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Legal manufacturer:

WuHan Youkey Bio-Medical Electronics Co., Ltd.
2nd Floor, Dingxin Industry park, Jiayuan Road, East Lake Development District, Wuhan.
430074, PRC*

Production sites:
Wuhan Youkey Bio-Medical Electronics Co., Ltd.
No. 3,6F, Unit 1, North Building of Xingye Building, Science and Technology Park of Wuhan
University, University Park Road, East Lake Development District, Wuhan, provincie Hubei,
PRC*

Authorized manufacturer for Europe:

Shanghai International Holding Corp GmbH (Europe) Eiffestraße 80 20537
Hamburg
GERMANY

Revision date 11/2019

Содержание D8

Страница 1: ...und system Instruction manual Model D8 WuHan Youkey Bio Medical Electronics Co Ltd IMPORTANT Read and understand this manual before operating the equipment After reading keep this manual in an easily...

Страница 2: ...4 Power condition 13 2 3 5 environment condition 13 2 3 6 Probe outline dimensions and weight 14 2 4 system configuration 14 2 4 1 Standard configuration 14 2 4 2 Components 15 2 5 Symbols description...

Страница 3: ...rameter 36 4 6 2 Power mode image optimization 37 4 7 Parameter adjustment about PW mode 38 4 7 1 PW mode image parameter 38 4 7 2 PW mode image optimization 38 5 Measure 41 5 1 Conventional measure 4...

Страница 4: ...Sound power setting 55 9 6 Acoustic power control 56 9 7 Acoustic output description 56 9 7 1 Damping output parameter 56 9 7 2 Acoustic output limit 57 9 7 3 The difference between the actual MI TI v...

Страница 5: ...by improper installation or environmental conditions that do not meet the requirements 2 Damage or loss caused by the supply voltage exceeding the specified range 3 Damage or loss of equipment or comp...

Страница 6: ...are that you must familiarize yourself with the operating instructions before use and operate and use it in strict accordance with the requirements and methods of operation of the operating instructio...

Страница 7: ...ukey Bio Medical Electronics Co Ltd Production address residence 2nd Floor Dingxin Industry park Jiayuan Road East Lake Development Zone 430074 Wuhan PEOPLE S REPUBLIC OF CHINA Contact 027 87797167 Af...

Страница 8: ...cate the safety and other important matters and their specific meanings are as follows Symbols and vocabulary Meaning DANGER Indicates that a hazardous situation may occur and if not avoided may resul...

Страница 9: ...f damaged ultrasound probe may cause the patient to be shocked 5 Before performing an ultrasound check check the surroundings to ensure safe use within the environment Do not operate the unit in an en...

Страница 10: ...will be submitted by the developer If you want a better experience please pay attention to download and upgrade 6 Do not use incompatible coupling agents disinfectants probe protective cover probe pun...

Страница 11: ...pling agent will be solidified on the probe head which will affect the quality of the ultrasound image The probe should be cleaned and disinfected before and after each ultrasonic examination 2 Ambien...

Страница 12: ...not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye 2 3 Product specifications 2 3 1 Imaging mode B mode M mode C mode PW mode Power mode 2 3 2 Software versio...

Страница 13: ...software security Antivirus frequency It is recommended to perform anti virus once a week to protect the system 2 3 4 Power condition Internal Battery 7 4V 2600mAh Charging power input DC 5V 2A Can no...

Страница 14: ...ly Convex array 2 4 1 Standard configuration Main unit 1 set Appendix condensation in the circuit board there is the risk of short circuit 3 Do not operate the unit in an environment with flammable or...

Страница 15: ...al kidney body surface 3 5MHz 2 0 5 0MHz C5 2Ks Large convex transducer Gynecology and obstetrics abdominal kidney body surface 3 5MHz 2 5 5 0MHz C8 5Ks Slightly convex transducer Gynecology and obste...

Страница 16: ...part of the BF application 2 Please refer to the instruction manual for this symbol to avoid accidents 3 This symbol represents the product serial number 4 This symbol represents the date of productio...

Страница 17: ...of the system Serial number Name Function 1 Transducer Transmit and receive ultrasound 2 Main Device Scanning control and data processing 3 Control Panel Operation control 4 Type Cinterface USB C por...

Страница 18: ...er off the scanner 3 Blue blinking the scanner is in freezing status 4 Blue solid the scanner is in scanning status 2 Main menu button 1 Change scan mode 2 Save image in freezing status 3 Battery ligh...

Страница 19: ...op up the probe selection dialog box Probe type Displays the currently used probe model or the default probe model Inspection type Displays the type of examination currently in use such as abdomen hea...

Страница 20: ...pause to get the spectrum It s the same function as update Drop down menu flag click to enter the corresponding image mode of all parameters adjustment Image parameter adjusting pulley Slide up and do...

Страница 21: ...ital Information Time Show the time that is the date and time of the system The date and time and display format preset path is preset system preset composite preset Time as the image freezes when the...

Страница 22: ...area A thumbnail showing a stored image or movie under the current patient s examination Thumbnail control area Page turning When you save an image with more than one page of thumbnail click button to...

