TEExp User Guide P20036-01
Contents
1. 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 scanplane rotation is motor driven with speed and direction selected with buttons on the endoscope handle Maximum speed 180 in approximately 5 seconds Scanplane rotation Field of view 90 maximum Transducer tip Length 35 mm dimensions Cross section maximum 14 mm x 12 5 mm Disinfection Spaulding class semi critical classification Electrical safety Conforms to applicable UL CSA IEC requirements for class BF Temperature accuracy 0 5 C within the range of 35 to 45 C 45 Table 7 Transducer specifications Transducer tip temperature limits Transducer Cable length Biocompatibility Environmental limits shipping and storage 46 Upper 45 C Lower 17 5 C Center Frequency 5 0 MHz 2m All patient contact materials of the TEExp transducer endoscope system comply with ISO 10993 1 The transducer is manufactured without natural rubber latex 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 Chapter 6 Acoustic output For acoustic output information see the ultrasound system user guide Table 8 Transducer Model TEExp Operating Mode 2D TIS TIB Index Label d Non scan TIC Non scan aprt Aaprt gt 1 Glob2. 38 Chapter 5 Conductor plate Salt water bath Figure 16 Conductor plate attachment b Connect the red leads to the transducer connector as shown in Figure 17 Figure 17 Transducer connector attachment 3 Press 4 Read the test result gt Leads The leads are not connected correctly Check the connections and test again TEExp User Guide 39 gt Fail There was a bite hole detected in the transducer array Stop the bite hole test procedure Do not use the TEExp transducer For remediation steps see If the transducer fails the test on page 43 gt Pass No bite holes were found gt All If all of the lights are illuminated the battery is low Replace the battery 5 After the test rinse the endoscopic shaft for one minute with a large volume of clean lukewarm water to remove residual saline solution for example eight liters 6 Dry the endoscopic shaft with a clean non linting towel Testing the endoscopic shaft To test the endoscopic shaft for bite holes Red lead Controller Black lead Bite hole indicator Water bath with 5 saline solution Copper or aluminum sheet Figure 18 Endoscopic shaft test setup 1 Insert the puncture test tool under the scanplane controller as shown in Figure 19 40 Chapter 5 Figure 19 Insertion of the puncture test tool 2 Immerse the scan head and endoscopic shaft in liquid to above the 40 cm mark but below the 90 cm mark WARNING
3. C 113 F 15 minutes Aniosyme DD1 0 5 at 38 C 100 F 15 minutes Salvanios pH7 0 5 at 38 C 100 F 15 minutes Cidezyme Enzol 1 10 at 38 C 100 F 1 3 minutes 1 Atthe point of use immediately after extracting the TEExp 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 2 Atthe cleaning station check the expiration date of the cleaner Check the temperature and concentration of the cleaning solution 3 Secure the control handle so it cannot fall into the cleaning solution Soak the endoscopic shaft in a plastic container filled with enzymatic cleaning solution according to the concentration and soak time indicated in Table 1 Enzymatic cleaners on page 21 Scrub the endoscopic shaft for at least three minutes using TEExp User Guide 21 8 9 a soft brush or single use endoscopic sponge moistened with enzymatic cleaner Follow the chemical manufacturer s precautions and instructions and observe dilution rates Do not soak the transducer longer than recommended by the chemical Caution manufacturer Caution Do not immerse the system cable connector or controller in any fluid While the endoscope is soaking clean the control handle and cord by wiping with a clean non linting cloth or single use endoscopic sponge moistened with one o
4. See To inspect the scan plane rotation on page 13 gt Leakage test or bite hole inspection test See Electrical leakage testing and bite hole detection on page 35 or Testing the transducer array on page 38 gt Clean and disinfect transducer See Cleaning and disinfecting on page 19 Contact FUJIFILM SonoSite or your local representative to report any damage or discrepancies Technical Support on page 2 15 To avoid injury to the patient gt FUJIFILM SonoSite recommends performing the above procedures prior to each exam gt Do not use the transducer if any metallic protrusions holes rough spots WARNING cracks or dents are found gt 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 FUJIFILM SonoSite or your local representative WARNING Some gels and sterilants can cause an allergic reaction in some individuals Precautions Techniques for introducing the TEExp 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 gt Maintaining an unobstructed airway is a prime consideration for all patients gt Prolonged pressure on the esophagus by the tip of the transducer may lead to a pressure necrosis condition
5. 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 gt 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 Achievable ALARA Please see the ultrasound system user guide gt 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 gt 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 gt The use of a bite guard during all TEExp examinations is mandatory to protect the transducer from possible damage gt 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 gt In addition to the high level disinfection a protective sheath may provide even greater protection against contam
6. Transducer tip with scan head Deflection brake Deflection control wheels Neutral marker TEExp User Guide 10 11 Transducer cable Transducer connector Scan plane control buttons Attachment ring Handle TEExp transducer controls The endoscope is designed for single handed operation of the deflection and scan plane controls Figure 4 on page 8 shows the user holding the endoscope handle in the left hand Thumb and first and second fingers operate the deflection 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 Figure 4 Transducer in left hand To avoid injury to the patient gt Do not use the TEExp transducer if any irregularity substandard function or WARNING unsafe condition is observed or suspected gt Do not use the TEExp transducer if any metallic protrusions holes rough spots cracks or dents are found To visually and tactilely inspect the transducer You should inspect the TEExp 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 the straight and deflected position 2 Examine the transducer tip for any holes or dents Tip deflection The TEExp transducer endoscope has two wheels for controlling the transducer tip deflection The wheels control a
