Chison SonoEye P5 User Manual
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Chison SonoEye P5 User Manual

Digital color doppler palm ultrasound system
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Digital Color Doppler Palm Ultrasound System
Digital Color Doppler Palm Ultrasound System
Model
SonoEye P5
USER MANUAL
Direction: CHUM SonoEye-P5-001a
th
June.5
,2020
Rev. 1.01
CHISON Medical Technologies Co., Ltd.
We reserve the right to make changes to this manual without prior notice.

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  • Page 1 Digital Color Doppler Palm Ultrasound System Digital Color Doppler Palm Ultrasound System Model SonoEye P5 USER MANUAL Direction: CHUM SonoEye-P5-001a 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 P5. Please verify that you are using the latest revision of this document. If you need to know the latest revision, contact your distributor.

  • Page 3: Table Of Contents

    Digital Color Doppler Palm Ultrasound System TABLE OF CONTENTS TABLE OF CONTENTS ..............................3 Chapter 1 Introduction ..............................1 System Overview ............................... 1 Contact Information ............................1 Chapter 2 System Safety .............................. 3 SafetyOverview ..............................3 Electrical Safety ..............................4 Labels ..................................
  • Page 4 Digital Color Doppler Palm Ultrasound System The System ............................... 26 Chapter 4 Control Panel ............................. 27 Overview of Display Area ..........................27 Start a New Exam ............................28 Probe ................................. 29 Switching Function ............................30 Switching Mode ............................... 30 Function Key Introduction ..........................31 Image Parameter Area ............................
  • Page 5 Digital Color Doppler Palm Ultrasound System Measurement Methods ............................ 41 B Mode Measurement ............................. 41 6.2.1 Vessel Measurement in B mode ......................42 6.2.2 Obstetrics Measurement in B mode ....................42 6.2.3 AbdomenMeasurement in B mode ..................... 44 6.2.4 CardiacMeasurement in B mode ......................45 B/M Mode Measurement ..........................
  • Page 6 Digital Color Doppler Palm Ultrasound System Troubleshooting ............................... 60 Service Responsibility ............................. 61 Chapter 10 System ..............................62 10.1 General Description............................62 10.2 Care and Maintenance ............................ 62 10.2.1 Inspecting Systems ..........................63 10.2.2 Cleaning and Disinfecting ........................63 10.3 System Operation Instructions ........................

  • Page 7: Chapter 1 Introduction

    1.1 System Overview Indicationsfor Use SonoEye P5 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 Fetal, Abdominal, OB/GYN, Urology, Lung, Cardiac.
  • Page 8 Digital Color Doppler Palm Ultrasound System US Agent Mr. Marco Mu, 2219 Rimland Drive,Suite 301,Bellingham, Barkley Villiage Bellingham,Washington,98226, UNITED STATES Phone: 360-3257028, Fax: 360-9253199, Email: us.agent@mid- link.net MID-LINK INTERNATIONAL CO., LTD CAUTION Federal law restricts the device to sale by or on the order of a licensed practitioner ortherapist.

  • Page 9: Table Of Contents

    Digital Color Doppler Palm Ultrasound System Chapter 2 System Safety 2.1 SafetyOverview 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 10: 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 toremove 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 11 Digital Color Doppler Palm Ultrasound System OXYGEN or WITH NITROUS OXIDE): The Equipment is not suitable for use in the environment with FLAMMABLE ANAESTHETIC MIXED WITH AIR (or WITH OXYGEN or WITH NITROUS OXIDE) Conduction Interference NOTE Image quality will effect by conducted disturbance. Please do not use the effected image. And put system in a simpler electromagnetic compatibility environment to start working, if conducted disturbance occurred, stop using it and change the position for acquiring a better image.
  • Page 12 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 13: Labels

    Digital Color Doppler Palm Ultrasound System 2.3 Labels Fig. 2-1: SonoEye P5 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 14: Other Device Labels

    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.  DO NOT touch patient and devices without IEC/EN 60601-1 approval to avoid the leakage current risk within the PATIENT ENVIRONMENT.
  • Page 15  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: ...

