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SonoSite TEExi User Manual

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TEExi Transducer
User Guide

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Summary of Contents for SonoSite TEExi

  • Page 1 TEExi Transducer User Guide...
  • Page 2 United States federal law restricts this device to sale by or on the order of a physician. SonoSite M-Turbo, SonoSite Edge II, SonoSite S Series, Sonosite, and the Sonosite logo are trademarks and registered trademarks of FUJIFILM Sonosite, Inc. in various jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation.

  • Page 3: Table Of Contents

    Changes in this version ..........................1-2 Conventions ..............................1-2 Warranty statement ............................. 1-2 Technical Support ..............................1-3 2. Getting Started About the TEExi transducer ..........................2-1 How scan plane rotation works ......................2-2 Intended uses ................................2-2 Contraindications ..............................2-2 Unpacking .................................. 2-3 Inspecting contents ..............................
  • Page 4 Temperature calibration test ........................5-4 Electrical safety ............................... 5-5 Electrical leakage testing and bite hole detection ..............5-5 Testing the endoscopic shaft ......................... 5-9 Transducer temperature rise .........................5-12 Output display ...............................5-12 Acoustic output ..............................5-13 6. Transducer Specifications TEExi/8-3 MHz transducer ..........................6-1...

  • Page 5: Introduction

    About the user guide This user guide provides information on the TEExi transducer. It is designed for a reader familiar with ultrasound and proper endoscopic techniques; it does not provide training in sonography, cardiology, or clinical practices. For information about the ultrasound system, see its user guide and other appropriate literature.

  • Page 6: Changes In This Version

    For labeling symbols used, see the ultrasound system user guide. Warranty statement The TEExi transducer is warranted for material and workmanship only, for a period of 12 months from date of shipment from FUJIFILM SonoSite. The warranty does not cover damage caused by patient bite, misuse by the end user, disinfecting or sterilizing incorrectly or with chemicals not recommended by FUJIFILM SonoSite, or circumstances beyond what is considered normal for the product’s intended application.

  • Page 7: Technical Support

    Technical Support To order sheaths, biteguards, tip covers, and other supplies, see www.civco.com. For technical support, contact FUJIFILM SonoSite as follows. 877-657-8118 Phone (U.S. or Canada) 425-951-1330, or call your local representative Phone (outside U.S. or Canada) 425-951-6700 ffss-service@fujifilm.com Email www.sonosite.com...
  • Page 8 Introduction...

  • Page 9: Getting Started

    The TEExi transducer is used to generate a set of ultrasound images or slices within a cone from the same position in the esophagus. The rotation of the scan plane is driven by a motor in the control handle.

  • Page 10: How Scan Plane Rotation Works

    (CW) Doppler imaging by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEExi transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient’s heart forms images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.

  • Page 11: Unpacking

    To unpack the transducer 1 Visually examine the shipping box, shipping case, and the TEExi transducer for any damage. 2 Note any breakage or other apparent damage, retain the evidence, and notify the carrier or shipping agency.

  • Page 12: Inspecting Contents

    Shipping case with TEExi transducer WARNING To avoid injury to patient: Proper care and maintenance are essential for safe operation of the TEExi transducer. The medical professional performing the exam must exercise sound medical judgment in selecting this transducer for use in a procedure.

  • Page 13: Transducer And System Interface

    “Technical Support” on page 1-3. WARNING To avoid injury to the patient, do not use the TEExi transducer if any irregularity, substandard function or unsafe condition is observed or suspected. Transducer and system interface The TEExi transducer consists of an electronically steered phased array ultrasound transducer assembly mounted in a sealed tip at the end of a conventional endoscope.

  • Page 14: Teexi Transducer Controls

    To visually and tactilely inspect the transducer You should inspect the TEExi 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 deflection section with the transducer in both straight and deflected position.

  • Page 15: Tip Deflection

    2 Examine the transducer tip for any holes or dents. Tip deflection The TEExi transducer handle has two wheels for controlling the transducer tip deflection. The wheels control anterior/posterior and left/right tip deflection. Figure 2-5 on page 2-7 shows the deflection wheels in the neutral (undeflected) position.

  • Page 16: Tip Deflection Brake

    To inspect Tip Deflection Inspect the tip deflection on the TEExi 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.

