User Guide
36 Pages
Preview
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TEEx Transducer
User Guide
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TEEx Transducer
User Guide
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 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801 Caution:
Federal (United States) law restricts this device to sale by or on the order of a physician.
M-Turbo, MicroMaxx, S Series, SonoSite, and the SonoSite logo are trademarks or registered trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. The SonoSite ultrasound system(s) referenced in this document may be covered by one or more of the following U.S. patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, 7449640, 7534211, 7549961, 7588541, 7591786, 7604596, 7643040, D456509, D461895, D509900, D538432, D544962, D558351, D559390, D591423, D592750, D592760, and by the following counterpart foreign patents: AU727381, AU730822, CA2372158, CA2373065, CN ZL 97113678.5, CN ZL 98106133.8, CN ZL 98108973.9, CN ZL 200830007734.8, DE60021552.0, DE60029777.2, DE60034670.6, DE69730563.5, DE6980539.6, DE69831698.3, DE60 2004 23 816.3-08, FR0815793, FR0875203, FR0881492, FR1175713, FR1180970, FR1589878, GB0875203, GB0881492, GB1175713, GB1180970, GB1180971, GB1589878, IT0815793, IT0881492, IT1175713, IT1589878, KR528102, KR532359, NO326202, NO326814, NZ542968, RCD000897368-0001, SP0815793, SP0881492, SP1589878. Patents pending.
P05341-03 03/2010 Copyright 2010 by SonoSite, Inc. All rights reserved.
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Contents Chapter 1: Overview About the user guide ... 1 Conventions ... 1 About the TEEx transducer ... 1 Intended uses ... 2 Contraindications ... 3 Warranty statement ... 3 Technical Support ... 3
Chapter 2: Getting Started Unpacking ... 5 Inspecting contents ... 6 Transducer and system interface ... 7 TEEx transducer controls ... 8 Tip deflection ... 8 Tip deflection brake ...10 Scanplane rotation ...11
Chapter 3: Examination Pre-exam inspection ...13 Precautions ...14 Bite guard ...14 Sterile sheath ...15 Emergency retraction ...15
Chapter 4: Cleaning, Disinfecting, and Storing Cleaning and disinfecting ...17 Storing ...18 Transducer ...18 Tip cover ...18 Shipping ...19 Disposal ...19
Chapter 5: Safety Standards compliance ...21 Annual inspection ...21 Safe operational use ...22 Thermal safety ...23 Thermal limits ...23 Reducing temperature ...23 Temperature calibration test ...23
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Electrical safety ... 24 Electrical leakage current test ... 24 Bite-hole detection ... 25 Acoustic output ... 26
Chapter 6: Transducer Specifications TEEx/8-3 MHz transducer ... 27
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Chapter 1: Overview Overview
Please read this user guide before using the transesophageal echocardiogram (TEEx/8-3 MHz or TEEx) transducer for the SonoSite® M-Turbo®, S Series™, or MicroMaxx® ultrasound system.
About the user guide This user guide provides information on the TEEx 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, SonoSite recommends having this user guide available for reference during all stages of TEEx transducer handling.
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. • 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.
About the TEEx transducer WARNING:
To avoid injury to a patient, the TEEx 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 TEEx transducer.
The TEEx transducer is an electronically steered phased array ultrasound transducer assembly, mounted in a sealed tip at the end of a conventional endoscope. The TEEx 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 scanplane is driven by a motor in the control handle.
Chapter 1: Overview
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For orientation purposes, you may choose to start scanning in one of the transverse planes--for example, the standard monoplane indicated as 0° on the system screen. After rotating the scanplane 90°, scanning occurs in the longitudinal plane, sweeping through two opposite quadrants of the cone. When the scanplane rotates 90° farther 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, one being the mirror image of the other. As shown in Figure 1, a 180° rotation of the scanplane fills all four quadrants of the conic imaging volume. 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. 1 4 2
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Figure 1 Multiplane Imaging 1
90° rotation sagittal to mirror image of transverse plane
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90° rotation transverse to longitudinal plane
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Conic imaging volume
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Quadrants filled by first 90° rotation
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Quadrants filled by second 90° rotation
Intended uses The TEEx 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 TEEx 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.
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Chapter 1: Overview
Contraindications Overview
WARNING:
The physician must consider all possible factors before starting the examination.
Contraindications for using the TEEx transducer: • 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
Warranty statement The TEEx transducer is warranted for material and workmanship only, for a period of 12 months from date of shipment from 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 SonoSite, or circumstances beyond what is considered normal for the product’s intended application.
