EDGE II P21x Transducer User Guide Supplement April 2020

Sonosite Edge II P21x Transducer User Guide Supplement Introduction ... 1 Document conventions ... 2 Getting Help ... 2 Imaging modes ... 3 Cleaning and disinfecting ... 3 Safety ... 4 Compatible accessories and peripherals ... 4 Labeling symbols ... 4 Acoustic output ... 5 Guidelines for reducing MI and TI ... 5 Output display ... 6 Transducer surface temperature rise ... 6 Acoustic output tables ... 7

Introduction This user guide supplement provides information on the P21x transducer, compatible with the Sonosite Edge II ultrasound system. The Sonosite Edge II ultrasound system is a general purpose ultrasound system. It is intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. FUJIFILM Sonosite is adding an existing transducer, the P21x, to the Sonosite Edge II ultrasound system in compliance with USFDA Guidance Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued June 27, 2019. The P21x transducer is already marketed for use on Sonosite M-Turbo ultrasound system. This supplement adds the transducer with limited exam types to the Sonosite Edge II ultrasound systems, which are cardiac, abdomen and lung. The clinical indication for the Sonosite Edge II does not change from previous clearance. In accordance with the Enforcement Policy for Imaging Systems Used During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, FUJIFILM Sonosite reminds users that imaging devices are not intended for the diagnosis of COVID-19. In vitro diagnostic testing is currently the only definitive method to diagnose COVID-19.

Introduction

1

Document conventions The document follows these conventions: A WARNING describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products. A Note provides supplemental information. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence. For a description of labeling symbols that appear on the product, see "Labeling symbols" in the ultrasound system user guide.

Getting Help For technical support, please contact FUJIFILM Sonosite as follows: Phone (U.S. or Canada)

+1-877-657-8118

Phone (outside U.S. or Canada)

+1-425-951-1330, or call your local representative

Fax

+1-425-951-6700

Email

[email protected]

Web

www.sonosite.com

Europe Service Center

Main: +31 20 751 2020 English support: +44 14 6234 1151 French support: +33 1 8288 0702 German support: +49 69 8088 4030 Italian support: +39 02 9475 3655 Spanish support: +34 91 123 8451

Asia Service Center

+65 6380-5581

Printed in the United States of America.

2

Introduction

Imaging modes Table 1: Available exam types and imaging modes Imaging mode Transducer

Exam type

2D M Mode

Colora

PW Dopplerb

CW Doppler

P21x

Abdomen



CVD, CPD



-

Cardiac



CVD, Var





Lung



CVD, CPD



-

a

Var = Color Doppler Variance, which is available in the cardiac exam only. CPD = Color Power Doppler, which is available in all exams except the cardiac exam type. CVD = Color Velocity Doppler.

b

For the cardiac exam type, PW TDI is also available.

Cleaning and disinfecting Table 2: Approved cleaners Product

Compatible transducer

Minimum wet contact timea

SaniCloth AF3b

P21x

3 minutes

PI-Spray II

P21x

10 minutes

a

For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum period of time. b Qualified for use as an intermediate-level disinfectant for mycobacteria. Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most current cleaners and disinfectants.

Table 3: Approved high-level compatible disinfectants Disinfectanta

Compatible transducer

Temperature

Disinfectant soak duration

Cidex

P21x

25oC, 77oF

45 minutes

a

Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most current cleaners and disinfectants.

Imaging modes

3

Table 3: Approved high-level compatible disinfectants Disinfectanta

Compatible transducer

Temperature

Disinfectant soak duration

Cidex OPA

P21x

20oC, 68oF

12 minutes

a

Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most current cleaners and disinfectants.

Safety WARNING

To avoid device damage or patient injury, do not use the P21x needle-guide bracket on patients with pacemakers or medical electronic implants. The needle-guide bracket for P21x contains a magnet that is used to ensure that the bracket is correctly oriented on the transducer. The magnetic field in direct proximity to the pacemaker or medical electronic implant may have an adverse effect.

