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Chison SonoEye P2, User Manual

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Chison SonoEye P2 User Manual Download Page 12

Digital Color Doppler Palm Ultrasound System

 

7 

 

2.3.2 Other Device Labels

 

The following table describes the purpose and location of safety labels and other important information 

provided on the equipment. 

Table 2-1: Symbol Icons 

Icon

 

Meaning

 

Identification 

and Rating 

Plate

 

• Manufacture’s name 

• Serial number 

 

Type-BF applied part 

2.4  Patient Environmental Devices 

Front side

 : 

 

 

Power switch 

 

Freeze button, P button, + button, - button 

Acceptable Devices 

The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT 

ENVIRONMENT. 

Anyone using the equipment must be able to recognize the ESD symbol and understand how to take the 

necessary precautionary procedures, as described in the caution below: 

 

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.   

ESD CAUTION

 

Sensitive part in system has been labeled with anti-static label, please pay attention on electrostatic 

protection. 

 

Summary of Contents for SonoEye P2

Page 1: ...ystem Digital Color Doppler Palm Ultrasound System Model SonoEye P2 USER MANUAL Direction CHUM SonoEye P2 001a June 5th 2020 Rev 1 01 CHISON Medical Technologies Co Ltd We reserve the right to make changes to this manual without prior notice ...

Page 2: ...dical Device Directive 93 42 EEC Accessories without the CE mark are not guaranteed to meet the 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 ...

Page 3: ...on Environmental Requirement 16 3 1 2 Electrical Requirements 16 3 2 Downloading and Installing the App 16 3 3 System Specifications 18 3 3 1 Console Overview 18 3 3 2 Physical Specifications 18 3 3 3 Image Modes 18 3 3 4 Type 19 3 3 5 System Configuration 19 3 4 System Positioning Transporting 20 3 5 Powering the System 21 3 5 1 Acclimation Time 21 3 5 2 Connecting the Electric Power 21 3 6 The S...

Page 4: ...t Methods 36 6 2 B Mode Measurement 36 6 2 1 Vessel Measurement in B mode 36 6 2 2 Small Organ Measurement in B mode 37 6 3 B M Mode Measurement 37 6 4 PW Mode Measurement 38 Chapter 7 Cine Memory 39 7 1 Image Storage 39 7 2 Manual playback 39 7 3 Automatic playback 39 7 4 Cine Save 39 Chapter 8 Side Menu 40 8 1 Archive 40 8 2 EasyView 42 8 3 Report 43 8 4 Setting 43 8 4 1 General 44 8 4 2 Languag...

Page 5: ...ecting Systems 52 10 2 2 Cleaning and Disinfecting 53 10 3 System Operation Instructions 58 10 4 Service Responsibility 58 Appendix A THE INFORMATION OF EC REPRESENTATIVE 60 Appendix B ACOUSTIC OUTPUT REPORT TABLE 61 Appendix C TRANSDUCER MAXIMUM SURFACE TEMPERATURE 65 Appendix D MEASUREMENT RESULTS SUMMARY 66 Appendix E GUIDANCE AND MANUFACTURER S DECLARATION 67 ...

Page 6: ...r any use that causes the acoustic beam to pass through the eye 1 2 Contact Information For additional information or assistance please contact your local distributor or the appropriate support resource shown below CHISON website www chison com Service Support CHISON Medical Technologies Co Ltd Tel 0086 400 8878 020 0086 0510 85311707 Fax 0086 0510 85310726 E mail service chison com cn Placing an ...

Page 7: ...mediately and inform the manufacturer or its designated agents Only connect this system either electronically or mechanically with devices that comply with the EN60601 1 standard Recheck the leakage current and other safety performance indices of the entire system to avoid potential system damage caused by leakage from a current superposition The system does not incorporate any specialized protect...

Page 8: ...hospitals CISPR 11 class A If it is used in a residential ENVIRONMENT for which CISPR 11 class B is normally required this equipment might not offer adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment Degree of protection against electric shock Type BF Applied part for Systems marked with BF ...

Page 9: ...s and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast transmitter 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 ultrasound system is used exceeds the applicable RF compliance level as sta...

Page 10: ...tion of the performance of this equipment could result Notice against User Modification The user should never modify this product User modifications may cause degradation in Electrical Safety Modification of the product includes changes in Cables length material wiring etc System configuration components User modifications may cause degradation in EMC performance Modification of the product includ...

