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SONON 300C Portable Ultrasound Device User Manual Rev. 2

1. Line Density B Line Density Backup Backup Import Backup Import Backup X Default Recording File Size 300MB RecordingFileSetting To allow to send via e mail with CH Recording File Document No HC IFU 001 Rev 1 12 HEALCERION User Manual Rev 2 X On show the radio button to select Recording file lt back Full Setting Mode Full Setting Mode poe Soran Device Setting To allow to send via e mail gt Image Filter Image Filter with Recording File Line Density Line Density Import Backup Import Backup RecordingFileSetting To allow to send via e mail with Recording File Caution Due to limited file attachment capacity in email please avoid a long time recording if you wish to send data by e mail Otherwise one recording file 10Mb could be divided into several different files to facilitate email 15 Mb transmission O am Recording File Size 6 6 2 5 Backup back Full Setting Mode Device Setting 474 A1e4 aome back o ke owe o Ee e o amp ereinen 10M8 e e ns want to back up O Charles Kim 10MB Import Backup Yes No O Mathew Yun 10MB Loading gt O Charles Kim 10MB 20 100 Select All Image Filter Line Density Recording File Size Select to the files that you want to back up Noname 10MB Files have been saved at Android gt Root SONON 300C iSO gt Document Backup Files as a YY MM DD00
2. the equivalent beam diameter at the point where the free field spatial peak pulse intensity integral is at a maximum centimeters See Section 6 2 5 1 of the Output Display Standard Measurement Methodology for Mechanical and Thermal Indices the focal length or azimuthal x and elevational y lengths if different centimeters the derated pulse average intensity at the point of global maximum reported MI watts per square centimeter Document No HC IFU 001 Rev 1 12 HEALCERION Appendix A Usage Agreement Usage Agreement for Personal Information The SONON 300C Usage Agreement Document No HC IFU 001 Rev 1 12 HEALCERION For the purpose of provision of basic services such as SONON 300C application user registration password retrieval etc Healcerion collects the following personal information categorized by patient information for the efficient management of user information and diagnosis information 1 Collected Personal Information The range of personal information collected for registration of application users E mail SONON 300C Serial Number Password Name of Organization The range of patient information for management of diagnosis data name gender age height weight operator hospital image We do not ask for any sensitive personal information such as race ideology place of birth political inclination criminal record health condition etc 2 Purpose of Collection and Utilization of Personal I
3. 4 In the Playlist screen the selected file is moved and the below file list is on top Document No HC IFU 001 Rev 1 12 HEALCERION 6 5 7 Diagnosis File Viewer lt back Playlist Benjamin Ryu PN YY MM DD 00 00 00 Display selected file image gt YY MM DD 00 00 00 YY MM DDO 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 Diagnosis File Viewer Display selected file video Tap the Diagnosis Image The Image Viewer will be displayed Tap the Diagnosis Cine File 4 The Cine File Viewer will be displayed Document No HC IFU 001 Rev 1 12 HEALCERION gt Patient Info ap Playlist Edit de Diagnosis File Viewer ate eee Benjamin Ryu YY MM DD 00 00 00 YY MM DD 00 00 00 Peter Lee YY MM DD 00 00 00 Selected Diagnosis File Image or Video CharlesKim YY MM DD 00 00 00 Mathew Yun YY MM DD 00 00 00 JamesKim YY MM DD 00 00 00 User Manual Rev 2 6 5 8 Send Diagnosis File via E mail back New Message lt back Diagnosis File Viewer To cc BCC Subject Display selected file image Attached File YYMMDD 000000 Diagnosis File Viewer ached rile Display selected file video Tap the Send button The default E mail Client App is displayed The Diagnosis Files are attached automatically 4 If the user inputs a text then tap the send button X If connected with the SONON 300C AP Pop up 17 will be displayed I
4. Parameter Accuracy Length 7 Ellipse 10 9 3 3 System controls affecting acoustic output The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables see 9 2 These tables show the highest possible acoustic intensity for a given mode obtainable only when the maximum combination of control settings is selected Most settings result in a much lower output It is important to note the following The duration of an ultrasound examination is as important as the acoustic output since patient exposure to output is directly related to the exposure time e Better image quality yields faster clinical results making it possible to complete the relevant ultrasound examination in a shorter period of time Therefore any control that improves the quality of the examination can help to reduce patient exposure even though it may not directly affect acoustic output 9 3 3 1 Clinical application selection Selecting the application appropriate to a particular ultrasound examination automatically provides acoustic output limits within FDA guidelines for that application Other parameters which optimize performance for the selected application are also set automatically and should assist in reducing the patient exposure time Document No HC IFU 001 Rev 1 12 HEALCERION 9 4 Specifications Item Specification Dimensions mm 77 6 W x 218 5 L x 39 2 H Weight g 390 with battery B
5. for bone near the focus and Tic for bone near the surface were introduced to provide the operator with the relative potentials for a tissue temperature rise According to the Standard for Real time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 2004 those thermal indices shall be displayed by ultrasound consoles It should be noted that a TI of 1 does not necessarily mean that tissues being scanned will increase in temperature by 1 C Almost every scanning situation departs from the assumed model conditions such as tissue types blood perfusions modes of operation and actual exposure times of the scanned area However the thermal indices provide information regarding the possible increase in the risks of potential thermal bioeffects and it provides a relative magnitude that can be used to implement ALARA In addition to tissue heating due to the generated ultrasound field the temperature of the probe head itself can also increase during the examination The operator should be aware that in the tissue region near the ultrasonic transducer there will be a superposition with the heating due to the ultrasound field which is not considered by the TI values e Non thermal effects refer to mechanical phenomena such as cavitation Non thermal bioeffects are caused by the interaction of ultrasound fields with very small pockets of gas stabilized gas bodies i e the generation growth vibra
6. Chris Song There are some empty fields in the patient information Please complete all fields Document No HC IFU 001 Rev 1 12 HEALCERION Gender O Male Female Age Height Weight Operator Hospital Memo 76 6 5 4 Patient List Edit d back Patient List Edit Patient List Edit Noname John Freda Jack Jung Q Jack Jung Q Benjamin Ryu E Anakin Choung Benjamin Ryu N Anakin Choung ater A De Peter Lee Feter Lee Charles Kim Z Charles Kim Mathew Yun Mathew Yun Add New Patient Caution Selected patient information and all diagnosis data cannot be recovered after deletion Do you still want to delete the patient information C Selected patient information has been deleted Pop up 12 Tap the Edit Button The Patient List Edit Screen is displayed Select a patient to delete 3 Tap the delete button 4 Pop up 11 Cancel move to previous screen Pop up 12 OK move to Patient List screen Document No HC IFU 001 Rev 1 12 HEALCERION 6 5 5 To delete No Name Diagnosis Data A back Patient Info Playlist Noname YY MM DD 00 00 00 Name DI Gender Male Female gt YY MM DD 00 00 00 Age Height Weight Me YY WMIM DD 00 00 00 YY MM DD 00 00 00 Operator YY MM DD 00 00 00 Hospital Memo E YY MM DD 00 00 00 YY MM DD 00 00 00 Caution Selected diagnosis data cannot be recovered after deletion Do you still want to del
7. The Ispta is the Spatial Peak Temporal Average Intensity The absolute maximum limit of Ispta is 720 mW cm2 as set by the FDA 510 k guidance of September 9 2008 9 3 2 Acoustic output and display on the SONON 300C MI and TI values are displayed on the scanning screen For all imaging modes of SONON 300C TIS equals TIB and is displayed as TI The SONON 300C chooses the correct category based on mode of operation and chosen application and presents only one TI to the operator It is therefore important that the operator chooses the right application The maximum possible MI and Ispta on the SONON 300C is within the limits set in Track 3 in the FDA 510 k guidance of September 9 2008 Ml lt 1 9 and Ispta lt 720 mW cm2 9 3 2 1 Display Accuracy and Acoustic Measurement Uncertainty The display accuracy and measurement precision of the output display are summarized in the table below The accuracy of the output display parameters depends on the measurement system precision the acoustic model used to calculate the parameters in the acoustic output of systems The measurement precision and overall accuracy of the measurements have been assessed by determining both the random and the systematic uncertainties and given in percent at a 95 confidence level Parameter Uncertainty Power 5 396 Document No HC IFU 001 Rev 1 12 HEALCERION 9 3 2 2 Measurement accuracy The measurement accuracy of the system is shown in the following tables
8. to save it as a Charles 1 2 Not import nor recover as a Charles 1 Save the same file Select to the files that you want to import lt back Full Setting Mode Device Setting sapac YY MM DD 00 00 10MB Image Filter YY MM DD 00 00 10MB Line Density s B YY MM DD 00 00 10MB Recording File Size YY MM DD 00 00 10MB Backup YY MM DD 00 00 10MB YY MM DD 00 00 10MB O O O O O O YY MM DD 00 00 10MB Back to Live Screen Sort by date Select to the files that you want capac e o e o O eae A Are you sure you want to O O O delete The data can not be O recovered after deletion O O O Hmmmoroo oma O Panen 0 o j me MM DD 00 Data is being deleted Data has been deleted 0 O 20 100 100 100 O WZMM70D700 00 10m Select to the files that you want to import lt back Full Setting Mode Device Setting YY MM DD 00 00 10MB Image Filter YY MM DD 00 00 10MB Line Density YY MM DD 00 00 10MB Recording File Size YY MM DD 00 00 10MB Backup Back to Live Screen Sort by date YY MM DD 00 00 10MB YY MM DD 00 00 10MB YY MM DD 00 00 10MB 0000000 II Select to the files that you want E ee Pack O O eh Pino ere Are you sure you want to O delete The data can not be recovered after delet