Technical Support To order sheaths, biteguards, tip covers, and other supplies, see www.civco.com. For technical support, contact SonoSite as follows. SonoSite Technical Support Phone (US or Canada):
877-657-8118
(Outside US and Canada):
425-951-1330 Or call your representative.
Fax:
425-951-6700
E-mail:
Web site:
www.sonosite.com Click Support
Chapter 1: Overview
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Europe Service Center Phone:
+44-(0)1462-444-800
E-mail:
Japan Service Center
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Phone:
+81-3-5304-5337
E-mail:
Chapter 1: Overview
Chapter 2: Getting Started 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 TEEx transducer. Call SonoSite or your local representative immediately. Getting Started
Unpacking Proper care and maintenance are essential. Follow the unpacking procedures. Contact SonoSite or your local representative immediately to report any damage or discrepancies. WARNING:
Unpack
To avoid injury to patient/operator, carefully inspect all equipment after receipt and prior to each use.
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Visually examine the shipping box, shipping case, and the TEEx transducer for any damage. Note any breakage or other apparent damage, retain the evidence, and notify the carrier or shipping agency. Verify that the shipping case contains the components listed on the packing list: • TEEx transducer • TEEx Transducer User Guide • TEEx Transducer Care • Bite guards (3) • Non-sterile tip covers (3)
Chapter 2: Getting Started
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Tip covers (3) Bite guards (3)
TEEx transducer
Figure 1 Shipping case with TEEx transducer WARNING:
To avoid injury to patient: • Proper care and maintenance are essential for safe operation of the TEEx transducer. • The examining physician must exercise sound medical judgment in selecting patients for this transducer.
Caution:
To avoid permanently damaging the transducer’s internal control wires, do not deflect the transducer tip using finger pressure directly on the tip. To avoid inadvertent damage to the transducer, read this user guide before handling and cleaning the TEEx transducer.
Inspecting contents After unpacking the contents, perform the following on the TEEx transducer: • Visual and tactile inspection. See “inspect visually and tactilely” on page 8. • Tip deflection inspection. See “Inspect Tip Deflection” on page 10. • Brake inspection. See “Inspect Tip Deflection Brake” on page 10. • Scanplane rotation inspection. See “Inspect Scanplane Rotation” on page 12. • Leakage test. See “Electrical safety” on page 24. Contact SonoSite or your local representative immediately to report any damage or discrepancies. See “Technical Support” on page 3. WARNING:
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To avoid injury to the patient, do not use the TEEx transducer if any irregularity, substandard function or unsafe condition is observed or suspected.
Chapter 2: Getting Started
Transducer and system interface The TEEx 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. 1 Getting Started
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Figure 2 TEEx transducer: 1
Flexible endoscopic shaft
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Transducer cable
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Articulation section
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Transducer connector
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Transducer tip with scanhead
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Scanplane control buttons
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Deflection brake
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Attachment ring
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Deflection control wheels
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Handle
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Neutral marker
Chapter 2: Getting Started
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TEEx transducer controls The endoscope is designed for one-hand operation of the deflection and scanplane controls. Figure 3 shows the user holding the endoscope handle in the left hand. Thumb and first and second fingers operate the deflection and scanplane controls. Check the mechanical operation and physical integrity of the transducer after taking it out of the box and before each exam.
Figure 3 Transducer in left hand WARNING:
To avoid injury to the patient: • Do not use the TEEx transducer if any irregularity, substandard function or unsafe condition is observed or suspected. • Do not use the TEEx transducer if any metallic protrusions, holes, rough spots, cracks, or dents are found.
inspect visually and tactilely
You should inspect the TEEx transducer visually and tactilely after taking it out of the box and before each exam. 1 Visually examine and feel the entire surface of the flexible shaft and deflection section with the transducer in both straight and deflected position. 2 Examine the transducer tip for any holes or dents.
Tip deflection The TEEx transducer endoscope has two wheels for controlling the transducer tip deflection. The wheels control anterior/posterior and left/right tip deflection. Figure 4 shows the deflection wheels in the neutral (undeflected) position. (There is no brake for left/right deflection.) The lower wheel has brake and freely-moving modes. In the brake mode, the movement of the deflection wheel is restrained. This is for holding the tip in a certain position. Special care should be taken when inserting and removing the transducer. Caution:
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To avoid damaging the transducer, do not deflect the distal tip of the transducer by direct application of force. Use the deflection wheels for this task.
Chapter 2: Getting Started
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Getting Started
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Figure 4 Deflection 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. Movement is 50° (within10°).