  • Page 16: Biological Safety

    Digital Color Doppler Palm Ultrasound System WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of 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...

  • Page 17: Scanning Patients And Education

    Digital Color Doppler Palm Ultrasound System Bone Thermal Index (TIB). Used when bone is near the focus of the image as in the third trimester OB examination, it provides an estimate of potential temperature increase in the bone or adjacent soft tissue. Cavitation: Cavitation may occur when sound passes through an area that contains a cavity, such as a gas bubble or air pocket (in the lung or intestine, for example).
  • Page 18 Digital Color Doppler Palm Ultrasound System  Select a low setting for each new patient. Output should only be increased during the examination if penetration is still required to achieve a satisfactory result, and after the Gain control has been moved to its maximum value.

  • Page 19: Understanding The Mi/Ti Display

    Digital Color Doppler Palm Ultrasound System diagnostic uses of ultrasound equipment include repeated scans for operator training, equipment demonstration using normal subjects, and the production of souvenir pictures or videos of a fetus. For equipment of which the safety indices are displayed over their full range of values, the TI should always be less than 0.5 and the MI should always be less than 0.3.
  • Page 20 Digital Color Doppler Palm Ultrasound System correctly and the education of the user to interpret the value appropriately. : (De-rating factor) In Situ intensity and pressure cannot currently be measured. Therefore, the acoustic power measurement is normally done in the water tank, and when soft tissue replaces water along the ultrasound path, a decrease in intensity is expected.
  • Page 21 Digital Color Doppler Palm Ultrasound System models Tissue temperature elevation depends on power, tissue type, beam width, and scanning mode. Six models are developed to mimic possible clinical situations. Thermal Models Composition Mode Specification Application Soft tissue Unscanned Large aperture (>1cm ) Liver PW Small aperture (<1cm ) Pencil System...
  • Page 22 Digital Color Doppler Palm Ultrasound System Cavitation is more likely to occur at high pressures and low frequencies in pulse ultrasound wave in the tissue, which contains the bubble or air pocket (for instance, the lung, intestine, or scan with gas contrast agents).
  • Page 23 Digital Color Doppler Palm Ultrasound System Controls Affecting Acoustic Output The potential for producing mechanical bioeffects (MI) or thermal bioeffects (TI) can be influnced by certain controls. Direct: The Acoustic Output control has the most significant effect on Acoustic Output. Indirect: Indirect effects may occur when adjusting controls.

  • Page 24: Chapter 3 Preparing The System For Use

    Digital Color Doppler Palm Ultrasound System Chapter 3 Preparing the System for Use 3.1 Site Requirement 3.1.1 Operation Environmental Requirement The following environmental conditions are within system tolerances for operation: Strong radiation sources or powerful electromagnetic waves (e.g. electro-magnetic waves from radio broadcasting) may result in image ghosting or noise.
  • Page 25 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.

  • Page 26: System Specifications

    SonoEye P5 system: Fig. 3-1 a: Console Overview Fig. 3-2: Firmware Front View for SonoEye P5 system From left to right: Freeze Button，P，- & + (They can be set as None, Freeze/Unfreeze, Gain+, Gain-, Depth+, Depth- and Save Image )

  • Page 27: Physical Specifications

    Image Modes B mode  B/M mode  Color Flow Map mode  PulsedWave Doppler mode  3.3.4 Type SonoEye P5 2.0MHz- 4.5MHz/3.0MHz-5.0MHz Convex Array  3.3.5 System Configuration Function SonoEye P5 √ B mode B/M mode Option PW mode...
  • Page 28 Digital Color Doppler Palm Ultrasound System √ Depth √ √ Focus √ Zoom Adjust sample Gate location Option Adjust size of sample Gate horizontal Option Adjust size of sample Gate vertical Option Adjust PW sample gate Option √ Compound √ Frequency Scaling √...
  • Page 29 Digital Color Doppler Palm Ultrasound System Vessel measure package Option Abdomen measure package Option Obstetrics measure package Option Cardiac measure package Option Lung measurement Option General report Option Vessel report Option Abdomen report Option Obstetrics report Option Cardiac report Option Lung report Option √...

