© Johnson & Johnson Medical NV/SA 2018All rights reserved. 041266-180601

The third party trademarks used herein are trademarks of their respective owners.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

Manufacturer and EU Authorized Representative(ACUNAV™ Catheter)

Siemens Medical Solutions USA, Inc.Ultrasound685 East Middlefield RoadMountain View, CA 94043U.S.A.

Siemens Healthcare GmbHHenkestr. 12791052 ErlangenGermany

Manufacturer and EU Authorized Representative (SOUNDSTAR® Catheter ) and distributor (ACUNAV™ Catheter)BW INC.JNJ NV/SA

European Ordering No. Outer Diameter Length System Compatibility

SNDSTR10 10F 90 cm Siemens SEQUOIA™, SC 2000™, CYPRESS™, ACUSON X300™

SNDSTR10G 10F 90 cm GE-VIVID i™, VIVID q™

10439011 8F 90 cm Siemens SEQUOIA™, SC 2000™, CYPRESS™, ACUSON X300™

10439236 8F 90 cm GE-VIVID i™, VIVID q™

European Ordering No. Outer Diameter Length System Compatibility

08255790 10F 90 cm Siemens SEQUOIA™, SC 2000™, CYPRESS™, ACUSON X300™, ACUSON X700™, S SERIES™

10043342 10F 90 cm GE-VIVID i™, GE-VIVID q™

10135936 8F 90 cm Siemens SEQUOIA™, SC 2000™, CYPRESS™, ACUSON X300™, ACUSON X700™, S SERIES™

10135910 8F 90 cm GE-VIVID i™, GE-VIVID q™

Longitudinal side-dire imaging plane displays anatomy and devices in standard echocardiographic format 64-element Parallel Drive Phased Array imaging technology provides high resolution imaging in all modes

7 mm aperture

Sequoia™ System 2-D imaging frequencies: 10.0MHz, 8.5MHz, 7.5MHz, 5.5MHz

Cypress™ System image frequencies: 7.0MHz, 6.0MHz

CV70™ System 2-D imaging frequencies: 9.0MHz, 7.0MHz, 5.0MHz

P50™ System 2-D imaging frequencies: 9.0MHz, 7.0MHz, 6.0MHz

GE Vivid™ i System 2-D imaging frequencies: 11.5MHz, 10.0MHz, 9.0MHz, 8.0MHz, 6.0MHz, 4.5MHz

X300 System 2-D imaging frequencies: 8.9MHz, 6.7MHz, 5.0MHz

X700 System 2-D imaging frequencies: 5.0MHz, 6.7MHz, 8.9MHz

SC2000 System 2-D imaging frequencies: 4MHz, 5MHz, 6MHz, 8MHz

SOUNDSTAR® Catheter Specifications

ACUNAV™ Ultrasound Catheter

Imaging Specifications

Real-Time Visualization

ACUNAV™ Catheter and SOUNDSTAR® CatheterIntracardiac Echocardiography Imaging Guide

This imaging guide is an introduction to intracardiac echocardiography imaging. It contains directions to obtain proper positioning and basic views used with the ACUNAV™ Catheters or SOUNDSTAR® Catheters.This guide assumes the following:1. A femoral vein approach is used for the insertion of the ACUNAV™ Catheters or SOUNDSTAR® Catheters.2. The catheter operator is standing at the patient’s right side, with the patient’s head to the left of

the operator.3. The system orientation is with the ACUSON System icon positioned to the left of the image vector.

This corresponds to the inferior portion of the scan plane.

HOME POSITION: RA, TV, RV ViewOnce the liver appears on the screen, advance the SOUNDSTAR® Catheter slightly into the mid right atrium (RA). This image of the RA, tricuspid valve (TV), and the right ventricle (RV) is referred to as the Home Position. In the Home Position, the SOUNDSTAR® Catheter is in an unlocked or neutral position, meaning there is no steering and the tension control knob is disengaged.

Left Atrium (LA), Esophagus (ESO), Descending Aorta (Dao)Descending Aorta – Rotate the SOUNDSTAR® Catheter clockwise from the left pulmonary veins. The aorta lies posterior to the left atrium. The esophagus and aorta may be viewed in the same view. Both structures are visualized between the left and right pulmonary veins. The esophagus will lie anterior to the descending aorta behind the left wall.Esophogus – rotate the SOUNDSTAR® Catheter slightly clockwise from the left pulmonary veins.