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Turn upper wheel clockwise to move the tip to the right. Movement is 50° (within10°).
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Turn lower wheel counterclockwise to move the tip posterior. Movement is 50° (within10°).
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Turn lower wheel clockwise to move the tip anterior. Movement is 125° (within 5°).
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Lower deflection control wheel
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Upper deflection control wheel
WARNING:
To avoid injury to the patient, if you observe a sharp “U-turn” of the transducer tip during the tip deflection inspection (that is, the transducer tip angle exceeds the maximum deflection angles given above), do not use the transducer.
Chapter 2: Getting Started
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Inspect Tip Deflection
Inspect the tip deflection on the TEEx transducer after taking it out of the box and before each exam. 1 Deflect the tip in all four directions and confirm that the angle is within the ranges specified in Figure 2 on page 7 (with reference to the endoscope shaft). 2 Confirm that the deflection controls operate smoothly. 3 Check that when the deflection controls are in the neutral position that the transducer tip is also in a neutral position (undeflected).
Tip deflection brake To retain the tip in a deflected position, friction can be applied to the anterior/posterior deflection control. The brake for the anterior/posterior deflection is a handle under the deflection wheel (see Figure 5). There is no brake for the right/left deflection.
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Figure 5 Tip deflection brake operation 1
Transducer tip
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Neutral position marker
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Tip control in unlocked position (brake off )
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Wheel position markers
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Tip control in locked position (brake on)
Inspect Tip Deflection Brake
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Inspect the tip deflection brake on the transducer after taking it out of the box and before each exam. 1 Confirm that the brake is in the unlocked position. 2 Deflect the tip to the anterior direction. 3 Move the brake to the locked position. 4 Confirm that the tip is locked in the deflected position. 5 Unlock the brake and confirm that the tip straightens easily. 6 Repeat steps 1-5 for the posterior direction.
Chapter 2: Getting Started
Scanplane rotation The scanplane rotation is driven by a motor in the transducer handle and is controlled by buttons on the handle (see Figure 6).
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Getting Started
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Figure 6 Scanplane rotation controls 1
Transducer tip
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Counterclockwise button (increases angle)
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Biplane button (rotates angle to orthogonal biplane)
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Clockwise button (decreases angle)
A scanplane indicator on the system screen shows the orientation. The scanplane angle is indicated by a marker and a value. See Figure 7. The screen shows the angle relative to the standard monoplane, displayed as 0°. The scanplane angle ranges from 0° to 180°. Angle
Marker
Figure 7 Scanplane indicator
Caution:
To avoid damaging the transducer connector, do not allow foreign material in the connector.
Chapter 2: Getting Started
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Scanplane Calibration
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Rotate scanplane
Press the outer buttons on the transducer handle: • The button closest to the transducer tip rotates the scanplane counterclockwise (scanplane angle increases). • The button farthest from the transducer tip rotates the scanplane clockwise (scanplane angle decreases). The scanplane rotates 180° from a standard transverse plane (short axis) to the longitudinal plane (long axis), ending at the mirror image of the first transverse plane (short axis). The angular position appears on the system screen. The 0° short axis reference position is defined as follows: When you view the transducer through the acoustic window of the transducer tip, the transducer is in the extreme clockwise position.
Change Biplane
Press the biplane button (the center button) on the endoscope handle. See Figure 6. The scanplane rotates at full speed from the current position to the orthogonal position. (For example, if the present position is 22°, the scanplane rotates to 112°. If the present position is 162°, the scanplane rotates to 72°.) Pressing the button again rotates the scanplane back to the original position.
Inspect Scanplane Rotation
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Connect the transducer, and turn on the ultrasound system. (For instructions, see the ultrasound system user guide.) A scanplane positioning calibration test automatically begins. This calibration cycle lasts 5 to 10 seconds. Afterward, the transducer temperature sensor is activated, and the transducer temperature is displayed, indicating that the transducer is ready for use. Press the scanplane rotation buttons. If the calibration test fails (no response from the scanplane buttons after calibration), reconnect the transducer to repeat the calibration test.
Inspect the scanplane rotation on the transducer after taking it out of the box and before each exam. 1 Connect the TEEx transducer to the ultrasound system. 2 Without inserting the transducer, obtain an image. For example, rest the transducer on a surface and adjust the gain to visualize the image on-screen. 3 Press the scanplane control buttons on the handle to rotate the scanplane counterclockwise (0° to 180°) and clockwise (180° to 0°). See Figure 6. 4 Confirm that the image on-screen changes in relation to the numbers on the scanplane indicator. See Figure 7. While you press the scanplane rotation buttons, the transducer motor should be running as the image is changing. Note: Do not rely only on the scanplane indicator on-screen to verify that the scanplane is rotating.
