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- Page 1 Digital Color Doppler Palm Ultrasound System Digital Color Doppler Palm Ultrasound System Model SonoEye P2 USER MANUAL Direction: CHUM SonoEye-P2-001a June.5 ,2020 Rev. 1.01 CHISON Medical Technologies Co., Ltd. We reserve the right to make changes to this manual without prior notice.
- Page 2 Essential Requirements of the Medical Device Directive. This manual is a reference for the SonoEye P2. Please verify that you are using the latest revision of this document. If you need to know the latest revision, contact your distributor.
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Page 3: Table Of Contents
Digital Color Doppler Palm Ultrasound System TABLE OF CONTENTS TABLE OF CONTENTS ..............................1 Chapter 1 Introduction ..............................1 System Overview ............................... 1 Contact Information ............................1 Chapter 2 System Safety .............................. 2 Safety Overview ..............................2 Electrical Safety ..............................3 Labels .................................. - Page 4 Digital Color Doppler Palm Ultrasound System 5.1.4 FHI ................................30 5.1.5 B/M Mode ..............................30 5.1.6 CFM Mode .............................. 30 5.1.7 PW mode ..............................31 5.1.8 B-Lines ..............................32 5.1.9 Biopsy Guide ............................32 5.1.10 SonoNeedle ............................32 5.1.11 SuperNeedle ............................33 5.1.12 SonoRemote ............................
- Page 5 Digital Color Doppler Palm Ultrasound System Service Responsibility ............................. 50 Chapter 10 System ..............................52 10.1 General Description............................52 10.2 Care and Maintenance ............................ 52 10.2.1 Inspecting Systems ..........................52 10.2.2 Cleaning and Disinfecting ........................53 10.3 System Operation Instructions ........................58 10.4 Service Responsibility .............................
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Page 6: Table Of Contents
1.1 System Overview Indications for Use SonoEye P2 Digital Color Doppler Palm Ultrasound System is intended for diagnostic ultrasound imaging in B (2D), B/M, CFM, Combined (B+CFM), Pulsed Wave and Fusion Harmonic Imaging modes. It is indicated for Pediatrics, Small Organ, Musculoskeletal, Peripheral Vessel, Carotid, Nerve, Lung. -
Page 7: Chapter 2 System Safety
Digital Color Doppler Palm Ultrasound System Chapter 2 System Safety 2.1 Safety Overview This section discusses measures to ensure the safety of both the operator and patient. To ensure the safety of both operator and patient, please read the relevant details in this chapter carefully before operating this system. -
Page 8: Electrical Safety
Digital Color Doppler Palm Ultrasound System Do not unplug system when the system is in active operation. Always go to EXAM screen when you need to remove the system. To prevent from arm or neck injury, the operator should not stay at the same position for too long during patient scanning without taking break. - Page 9 Locate the equipment as far away as possible from other electronic equipment. Be sure to use only the cables provided by or designated by CHISON. Connect these cables following the installation procedures (e.g. wire power cables separately from signal cables).
- Page 10 Digital Color Doppler Palm Ultrasound System WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of this medical system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Page 11: Labels
Digital Color Doppler Palm Ultrasound System 2.3 Labels Fig. 2-1: SonoEye P2 Label 2.3.1 Warning Symbols Icon Meaning Refer to instruction manual/booklet. Caution, consult accompanying documents. This symbol advises the reader to consult the accompanying documents for important safety related information such as warnings and pre-cautions that cannot be presented on the device itself. -
Page 12: Other Device Labels
Sensitive part in system has been labeled with anti-static label, please pay attention on electrostatic protection. ESD CAUTION Sensitive part in system has been labeled with anti-static label, please pay attention on electrostatic protection. CAUTION: DO NOT connect any device without approval by CHISON within the PATIENT ENVIRONMENT. - Page 13 DO NOT use unapproved devices. If devices are connected without the approval of CHISON, the warranty will be INVALID. The system can’t be used with HF surgical equipment, otherwise the burns to patient may occur. Any device connected to this system must conform to one or more of the requirements listed below: ...