7. Safety Patient safety is ensured only when a well designed product is used in a safe and responsible manner It is important that you establish and use a check out 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 The TEExp transducer has no protection in the event of a neutral electrode fault of a high frequency surgical device When using the TEExp transducer with high frequency NARRID surgical equipment monitor the scan head temperature and remove the transducer from the area if you observe an increase in temperature Standards compliance The TEExp 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 For a list of applicable standards and requirements see the 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 gt Temperature calibration test See Guidelines for reducing MI and TI on page 33 gt Leakage current test See Electrical leakage testing and bite hole detection on page 35 29 Safe operational use To avoid injur
8. bite hole electrical leakage testing 36 Chapter 5 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 Assemble the following items for each test gt Water bath with a 5 saline solution 50g NaCl 1 liter water gt A conductor plate made of copper or aluminum with an area of at least 25 cm one is included with bite hole indicator kit gt Bite hole indicator with leads gt Puncture test tool included with TEExp transducer TEExp User Guide 37 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 Copper or aluminum sheet Figure 15 Transducer array test setup 1 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 cable or connector in any fluid Do not allow the endoscopic shaft to contact the conductor plate Doing so Caution could result in an inaccurate test result 2 Connect the Bite hole indicator 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 16 Use the lead attached to the conductor plate Do not submerge the indicator Note s clip
9. shaft with a clean non linting towel If no bite holes are 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 of the tester and the outcome of the test 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 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 TEExp User Guide 43 Chapter 5 Chapter 6 Transducer specifications TEExp 8 3 MHz transducer Table 7 Transducer specifications 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 Lu deflection wheel will deflect the tip posterior Steering orientation Clockwise rotation of the upper deflection control wheel will deflect the tip to the right Counterclockwise rotation of the upper deflection wheel will deflect the tip to the left Anterior 120 Tip deflection Posterior gt 40 Right and Left 240
10. system screen 8 Wait three minutes or until the temperature display is stabilized at 43 3 0 5 C plus minus any water bath temperature deviation 9 Observe that the Warning pop up window appears If the temperature warning works as described in Thermal limits on page 31 the transducer passes the test If not contact FUJIFILM SonoSite or your local representative Electrical safety Maximum cable length Table 6 TEExp Maximum cable length Description Maximum Cable Length TEExp Transducer 7 1 ft 2 2 m a For transducers maximum cable length is measured between the strain reliefs The stated lengths do not include the lengths of cable in the following locations underneath the strain reliefs inside the transducer enclosure or inside the transducer connector Electrical leakage testing and bite hole detection The endoscope 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 bites or improper handling can result in fluids entering the endoscopic shaft and the patient being exposed to an electrical current FUJIFILM SonoSite tests each TEExp transducer for electrical isolation and leakage current before it is shipped to a customer TEExp User Guide 35 It is important
11. 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 To avoid injury to the patient do not use the transducer if the insulating WARNING k material has been punctured or otherwise compromised Note Electrical leakage testing and bite hole detection are separate procedures that may be performed at different times Electrical leakage testing You should establish a program for measuring the electrical leakage current on a regular basis As a minimum electrical current leakage tests must be performed once per year or as required by local regulation Only qualified personnel should measure electrical leakage current Take all WARNING necessary precautions to avoid contact with non insulated parts that have applied voltage Bite hole detection A basic understanding of the TEE transducer components is important to successfully performing a bite hole detection test In this guide you will find references to the following components Connector Controller Cannot be submerged Can be submerged Endoscopic shaft Scan head You should maintain a record of electrical current leakage and bite hole test results for each TEExp transducer Preparing for
12. treatment to the esophagus 4 Chapter 2 gt Inability to swallow or accommodate the transducer gt 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 To avoid injury to patient operator carefully inspect all equipment after receipt and prior to each use WARNING Unpack the transducer Tip covers 3 Bite guards 3 Puncture testing tool TEExp transducer Figure 2 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 3 Verify that the shipping case contains the components listed on the packing list gt TEExp transducer gt TEExp Transducer User Guide gt TEE Transducer Care contains cleaning and disinfection instructions TEExp User Guide gt Bite guards 3 gt Puncture test tool gt Non sterile tip covers 3 To avoid injury to patient gt Proper care and maintenance are essential for safe operation of the TEExp WARNING transducer gt The medical professional performing the exam must exercise sound medical judgment in selecting this transducer for use in a procedure To avoid permanently damaging the transducer s internal c
