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Digital Color Doppler Palm Ultrasound System

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

80% Ethanol

（

Using clean

cloth soak the liquid

）

Any

Wipe

Ethanol

Clean or

Disinfection

70% Isopropyl alcohol

（

Using clean cloth soak

the liquid

）

Any

Wipe

Isopropyl alcohol

Clean or

Disinfection

Clinell Sporicidal Wipes

GBR

Wipe

Sodium

Percarbonate Citric

Acid

Disinfection

mikrozid PAA wipes

DEU

Wipe

peracetic

acid,Hydrogen

peroxid,Acetic acid

Disinfection

Universal wipes

GBR

Wipe

Quaternary
ammonium

Disinfection

perform classic wipes EP

DEU

Wipe

Disinfection

CAUTION

These transducers are not designed to withstand heat sterilization methods. Exposure to

temperatures in excess of 60 º C will cause permanent damage. The transducers are not

designed to be totally submerged in fluid, as permanent damage will result if the entire

transducer is submerged.

System Safety

Handling precautions

Ultrasound systems are highly sensitive medical instruments that can easily be damaged by improper

handling. Use care when handling and protect from damage when not in use. DO NOT use a damaged or

defective system. Failure to follow these precautions can result in serious injury and equipment damage.

Electrical shock hazard:

The system is driven with electrical energy that can injure the patient or user if live internal parts are

contacted by conductive solution:



DO NOT immerse the system into any liquid beyond the level indicated by the immersion level diagram.

Never immerse the system connector into any liquid.



Prior to each use, visually inspect the system lens for cracks, cuts, tears, and other signs of physical

damage. DO NOT use a system that appears to be damaged until you verify functional and safe

Summary of Contents for SonoEye P3

Page 1: ...ystem Digital Color Doppler Palm Ultrasound System Model SonoEye P3 USER MANUAL Direction CHUM SonoEye P3 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 P3 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: ...1 Operation 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 19 3 3 3 Image Modes 19 3 3 4 Type 19 3 3 5 System Configuration 19 3 4 System Positioning Transporting 21 3 5 Powering the System 21 3 5 1 Acclimation Time 21 3 5 2 Connecting the Electric Power 21 ...

Page 4: ...ulation 36 6 1 Measurement Methods 36 6 2 B Mode Measurement 36 6 2 1 Vessel Measurement in B mode 36 6 2 2 Abdomen Measurement in B mode 37 6 2 3 Cardiac Measurement in B mode 37 6 3 B M Mode Measurement 38 6 4 PW Mode Measurement 38 Chapter 7 Cine Memory 40 7 1 Image Storage 40 7 2 Manual playback 40 7 3 Automatic playback 40 7 4 Cine Save 40 Chapter 8 Side Menu 41 8 1 Archive 41 8 2 EasyView 43...

Page 5: ...Care and Maintenance 53 10 2 1 Inspecting Systems 53 10 2 2 Cleaning and Disinfecting 54 10 3 System Operation Instructions 59 10 4 Service Responsibility 60 Appendix A THE INFORMATION OF EC REPRESENTATIVE 62 Appendix B ACOUSTIC OUTPUT REPORT TABLE 63 Appendix C TRANSDUCER MAXIMUM SURFACE TEMPERATURE 67 Appendix D MEASUREMENT RESULTS SUMMARY 68 Appendix E GUIDANCE AND MANUFACTURER S DECLARATION 69...

Page 6: ...se or 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...

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: ... 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 stated in the immunity declaration the ultrasound system should be observed to verify normal operation If abnormal operation is observed additional measures may be necessary such as re orienting or relocating the ul...

Page 10: ...se 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 includes changes in Cables length material wiring etc System installation layout System configuration components ...

Page 11: ...nted 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 manua...

Page 12: ...ronmental 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 ...

Page 13: ...tibility 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 devices other than those recommended above if the devices and their specifications installation and interconnection with the system conform to the requiremen...

Page 14: ... 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 Thermal Index TI provides a statistical estimate of the potential temperature elevation in centigrade of tissue temperature Three forms of TI are available Soft Tissue Thermal Index TIS Bone Thermal ...

Page 15: ...rasound 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 of ultrasound including education as to potential hazards Operators should understand the likely influence of the machine controls the operating mode e g B mode color Doppler imaging or spectral Doppler and system frequency on thermal and...

Page 16: ...mended Examples of non 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 Avoid frequent re...