Page 11: ...ted on the device itself The CE mark of Conformity indicates this equipment conforms to the Council Directive 93 42 EEC Serial number of the device This symbol is accompanied by the name and the address of the manufacturer and the manufacturing date of the device in the form YYYY MM IPX7 IPX1 Protection against the effects of immersion This label indicates immersed part Refer to instruction manual...

Page 12: ...Devices The Patient Environmental devices shown above are specified to be suitable for use within the PATIENT ENVIRONMENT Anyone using the equipment must be able to recognize the ESD symbol and understand how to take the necessary precautionary procedures as described in the caution below ESD CAUTION Sensitive part in system has been labeled with anti static label please pay attention on electrost...

Page 13: ...plies approved or recommended in these instructions for use Peripheral used in the patient environment The system has been verified for overall safety compatibility and compliance with the printer which is Mopria certified CAUTION Printing quality may vary depending on the printer If there is any quality problem Chison will not be responsible The system may also be used safely while connected to d...

Page 14: ...nts of the prudent use of diagnostic ultrasound outweigh the risks if any that may be present Heating Elevating tissue temperature during obstetrical examinations creates medical concerns At the embryo development stage the rise in temperature and the length of time exposed to heat combine to determine potential detrimental effects Exercise caution particularly during Doppler Color exams The Therm...

Page 15: ... the shortest possible time to achieve a satisfactory diagnosis ALARA As Low As Reasonably Achievable 2 6 1 Safe Scanning Guidelines Ultrasound should only be used for medical diagnosis and only by trained medical personnel Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of the equipment in the interpretation of the results and images and in the safe use ...

Page 16: ...d in accordance with Table 2 2 below as a reference TI Maximum exposure time minutes 0 7 60 1 0 30 1 5 15 2 0 4 2 5 1 Table 2 2 Maximum recommended exposure times for an embryo or fetus Non diagnostic use of ultrasound equipment is not generally recommended Examples of non diagnostic uses of ultrasound equipment include repeated scans for operator training equipment demonstration using normal subj...

Page 17: ...ans an increased potential for thermal effects can be expected as the TI increases A high index does not mean that bioeffects are occurring but only that the potential exists and there is no consideration in the TI for the scan duration so minimizing the overall scan time will reduce the potential for effects These operator control and display features shift the safety responsibility from the manu...

Page 18: ...e and bone Unscanned Bone at focus Fetus head PW Soft tissue Describes low fat content tissue that does not contain calcifications or large gas filled spaces Scanned auto scan Refers to the steering of successive burst through the field of view e g B and color mode Unscanned Emission of ultrasonic pulses occurs along a single line of sight and is unchanged until the transducer is moved to a new po...

Page 19: ...ndication of acoustic levels being generated by the system Only display and report TIS or TIB and start from 0 4 if maximum TI 1 0 display in increments of 0 2 for values of indices of 2 0 or less and 0 5 for values of indices greater than 2 0 Below is a simple guideline for the user when TI exceeds one limit exposure time to 4 6 TI minutes based on the National Council on Radiation Protection Exp...

Page 20: ...minimum necessary acoustic output to get the best diagnostic image or measurement during an examination Begin the exam with the system that provides an optimum focal depth and penetration Acoustic Output Default Levels In order to assure that an exam does not start at a high output level the system initiates scanning at a reduced default output level This reduced level is preset programmable and d...

Page 21: ...of environment is between 0 to 38 the system can work continuously in normal If the temperature of environment is over 38 the system can detect the temperature and stop working while overheating 3 1 2 Electrical Requirements Power Requirements DC 5V Power Consumption 10VA Voltage Fluctuation 5 WARNING Maintain a fluctuation range of less than 10 of voltage labeling on rear panel of the system othe...

Page 22: ... touch 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 Power on Press for 3 seconds to turn on the system The blue light is on while th...

Page 23: ... 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 Dimensions of main unit approx 64mm Width 170mm Height 24mm Depth Net Weight 200g 3 3 3 Image Modes B mode ...

Page 24: ...ype C cable Identify probe Switch exam mode Gain Depth STC 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 Freeze Unfreeze B distance B Circumference B Area B Volume B M Distance Option B M Time Option B M HR Option PW Velocity Option PW Time Option Vessel m...

Page 25: ... 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 Physicial key Setting Archives Tutorials Easyview Demo About Standard 3 4 System Positioning Transporting Moving the System When moving or transporting the system take the precautions de...

