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TEExp Transducer

User Guide

Summary of Contents for SonoSite TEExp

Page 1: ...TEExp Transducer User Guide ...

Page 2: ...175173 designated in FR and GB Part Number P20036 09 Publication date November 2019 Copyright 2019 FUJIFILM SonoSite Inc All rights reserved Manufacturer FUJIFILM 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 EC Authorized Representative FUJIFILM SonoSite B V Joop Geesinkweg 140 1114 AB Amsterdam The Netherlands Australia Sponsor FUJIFILM...

Page 3: ...ted 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 ...

Page 4: ...ransporting 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 ...

Page 5: ...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 th...

Page 6: ...LM 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 Change Description Added references Added refe...

Page 7: ...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 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 ...

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

Page 9: ...equency 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 us...

Page 10: ...cer 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 esopha...

Page 11: ...acking 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 ...

Page 12: ...esting 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 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...

Page 13: ...onal endoscope It connects to the ultrasound system with a cable and connector see Figure 2 2 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 1 2 3 4 5 7 8 9 10 ...

Page 14: ...ly 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 a...

Page 15: ...ducer pointing away with control wheels up and the flexible shaft in a straight position 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 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...

Page 16: ...er 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 Figure 2 5 Tip flexion lock operation WARNING To avoid injury to the patient if you obs...

Page 17: ...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 ...

Page 18: ... 7 Figure 2 8 Scan plane indicator 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...

Page 19: ... 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 ...

Page 20: ...2 12 Getting started ...

Page 21: ...nd 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 flexi...

Page 22: ...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 ...

Page 23: ...livered with three bite guards Figure 3 1 For patients with dentures you must still use a bite guard Remove the dentures before placing the bite guard in the patient s mouth After removal of dentures place the bite quard with the soft syrofoam cover still on for patient comfort If you need help ordering more bite guards contact CIVCO Medical Solutions Re use cleaning and sterilization of the bite ...

Page 24: ...ath 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 flexe...

Page 25: ...king into the endoscopic shaft and exposing the patient to an electrical current If damage is evident discontinue use and contact FUJIFILM SonoSite or your local representative Confirm that cleaning and disinfecting materials are appropriate for your facility s use FUJIFILM SonoSite routinely tests cleaners and disinfectants for use with FUJIFILM SonoSite systems and transducers Disinfectants and ...

Page 26: ...nts of the TEExp transducer have different cleaning requirements and restrictions than others The cleaning testing and disinfection procedures frequently refer to specific components of the transducer See Figure 4 1 for a diagram of the transducer components Figure 4 1 Transducer components Table 4 1 Manual workflow Steps 1 Cleaning 2 Leakage testing 3 Disinfecting Connector Cable Controller Endos...

Page 27: ...minimum bend diameter can damage the endoscope or its watertight coating Do not use unapproved cleaning agents such as alcohol or bleach for example Sani Cloth wipes as these can damage the transducer and void the warranty For more information about approved cleaning agents see Table 4 2 Do not skip any steps or abbreviate the cleaning and disinfecting process in any way Table 4 2 Approved cleaner...

Page 28: ...cleaner b Clean the control handle and cord by wiping with a clean non linting cloth or single use endoscopic sponge moistened with the approved cleaner To remove any residual cleaner wipe both components again with a clean non linting cloth or singe use endoscopic sponge moistened with clean water Do not wipe the connector 6 Rinse the endoscopic shaft by soaking it in a large volume of clean luke...

Page 29: ...is not the same test as the electrical safety test see Electrical safety test on page 5 8 You should perform the electrical leakage test on the TEExp before or after every use and maintain a record of test results for each TEExp transducer Required equipment Container with one of the following Cidezyme Enzol 0 9 saline Conductivity probe ULT 2000 series leakage tester preset to test the TEExp prob...

Page 30: ...own 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 You will feel the fork adapter snap into position and may hear a click Figure 4 3 Insertion of the fork adapter Note Do not allow the fork adapter to swivel during the test ...

Page 31: ...s Fail 10 If it passes repeat steps 7 and 8 to complete three tests If any of the results are Fail electrical leakage was detected Do not use the TEExp transducer For remediation steps see If the transducer fails the test on page 4 10 11 Rinse the transducer in a large volume of clean water for example eight liters for at least three minutes and visually inspect it for damage before proceeding to ...

Page 32: ...disinfectants Disinfectanta b Anioxyde 1000 Opal Anioxy Twin Opaster Anios Cidex PeraSafe Cidex OPA Rapicide HLD Sterilant Cidex Plus Rapicide OPA 28 DisOPA Rapicide PA Gigasept PAA Concentrate Revital Ox Resert HLD Gigasept Pearls Sekusept AKtiv McKesson OPA 28 Steranios 2 Metricide TD 100 TD 5 Metricide 28 TD 100 TD 8 Metricide Plus 30 Tristel Generator Solution Metricide OPA Plus Wavicide 01 Nu...

Page 33: ...ducer 1 Rinse the transducer by soaking it for at least one minute in a large volume of sterile deionized water for example eight liters Discard the rinse water 2 Important To ensure that no residual disinfectant remains on the scan head or endoscopic shaft repeat step 1 at least two more times for a minimum total of three rinse cycles Dispose of the water after each rinse Some disinfectant manufa...

Page 34: ...or other identification of the person who performed the cleaning Check the guidelines for proper record keeping on your TEE probe cleaning disinfecting and electrical leakage testing If no electrical leakage is detected To identify the transducer as safe you should include a sticker or certificate that travels with the transducer that includes the date of the test the name or other identification ...