Page 17: ... 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 manufacturer to the user So it is very important to have the Ultrasound systems display the acoustic output indices correctly and the education of the user to interpret the value appropriately R...

Page 18: ...ing 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 position For instance the PW mode TI TI is defined as the ratio of the In Situ acoustic power W 3 to the acoustic power required to raise tissue temperature by 1 C Wdeg TI W 3 Wdeg Three TIs corres...

Page 19: ... 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 Exposure Criteria for Medical Diagnostic Ultrasound I Criteria Based on Thermal Mechanisms Report No 113 1992 Operator Control Features The user should be aware that certain operator controls may affect the acou...

Page 20: ...surement 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 depends upon the exam icon and system selected It takes effect when the sy...

Page 21: ...ronment is between 0 to 38 the system can work continuously in normal If the temperature of environment is over 38 C 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 otherwise...

Page 22: ...h 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 terminal 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 the s...

Page 23: ...18 3 3 System Specifications 3 3 1 Console Overview SonoEye P3 system Fig 3 1 a Console Overview Fig 3 3 Firmware Front View SonoEye P3 From left to right Freeze Button P They can be set as None Freeze Unfreeze Gain Gain Depth Depth and Save Image ...

Page 24: ...MHz 4 0MHz Phased Array 3 3 5 System Configuration Function SonoEye P3 B mode B M mode Option PW mode Option CFM mode Option FHI Option Type 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 Unfreez...

Page 25: ...e Option Auto vascular tracking Option Instant AIO Biopsy Guide Option SonoNeedle Option SuperNeedle Option SonoRemote Option Save Cine 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 r...

Page 26: ... System Take extra care when you move the system long distances Use extra care when crossing door or elevator thresholds Caution Walk slowly and carefully when moving the system Be sure the pathway is clear Do not let the system strike walls or doorframe Transporting the System After preparing the system as described above take the following additional precautions Before transporting place the sys...

Page 27: ...owed to connect to the system otherwise there is possibility of electricity shock Connect the connector from the SonoEye P3 system to displayer Caution The system can only be disconnected with displayer while the power supply is off to prevent damage to 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 ...

Page 28: ...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 Freeze 10 Logo 11 Patient information 12 End Exam 13 Connection status 14 Image parameter area 15 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: ...o display 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 f...

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: ...l the 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 termina...

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: ...llipse 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 measurem...

Page 42: ...t in 6 1 Spleen 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 Renal 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 GB Volume Length cm Refer to Distance measurement in 6 1 Width cm Refer to Distance measuremen...

Page 43: ...istance between two points It is a measurement between the two horizontal lines that lean on the two cursors The position of the vertical time line does not affect the distance measurement Distance measurement is the same as distance measurement in B mode 2 Time Time is the measurement between the two vertical time lines created by two cursors The position of the horizontal distance line does not ...

Page 44: ... 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 45: ...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 46: ...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 47: ... 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 48: ...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 49: ...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 Abdomen Cardiac and Lung can be selected 8 4 Setting Press the setting button to enter the setting interface ...

Page 50: ...tal Color Doppler Palm Ultrasound System 45 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 51: ...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 52: ...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 53: ...Digital Color Doppler Palm Ultrasound System 48 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 54: ...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 55: ...t 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 th...

Page 56: ... 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 57: ... 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 58: ...ollowing 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 59: ...maging the system during cleaning and disinfection After each exam clean and disinfect the system CAUTION Prevent any fluid from entering electrical or metal portions of the cable s connector during the cleaning and disinfecting process Damage due to fluid in these areas may result Scrub the system as needed using a soft sponge gauze or cloth to remove all visible residue from the system surface U...

Page 60: ...temperatures in excess of 60 º C will cause permanent damage The transducers are not designed to be totally submerged in fluid as permanent damage will result if the entire transducer is submerged System Safety Handling precautions Ultrasound systems are highly sensitive medical instruments that can easily be damaged by improper handling Use care when handling and protect from damage when not in u...

Page 61: ...ses 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 DO NOT use an expired system sheath Before using a sheath verify if it has expired System handling and infection control This information is i...

Page 62: ... with a soft cloth and rinsing with flowing water Wash the system with mild soap in lukewarm water Scrub the system as needed using a soft sponge gauze or cloth to remove all visible residue from the system surface Prolonged soaking or scrubbing with a soft bristle brush such as a toothbrush may be necessary if material has dried onto the system surface WARNING To avoid electrical shock always tur...