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Page 14: Biological Safety
Digital Color Doppler Palm Ultrasound System this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 2.5 Biological Safety This product, as with all diagnostic ultrasound equipment, should be used only for valid reasons and should be used both for the shortest period of time and at the lowest power settings necessary (ALARA - As Low As Reasonably Achievable) to produce diagnostically acceptable images. -
Page 15: Scanning Patients And Education
Digital Color Doppler Palm Ultrasound System likelihood of cavitation and the related adverse effects. MI recognizes the importance of non-thermal processes, cavitation in particular, and the Index is an attempt to indicate the probability that they might occur within the tissue. 2.6 Scanning Patients and Education The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe use of this ultrasound system. -
Page 16: Understanding The Mi/Ti Display
Digital Color Doppler Palm Ultrasound System Take particular care to reduce output and minimize exposure time of an embryo or fetus when the temperature of the mother is already elevated. Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when exposing: an embryo less than eight weeks after gestation;... - Page 17 Digital Color Doppler Palm Ultrasound System maximum de-rated Ispta must be ≤ 720 mW/cm and either the global maximum MI must be ≤ 1.9 or the global maximum de-rated Ispta must be ≤ 190 W/cm . An exception is for ophthalmic use, in which case the TI = max (TIS_as) is not to exceed 1.0;...
- Page 18 Digital Color Doppler Palm Ultrasound System 0.8710 0.6607 0.5012 0.3548 0.8128 0.5370 0.3548 0.2113 0.7586 0.4365 0.2512 0.1259 0.7080 0.3548 0.1778 0.0750 0.6607 0.2884 0.1259 0.0447 0.6166 0.2344 0.0891 0.0266 0.5754 0.1903 0.0631 0.0158 I’=I*RF Where I’ is the intensity in soft tissue, I is the time-averaged intensity measured in water. Tissue Model: Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode.
- Page 19 Digital Color Doppler Palm Ultrasound System tissue, which contais the bubble or air pocket (for instance, the lung, intestine, or scan with gas contrast agents). The threshold under optimum conditions of pulsed ultrasound is predicted by the ration of the peak pressure to the square root of the frequency.
- Page 20 Digital Color Doppler Palm Ultrasound System HINTS: Raise the Acoustic Output only after attempting image optimization with controls that have no effect on Acoustic Output, such as Gain and STC. WARNING: Be sure to have read and understood control explanations for each mode used before attempting to adjust the Acoustic Output control or any control that can effect Acoustic Output.
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Page 21: Chapter 3 Preparing The System For Use
3.2 Downloading and Installing the App Downloading the App Use a computer to obtain the.apk installation package from Chison and move it to a mobile device. Installing the App Select the file which ended by .apk to install APP. - Page 22 Allow. If you touch Deny, you cannot use App until you give access to shared device storage in the Android App Permissions settings. Updating the App Use a computer to obtain the.apk update package from Chison and move it to the mobile device. Select the update package to install APP. Turning the System On and Off 1.
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Page 23: System Specifications
Digital Color Doppler Palm Ultrasound System 3.3 System Specifications 3.3.1 Console Overview SonoEye P2 system: Fig. 3-1: Console Overview Fig. 3-2: Firmware Front View From left to right: Freeze Button，P，- & + (They can be set as None, Freeze/Unfreeze, Gain+, Gain-, Depth+, Depth- and Save Image) 3.3.2 Physical Specifications... -
Page 24: Type
Digital Color Doppler Palm Ultrasound System B/M mode Color Flow Map mode Pulsed Wave Doppler mode 3.3.4 Type SonoEye P2 4.5MHz-10.0MHz/7MHz-12.0MHz Linear Array 3.3.5 System Configuration Function SonoEye P2 √ B mode B/M mode Option PW mode... -
Page 25: System Positioning & Transporting
Digital Color Doppler Palm Ultrasound System General report Option Vessel report Option Small Organ report Option Lung report Option √ English Interface Multi-language Interface Option Auto vascular tracking Option √ Instant AIO Biopsy Guide Option √ Save Cine √ Save Image Cine Loop Option Annotation... -
Page 26: Powering The System
Abnormal system is not allowed to connect to the system; otherwise there is possibility of electricity shock. Connect the connector from the SonoEye P2 system to displayer. Caution ... - Page 27 Digital Color Doppler Palm Ultrasound System the system. If system is not correctly or completely connected with displayer, this may cause mis-operation, e.g. the system cannot be recognized, mis-recognized, or the system may drop off from the main unit and be damaged.
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Page 28: Chapter 4 Control Panel
Digital Color Doppler Palm Ultrasound System Chapter 4 Control Panel 4.1 Overview of Display Area Fig 4.1a Display Interface 1. Side Menu 2. Application 3. Parameters control Center Line Full Screen B/M mode PW mode CFM mode Freeze Logo 10. Patient information 11. -
Page 29: Start A New Exam
Digital Color Doppler Palm Ultrasound System 4.2 Start a New Exam Press to end the current exam, and start a new patient. To add patient information: 1. On the imaging display, touch the ID number. 2. On the patient Info display, type the patient information. 3. - Page 30 Digital Color Doppler Palm Ultrasound System...