Page 26: ...age from vibration Avoid unpaved roads excessive speeds and erratic stops or starts 3 5 Powering the System 3 5 1 Acclimation Time After being transported the unit requires one hour for each 2 5 ºC increment if its temperature is below 10 ºC or above 38 ºC 3 5 2 Connecting the Electric Power After making sure the power supply on displayer is normal status and the voltage type is matched to the pow...

Page 27: ...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 Deactivating the System Disconnect the connector from displayer to deactivate the system ...

Page 28: ...1 Overview of Display Area Fig 4 1a Display Interface 1 Side Menu 2 Application 3 Parameters control 3 Center Line 4 Full Screen 5 B M mode 6 PW mode 7 CFM mode 8 Freeze 9 Logo 10 Patient information 11 End Exam 12 Connection status 13 Image parameter area 14 Focal indicator ...

Page 29: ...on Patient Information MRN Medical Record Number ID Patient ID Date Date of the study First Name Input patient s First Name Middle Name Input patient s Middle Name Last Name Input patient s Last Name Sex Select the patient s sex Age Set the patient s age the system will automatically calculate the patient s birthday Birth Set the patient s birthday the system will automatically calculate the patie...

Page 30: ...Digital Color Doppler Palm Ultrasound System 25 ...

Page 31: ...Digital Color Doppler Palm Ultrasound System 26 4 3 Probe Press to display current probe preset Choose the desired preset to start an exam ...

Page 32: ...unction Key Introduction Button Name Function Freeze Touch this icon to freeze the current image Preset Press this button to select preset AIO Press this button to optimize current image Auto vascular tracking Press this key to help user identify artery and vein in current image automatically Freq Press this button in phantom preset to adjust the Freq Image save Press this key to save image ...

Page 33: ...PW Mode Side Menu Press to enter the side menu list Full Screen Press the key to turn on the full screen function Measure Press this key to enter measurement Ellipse Press this key to start ellipse measurement Distance Press this key to start distance measurement Mark Press this button and the user can select the content to add in current exam interface Annotation Press this button to add annotati...

Page 34: ... this button to clear all the content that user have added in current exam interface 4 7 Image Parameter Area Display information about Patient ID Frequency time current exam and etc 4 8 Cine Control No Item Description 1 Starts Cine playback Stops Cine playback 2 Press and slide on the processing bar to view frames 3 Current Total The number corresponds to the current frame and total frame ...

Page 35: ...single B mode image B mode is the basic operating mode for two dimensional scanning and diagnosis 5 1 4 FHI Press Freq button to open its sub menu select the expected frequency to optimize current image Press Freq again to exit FHI selection menu FHI is used for improving SNR Signal to Noise Ratio and remitting pseudo morphism on current image Thus the image quality is improved by this function 5 ...

Page 36: ...r examination The site where PW Doppler data is derived appears graphically on the B mode image 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 Press ID number and enter the appropriate patient data Select the application...

Page 37: ... 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 Delete B Lines Press the existed B Lines with single push to active current B Lines press the Delete icon on the left of i...

Page 38: ... camera on the original terminal will automatically turn on The ultrasound screen and camera screen will be displayed on the PC Before connecting users can set up video microphone and speakers on the original terminal The video data on the originate terminal will be displayed on the answering terminal Before connecting the user can set the video microphone and speaker on the answering terminal Not...

Page 39: ...me state press the angle icon to adjust the angle 4 PW Sample Gate At real time state use two fingers to slide it outward to adjust the size of sample gate At real time state press the sample gate and move it to adjust the location 5 Baseline At real time state press the baseline and move it to up and down to adjust the location 5 4 After Capturing the Image 5 4 1 Adding Annotation Annotation can ...

Page 40: ...he body mark list displays select the body mark in desired application The body mark displays in image area 3 Slide the blue dot to adjust the probe direction 4 To move the body mark press it and move it to target position 5 4 3 Adding Mark Operation 1 Freeze image and slide the menu list to select 2 The submenu appears press The mark displays in image area 3 Slide the blue dot to adjust the mark ...

Page 41: ...se icon under the measure menu to enter into measurement Click in the B image area it will display an ellipse with four icon you can move the by dragging your finger on B image area to fit it s position After measurement the result will appear on the exam interface Repeat the above step to start a new measurement press can delete the current measurement result Press can delete all the measurements...