Page 63: ...ed to be totally submerged in fluid Permanent damage will result if the entire transducer is submerged Place the cleaned and dried system in contact with the germicide for the time specified by the germicide manufacturer Ultrasound transducers can easily be damaged by improper handling and by contact with certain chemicals Failure to follow these precautions can result in serious injury and equipm...

Page 64: ...to ensure optimum operation and safety Daily inspect the systems After each use clean the system disinfect the 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 ...

Page 65: ... patient where scanning will be performed After the examination is complete follow the cleaning and disinfecting or sterilizing procedures as appropriate 10 4 Service Responsibility The 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 ...

Page 66: ...uidance for Diagnostic Ultrasound and Fetal Doppler Ultrasound Medical Devices September 8 1989 draft 4 FDA CDRH 510 K Diagnostic Ultrasound Guidance Update of 1991 April 26 1991 draft 5 Biological Effects of Ultrasound Mechanisms and Clinical Implications NCRP Report No 74 December 30 1983 6 Exposure Criteria for Medical Diagnostic Ultrasound I Criteria Based on Thermal Mechanisms NCRP Report No ...

Page 67: ...nd System 62 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 68: ...04 0 04 0 04 0 04 Acoustic Parameters pr α at ZMI MPa 3 09 P mW 0 92 0 92 0 67 P1 1 mW 0 92 0 92 Zs cm 0 90 Zb cm 0 90 ZMI cm 1 15 Zpii α cm 1 15 fawf MHz 7 93 8 20 8 20 10 65 Other Information prr Hz srr Hz 9 00 npss NA 1 00 Ipa α at Zpii α W cm 2 437 39 Ispta α at Zpii α or Zsii α mW cm 2 0 09 Ispta at Zpii or Zsii mW cm 2 0 09 pr at Zpii MPa 4 15 Operating control conditions Focus cm 1 50 5 50 ...

Page 69: ...Acoustic Parameters pr α at ZMI MPa 3 50 P mW 2 68 2 68 2 68 P1 1 mW 2 68 2 68 Zs cm 0 95 Zb cm 0 95 ZMI cm 1 05 Zpii α cm 1 05 fawf MHz 8 24 8 20 8 20 8 20 Other Information prr Hz 245 srr Hz npss NA 1 00 Ipa α at Zpii α W cm 2 450 24 Ispta α at Zpii α or Zsii α mW cm 2 10 26 Ispta at Zpii or Zsii mW cm 2 15 22 pr at Zpii MPa 4 55 Operating control conditions Focus cm 1 50 5 50 5 50 5 50 Depth cm...

Page 70: ... Acoustic Parameters pr α at ZMI MPa 3 17 P mW 2 81 2 81 2 81 P1 1 mW 2 81 2 81 Zs cm 0 75 Zb cm 0 75 ZMI cm 0 75 Zpii α cm 0 75 fawf MHz 5 93 5 93 5 93 5 93 Other Information prr Hz srr Hz 3 54 npss NA 9 00 Ipa α at Zpii α W cm 2 499 13 Ispta α at Zpii α or Zsii α mW cm 2 2 74 Ispta at Zpii or Zsii mW cm 2 2 74 pr at Zpii MPa 3 61 Operating control conditions Focus cm 1 00 1 00 1 00 1 00 Depth cm...

Page 71: ...ameters pr α at ZMI MPa 3 08 P mW 7 11 7 11 7 11 P1 1 mW 7 11 7 11 Zs cm 0 50 Zb cm 0 85 ZMI cm 1 05 Zpii α cm 1 05 fawf MHz 6 67 6 66 6 66 6 66 Other Information prr Hz 4500 srr Hz npss NA 1 00 Ipa α at Zpii α W cm 2 513 21 Ispta α at Zpii α or Zsii α mW cm 2 432 56 Ispta at Zpii or Zsii mW cm 2 710 03 pr at Zpii MPa 3 82 Operating control conditions Focus cm 1 50 7 00 7 00 7 00 Depth cm 8 90 8 9...

Page 72: ...m Ultrasound System 67 Appendix C TRANSDUCER MAXIMUM SURFACE TEMPERATURE Transducer model Maximum surface temperature Contacting human tissue mimicking material Maximum surface temperature Suspending in air SonoEye P3 39 9 36 5 ...

Page 73: ...tem 68 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 74: ...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 75: ...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 76: ...Digital Color Doppler Palm Ultrasound System 71 ...

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