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Page 31: Probe
Digital Color Doppler Palm Ultrasound System 4.3 Probe Press to display current probe preset. Choose the desired preset to start an exam. -
Page 32: Switching Function
Digital Color Doppler Palm Ultrasound System 4.4 Switching Function Slide the top left along the buttons to show Freq. 4.5 Switching Mode Available imaging modes are B, CFM, PW, B/M Mode. 4.6 Function Key Introduction Button Name Function Freeze Touch this icon to freeze the current image Preset Press this button to select preset. - Page 33 Digital Color Doppler Palm Ultrasound System Cine save Press this key to save cine B Mode Press this key to enter B mode. B/M Mode Press this key to enter B/M mode. CFM Mode Press C to enter CFM Mode. PW Mode Press PW to enter PW Mode.
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Page 34: Image Parameter Area
Digital Color Doppler Palm Ultrasound System Arrow Press this button to add arrow in current exam interface. BodyMark Press this button to add body mark in current exam interface. Clear Press this button to clear all the content that user have added in current exam interface. -
Page 35: Chapter 5 Imaging
5.1.1 System Identify The App will identify the system automatically while system is connected. Caution When inserting the system, please make sure the surface which has CHISON logo is always upside. 5.1.2 Select Application Click icon, the examination interface will pop-up, according to the type of probe to select corresponding application. -
Page 36: Pw Mode
Digital Color Doppler Palm Ultrasound System screen only displays color mode operation interface. Fig. 5-1 CFM Mode 5.1.7 PW mode Intended Use: Doppler is intended to provide measurement data concerning the velocity of moving tissues and fluids. PW Doppler lets you examine blood flow data selectively from a small region called the Sample Volume. The X axis represents time while the Y axis represents velocity in either a forward or reverse direction. -
Page 37: B-Lines
Digital Color Doppler Palm Ultrasound System Press the corresponding button to transfer the exam mode between real time B-mode with Doppler mode (with audio). Sample along the whole length of the vessel. Ensure that the system is parallel to flow. Listen, then look, when positioning the sample volume cursor. -
Page 38: Superneedle
Digital Color Doppler Palm Ultrasound System 5.1.11 SuperNeedle SuperNeedle is to balance the B mode image. Select SuperNeedle, the user can optimize image by adjusting angles. 5.1.12 SonoRemote SonoRemote enables remote real-time ultrasound diagnosis. Install SonoRemote on PC and open it, check the network connection. The SonoRemote will register an ID automatically when you first log in to it. -
Page 39: Parameter Adjustment In Pw Mode
Digital Color Doppler Palm Ultrasound System 6. Sample Gate In the real-time state of CFM mode, press the blood flow sampling gate and move it to adjust the position. In the real-time state of CFM mode, press and hold the lower left corner of the blood flow sampling gate. After the adjustment mark appears, slide left and right to adjust the horizontal size of the blood flow sampling gate, and slide up and down to adjust the vertical size of the blood flow sampling gate. -
Page 40: Adding Bodymark
Digital Color Doppler Palm Ultrasound System 4. To edit existed comment, press and hold it, the soft icon board appears, the user can re-input comment. 5.4.2 Adding BodyMark Operation: 1. Freeze image and slide the menu list to select 2. The secondary menu appears, press . -
Page 41: Chapter 6 Measurement And Calculation
Digital Color Doppler Palm Ultrasound System Chapter 6 Measurement and Calculation 6.1 Measurement Methods: The system contains Distance, Ellipse. 1. Distance Measurement steps: Click the『Distance』icon under the measurement menu to enter into measurement. Click the B image area; it will display a segment with two “+” icon. One of the “+” is active, you can move it by dragging your finger to fit the one point of the line. -
Page 42: Small Organ Measurement In B Mode
Digital Color Doppler Palm Ultrasound System appears in image area. Use a finger to slide on the top right or left corner to adjust location, press image area to finish measurement. The measurement results display on result area. Meas. item name mark unit Meas. -
Page 43: Pw Mode Measurement
Digital Color Doppler Palm Ultrasound System 6.4 PW Mode Measurement 1. Velocity Press Freeze after finish the scan, select the velocity in menu, the blue “+” displayed on the screen, move it to desired position to start measurement. The result will display on image area and result area. Repeat the above steps to start new measurement. -
Page 44: Chapter 7 Cine-Memory
Digital Color Doppler Palm Ultrasound System Chapter 7 Cine-Memory This chapter introduces the theory of saving images in Cine-Memory and the operation of image playback in Cine-Memory. 7.1 Image Storage Images in B-mode can be stored in Cine-Memory at the unit of frame in time sequence. If the storage is full of images, when storing a latest new frame image, the first saved frame image will be removed out of Cine- Memory. -
Page 45: Chapter 8 Side Menu
Digital Color Doppler Palm Ultrasound System Chapter 8 Side Menu The setting function is used to set the system’s startup operating environment, state and configuration parameters of each exam mode. The settings are stored in system's memory and are not lost when the power is turned off. - Page 46 Digital Color Doppler Palm Ultrasound System Press on the top right corner of the screen, user can manage archive according to ID, MRN and Name. Select archive: Press archive and hold it, the current archive is selected. : Select all archives. : Press it to delete selected archive.
