FujiFilm SonoSite TEExp User manual

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 [phone]
Email [e-mail]
Web www.sonosite.com
Europe Service Center Main: [phone]
English support: [phone]
French support: [phone]
German support: [phone]
Italian support: [phone]
Spanish support: [phone]
Asia Service Center [phone]

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.

Getting started 2-3
Unpack the transducer
Figure 2-1 Shipping case with TEExp transducer
1Visually examine the shipping box, shipping case, and the TEExp transducer for any damage.
2Note any breakage or other apparent damage, retain the evidence, and notify the carrier or shipping
agency.
3Verify that the shipping case contains the components listed on the packing list:
TEExp transducer
TEExp Transducer User Guide
TEE Transducer Care (contains cleaning, testing, and disinfection instructions)
Bite guards/blocks (3)
Puncture test tool
Non-sterile tip covers (3)
WARNING To avoid injury to patient:
Proper care, maintenance, and a detailed understanding of the procedure are
essential for safe operation of the TEExp transducer.
The medical professional performing the exam must exercise sound medical
judgment in selecting this transducer for use in a procedure.
Tip covers (3)
Bite guards (3)
Puncture testing tool
TEExp transducer

2-4 Getting started
Inspecting contents
After unpacking the contents, perform the following on the TEExp transducer:
Visual and tactile inspection. See “To visually and tactilely inspect the transducer” on page 2-6.
Tip flexion inspection. See “To inspect tip flexion” on page 2-8.
Lock inspection. See “To inspect the tip flexion lock” on page 2-9.
Scan plane rotation inspection. See “To inspect the scan plane rotation” on page 2-11.
Leakage test. See “Testing the transducer for electrical leakage” on page 4-5.
Contact FUJIFILM SonoSite or your local representative immediately to report any damage or discrepancies.
See “Technical Support” on page 1-2.
Cautions To avoid permanently damaging the transducer’s internal control wires, do not
manually flex the tip in any direction. Use the control wheels only for this
purpose.
To avoid inadvertent damage to the transducer, read this user guide before
handling and cleaning the TEExp transducer.
WARNING To avoid injury to the patient, do not use the TEExp transducer if any
irregularity, substandard function or unsafe condition is observed or suspected.

Getting started 2-5
Transducer and system interface
The TEExp transducer consists of an electronically steered phased array ultrasound transducer assembly
mounted in a sealed tip at the end of a conventional endoscope. It connects to the ultrasound system with
a cable and connector (see Figure 2-2.).
Figure 2-2 TEExp transducer
1 Flexible endoscopic shaft 7 Transducer cable
2 Articulation section 8 Transducer connector
3 Transducer tip with scan head 9 Scan plane control buttons
4 Anterior/posterior flexion lock 10 Attachment ring
5 Flexion control wheels 11 Handle
6 Neutral marker
1
2
3
4
5
7
8
9
10
6
11

2-6 Getting started
TEExp transducer controls
The endoscope is designed for single-handed operation of the flexion and scan plane controls. Figure 2-3
shows the user holding the endoscope handle in the left hand. Thumb and first and second fingers operate
the flexion and scan plane controls.
Check the mechanical operation and physical integrity of the transducer after taking it out of the box and
before each exam.
Figure 2-3 Transducer in left hand
To visually and tactilely inspect the transducer
You should inspect the TEExp transducer visually and tactilely after taking it out of the box and before
disinfecting.
1Visually examine and feel the entire surface of the flexible shaft and flexion section with the transducer in
both the straight and flexed position.
2Examine the transducer tip for any holes or dents.
Tip flexion
The TEExp transducer endoscope has two wheels for controlling the transducer tip flexion.
The wheels control anterior/posterior and left/right tip flexion. Figure 2-4 on page 2-7 shows the wheels
in the neutral (unflexed) position.
WARNING To avoid injury to the patient:
Do not use the TEExp transducer if any irregularity, substandard function, or
unsafe condition is observed or suspected.
Do not use the TEExp transducer if any metallic protrusions, holes, rough
spots, cracks, or dents are found.

