M-Turbo User Guide Supplement P13286-01B PDF download

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.

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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.

1

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

-

IMT

3

-

Msk

3

-

Nrv

3

-

SmP

3

-

Vas

3

-

Ven

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)

3

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.

4

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

NA

TIC, TIB, or TIS

No

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

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*