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Related Manuals for FujiFilm SonoSite TEExp
Summary of Contents for FujiFilm SonoSite TEExp
- Page 1 TEExp Transducer User Guide...
- Page 2 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.
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Page 3: Table Of 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 .................................. - Page 4 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...
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Page 5: 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. -
Page 6: Changes In This Version
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. - Page 7 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 Europe Service Center Main: +31 20 751 2020 English support: +44 14 6234 1151...
- Page 8 Introduction...
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Page 9: Getting Started
Getting started About the TEExp transducer FUJIFILM SonoSite does not recommend the use of WARNINGS 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. -
Page 10: Intended Uses
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 To avoid injury to patient/operator, carefully inspect all equipment after receipt and prior to each use. - Page 11 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.
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Page 12: Inspecting Contents
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. “Technical Support” on page 1-2. 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. -
Page 13: Transducer And System Interface
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 Figure 2-2.). a cable and connector (see Figure 2-2 TEExp transducer Flexible endoscopic shaft... -
Page 14: Teexp Transducer Controls
TEExp transducer controls Figure 2-3 The endoscope is designed for single-handed operation of the flexion and scan plane controls. 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. - Page 15 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.
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Page 16: Tip Flexion Lock
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. -
Page 17: Scan Plane Rotation
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. - Page 18 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 Transducer tip Counterclockwise button (increases angle) Biplane button (rotates angle to orthogonal biplane) Clockwise button (decreases angle) A scan plane indicator on the system screen shows the orientation.
- Page 19 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.
- Page 20 2-12 Getting started...
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Page 21: Examination
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: “To visually and tactilely inspect the transducer”... -
Page 22: Precautions
Low-voltage electrical leakage test. See page 4-5 . “Transducer Care” Clean and disinfect transducer. See 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... -
Page 23: Bite Guard/Block
Damage to the transducer from failure to use a bite guard voids the transducer warranty. Use of a bite guard is mandatory for TEExp transducers. Each TEExp transducer from FUJIFILM SonoSite is 3-1). For patients with dentures, you must still use a bite guard. -
Page 24: Sterile Sheath
TEExp transducer may occur. To provide suitable acoustic coupling within the sheath, FUJIFILM SonoSite recommends using a sterile gel. To apply a transducer sheath FUJIFILM SonoSite recommends the use of market-cleared, transducer sheaths for intracavitary applications. -
Page 25: Transducer Care
FUJIFILM SonoSite routinely tests cleaners and disinfectants for use with FUJIFILM SonoSite systems and transducers. Disinfectants and cleaning methods listed in this chapter are recommended by FUJIFILM SonoSite for efficacy and material compatibility with the products. Ensure that the disinfectant type, concentration, and contact time are appropriate for the equipment and application. -
Page 26: Process Overview
Process overview For manual cleaning, electrical leakage testing, and disinfecting the transducer, the following workflow is recommended. If using an automated disinfection process, follow manufacturer procedures. Table 4-1: Manual workflow Steps 1 Cleaning 2 Leakage testing 3 Disinfecting Transducer components Some components of the TEExp transducer have different cleaning requirements and restrictions than others. -
Page 27: Cleaning The Transducer
Do not skip any steps or abbreviate the cleaning and disinfecting process in any way. Cleaners and disinfectants not listed on FUJIFILM SonoSite's website have not been evaluated for compatibility and may cause damage to the transducer. For approved chemicals, follow the manufacturer’s instructions for concentration, temperature, and duration. - Page 28 9 Dry the transducer with a clean, non-linting towel. 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.
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Page 29: Testing The Transducer For Electrical Leakage
Testing the transducer for electrical leakage Caution If the watertight coating on the scan head or endoscopic shaft has been damaged or punctured, contact FUJIFILM SonoSite for instructions on cleaning and returning the transducer for repair. About leakage testing Electrical leakage caused by bite holes or other damages to the endoscope surface can be detected using a transducer leakage tester, such as the ULT-2000 series. - Page 30 To test the transducer for electrical leakage 1 Insert the transducer connector into the transducer adapter as shown in Figure 4-2. Figure 4-2 Insertion of the transducer connector 2 Insert the fork adapter securely in between the flexion control wheels as shown in Figure 4-3.
- Page 31 11 Rinse the transducer in a large volume of clean water (for example, eight liters) for at least three minutes. “Disinfecting the transducer” and visually inspect it for damage before proceeding to on page 4-8. If damage is evident, discontinue use of the transducer, and contact FUJIFILM SonoSite or your local representative. Transducer Care...
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Page 32: Disinfecting The Transducer
Do not steam, autoclave, or expose the transducer to Ethylene Oxide. Cleaners and disinfectants not listed on FUJIFILM SonoSite's website have not been evaluated for compatibility and may cause damage to the transducer. For a list of approved disinfectants, see www.sonosite.com/support/cleaners-disinfectants. - Page 33 To disinfect the transducer 1 Verify that the transducer has been cleaned using the procedure described in “Cleaning the transducer” on page 4-3. 2 At the disinfection station, prepare the disinfectant for use: a Check the expiration date on the bottle to ensure that the disinfectant has not expired. b Check that the disinfectant has the concentration recommended by the manufacturer (for example, use a chemical strip test).