  • Page 30: System Positioning & Transporting

    Digital Color Doppler Palm Ultrasound System √ Save Image Cine Loop Option Annotation Option Bodymark Option Mark Option Patient management Option Voice/Angle/Baseline on PW Option Content in interference: Image area(Probe type, frequency, probe direction, Image depth √ and depth ruler, gray scale ruler, color power ruler, cine loop ruler, focus position, AIO, A.P., battery condition) Title area:(menu, switch probe, product logo, patient ID, End exam ) √...
  • Page 31 Digital Color Doppler Palm Ultrasound System When moving or transporting the system, take the precautions described below to ensure maximum safety for personnel, the system and other equipment. Before Moving the System Completely switch off the system. NOTE To prevent damage to the cable, DO NOT pull excessively on the cable or sharply bend the cable while wrapping it.

  • Page 32: 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 P5 system to displayer. Caution ...

  • Page 33: 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 4. Center Line 5. Full Screen 6. B/M mode 7. PW mode 8. CFM mode 9.

  • Page 34: 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 35: 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 36: 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.

  • Page 37: Function Key Introduction

    Digital Color Doppler Palm Ultrasound System 4.6 Function Key Introduction Button Name Function Freeze Touch this icon to freeze the current image Preset Press this button to select preset. Press this button to optimize current image. Auto vascular Press this key to help user identify artery and tracking vein in current image automatically.
  • Page 38 Digital Color Doppler Palm Ultrasound System 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. Side Menu Press to enter the side menu list. Full Screen Press the key to turn on the full screen function.

  • Page 39: 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 40: Chapter 5 Imaging

    Digital Color Doppler Palm Ultrasound System Chapter 5 Imaging This chapter will introduce image display modes and the operation of image control and adjustment. 5.1 Select Scan Mode 5.1.1 System Identify The App will identify the system automatically while system is connected. 5.1.2 Select Application Click...

  • Page 41: Cfm Mode

    Digital Color Doppler Palm Ultrasound System 5.1.6 CFM Mode Color Flow Map is a technique for imaging blood flow by displaying flow data such as velocity and direction on B mode image. Based on Doppler Effect, normally the blood flow moving toward the probe scan direction is marked in red, while blood flow moving away from probe scan direction is marked in blue.

  • Page 42: B-Lines

    Digital Color Doppler Palm Ultrasound System (Sample Volume Gate). The Sample Volume Gate can be moved anywhere within B-mode image. PW mode Exam Procedure:  Connect the appropriate system, leaving the systems in their respective holders.  Position the patient for the examination. ...

  • Page 43: Biopsy Guide

    Digital Color Doppler Palm Ultrasound System  Edit pleural line: Press the Edit icon on the left of image, press the image with single finger and blue line display, move the blue line with finger to edit pleural line.  Add B-Lines: Press Add icon on the left of image, a yellow line displayed, press it and move it to the target position and release finger to add B-lines.

  • Page 44: Functional Description Of Parameter Adjustment

    Digital Color Doppler Palm Ultrasound System account automatically when you first log into it. After registration, each time you open it, SonoRemote will log in your account automatically. Check the network connection on system, click SonoRemote icon to open it. The SonoRemote will register an account automatically when you first log into it.

  • Page 45: 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.