Page 35: ...ed 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 1 Place the transducer in a clean approved container To identify the transducer as clean containers used to transport clean transducers should carry a cleanliness verification sticker or certificate For more Caution...

Page 36: ...toring the transducer Follow society guidelines and recommendations To store the transducer 1 Clean test and disinfect the TEExp transducer See Transducer Care on page 4 1 2 Store the transducer so that it hangs freely and vertically and observe the following precautions Store the transducer away from any contaminated transducers WARNING Whenever possible avoid shipping a contaminated transducer B...

Page 37: ...mmended storage temperature range is between 0 C 32 F and 45 C 113 F If using a wall mounted rack for storage ensure that It is securely mounted The storage slots do not mar the transducer or the endoscopic shaft 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 Caution The tip cover is ...

Page 38: ...4 14 Transducer Care ...

Page 39: ...vice 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 For a list of applicable standards and requirements see the SonoSite X Porte User Guide Annual inspection In addition to the regular inspections described elsewhere in this document perform the following tests at least annually on the TEExp transducer...

Page 40: ...age 3 4 to assure a safe retraction of the transducer The mechanism is designed to provide safe operation during normal use Perform a low voltage electrical leakage test after cleaning the transducer but before disinfecting it If leakage is detected do not use the transducer See Testing the transducer for electrical leakage on page 4 5 Do not use conventional coupling gel intended for external use...

Page 41: ... C and 43 C The X Porte system includes safety features designed to assist the user in modifying treatment to prevent thermal damage to the patient during use When the scan head temperature is below 17 5 C the scan is stopped the scan head temperature flashes on the screen and the following message appears Figure 5 1 Low temperature warning message Cautions To avoid damaging the equipment clean an...

Page 42: ...eeds 45 C at any time the scan is halted and the following message appears Figure 5 3 High temperature warning message If a communication error occurs and the TEExp thermistor cannot be read the scan is halted and will not resume until the thermistor can be read and the temperature is within operating limits The transducer temperature is approaching upper limits Pressing the Freeze button may redu...

Page 43: ... imaging changes reduce the transducer surface temperature In any imaging mode freezing the image temporarily reduces the transducer surface temperature Guidelines for reducing MI and TI To reduce MI increase depth Table 5 4 Guidelines for reducing TI TIS TIC TIB Transducer CPD Color settings PW settings Box width Box height Box depth PRF Depth Optimize Depth TEExp Decrease or lower setting of par...

Page 44: ... accuracy of 0 1 C To test the calibration 1 Adjust the water bath temperature to 43 3 0 1 C and monitor the temperature with the gauge 2 If an accurate and stable water bath is not available account for the added inaccuracy when reading the temperature from the ultrasound system Deviation of more than 0 5 C is not acceptable Maintaining this accuracy without temperature regulation may be difficul...

Page 45: ...ucer for electrical isolation and leakage current before it is shipped to a customer The endoscopic shaft does not have any electrically conducting surfaces and is covered with a layer of material that does not permit fluids nor electricity to pass through it The transducer s electrical safety is maintained by keeping this material intact Punctures in this material such as those resulting from bit...

Page 46: ...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 You should maintain a record of the test results for each TEExp transducer WARNING Only qualified personnel should perform the electrical safety test Take all necessary precautions to avoid contact with non insulated parts that have applied voltage ...

Page 47: ...rior 120 Posterior 40 Right and Left 40 Scan plane rotation The transducer scans images in any plane within a nominal 180 cone from a transverse plane through the longitudinal plane and ending at the mirror of the first transverse plane The scan plane rotation is motor driven with speed and direction selected with buttons on the endoscope handle Maximum speed 180 in approximately 5 seconds Field o...

Page 48: ...s measured between the strain reliefs Biocompatibility All patient contact materials of the TEExp transducer endoscope system comply with ISO 10993 1 The transducer is manufactured without natural rubber latex Environmental limits shipping and storage Temperature Shipping 35 to 65 C Storage 0 to 45 C Humidity 15 to 95 R H Pressure 700 to1060 hPA 0 7 1 05 ATM ...

Page 49: ...0 Other information prr Hz 1750 srr Hz 50 0 npps 1 Ipa α at zpii α W cm2 366 Ispta α at zpii α or zsii α mW cm2 26 3 Ispta at zpii or zsii mW cm2 33 5 pr at zpii MPa 3 38 Operating controls Exam type Crd Optimization Pen Depth cm 4 0 Sector width Narrow a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No da...

Page 50: ...400 srr Hz 30 8 npps 1 Ipa α at zpii α W cm2 244 Ispta α at zpii α or zsii α mW cm2 31 5 Ispta at zpii or zsii mW cm2 54 9 pr at zpii MPa 2 74 Operating controls Exam type Crd Optimization Pen Depth cm 4 0 a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition sin...

Page 51: ...α at zpii α W cm2 289 Ispta α at zpii α or zsii α mW cm2 327 5 Ispta at zpii or zsii mW cm2 386 0 pr at zpii MPa 2 86 Operating controls Exam type Crd Crd Sample volume size mm 1 2 Sample volume position Zone 1 16 mm Zone 1 16 mm PRF Hz 1008 1562 TDI On Off a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses N...

Page 52: ...ormation prr Hz srr Hz npps Ipa α at zpii α W cm2 Ispta α at zpii α or zsii α mW cm2 Ispta at zpii or zsii mW cm2 pr at zpii MPa Operating controls Exam type Crd Sample volume position Zone 5 53 mm a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the g...

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