SonicEye® User Manual
Contents
1. 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 17 Acoustic Output Reporting Table for Track 3 PWD 8 B PWD Mode a oe index table FDA Aaprt lt l gt 1cm 1cm me E m Mpa 206 A 7 rs MA AER A a min of Wos z1 mm NES lta3 Z1 EC CS a me fe zo EA dez fom Ca EE TEA k of X B PW 0 5 0 33 associated acoustic parameters olo o gt a o M w e 3 u JJ T Q 3 pr at max Pllmax deq at max Pllmax focal length in X cm n NECIO Vascular Vascular Vascular Artery Artery Artery O O S pa ab Ka pra O focal length in Y cm W cm loa3 at Mimax Application B depth cm Frequency B PW Gate size Focus B PW Velocity Range operating control conditions ep a1 68 e a CI E A E ICI IC IC IC o fe foe E mo me om 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 Vessel2. 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 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 Warning 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 8 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
3. information conditions operating control 3 emark D min of Wo 3 z1 lta 3 Z1 Z o o o O O O O O 3 3 3 3 3 3 s z at Pll 3max deq Zsp o 3 dim of Aaprt in X dim of Aaprt in Y O O 3 Q3 PRF pr at max Pllmax E N 00 O1 deq at max Pllmax focal length in X 3 o O focal length in Y lpa 3 at Mimax W cm 286 5 Vascular Artery lt a ce index not required for this operating mode Application Depth cm MHz m Frequency Focus C Vascular Artery High H 2 a this probe is not intended for transcranial or neonatal cephalic use no measurement data reported due to a or b Peripheral Vascular application is equivalent to Peripheral Vessel application 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 16 Acoustic Output Reporting Table for Track 3 M 8 B M Mode index table FDA PA TIC Aaprt lt Aaprt gt global maximum index value 122 ose lt 04 lt 04 b soe of Wo3 z1 ta 3 Z1 Ce 1 20 snl rem ue 62 7o35 638 es 4 o e os pr at max Pllmax 3 85 deg at max Pllmax 0 27 focal length in Y 20 EM cm MHz m U ab oO Q 2 V ma O O O 0 O O O YW YW CU other information loa 3 at Mlmax 286 5 CO E E frequency MHz High H High H focus control operating conditions
4. or wrinkles over the lens 7 Wrap the finger and head of probe with a sterile elastic band See Figures 17 and 18 Figure 17 Figure 18 8 Extend the probe cover to its full length 9 Apply sterile ultrasound gel to the outside of the sheath over the covered lens 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 19 below Figure 19 3 Apply ultrasound gel to the lens of the probe 4 Cover the probe hand with a sterile glove See Figure 20 Figure 20 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 13 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 and there is adequate ultrasound gel inside the glove See Figure 21 Figure 21 6 Apply sterile ultrasound gel outside of the glove over the covered lens Warning The SonicEye is not 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 app
5. 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 There are no user serviceable or user repairable parts in the SonicEye Refer all such Warning l I 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 20
6. 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 performing 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 lcon 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 SonicEye Optional Parts Sonivate Medical supplies 2 packs of Finger Cots and 2 packs of Probe Caps with the probe Additional optional parts are available to order separately Contact Distributor for Ordering Information Use of SonicEye with Finger Cot NOTE Finger Cots are optional and provided to allow secure f
7. 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 8880 SW Nimbus Avenue Suite A Beaverton OR 97008 USA www sonivate com inquire sonivate com Customer Service Phone Number 971 238 3767 Patent The SonicEye Probe is protected by US Patent 8211026 and other pending and international patents Information 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 2 Contents A A A 4 Tecnica Suppo e ade te ad 5 ENVIO mental CONAMONS Sarai adas 5 SonicEye O Indications tor Us cemnc shared a councticsealeatsotelele is aieiakes 6 SONICE VCO COMMAINCICAIIONS ansias coins 6 Connect ie SON CEA nee econ a a een ee 7 Inspect the SonicEyeO spikera a e E Aa TE aa i n O Raa a O aaie Traa 7 Use ihe Ultrasound SS Miss 7 Prepare the SONCE Ve TORU S Eines eE iS 8 Scanning With the SoniCE VSO ui iaa 9 TO GIEd e a E 15 LO Disinfect Wipe Method iccics ini arsvenenies raisin mateotigieiutevaiet etstive a ais 15 Acoustic Output Reporting Table for Track 3 B Mode ooooccccnncccconooncccnnnccnonnnoncccnnnnonononanncnnnnnnnnnnnannrenn
8. 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 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 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 15 Acoustic Output Reporting Table for Track 3 B Mode index table FDA A OTS B TIS Aaprt lt Aaprt gt 1cm 1cm global maximum index value 122 oso o U ab ab Q 2 V ma O O O 0 O O O YW YW CU other
9. a 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 TI 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 may result in patient injury or equipment failure Caution Do not drop avoid mechanical 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