Chapter 2: Getting Started
Chapter 3: Examination While echocardiographs from the transesophageal or transgastric position provide important clinical data not available from any other view, the examining physician must consider a number of conditions when selecting a patient for safe use of the transducer. 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 3. WARNING:
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 un-braked state. See Figure 5 on page 10. Exam
Pre-exam inspection Perform the following before each exam: • Visual tactile inspection. See “inspect visually and tactilely” on page 8. • Tip deflection inspection. See “Inspect Tip Deflection” on page 10. • Brake inspection. See “Inspect Tip Deflection Brake” on page 10. • Scanplane rotation inspection. See “Inspect Scanplane Rotation” on page 12. • Leakage test or bite-hole inspection test. See “Electrical leakage current test” on page 24 or “Bite-hole detection” on page 25. • Clean and disinfect transducer. See “Cleaning, Disinfecting, and Storing” on page 17. Contact SonoSite or your local representative to report any damage or discrepancies.See “Technical Support” on page 3. WARNING:
To avoid injury to the patient: • 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 deflection test a sharp “U-turn” of the transducer tip is observed (the transducer tip angle exceeds the maximum deflection angles), do not use the transducer. Call SonoSite or your local representative. Some gels and sterilants can cause an allergic reaction in some individuals.
Chapter 3: Examination
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Precautions Techniques for introducing the TEEx transducer into the patient are beyond the scope of the user guide. There are numerous medical texts and articles that thoroughly address this topic. 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 bioeffects demonstrated at the acoustic output levels of the TEEx transducer, it is prudent to minimize patient exposure to ultrasound according to the principle of ALARA (As Low As Reasonably Achievable). 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. This includes restrictions on food and liquid intake as well as a thorough explanation of the examination procedure and other instructions as the particular situation warrants. • The use of a bite guard during all TEEx examinations is mandatory to protect the transducer from possible damage. • The use of protective gloves during the examination is encouraged. Please see the U.S. Food and Drug Administration’s Medical Alert on Latex Products (FDA 1991). • In addition to the high level disinfection, a protective sheath may provide even greater protection against contamination of the probe. Contact CIVCO for protective sheaths and applicators for protective sheaths.
Bite guard Caution:
To avoid damaging the transducer, use a bite guard during all TEEx examinations. Biting the endoscope may cause severe, permanent damage to the transducer, making it unsafe for future patient use. Damage to the transducer from failure to use a bite guard voids the transducer warranty.
Each TEEx transducer from SonoSite is delivered with three bite guards. Use of a bite guard is mandatory. Contact a local SonoSite representative if you need help ordering more bite guards. Re-use, cleaning, and sterilization of the bite guards should be done according to instructions provided by the manufacturer of the bite guard.
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Chapter 3: Examination
Figure 1 Bite guard: Side view (left) and front view (right)
Sterile sheath There are various sterile sheaths available to eliminate direct contact between the patient and the endoscope. Follow the user instructions for a particular sheath when applying and removing the sheath from the TEEx transducer. Contact CIVCO to order sterile sheaths and applicators for sterile sheaths. Caution:
To provide suitable acoustic coupling within the sheath, SonoSite recommends using a sterile gel. Install Transducer Sheath
Note: SonoSite recommends the use of market-cleared, transducer sheaths for intracavitary applications. To lessen the risk of contamination, install the sheath only when you are ready to perform the procedure. 1 Place gel inside the sheath. 2 Insert the transducer into the sheath. 3 Pull the sheath over the transducer and cable until the sheath is fully extended. 4 Secure the sheath using the bands supplied with the sheath. 5 Check for and eliminate bubbles between the footprint of the transducer and the sheath. Any bubbles between the footprint of the transducer and the sheath can affect the ultrasound image. 6 Inspect the sheath to ensure that there are no holes or tears.
Emergency retraction If the transducer tip should get jammed in a deflected position inside the patient and if all attempts to release the deflected tip should fail, follow the procedure “Retract Transducer” to assure a safe retraction of the transducer.
Chapter 3: Examination
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Exam
To avoid damaging the TEEx transducer, ensure that its tip is straight during application and removal of the sheath. During removal of the sheath, be careful not to use excessive force on the transducer tip; otherwise permanent damage to the TEEx transducer may occur.