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Page 34: Identifying The Transducer As Clean And Safe
4 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. 5 If not already in place, apply a clean tip cover over the transducer scan head. The tip cover encloses and protects the scan head from mechanical strain and impact during transportation and storage. -
Page 35: Transporting The Transducer
To identify the transducer as unsafe to use, you should include a sticker or certificate that travels with the transducer that includes the date of the test, the name or other identification of the tester, and the outcome of the test. Transporting the transducer When transporting the TEExp transducer, you must take precautions to protect the transducer from damage and avoid cross-contamination. -
Page 36: Storing The Transducer
Whenever possible, avoid shipping a contaminated transducer. Before shipping, ensure the transducer has been cleaned, tested, and disinfected using the steps detailed in this chapter or according to special instructions received from FUJIFILM SonoSite. If you are returning the transducer to FUJIFILM SonoSite, document the disinfection on a “Declaration of Cleanliness,”... -
Page 37: Disposing Of The Transducer
The rack is sized and positioned to prevent the transducer from inadvertently falling. 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. Transducer Care 4-13... - Page 38 4-14 Transducer Care...
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Page 39: Safety
If any irregularity, substandard functioning, or unsafe condition is observed or suspected, do not use the TEExp transducer. Call FUJIFILM SonoSite or your local representative. WARNING The TEExp transducer has no protection in the event of a neutral electrode fault of a high frequency surgical device. -
Page 40: Safe Operational Use
Avoid forceful intubation pressure which can cause lacerations or perforation of the gastrointestinal tract. Remove the transducer from the patient when using a defibrillator. FUJIFILM SonoSite recommends cleaning and disinfecting transducers after “Transducer Care” each use. See on page 4-1. -
Page 41: Thermal Safety
Cautions To avoid damaging the equipment, clean and disinfect the transducer using the recommended procedures only. To avoid damaging the transducer, the TEExp transducer shall be handled only by trained personnel. The TEExp transducer is a precision instrument and can be inadvertently damaged. Thermal safety Experts generally agree that to avoid damage to body tissues during long-term exposures, the temperature of the transducer tip where contacting tissue should be less than 43°... - Page 42 If the temperature exceeds 41° C, the scan head temperature is highlighted on the screen to indicate that you are close to the maximum safe operating temperature. If the temperature exceeds 43° C, the scan head temperature flashes on the screen and the following message appears: The transducer temperature is approaching upper limits.
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Page 43: Reducing Temperature
Cannot read the transducer temperature. The system will resume imaging when the temperature can be determined. Please contact FUJIFILM SonoSite Technical Support at 1-877-657-8118 Figure 5-4 Transducer communication error message Reducing temperature The following are general guidelines for reducing temperature in 2D or Doppler imaging modes: Scan using 2D mode (2D imaging typically results in the lowest transducer surface temperature). -
Page 44: Output Display
Output display The following table indicates whether, for each operating mode, the value of TI or MI is greater than or equal to 1.0, thus requiring display. Table 5-5: MI or TI value by operating mode Operating mode TIC, TIB, or TIS 2D/M Mode ≥1.0 <1.0... -
Page 45: Electrical Safety
It is important that you establish and use a standardized procedure to ensure that the transducer is safe to use and functions properly prior to each use. If any irregularity, substandard functioning, or unsafe condition is observed or suspected, do not use the TEExp transducer. Call FUJIFILM SonoSite or your local representative. -
Page 46: Electrical Safety Test
Electrical safety test You should establish a program for measuring the electrical leakage current on a regular basis. As a minimum, electrical current leakage tests according to IEC 60601-1 must be performed once per year, or as required by local regulation. The leakage limits associated with Type BF (Body Floating) Applied Part must be met. -
Page 47: Transducer Specifications
Transducer specifications TEExp/8-3 MHz transducer External Diameter: 10.5 mm Endoscopic shaft Length: 110 cm Clockwise rotation of the lower control wheel will flex the tip anterior. Counterclockwise rotation of the lower wheel will Steering orientation flex the tip posterior. Clockwise rotation of the upper control wheel will flex the tip to the right. - Page 48 Upper: 45° C Transducer tip Lower: 17.5° C temperature limits Center Frequency 5.0 MHz Transducer 7.2 ft/2.2 m (as measured between the strain reliefs) Maximum cable length All patient contact materials of the TEExp transducer/ Biocompatibility endoscope system comply with ISO 10993-1. The transducer is manufactured without natural rubber latex.
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Page 49: Acoustic Output
Acoustic output For acoustic output information, see the ultrasound system user guide. Table 6-1: Transducer model: TEExp Operating mode: 2D Index label Below Below surface surface surface surface surface Maximum index value Index component value at z (MPa) 2.60 r,α P (mW) (mW) (cm) - Page 50 Table 6-2: Transducer model: TEExp Operating mode: 2D + M Mode Index label Below Below surface surface surface surface surface Maximum index value Index component value at z (MPa) 2.09 r,α P (mW) (mW) (cm) (cm) (cm) 1.75 (cm) 1.75 pii,α...
- Page 51 Table 6-3: Transducer model: TEExp Operating mode: PW Doppler Index label Below Below surface surface surface surface surface Maximum index value Index component value at z (MPa) 2.64 r,α P (mW) 32.8 (mW) 32.8 (cm) (cm) 0.60 (cm) (cm) pii,α (MHz) 4.01 4.01...
- Page 52 Table 6-4: Transducer model: TEExp Operating mode: CW Doppler Index label Below Below surface surface surface surface surface Maximum index value Index component value at z (MPa) r,α P (mW) 25.9 (mW) 25.9 (cm) (cm) 0.90 (cm) (cm) pii,α (MHz) 4.00 prr (Hz) srr (Hz)
- Page 54 P20036-09 *P20036-09*...
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