13. 3 Biplane button rotates angle to orthogonal biplane 4 Clockwise button decreases angle 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 8 on page 13 The screen shows the angle relative to the standard monoplane displayed as 0 The nominal scan plane angle ranges from 0 to 180 and is accurate within 7 12 Chapter 2 Figure 8 scan plane indicator To avoid damaging the transducer connector protect the connector from dirt Caution and moisture 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 gt The button closest to the transducer tip rotates the scan plane counterclockwise scan plane angle increases gt The button farthest from the transducer tip rotates the scan plane clockwise 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 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 transduce
14. 6 SonoSite FUJIFILM TEExp Transducer User Guide Manufacturer EC Authorized Representative FUJIFILM SonoSite Inc Emergo Europe 21919 30th Drive SE Molenstraat 15 Bothell WA 98021 USA 2513 BH The Hague T 1 888 482 9449 or 1 425 951 1200 The Netherlands F 1 425 951 1201 Australia Sponsor FUJIFILM SonoSite Australasia Pty Ltd 114 Old Pittwater Road BROOKVALE NSW 2100 Australia CE 0086 SonoSite the SonoSite logo and X Porte are registered and unregistered trademarks of FUJIFILM SonoSite Inc in various jurisdictions All other trademarks are the property of their respective owners Patents US 6 371 918 CA 2 373 065 DE 60021552 0 FR 1175173 and GB 1175173 Part Number P20036 01 Publication Date April 2015 Copyright 2015 FUJIFILM SonoSite Inc All Rights reserved Chapter 1 Introduction About the user QUIGE eessesssssessescseccsssccssesssecssccsscccssccssccssecescesscessccsacessscesscesscesseessees 1 CONVENTIONS iienaa ii Tiei E a 1 Warranty StateMentiseisssssisssiesssssccsesoncsssssisosensessssnensssaasessssosossassgnussoussdeasensssssazenosessessiase 2 TECH Gal SU PPOM seccecevssasscscaicesesscsesssesssscessceasacousceyssensasbscstesscssesseadedasebicsasacaussnsstanssicicess 2 Chapter 2 Getting started About the TEEXp transducer sessssssscsssssscsseccssssccsneecsssscesscesssnecssnseessseesensesssseesenseeees 3 How scan plane rotation works sescsscsssess
15. Anioxyde 1000 2326 73 F 15 minutes Cidex 23 C 73 F 45 minutes Cidex OPA 23 C 73 F 12 minutes Korsolex extra Less than 45 C 113 F 15 minutes Metricide 25 C 77 F 45 minutes Nu Cidex 20 C 68 F 15 minutes PeraSafe less than 45 C 113 F 15 minutes Sekusept AKtiv less than 45 C 113 F 15 minutes TD 100 amp TD 5 Auto Auto Tristel Generator Solution Auto Auto Wavicide 01 24 C 75 F 45 minutes 1 Verify that the transducer has been cleaned using the procedure described in Cleaning the transducer on page 21 2 If you are using an automated disinfection process skip the rest of this procedure and refer to the manufacturer s instructions To manually disinfect the transducer proceed to step 3 3 At the disinfection station 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 endoscopic sponge moistened with disinfectant solution 5 Rinse the cable and connector by wiping them with a sterile non linting cloth or single use endoscopic sponge moistened with sterile water 6 Secure the control handle so it cannot fall into the cleaning solution Disinfect the transducer by soaking the shaft in the disinfection fluid Do not exceed the soak time indicated in Table 2 Approved disinfectants and soak times on page 23 Do not soak the transducer longer than recom
16. Do not immerse the controller the cable or the connector in any fluid Do not allow the endoscopic shaft to contact the conductor plate Doing so Caution could result in an inaccurate test result 3 Connect the Bite hole indicator to the puncture test tool and the copper sheet a Connect the black lead to the copper or aluminum sheet in the salt water bath as shown in Figure 20 Use the lead attached to the conductor plate Do not submerge the indicator Note i clip TEExp User Guide 41 Conductor plate Salt water bath Figure 20 Conductor plate attachment b Connect the red leads to the puncture test tool as shown in Figure 21 Note Each clip should be attached separately to the puncture test tool Figure 21 Puncture test tool attachment 4 Press 5 Read the test result 42 Chapter 5 gt Leads The leads are not connected correctly Check the connections and test again gt Fail There was a bite hole detected in the endoscopic shaft Stop the bite hole test procedure Do not use the TEExp transducer For remediation steps see If the transducer fails the test on page 43 gt Pass No bite holes were found gt All If all of the lights are illuminated the battery is low Replace the battery 6 After the test rinse the endoscopic 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
17. aging plane Scan head Figure 1 Rotating to different imaging planes 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 Intended uses The TEExp transducer is an endoscopic transducer 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 TEExp 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 Contraindications WARNING The physician must consider all possible factors before starting the examination Contraindications for using a transesophageal transducer include but are not limited to the following gt Fetal imaging gt Pediatric imaging gt Imaging when the patient exhibits the following or similar conditions gt Esophageal stricture spasms lacerations and trouble swallowing dysphagia gt Esophageal diverticula esophageal varices swollen veins gt Gastrointestinal bleeding gt Peptic ulcers hiatal hernia esophageal webs and rings gt Recent radiation