  • Page 46: Adding Bodymark

    Digital Color Doppler Palm Ultrasound System and frozen image. WARNING: You must ensure that the entered annotationsare correct. Incorrect annotations may cause misdiagnosis! Operation: 1.Freeze image and slide the menu list to select 2.Thesubmenu appears, press . “︱”is displayed in image area and the soft icon board appeared in the bottom of screen.

  • Page 47: 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 48: Vessel Measurement In B Mode

    Digital Color Doppler Palm Ultrasound System Distance measurement is the same as section 6.1. 2. Area Area measurement is the same as section 6.1. 3. Circumference Circumferencemeasurement is the same as section 6.1. 4. Volume Volumemeasurement is the same as section 6.1. 6.2.1 Vessel Measurement in B mode IMT(Auto):Press CALC icon to enter Vascular measurement, click IMT(Auto) icon, the sampling frame...
  • Page 49 Digital Color Doppler Palm Ultrasound System Meas. item mark unit Meas. Method and calc. formula name Refer to “Distance” measurement in 6.1 Hadlock EDD=System Data-GA×7 days+280 days Hadlock Refer to “Distance” measurement in 6.1 Hadlock EDD=System Data-GA×7 days+280 days AC(Ellipse) Refer to “Ellipse”...

  • Page 50: Abdomenmeasurement In B Mode

    Digital Color Doppler Palm Ultrasound System AFI_1 Refer to “Distance” measurement in 6.1 AFI_2 Refer to “Distance” measurement in 6.1 AFI_3 Refer to “Distance” measurement in 6.1 AFI_4 Refer to “Distance” measurement in 6.1 AFI= AFI_1+ AFI_2+ AFI_3+ AFI_4 6.2.3 AbdomenMeasurement in B mode Meas.

  • Page 51: Cardiacmeasurement In B Mode

    Digital Color Doppler Palm Ultrasound System IVCExp Refer to “Distance” measurement in 6.1 6.2.4 CardiacMeasurement in B mode Meas. item mark unit Meas. Method and calc. formula name IVSd IVSd Refer to “Distance” measurement in 6.1 LVIDd LVIDd Refer to “Distance” measurement in 6.1 LVPWd LVPWd Refer to “Distance”...

  • Page 52: B/M Mode Measurement

    Digital Color Doppler Palm Ultrasound System ESV(A2C/A4C) EDV-ESV L/min HR*SV/1000 100*SV/EDV SV/BSA CO/BSA IVC Ins IVC Ins Refer to “Distance” measurement in 6.1 IVC Exp IVC Exp Refer to “Distance” measurement in 6.1 LVOT Diam LVOT Diam Refer to “Distance” measurement in 6.1 Refer to “Ellipse”...

  • Page 53: Pw Mode Measurement

    Digital Color Doppler Palm Ultrasound System 3. HR HR is the measurement between the two vertical lines that are created by two cursors in beat per minute (BPM). The position of the horizontal distance line does not affect HR. 6.4 PW Mode Measurement 1.

  • Page 54: 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 55: 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 56 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 archiveis selected. : Select all archives.

  • Page 57: Easyview

    Digital Color Doppler Palm Ultrasound System : Press it to delete selected archive. Press selected archive to enter EasyView. 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 58: 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 selectedimage. 8.3 Report Select the report from side menu, press “<” on the top left corner to return to the exam interference. Press right corner...

  • Page 59: General

    Digital Color Doppler Palm Ultrasound System 8.4.1 General Set STC display and IDdisplay on system. 8.4.2 Language Press language to select the needed language. The system supports English, Chinese and Deutsch.
  • Page 60 Digital Color Doppler Palm Ultrasound System...

  • Page 61: 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.

  • Page 62: Firmware Update

    Digital Color Doppler Palm Ultrasound System 8.4.5 Firmware Update Select firmware update to upgrade system software version. 8.4.6 Function Management Select function management to manage system functions. 8.5 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.