9. ay in Single tap FL position in side ruler area D Anew FL message is displayed 3 Anew FL marker is displayed X In Zoom Mode the FL Control function does not work HA 6 4 4 4 Depth Control Depth Control Depth Control 5 wn ae Eee i i u i hod I ie i s BET fagy Fi 7 on 1 r Aa i i i i i oS 5 i i i i i i i m un Keng Drag the side ruler area Anew depth message is displayed X Drag up sets the depth to the lower position X Drag down sets the depth to the deeper position X In Zoom Mode the Depth Control function does not work 6 4 4 5 TGC Control TGC Control TGC Control X un 10 jun in Tap the TGC Button The TGC Slide bar and drag action by user is displayed 3 Anew TGC message is displayed Divide the entire length into four sections During Zoom in action the TGC control function does not work Select the section including drag action Drag left action decreases the brightness of the section Drag right action increases the brightness of the section Depending on the drag action the corresponding text is displayed indicating the action time Document No HC IFU 001 Rev 1 12 HEALCERION 6 4 4 6 DR Control TGC Control TGC Control eee ER u oe l un m oO rm un Tap the DR Control Button The DR Control slide bar and drag action will be
10. 00 Jack Jung 10MB Benjamin Ryu 10MB Anakin Choung 10MB Charles Kim 10MB Mathew Yun 10MB O Noname 10M O xung 10MB O Benjamin ays _ 10MB O Anakin choung 10MB O enarteskim 10M O Mathew Yun _10MB O charieskim_ 10MB Charles Kim 10MB Select All back Full Setting Mode Device Setting Image Filter o Line Density 2 Recording File Size o Do you want to back up data Import Backup baadi Teona 20 100 Select to the files that you want to back up O Ferm ons O Denn om O Bonn om O frst Gena 1008 O rem om O Mathew Yun 10MB CJ Charles Kim 10MB Files have been saved at Android gt Root SONON 300C iSO gt Document Backup Files as a YY MM DD00 00 m aes Select to the files that you want to back up Device Setting Noname 10MB Image Filter Image Filter O Noname 10MB Line Density Line Density O Jack Jung 10MB i ile Si Benjamin R 10MB Recording File Size Recording File Size O O Charles Kim 10MB Import Backup Import Backu p p O Mathew Yun 10MB O Charles Kim 10MB Device Setting Do you want to back up data Backup Setting Mode Backup Setting Mode Select to the files that you want to back up Device Setting Device Setting Image Filter O Line Density O Recording File Size O O Posinehons 10m Import Backup O O Mathew Yun 10MB O Char
11. 1 Launch the App Store app 2 Search for SONON 300C 3 Select the SONON 300C App and Install 4 Enter the user s Apple password 5 Automatic installation 5 2 2 Android 1 Launch the Google Play App 2 Search for SONON 300C 3 Select the SONON 300C App and Install 4 Automatic installation Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 6 Operating the Device 6 1 SONON 300C Device Start Up 6 1 1 Power On 6 1 2 Power Off 6 2 Network Interface Technical Specifications Wi Fi 6 3 Probe Orientation 6 4 Presets 6 5 Operating Procedure 6 6 Settings Document No HC IFU 001 Rev 1 12 HEALCERION User Manual Rev 2 6 1 Device Start Up 6 1 1 Power On Press the power button for 1 2 seconds The Wi Fi button is changed to blue 3 The device is in the ready state 6 1 2 Power Off Press the power button for 1 2 seconds 4 The power button is changed to yellow from white The device is off 6 2 Network Interface Technical Specifications Wi Fi 2 4 GHz only Soft AP mode SSID SONON 300C Serial Number XXXXXXXX 6 3 Probe orientation The probe is provided with an orientation marking This mark is used to identify the end of the probe corresponding to the side of the image having the orientation mark on the scanning screen Tap Line 1 Marker a 4 A he 7 TF oft wn Saget Basis Seas f y uw coo s HA 6
12. 29 Maai gt No Name Description 1 TGC Button Control TGC Time Gain Compensation 2 DR Button Control DR Dynamic Range 3 Freeze Button Change to Freeze Mode 4 Cine File Saving Button Save as movie files 5 Patient Info Button Call Patient Information Screen 6 Setting Button Call Setting Menu Screen 7 Playlist Button Call Playlist Screen 8 Line 1 Marker Button Displays mirrored image reversed image 9 Diagnosis Info Area Displays current diagnosis information 10 Patient Info Area Displays current patient information 11 FL Marker Button Display current FL Focal Length and set a new FL by tap action 12 Side Ruler Area The restricted area as setting Depth control by drag action or FL control by tap action Document No HC IFU 001 Rev 1 12 HEALCERION 4 2 4 Freeze Mode Screen Layout No Name Clear Button Measurement Button Live Button still shot Saving Button Patient Info Button Freeze Mode Status Icon Oo O1 By CG N Document No HC IFU 001 Rev 1 12 Description All measurements Notes are cleared Length Ellipse Measurement Annotation Change to Live Mode Save current Diagnostic Image Call Patient Information Screen All measurements Notes are cleared HEALCERION 4 3 Battery Caution e Do not place the battery near a heat source or expose it to direct flames Such exposure may lead to corrosive liquid leakage electrical shock or fire e If any liquid from the battery
13. HC IFU 001 Rev 1 12 HEALCERION 5 1 Mobile Device Requirements Warning e If you remove and reinstall the app all stored information will be deleted and cannot be recovered e Intended for use with standard Android v 4 1 or later and iOS operating systems v 7 0 or later Android rooting and iOS jailbreaking removes the limitations on the manufactured devices running the standard OS and thus the SONON 300C is not intended for use with these devices Healcerion is not responsible for any error in usage e Do not use anything other than a recommended mobile device Caution e After installing the SONON 300C App from the App Store Google Play the new version is recognized and it is automatically updated At this time firmware is also automatically upgraded Notes e When you operate the SONON 300C HEALCERION needs your personal information Please read Appendix A Usage Agreement Document No HC IFU 001 Rev 1 12 HEALCERION The minimum requirements for the mobile device are listed in the table below Item Minimum requirements iPhone 5 5S iPad 3 4 generation or later Target Device Galaxy S3 S4 Note 2 Note 3 Note S3 Note S5 Galaxy Tab 10 1 2012 version 2013 version 2014 version or later IOS 7 0 or later Mobile OS Version Android 4 1 or later 9 2 Installation of the Mobile App Note For the iPhone installation of the SONON 300C mobile app requires an iTunes registration and password 5 2 1 IOS
14. HEALCERION 53 6 4 3 Start Screen Move to Setting Screen HEALCERION Patient Info Start Scan Free Space 6 2G Move to Patient Info Screen Move to Live Screen Diagnosis Data Usage 2 8G E x When the SONON 300C is connected to the mobile application and if the user taps the start button it is available to start a scan X When the SONON 300C is not connected to the mobile application the user can t use the scan functions When the HW device connection is not ready and if the user taps the start button Print Pop up 6 Connection with SONON is Not working Please retry to connect with SONON H Document No HC IFU 001 Rev 1 12 F 6 4 4 Live Screen 6 4 4 1 Default Screen Live Mode Function Zoom in amp out Depth Control Focal Length Control TGC Control DR Dynamic Range Control Recording Cine File Saving Default Live Mode Status Patient Info No name If the user selects a particular patient in the Start Screen the patient info is displayed in the Live Mode screen TGC Brightness Contrast 50 Slide Bar DR 75dB i a u 6 4 4 2 Zoom Action Pinch Out 15 Pinch in Back to the normal ratio screen in Live mode D Pinch Out Zoom in Action The zoom message in ratio will be displayed HA 6 4 4 3 FL Control FL 2 Fy O 0 2 h ff a yer O un in birer Pi eee bey es m eo Yu 3 gt
15. IFU 001 Rev 1 12 HEALCERION Date 2014 02 01 2014 05 28 2014 10 27 Chapter 1 General 1 1 About This User Manual 1 2 Text Conventions Document No HC IFU 001 Rev 1 12 HEALCERION User Manual Rev 2 1 1 About This User Manual Product name Portable Ultrasound Device Trademark SONON ULTRASOUND IMAGING SYSTEM Model SONON 300C e Please read and understand all the instructions in this User Manual before attempting to operate the SONON 300C equipment e Keep this User Manual with the product for future reference e Some options or features may not be available in some countries e The screen graphics and illustrations in this User Manual are for illustrative purposes only and may differ from what is displayed on the screen e All references to standards and regulations and their revisions are valid as of the date of publication of this User Manual 1 2 Text Conventions The manual uses the following conventions for Warnings Cautions and Notes Notice Important information that must be read before proceeding Chapter 2 Introduction 2 1 Intended Use 2 1 1 Intended Patient Population 2 1 2 Intended User Profile 2 1 3 Operating Principles 2 2 Contraindications Document No HC IFU 001 Rev 1 12 HEALCERION 2 1 Intended Use The SONON Ultrasound Imaging System Model SONON 300C is indicated for ultrasound echo imaging measurement and analysis of the human body for general clinical applications inclu
16. WIFI Setup Battery 15 Device Temperature NORMAL OVER WIFI Setup SSID mSONO Wifi setup o KEY Current Application Change Current Application General Wi Fi Setup Device Setting Device name Key Confirm Key Firmware version Key Wifi setup Confi onfirm Key Document No HC IFU 001 Rev 1 12 HEALCERION 6 6 2 2 Image Filter lt back Full Setting Mode Full Setting Mode Device Setting Device Setting Average Filter mage Filter Use Average Filter O Line Density FIR IIR Recording File Size Manual Alpha C Backup Alpha Value c gt Backup A Line Density Recording File Size Import Backup Import Backup lt back Image Filter Average Filter Use Average Filter FIR IR Manual Alpha Alpha Value gt o ar Document No HC IFU 001 Rev 1 12 HEALCERION 6 6 2 3 Line Density lt back Full Setting Mode Device Setting Image Filter Recording File Size Backup Import Backup lt back Line Density OFF ON Cp Document No HC IFU 001 Rev 1 12 Device Setting Image Filter Recording File Size Backup Import Backup HEALCERION Full Setting Mode OFF ON X Default Off OD 6 6 2 4 Recording File Size Full Setting Mode Device Setting Device Setting Default Off 4 To allow to send via e mail Image Filter Image Filter with Recording File
17. a separate section Article 8 Limitation of Responsibility Regarding the SERVICE 1 The COMPANY shall make its best effort to maintain the best possible security by avoiding information leakage of the diagnosis data of the users to any third party excluding doctors and those with rights to such diagnosis data However the COMPANY is not responsible when such diagnosis data is revealed exposed or damaged due to the following reasons 1 Leakage of password due to inattention of the user 2 When the deletion of diagnosis function has been executed 3 When the SONON 300C application has been removed 4 Due to other force majeure causes such as natural disaster Document No HC IFU 001 Rev 1 12 HEALCERION Article 9 Responsibility of the COMPANY 1 The COMPANY shall not conduct any actions that violate related laws this agreement or public morals and make its best effort to maintain its provision of stable and secure products conforming to this agreement 2 The COMPANY shall establish a proper security system for the protection of the personal information including credit information of the members in order to allow them to safely utilize the SERVICE and post and conform to the Privacy Policy 3 The COMPANY shall immediately work to rectify any complaint or opinion of the members through appropriate procedures when such complaint or opinion is considered objectively reasonable When an immediate resolution is not