18. al Maximum Index Value 1 2 a b Pr3 MPa 2 60 Wo mW min of W 3 Z la 3 Z1 mW E 5 Z cm 3 Zp cm e m L gE Zp cm 3 a Z PIl zmax 1 7 2 deg Zsp cm fi MHz 4 60 Dim of Aaprt X cm Y cm PD usec 0 325 PRF Hz 1750 pele MPa 3 38 2S E cm O Focal Length FL cm Fly cm Ipa 3 MImax W cm 366 Control 1 Exam Type Crd 2s Control 2 Optimization Diff k Control 3 Depth 4 0cm amp 9 5 Control 4 Sector Width Narrow Control 5 a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode TEExp User Guide 47 Table 9 Transducer Model TEExp Operating Mode M Mode TIS TIB Index Label d Non scan TIC Scan Non scan Aaprt lt 1 Aaprt gt 1 Global Maximum Index Value 1 3 a a b Pr3 MPa 2 67 Wo mW min of W 3 Z lq 3 Z1 mW Zi cm ge Zbp cm g 5 Zsp cm SS Z Pll max 2 2 3 deqlZsp cm fe MHz 4 37 Dim of Aaprt X cm Y cm PD usec 0 329 PRF Hz 800 P Pllmax MPa 3 72 8 deq Pllmax c
19. ature is approaching upper limits The system will resume imaging when the transducer cools to 43 0 C Figure 13 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 32 Chapter 5 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 14 Transducer communication error message Reducing temperature The following are general guidelines for reducing temperature in 2D or Doppler imaging modes gt Scan using 2D mode 2D imaging typically results in the lowest transducer surface temperature gt In 2D imaging select the average optimization setting and increasing the image depth gt In PW Doppler imaging position the Doppler sample gate to a deeper depth gt In CW Doppler imaging no imaging changes reduce the transducer surface temperature gt 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 3 Guidelines for reducing TI TIS TIC TIB PW CPD Color Settings Settings Transducer Box Depth ee t 4 t Increase or raise setting parameter to reduce TI i Decrease or lower setting param
20. b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode TEExp User Guide 49 Table 11 Transducer Model TEExp Operating Mode CW Doppler TIS TIB Index Label M Non scan TIC Scan Non scan Aaprt lt 1 Aaprt gt 1 Global Maximum Index Value a a T3 b Pr 3 MPa Wo mW 25 9 min of W z1 lta 3Z1 mW Y z Z1 cm 3 g z Zbp cm E 5 Zsp cm 0 90 3 amp Z Pll zmax cm 3 deqlZsp cm 0 35 iie MHz 4 00 Dim of Aaprt X cm 0 43 Y cm 0 90 PD usec PRF Hz S DOPIS MPa Z z deq Pllmax cm 0 34 o amp Focal Length FL cm lt E FLy cm lI a 3 Mlmax W cm Control 1 Exam Type Crd Nn 25 Control 2 Sample Volume Position Zone 5 53 ees mm a9 5 Control 3 O Control 4 a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 50 Chapter 6 TEExp U
21. ction solutions Check the expiration dates and do not use solutions that have surpassed their expiration dates Follow the manufacturer s recommendations for verifying the concentration and efficacy of all cleaning and disinfection solutions for example a chemical strip test 20 Chapter 4 Cleaning the transducer Be sure to use the appropriate Personal Protective Equipment PPE whenever WARNING necessary Always disconnect the transducer from the system before cleaning When Caution disconnecting the transducer from the system follow the steps in the X Porte User Guide Cautati Do not bend the endoscopic shaft smaller than a 20 cm 8 inch curve Exceeding this minimum bend diameter can damage the endoscope or its watertight coating Do not use unapproved cleaning agents such as alcohol or bleach for example Caution Sani Cloth wipes as these can damage the transducer For more information about approved cleaning agents see Table 1 Enzymatic cleaners on page 21 Caution Do not skip any steps or abbreviate the cleaning and disinfection process in any way Before using any cleaning agent that is not listed in the table below contact FUJIFILM SonoSite to verify that it will not damage the transducer To clean the transducer Table 1 Enzymatic cleaners Cleaner Concentration Temperature Duration Prolystica 1 5 at 33 43 C 91 109 F 2 5 minutes then rinse immediately Hexanios G R 0 5 at less than 45
22. d impact during transportation and storage Keep the tip cover on until preparing the transducer for use The tip cover is a single use device Do not reuse tip covers Doing so can result in Caution ae contamination of or damage to the scan head When handling a clean transducer always take appropriate precautions to prevent Caution ere cross contamination 11 To transport the transducer refer to the procedures detailed in Transporting the transducer on page 25 12 To store the transducer refer to the procedure detailed in Storing the transducer on page 26 13 Dispose of the disinfectant according to the manufacturer s guidelines Wear the appropriate personal protective equipment PPE when handling WARNING disinfectants 24 Chapter 4 Identifying the transducer as clean To identify the transducer as clean containers used to transport clean transducers should carry a verification sticker or certificate that include the date cleaned and the name or other identification of the person who performed the cleaning Transporting the transducer When transporting the TEExp 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 Do not bend the endoscopic shaft smaller than a 20 cm 8 inch curve Exceeding Caution ds a this minimum bend diameter can damage the endoscope or its watertight coatin
23. eter to reduce TI TEExp User Guide 33 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 4 MI or TI value by operating mode Operating mode nue or TIS 2D M Mode Be ilies CPD Color ie ae PW Doppler ele el CW Doppler lt 1 0 21 0 Transducer surface temperature rise Table 5 Surface temperature rise Still air te Simulated use 3 6 6 C Temperature calibration test At least once a year verify the temperature measurement function to the specifications To set up the test Assemble the following items for the test gt Temperature stabilized water bath gt Temperature gauge with 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 difficult 34 Chapter 5 3 Connect the TEExp transducer to the ultrasound system or select it if you are using the Triple Transducer Connect 4 Freeze the image 5 Put the transducer tip in the water bath 6 At least 10 cm of the distal end must be submerged 7 Observe the temperature indicated on the