  • Page 63: Demo

    Digital Color Doppler Palm Ultrasound System 8.6 Demo Click Demo to enter it, the user can view the exam images and cines. Exit Demo: press anywhere on screen, then press “<” on the top left corner to exit demo. 8.7 About Press About to check the current software version.

  • Page 64: 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 65 Digital Color Doppler Palm Ultrasound System Don’t scratch the system surface while using it. Please use the authorized ultrasound gel during scanning. Using un-authorized gel may cause scratch or damage to system surface. Please keep the system clean and dry. ℃...

  • Page 66: Safety Check

    Digital Color Doppler Palm Ultrasound System 9.3 Safety Check To ensure the system work normally, please make a maintenance plan, check the safety of the system periodically. If there is any abnormal phenomenon with the machine, please contact our authorized agent in your country as soon as possible.

  • Page 67: Service Responsibility

    If users install, use and maintain the system fully according to CHISON’s installation manual, operation manual and service manual, then SonoEye P5 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 68: Chapter 10 System

    Digital Color Doppler Palm Ultrasound System Chapter 10 System 10.1 General Description Transducer Scanhead (Lens) Fig.6-1:Convex Probe Overview The systemprovides high spatial and contrast ultrasound imaging of frequencies from 2.0MHz to 4.5MHz. 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 69: Inspecting Systems

    Digital Color Doppler Palm Ultrasound System 10.2.1 Inspecting Systems Before and after each use, inspect carefully the system’s lens, cable, casing, and connector. Look for any damage that would allow liquid to enter the system. If any damage is suspected, do not use the system until it has been inspected and repaired/replaced by an authorized Service Representative.
  • Page 70 Digital Color Doppler Palm Ultrasound System Recommended materials for cleaning and disinfecting transducer Qualified Active Ingredients Time Solution Origin Purpose Isopropyl alcohol/Didecyl WIP'ANIOS Wipe Disinfection dimethyl ammonium chlorides Ethanol 80% Ethanol（Using clean Clean or Wipe Disinfection cloth soak the liquid） 70% Isopropyl alcohol Isopropyl alcohol Clean or...
  • Page 71 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 72 Digital Color Doppler Palm Ultrasound System DO NOT use pre-lubricated condoms as a sheath. In some cases, they can damage the system. Lubricants in these condoms may not be compatible with system construction. Devices containing latex may cause severe allergic reaction in latex sensitive individuals. Refer to FDA’s March 29, 1991 Medical Alert on latex products.
  • Page 73 Digital Color Doppler Palm Ultrasound System System Cleaning process: DO disconnect the system from the displayer prior to cleaning/disinfecting the system. Failure to do so could damage the system. Perform Cleaning system after each use  Disconnect the system and remove all coupling gel from the system by wiping with a soft cloth and rinsing with flowing water.
  • Page 74 Digital Color Doppler Palm Ultrasound System Disinfecting the systems: After each use, please disinfect the systems.Ultrasound systems can be disinfected using liquid chemical germicides. The level of disinfection is directly related to the duration of contact with the germicide. Increased contact time produces a higher level of disinfection. In order for liquid chemical germicides to be effective, all visible residue must be removed during the cleaning process.
  • Page 75 Digital Color Doppler Palm Ultrasound System Do not use a damaged or defective system. Coupling gels DO NOT use gels (lubricants) that are not recommended. They may damage the system and void the AQUASONIC Gel made by R. P. Kincheloe Company in USA is recommended. warranty.

  • Page 76: System Operation Instructions

    Digital Color Doppler Palm Ultrasound System As necessary: inspect the system, clean the system, disinfect the 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 77 Digital Color Doppler Palm Ultrasound System REFERENCE: 1) AIUM/NEMA: Standard For Real-Time Display of Thermal and Mechanical Acoustic Output Indices On Diagnostic Ultrasound Equipment, Revision 2. NEMA Standards Publication UD 3-2004; American Institute of Ultrasound in Medicine, Laurel MD; National Electrical Manufacturers Association, Rosslyn, VA;...