18. cm2 where z2zbp centimeters j 1 69 4 j centimeters the axial distance at which TIB is a global maximum i e zsp zB 3 centimeters the axial distance corresponding to the maximum of the derated spatial peak pulse intensity integral megapascals the equivalent beam diameter as a function of axial distance z It is equal to 4 11 Wo ITA z 0 5 where ITA z is the temporal average intensity as a function of z centimeters HEALCERION fc Dim of Aaprt PD PRF Pr PIImax deq Pllmax FL lPa 3s Mlmax the center frequency MHz For MI fc is the center frequency associated with the transmit pattern giving rise to the global maximum reported value of MI For TI for combined modes involving transmit patterns of unequal center frequency fc is defined as the overall range of center frequencies of the respective transmit patterns the active aperture dimensions for the azimuthal x and elevational y planes centimeters the pulse duration microseconds associated with the transmit pattern giving rise to the reported value of MI the pulse repetition frequency associated with the transmit pattern giving rise to the reported value of MI Hz the peak rarefactional pressure at the point where the free field spatial peak pulse intensity integral is at a maximum megapascals See Section 6 2 4 1 of the Output Display Standard Measurement Methodology for Mechanical and Thermal Indices
19. likely however the COMPANY shall notify the member of the reason for such delay and the future settlement schedule Article 10 Responsibility Regarding User ID and Password 1 All responsibility regarding the user ID and password lies solely with the user and any civil criminal responsibility due to negligent management of the ID and password also lies solely with the user 2 The user shall not allow any third party to have access to his or her user ID and password 3 When the user realizes that there has been a theft of his her user ID and or password or becomes aware that they are being used by a third party he she shall immediately notify the COMPANY and comply with any measures taken by the COMPANY 4 The user is fully responsible for any and all loss caused by nonfulfillment of the notification cited above in Clause 3 or noncompliance with the COMPANY s measures Article 11 Responsibility of the User 1 The user shall conform to any and all related laws and ordinances regulations set by this agreement and usage guideline provided by the COMPANY and shall not conduct any behavior that may interrupt other operations of the COMPANY 2 The user shall be prohibited from the following behavior regarding utilization of the SERVICE A Registration of false information at registration or alteration of the SERVICE Illegal usage of others information C Transmitting or posting information computer programs etc other tha
20. list Screen 3 Add New Patient Button 4 Edit Patient List Button Document No HC IFU 001 Rev 1 12 HEALCERION 6 5 2 Playlist lt back Patient List Patient Info Edit Playlist Noname Benjamin Ryu Jack Jung Y MIM DD 00 00 00 Name Gender YY MM DD 00 00 00 AnakinChoung Fe Re YY MM DD 00 00 00 Height Weight YY MM DD 00 00 00 Peter Lee Charles Kim Operator YY MM DD 00 00 00 Mathew Yun Hospital Paul Hong Note YY MM DD 00 00 00 Add New Patient Select all Delete Y x Move to Live screen with selected Patient Info Choose and tap a patient in the Patient List screen The Patient Info Screen will be displayed 3 Tap the playlist button 4 The playlist screen will be displayed Document No HC IFU 001 Rev 1 12 HEALCERION Patient Info Patient Info ap Name Anakin Choung Anakin Choung Gender Male Age 44 Height 175cm Weight 80 Kg Operator Chris Redfield Hospital Umbrella Hospital YY MM DD 00 00 00 Jack Jung Jack Jung Benjamin Ryu Benjamin Ryu YY MM DD 00 00 00 YY MM DD 00 00 00 Peter Lee Peter Lee YY MM DD 00 00 00 CharlesKim Memo CharlesKim YY MM DD 00 00 00 Mathew Yun Mathew Yun YY MM DD 00 00 00 JamesKim JamesKim Start Scan X Move to the LIVE screen with selected patient info YY MM DD 00 00 00 GOUE BOB Chris Song Chris Song Patient Info Anakin Choung Patient Info ap Anakin Choung J
21. the accompanying documents Freeze mode This symbol means that an image is frozen Standby This symbol s function is to turn the device on or put it in standby mode Wi Fi This symbol means wireless communication Manufacturer information This symbol is followed by the name and address of the device manufacturer Manufacture Date This symbol is followed by the device manufacture date in the form of YYYY MM Serial Number This symbol is followed by the device serial number Model name This symbol represents the model name of the product Representative information The manufacturer s EU representative information shows with this symbol This way up Indicates the correct upright position of the transport package Fragile handle with care He FFB 2 2 SD SiO BP amp A x Keep dry Indicates the need for separate collection for electrical and electronic equipment in compliance with the Waste Electrical and Electronic Equipment WEEE Directive For more information see Section 3 9 Disposal This symbol means Caution Federal law restricts this device to sale by or on the order of a physician Ale Document No HC IFU 001 Rev 1 12 HEALCERION 3 2 General Safety Warnings e Only authorized personnel shall perform any type of repair on the SONON 300C Never attempt to open a transducer or transducer connector This will void the warranty e Probes are not delivered sterile Before the firs
22. 0601 1 2 The essential performance refers to section 9 1 4 of this manual User Manual Rev 2 3 5 Coupling Gels Applying In order to ensure the optimal transmission of energy between the patient and probe a conductive gel or couplant must be applied liberally to the patient where the scanning will be performed Precautions Coupling gels should NOT contain any of the following ingredients as they are known to Cause probe damage e Methanol ethanol isopropanol alcohol or any other alcohol based products e Mineral oils e lodine e Lotions e Lanolin e Aloe vera e Olive oil e Methyl or ethyl parabens para hydroxybenzoic acid e Dimethylsilicone Coupling gels are recommended that use the following Name Manufacturer Aquasonics 100 Parker Laboratory Inc Clear Image Sonotech Inc Scan Parker Laboratory Inc Sonogel Sonogel Vertriebs 3 6 Bioeffects and Safety of Ultrasound Scans Thermal Safety Maintaining a safe thermal environment for the patient has always been a design priority at Healcerion The operating temperature of the ultrasound probe must remain below 43 C Whenever ultrasound waves travel through tissue there always is a certain risk of damage There has been a great deal of research on the impact that high frequency waves can have on different kinds of tissues under defined conditions and There is to date no evidence that diagnostic ultrasound has produced any harm to humans incl
23. 1 12 HEALCERION Caution SONON temperature is overheated Please turn off the power and Re use after cooling e Ifthe SONON 300C handgrip s temperature is over 48 C the pop up below will be displayed Caution SONON temperature is overheated SONON turn off automatically 8 1 4 Low Battery Message e Ifthe SONON 300C battery level is under 30 the pop up below will be displayed Caution SONON Battery is low powered Please turn off the power and charge before use Document No HC IFU 001 Rev 1 12 HEALCERION 8 2 Connection Errors 8 2 1 Network Error Message When the HW device connection is not ready and if the user taps the start button the pop up below will be displayed Connection with SONON is Not working Please retry to connect with SONON OK D 8 2 2 Firmware Upgrade Error Message lf the Firmware Upgrade has failed or another error has occurred the pop up below will be displayed Caution Firmware Upgrade is failed Please re try to upgrade Firmware C w gt 8 2 3 Wi Fi AP missing Error Message If the Wi Fi AP signal is missing the pop up below will be displayed Caution SONON AP is missing Please push the Wi Fi Button long Wi Fi Rebooting C Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 9 Technical Data Information 9 1 Safety Conformance 9 2 Acoustic Output Reporting Tables 9 3 Acoustic Output 9 4 Specifications Document No HC IFU 001 R
24. 4 Operating Procedure 6 4 1 User Interaction interaction Drag Any Direction Flicking Flicking Left and Right ote 6 4 2 App Log In 6 4 2 1 Initial setting screen HEALCERION Terms amp Conditions Welcome Agree Agree All input fields must be filled to go to the next process There are some empty fields in your initial information Please complete all fields Document No HC IFU 001 Rev 1 12 HEALCERION Enter your Information Organization fo Serial Number Po Password Po Confirm your Password fo E mail Address Po CY Next Move to App initial screen 51 lf the PW value does not match the confirm PW value print Pop up 2 Please re input your Password and re confirm the Password 6 4 2 2 App Initial Screen forgot my PW lf the PW input information is incorrect print Pop up 3 Password isnot correct Please re input your Password Document No HC IFU 001 Rev 1 12 HEALCERION O1 D 6 4 2 3 Find password HEALCERION a pw Please input E mail when you input initial setting lf the Serial Number is incorrect print Pop up 4 The Serial Number entered is not a valid value Please check your Serial Number and re input Pop up 4 lf the E mail address is incorrect print Pop up 5 E mail address is not valid Please check your e mail address and re input Pop up 5 Document No HC IFU 001 Rev 1 12
25. A file named Charles already exists Do you want to save it as a Charles 1 YY MM DD 00 00 10MB O O O YY MM DD 00 00 10MB Backup YY MM DD 00 00 10MB Loading YY MM DD 00 00 10MB 20 100 Fan YY MM DD 00 00 10ME f ok Not import nor Save a same file NEE Same 35 a Charles 1 Sort by date When there isn t any file that has same name with a file already exists OOOO0O0O0 Data import has been completed You can check the data in Patient info mode Sort by date lt back Import Setting Mode Import Setting Mode Select to the files that you want to import Select to the files that you want Device Setting Device Setting to import u O nummmoyoooe som Image Filter Image Filter Remaining Line Density SU ids REP 10MB iine Density YY MM DD 00 00 10MB capacity 0 YY MM DD 00 00 10MB Pen Recording File Size Recording File Size YY MM DD 00 00 10M YY MM DD 00 00 10MB YY MM DD 00 00 10MB Backup Backup Import Backup YY MM DD 00 00 10MB YY MM DD 00 00 10MB YY MM DD 00 00 10MB lmportBackup YY MM DD 00 00 10MB YY MM DD 00 00 10MB YY MM DD 00 00 10ME Back to Live Screen Caution Sapce for import data is not enough Please retry after secure space 4 back Import Setting Mode Import Setting Mode R i Select to the files that you want to import Device Setting ema Device Setting YY MM DD 00 00 10MB rn I