24. f the cleaners listed in Table 1 Enzymatic cleaners on page 21 To remove any residual cleaner wipe both components again with a clean non linting cloth or singe use endoscopic sponge moistened with water Do not wipe the connector Rinse the endoscopic shaft by 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 Visually inspect the scan head and endoscopic shaft for remaining biological material If any is found repeat the cleaning process Test the transducer for bite holes For information about leakage and bite hole detection see Electrical leakage testing and bite hole detection on page 35 If the watertight coating on the scan head or endoscopic shaft has been damaged or Caution punctured contact FUJIFILM SonoSite for instructions on cleaning and returning the transducer for repair Dry the transducer with a clean non linting towel Proceed immediately to the disinfection process See Disinfecting the transducer on page 22 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 22 Chapter 4 To disinfect the transducer Table 2 Approved disinfectants and soak times
25. f the temperature sensor is not working properly when you connect the transducer to the system the image freezes and a warning appears Thermal limits The imaging temperature range for the TEExp transducer is between 18 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 The transducer temperature is below the minimum limit of 17 5 C The system will resume imaging when the transducer warms to 18 0 C Figure 11 Low temperature warning message 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 TEExp User Guide 31 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 Pressing the Freeze button may reduce the power The system will STOP imaging in three minutes if the temperature continues to rise Figure 12 High temperature caution message If the scan head temperature stays above 43 C for more than 3 minutes or if it exceeds 45 C at any time the scan is halted and the following message appears The transducer temper
26. g To transport a soiled transducer for cleaning A soiled transducer is one that has been contaminated and must be cleaned before using it in an exam 1 Place the transducer in a clean approved container To prevent cross contamination or unprotected exposure of personnel to biological material containers used to transport contaminated transducers should carry an ISO biohazard label similar to the following WARNING Ensure the transducer is dry before placing it in a closed container Condensation Caution from a damp transducer can damage the connector and endoscope 2 Transport the transducer in the container to the point of processing Do not open the container until the transducer is ready to be cleaned Caution Do not leave the TEExp 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 TEExp User Guide 25 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 information see Identifying the transducer as clean on page 25 2 Transport the transducer in the container to the point of use Do not open the container until the transducer is ready to be used To ship a tran
27. he TEExp transducer may occur Caution 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 To lessen the risk of contamination apply the sheath only when you are ready to perform the procedure 1 Place gel inside the sheath TEExp User Guide 17 2 Insert the transducer into the sheath 3 Pull the sheath over the transducer endoscope shaft 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 To retract the transducer on page 18 to ensure a safe retraction of the transducer To retract the transducer 1 Disconnect the transducer from the ultrasound system 2 Atan accessible location between the transducer handle and the patient cut the entire endoscope shaft including all internal wiring using heavy duty cutting pliers or another suitable tool The deflect
28. ide 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 4 To avoid trauma to the patient s stomach or esophagus do not WARNING 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 unlocked state See Figure 9 on page 17 WARNING Pre exam inspection 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 TEExp transducer Call FUJIFILM SonoSite or your local representative immediately Perform the following before each exam gt Visual tactile inspection See To visually and tactilely inspect the transducer on page 8 gt Tip deflection inspection See To inspect tip deflection on page 11 gt Brake inspection See To inspect tip deflection brake on page 11 gt Scanplane rotation inspection
29. ination of the transducer Contact CIVCO for protective sheaths and applicators for protective sheaths 16 Chapter 3 Bite guard To avoid damaging the transducer use a bite guard during all TEExp examinations Biting the endoscope may cause severe permanent damage to Caution 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 TEExp transducer from FUJIFILM SonoSite is delivered with three bite guards Figure 9 Using a bite guard is mandatory If you need help ordering more bite guards contact CIVCO Medical Solutions Re use cleaning and sterilization of the bite guards should be done according to instructions provided by the manufacturer of the bite guard Side view Front view Figure 9 Bite guard Sterile sheath Use a sterile sheath whenever examining a patient that poses an isolation risk 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 TEExp transducer Contact CIVCO to order sterile sheaths and applicators for sterile sheaths To avoid damaging the TEExp transducer ensure that the 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 t
30. intestinal tract Remove the transducer from the patient when using a defibrillator FUJIFILM SonoSite recommends cleaning and disinfecting transducers after each use See Cleaning and disinfecting on page 19 v WARNING v Vv Vv Vv vv To avoid injury to the patient and damage to the transducer use a bite guard WARNING during all transesophageal exams To maintain proper level of sterility the use of a protective sheath in addition to WARNING the high level disinfection may provide the proper level of protection against contamination of the transducer Some transducer sheaths contain natural rubber latex and talc which can cause WARNING allergic reactions in some individuals See 21 CFR 801 437 User labeling for devices that contain natural rubber 30 Chapter 5 To avoid damaging the equipment clean and disinfect the transducer using the men recommended procedures only To avoid damaging the transducer the TEExp transducer shall be handled only Caution 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 C A thermal safety system in the ultrasound system displays the transducer s operating temperature on screen and prevents it from exceeding given limits I
