
Non-scan Scan
Español
Associated Acoustic Parameter
Global Maximum Index Value pr.3
MI
TIB Deutsch
Index Label
English
Acoustic output tables
(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.
5
Table 3: Transducer Model: HFL38x
Operating Mode: CPD/Color
Index Label
Associated Acoustic Parameter
Global Maximum Index Value pr.3
Other Information
(MPa)
1.1 2.556
TIB
Non-scan
TIC
Aaprt≤1
Aaprt>1
Nonscan
1.0
-
-
-
(b)
37.69
-
-
#
Scan
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
MI
TIS
1.2
- -
5.328
5.324
-
-
-
#
0.44 0.4
- -
- -
- -
# #
0.525 2597 3.187 -
FLx (cm)
1.32
-
-
#
FLy (cm)
2.5
-
-
#
Color Ven Med/ 2.7 cm/ 2841 Top/ Short
- - -
- - -
- - -
- - -
-
-
-
-
2
(W/cm )
Control 1: Mode Control 2: Exam Type Control 3: Optimization/Depth/PRF
Control 4: Color Box Position/Size
325.5 Color Any Low/ 3.3 cm/ Any Any
(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.
6
Operating Mode: PW Doppler TIS
Index Label
Aaprt>1
-
1.1
-
-
43.01
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
deq(zsp)
(cm)
fc
(MHz)
(cm)
Focal Length
2.0
(b)
43.01
#
1.1 0.33
5.32
-
5.30
-
5.30
#
- -
1.04 0.4
- -
1.04 0.4
# #
1.29 1008 2.404 0.21
FLx (cm)
-
3.72
-
#
FLy (cm)
-
2.5
-
#
323.35
Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position
Bre/Vas SmP/IMT 1 mm 1008 Zone 2
Control 1: Exam Type
Any
Any
1 mm 6250 Zone 7
1 mm 6250 Zone 7
Português
(W/cm )
2
Italiano
deq@Pllmax
TIC
Français
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
0.9
Non-scan
Español
Associated Acoustic Parameter
Aaprt≤1
(mW)
IPA.3@MImax Operating Control Conditions
1.0 2.37
Non-scan Scan
W0
Dim of Aaprt
Other Information
(MPa)
TIB
Deutsch
Global Maximum Index Value pr.3
MI
English
Table 4: Transducer Model: HFL38x
(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.
7
Table 5: Transducer Model: HFL50x
Operating Mode: 2D TIS
Index Label
Associated Acoustic Parameter
Global Maximum Index Value pr.3
Other Information
Non-scan Scan
Aaprt≤1
Aaprt>1 -
1.3 (MPa) 3.051
(a)
-
W0
(mW)
#
-
min of [W.3(z1),ITA.3(z1)]
(mW)
-
z1
(cm)
-
zbp
(cm)
-
zsp
(cm)
[email protected] (cm)
fc
(MHz)
PD PRF pr@PIImax deq@Pllmax Focal Length IPA.3@MImax Control 1: Exam Type Control 2: Optimization Control 3: Depth Control 4: MBe
Non-scan
TIC
-
(b)
-
#
- 1.2
deq(zsp) Dim of Aaprt
Operating Control Conditions
MI
TIB
- 5.36
#
-
-
-
#
X (cm) Y (cm) (μsec) 0.521 (Hz) 2733 (MPa) 3.81
# #
- -
- -
- -
# #
(cm)
-
FLx (cm)
#
-
-
#
FLy (cm)
#
-
-
#
- - - -
- - - -
- - - -
2
(W/cm )
493 Any Any 3.3 On
- - - -
- - - -
(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.
8
Operating Mode: PW Doppler TIS
Index Label
Associated Acoustic Parameter
Aaprt≤1
Aaprt>1
-
1.1
-
-
42.6
(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
1.9
(b)
42.6
#
1.1 0.33
5.34
-
5.34
-
5.34
#
- -
1.08 0.40
- -
1.08 0.40
# #
1.29 1008 3.23 0.22
FLx (cm)
-
3.72
-
#
FLy (cm)
-
2.44
-
#
Any 1 mm 1563 3125 Zone 8
- - -
2
(W/cm )
Italiano
deq@Pllmax
TIC
Français
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
1.0
Non-scan
Español
Other Information
1.2 2.69
Non-scan Scan
W0
Dim of Aaprt
308
Control 1: Exam Type Control 2: Sample Volume Control 3: PRF
Any 1 mm 1008
- - -
Control 4: Sample Volume Position
Zone 4
-
-
Any 1 mm 1563 3125 Zone 8
- - -
Português
Operating Control Conditions
(MPa)
TIB
Deutsch
Global Maximum Index Value pr.3
MI
English
Table 6: Transducer Model: HFL50x
-
(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.
9
Table 7: Transducer Model: L25x
Operating Mode: 2D TIS
Index Label
Associated Acoustic Parameter
Global Maximum Index Value pr.3
Other Information
(MPa)
1.2 2.87
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 Control 1: Exam Type
Operating Control Conditions
M.I.
TIB
Control 2: Optimization Control 3: Depth Control 4: MBe
0.8
Non-scan
TIC
-
(b)
-
#
- -
6.11
#
-
-
-
#
# #
- -
- -
- -
# #
0.630 1061 3.39 -
FLx (cm)
#
-
-
#
FLy (cm)
#
-
-
#
-
-
-
-
-
- - -
- - -
- - -
- - -
- - -
2
(W/cm )
478 Nrv/Msk/ Ven/Vas Any 1.9 - 2.2 On
(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.
10
Operating Mode: PW Doppler 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
1.7
(b)
32.1
#
0.75 0.30
#
-
#
-
6.00
#
- -
# #
- -
0.76 0.30
# #
# # # 0.21
FLx (cm)
-
#
-
#
FLy (cm)
-
#
-
#
2
(W/cm )
Italiano
deq@Pllmax
TIC
Français
PD PRF pr@PIImax
X (cm) Y (cm) (μsec) (Hz) (MPa)
#
Non-scan
Español
Other Information
(a) #
Non-scan Scan
W0
Dim of Aaprt
#
Control 1: Exam Type
-
-
-
-
Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position
- - -
- - -
- - -
- - -
Vas/Ven/ Nrv 8 mm 1953 Zone 7
- Português
Operating Control Conditions
(MPa)
TIB
Deutsch
Global Maximum Index Value pr.3
M.I.
English
Table 8: Transducer Model: L25x
- - -
(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.
11
P13895-03
*P13895-03*
SonoSite, Inc.
SonoSite Ltd
21919 30th Drive SE Bothell, WA 98021 USA T: 1-888-482-9449 or 1-425-951-1200 F: 1-425-951-1201
Alexander House 40A Wilbury Way Hitchin, Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801
P14144-01
*P14144-01* 12
10/2010 Copyright 2010 by SonoSite, Inc. All rights reserved.
0086