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TEExi Transducer

User Guide

Summary of Contents for TEExi

Page 1: ...TEExi Transducer User Guide...

Page 2: ...1175173 and GB 1175173 Part Number P21458 05 Publication date April 2018 Copyright 2018 FUJIFILM SonoSite Inc All rights reserved Manufacturer FUJIFILM SonoSite Inc 21919 30th Drive SE Bothell WA 9802...

Page 3: ...transducer 2 1 How scan plane rotation works 2 2 Intended uses 2 2 Contraindications 2 2 Unpacking 2 3 Inspecting contents 2 4 Transducer and system interface 2 5 TEExi transducer controls 2 6 Tip de...

Page 4: ...ransducer 4 9 Disposing of the transducer 4 9 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 4 Temperatur...

Page 5: ...r 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 use...

Page 6: ...ot require performance in sequence 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...

Page 7: ...877 657 8118 Phone outside U S or Canada 425 951 1330 or call your local representative Fax 425 951 6700 Email ffss service fujifilm com Web www sonosite com Europe Service Center Main 31 20 751 2020...

Page 8: ...1 4 Introduction...

Page 9: ...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: ...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 Intended uses The TEExi transdu...

Page 11: ...procedures Contact FUJIFILM SonoSite or your local representative immediately to report any damage or discrepancies To unpack the transducer 1 Visually examine the shipping box shipping case and the T...

Page 12: ...ation on page 2 11 Leakage test See Electrical safety on page 5 5 WARNING To avoid injury to patient Proper care and maintenance are essential for safe operation of the TEExi transducer The medical pr...

Page 13: ...red 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 3 Figure 2 3...

Page 14: ...ct 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 t...

Page 15: ...ake 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 Figure 2 5 Deflect...

Page 16: ...s 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...

Page 17: ...ock the brake and confirm that the tip straightens easily 6 Repeat steps 1 5 for the posterior direction Scan plane rotation The scan plane rotation is driven by a motor in the transducer handle and i...

Page 18: ...scan plane angle decreases The scan plane 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 ax...

Page 19: ...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 9 4 Confirm that the im...

Page 20: ...2 12 Getting Started...

Page 21: ...egularity substandard functioning or unsafe condition do not use the TEExi transducer Call FUJIFILM SonoSite or your local representative immediately Perform the following before each exam Visual tact...

Page 22: ...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...

Page 23: ...le 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 TEExi transdu...

Page 24: ...d in a deflected position inside the patient and if all attempts to release the deflected tip should fail follow the procedure To retract the transducer to assure a safe retraction of the transducer T...

Page 25: ...nd 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 c...

Page 26: ...sposing of cleaning and disinfection solutions Check the expiration dates and do not use solutions that have surpassed their expiration dates Follow the manufacturer s recommendations for verifying th...

Page 27: ...ING Be sure to use the appropriate Personal Protective Equipment PPE whenever necessary Cautions Always disconnect the transducer from the system before cleaning When disconnecting the transducer from...

Page 28: ...soaking it in a large volume of clean lukewarm water for example eight liters for at least three minutes to remove residual cleaning solution Residual cleaners left on the transducer can cause damage...

Page 29: ...ion check the expiration of the disinfectant Check the temperature and concentration of the solution 4 Disinfect the cable and controller by wiping them with a sterile non linting cloth or single use...

Page 30: ...s evident discontinue use of the transducer and contact FUJIFILM SonoSite or your local representative 11 If not already in place apply a clean tip cover over the transducer scan head The tip cover en...

Page 31: ...er 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 To tran...

Page 32: ...ducer scan head 2 Place the transducer in the shipping case and seal it 3 Ship the transducer using the following precautions Clearly label the case as fragile Caution Ensure the transducer is dry bef...

Page 33: ...sed containers or where condensation may occur Use a tip cover when storing the transducer to prevent damage to the scan head The tip cover encloses and protects the scan head from mechanical strain a...

Page 34: ...4 10 Cleaning disinfecting transporting storing and disposing of the transducer...

Page 35: ...ice Symbols and terms used on the transducer are explained in the ultrasound system user guide For a list of applicable standards and requirements see the ultrasound system user guide Annual inspectio...

Page 36: ...etraction on page 3 4 to assure a safe retraction of the transducer The deflection mechanism is designed to provide safe operation during normal use Perform a bite hole detection test after cleaning t...

Page 37: ...rs This warning appears only once per exam To continue press OK If the temperature reaches 42 5 C the image freezes and cannot be unfrozen until the temperature falls below 42 0 C To resume imaging pr...

Page 38: ...tions See Thermal safety on page 5 3 To prepare for the temperature calibration test assemble the following items Temperature stabilized water bath Temperature gauge with accuracy of 0 1 C To test the...

Page 39: ...ient being exposed to an electrical current FUJIFILM SonoSite tests each TEExi transducer for electrical isolation and leakage current before it is shipped to a customer It is important that you estab...

Page 40: ...le 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 fo...

Page 41: ...cator to the transducer connector and the conductor plate a Connect the black lead to the conductor plate in the salt water bath as shown in Figure 5 4 on page 5 8 WARNING Do not immerse the controlle...

Page 42: ...d 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 conn...

Page 43: ...ttery is low Replace the battery Testing the endoscopic shaft To test the endoscopic shaft for bite holes or current leakage Figure 5 6 Endoscopic shaft test setup 1 Insert the puncture test tool unde...

Page 44: ...8 Conductor plate attachment bConnect the red leads to the puncture test tool as shown in Figure 5 9 on page 5 11 WARNING Do not immerse the controller the cord or the connector in any fluid Caution D...

Page 45: ...ic shaft for one minute with a large volume of clean lukewarm water to remove residual saline solution for example eight liters 7 Dry the endoscopic shaft with a clean non linting towel If no bite hol...

Page 46: ...st the name or other identification of the tester and the outcome of the test Transducer temperature rise Output display Table 5 3 Transducer surface temperature rise internal use Test TEExi Still air...

Page 47: ...c PRF Hz pr PIImax MPa deq Pllmax cm 0 28 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Card Control 2 Sample Volume Size 1mm Control 3 Sample Volume Po...

Page 48: ...mation PD sec PRF Hz pr PIImax MPa deq Pllmax cm 0 34 Focal Length FLx cm FLy cm IPA 3 MImax W cm2 Operating Control Conditions Control 1 Exam Type Card Control 2 Sample Volume Zone 2 Control 3 Contro...

Page 49: ...erior 120 minimum 130 maximum Posterior 40 minimum 60 maximum Right and Left 40 minimum 60 maximum Scan plane rotation The transducer scans images in any plane within a 180 nominal cone from a transve...

Page 50: ...17 5 C Transducer Center Frequency 5 0 MHz Cable length 2 m Biocompatibility All patient contact materials of the TEExi transducer endoscope system comply with ISO 10993 1 The transducer is latex fre...

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