Compatible accessories and peripherals Table 4: Accessories and peripherals Description

Maximum Cable Length

P21x transducera

6.0 ft /1.8 m

a

For transducers, maximum cable length is measured between the strain reliefs. The stated lengths do not include the lengths of cable in the following locations: underneath the strain reliefs, inside the transducer enclosure, or inside the transducer connector.

Labeling symbols Table 5: Standards labeling symbols Symbol

Title

Standards development organization (SDO)

Medical Device

EU MDR

Reference number

Description

EU MDR Indicates the item the label is adhered Annex I, 23.2 to is categorized as a medical device (q) per the MDR, Annex 1, 23.2, q.

This is in addition to the labeling symbols listed in the Sonosite Edge II ultrasound system user guide.

4

Safety

Acoustic output Guidelines for reducing MI and TI Table 6: Guidelines for reducing mechanical index (MI) Transducer

Depth

P21x



Decrease or lower setting of parameter to reduce MI. Increase or raise setting of parameter to reduce MI. Table 7: Guidelines for reducing thermal index (TI) CPD Settings Transducer P21x

Box Width

Box Height

Box Depth



PRF



Depth



Optimize

PW Settings

 (PRF)

Decrease or lower setting of parameter to reduce TI. Increase or raise setting of parameter to reduce TI.

Acoustic output

5

Output display Table 8: TI or MI 1.0 Transducer

Index

2D/ M Mode

CPD/ Color

PW Doppler

CW Doppler

P21x

MI

Yes

Yes

Yes

No

TIC, TIB, or TIS

Yes

Yes

Yes

Yes

Transducer surface temperature rise Table 9: Transducer Surface Temperature Rise, External Use (°C )

6

Test

P21x

Still air

17.2

Simulated use

8.5

Acoustic output

Acoustic output tables Table 10: Transducer model: P21x Operating mode: 2D TIS Index label Maximum index value

MI 1.4

Acoustic parameters Other information Operating controls

Below surface

# #

2.3 #

# #

171.7

- 3.65

fawf (MHz)

1.93

zpii,α (cm)

3.65

prr (Hz) srr (Hz) npps

4444 34.7 1

#

#

1.94

192 31.5

Ispta at zpii or zsii (mW/cm2)

41.9

Exam type Optimization Depth (cm) MB/THI Sector Width

Crd Res 4.7 On Any

pr at zpii (MPa)

#

At surface

-

zMI (cm)

Ispta,α at zpii,α or zsii,α (mW/cm2)

Below surface

(a) #

zs (cm)

Ipa,α at zpii,α (W/cm2)

TIC

1.92

P (mW) P1x1 (mW) zb (cm)

At surface

(a) #

Index component value pr,α at zMI (MPa)

At surface

TIB

2.44 Crd Pen 27 Off Narrow

(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.) - Not applicable for this transducer/mode.

Acoustic output

7

Table 11: Transducer model: P21x Operating mode: M Mode TIS Index label Maximum index value

MI 1.4

Acoustic parameters Other information Operating controls

Below surface

# #

fawf (MHz)

1.93

Ipa,α at zpii,α (W/cm2)

295

1.4 79.5 32.2

79.7

5.1 #

1.93

1.94

Crd Pen 30 Off

Abd Pen 32 Off

800 - 1 197.8

Ispta at zpii or zsii (mW/cm2)

396.2

Exam type Optimization Depth (cm) THI

Abd Res 10.2 On

pr at zpii (MPa)

1.1

3.50 5.1

Ispta,α at zpii,α or zsii,α (mW/cm2)

0.3

At surface

#

zMI (cm)

prr (Hz) srr (Hz) npps

Below surface

1.4 #

zs (cm)

zpii,α (cm)

TIC

1.94

P (mW) P1x1 (mW) zb (cm)

At surface

(a) #

Index component value pr,α at zMI (MPa)

At surface

TIB

2.72

(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.) - Not applicable for this transducer/mode.

