SonoSite TEExi Manual de usuario

TEExi Transducer

User Guide

SonoSite M-Turbo, SonoSite Edge II, SonoSite S Series, Sonosite, and the Sonosite logo are trademarks and registered trademarks of

FUJIFILM Sonosite, Inc. in various jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation.

All other trademarks are the property of their respective owners.

Patents: US 6,371,918, CA 2,373,065, DE 60021552.0, FR 1175173 and GB 1175173.

Part Number: P21458-05

Publication date: April 2018

Manufacturer

FUJIFILM 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

EC Authorized Representative

FUJIFILM SonoSite B.V.

Joop Geesinkweg 140

1114 AB Amsterdam,

The Netherlands

Australia Sponsor

FUJIFILM SonoSite Australasia Pty Ltd

114 Old Pittwater Road

BROOKVALE, NSW, 2100

Australia

Caution United States federal law restricts this device to sale by or on the order of a

physician.

iii

CONTENTS

1. Introduction

About the user guide .......................................................................................................................................... 1-1

Changes in this version ............................................................................................................................. 1-2

Conventions .................................................................................................................................................... 1-2

Warranty statement ............................................................................................................................................. 1-2

Technical Support .................................................................................................................................................. 1-3

2. Getting Started

About the TEExi transducer ............................................................................................................................. 2-1

How scan plane rotation works ............................................................................................................ 2-2

Intended uses .......................................................................................................................................................... 2-2

Contraindications ................................................................................................................................................... 2-2

Unpacking .................................................................................................................................................................. 2-3

Inspecting contents .............................................................................................................................................. 2-4

Transducer and system interface .................................................................................................................. 2-5

TEExi transducer controls .................................................................................................................................. 2-6

Tip deflection .................................................................................................................................................. 2-7

Tip deflection brake .................................................................................................................................... 2-8

Scan plane rotation ..................................................................................................................................... 2-9

3. Examination

Pre-exam inspection ............................................................................................................................................ 3-1

Precautions ............................................................................................................................................................... 3-2

Bite guard ......................................................................................................................................................... 3-3

Sterile sheath ................................................................................................................................................. 3-3

Emergency retraction .......................................................................................................................................... 3-4

CONTENTS

4. Cleaning, disinfecting, transporting, storing, and disposing

of the transducer

Cleaning and disinfecting .................................................................................................................................. 4-1

Cleaning the transducer ........................................................................................................................... 4-3

Disinfecting the transducer ..................................................................................................................... 4-5

Identifying the transducer as clean .............................................................................................................. 4-7

Transporting the transducer ............................................................................................................................. 4-7

Storing the transducer ........................................................................................................................................ 4-9

Disposing of the transducer ............................................................................................................................. 4-9

5. Safety

Standards compliance ......................................................................................................................................... 5-1

Annual inspection .................................................................................................................................................. 5-1

Safe operational use ............................................................................................................................................ 5-2

Thermal safety ........................................................................................................................................................ 5-3

Thermal limits ................................................................................................................................................. 5-3

Reducing temperature .............................................................................................................................. 5-4

Temperature calibration test .................................................................................................................. 5-4

Electrical safety ....................................................................................................................................................... 5-5

Electrical leakage testing and bite hole detection ...................................................................... 5-5

Testing the endoscopic shaft ................................................................................................................. 5-9

Transducer temperature rise .........................................................................................................................5-12

Output display .......................................................................................................................................................5-12

Acoustic output ....................................................................................................................................................5-13

6. Transducer Specifications

TEExi/8-3 MHz transducer ............................................................................................................................... 6-1

Introduction 1-1

CHAPTER 1

Introduction

The TEExi transducer is a transesophageal echocardiographic transducer designed to

operate with the FUJIFILM SonoSite M-Turbo, SonoSite S Series, or SonoSite Edge II

ultrasound system.

Transesophageal procedures carry a variety of inherent risks to the patient. The information

and instructions in this user guide are intended to help you minimize those risks. In addition,

the TEExi transducer is a highly complex and delicate precision instrument. Misuse or poor

handling may severely shorten the service life.

About the user guide

This user guide provides information on the TEExi transducer. It is designed for a reader

familiar with ultrasound and proper endoscopic techniques; it does not provide training in

sonography, cardiology, or clinical practices. For information about the ultrasound system,

see its user guide and other appropriate literature.