31. ion mechanism is now released and the transducer may be safely retracted 18 Chapter 3 CHAPTER 4 Chapter 4 Cleaning disinfecting transporting storing and disposing of the transducer Cleaning and disinfecting The TEExp transducer is categorized as semi critical in the Spaulding classification system and must be cleaned and disinfected after each exam It is important that the cleaning and disinfection process not be rushed or shortened 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 For the latest list of compatible disinfectants see Table 2 Approved disinfectants and soak times on page 23 Some components of the TEExp transducer have different cleaning requirements and restrictions than others The cleaning and disinfection procedures frequently refer to specific components of the transducer See Figure 10 for a diagram of the transducer components and their names Connector Controller Cannot be immersed in liquid 90 cm Can be immersed in liquid Endoscopic shaft Scan head Figure 10 Transducer component names Carefully follow the chemical manufacturer s instructions and recommendations for preparing using and disposing of cleaning and disinfe
32. l who has received appropriate WARNING training in endoscopic techniques as dictated by current relevant medical practices as well as in proper operation of the ultrasound system and transducer To avoid inadvertent damage to the transducer read this user Caution guide before handling and cleaning the TEExp transducer The TEExp transducer is an electronically steered phased array ultrasound transducer assembly mounted in a sealed tip at the end of a conventional endoscope The TEExp 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 How scan plane rotation works To familiarize yourself with scan plane 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 plane The only two planes that are equivalent are the two transverse planes at 0 and 180 one being the mirror image of the other As shown in Figure 1 on page 4 a 180 rotation of the scan plane fills all four quadrants of the conic imaging volume 0 imaging plane 90 im
33. m os Focal Length FL cm z FLy cm Ip 3 M max W cm 339 gt 2 Control 1 Exam Type Crd 5 2 Control 2 Optimization Diff Control 3 Depth 5 1cm iy S Control 4 a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 48 Chapter 6 Table 10 Transducer Model TEExp Operating Mode PW Doppler TIS TIB Index Label d Non scan Non scan aprt lt 1 Aaprt gt 1 Global Maximum Index Value 1 3 a 1 9 b Pr3 MPa 2 64 Wo mW 33 4 min of W 3 Z lta 3 Z mW z Zi cm g g z cm z Zsp cm 0 60 S amp z Pll max cm 0 6 Ee cm 0 32 i MHz 4 01 Z 4 00 Dim of Aaprt X cm 0 38 Y cm 0 90 PD usec 1 123 PRF Hz 1008 5 Pr Pllmax MPa 2 86 z ean cm 0 32 O 2 Focal Length FL cm a FLy cm Ip a 3 Mlmax W cm 289 Control 1 Exam Type Crd Crd Control 2 Sample Volume Size 1mm 5 mm 25 Control 3 Sample Volume Position Zone 1 Zone 1 16 z 3 16mm mm eae Control 4 PRF 1008 1562Hz z Hz Control 5 TDI On off a This index is not required for this operating mode value is lt 1
34. mended by the chemical WARNING manufacturer Prolonged soaking in chemical disinfectants can cause damage to the transducer and chemical burns to the patient TEExp User Guide 23 Do not use unapproved disinfecting agents such as alcohol or bleach for example Sani cloth wipes as these can damage the transducer For more information about Caution oe ae i approved disinfecting agents see Table 2 Approved disinfectants and soak times on page 23 Caution Do not immerse the system cable connector or controller in any fluid 7 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 Chemical disinfectants can cause harm to the patient if not completely removed WARNING from the transducer For more information see the disinfectant manufacturer s instructions 8 Important To ensure that no residual disinfectant remains on the scan head or endoscopic shaft repeat step 7 at least two more times for a minimum total of three rinse cycles Dispose of the water after each rinse Some disinfectant manufacturers may recommend additional rinsing See the manufacturer s guidelines for more information 9 Dry the transducer with a sterile non linting towel or medical grade air 10 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 an
35. nd 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 and through misuse or poor handling procedures can have its service life severely shortened WARNING To help avoid conditions that may cause harm to the patient or damage to the transducer it is important that personnel using or handling this transducer read and understand the instructions warnings cautions and training material contained in this user guide If you have questions about any of the information contained in this user guide contact FUJIFILM SonoSite or your local representative About the user guide This user guide provides information on the TEExp 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 TEExp transducer handling Conventions The document follows these conventions gt A WARNING describes precautions necessary to prevent injury or loss of life gt A Caution describes precautions necessary to protect the products gt A Note provides supplemental inf
