SonicEye® Diagnostic Ultrasound Transducer
Contents
1. ab ab cq 4 o O U O O O 0 O O O V YW CU other information lpas at Mlmax 286 5 Application E ies ery eg frequency MHz High H High H focus control operating conditions a index not required for this operating mode b this probe is not intended for transcranial or neonatal cephalic use no measurement data reported due to a or b Remark Peripheral Vascular application is equivalent to Peripheral Vessel application 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 14 Acoustic Output Reporting Table for Track 3 PWD 8 B PWD Mode a ee index table FDA Aaprt lt A gt 1cm 1cm mr E bs Mpa 206 A ar zo ETMEN gt min of Woa z1 u NES lta3 Z1 EC CS ME me fe zp CA ealz fom Co aa ee TEA k of X B PW 0 5 0 33 associated acoustic parameters olo O a o N de o 3 u JJ T Q pr at max Pllmax deq at max Pllmax focal length in X cm T eR Vascular Vascular Vascular Artery Artery Artery O O S oO E O focal length in Y cm W cm lpa 3 at Mimax Application B depth cm Frequency B PW Gate size Focus B PW Velocity Range operating control conditions aar we Tepe ef fe Te es os E ICI ICI ICI E FC o fo fe AE mo ne Tom2. 1 Examine the SonicEye lens housing cable and strain relief before each use 2 Inspect for cracks tears sharp edges or exposed wiring 3 Confirm the probe is intact and is not damaged Warning Do not use a damaged or defective probe Failure to follow these precautions may result in injury to the operator or patient Use the Ultrasound System Refer to the Ultrasound System s User Guide for information on how to e Power on the system e Start an exam e Acquire or optimize an image e Perform measurements e Execute other system related tasks Caution See the Ultrasound System s User Guide for additional safety information 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 6 Prepare the SonicEye for Use For General Use 1 Ensure the probe fits snugly on your finger Adjust the fit by inserting a finger cot S M L into the probe opening See Figure 1 Place the probe on your finger Route the cable up your arm and over your shoulder If desired secure the cable at your wrist shoulder and or belt See Figure 2 5 Apply a liberal amount of gel to the transducer Figure 1 Caution Figure 2 Proper fitting is important A snug fit is required so probe doesn t rotate on finger If probe is too tight discomfort or reduced blood circulation can occur Warning Cable attached to user can snag on objects causing damage to probe or host system Caution Warn
3. TIC 1cm 1cm global maximum index value 122 0o59 lo EO A min of Wos z1 NN lia 3 Z1 Z O N ej Lo O O mb h z at PIl 3max deq Zsp o 3 associated acoustic parameters X O O 3 A eae ess dim of Aaprt in X dim of Aaprt in Y o 3 U T R pr at max Pllmax L N o o on ee deq at max Pllmax focal length in X other information o 3 focal length in Y lpa 3 at MImax W cm 286 5 Vascular Vascular Artery Artery 2 5 Application Depth cm MHz m conditions Frequency 7 08 dim of Asorin X 051 dimot AmminY EA PRE Prat max Plima dea at max Plime focal lengthinX em focal lengthinY Toas at Mines Focus O MEN operating control Focus C a index not required for this operating mode b this probe is not intended for transcranial or neonatal cephalic use no measurement data reported due to a or b Remark Peripheral Vascular application is equivalent to Peripheral Vessel application 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 13 Acoustic Output Reporting Table for Track 3 M 8 B M Mode index table FDA a es TIC Aaprt lt Aaprt gt global maximum index value 122 oso lt o4 lt 04 0 ie of Wo3 z1 NN ta 3 Z1 2 1 20 snes em muz ese 7o35 635 es 4 eos os pr at max Pllmax 3 85 deg at max Pllmax 0 27 focal length in Y 20 e EM cm MHz m U
4. the opening at rear of the probe The lens should now face the bottom of the cover See Figure 4 below Figure 4 5 Insert a gloved finger into the opening at rear of the probe See Figure 5 below Figure 5 6 Ensure there are no air bubbles or wrinkles over the lens 7 Wrap the finger and head of probe with a sterile elastic band See Figure 6 below Figure 6 8 Extend the probe cover to its full length 9 Liberally apply sterile ultrasound gel to the covered lens 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 9 Use of SonicEye with Sterile Glove NOTE Sonivate Medical suggests using size Large 8 or greater sterile gloves e g Biogel Skinsense 31480 00 Materials such as polychloroprene or latex will more readily stretch over the probe 1 Prepare for ultrasound guided procedure using approved sterile protocols 2 Place SonicEye probe on finger See Figure 7 below Figure 7 3 Apply ultrasound gel to the lens of the probe 4 Cover the probe hand with a sterile glove See Figure 8 Figure 8 5 Place sterile glove on your other hand then adjust the glove on the probe hand as needed Ensure there are no bubbles or wrinkles over the lens See Figure 9 below Figure 9 6 Liberally apply sterile ultrasound gel to the covered lens 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 10 Warning The SonicEye is no