Page 42: ... Thyroid Vol Length cm Refer to Distance measurement in 6 1 Width cm Refer to Distance measurement in 6 1 Height cm Refer to Distance measurement in 6 1 Volume ml Volume Length Width Height 3 14159265 6 6 3 B M Mode Measurement 1 Distance This feature allows the measurement of the distance between two points It is a measurement between the two horizontal lines that lean on the two cursors The posi...

Page 43: ...ed position to start measurement The result will display on image area and result area Repeat the above steps to start new measurement 2 Time Press Freeze after finish the scan select the time in menu there are two 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 a new measurement ...

Page 44: ...ut of Cine Memory Therefore there are always the latest images in the storage All the images in Cine Memory can be played back manually or automatically Fig 7 1 Movie playback bar diagram 7 2 Manual playback After clicking the button to freeze the image the movie playback bar pops up At this time slide to right in image area to display the images in ascending order of frames that is the same order...

Page 45: ...ed 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 8 1 Archive Press on the top left corner of the screen select archive to enter the archive management ...

Page 46: ... 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 Press selected archive to enter EasyView ...

Page 47: ...syView 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: ...t 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 8 4 Setting Press the setting button to enter the setting interface ...

Page 49: ...tal Color Doppler Palm Ultrasound System 44 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: ...on 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: ...s 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 Press and select tutorials to enter it there is a short video to help you learn the system 8 6 Demo Click Demo to enter it the user can view the exam images and cines ...

Page 52: ...Digital Color Doppler Palm Ultrasound System 47 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 53: ...ed please contact our authorized agent in your country in advance Any cleaning by unauthorized person may result in system malfunction or affect its features 9 2 System Maintenance According to the purposes the system is used on the surface of patient body Caution No matter which type of examination is performed please always try to reduce the unnecessary radiation of ultrasound wave to the patien...

Page 54: ... cloth moistened with alcohol and then dry it Aeration and let the system become dry in normal temperature Please strictly keep the system away from the paint thinner ethylene oxide other organic solvent etc Please keep the system inside the system case when it is not in use Dipping the system into any liquid is strongly prohibited Caution Please immediately stop using the system and system if the...

Page 55: ... frozen status Adjust the transmission frequency gain or STC control Ensure the system is connecting correctly Defreeze the system by pressing the FREEZE icon Image quality is abnormal Examination mode is not correct The image post processing setting is abnormal Adjust image post processing settings or set it to default The system is not working properly Internal circuit protection Restart the sys...

Page 56: ... s authorized service engineer If CHISON headquarter service center provides the calibration certificate for the related system or transducer then user could continue use the system or transducers according to the calibration certificate However if CHISON headquarter service center concludes that the system or transducer is no longer complied to the safety and effectiveness standard then user shou...

Page 57: ...following precautions Do not drop the transducer on hard surface This can damage the transducer elements and compromise the electrical safety of the transducer Avoid kinking or pinching the transducer cable Use only approved ultrasonic coupling gels Follow the instructions for cleaning and disinfecting that come with each system 10 2 1 Inspecting Systems Before and after each use inspect carefully...

Page 58: ...nfectant liquid Make sure that the surface of the system and cable is wetted thoroughly with the cleaning disinfectant Allow system to air dry completely Recommended materials for cleaning and disinfecting transducer Solution Origin Qualified Use Active Ingredients Purpose Time WIP ANIOS FRA Wipe Isopropyl alcohol Didecyl dimethyl ammonium chlorides Disinfection NA 80 Ethanol Using clean cloth soa...

Page 59: ...em 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 Inspect systems for sharp edges or rough surfaces that may injure sensitive tissue DO NOT apply excessive force to the system connector when inserting into the system port Special handlin...

Page 60: ...refore to minimize the risk of disease transmission by using barriers and through proper processing between patients Risk of Infection ALWAYS clean and disinfect the system between patients to the level appropriate for the type of examination and use FDA cleared system sheaths where appropriate Adequate cleaning and disinfection are necessary to prevent disease transmission It is the responsibilit...

Page 61: ...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 Thoroughly clean the system as described earlier before attempting disinfection You MUST disconnect the system from the displayer prior to cleaning disinfecting the system Fa...