36. nterior posterior and left right tip deflection Figure 5 on page 10 shows the deflection wheels in the neutral undeflected position There is no brake for left right deflection 8 Chapter 2 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 To avoid damaging the transducer do not deflect the distal tip of the transducer Caution by direct application of force Use the deflection wheels for this task TEExp User Guide Figure 5 Deflection controls 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 to move the tip posterior 4 Turn lower wheel clockwise to move the tip anterior 5 Lower deflection control wheel 6 Upper deflection control wheel To avoid injury to the patient if you observe a sharp U turn of the transducer WARNING ee tip during the tip deflection inspection do not use the transducer 10 Chapter 2 To inspect tip deflection Inspect the tip deflection 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 1 Deflect the tip in all four direction
37. on page 19 2 Store the transducer so that it hangs freely and vertically and observe the following precautions 26 Chapter 4 gt Store the transducer away from any contaminated transducers gt Store the transducer in an environment that is safe and has good airflow Do not store the transducer in closed containers or where condensation may occur gt 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 and impact during storage Keep the tip cover on until preparing the transducer for use The tip cover is a single use device Do not reuse tip covers Doing so can result Caution heh in contamination of or damage to the transducer gt Avoid direct sunlight and exposure to x rays Recommended storage temperature range is between 0 C 32 F and 45 C 113 F gt If using a wall mounted rack for storage ensure that gt It is securely mounted gt The storage slots do not mar the transducer or the endoscopic shaft gt The rack is sized and positioned to prevent the transducer from inadvertently falling gt Make sure the connector is supported and secure Disposing of the transducer Do not destroy the transducer by incinerating or burning it Return the AMARNING transducer to FUJIFILM SonoSite or your local representative for disposal TEExp User Guide 27 28 Chapter 4 CHAPTER 5 Chapter 5
38. ontrol wires do not Caution eer ag deflect the transducer tip using finger pressure directly on the tip To avoid inadvertent damage to the transducer read this user guide before ceil handling and cleaning the TEExp transducer Inspecting contents After unpacking the contents perform the following on the TEExp transducer gt Visual and tactile inspection See To visually and tactilely inspect the transducer on page 8 gt Tip deflection inspection See To inspect tip deflection on page 11 gt Brake inspection See To inspect tip deflection brake on page 11 gt Scan plane rotation inspection See To inspect the scan plane rotation on page 13 gt Leakage test See Electrical safety on page 35 Contact FUJIFILM SonoSite or your local representative immediately to report any damage or discrepancies See Technical Support on page 2 To avoid injury to the patient do not use the TEExp transducer if any irregularity PARNIM substandard function or unsafe condition is observed or suspected 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 a cable and connector See Figure 3 on page 7 6 Chapter 2 Figure 3 TEExp transducer 1 Flexible endoscopic shaft Articulation section
39. ormation gt Numbered and lettered steps must be performed in a specific order gt Bulleted lists present information in list format but do not imply a sequence For labeling symbols used see the ultrasound system user guide Warranty statement The TEExp 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 Technical Support To order sheaths biteguards tip covers and other supplies see www civco com For technical support contact FUJIFILM SonoSite as follows Phone U S or Canada Phone Outside U S or Canada Fax E mail Web Europe Service Center Asia Service Center 877 657 8118 425 951 1330 or call your local representative 425 951 6700 service sonosite com www sonosite com 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 65 6380 5581 Chapter 1 CHAPTER 2 Chapter 2 Getting started About the TEExp transducer To avoid injury to a patient the TEExp transducer is intended for use by a medical professiona
40. r is in the extreme clockwise position To change the biplane Press the Biplane button the center button on the endoscope handle See Figure 7 on page 12 The scan plane rotates at full speed from the current position to the orthogonal position For example if the present position is 22 the scan plane rotates to 112 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 gel on the transducer and then turn up the gain to obtain an image TEExp User Guide 13 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 7 on page 12 4 Confirm that the image on screen changes in relation to the numbers on the scan plane indicator See Figure 8 on page 13 While you press the scan plane rotation buttons the transducer motor should be running as the image is changing Do not rely only on the on screen scan plane indicator to verify that the scan plane is rotating 14 Chapter 2 CHAPTER 3 Chapter 3 Examination While echocardiographs from the transesophageal or transgastric position prov
41. ransporting storing and dis posing of the transducer Cleaning and disinfecting ccssssssccsseessscssescccssseceessseecsssnsssceessseceessnesesssneeesssneeeeseee 19 Cleaning the transducer Disinfecting the transducer Identifying the transducer as clean Transporting the transducer ssescssescsseeccssesesseeccssesessscecssscessscecsseeessseecsseeeeseeeesses 25 Storing the traNSCUCEN ccsssesssecsseccssscssecssecsssccseecsssssssccssccssccsnscesseesscesscesacecscesseessses 26 Disposing of the transSCUcel ecsssssscccsssssescsssececsseseessseecsesseecsssseceessntsecesnseesssneeeets 27 Chapter 5 Safety Standards COMPHIANCE sesesssecssssssescssscssccssccssseessecssccsssecsscsenecesseesscesacssaeeeseecsseeesees 29 Annual 1MSP Cth On sssrinin iaaa 29 Safe operational USC ccccssssssssscssecssssecsssssssssecsssecsssscessnecsssscessuscssssccssssessseessasessssees 30 Thermal safety snaois iaia iaasa 31 Thermal MitS niia 31 Reducing teMperature esccosscccssscrssescsseecssseessssesssseessnessssseessneessnseessneessnees 33 Guidelines for reducing MI and Tl aw sssssssssssscccssescccsssesesesseecesssseeeeeenseeesenees 33 OUTPUT display sissesissesssnsscassssnssssednanscnsissbetieoenavobiouecensdesboscrbtassenossesnasszsaiersbisentonecs 34 Transducer surface temperature Lise eccssesscscssesscecsssescecssececesseeceesseeeeees 34 Temperature Calibration test sescsse