8

Acoustic output

Table 12: Transducer model: P21x Operating mode: CPD/Color TIS Index label Maximum index value

MI 1.4

Acoustic parameters Other information Operating controls

Below surface

135.6 121.7

fawf (MHz)

1.93

Ipa,α at zpii,α (W/cm2)

295

Ispta at zpii or zsii (mW/cm2)

13.2

Mode Exam type 2D Optimization/Depth (cm) Color Optimization/PRF

pr at zpii (MPa)

THI Color box size

2.4 1.3

135.6 121.7

134.4

- 5.1

Ispta,α at zpii,α or zsii,α (mW/cm2)

1.3

At surface

-

zMI (cm)

prr (Hz) srr (Hz) npps

Below surface

1.3 1.3

zs (cm)

zpii,α (cm)

TIC

1.94

P (mW) P1x1 (mW) zb (cm)

At surface

1.3 1.3

Index component value pr,α at zMI (MPa)

At surface

TIB

5.1 2.16

2.16

2.16

CVD Abd Pen/7.5 Med/Any

CVD Lung Pen/4.7 Med/2500 Hz

CVD Lung Pen/4.7 Med/2500 Hz

On Any

N/A Small

N/A Small

CVD Lung Pen/4.7 Med/ 1524 Hz N/A Small

881 13.8 1 9.6 2.72

(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.) - Not applicable for this transducer/mode.

Acoustic output

9

Table 13: Transducer model: P21x Operating mode: CW Doppler TIS Index label Maximum index value

MI (a)

Acoustic parameters Other information Operating controls

Below surface

108.8 108.8

3.1 3.6

108.8 108.8

108.8

1.2 #

fawf (MHz)

#

Ipa,α at zpii,α (W/cm2)

#

Ispta at zpii or zsii (mW/cm2)

#

zpii,α (cm)

#

prr (Hz) srr (Hz) npps

# # #

Exam type Sample volume position

1.0

At surface

1.2

zMI (cm)

pr at zpii (MPa)

Below surface

3.6 0.9

zs (cm)

Ispta,α at zpii,α or zsii,α (mW/cm2)

TIC

#

P (mW) P1x1 (mW) zb (cm)

At surface

1.0 1.0

Index component value pr,α at zMI (MPa)

At surface

TIB

2.0

2.0

2.0

Crd Zone 0

Crd Zone 0

Crd Zone 0

# #

(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.) - Not applicable for this transducer/mode.

10

Acoustic output

Table 14: Transducer model: P21x Operating mode: PW Doppler TIS Index label Maximum index value

MI 1.2

Acoustic parameters Other information Operating controls

Below surface

zpii,α (cm)

fawf (MHz) prr (Hz) srr (Hz) npps

Ipa,α at zpii,α (W/cm2)

Ispta,α at zpii,α or zsii,α (mW/cm2)

200.3 78.4

1.0

At surface 2.8

3.7 93.8 93.8

201.2

3.1 0.60 5.0 5.0 2.15

2.22

2.17

2.12

Crd 3 3906 Zone 4

Crd 1 15625 Zone 0

Crd 1 3906 Zone 5

1562 - 1 216 400.8

Ispta at zpii or zsii (mW/cm2)

830.4

Exam type Sample volume size (mm) PRF (Hz) Sample volume position

Crd 1 1563 Zone 2

pr at zpii (MPa)

Below surface

3.7 1.3

zs (cm)

zMI (cm)

TIC

1.73

P (mW) P1x1 (mW) zb (cm)

At surface

1.3 0.8

Index component value pr,α at zMI (MPa)

At surface

TIB

2.5

(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.) - Not applicable for this transducer/mode.

Acoustic output

11

12

Acoustic output

P28967-01

*P28967-01*