5. SONIVATE MEDICAL POINTING ULTRASOUND IN A NEW DIRECTION sonicEye Diagnostic Ultrasound Transducer Model HFL FKDS 01 User Guide For use with Fukuda UF 760AG Ultrasound System Manufactured By Sonivate Medical Inc 8305 Creekside Place Suite C Beaverton OR 97008 USA www sonivate com inquire sonivate com Customer Service Phone Number 971 238 3767 Caution United States federal law restricts this device to sale by or on the order of a licensed healthcare practitioner NOTE SonicEye is a registered trademark of Sonivate Medical Inc 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 2 Contents o aan ahaa enceanaeanebaetina euaacuetasdeinana ion iataea ie atalaed atudaaahescenee 4 TECNICA UI o tal othe eases canals aon laa dd 5 SONCE VED INGICATONS tor Ususario ica dei N a ede 5 SONICE VER C ntraindicati hS seassa annia a E aa a a E E aa 5 COnnecMHNE SOMICE VOR sii a e e ENN 6 ASPECTO a e o ds a o ea id 6 Use the Ultrasound SySt M cccccccccccseeeseecceeeeeeaaeeseeceeeeeeeeeeeeeceeeeeeesaeeseeeeeeeessaseeeeeeeeeeessuaeaeeeeeeeeeeesagas 6 Prepare thie SonicEye O Tor USO score 7 SCANNING wine Sonic E VOR ind ia 8 O NN 12 TO DISIRt6ct WIDE MEeI0d airis do cil dd 12 Acoustic Output Reporting Table for Track 3 B Mode 00occccccnnccccooonncccnncccnncnnoncccnnncnnonnonnncnnnnnnnnonannnrennnnnnos 13 Acoustic Output Reporting
6. Table for Track 3 M amp B M MO ocoooooccccnnncccccccconccnnnnnnonnnnoncnnnnnnnnnonannenons 14 Acoustic Output Reporting Table for Track 3 PWD 8 B PWD Mode oocccccccccocccnnccccocccnncccconcconcnonononos 15 Acoustic Output Reporting Table for Track 3 B Color B Color PWOD ooococccccconccnccccnoocconcnononccnnononons 16 TIVO AIA RA Pe nes ts 0 17 Miscellaneous Cautions and WarningS cooccccnnnccccnonnnnnonnnnnonononnnnnnnnnnnnnonnnnennnnnnonnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnns 17 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 3 Introduction This user guide provides instructions for using the SonicEye ultrasound transducer This guide is intended for a user familiar with standard ultrasound technique See the Fukuda UF 760AG Ultrasound Imaging System User Guide for information on preparation use and maintenance of the ultrasound system as well as additional safety information Symbols used on the SonicEye transducer and associated packaging are defined here for user reference Definition Designates the SonicEye serial number assigned during manufacture Designates the SonicEye part number assigned to the probe Indicates date of manufacture Indicates the name of the manufacturer E L Eg 0 x lt O lt Prescription only device restricted to use by or on the order of a physician Caution consult accompanying documents Type BF patient appli
7. ed part B body F floating applied part cap NA gt I Y Y NX Not for general waste Po Indicates the SonicEye has been tested to ensure protection of the equipment inside the enclosure against harmful ingress of water when immersed at 1 meter for a 30 minute duration The following conventions are used throughout this user guide e A WARNING is used to convey information to prevent injury or loss of life e A CAUTION is used to convey information regarding special care to be exercised by the user for the safe and effective use of the device 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 4 Technical Support For technical support for the SonicEye transducer contact Sonivate Medical at the following Phone 971 238 3767 E mail inquire sonivate com Website www sonivate com For technical support for the Fukuda UF 760AG Ultrasound Imaging System refer to the manufacturer s user guide SonicEye Indications for Use The SonicEye ultrasound transducer is a general purpose transducer intended for use by a qualified clinician for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following applications Pediatric Small Organ breast thyroid testicles prostate Musculo skeletal conventional and superficial and Peripheral Vessel SonicEye Contraindications There are no known contraindications for use of the SonicEye Caution T
8. gt me Energy Steering a index not required for this operating mode b this probe is not intended for transcranial or neonatal cephalic use no measurement data reported due to a or b Remark Peripheral Vascular application is equivalent to Peripheral Vessel application 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 15 Acoustic Output Reporting Table for Track 3 E amp a index table FDA Aaprt lt O gt 1cm 1cm fob peor devas A oD CO CECI min of Wo3 Z1 lta3 Z1 Zsp on 1 6 E z at Pll amas sas eooo fe ROMEO ee a CETE OES CE os a Pme e wo prat max Plimx MPa 385 deg at max Plimax om focal length inx cm 16 19 1145 a7 o focal lengthinY fem Te A bas at Mina 286 5 Subapplication Artery ie tan ae O A Depth Frequency B C PW ae J 8 2 6 2 5 4 2 5 E el CN Focus B C PW a Energy d DOS mm O e kHz MU EN E ES l i associated acoustic parameters 0 1 other information Velocity Range Resolution CFM Window width CFM Window height Steering ep O Lo E O O O Cc O O O _ o O Gatesize a index not required for this operating oe b this probe is not intended for transcranial or neonatal cephalic use no measurement data reported due to a or b Remark Peripheral Vascular application is equivalent to Peripheral Ves