42. s 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 6 There is no brake for the right left deflection ix amp Figure 6 Tip deflection brake operation 1 Transducer tip 4 Neutral position marker 2 Tip control in unlocked position brake off 5 Wheel position markers 3 Tip control in locked position brake on To inspect 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 TEExp User Guide 11 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 Scan plane rotation The scan plane rotation is driven by a motor in the transducer handle and is controlled by buttons on the handle see Figure 7 kan x e Figure 7 scan plane rotation controls 1 Transducer tip 2 Counterclockwise button increases angle
43. sducer Whenever possible avoid shipping a contaminated transducer Before shipping ensure the transducer has been cleaned and disinfected using the steps detailed in Cleaning and disinfecting on page 19 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 and attach it to the packing list WARNING 1 If not already in place insert a tip cover over the transducer scan head The tip cover is a single use device Do not reuse tip covers Doing so can result in Caution eee contamination of or damage to the scan head 2 Place the transducer in the shipping case and seal it When shipping the transducer in the shipping case do not allow any part of the Caution pi transducer to protrude beyond the case 3 Ship the transducer using the following precautions gt Clearly label the case as fragile gt Do not stack items on top of the case gt Do not exceed the shipping temperature range 35 C 31 F to 65 C 149 F gt Do not open the case until it reaches its final destination After arrival the transducer must be cleaned and disinfected using the procedures detailed in Cleaning and disinfecting on page 19 before it can be used Storing the transducer To store the transducer 1 Clean and disinfect the TEExp transducer See Cleaning and disinfecting
44. secssecsssccssecscssscsenecessecsecesacesseeessees 3 Intended USES ineens eaea Tiaa EEA EE AEAEE 4 GOMMBPALA CI CATIONS az scisca25 sacs scesctcasscdentaadsssszesscousnsseasasiasncevsdelosascaabaadasssctsseossssaeuenbcatacieas 4 WT PACK IAG ensenhas iaeei aaa t eatas ea ISES ESE LE ERE aE 5 INSPECTING COMtentS uu eceecssssscseecsssneecsscnsessecnsessecnscesscnscessccsecusesssencesssenseessensessseneesees 6 Transducer and system interface ssssscccsssescccssescsccseecessneessssneeeceesnseecessneesseaneeeses 6 TEEXp transducer controls sesssssscssecssssssscsssecsscsssccesscescesssssasecssecsuecsnseeseecsscesscsensess 8 WIP CERO CHON sescssvacastevsistsssascedsstasssteaizsttanssttaceracscrsdodslaesetestistasieledbeathe atisiueaeirdeiond 8 Tip deflection brake SCAN Plane rOtatiOn cssecsssecssecssessseccseccssecsscssseccssccssceeasecseecssecsssceseecsaeeesseeses 12 Chapter 3 Examination Pre EXAM INSPECTION cecsesssscncsesssnsssnscrsssnsenssenserssenecresensssssenscrsssnsseasensssnsensssacenesease 15 PRECAUTIONS sssccseesssesnssessusssinscsseetcssosscanognnzentassssssastsniesonoicesestsssisenenasataassusessssconseoneponveciee Bite QUI sescccccsscsesssssasascestawssnascusneysanassevvauscnatosiva ssanzensawssebausossnyscbaddosoausesatessnsbesnate Sterile sheath n Emergency Eta CtiOn scsssscssssssssassssnnsesasssneessvesesvesnsennascsnnsssnestsenenegabnassnsessssconsoonaysbventts 18 Chapter 4 Cleaning disinfecting t
45. ser Guide 51 SonoSite FUJIFILM P20036 01
46. sssssescssssscsseecssscessseeecsesessseeecnseeesseeesees 34 Electrical Sate ty s csscsasscscasssssasasssscvesscnshcuesseconsatstonsncorodaceesonsdscosssveaqnasascennadtessrssesenbnasniec 35 Maximum cable length sssssssssssssseesesscssseecsnssssseessnsscsssseseseesssneeseneeessnees 35 Electrical leakage testing and bite hole detection 00 sesssssesseseeeenees 35 Electrical leakage testing sssessssscssesecsssecsssecssseecnsecesssessseecssseeessseesees 36 Bite hole detection esssssscssesecsssscssesecsseserseseessesecseseesseeessssseesesessseeesses 36 Preparing for bite hole electrical leakage testing 36 Testing the transducer array ssesscssesccssesecsssecsseccssscsesseesnssecsseersseeeese 38 Testing the Endoscopic Shaft scsssssscccsssesccssseecscsssseecsssseseesseeeeesnees 40 If no bite holes are detected ou eessssssssssesssscsssseesescessseesseeesssneessees 43 If the transducer fails the test sssssseesssssesssseessscesssseesssessssnseeseseense 43 Chapter 6 Transducer specifications TEEXp 8 3 MHZ transducer sssssssasscasnsssssscsssssessonsssunisensnsssnassonsnscansasetasosanasesenssosnavaenees 45 Acoustic output CHAPTER 1 Chapter 1 Introduction The TEExp transducer is a transesophageal echocardiographic transducer designed to operate with the X Porte ultrasound system built by FUJIFILM SonoSite Inc Transesophageal procedures carry a variety of inherent risks to the patient The information a
47. y to the patient gt Consult the medical literature regarding techniques complications and hazards prior to transesophageal procedures Study this user guide thoroughly prior to performing a transesophageal procedure gt The TEExp 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 Check the transducer prior to each use to assure that it is safe to use and functions properly 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 See Pre exam inspection on page 15 If the transducer tip should get jammed in a deflected position inside the patient and all attempts to release the deflected tip should fail follow procedure To retract the transducer on page 18 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 the transducer but before disinfecting it If a bite hole is detected do not use the transducer See Bite hole detection on page 36 Do not use conventional coupling gel intended for external use Avoid forceful intubation pressure which can cause lacerations or perforation of the gastro
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