TEExp Transducer User Guide Nov 2019

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

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4. Transducer Care

CONTENTS

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

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CHAPTER 1

Introduction

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. 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.

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).

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Changes in this version 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.

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.

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Introduction

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

[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

Introduction

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1-4

Introduction

CHAPTER 2

Getting started

Getting started

About the TEExp transducer 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.

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.

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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 WARNING

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

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

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To avoid injury to patient/operator, carefully inspect all equipment after receipt and prior to each use.

Getting started

Unpack the transducer

Tip covers (3) Bite guards (3) Puncture testing tool TEExp transducer

Figure 2-1 Shipping case with TEExp transducer 1 Visually examine the shipping box, shipping case, and the TEExp transducer for any damage. 2 Note any breakage or other apparent damage, retain the evidence, and notify the carrier or shipping agency. 3 Verify 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.

Getting started

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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.

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. WARNING

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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

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.). 1

4

9

11

5 6

2

10

7

3

8

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

Getting started

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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 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.

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. 1 Visually examine and feel the entire surface of the flexible shaft and flexion section with the transducer in both the straight and flexed position. 2 Examine 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.

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Getting started

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. 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

2

3

4

5

6

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. 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)

Getting started

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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.

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. 1 Flex the tip in all four directions. 2 Confirm that the flexion controls operate smoothly. 3 Check 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.

1

2 3

4

5

Figure 2-5 Tip flexion lock operation

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1

Transducer tip

4

Neutral position marker

2

Tip control in unlocked position

5

Wheel position markers

3

Tip control in locked position

Getting started

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. 1 Confirm that the lock control is in the unlocked position. 2 Flex the tip to the anterior direction. 3 Move the lock control to the locked position. 4 Confirm that the tip is locked in the flexed position. 5 Unlock the control and confirm that the tip straightens easily. 6 Repeat 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. 0° imaging plane 90° imaging plane

Scan head Figure 2-6 Rotating to different imaging planes

Getting started

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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). 1

2 3 4

Figure 2-7 Scan plane rotation controls 1

Transducer tip

2

Counterclockwise button (increases angle)

3

Biplane button (rotates angle to orthogonal biplane)

4

Clockwise button (decreases angle)

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 Caution

To avoid damaging the transducer connector, protect the connector from dirt and moisture.

To initialize the scan plane to 0 degree plane 1 Connect the transducer, and turn on the ultrasound system. (For instructions, see the ultrasound system user guide.) 2 Press 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).

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Getting started

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. 1 Connect the TEExp transducer to the ultrasound system. 2 Without inserting the transducer, place a small amount of sterile gel on the transducer, and then turn up the gain to obtain an image. 3 Press 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. 4 Confirm 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.

Getting started

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CHAPTER 3

Examination

Examination

TEE is a semi-invasive procedure that offers improved image access to the heart and surrounding vessels due to the close proximity to the heart from the esophagus. Careful consideration for its use should be made by the examining physician. Follow ASE, SCA, and ACEP guidelines. The list of contraindications and considerations do not constitute a complete list of all possible factors the examining physician must consider before starting the examination. They are presented only as examples. See “Contraindications” on page 2-2. WARNINGS

To avoid trauma to the patient’s stomach or esophagus, do not use excessive force during insertion, positioning, or withdrawal. To prevent damage to the patient’s esophagus when inserting or withdrawing the transducer, the control wheel must be in the freely moving, neutral, and unlocked state. See Figure 2-5 on page 2-8.

Pre-exam inspection It is important to establish and use a check-out procedure to ensure that the transducer is safe to use and functions properly prior to each use. If you observe or suspect any irregularity, substandard functioning, or unsafe condition, do not use the TEExp transducer. Call FUJIFILM SonoSite or your local representative immediately. Perform the following before each exam: Visual 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.

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Low-voltage electrical leakage test. See “Testing the transducer for electrical leakage” on page 4-5 . Clean and disinfect transducer. See “Transducer Care” on page 4-1. Contact FUJIFILM SonoSite or your local representative to report any damage or discrepancies. See “Technical Support” on page 1-2. WARNINGS

To avoid injury to the patient: FUJIFILM SonoSite recommends performing the above procedures prior to each exam. Do not use the transducer if any metallic protrusions, holes, rough spots, cracks, or dents are found. If, during the flexion test, a sharp “U-turn” of the transducer tip is observed (the transducer tip angle exceeds the maximum flexion angles), do not use the transducer. Call FUJIFILM SonoSite or your local representative. Some gels and sterilants can cause an allergic reaction in some individuals.

Precautions Techniques for introducing the TEExp transducer into the patient are beyond the scope of the user guide. Guidelines for training and procedural protocols are set forth by the American Society of Echocardiograph and the American Academy of Emergency Physicians. A complete understanding of the risks and complications, along with optimal training are recommended to perform this procedure. Observe the following precautionary measures when conducting an exam: Maintaining an unobstructed airway is a prime consideration for all patients. Prolonged pressure on the esophagus by the tip of the transducer may lead to a pressure necrosis condition. Thus, in operating room monitoring applications, the tip should be removed from the esophagus wall when not scanning by releasing it in the neutral position. If continuous monitoring is required, the transducer tip should be repositioned often. Long-term exposure to ultrasound should be minimized. Although there have never been any bio-effects demonstrated at the acoustic output levels of the TEExp transducer, it is prudent to minimize patient exposure to ultrasound according to the principle of As-Low-As-Reasonably-Achievable (ALARA). Please see the ultrasound system user guide. In consideration of the above two points, you should freeze the image, which turns off the power to the transducer, and allow the endoscope deflection controls to be disengaged whenever active scanning is not desired. Proper patient preparation is essential for successful examinations. Refer to guidelines.

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Examination