26. ALCERION Article 5 Termination of SERVICE 1 The COMPANY may temporarily suspend provision of the SERVICE due to causes of force majeure such as repair inspection replacement or malfunction interruption of communication etc 2 The COMPANY is not responsible for compensation for any loss to the users or any third party caused by a temporary suspension of the SERVICE due to reasons clarified in Clause 1 However this is NOT so if the COMPANY undertakes such alteration with bad intentions or significant errors Article 6 Usage Registration and Removal 1 The user shall apply for registration of usage of the SONON 300C application by inputting personal information as required by the COMPANY and agreeing with this agreement 2 The user may at any time remove the SONON 300C application However upon removal of the SONON 300C application all collected information is deleted and the COMPANY is not responsible for any loss to the user or any third party caused by the removal Article 7 Personal Information Protection 1 The COMPANY conforms to all matters regulated by laws and ordinances such as the Act on the Promotion of Information and Communication Network Use and Protection of Information etc 2 The COMPANY shall establish and post a Privacy Policy on the first SERVICE screen in order to protect the personal information of the members In addition further details on the Privacy Policy shall be available in
27. English version e familiar with ways to use mobile devices e able to set up communication between the device and mobile devices e able to keep track of communication status e familiar with the use of apps in mobile devices e able to set up and install SW updates e able to understand and use contents of SW UI e well trained about existing ultrasound e fully understands the manual accompanying the product e corrected visual acuity 1 0 or better e read through the user manual and keeps in mind precautions and key functions of the product e N A Document No HC IFU 001 Rev 1 12 HEALCERION 2 1 3 Operating Principles The SONON 300C utilizes pulsed echo technology to determine the depth and location of tissue interfaces and measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver Ultrasound waves are emitted from the transducer propagate through various tissues and return to the transducer as reflected echoes The returned echoes are converted into electrical impulses by transducer crystals then further processed in order to form the ultrasound image presented on the screen The echo signals are amplified and processed by several analog and digital circuits with filters for many frequency and time response options transforming the high frequency electrical signals into a series of digital image signals which are stored in memory The ultrasound image is based on t
28. HEALCERION SONON 300C Portable Ultrasound Device User Manual Rev 2 TABLE OF CONTENTS Chapter 1 General 1 1 About This User Manual 1 2 Text Conventions Chapter 2 Introduction 2 1 Intended Use 2 1 1 Intended Patient Population 2 1 2 Intended User Profile 2 1 3 Operating Principles 2 2 Contraindications Chapter 3 Safety 3 1 Symbols 3 2 General Safety 3 3 Electric Safety 3 3 1 Immersion Level 3 4 Electromagnetic Compatibility 3 5 Coupling Gels 3 6 Bioeffects and Safety of Ultrasound Scans 3 6 1 Prudent Use 3 6 2 Bioeffects 3 7 Environmental Conditions 3 8 Other Recommendations 3 9 Disposal Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 4 Device Description 4 1 Product Description 4 1 1 Package Contents 4 1 2 Device Overview 4 2 Screen Layout 4 2 1 Basic Layout 4 2 2 Live Mode Screen Layout 4 2 3 Freeze Mode Screen Layout 4 3 Battery 4 3 1 Battery Level Indicator 4 3 2 Removing and Inserting the Battery 4 3 3 Battery Specifications Chapter 5 Installation of Software 5 1 Mobile Device Requirements 5 2 Installation of the Mobile App 5 2 1 iOS 5 2 2 Android Chapter 6 Operating the Device 6 1 SONON 300C Device Start Up 6 1 1 Power On 6 1 2 Power Off 6 2 Network Interface Technical Specifications Wi Fi 6 3 Probe Orientation 6 4 Operating Procedure Document No HC IFU 001 Rev 1 12 HEALCERION 6 5 Patient Information 6 6 Settings Chapter 7 Maintenance 7 1 Inspecting Probes 7 2 Planned Mainten
29. N hereinafter COMPANY Document No HC IFU 001 Rev 1 12 HEALCERION Article 2 Terms and Definitions 1 Application refers to the mobile application manufactured and managed by the COMPANY with the purpose of aiding users who have registered a password to have access to ultrasonic diagnosis by using the ultrasonic diagnosis instrument SONON 300C 2 User refers to a person who has registered information including personal information for the purpose of utilization of the SERVICE provided by the COMPANY and is able to access an ultrasonic diagnosis using the ultrasonic instrument SONON 300C through free utilization of the SERVICE with the registered password 3 SONON 300C refers to the medical instrument that visualizes the inside of the human body using ultrasonic waves and the wireless mobile ultrasonic diagnosis instrument manufactured by the COMPANY 4 Password refers to combinations of letters and numbers that are set up by members for the purpose of identification of members and protection of their rights and passwords and registered to the SERVICE 5 Personal Information refers to information regarding a specific individual such as e mail name of organization etc it also includes any information that has the potential to be combined with other information to make identification of a specific individual feasible 6 Removal refers to the action of removing the Application from the mobil
30. OTE UT is the AC mains voltage prior to application of the test level Electromagnetic immunity The SONON 300C is intended for use in electromagnetic environments as specified below The customer or the user of the SONON 300C should ensure that it is used in such an environment IMMUNITY IEC 60601 TEST Compliance Electromagnetic environment guidance test LEVEL level Portable and mobile RF communications equipment should be used no closer to any part of the SONON 300C including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Document No HC IFU 001 Rev 1 12 Recommended separation distance Conducted RF 3 Vrms 3 Vrms V1 IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m E1 IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2VP 80MHZ to 800 MHz d 1 2VP 800MHZ to 2 5 GHz d 2 3VP where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol GY NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situat
31. ack Jung Benjamin Ryu Peter Lee CharlesKim YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 Jack Jung Benjamin Ryu Peter Lee Charles Kim 2 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 Mathew Yun Mathew Yun YY MM DD 00 00 00 JamesKim JamesKim YY MM DD 00 00 00 Chris Song Chris Song Caution Selected diagnosis data cannot be recovered after deletion Do you still want to delete the selected data Selected diagnosis data has been deleted 6 5 3 Patient Info Edit 4 back Patient Info Patient Info Edit Name Name Gender Gender Age Age Height Height Weight i B Weight Operator Operator Note Note The Patient Info Is saved gt Pop up 9 Tap the Edit button The Patient Info Edit screen is displayed lf the user edits the patient info then tap the save button The Cancel button will move the page back to the previous screen 4 Print Pop up 9 OK move to the Patient Info screen OVO Document No HC IFU 001 Rev 1 12 HEALCERION Gender Male Age 44 Weight 80 Kg Patient Info Operator Chris Redfield Peterlee Hospital Umbrella Hospital CharlesKim Memo Playlist Chris Song Start Scan Patient Info Jack Jung Benjamin Ryu AnakinChoung Peter Lee CharlesKim Mathew Yun JamesKim
32. afe Use of Diagnostic Ultrasound Equipment Safety Group of the British Medical Ultrasound society 2010 Special care regarding ALARA should be taken with obstetric examinations as any potential bioeffects are likely to be of the greatest significance to the embryo or fetus It is strongly recommended to consider ALARA when conducting ultrasound scans See Appendix 1 The SONON Ultrasound Imaging System Model SONON 300C is a single mode B Mode single output 3 5 MHz low ultrasonic powered device The factors that the operator can control are below and the output value is less than 1 MI and TI 1 TGC Time Gain Compensation 2 DR Dynamic Range 3 FL Focal Length 4 Depth 5 Image Filter 6 Line Density When only operated in B mode the SONON Ultrasound Imaging System is safe because exposure time to the patient applied part is not concentrated in one place In addition Healcerion provides the generic content of an education program with AIUM Medical Ultrasound Safety AIUM 2014 refer to appendix and additional education For example a doctor who used the SONON Ultrasound Imaging System to verify the status of a baby prohibits inordinate inspection in order to show to its family or other meaningless situations Document No HC IFU 001 Rev 1 12 HEALCERION 3 6 2 Bioeffects e Thermal effects refer to the heating of soft tissue and bone The thermal indices Tis for soft tissue Tlb
33. ance 7 3 Cleaning amp Disinfecting Chapter 8 Error Messages 8 1 Device Messages 8 2 Connection Errors Chapter 9 Technical Data Information 9 1 Safety Conformance 9 2 Acoustic Output amp Index Determination 9 3 Acoustic Output 9 4 Specifications Chapter 10 Glossary Abbreviations Appendix A Usage Agreement Appendix B Medical Ultrasound Safety Document No HC IFU 001 Rev 1 12 HEALCERION The SONON 300C is a diagnostic ultrasound equipment which transmits ultrasound waves into body tissues and forms images from the received echoes The SONON 300C is a Class Ila Active Diagnostic Medical Product according to MDD 93 42 EEC regulations for use on human patients The SONON 300C was developed and manufactured by HEALCERION For more information please contact HEALCERION HEALCERION Address RM 509 amp 510 72 Digital ro 26 Gil Guro gu Seoul Korea Telephone 82 70 7582 6325 www healcerion com For USA only Caution Federal law restricts this device to sale by or on the order of a physician Document No HC IFU 001 Rev 1 12 HEALCERION Revision History Revision User Manual Revision 0 Initial release User Manual Revision 1 Amendment 9 2 Acoustic Output amp Index Determination Amendment 9 3 Acoustic Output User Manual Revision 2 Amendment 6 Operating the Device Amendment 9 2 Acoustic Output Reporting Table Amendment Appendix A Usage Agreement Document No HC