Getting started 2-7
The lower wheel controls the anterior/posterior flexion of the tip. You can lock this control into position. The
upper wheel controls the left/right flexion of the probe tip, and cannot be locked.
Always have the probe in a neutral, unlocked position during insertion and removal of the transducer.
Figure 2-4 Flexion controls. For orientation purposes, hold the transducer pointing away with control
wheels up and the flexible shaft in a straight position.
Caution To avoid damaging the transducer, do not flex the distal tip of the transducer by
direct application of force. Use the flexion wheels for this task.
1 Turn upper wheel counterclockwise to move the tip to the left.
2 Turn upper wheel clockwise to move the tip to the right.
3 Turn lower wheel counterclockwise to move the tip posterior.
4 Turn lower wheel clockwise to move the tip anterior.
5 Anterior/posterior flexion control (lower wheel)
6 Left/right flexion control (upper wheel)
1 2
6
5
34

2-8 Getting started
To inspect tip flexion
Inspect the tip flexion on the TEExp transducer after taking it out of the box and before each exam. For
orientation purposes, hold the transducer pointing away with control wheels up and the flexible shaft in a
straight position.
1Flex the tip in all four directions.
2Confirm that the flexion controls operate smoothly.
3Check that when the flexion controls are in the neutral position that the transducer tip is also in a neutral
position (unflexed).
Tip flexion lock
To retain the tip in a flexed position, friction can be applied to the anterior/posterior flexion control.
The lock for anterior/posterior flexion is a handle located under the lower control wheel (see Figure 2-5).
There is no lock for left/right flexion.
Figure 2-5 Tip flexion lock operation
WARNING To avoid injury to the patient, if you observe a sharp “U-turn” of the
transducer tip during the tip flexion inspection, do not use the transducer.
1 Transducer tip 4 Neutral position marker
2 Tip control in unlocked position 5 Wheel position markers
3 Tip control in locked position
2
34
5
1

Getting started 2-9
To inspect the tip flexion lock
Inspect the tip flexion lock on the transducer after taking it out of the box and before each exam.
1Confirm that the lock control is in the unlocked position.
2Flex the tip to the anterior direction.
3Move the lock control to the locked position.
4Confirm that the tip is locked in the flexed position.
5Unlock the control and confirm that the tip straightens easily.
6Repeat steps 1-5 for the posterior direction.
Scan plane rotation
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 2-6, a 180° rotation of the scan
plane fills all four quadrants of the conic imaging volume.
Figure 2-6 Rotating to different imaging planes
Scan head
90° imaging plane
0° imaging plane

2-10 Getting started
The scan plane rotation is driven by a motor in the transducer handle and is controlled by buttons on the
handle (see Figure 2-7).
Figure 2-7 Scan plane rotation controls
A scan plane indicator on the system screen shows the orientation. The scan plane angle is indicated by a
marker and a value (see Figure 2-8). The screen shows the angle relative to the standard monoplane,
displayed as 0°. The nominal scan plane angle ranges from 0° to 180° and is accurate within +/- 7°.
Figure 2-8 Scan plane indicator
To initialize the scan plane to 0 degree plane
1Connect the transducer, and turn on the ultrasound system. (For instructions, see the ultrasound system
user guide.)
2Press the scan plane rotation buttons.
To rotate the scan plane
Press the outer buttons on the transducer handle:
The button closest to the transducer tip rotates the scan plane counterclockwise from 0-180° (scan
plane angle increases).
1 Transducer tip
2 Counterclockwise button (increases angle)
3 Biplane button (rotates angle to orthogonal biplane)
4 Clockwise button (decreases angle)
Caution To avoid damaging the transducer connector, protect the connector from dirt
and moisture.
1
2 43

Getting started 2-11
The button farthest from the transducer tip rotates the scan plane clockwise from 180-0° (scan plane
angle decreases).
Full rotation of the imaging plane can be rotated forward from the standard transverse 0° plane to 180°
(mirror image of the standard transverse plane). You can then rotate backward from 180° back to 0°. You
may need small incremental degree changes to optimize your view. Note the on-screen display of your
current rotations and degree settings.
To change the biplane
Press the biplane button (the center button) on the endoscope handle. See Figure 2-7 on page 2-10.
The scan plane rotates at full speed from the current position 90° to the orthogonal position (For example,
if the present position is 22°, the scan plane rotates to 112°. If the present position is 162°, the scan plane
rotates to 72°.)
Pressing the button again rotates the scan plane back to the previous position.
To inspect the scan plane rotation
Inspect the scan plane rotation on the transducer after taking it out of the box and before each exam.
1Connect the TEExp transducer to the ultrasound system.
2Without inserting the transducer, place a small amount of sterile gel on the transducer, and then turn up
the gain to obtain an image.
3Press the scan plane control buttons on the handle to rotate the scan plane counterclockwise (0° to 180°)
and clockwise (180° to 0°). See Figure 2-7 on page 2-10.
4Confirm that the image on-screen changes in relation to the numbers on the scan plane indicator. See
Figure 2-8 on page 2-10.
While you press the scan plane rotation buttons, the transducer motor should be running as the image is
changing.
Do not rely only on the on-screen scan plane indicator to verify that the scan plane is rotating.

2-12 Getting started