  • Page 17: Scan Plane Rotation

    Figure 2-6 Tip deflection brake operation Transducer tip Neutral position marker Tip control in unlocked position (brake off) Wheel position markers Tip control in locked position (brake on) To inspect the tip deflection brake 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.
  • Page 18 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 scan plane angle ranges from 0° to 180°. Angle Marker Figure 2-8...
  • Page 19 Inspect the scan plane rotation on the transducer after taking it out of the box and before each exam. 1 Connect the TEExi 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.
  • Page 20 2-12 Getting Started...

  • Page 21: Examination

    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 TEExi transducer. Call FUJIFILM SonoSite or your local representative immediately.

  • Page 22: Precautions

    The use of a bite guard during all TEExi 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).

  • Page 23: Bite Guard

    Damage to the transducer from failure to use a bite guard voids the transducer warranty. Each TEExi transducer from FUJIFILM SonoSite is delivered with three bite guards. Use of a bite guard is mandatory. If you need help ordering more bite guards, contact CIVCO Medical Solutions.

  • Page 24: Emergency Retraction

    To install a transducer sheath Note FUJIFILM 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.

  • Page 25: Cleaning, Disinfecting, Transporting, Storing, And Disposing Of The Transducer

    In addition to protecting patients and employees from disease transmission, the disinfectant you choose must be safe for the transducer. FUJIFILM SonoSite routinely reviews new medical disinfectants for compatibility with the transducer control housing, cable, endoscopic shaft, and scan head.
  • Page 26 Cable Connector Controller Cannot be immersed in liquid 90 cm Can be immersed in liquid Endoscopic shaft Scan head Figure 4-1 Transducer component names Carefully follow the chemical manufacturer’s instructions and recommendations for preparing, using, and disposing of cleaning and disinfection solutions. Check the expiration dates, and do not use solutions that have surpassed their expiration dates.

  • Page 27: Cleaning The Transducer

    Cidezyme/Enzol 5 minutes 1 At the point of use, immediately after extracting the TEExi from the patient, wipe the transducer, including the cable, controller, endoscopic shaft, and scan head with a cloth or wipe moistened with water. Be sure to remove all visible biological material. Do not wipe the connector.
  • Page 28 8 Dry the transducer with a clean, non-linting towel. 9 Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use of the transducer, and contact FUJIFILM SonoSite or your local representative.

  • Page 29: Disinfecting The Transducer

    Disinfecting the transducer Caution Do not steam, autoclave, or expose the transducer to Ethylene Oxide. If using an automated disinfection process, follow manufacturer procedures. For manual disinfection, use the following procedure: To disinfect the transducer Table 4-2: Approved disinfectants and soak times Disinfectant Duration Anioxyde 1000...
  • Page 30 9 Dry the transducer with a sterile, non-linting towel or medical-grade air. 10 Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use of the transducer, and contact FUJIFILM SonoSite or your local representative.

  • Page 31: Identifying The Transducer As Clean

    (or other identification) of the person who performed the cleaning. Transporting the transducer When transporting the TEExi transducer, you must take precautions to protect the transducer from damage and avoid cross-contamination. Be sure to use a container approved by your organization. Caution Do not bend the endoscopic shaft smaller than a 20 cm (8 inch) curve.
  • Page 32 Caution Do not leave the TEExi transducer in a sealed container for long periods of time. To transport a clean transducer A clean transducer is one that has completed the cleaning and disinfection process, has been stored properly, and is ready to be used in an examination.

  • Page 33: Storing The Transducer

    Make sure the connector is supported and secure. Disposing of the transducer WARNING Do not destroy the transducer by incinerating or burning it. Return the transducer to FUJIFILM SonoSite or your local representative for disposal. Cleaning, disinfecting, transporting, storing, and disposing of the transducer...
  • Page 34 4-10 Cleaning, disinfecting, transporting, storing, and disposing of the transducer...

  • Page 35: Safety

    Standards compliance The TEExi transducer conforms to the Medical Device Directive 93/42/EEC. It is a class IIA medical device. Symbols and terms used on the transducer are explained in the ultrasound system user guide.

  • Page 36: Safe Operational Use

    Study this user guide thoroughly prior to performing a transesophageal procedure. The TEExi 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.

  • Page 37: Thermal Safety

    To avoid damaging the equipment, clean and disinfect the transducer using the Cautions recommended procedures only. To avoid damaging the transducer, the TEExi transducer shall be handled only by trained personnel. The TEExi transducer is a precision instrument and can be inadvertently damaged.

