M-Turbo User Guide Supplement P13895-02A PDF download

M-Turbo Ultrasound System S Series Ultrasound System

User Guide Supplement P13895-02

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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 either registered trademarks or trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. The SonoSite ultrasound systems 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, 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, 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.

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English Deutsch

M-Turbo Ultrasound System S Series Ultrasound System User Guide Supplement P13895-02 Introduction ...1 Imaging ...1 Safety ...3

Español

Introduction

Français

This user guide supplement updates acoustic output information and describes SonoMBe™ multi-beam imaging, enhanced (MBe), available on HFL38x/13-6 MHz and HFL50x/15-6 MHz transducers and on the following ultrasound systems: • M-Turbo® ultrasound system • S Series™ ultrasound system

Imaging Italiano

2D imaging WARNING:

To avoid incorrect needle placement when MBe is on: Português

• 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.)

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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 trapezoidal or triangular outline indicates the affected area. (See Figure 2.) Use a 17-gauge to 25-gauge needle (recommended). You can angle the needle up to 50° from the transducer surface. (See Figure 1.) Beyond 50°, the needle may be less enhanced. 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. 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. 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. • 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. Available in Breast, MSK, Nerve, and Small Parts exams and in full-screen imaging only. If MBe is on, the MB control is unavailable.

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1

0 - 50°

Figure 1: For best results, angle the needle only up to 50° from the transducer surface: 1 Needle 2 Transducer

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English Deutsch

2 1 3

Español

4

Français

Figure 2: Image with MBe on:

Italiano

1 Needle 2 Outlined area affected by MBe 3 Dotted line 4 Unenhanced area

Safety Português

Output display Table 1: TI or MI ≥ 1.0 2D/ M Mode

CPD/ Color

PW Doppler

CW Doppler

MI

Yes

-

TIC, TIB, or TIS

No

Yes

-

MI

Yes

-

TIC, TIB, or TIS

No

Yes

-

Transducer Model

Index

HFL38x

HFL50x

3

Acoustic output tables Table 2: Transducer Model: HFL38x/13-6

Operating Mode: 2D TIS

Index Label

Associated Acoustic Parameter

Global Maximum Index Value pr.3

Other Information

(MPa)

1.1 2.56

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)

[email protected] (cm)

fc

(MHz)

PD PRF pr@PIImax

X (cm) Y (cm) (μsec) (Hz) (MPa)

deq@Pllmax

(cm)

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

- 5.33

#

-

#

# #

- -

# #

0.525 2450 3.19 -

FLx (cm)

#

-

#

FLy (cm)

#

-

#

(W/cm2)

325.3 Nrv/Bre/ SmP/Msk Any 3.3 cm 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.

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Operating Mode: CPD/Color

Index Label

Associated Acoustic Parameter

TIC

Aaprt≤1

Aaprt>1

1.0

-

(b)

37.69

-

#

(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

- 5.328

5.324

-

#

0.44 0.4

- -

# #

0.525 2597 3.187 -

FLx (cm)

1.32

-

#

FLy (cm)

2.5

-

#

2

(W/cm )

Control 4: Color Box Position/Size

325.5 Color Any Low/ 3.3 cm/ Any Any

Color Ven Med/ 2.7 cm/ 2841 Top/ Short

Português

Control 1: Mode Control 2: Exam Type Control 3: Optimization/Depth/PRF

Italiano

deq@Pllmax

-

Français

PD PRF pr@PIImax

X (cm) Y (cm) (μsec) (Hz) (MPa)

1.2

Español

Other Information

1.1 2.556

Non-scan

Nonscan

Scan

W0

Dim of Aaprt

Operating Control Conditions

(MPa)

TIB Deutsch

Global Maximum Index Value pr.3

MI

TIS

English

Table 3: 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.

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Table 4: Transducer Model: HFL38x

Operating Mode: PW Doppler TIS

Index Label

Associated Acoustic Parameter

Global Maximum Index Value pr.3

(MPa)

Aaprt≤1

Aaprt>1

-

1.1

-

43.01

(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)

Focal Length IPA.3@MImax

0.9

Non-scan

TIC

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

-

#

(W/cm )

323.35

Control 2: Sample Volume Control 3: PRF Control 4: Sample Volume Position

Bre/Vas SmP/IMT 1 mm 1008 Zone 2

2

Control 1: Exam Type Operating Control Conditions

1.0 2.37

Non-scan Scan

W0

Dim of Aaprt

Other Information

MI

TIB

Any

1 mm 6250 Zone 7

(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: 2D TIS

Index Label

Aaprt>1 -

(a)

-

W0

(mW)

#

-

min of [W.3(z1),ITA.3(z1)]

(mW)

-

z1

(cm)

-

zbp

(cm)

-

zsp

(cm)

[email protected] (cm)

fc

(MHz)

Focal Length

Control 1: Exam Type Control 2: Optimization Control 3: Depth Control 4: MBe

-

#

- - 5.36

#

-

#

X (cm) Y (cm) (μsec) 0.521 (Hz) 2733 (MPa) 3.81

# #

- -

# #

(cm)

-

FLx (cm)

#

-

#

FLy (cm)

#

-

#

2

(W/cm )

493

Português

IPA.3@MImax

(b)

Italiano

deq@Pllmax

-

1.2

deq(zsp)

PD PRF pr@PIImax

TIC

Français

Associated Acoustic Parameter

Aaprt≤1

Non-scan

Español

Other Information

Non-scan Scan

1.3 (MPa) 3.051

Dim of Aaprt

Operating Control Conditions

TIB Deutsch

Global Maximum Index Value pr.3

MI

English

Table 5: Transducer Model: HFL50x

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.

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Table 6: Transducer Model: HFL50x

Operating Mode: PW Doppler TIS

Index Label

Associated Acoustic Parameter

Global Maximum Index Value pr.3

Other Information

(MPa)

1.2 2.69

Non-scan Scan

Aaprt≤1

Aaprt>1

-

1.1

-

42.6

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

TIB

1.0

Non-scan

TIC

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

-

#

2

(W/cm )

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

(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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P13895-02

*P13895-02*