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Page 47: Easyview
Digital Color Doppler Palm Ultrasound System 8.2 EasyView Press EasyView to check the patient information, saved images and cines. Press on the top right corner of the displayer, the user can set the image preview mode. Press an image and hold it to select the current image, the frame of image will turn to blue. -
Page 48: Report
Digital Color Doppler Palm Ultrasound System : Press this button to send selected image to external media device. : Press this button to select all images. : Press this button to delete current image. 8.3 Report Select the report from side menu, press “<” on the top left corner to return to the exam interference. Press on the top right corner to select the report type, the General, Vessel, Small Organ and Lung can be selected. -
Page 49: General
Digital Color Doppler Palm Ultrasound System 8.4.1 General Set STC display and ID display on system. 8.4.2 Language Press language to select the needed language. The system supports English, Chinese and Deutsch. -
Page 50: Button Configuration
Digital Color Doppler Palm Ultrasound System 8.4.3 Button Configuration Select the button configuration to set the key function. Button Function “+” “-” None/Freeze, Unfreeze/Gain+/ Gain-/Depth+/Depth-/Save Image “P” 8.4.4 Administrator Click the Administrator to manage accounts. 8.4.5 Firmware Update Select firmware update to upgrade system software version. -
Page 51: Function Management
Digital Color Doppler Palm Ultrasound System 8.4.6 Function Management Select function management to manage system functions. Tutorials The first time you enter the app, it displays tutorials to familiarize you with the features of the system. You can view the Tutorials at any time. Press and select tutorials to enter it, there is a short video to help you learn the system. -
Page 52: About
Digital Color Doppler Palm Ultrasound System Exit Demo: press anywhere on screen, then press “<” on the top left corner to exit demo. About Press About to check the current software version. -
Page 53: Chapter 9 System Maintenance
Digital Color Doppler Palm Ultrasound System Chapter 9 System Maintenance 9.1 Cleaning Caution Before cleaning any part of the system, please make sure that the system is turned off and the power cord is disconnected from the power supply socket. Otherwise there will be danger of electricity shock. Cleaning method: Please use a piece of soft and dry cloth to clean the system. -
Page 54: Safety Check
Digital Color Doppler Palm Ultrasound System ℃ Please don’t use or preserve the system where it is over 50 Please carefully check the system surface before using. If there is any abnormal phenomenon (eg. there’s a leakage on the system surface), please stop using the system immediately and contact our authorized agent in your country as soon as possible. -
Page 55: Service Responsibility
If users install, use and maintain the system fully according to CHISON’s installation manual, operation manual and service manual, then SonoEye P2 main unit has a life time of 5 years, The warranty of the system after ex-work is as the time in the warranty card. - Page 56 NOT suggested to continue using the system and transducers even the system and transducers seem work properly. But if user still wants to continue using the system and transducers, user should first contact CHISON service center at CHISON headquarter to arrange the necessary safety check and calibration by CHISON’s authorized service engineer.
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Page 57: Chapter 10 System
Digital Color Doppler Palm Ultrasound System Chapter 10 System 10.1 General Description Transducer Scanhead (Lens) Fig.6-1: Linear Probe Overview The system provide high spatial and contrast ultrasound imaging of frequencies from 4.5MHz to 10.0MHz. These systems operate by pulsing sound waves into the body and listening to the returning echoes to produce high-resolution brightness mode, and a real time display. -
Page 58: Cleaning And Disinfecting
Digital Color Doppler Palm Ultrasound System WARNING The systems are designed to be used only with this ultrasound system. Use of these systems on any other device or a non-qualified device may cause electrical shock or damage on the system/transducer. 10.2.2 Cleaning and Disinfecting This section provides information and instructions for properly cleaning and disinfecting the system. - Page 59 You need to perform a more thorough inspection, including the cable, strain relief, and connector, each time you clean the system. Electrical leakage checks should be performed on a routine basis by CHISON Service or qualified hospital personnel. Mechanical hazard: A defective system or excess force can cause patient injury or system damage: ...