10. application 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 18 Acoustic Output Reporting Table for MAA 3 on amp no index table FDA Aaprt lt E e gt 1cm 1cm R BE A E R E E E CO e a min of Wo x Z1 lta3 Z1 Zsp aa 1 6 mA z at Pll amax as a e oife f ee presea ee fesa amotai on a os os os _ lt PRE prat max Plimx MPa 385 des at max Plimax om focal lengthinX cm aetna 17 focal lengthinY om poe ee e nas at Mimax 286 5 Subapplication Artery Depth Frequency B C PW ae che 8 2 6 2 5 4 2 5 ed mz Focus B C PW cmo Energy d Zo mm Oo 6 khz E ae ES High CN le EQ associated acoustic parameters 0 1 other information Gatesize Velocity Range Ww Cc O Lo Cc O O O pa C O O O Cc 4 ab o O a i a COOR MEC E 225 25 A A E ee 6 6 pi 1 e ee EA dt O A ie ae mo Tt Resolution High CFM Window width CFM Window height Steering no a index not required for this operating me 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 19 The ALARA Principle The Fukud
11. ing documents Type BF patient applied part B body F floating applied part S Not for general waste D N 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 E Copyright 2015 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 Environmental Conditions 10 C to 40 C 30 75 R H 800hPa to 1060hPa 10 C to 60 C 10 to 95 RH 800hPa to 1060hPa Operating Conditions Shipping and Storage Conditions 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 5 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 b
12. it for fingers of multiple sizes Larger fingers may not require the use of a finger cot but can be used for increased comfort if desired 1 Hold the probe in one hand and the finger cot of desired size in the other hand 2 Insert the finger cot into the opening of the rear of the probe with the ribs facing towards the lens or bottom of probe See Figure 3 Figure 3 3 Insert finger into probe If necessary adjust finger cot placement or size for best fit and or comfort 4 Finger cots may be used with or without probe cap and during sterile or non sterile procedures 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 9 Use of SonicEye with Probe Cap NOTE Cap and finger cot if used should be placed on probe priorto insertion into sterile glove or sheath Figure 4 1 Hold the probe in one hand and the probe cap in the other hand See Figure 5 Figure 5 2 Gently squeeze the plastic latches of the probe cap together to allow insertion in the finger cavity of the probe See Figure 6 Figure 6 3 Insert the probe cap until it is securely in place and the latches lock into place in the recess cavity on the rear of the probe See Figure 7 and 8 Figure 8 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 10 4 If desired place a finger cot inside the probe See Figure 9 Figure 9 5 Insert preferred finger into pr
13. ly 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 14 Cleaning and Disinfecting the SonicEye To Clean 1 Disconnect the SonicEye from the ultrasound system 2 Remove any transducer sheath or glove used 3 Remove all coupling gel and other debris from probe by wiping with a soft damp cloth or gently washing with lukewarm water until all visible particulates or residues have been removed To Disinfect Wipe Method 1 Ensure the SonicEye is thoroughly cleaned prior to disinfection Use a Sani Cloth Plus Germicidal Disposable Cloth or Isopropyl Alcohol IPA to wipe the probe and cable gt ei ee Thoroughly wet the probe and cable with a wipe Allow the treated surface to remain visibly wet for 5 minutes Use additional wipes if needed to assure the full 5 minute wet contact time Allow to air dry or dry with a clean soft cloth before storage Store in a manner to minimize recontamination Caution Warning The SonicEye must be cleaned after every use Proper cleaning is necessary for effective disinfection
14. nnnnos 16 Acoustic Output Reporting Table for Track 3 M amp B M Mod oooccccccncccccccoonccnnncccccnnonnccnnnnnononnnanncnnnnnnnos 17 Acoustic Output Reporting Table for Track 3 PWD 8 B PWD Mode oooccccccccocccnnccccocccncncccnoccnnnccononons 18 Acoustic Output Reporting Table for Track 3 B Color 4 B Color PWD oococoooocccncccccooccnnccononncnncnnnannons 19 SALA A e o o do e dd AO 20 Miscellaneous Cautions and WAarningS coccccccnnccccononnnnnnnnnnnonnnnnnnnnnnnnonononnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnnnnnnnnnnnnns 20 40012 Rev E Copyright 2015 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 G Gig JJ lt O lt Prescription only device restricted to use by or on the order of a physician Caution consult accompany
15. obe To allow your finger to more easily fit into probe with a finger cot hold the tab of the cot in place with your thumb as you insert your finger into the probe 6 The probe and cap are now ready for insertion into a glove or sheath See Figures 10 and 11 7 Scan with the SonicEye as described in section Scanning with the SonicEye NOTE The groove on the cap serves as an alignment indicator for the center of the array See Figures 10 and 11 Figure 10 Figure 11 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 11 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 outward See Figure 12 Figure 12 4 Take the opposite corner of the cover and wrap it behind the probe leaving the sheath tightly wrapped around the lens area of the probe See Figures 13 and 14 Figure 13 Figure 14 5 Pinch the sheath approximately 1 5 behind the probe and push the sheath and finger through the probe opening See Figures 15 and 16 Figure 15 Figure 16 40012 Rev E Copyright 2015 Sonivate Medical Inc All rights reserved Page 12 6 Ensure there are no air bubbles
16. ody 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 The 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 6 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 Fuk
17. uda 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 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 E Copyright 2015 Sonivate Medical Inc All rights reserved Page 7 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 gel to the transducer Figure 1 Figure 2 Caution Proper fitting is
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