34. attery e Type ecnaigeane Li ion e Capacity 2600 mAh Wireless e Type Soft AP Communication e Frequency 2 4 GHz Mobile App e OS iOS Android e Type BF Applied Part Non Continuous Operation Max 10 min with 10 min resting time e Internally Powered Equipment e Probe head IPX7 e Frequency 3 5 MHz Ultrasound e Module Convex e Depth 5 cm to 20 cm e SONON 300C Firmware version 1 0 Mobile device SONON 300C App version 1 0 IEC 60601 1 Software Version Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 10 Glossary Abbreviations Document No HC IFU 001 Rev 1 12 Heatcerion IEC Meaning Aaprt CMI Normalizing Coefficient Deg Equivalent Aperture Diameter d 6 deq Equivalent Beam Diameter awf Acoustic Working Frequency Ipa Ipa a Attenuated Pulse Average Intensity lpi Ipi a Attenuated Pulse Intensity Integral lta Z lta a Z Attenuated Temporal Average Intensity Izpta Z Spatial Peak Temporal Average Intensity Izpta a Z Attenuated Spatial Peak Temporal Average Intensity MI p Pa P1 pi pr Pra Peak Rarefactional Acoustic Pressure Attenuated Peak Rarefactional Acoustic Pressure prr TI TIB Pulse Repetition Rate Bone Thermal Index TIC Cranial Bone Thermal Index TIS Soft Tissue Thermal Index td X Y xy 12dB OulputBeamDmensons sam Document No HC IFU 001 Rev 1 12 Acoustic Attenuation Coefficient 12db Output Beam Ar
35. ding obstetrics OB gynecology GY and general abdominal imaging Its user interface and portability enable it to be used in primary care and special care areas such as medical office settings clinics and emergency rooms in hospitals lt consists of a battery operated compact size portable ultrasound transducer that communicates wirelessly with iOS and Android mobile devices Its function is to acquire ultrasound echo data and display it in B mode on a mobile device 2 1 1 Intended Patient Population Item Description Age All ages Weight N A Gender Males and females Do not use with patient who will be harmed by applying ultrasound meat e g with an implanted pacemaker Nationality Multiple Patient state Patient is not user not relevant only used by related experts 2 1 2 Intended User Profile Item Education Knowledge Language understanding Experience Vision Memory Permissible impairments Description e Professionals who have completed related courses including emergency medical technicians nurses and medical students e have basic knowledge of ultrasound e have an understanding of physiological effects of ultrasound e able to intuitively recognize and understand SW UI and HW UI e able to distinguish mobile devices to which SW is applied e able to understand updates e able to understand terms used for the product and its manual e able to understand the methodology in the manual
36. displayed Anew DR Message is displayed X Depending on the drag action the corresponding text is displayed indicating the action time X Drag right to increase DR XX dB X Drag left to decrease DR YY dB H 6 4 4 7 Cine File Saving Live Q on s gt in 1 oomo 2 1 EO rn J is a Recording time display End Recording X cine File size is limited 15MB and in REC screen display timer Tap the Cine File Saving Button gt Recording Timeline and Timeline Message is displayed Repeat tapping Cine File Saving Button End Recording Message is displayed X If the patient info is not set Pop up 7 will be displayed There is no Patient Info This Patient name will be saved as Noname HA 6 4 5 Freeze Screen While scanning press the Function button to freeze the image 6 4 5 1 Default Screen Freeze Freeze oO an in Document No HC IFU 001 Rev 1 12 HEALCERION o Selb 6 4 5 2 Zoom Action xk En O wkk wkk 5 Pinch in Back to the normal ratio screen in freeze mode Pinch Out Action 2 Zoom screen in ratio X While in the zoom screen the user can go back to the normal ratio by using the pinch in action Document No HC IFU 001 Rev 1 12 HEALCERION a BEE 6 4 5 3 Measurement Length Measurement Ww Measurement Previous Object Saeaeeaeeaetanan ta ay un Single tap the Measur
37. e Spray disinfect onto the surface of the probe head e Repeat step one two or three times e Let stand for about 1 minute e Wipe off the disinfectant with a clean cloth Recommended disinfectants In order to provide users with options in choosing a disinfectant HEALCERION routinely reviews new medical disinfectants for compatibility with the system Although a necessary step in protecting patients and employees from disease transmission liquid chemical disinfectants must also be selected to minimize potential damage to the transducer Document No HC IFU 001 Rev 1 12 HEALCERION 107 The following disinfectants can be used on the system Name Manufacture Dispatch Clorox Transeptic PARKER Document No HC IFU 001 Rev 1 12 HEALCERION 8 1 Device Messages 8 2 Connection Errors 8 3 Operating Errors Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 8 Error Messages 8 1 Device Messages 8 1 1 FAN Error Message lf there is a fan error the pop up below will be displayed Caution SONON FAN control is error Please Reboot SONON 8 1 2 Battery Charging Message lf the user connects the power cable when the SONON 300C power is on the pop up below will be displayed Caution Battery Charging is activated only power off situation SONON willturn off automatically 8 1 3 Temperature Message X If the SONON 300C handgrip s temperature is over 40 C the pop up below will be displayed Document No HC IFU 001 Rev
38. e device by the User Article 3 Manifestation Description and Amendment of the Agreement 1 This agreement is valid only by being posted for users on the service screen or otherwise notified 2 The COMPANY may amend contents of this agreement as long as there is no violation of laws or other related ordinances regarding regulation of the agreement and shall notify any changes through the procedure clarified in Article 1 above However significant matters regarding the rights and duties of users shall be posted fifteen 15 days prior to the implementation of amended content 3 The COMPANY bears no responsibility for any loss or damage to Users due to their ignorance of the amended agreement 4 For matters not clarified in this agreement all cases shall be considered according to the Act on the Promotion of Information and Communication Network Use and Protection of Information other related laws and ordinances or appropriate customs Article 4 Content and Alteration of Service 1 The COMPANY may alter the contents of the SERVICE when it is unavoidable and shall issue notification of such altered contents and implementation date seven 7 days in advance 2 The COMPANY is not responsible for compensation for any loss to the users due to alteration of the SERVICE contents However this is NOT so if the COMPANY undertakes such alteration with bad intentions or significant errors Document No HC IFU 001 Rev 1 12 HE
39. e try after securing enough space 7 1 Inspecting Probes 7 2 Planned Maintenance 7 3 Cleaning amp Disinfecting Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 7 Maintenance User Manual Rev 2 7 1 Inspecting Probes After each use inspect the probe s lens and casing Look for any damage that would allow liquid to enter the probe If any damage is found the probe must not be placed into any liquid e g for disinfection and must not be used until it has been inspected and repaired replaced by a HEALCERION Service Representative 7 2 Planned Maintenance After Before i Dai As N Do the Following aily Each Use s Necessary Inspect the Probe head V V y Clean the Probe head V V Document No HC IFU 001 Rev 1 12 HEALCERION 106 7 3 Cleaning amp Disinfecting Recommendations for cleaning the ultrasound probe e Remove all coupling gel and other visible substances from the probe by wiping with a soft dry cloth If necessary to remove material dried on the surface the cloth can be moistened with lukewarm water e After each use inspect the probe s lens and casing Look for any damage that would allow liquid to enter the probe If any damage is found the probe must not be placed into any liquid e g for disinfection and must not be used until it has been inspected and repaired replaced by a HEALCERION Service Representative Recommendations for disinfecting the ultrasound probe after cleaning
40. ea Pulse Beam Width Pulse Average Intensity Pulse Intensity Integral Temporal Average Intensity Mechanical Index Output Power Attenuated Output Power Bounded Output Power i Pulse Pressure Squared Integral Thermal Index Pulse Duration same HEALCERION Zbp Zbp ZS FDA MI TISscan TISnon scan TIB TIC Aaprt Or 3 Wo W s z1 ITA 3 Z1 Zi Zbp Zsp Z PIl 3max dea Z Document No HC IFU 001 Rev 1 12 Distance from the Source to a Specified Point same Depth for TIB Depth at which the relevant index is maximum Break Point Depth same Depth for TIS Depth at which the relevant index is maximum Meaning the Mechanical Index the Soft Tissue Thermal Index in an auto scanning mode the Soft Tissue Thermal Index in a non auto scanning mode the Bone Thermal Index the Cranial Thermal Index the area of the active aperture square centimeters the derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI megapascals the ultrasonic power except for TlSscan in which case it is the ultrasonic power passing through a one centimeter window milliwatts the derated ultrasonic power at axial distance z1 milliwatts the derated spatial peak temporal average intensity at axial distance Z1 milliwatts per square centimeter the axial distance corresponding to the location of max min W 3 Z ITA 3 z x 1
41. ement Button The sub menu will be displayed then tap the Length Button OVO Two position icons in a predefined position will be displayed then draw a dotted line between the icons The user can move the position icons with the drag action Document No HC IFU 001 Rev 1 12 HEALCERION 64 4 The length between the icons displayed in real time corresponds to the user s moving action Make another single tap on the Measurement Button then tap the Length Button again Another two position icons separate from the previous position icons will be displayed D The length between the second pair of icons is displayed The maximum number of measurement objects is 10 including Area objects Deleting each measurement object is not available Pop up 8 will be displayed once the measurement object limit has been reached Maximum Measurement object limitis 10 You can not add any more objects Document No HC IFU 001 Rev 1 12 HEALCERION 6 4 5 4 Measurement Ellipse Measurement in r in in j Sg Single tap the Measurement Button The sub menu icon will be displayed then tap the Ellipse Button The Ellipse position icon will be displayed 4 Ellipse measurement is displayed Document No HC IFU 001 Rev 1 12 HEALCERION a BEEEE ig O Sa v m in I om y baie Ea pd in The user can move the position icons with the drag action Four position icons with predefined position