  • Page 78: 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 DimdiNo.:DE/0000040627 E-mail: shholding@hotmail.com...

  • Page 79: Appendix B: Acoustic Output Report Table

    Digital Color Doppler Palm Ultrasound System Appendix B: ACOUSTIC OUTPUT REPORT TABLE Transducer Model: SonoEye P5 Operation Mode: B Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.05 0.11 0.11 0.25 Index component Value 0.11 0.11 0.11 0.11...
  • Page 80 Digital Color Doppler Palm Ultrasound System spta.α (mW/cm 0.79 pii.α Zsii.α spta (mW/cm 0.82 Zsii at Z (MPa) 1.79 Focus (cm) 3.00 3.00 3.00 3.00 Operating Depth (cm) 16.00 16.00 16.00 16.00 control Freq 2.00 2.00 2.00 2.00 conditions...
  • Page 81 Digital Color Doppler Palm Ultrasound System Transducer Model: SonoEye P5 Operation Mode: B+M Index Label Below Below Surface Surface Surface Surface Maximum Index Value 1.12 0.26 0.58 0.36 Index component Value 0.26 0.18 0.26 0.58 r.α (MPa) 1.65 (mW) 20.12 20.12...
  • Page 82 Digital Color Doppler Palm Ultrasound System spta.α (mW/cm 8.77 pii.α Zsii.α spta (mW/cm 8.89 Zsii (MPa) 1.75 Focus (cm) 3.00 3.00 3.00 3.00 Operating Depth (cm) 16.00 16.00 16.00 16.00 control Freq 2.00 2.00 2.00 2.00 conditions...
  • Page 83 Digital Color Doppler Palm Ultrasound System Transducer Model: SonoEye P5 Operation Mode:B+CFM Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.88 0.22 0.22 0.50 Index component Value 0.22 0.22 0.22 0.22 r.α (MPa) 1.39 (mW) 24.21 24.21 28.90...
  • Page 84 Digital Color Doppler Palm Ultrasound System spta.α (mW/cm 0.50 pii.α Zsii.α spta (mW/cm 0.51 Zsii at Z (MPa) 1.73 Focus (cm) 3.00 3.00 3.00 5.00 Operating Depth (cm) 16.00 16.00 16.00 16.00 control Freq 3.00 3.00 3.00 3.00 conditions...
  • Page 85 Digital Color Doppler Palm Ultrasound System Transducer Model: SonoEye P5 Operation Mode:PW Index Label Below Below Surface Surface Surface Surface Maximum Index Value 0.63 0.20 0.74 0.38 Index component Value 0.15 0.20 0.16 0.74 r.α (MPa) 1.00 (mW) 21.79 18.92 22.59...
  • Page 86 Digital Color Doppler Palm Ultrasound System spta.α (mW/cm 109.67 pii.α Zsii.α spta (mW/cm 213.87 Zsii at Z (MPa) 1.22 Focus (cm) 4.00 11.00 4.00 7.00 Operating Depth (cm) 16.00 16.00 16.00 16.00 control Freq 3.00 3.00 3.00 3.00 conditions 2000 2000 2000 2000...

  • Page 87: Appendix C: Transducer Maximum Surface Temperature

    Digital Color Doppler Palm Ultrasound System Appendix C: TRANSDUCER MAXIMUM SURFACE TEMPERATURE Maximum surface Maximum surface temperature(℃) temperature(℃) Transducer model Contacting human-tissue mimicking material Suspending in air SonoEye P5 <37.6 <31.4...

  • Page 88: 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 89: 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 90 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 environment –...
  • Page 91 Digital Color Doppler Palm Ultrasound System equipment See table 9 See table 9 equipment should be at levels characteristic of a IEC 61000-4-3 typical location in a typical commercial or hospital environment.
  • Page 92 Digital Color Doppler Palm Ultrasound System...

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