Page 62: ...commended They may damage the system and void the warranty AQUASONIC Gel made by R P Kincheloe Company in USA is recommended In order to assure optimal transmission of energy between the patient and system a conductive gel must be applied liberally to the patient where scanning will be performed DO NOT apply gel to the eyes If there is gel contact to the eye flush eye thoroughly with water Couplin...

Page 63: ... system is a precise electronic system Only an authorized service contractor should replace defective parts Failures caused by unauthorized service are not the responsibility of the manufacturer 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 ...

Page 64: ...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 ...

Page 65: ...nd System 60 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: ... 24 0 24 0 24 0 24 Acoustic Parameters pr α at ZMI MPa 1 93 P mW 6 06 6 06 6 33 P1 1 mW 6 06 6 06 Zs cm 2 00 Zb cm 2 00 ZMI cm 1 55 Zpii α cm 1 55 fawf MHz 4 80 8 22 8 22 7 62 Other Information prr Hz srr Hz 27 63 npss NA 1 00 Ipa α at Zpii α W cm 2 88 02 Ispta α at Zpii α or Zsii α mW cm 2 0 36 Ispta at Zpii or Zsii mW cm 2 0 36 pr at Zpii MPa 2 53 Operating control conditions Focus cm 2 00 3 00 ...

Page 67: ...Acoustic Parameters pr α at ZMI MPa 2 25 P mW 6 85 6 85 6 85 P1 1 mW 6 85 6 85 Zs cm 1 25 Zb cm 1 65 ZMI cm 1 65 Zpii α cm 1 65 fawf MHz 4 85 4 88 4 88 4 88 Other Information prr Hz 513 srr Hz npss NA 1 00 Ipa α at Zpii α W cm 2 100 05 Ispta α at Zpii α or Zsii α mW cm 2 16 44 Ispta at Zpii or Zsii mW cm 2 18 95 pr at Zpii MPa 2 55 Operating control conditions Focus cm 2 00 3 00 3 00 3 00 Depth cm...

Page 68: ...coustic Parameters pr α at ZMI MPa 2 14 P mW 10 74 10 74 7 73 P1 1 mW 10 74 10 74 Zs cm 2 05 Zb cm 2 05 ZMI cm 0 90 Zpii α cm 0 90 fawf MHz 5 37 7 60 7 60 8 74 Other Information prr Hz srr Hz 4 50 npss NA 8 00 Ipa α at Zpii α W cm 2 209 60 Ispta α at Zpii α or Zsii α mW cm 2 0 39 Ispta at Zpii or Zsii mW cm 2 0 40 pr at Zpii MPa 2 24 Operating control conditions Focus cm 1 00 1 50 1 50 0 50 Depth ...

Page 69: ...ameters pr α at ZMI MPa 0 77 P mW 5 91 5 91 5 91 P1 1 mW 5 91 5 91 Zs cm 1 00 Zb cm 1 50 ZMI cm 1 55 Zpii α cm 1 55 fawf MHz 5 19 5 18 5 18 5 18 Other Information prr Hz 4500 srr Hz npss NA 1 00 Ipa α at Zpii α W cm 2 25 72 Ispta α at Zpii α or Zsii α mW cm 2 209 29 Ispta at Zpii or Zsii mW cm 2 366 44 pr at Zpii MPa 0 99 Operating control conditions Focus cm 2 00 1 50 1 50 1 50 Depth cm 8 90 8 90...

Page 70: ...m Ultrasound System 65 Appendix C TRANSDUCER MAXIMUM SURFACE TEMPERATURE Transducer model Maximum surface temperature Contacting human tissue mimicking material Maximum surface temperature Suspending in air SonoEyeP2 37 4 32 0 ...

Page 71: ...tem 66 Appendix D MEASUREMENT RESULTS SUMMARY Measurement Useful Range Accuracy Distance Image area 5 Circumference trace method ellipse method Image area 5 Area trace method ellipse method Image area 10 Volume Image area 5 Angle Image area 5 ...

Page 72: ...issions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 SonoEye uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A SonoEye is suitable for use in all professional healthcare environments like physicians offices dental office...

Page 73: ...terial the relative humidity should be at least 30 Power frequency frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital Radiated RF EM fields IEC61000 4 3 3V M 80MHz 2 7GHz 80 AM at 1KHz 3V M 80MHz 2 7GHz 80 AM at 1KHz Radiated RF EM fields should be at levels chara...

Page 74: ...Digital Color Doppler Palm Ultrasound System 69 ...

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