To aid in safeguarding the patient and ensuring reliable transducer operation, FUJIFILM

SonoSite recommends having this user guide available for reference during all stages of

TEExi transducer handling.

WAR NING To help avoid conditions that may cause harm to the patient or

damage to the transducer, it is important that personnel using or

handling this transducer read and understand the instructions,

warnings, cautions, and training material contained in this user

guide. If you have questions about any of the information

contained in this user guide, contact FUJIFILM SonoSite or your

local representative.

1-2 Introduction

Changes in this version

Conventions

The user guide 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 steps in procedures must be performed in order.

Single-step procedures begin with .

Items in bulleted lists do not require performance in sequence.

For labeling symbols used, see the ultrasound system user guide.

Warranty statement

The TEExi transducer is warranted for material and workmanship only, for a period of 12 months from date

of shipment from FUJIFILM SonoSite.

The warranty does not cover damage caused by patient bite, misuse by the end user, disinfecting or

sterilizing incorrectly or with chemicals not recommended by FUJIFILM SonoSite, or circumstances beyond

what is considered normal for the product’s intended application.

Chapter Description

Chapter 4 Updated cleaning and disinfecting guidelines

Introduction 1-3

Technical Support

To order sheaths, biteguards, tip covers, and other supplies, see www.civco.com.

For technical support, contact FUJIFILM SonoSite as follows.

Phone

(U.S. or Canada)

877-657-8118

Phone

(outside U.S. or

Canada)

425-951-1330, or call your local representative

Fax 425-951-6700

Email ffss-service@fujifilm.com

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

1-4 Introduction

Getting Started 2-1

CHAPTER 2

Getting Started

About the TEExi transducer

The TEExi transducer is an electronically steered phased array ultrasound transducer

assembly, mounted in a sealed tip at the end of a conventional endoscope.

The TEExi transducer is used to generate a set of ultrasound images or slices within a cone

from the same position in the esophagus. The rotation of the scan plane is driven by a

motor in the control handle.

WAR NING FUJIFILM SonoSite does not recommend the use of

high-frequency electromedical devices in proximity to its

systems. FUJIFILM SonoSite equipment has not been validated

for use with high-frequency electrosurgical devices or

procedures. Use of high-frequency electrosurgical devices in

proximity to its systems may lead to abnormal system behavior

or shutdown of the system.

To avoid the risk of a burn hazard, do not use the transducer

with high-frequency surgical equipment. Such a hazard may

occur in the event of a defect in the high-frequency surgical

neutral electrode connection.

To avoid injury to a patient, the TEExi transducer is intended for

use by a licensed physician who has received appropriate

training in endoscopic techniques as dictated by current

relevant medical practices, as well as in proper operation of the

ultrasound system and transducer.

Caution To avoid inadvertent damage to the transducer, read this user

guide before handling and cleaning the TEExi transducer.

2-2 Getting Started

How scan plane rotation works

To familiarize yourself with scan plane rotation, you may choose to start scanning in one of the transverse

planes — for example, 0° on the system screen is the standard monoplane. If you rotate the scan plane 90°,

you are now scanning in the longitudinal plane, sweeping through two opposite quadrants of the cone.

If you continue to rotate the scan plane another 90° in the same direction, scanning occurs in the mirror

image of the first transverse plane. The only two planes that are equivalent are the two transverse planes at

0° and 180°, one being the mirror image of the other. As shown in Figure 2-1 on page 2-2, a 180° rotation

of the scan plane fills all four quadrants of the conic imaging volume.

Figure 2-1 Rotating to different imaging planes

The direction of the tip of the endoscope is easily steered using the deflection control wheels on the handle

of the transducer to allow exact positioning of the transducer in the esophagus.

Intended uses

The TEExi transducer is designed for 2D, M Mode, color Doppler (Color), pulsed wave (PW) Doppler, and

continuous wave (CW) Doppler imaging by applying ultrasound energy through the esophagus or stomach

of the patient into the heart. The TEExi transducer is intended to be used on adults only. Backscattered

ultrasound energy from the patient’s heart forms images of the heart to detect abnormalities in structure or

motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the

velocities of blood flowing in the heart.

Contraindications

Contraindications for using the TEExi transducer include, but are not limited to, the following:

Fetal imaging

Pediatric imaging

WAR NING The physician must consider all possible factors before starting the examination.

0° imaging plane

90° imaging plane

Scan head

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