Left Atrium (LA) – Right Inferior Pulmonary Vein (RIPV)The right pulmonary veins will appear close to the imaging surface of the SOUNDSTAR® Catheter image. To visualize the right inferior pulmonary vein (RIPV), continue clockwise rotation beyond the left pulmonary veins and slightly beyond the esophagus view. Utilize Doppler to assist with identifying the pulmonary vein inflow.

Right Inferior Pulmonary Vein (RIPV) and Right Superior Pulmonary Vein (RSPV) Short AxisThe right pulmonary veins will appear close to the imaging surface of the SOUNDSTAR® Catheter image. From the left atrium/right inferior pulmonary vein view continue a slight clockwise rotation of the catheter to visualize both the inferior and superior pulmonary veins in a short axis. Utilize color Doppler to assist with identifying the pulmonary vein inflow.

Left Atrium – Right Superior Pulmonary Vein (RSPV) Long AxisThe right pulmonary veins will appear close to the imaging surface of the SOUNDSTAR® Catheter image. In order to view the right superior pulmonary vein (RSPV) more longitudinally, advance the catheter higher in the right atrium and continue clockwise rotation. In many cases, the addition of posterior tilt and right/left steering at this time will further optimize the image. Utilize color Doppler to assist with identifying the pulmonary vein inflow.

Left Ventricle (LV)A long axis view of the left ventricle (LV) can be seen by returning the catheter beam to the Home Position and withdrawing the SOUNDSTAR® Catheter low in the right atrium, visualizing the Eustachian ridge. Using the top control on the catheter handle (P-A), the knob is rotated clockwise, which puts an anterior tilt on the catheter tip. The catheter is then advanced through the tricuspid valve into the right ventricle (RV). When the catheter is in the RV, the anterior steer is released. Rotate the catheter clockwise. The imaging beam will move from imaging the RV to imaging the LV. A pericardial effusion can be visualized from these views.

Right Atrium, Left Ventricular Outflow Tract (LVOT)From the RVOT view, rotate the catheter very slightly clockwise. The aortic valve and left ventricular outflow tract (LVOT) will begin to appear in the middle of the screen. You may also be able to see the pulmonary artery and/or pulmonary valve just behind the aortic valve.

Left Atrium (LA) – Left Inferior Pulmonary Vein (LIPV) and Left Superior Pulmonary Vein (LSPV)The left inferior pulmonary vein (LIPV) and the left superior pulmonary vein (LSPV) are often visualized in the same imaging plane. To visualize the LIPV, rotate the SOUNDSTAR® Catheter clockwise from the CS/MV/LAA view slightly. The LIPV and LSPV are often visualized in the same plane. A slight clockwise rotation from the LIPV may be needed to visualize the LSPV. Utilize color Doppler to assist with identifying the pulmonary vein inflow.

Right Atrium, Right Ventricular Outflow Tract (RVOT)From the mid right atrial Home Position with no steering activated, rotate the SOUNDSTAR® Catheter slightly clockwise or to the patient’s left side. You will begin to see the aortic valve just above the RVOT.

Right Atrium (RA), Coronary Sinus (CS), Left Atrium (LA), Mitral Valve (MV), Left Atrial Appendage (LAA)Rotate the SOUNDSTAR® Catheter clockwise from the RVOT view. The coronary sinus (CS) will be visual-ized directly below the right atrium (RA) in the same plane as the mitral valve (MV). The left atrial appendage (LAA), also in the same plane as the MV, will appear as an “out-pouching” from the left atrium (LA).

The intracardiac imaging terms used in this imaging guide are defined below:

Clockwise: describes the rotation of the catheter away from the operator.Counterclockwise: describes the rotation of the catheter towards the operator.Depth: increases or decreases the depth of penetration or field of view.Home Position: this refers to an ultrasound image that displays the right atrium, right ventricle, and tricuspid valve. The catheter is positioned in the mid-right atrium.Neutral Position: the neutral position ridges located on the catheter handle are aligned. No steering or tension is applied.Scan Plane: how ultrasound images the body; two-dimensional; a slice of an anatomical structureTension Control Knob: provides graduated tension to the steering mechanism of the catheter tip.

ACUNAV™ and ACUSON are trademarks of Siemens Medical Solutions USA, Inc.

ACUNAV™ Catheter and SOUNDSTAR® CathetersIntracardiac Echocardiography Imaging Guide