  • Page 38: Reducing Temperature

    Deviation of more than +/- 0.5° C is not acceptable. Maintaining this accuracy without temperature regulation may be difficult. 2 Connect the TEExi transducer to the ultrasound system or select it if you are using the Triple Transducer Connect.

  • Page 39: Electrical Safety

    If not, contact FUJIFILM SonoSite or your local FUJIFILM SonoSite representative. Electrical safety You should perform the electrical leakage current test on the TEExi transducer after taking it out of the box. You should also perform it either before each exam or—if you perform the bite-hole inspection test before each exam—yearly (at a minimum).
  • Page 40 Figure 5-2 TEExi components You should maintain a record of electrical current leakage and bite hole test results for each TEExi transducer. Preparing for bite-hole/electrical leakage testing Test both the transducer array and the endoscopic shaft for bite holes. You can use the same equipment for both tests, however the tester connection points are different for each test.
  • Page 41 Testing the transducer array To test the transducer array for bite holes or current leakage Red leads Controller Black lead Bite hole indicator Water bath with 5% saline solution Conductor plate Figure 5-3 Transducer array test setup 1 After securing the controller so it does not fall into the water bath, immerse the scan head and endoscopic shaft in liquid to above the 40 cm mark, but below the 90 cm mark.
  • Page 42 Conductor plate Salt-water bath Figure 5-4 Conductor plate attachment b Connect the red leads to the knurled socket cap screws on the transducer connector as shown in Figure 5-5. Figure 5-5 Transducer connector attachment 3 On the Bite hole indicator, press 4 Read the test result: Leads - The leads are not connected correctly.

  • Page 43: Testing The Endoscopic Shaft

    Figure 5-6 Endoscopic shaft test setup 1 Insert the puncture test tool under the scan plane controller as shown in Figure 5-7. The puncture test tool is included with the TEExi transducer. Figure 5-7 Insertion of the puncture test tool. Safety...
  • Page 44 2 Immerse the scan head and endoscopic shaft in liquid to above the 40 cm mark, but below the 90 cm mark. WARNING Do not immerse the controller, the cord, or the connector in any fluid. Caution Do not allow the endoscopic shaft to contact the conductor plate. Doing so could result in an inaccurate test result.
  • Page 45 If the bite hole test was performed as part of the cleaning process, continue to clean and disinfect the transducer. If the transducer fails the test Do not use the transducer. Do not connect the transducer to an ultrasound system. Contact FUJIFILM SonoSite for repair. Safety 5-11...

  • Page 46: Transducer Temperature Rise

    Transducer temperature rise Table 5-3: Transducer surface temperature rise, internal use Test TEExi Still air Simulated use 4.7 (≤6°C) Output display Table 5-4: TI or MI ≥...

  • Page 47: Acoustic Output

    Acoustic output Table 5-5: Transducer Model: TEExi Operating Mode: PW Doppler Index Label M.I. Non-scan Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value Associated (MPa) Acoustic (mW) 35.8 Parameter min of (mW) TA.3 (cm) (cm) (cm) 2.57 z@Pll (cm) .3max...
  • Page 48 Table 5-6: Transducer Model: TEExi Operating Mode: CW Doppler Non-scan Index Label M.I. Scan Non-scan ≤1 >1 aprt aprt Global Maximum Index Value Associated (MPa) Acoustic (mW) 34.4 Parameter min of W )] (mW) TA.3 (cm) (cm) (cm) z@Pll (cm) .3max...

  • Page 49: Transducer Specifications

    Transducer Specifications TEExi/8-3 MHz transducer External Diameter: 10.5 mm Endoscopic shaft Length: 110 cm Clockwise rotation of the lower deflection control wheel will deflect the tip anterior. Counterclockwise rotation of the lower deflection wheel will deflect the tip posterior. Steering...
  • Page 50 Upper: 42.5° C temperature Lower: 17.5° C limits Transducer Center Frequency 5.0 MHz Cable length All patient contact materials of the TEExi transducer/endoscope Biocompatibility system comply with ISO 10993-1. The transducer is latex free. Temperature: Environmental Shipping: -35° to+65° C limits (shipping Storage: 0°...
  • Page 52 P21458-05 *P21458-05*...

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