9. he SonicEye probe is not intended for intracavity use such as the following e Transesopohageal Use e Transvaginal Use e Transrectal Use The SonicEye probe is not indicated for therapeutic use and is not indicated for use through surgical openings in the skin The SonicEye is not intended to be used in intraoperative applications Refer to the Ultrasound System s User Guide for additional safety information Observe the ALARA As Low As Reasonably Achievable Principle when scanning to limit patient ultrasound exposure to the minimum required to achieve diagnostic image quality Refer to the Ultrasound System s User Guide for additional information about how to optimize image quality while still practicing the ALARA Principle 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 5 Using the SonicEye Connect the SonicEye 1 Inspect the SonicEye and system connectors Ensure no foreign material is present 2 Remove the probe connector protection from the probe receptacle 3 Connect the probe connector to the probe receptacle 4 Turn the lever on the probe connector clockwise 90 to lock the probe connector See Fukuda UF 760AG Ultrasound System s User Guide for drawings and pictures for attaching the probe Confirm proper connection of the SonicEye to the Fukuda UF 760AG Ultrasound System following instructions outlined in the Ultrasound System s User Guide Inspect the SonicEye
10. ing Sonivate Medical recommends the use of Aquasonic gel or equivalent to ensure suitable acoustic coupling without damaging the SonicEye Some gels may be incompatible with transducer materials Sterile gel must be used for sterile procedures Sonivate Medical recommends cleaning the SonicEye after each use Ultrasound can produce harmful effects and may result in injury to the patient Use the lowest exposure time and ultrasound levels necessary to minimize negative effects on the patient Observe the ALARA As Low As Reasonably Achievable principle and increase output only when necessary to achieve diagnostic image quality Refer to the Ultrasound System s User Guide for additional information about how to optimize image quality while still practicing the ALARA principle 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 7 Scanning with the SonicEye Use the probe on the finger in the same manner as you would use a normal probe to scan By wearing the probe on the finger you can use the same hand to assist in performing the scanning by stabilizing the region or body part being imaged or feeling tactilely with the finger or hand doing the scanning Keep the hand relaxed during scanning as only sufficient force to adequately couple the probe to the body being imaged is required By not having to grip a hand held probe you should be able to relax your arm and shoulder while scanning When performi
11. ner to minimize recontamination Caution The SonicEye must be cleaned after every use Proper cleaning is necessary for effective disinfection Use your hospital or clinic standard cleaning guidelines for ultrasound transducers Clean the SonicEye as soon as practical after use e g at the point of use to minimize soiled materials drying onto the probe Users should follow OSHA Bloodborne Pathogens Universal Precautions when handling and cleaning a soiled SonicEye Avoid damage to the SonicEye do not use hot water Warning The SonicEye can easily be damaged by contact with certain chemicals Failure to follow Sonivate Medical recommendations and precautions can result in serious injury or equipment damage Avoid electrical shock disconnect the SonicEye from the system before cleaning Avoid injury always wear the appropriate personal protective equipment when cleaning or disinfecting the SonicEye The SonicEye cannot be sterilized using steam ethylene oxide gas Steris or Sterrad processes Do not immerse the SonicEye system connector into any liquid Avoid infection use only the recommended disinfection solution strength and duration of contact Sonivate Medical does not endorse disinfection efficacy claimed by the disinfectant manufacturer 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 12 Acoustic Output Reporting Table for Track 3 B Mode index table FDA Pi