42. ete the selected data Pop up 13 Selected diagnosis data has been deleted Pop up 14 Tap the playlist button on No Name Info No Name s Playlist will be displayed Tap the Edit button The Playlist Edit Screen is displayed Select a patient to delete ONOG If you delete selected files tap the delete button Pop up 13 OK Print pop up 14 Document No HC IFU 001 Rev 1 12 HEALCERION Select all Playlist Edit YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 YY MM DD 00 00 00 Cancel Move to Previous Screen D Pop up 14 OK Go to Playlist screen 6 5 6 To move Diagnosis Data to legacy Patient list lt back Playlist Edit Noname Choose to Owner Noname YY MM DD 00 00 00 YY MM DD 00 00 00 Benjamin Ryu YY MIM DD 00 00 00 Anakin Choung YY MM DD 00 00 00 Peter Lee YY MM DD 00 00 11 Charles Kim er Mathew Yun YY MM DD 00 00 11 The Diagnosis files are moved OK Pop up 15 There is no file to move Please select files to move first Ta Pop up 16 Document No HC IFU 001 Rev 1 12 HEALCERION Print Pop up 15 The Diagnosis files are moved Tap the Move button Print Pop up 16 Choose to owner Print Pop up 15 OK Move to Playlist screen Playlist Noname YY MM DD 00 00 11 YY MM DD 00 00 11 YY MM DD 00 00 11 YY MM DD 00 00 11 YY MM DD 00 00 11 YY MM DD 00 00 11 YY MM DD 00 00 11
43. ev 1 12 HEALCERION 9 1 Safety Conformance 9 1 1 Conforms to the following safety standards e IEC 60601 1 Electrical Medical Equipment e IEC 60601 1 2 Electromagnetic Compatibility e EC 60601 1 6 Usability e IEC 62304 Software Life Cycle Processes e IEC 60601 2 37 Particular Requirements for the Safety of Ultrasound Medical Diagnostic and Monitoring Equipment e IEC 62359 Ultrasonics Field Characterization Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields e ISO 10993 Biological Evaluation of Medical Devices 9 1 2 Essential Performance e Acquisition of ultrasound images e Display of ultrasound images on main display e Measurement of ultrasound images Document No HC IFU 001 Rev 1 12 HEALCERION 9 1 3 Marking plate ID Label e Model SONON300C Position The bottom surface of the device Examples SONON Ultrasound Imaging System REF SONON 300C POWER Rechargeable SN XXXXXX Li ion Battery mf yyyy MM DO7 4 V 2600mAh wl HEALCERION Co Ltd A RM 509 amp 510 Digital Ro 26 Gil 72 Guro Gu Seoul Korea Tel 82 70 7582 6326 ecke Allnew AG Dammstrasse 19 6301 Zug Switzerland TEL 41 41 914 14 14 Operation Max 10 min with 10 min resting time Depressed Markings Position The side surface of the device Examples AN pon t connect micro USB connector to SONON during the use Only for battery charging R FIET Made in Ko
44. ev 2 5 Insert the new battery r 6 Slide the lock button down User Manual Rev 2 7 Slide the cover back on 8 Slide the battery cover back in place lt lt u 4 3 3 Battery charging process 1 Plug the adapter cable into the adapter 2 The green light turns on after the cable is connected i u 3 Plug the cable into the Battery Dock 4 Place the battery on the battery dock and push to insert it into the battery dock 4 5 Slide the battery into the battery dock N 6 Push the button on the battery dock Document No HC IFU 001 Rev 1 12 HEALCERION 4 7 Remove the battery User Manual Rev 2 4 3 4 Device charging Process 1 Open the side cover on the device 2 Plug the USB cable into the device Beet SEO SERENA ODIs Make eee 4 3 3 Battery Specifications Item jg Specification 2 2 Description Rechargeable Li ion Battery Pack Capaciy 2600 MAh 74V 2 2 2 2 2 Lifetime Guarantee 6 months Manufacturer SAMSUNGSDI Model MBP 2S1PSD26 Cell Type MR Dimensions _L W H L 0 2 W 0 2 H 40 2mm 000030 Safety POM Logies sss Notes e For information about purchasing a battery please contact HEALCERION Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 5 Installation of the Mobile App 5 1 Mobile Device Requirements 5 2 App Installation Process 5 2 1 IOS 5 2 2 Android Document No
45. f you want to send an E mail please disconnect with SONON AP and use Cellularnetwork or other Wi Fi network OK Pop up 17 Diagnosis File Viewer f I New Message To CC BCC Subject Selected Diagnosis File Image or Video Attached File YYMMDD 000000 lf sending with the recording file is not allowed in the setting print Pop up 18 Caution To send with Recording File is not allowed in setting mode Please check options and set recording file size Pop up 18 Document No HC IFU 001 Rev 1 12 HEALCERION 84 6 5 9 Add new patient Gender Male Age 44 Age Weight 80 Kg e nakin SREE S i ung AnakinChoung F Operator Chris Redfield Anakincnouns Weight i Hospital CharlesKim Memo Charles Kim Memo Playlist Chris Song Start Scan Chris Song Y In left menu the new patient information is updated The entire input field must be fully filled to go to the next process If there are some empty fields in the screen print Pop up 19 There are some empty fields in the patient information Please complete all fields Pop up 19 H Document No HC IFU 001 Rev 1 12 T 6 6 Settings 6 6 1 Brightness amp Contrast Control Tap the setting button The sub menu for Quick Brightness Control is displayed 3 Drag the Control bar icon and set the brightness level Document No HC IFU 001 Rev 1 12 HEALCERION Brightness Contr
46. he measurements Document No HC IFU 001 Rev 1 12 HEALCERION Notes e Ultrasound probes are highly sensitive medical instruments that can easily be damaged by improper handling Use care when handling and protect the equipment from damage when not in use e DO NOT use a damaged or defective probe Failure to follow these precautions can result in serious injury and equipment damage e Transducer damage can result from contact with inappropriate couplings or cleaning agents e Do not soak or saturate the transducer with solutions containing alcohol bleach ammonium chloride compounds hydrogen peroxide or any incompatible solutions e Inspect the probe prior to use for damage or degeneration to the housing strain relief lens or seal A thorough inspection should be conducted during the cleaning process e If a probe has been dropped on the floor or on any other hard surface do not use the probe any more That may increase the risk of electric shock due to damaged electrical insulation Document No HC IFU 001 Rev 1 12 HEALCERION 3 3 Electric Safety The probe is driven by electrical energy that can harm patients and users if live internal parts come in contact with conductive solutions Beet SEO eNO DNs Ween Meee User Manual Rev 2 3 3 1 Immersion Level a 3 4 Electromagnetic Compatibility e he system must retain the essential performance of the ultrasound system in an EMC environment according to IEC 6
47. he mechanical oscillations of a crystal excited by electrical pulses the piezoelectric effect Numerous crystals are assembled to form a transducer A transducer converts one type of energy into another Based on the pulse echo principle occurring with ultrasound piezoelectric crystals ultrasound transducers convert electricity into sound Document No HC IFU 001 Rev 1 12 HEALCERION 2 2 Contraindications The SONON 300C is not intended for e ophthalmic use or any use causing the acoustic beam to pass through the eye e intra operative use e g defined as introducing a probe into a surgical incision or burr hole e endocavity use or e imaging an open wound Document No HC IFU 001 Rev 1 12 HEALCERION Chapter 3 Safety 3 1 Symbols 3 2 General Safety 3 3 Electric Safety 3 3 1 Immersion Level 3 4 Electromagnetic Compatibility 3 5 Coupling Gels 3 6 Bioeffects and Safety of Ultrasound Scans 3 6 1 Prudent Use 3 6 2 Bioeffects 3 7 Environmental Conditions 3 8 Other Recommendations 3 9 Disposal Document No HC IFU 001 Rev 1 12 HEALCERION 3 1 Symbols some symbols used with electrical medical equipment have been accepted as standard by the IEC They serve for marking connections accessories and also as warnings Symbol Description Function Electrical protection Insulated patient application Type BF Warning This symbol indicates a hazard Consult accompanying documents This symbol advises the reader to consult
48. ion O O O O Mm 00 00 00 10M lt back Full Setting Mode Import Setting Mode Select to the files that you want to import Device Setting Do you want toimport data gt gt Device Setting YY MM DD 00 00 10MB z Image Filter Image Filter YY MM DD 00 00 10MB Remaining Line Density Line Density capacity YY MM DD 00 00 10MB Recording File Size Recording File Size YY MM DD 00 00 10MB YY MM DD 00 00 10MB Import Backup Import Backup YY MM DD 00 00 10MB YY MM DD 00 00 10ME Back to Live Screen lt back Full Setting Mode Im j 5 Device Settin Device Setting Do you want to import data 2 YY MM DD 00 00 10MB i Remaining Image Filter Image Filter YY MM DD 00 00 10MB capacity Line Density Line Density YY MM DD 00 00 10MB Recording File Size Recording File Size YY MM DD 00 00 10MB Backup Backup YY MM DD 00 00 10MB YY MM DD 00 00 10M4 Back to Live Screen Back to Live Screen Do you want to cancel importing Document No HC IFU 001 Rev 1 12 HEALCERION 102 lo back Import Setting Mode When there is a file that ha same name with a file already exists Select to the files that you want Device Setting YY MM DD 00 00 10MB 5 E A O Image Filter Remaining Line Density PUMN EN OFON ae capacity oO Recording File Size
49. ions Electromagnetic propagation is affected by absorption and reflection from structures objects and people Document No HC IFU 001 Rev 1 12 HEALCERION a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SONON 300C is used exceeds the applicable RF compliance level above the SONON 300C should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SONON 300C b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the SONON The SONON 300C is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SONON 300C can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SONON 300C as recommended below according to the maximum output power of the communications equipment Rated maximum Se
50. les Kim 10MB Do you want to back up data Image Filter Line Density Recording File Size Import Backup Backup Setting Mode o Device Setting 7 Files selected 70MB Files have been saved at O EEE Noname 10MB Android gt Root SONON 300C iSO gt Document oO line Density acung 10MB Backup Files as a YY MM DD00 00 Recording File Size Benjamin Ryu 10MB x Es Loadin Charles Kim 10MB 8 Import Backup 20 100 u Mathew Yun 10MB Charles Kim 10MB lt back Backup Setting Mode Backup Setting Mode Select to the files that you want to back up Device Setting Image Filter O Line Density O Recording File Size O O O O Mathew Yun 10MB charlesKim 10MB Device Setting Do you want to back up data Image Filter Line Density Recording File Size Import Backup Import Backup Backup Setting Mode Device Setting 4 Files selected 40MB Android gt Root SONON 300C Image Filter iSO gt Document Backup Files i 1 as a YY MM DD00 00 Line Density Files have been saved at O ae une O oO Recording File Size Benjaminryu D oe Loading imap Olsen 20 100 O ane O fres Document No HC IFU 001 Rev 1 12 HEALCERION 98 LL 6 6 2 6 Import Backup Sort by date Select to the files that you want to import K back Full Setti