- Page 60 Digital Color Doppler Palm Ultrasound System System handling and infection control: This information is intended to increase user awareness of the risks of disease transmission associated with using this equipment and provide guidance in making decisions directly affecting the safety of the patient as well as the equipment user.
- Page 61 Digital Color Doppler Palm Ultrasound System To avoid electrical shock, always turn off the system and disconnect the system before cleaning the system. CAUTION Take extra care when handling the lens face of the system. The lens face is especially sensitive and can easily be damaged by rough handling.
- Page 62 Digital Color Doppler Palm Ultrasound System to the cable. Transducer damage can result from contact with inappropriate coupling or cleaning agents: • Do not soak or saturate transducers with solutions containing alcohol, bleach, ammonium chloride compounds or hydrogen peroxide. •...
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Page 63: System Operation Instructions
Digital Color Doppler Palm Ultrasound System Returning/Shipping Systems and Repair Parts Transportation dept. and our policy require that equipment returned for service MUST be clean and free of blood and other infectious substances. When you return a system for service, you need to clean and disinfect the system prior to packing and shipping the equipment. - Page 64 Digital Color Doppler Palm Ultrasound System AIUM, September1988 8) Geneva Report on Safety and Standardization in Medical Ultrasound, WFUMB, May 1990 Medical Ultrasound Safety, AIUM, 1994 9) Medical Electrical Equipment standard IEC 60601-1, IEC60601-1-2, IEC 60601-2-37 10) Diagnostic Ultrasound Physics and Equipment, edit by P. R. Hoskins, in 2003...
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Page 65: Appendix A: The Information Of Ec Representative
Digital Color Doppler Palm Ultrasound System Appendix A: THE INFORMATION OF EC REPRESENTATIVE Shanghai International Holding Corp. GmbH (Europe) Add: Eiffestrasse 80, 20537 Hamburg, Germany Tel: +49-40-2513175 Fax:+49-40-255726 Dimdi No.:DE/0000040627 E-mail: shholding@hotmail.com... -
Page 66: Appendix B: Acoustic Output Report Table
Digital Color Doppler Palm Ultrasound System Appendix B: ACOUSTIC OUTPUT REPORT TABLE Transducer Model: SonoEye P2 Operation Mode: B Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.88 0.24 0.24 0.24 Index component Value 0.24 0.24 0.24 0.24... - Page 67 Digital Color Doppler Palm Ultrasound System Transducer Model: SonoEye P2 Operation Mode: B+M Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.02 0.22 0.32 0.28 Index component Value 0.18 0.22 0.18 0.32 r.α (MPa) 2.25 (mW) 6.85 6.85...
- Page 68 Digital Color Doppler Palm Ultrasound System Transducer Model: SonoEye P2 Operation Mode: B+CFM Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.92 0.38 0.38 0.62 Index component Value 0.38 0.38 0.38 0.38 r.α (MPa) 2.14 (mW) 10.74 10.74...
- Page 69 Digital Color Doppler Palm Ultrasound System Transducer Model: SonoEye P2 Operation Mode: PW Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.34 0.15 0.54 0.30 Index component Value 0.15 0.10 0.15 0.54 r.α (MPa) 0.77 (mW) 5.91 5.91...
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Page 70: Appendix C: Transducer Maximum Surface Temperature
Digital Color Doppler Palm Ultrasound System Appendix C: TRANSDUCER MAXIMUM SURFACE TEMPERATURE Maximum surface Maximum surface temperature(℃) Transducer model temperature(℃) Contacting human-tissue mimicking material Suspending in air SonoEyeP2 <37.4 <32.0... -
Page 71: Appendix D: Measurement Results Summary
Digital Color Doppler Palm Ultrasound System Appendix D: MEASUREMENT RESULTS SUMMARY Measurement Useful Range Accuracy Distance Image area <±5% Circumference: Image area <±5% trace method,ellipse method Area: Image area <±10% trace method,ellipse method Volume Image area <±5% Angle Image area <±5%... -
Page 72: Appendix E: Guidance And Manufacturer's Declaration
Digital Color Doppler Palm Ultrasound System Appendix E: GUIDANCE AND MANUFACTURER’S DECLARATION 1. Guidance and manufacturer’s declaration – electromagnetic emissions SonoEye is intended for use in the electromagnetic environment specified below. The customer or the user of SonoEye Series should assure that it is used in such an environment. - Page 73 Digital Color Doppler Palm Ultrasound System 2. Guidance and manufacturer’s declaration – electromagnetic immunity The SonoEye is intended for use in the electromagnetic environment the SonoEye should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic test level...
- Page 74 Digital Color Doppler Palm Ultrasound System...
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