12. ng ultrasound needle guided procedures wear the probe on your non dominant hand reserving your dominant hand to perform the actual procedure You may need to move the patient or reorient yourself to the patient to change the probe orientation during scanning Other than ergonomic factors in using the SonicEye all traditional techniques of ultrasound scanning apply to the probe Transducer Orientation The distal end tip of the transducer corresponds to the side of the screen marked with the Medical Application Icon on the Imaging System screen The scan orientation can be reversed by using the F1 button beneath the screen Verify proper screen orientation by placing finger or instrument on tip of transducer and viewing image on screen before draping Caution See the Ultrasound System s User Guide for additional information on body mechanics and healthy scanning guidelines Use of SonicEye with Sterile Probe Cover NOTE Sonivate Medical suggests the use of a 3 5 9 cm wide sterile probe cover e g CIVCO 610 637 1 Prepare for ultrasound guided procedure using approved sterile protocols 2 Apply ultrasound gel to the lens of the probe 3 Insert and place the probe at one corner of the sterile cover The lens should face the opposite corner See Figure 3 below Figure 3 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 8 4 Take the opposite corner of the cover and insert it through
13. sel application 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 16 The ALARA Principle The Fukuda UF 760AG Ultrasound System s Operator manual contains a complete description of the ALARA As Low As Reasonably Achievable principal and outlines specific steps an operator can take to minimize exposure to ultrasound energy while still obtaining a diagnostic image For the SLA probe specific steps can be taken by the operator to reduce ultrasound energy including increasing the depth setting all modes increasing the box depth in color Doppler mode reducing the PRF setting in color Doppler mode and reducing the PRF in PW Doppler In addition the system displays in real time the MI or appropriate Tl numbers for all conditions allowing the operator to see the effect of changing any settings which may affect output The SonicEye probe s output in the worst case output settings are reflected by the real time display within the measurement and display uncertainty Changes to the operator settings may affect the acoustic output of the probe Users of the SonicEye probe should refer to the ALARA principle as outlined in the Ultrasound System s user manual and adjust the operator settings as needed Miscellaneous Cautions and Warnings The SonicEye can easily be damaged by rough or improper handling A damaged probe Caution may result in patient injury or equipment failure Do not drop avoid mechanical
14. shock or impact to the SonicEye Do not apply excessive bending or pulling force to the cable Do not allow the cable when attached to the user to snag on an object Do not use with a defibrillator The SonicEye is not a defibrillation approved applied part Ultrasound use may be linked to musculoskeletal disorders such as tendonitis or carpal tunnel syndrome Unusual user fatigue when using the SonicEye may require discontinued use Warning There are no user serviceable or user repairable parts in the SonicEye Refer all such issues to service personnel only Avoid risk of explosion do not use near flammable gases or anesthetics Avoid patient injury due to burns do not use with high frequency surgical equipment 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 17
15. t intended to be used for intraoperative or intracavitary applications To prevent contamination during procedures requiring sterile technique the use of sterile transducer sheaths or gloves and sterile coupling gel is required Do not apply the sheath and gel until you are ready to perform the procedure Caution Some gloves and or transducer sheaths may contain natural rubber latex which can cause allergic reactions in some humans Certain types of gloves including textured gloves do not transmit ultrasound energy efficiently User must confirm adequate image quality before initiating any procedure 40012 Rev B Copyright 2014 Sonivate Medical Inc All rights reserved Page 11 Cleaning and Disinfecting the SonicEye To Clean 1 Disconnect the SonicEye from the ultrasound system 2 Remove any transducer sheath used 3 Remove all coupling gel and other debris from probe by wiping with a soft damp cloth until all visible particulates or residues have been removed To Disinfect Wipe Method 1 Ensure the SonicEye is thoroughly cleaned prior to disinfection 2 Use a Sani Cloth Plus Germicidal Disposable Cloth to wipe the probe and cable 3 Thoroughly wet the probe and cable with a wipe 4 Allow the treated surface to remain visibly wet for 5 minutes 5 Use additional wipes if needed to assure the full 5 minute wet contact time 6 Allow to air dry or dry with a clean soft cloth before storage Store in a man
Download Pdf Manuals
Related Search