51. mage Filter Image Filter YY MM DD 00 00 10MB Line Density YY MM DD 00 00 10MB Line Density YY MM DD 00 00 10MB Recording File Size YY MM DD 00 00 10MB Recording File Size YY MM DD 00 00 10MB YY MM DD 00 00 10MB YY MM DD 00 00 10MB Backup Backup es Import Backup YY MM DD 00 00 10MB YY MM DD 00 00 10MB YY MM DD 00 00 10MB OOOO0O0 YY MM DD 00 00 10MB Back to Live Screen Back to Live Screen YY MM DD 00 00 10MB QO Caution Are you sure you want to oO O delete The data can not be recovered after deletion os Data has been deleted Data is bening deleted 100 100 20 100 lt back Import Setting Mode Import Setting Mode Select to the files that you want to import Select to the files that you want to import Device Setting Device Setting YY MM DD 00 00 10MB Image Filter Image Filter Line Density YY MM DD 00 00 10MB line Denaiy ile Si YY MM DD 00 00 10MB aa Ci Recording File Size MM DD Recording File Size Backup YY MM DD 00 00 10MB Back to Live Screen Backup Import Backup YY MM DD 00 00 10MB YY MM DD 00 00 10MB III 50 OOOOC0O NENEN ENE ENE zizi 2 z 2 z z z z 2 z 2 z z s 15 5 5 5 5 S g I amp I IS ISISI S 8 18 118 8 8 8 8 o Je Is s 5 5 Cancel Caution There is not enough space for importing data Please r
52. n that determined by the COMPANY D Violation of any intellectual property rights such as copyrights of the COMPANY or any other third party Document No HC IFU 001 Rev 1 12 HEALCERION E Any behavior that defames the COMPANY or another third party and interferes with business operation F Revealing or posting to the COMPANY any obscene or violent message video audio or any other information that goes against public morals G Utilizing the SERVICE for business purposes without the consent of the COMPANY Any behavior that violates other related laws and ordinances or regulations of the COMPANY Article 12 Copyright Ownership and Usage Limitation 1 All copyrights and intellectual property rights of the contents created by the COMPANY belong to the COMPANY 2 The user may not use information that belongs to the COMPANY due to intellectual property rights for business purposes or provide it to any third party through copying transmitting publishing distributing broadcasting etc without the prior consent of the COMPANY 3 When utilizing any copyright that belongs to the user the COMPANY shall notify the corresponding user according to this agreement Article 13 Arbitration 1 The COMPANY shall establish and manage a department for compensating for loss in order to reflect and apply reasonable opinions or complaints reported by the members and compensate for any loss 2 The COMPANY shall place a priority on
53. nformation A In Relation to the Registration and Management of SONON 300C Application Users Personal information may be collected for the purpose of identifying the SONON 300C application user confirmation of user qualification prevention of illegal usage of service and password retrieval service B In Relation to the Registration and Management of Patient Information Regarding Ultrasonic Image Information Obtained by the SONON 300C Personal Information may be collected for the purpose of discerning the target patient or diagnosed person of the corresponding ultrasonic image information and establishing reference data for future treatment C The entered information shall not be collected and utilized for any other purpose such as marketing and provision of product information etc The company however may contact users with service related notifications for troubleshooting etc 3 Duration of Retention and Utilization of Collected Personal Information The duration of retention and utilization of personal information is until the point of removal of the SONON 300C application The collected personal information is saved on the mobile device through the SONON 300C application and deleted simultaneously with the removal of the SONON 300C application Article 1 Purpose This Agreement is intended to regulate matters related to the usage of the service of the SONON 300C application hereinafter SERVICE provided by HEALCERIO
54. ng Mode Device Setting Image Filter Do you Ha to import data O Line Density Recording File Size Backup O CO E O Sort by date C back Full Setting Mode to import adi a Remaini YY MM DD 00 00 10MB YY MM DD 00 00 10MB O YY MM DD 00 00 10MB YY MM DD 00 00 10MB O YY MM DD 00 00 10MB O YY MM DD 00 00 10MB O YY MM DD 00 00 10M8 O Device Setting Image Filter Line Density Recording File Size Backup Back to Live Screen OOOOOOO 0 o D Caution There is not enough space for importing data Please re try after securing enough space lt back Full Setting Mode Device Setting Image Filter Recording File Size Sort by Date Select to the files that you want toimport _ Remaining Loading 20 100 rm700 0020 zoma O Frmmwoopoom sone O Error som O rm7oo7e6 0 some O Error zoma O rmmroo7e6a0 son O w mm p0 00 00_10mq YY MM DD 00 00 10MB When there isn t any file that has same name with a file already exists Do you want to import Cs 7 No Document No HC IFU 001 Rev 1 12 completed You can check the data in Patient info mode HEALCERION 0 BEREEEE User Manual Rev When there is a file that ha same name with a file already exists Caution A file named Charles already exists Do you want
55. o HC IFU 001 Rev 1 12 HEALCERION Track3 For FDA 0 02766 W cm 0 2535 0 7861 10 0285 W cm 9 3 Acoustic output 9 3 1 Definition of the acoustic output parameters 9 3 1 1 Thermal Index Tl is an estimate of the temperature increase of soft tissue or bone There are three thermal index categories e TIS Soft tissue thermal index the main TI category Used for applications that do not image bone e TIB Bone thermal index for bone located in a focal region Used for fetal applications e TIC Cranial bone thermal index for bone located close to the surface Used for transcranial application References to the calculation of Tl can be found in e NEMA Standards Publication UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2 e IEC 60601 2 37 Medical Electrical Equipment Part 2 37 Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment 9 3 1 2 Mechanical Index MI is the estimated likelihood of tissue damage due to cavitation The absolute maximum limit of the MI is 1 9 as set by the U S Food and Drug Administration FDA 510 k guidance on ultrasound systems issued September 9 2008 Guidance for Industry and FDA Staff Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document No HC IFU 001 Rev 1 12 HEALCERION 9 3 1 3 Ispta
56. ol T j F Ber Ae ai ti r 7 Te a i ae er rn afl ur Contrast Control 6 6 2 Full Setting Mode Brightness Control _o Contrast Control Full Setting Mode Device Setting Image Filter Recording File Size Backup Device Setting Import Backup Tap the setting button Tap the Full Setting Mode Button 3 The screen is changed to Full Setting Mode Document No HC IFU 001 Rev 1 12 HEALCERION 87 6 6 2 1 Device Setting K back Full Setting Mode rs ee en Device Setting C Image Filter Er f a X Device Setting Image Filter Se Line Density Recording File Size Backup Backup Import Backup Import Backup Device name mSONO_0001 1 Firmware version 1 0 0 Update Battery 15 Device Temperature NORMAL OVER WIFI Setup SSID mSONO KEY eK kK ek ok Change Current Application General Device Name Change Button Firmware update button 3 Wi Fi Setting Button Document No HC IFU 001 Rev 1 12 HEALCERION Full Setting Mode Device name Firmware version Battery Device Temperature WIFI Setup Current Application Change Update j Change 6 6 2 1 1 Device Name Change Device name mSONO_ 0001 I Full Setting Mode Firmware version 1 0 0 Device Setting Device name 1 Update Firmwa
57. overed with synthetic materials IEC 61000 4 2 7 the relative humidity should be at least 30 Document No HC IFU 001 Rev 1 12 HEALCERION Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage short interruptions and voltage variations on power supply input lines IEC 61000 4 11 dips Power frequency 50 60 Hz magnetic field IEC 61000 4 8 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for5s Compliance for all test levels Controlled shutdown return to disturbance condition operator s intervention Power on switch with pre after 3A m 50 and 60Hz The main power quality should be that of a typical commercial or hospital environment The main power quality should be that of a typical commercial or hospital environment The main power quality should be that of a typical commercial or hospital environment If the user of the ME SYSTEM requires continuous operation and in which the main power is interrupted it is recommended that the SYSTEM be powered by an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical commercial or hospital environment N
58. paration distance according to frequency of transmitter output power of M transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 23 0 73 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Document No HC IFU 001 Rev 1 12 HEALCERION 9 2 Acoustic Output Reporting Tables Scan Aaprt lt 1 Aaprt gt 1 Non scan cm cm Maximum index value 0 786121118 0 253 0 640323 gt 0 357174 Associated Pr az 1 4172 acoustic 6 3cm Mpa parameters 33 1 714 Min of Pa zs Ita a zs N A Z bp 1 7144 3 zat max lpi a m 0 0375 deq zb 1 143 Fawf MHz 3 25 Dim of X 1 14 Aaprt T Other information td 1 46 Prr PRF 0 472ms pr at max Ipi Pa 1 417 Peak rarefactional deq at max Ipi lpi at max MI 0 16990 Focal FLx 0 08 Length PAINE ery 1 04 Control 1 Operating control conditions Control 2 Control 3 Document N
59. re version 2 Update Device name Battery Batte 15 Firmware version Device Temperature Device Temperature NORMAL OVER maaha gt WIFI Setup SSID mSONO Wifi setup En KEY current Application 3 Change Current Application General Firmware Update Device Setting Device name Firmware version Wifi setup Document No HC IFU 001 Rev 1 12 HEALCERION 6 6 2 1 2 Firmware Upgrade mSOND_0001 Device name Change Firmware version 1 00 1 Update Battery 15 Device Temperature NORMAL OVER Device Setting Device name Firmware version SSID mSONO Wifi setup KE cc a WIFI Setup Change Current Application General rent Version 1 0 0 New Version 1 0 1 New Version Do you want to device update Full Setting Mode 1 Update Device name Firmware version Battery Device Temperature WIFI Setup Current Application Firmware Update Current Version 1 0 0 1 0 1 Do you want to device update Cancel When Device Update is impossible the message below is displayed Firmware Update Current Version 1 0 0 New Version 1 0 0 There is no available update version HEALCERION Document No HC IFU 001 Rev 1 12 90 6 6 2 1 3 Wi Fi Setup Device name mS50N0_0001 Change z B Full Setting Mode Firmware version 10 0 Device Setting Device name Update z Firmware version Update Device name Battery Firmware version Dewlce Temperature
60. rea Document No HC IFU 001 Rev 1 12 HEALCERION 115 9 1 4 Guidance and Manufacturer s Declaration Warning e SONON 300C requires special precautions regarding EMC e SONON 300C should not be used adjacent to or stacked with other equipment Electromagnetic emissions The SONON 300C is intended for use in electromagnetic environments as specified below The customer or the user of the SONON 300C should ensure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR11 Group 1 The SONON 300C uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment RF emissions CISPR11 The SONON 300C is suitable for use in all medical establishments i e hospitals clinics Harmonic emissions IEC Class A etc The SONON 300C is intended for 61000 3 2 professional use only Voltage fluctuations flicker Complies emissions IEC6100 3 3 Electromagnetic immunity The SONON 300C is intended for use in electromagnetic environments as specified below The customer or the user of the SONON 300C should ensure that it is used in such an environment IEC 60601 Electromagnetic environment IMMUNITY test Compliance level 9 test level Guidance Floors should be wood concrete Electrostatic or ceramic tile If floors are 6 kV contact discharge ESD re c
