FujiFilm SonoSite TEExp Manuale utente
TEExp Transducer
User Guide
SonoSite and SonoSite X-Porte are registered and unregistered trademarks of FUJIFILM Sonosite, Inc. in various jurisdictions. FUJIFILM
is a registered trademark of FUJIFILM Corporation. 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, EP 1175173 designated in FR and GB.
Part Number: P20036-09
Publication date: November 2019
Copyright © 2019 FUJIFILM SonoSite, Inc. All rights reserved.
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 .................................................................................................................................................. 1-2
2. Getting started
About the TEExp transducer ........................................................................................................................... 2-1
Intended uses .......................................................................................................................................................... 2-2
Contraindications ................................................................................................................................................... 2-2
Unpacking .................................................................................................................................................................. 2-2
Inspecting contents .............................................................................................................................................. 2-4
Transducer and system interface .................................................................................................................. 2-5
TEExp transducer controls ................................................................................................................................ 2-6
Tip flexion ........................................................................................................................................................ 2-6
Tip flexion lock .............................................................................................................................................. 2-8
Scan plane rotation ..................................................................................................................................... 2-9
3. Examination
Pre-exam inspection ............................................................................................................................................ 3-1
Precautions ............................................................................................................................................................... 3-2
Bite guard/block ........................................................................................................................................... 3-3
Sterile sheath ................................................................................................................................................. 3-4
Emergency retraction .......................................................................................................................................... 3-4
iv
CONTENTS
4. Transducer Care
Before getting started ......................................................................................................................................... 4-1
Process overview ......................................................................................................................................... 4-2
Transducer components ........................................................................................................................... 4-2
Cleaning the transducer ..................................................................................................................................... 4-3
Testing the transducer for electrical leakage ......................................................................................... 4-5
About leakage testing ............................................................................................................................... 4-5
Disinfecting the transducer ............................................................................................................................... 4-8
Identifying the transducer as clean and safe ........................................................................................4-10
Transporting the transducer ...........................................................................................................................4-11
Storing the transducer ......................................................................................................................................4-12
Disposing of the transducer ...........................................................................................................................4-13
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 .............................................................................................................................. 5-5
Guidelines for reducing MI and TI ....................................................................................................... 5-5
Output display ............................................................................................................................................... 5-6
Transducer surface temperature rise ................................................................................................ 5-6
Temperature calibration test .................................................................................................................. 5-6
Electrical safety ....................................................................................................................................................... 5-7
Electrical safety test .................................................................................................................................... 5-8
6. Transducer specifications
TEExp/8-3 MHz transducer ............................................................................................................................. 6-1
Acoustic output ...................................................................................................................................................... 6-3
Introduction 1-1
CHAPTER 1
Introduction
The TEExp transducer is a transesophageal echocardiographic transducer designed to
operate with the SonoSite X-Porte ultrasound system built by FUJIFILM SonoSite, Inc.
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 TEExp 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 TEExp transducer. It is designed for a reader
familiar with ultrasound and proper endoscopic techniques; it does not provide training in
sonography, cardiology, echocardiography, 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, SonoSite
recommends having this user guide available for reference during all stages of TEExp
transducer handling, and refer to guidelines from the American Society of
Echocardiography for Point of Care TEE (ASE) and the Academy of Emergency Physicians
(ACEP).
WARNING 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 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 labeling symbols used, see the ultrasound system user guide.
Warranty statement
The TEExp 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 incorrectly
or with chemicals not approved by FUJIFILM SonoSite, or circumstances beyond what is considered normal
for the product’s intended application.
Technical Support
To order sheaths, bite guards, tip covers, and other supplies, see www.civco.com.
Change Description
Added references Added references to ACEP, ASE, and SCA guidelines.
Clarified terminology Changed the term “deflection” to “flexion,” which describes
the behavior of the probe more appropriately.
Bite guard/bite block Added “bite block” as an additional term to prevent
confusion. Emphasized bite guard use.
Leakage tester update Updated the leakage test procedure to support the new
leakage tester. Integrated the leakage test into the cleaning
and disinfection process.
Introduction 1-3
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 TEExp transducer
The TEExp transducer is an electronically steered phased array ultrasound transducer
assembly, mounted in a sealed tip at the end of a conventional endoscope.
The TEExp 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.
WARNINGS 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 TEExp transducer is intended
for use by a medical professional 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. Adhere to the standards and
protocols from the American Society of Echocardiography for Point of
Care TEE and the American College of Emergency Physicians.
Caution To avoid inadvertent damage to the transducer, read this user
guide before handling and cleaning the TEExp transducer.
2-2 Getting started
Intended uses
The TEExp transducer is an endoscopic transducer 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 TEExp 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 a transesophageal transducer include, but are not limited to, the following:
Fetal imaging
Pediatric imaging
Imaging when the patient exhibits the following or similar conditions:
Esophageal stricture, spasms, lacerations, and trouble swallowing (dysphagia)
Esophageal diverticula, esophageal varices (swollen veins)
Gastrointestinal bleeding
Peptic ulcers, hiatal hernia, esophageal webs and rings
Recent radiation treatment to the esophagus
Inability to swallow or accommodate the transducer
History of gastroesophageal diseases
Unpacking
Proper care and maintenance are essential. Follow the unpacking procedures. Contact FUJIFILM SonoSite or
your local representative immediately to report any damage or discrepancies.
WARNING The physician must consider all possible factors before starting the examination.
WARNING To avoid injury to patient/operator, carefully inspect all equipment after receipt
and prior to each use.
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