EDGE User Guide Errata P15199-02 PDF download

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.

Edge, SonoSite, and the SonoSite logo are trademarks or registered trademarks of 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, 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

Edge User Guide Supplement P15653-02

Introduction

Español

Introduction ... 1 Imaging ... 1 Measurements and Calculations ... 2 Safety ... 2

Deutsch

Contents

This user guide supplement provides information on the C8x transducer, compatible with the Edge™ ultrasound system. Français

Imaging Imaging modes and exams available by transducer Transducer, Exam Type, and Imaging Mode

Italiano

PW Doppler

CW Doppler

Prostate

Color2

C8x

CPD2

Exam Type

3

-

Português

Transducer

2D1 M Mode1

Imaging Mode

1. The optimization settings for 2D are Res, Gen, and Pen. 2. The optimization settings for Color are low, medium, and high (flow sensitivity) with a range of PRF settings.

1

Measurements and Calculations Volume calculations Transducer

Exam Type

C8x

Prostate

Safety Guidelines for reducing MI and TI MI Transducer

Depth

C8x

↑

↓ Decrease or lower setting of parameter to reduce MI. ↑ Increase or raise setting of parameter to reduce MI.

TI (TIS, TIC, TIB) CPD Settings Transducer

C8x

Box Width

Box Height

Box Depth

↓

↓ Decrease or lower setting of parameter to reduce TI. ↑ Increase or raise setting of parameter to reduce TI.

2

PRF

Depth ↑

Optimize

PW Settings ↓ (Depth)

English

Output display TI or MI ≥ 1.0 CPD/ Color

PW Doppler

CW Doppler

MI

Yes

-

TIC, TIB, or TIS

No

Yes

-

Index

C8x

Deutsch

2D/ M Mode

Transducer Model

Test

C8x

Still air

11.3

Simulated use

5.5

Español

Transducer Surface Temperature Rise, Internal Use (°C )

Français Italiano Português

3

Acoustic output tables Table 1: Transducer Model: C8x

Operating Mode: 2D TIS

Index Label

Associated Acoustic Parameter

Global Maximum Index Value pr.3

Other Information

1.1

(MPa)

Non-scan Scan

Aaprt≤1

Aaprt>1

(a)

-

#

-

Non-scan

TIC

-

(b)

-

#

2.48

W0

(mW)

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

(mW)

-

z1

(cm)

-

zbp

(cm)

zsp

(cm)

deq(zsp)

(cm)

fc

(MHz)

- 1.2

- -

5.53

#

-

#

-

#

-

#

PD PRF pr@PIImax

X (cm) Y (cm) (μsec) 0.239 (Hz) 9524 (MPa) 3.11

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

-

FLx (cm)

#

-

#

FLy (cm)

#

-

#

(W/cm2)

264 Pro Pen 2.5 - 3.2 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 is 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 is not applicable for this transducer/mode.

4

Operating Mode: M Mode TIS

Index Label

Associated Acoustic Parameter

Aaprt≤1

Aaprt>1

-

(a)

-

#

Non-scan

TIC

(a)

(b)

#

3.16

(mW)

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

(mW)

-

z1

(cm)

-

zbp

(cm)

-

zsp

(cm)

deq(zsp)

(cm)

fc

(MHz)

1.1

Español

# # -

#

-

#

-

#

-

#

-

#

-

#

PD PRF pr@PIImax

X (cm) Y (cm) (μsec) 0.427 (Hz) 800 (MPa) 3.83

deq@Pllmax

(cm)

Focal Length IPA.3@MImax

-

#

-

#

FLy (cm)

-

#

-

#

482 Pro

Português

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

#

FLx (cm) (W/cm2)

Italiano

5.07

Français

Othe r Information

(MPa)

Non-scan Scan

W0

Dim of Aaprt

Operating Control Conditions

1.4

TIB Deutsch

Global Maximum Index Value pr.3

M.I.

English

Table 2: Transducer Model: C8x

Pen 4.2

(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 is 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 is not applicable for this transducer/mode.

5

Table 3: Transducer Model: C8x

Operating Mode: Color TIS

Index Label

Associated Acoustic Parameter

Global Maximum Index Value pr.3

Other Information

1.4

(MPa)

Non-scan Scan

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)

PD PRF pr@PIImax

X (cm) Y (cm) (μsec) (Hz) (MPa)

deq@Pllmax

(cm)

Focal Length IPA.3@MImax

Non-scan

TIC

-

(b)

-

#

3.18

W0

Dim of Aaprt

Operating Control Conditions

M.I.

TIB

0.8

- -

4.82

#

-

#

-

#

-

#

0.694 2548 3.63 -

FLx (cm)

#

-

#

FLy (cm)

#

-

#

(W/cm2)

Control 1: Exam Type Control 2: Mode Control 3: 2D Optimization/Depth Control 4: Color Optimization/PRF Control 5: Color Box Position/Size

555 Pro CVD Pen / 1.5 1.9 High / Any Short & narrow / 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 is 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 is not applicable for this transducer/mode.

6

Operating Mode: PW Doppler TIS

Index Label

Associated Acoustic Parameter

Aaprt≤1

Aaprt>1

-

(a)

-

#

Non-scan

TIC

2.0

(b)

36.0

#

2.59

(mW)

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

(mW)

-

z1

(cm)

-

zbp

(cm)

-

zsp

(cm)

deq(zsp)

(cm)

fc

(MHz)

1.1

Español

1.10 0.28 -

#

-

4.79

#

-

#

-

1.12

#

-

#

-

0.40

#

PD PRF pr@PIImax

X (cm) Y (cm) (μsec) 1.131 (Hz) 1008 (MPa) 3.10

deq@Pllmax

(cm)

Focal Length IPA.3@MImax

0.28

FLx (cm)

-

#

-

#

FLy (cm)

-

#

-

#

(W/cm2)

296 Pro

Pro

1 mm

Zone 5

1008

3125

Português

Control 1: Exam Type Control 2: Sample Volume Size Control 3: Sample Volume Position Control 4: PRF

Italiano

4.79

Français

Other Information

(MPa)

Non-scan Scan

W0

Dim of Aaprt

Operating Control Conditions

1.2

TIB Deutsch

Global Maximum Index Value pr.3

M.I.

English

Table 4: Transducer Model: C8x

(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 is 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 is not applicable for this transducer/mode.

7

P15653-02

*P15653-02*