61. s will be displayed then draw a dotted line between the icons The length between the icons shown in real time corresponds to the user s moving action A and B and the length of the Ellipse is displayed 6 4 5 5 Annotation Measurement Measurement Device Virtual Keyboard Measurement e Device Virtual Keyboard AAA input Measurement e Sg j in Single tap the Measurement Button then tap the sub menu Annotation Button The virtual keyboard will be displayed Text input box Input user s note 8 9 Note text User can drag note text 6 4 5 6 Clear ge O 5 j um Single tap the Clear icon button All measurement objects are deleted Hm 6 4 5 7 Still Shot Saving Measurement Single tap the still shot Save Button Atext that says The still shot is saved will be displayed for 2 seconds X The still shot image will have all diagnosis information about the operator s action like a screen capture X If the patient info is not saved Pop up 7 will be displayed There is no Patient Info This Patient name will be saved as Noname Document No HC IFU 001 Rev 1 12 HEALCERION 71 6 5 Patient Information 6 5 1 Patient List Patient List Noname Jack Jung Mathew Yun 4 Add New Patient Tap the patient info icon Same as the Freeze Mode Patient Info Button Patient
62. should come in contact with an eye immediately wash the eye with plenty of water and seek medical assistance as soon as possible e Do not immerse or expose the battery to water e The AC adapter must be kept outside the patient environment refer to IEC 60601 1 LLLLLLLLLLLLLLLLLLLLLLL ae k Z ae x x Patient environment The SONON 300C is powered by a lithium ion battery The battery is not fully charged prior to shipment To maximize battery life it is recommended that the battery be fully charged before initial use Use only the AC adapter provided with the SONON 300C Document No HC IFU 001 Rev 1 12 HEALCERION 4 3 1 Battery Level Indicator The battery level indicator is displayed by color and flash rate The following icons are displayed Battery Level Description Not charging Power LED is off not flashing Charging Power LED is flashing Green Fully Charged Power LED is Green not flashing X The battery should not be charged in the Power On state To charge the battery power should be turned off Condition Operation 10 minutes Time to Fully Charge 3 Hours Document No HC IFU 001 Rev 1 12 HEALCERION User Manual Rev 2 4 3 2 Removing and Inserting the Battery 1 Slide the lock button down 2 Slide the battery cover toward the lock button i User Manual Rev 2 3 Remove the battery cover 4 Remove the battery Bese REO SEEN ODDEN Make eee User Manual R
63. t use it is MANDATORY to clean and disinfect probes to avoid infections or disease transmission e Probes must be cleaned and disinfected before they are replaced or disposed of e Do not modify this device without the authorization of HEALCERION e Do not use the probe with high frequency surgical equipment Doing so may damage the equipment e If you lose your tablet PC or smart phone the stored data cannot be recovered Please take care not to lose these items e Must comply with Operation conditions Max 10 min with 10 min resting time Cautions e Do not touch the patient and the charging connectors simultaneously e This equipment should be used in compliance with applicable laws Some jurisdictions restrict certain uses such as gender determination e Changing the display settings can affect image quality and compromise diagnostic quality The user is responsible for using appropriate display settings to achieve appropriate image quality e Ultrasound procedures should be performed prudently using the principle of ALARA As Low As Reasonably Achievable It is strongly recommended to consider ALARA when conducting ultrasound scans See Section 3 6 for additional information Features that facilitate measurements must be used with extreme care Such measurements are suggestions of the system If in doubt verify the measurement results with manual measurement methods The user is responsible for the diagnostic interpretations of t
64. the complaints and opinions of the members over other matters When an immediate resolution is not likely however the COMPANY shall immediately notify the members of the reason for such delay and the future settlement schedule Article 14 Jurisdiction and Governing Law 1 The Law of the Republic of Korea shall be the governing law over the interpretation of this agreement and disputes between the COMPANY and its members 2 In the case of any lawsuit arising from disputes between the COMPANY and its members regarding this agreement and the SERVICE the court of jurisdiction shall be determined according to the Civil Procedure Code CPC Document No HC IFU 001 Rev 1 12 HEALCERION Appendix B Medical Ultrasound Safety This document is only available in English To contact the AIUM concerning their publications American Institute of Ultrasound in Medicine 14750 Sweitzer Lane Suite 100 Laurel Maryland 20707 5906 http www aium org Document No HC IFU 001 Rev 1 12 HEALCERION
65. tion and possible collapse of microbubbles within the tissue This behavior is referred to as cavitation Medical Ultrasound Safety 2nd Edition AIUM 2009 American Institute of Ultrasound in Medicine Consensus Report on Potential Bioeffects of Diagnostic Ultrasound AIUM 2008 Guidelines for the safe Document No HC IFU 001 Rev 1 12 HEALCERION use of diagnostic ultrasound equipment Safety Group of the British Medical Ultrasound Society 2010 The potential of cavitation increases with the rarefactional peak pressure but decreases with the pulse frequency Therefore the Mechanical Index MI was introduced to take account of both pressure and frequency The higher the MI the greater the risk of non thermal bioeffects 3 7 Environmental Conditions Probes must be operated stored and transported within the parameters outlined below Item Operational Storage amp Transport Temperature 18 C to 35 C 10 C to 50 C 64 4 F to 86 F 14 F to 122 F Humidity 30 to 75 noncondensing 10 to 85 noncondensing Pressure 700hPa 3000m to 700hPa 3000m to 1060hPa 1060hPa Document No HC IFU 001 Rev 1 12 HEALCERION 3 8 Other Recommendations Like most high frequency computing devices the electronic components of the SONON 300C will generate some heat while operating normally and as intended The SONON 300C is equipped with safety mechanisms which will automatically reduce computing speed frame rate and ultimately shut do
66. tructions or your local authorities Chapter 4 Device Description 4 1 Product Description 4 1 1 Package Contents 4 1 2 Device Overview 4 2 Screen Layout 4 2 1 Basic Layout 4 2 2 Live Mode Screen Layout 4 2 3 Freeze Mode Screen Layout 4 3 Battery 4 3 1 Battery Level Indicator 4 3 2 Removing and Inserting the Battery 4 3 3 Battery Specifications Document No HC IFU 001 Rev 1 12 HEALCERION 4 1 Product Description 4 1 1 Package Contents e SONON 300C e Battery Pack 2EA Adapter for SONON 300C e Battery Charger Adapter for Battery Charger e Power cord 2EA P e e User Manual Book Quick Start Manual Guidel Document No HC IFU 001 Rev 1 12 HEALCERION 28 4 2 Screen Layout 4 2 1 Device Overview No Name Function 1 Probe head To be applied to the patient 2 Power Button Power On Off Battery Charging Indicator Green 3 Wi Fi Button Wi Fi Reset Wi Fi Indicator Blue Green 4 Function Button Freeze Screen Live Screen Toggle Blue Document No HC IFU 001 Rev 1 12 HEALCERION 4 2 2 Basic Layout Title Bar Vertical Grid Phone No Name Title Bar View Screen Area Action Bar Go N Title Bar Horizontal Grid only Tablet Description Mode and Major Function Indicator Displays Diagnostic Image and Information Function Menu Button Document No HC IFU 001 Rev 1 12 HEALCERION 30 4 2 3 Live Mode Screen Layout ay in 1 a
67. uding the developing fetus Guidelines for the Safe Use of Diagnostic Ultrasound Equipment Safety Group of the British Medical Ultrasound Society 2010 Physiological effects due to ultrasound are generally assumed to be deterministic and only occur above a certain threshold in contrast to ionizing radiation which causes effects accidentally Thus ultrasound examinations can be conducted very safely if certain procedures are followed Therefore it is recommended to read the following sections and study the cited literature 3 6 1 Prudent Use Despite the relatively low risks of ultrasound scans as compared to other imaging techniques the operator must choose exposure levels with caution to minimize the risks of bioeffects A fundamental approach to the safe use of diagnostic ultrasound is to use the lowest output power and the shortest scan time consistent with acquiring the required diagnostic information This is the ALARA principle i e As Low As Reasonably Achievable It is acknowledged that in some situations it is reasonable to use higher output or longer examination times than in others for example the risks of missing a fetal anomaly must be weighed against the risks of harm from potential bioeffects Document No HC IFU 001 Rev 1 12 HEALCERION Consequently it is essential for operators of ultrasound scanners to be properly trained and fully informed when making decisions of this nature Guidelines for the S
68. wn the device before any risk of overheating occurs The SONON 300C is verified to comply with harmonized safety standards under any operating condition described in this user manual See Section 3 7 Environmental Conditions To help keep the SONON 300C operating temperature at the optimal level and to ensure longer scanning times with the maximum frame rate it is recommended to hold the SONON 300C so that there is good contact between the device and the hand The image display of the mobile device is dependent on ambient light avoid direct sunlight on the display when scanning and reviewing images Document No HC IFU 001 Rev 1 12 HEALCERION User Manual Rev 2 3 9 Disposal This symbol indicates that electrical and electronic equipment waste must not be disposed as unsorted municipal waste and must be collected separately Please contact the manufacturer or an authorized disposal company to decommission your equipment according to local regulations Battery disposal A separate collection symbol is affixed to batteries or its packaging to advise you that it must be recycled or disposed of in accordance with local and national laws To minimize potential impacts to the environment and human health it is important that all marked batteries that you remove from the product are properly recycled or disposed of For information on how batteries may be safely removed from the device please consult the equipment ins

SONON 300C Portable Ultrasound Device User Manual Rev. 2

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