Страница 23: ...passwords browse all patient information Ordinary account Can only manage patient information under this account First aid mode No need to log in to the password only the patient information under the...

Страница 24: ...ight work Battery level indicator Two grids are always bright More than 75 of electricity One grid is always bright left 50 75 of electricity One grid is always bright right 25 50 of electricity Slow...

Страница 25: ...ble and power adapter to charge the scanner to full capacity The battery have self discharge rate about 1 one day You need to charge and discharge the scanner every month no mater you use it or not Wh...

Страница 26: ...eat when connect the display device to the scanner WAR NING 1 The use of abnormal heating probes may burn patients 2 If any abnormality is found the probe is faulty Turn off the scanner immediately an...

Страница 27: ...ediately Android Connect the straight USB C to the scanner USB C port connect the elbow USB C to the Android device and you will get images immediately 4 Detailed operation introduction 4 1 Image mode...

Страница 28: ...o dimensions by assigning a brightness level based on the echo signal amplitude To achieve the best possible image quality properly adjust the display brightness gain depth settings viewing angle and...

Страница 29: ...nsated and the depth gain is adjusted in different segments Effect By adjusting the signal gain in a specific depth range the echo of the tissue image is uniform Frequency Resume The emission frequenc...

Страница 30: ...ch improves the contrast resolution and reveals the location of the lesion more easily L R Flip U D Flip Resume By changing the way the image is displayed to obtain a better viewing angle the vertical...

Страница 31: ...c tissue optimizations fat fluid routine and muscle 4 4 Parameter adjustment about M mode Motion mode M Mode is an extension of B mode It provides a trace of the B image displayed over time A single b...

Страница 32: ...uency value is displayed in real time on the image parameter area on the left side of the screen There are three frequency modes in the fundamental wave or the harmonic wave penetrating power conventi...

Страница 33: ...pseudo color maps which are effective for real time frozen and movie playback images Gray Map Resume Adjust the black and white gray scale contrast to optimize the image Effect D8 pocket ultrasound sy...

Страница 34: ...ft side of the screen provides real time parameter information which allows you to adjust the following parameters Adjustment method Parameter term Control panel adjustment Gain depth SoftKey adjustme...

Страница 35: ...ustic beam in color mode thus changing the angle between the acoustic beam and the direction of blood flow is only effective for the linear array probe Wall filter Resume The low frequency noise cause...

Страница 36: ...of the image evenly and the detection depth also increases Influence In clinical application proper sound power should be selected according to the actual situation and ALARA sound power principle 4 6...

Страница 37: ...ain value is displayed in real time in the image parameter area above the screen Effect If the gain is too high it will amplify the noise if the gain is too low it is easy to lose the blood flow signa...

Страница 38: ...ng the image parameter area on the left side of the screen provides real time parameter information which allows you to adjust the following parameters Adjustment method Parameter term Control panel a...

Страница 39: ...Corresponding to the adjustable contrast range of the image the larger the dynamic range the richer the level of image display and more information but the noise will also increase Influence This fea...

Страница 40: ...esume The correction angle is adjusted rapidly by 60 degrees step and the angle value is displayed on the right side of the spectrum map in real time Influence This feature is valid for real time froz...

Страница 41: ...and identify the characteristic lesions in the fluctuation cycle Influence This feature is valid for real time frozen and movie playback images Invert Resume Turn on this function to flip the spectrum...

Страница 42: ...and perimeter of a closed curve area on the ultrasound image Length ratio Measure the length of the two lines on the ultrasonic image and calculate the ratio Area ratio Measure the area of two enclos...

Страница 43: ...e This product provides the following application measurement capabilities Conventional measurement Abdominal application measuring package Obstetrical application measuring package Gynecological appl...

Страница 44: ...ion It is often necessary to add comments to ultrasound images during diagnosis D8 pocket ultrasound system supports two annotation types typing characters and indicating arrowheads 6 3 Body mark for...

Страница 45: ...15 15 15 C Maximum detection depth mm 180 170 60 60 60 D lateral resolution mm 2 depth 80 3 80 depth 130 2 depth 80 3 80 depth 130 2 depth 50 1 depth 50 2 depth 50 E Azimuthal resolution mm 1 depth 80...

Страница 46: ...tly identified and there is no aliasing It can be correctly identified and there is no aliasing PW P Service frequency MHz 2 0 3 5 2 5 3 5 5 0 6 0 6 0 7 5 5 0 6 0 Q Depth of investigation mm 120 120 4...

Страница 47: ...it Operation steps for reference only 1 Put coupling agent into the probe cover to get clear images 2 Ensure sterility when the probe goes into the protective cover Making the protective cover proper...

Страница 48: ...er each detection The machine shall be off during cleaning and disinfection process CAUTION 1 During cleaning or disinfection please wear antibacterial gloves to prevent infection 2 After disinfection...

Страница 49: ...on please refer to the instructions on concentration of disinfectant solution and disinfection methods provided by the manufacturer After cleaning wipe the probe with sterilizing cloth or gauze then l...

Страница 50: ...case of probe failure Product must be sent back to the company for repair Check the following items after cleaning and disinfection Inspection items Inspection methods Acceptance Criteria Acoustical l...

Страница 51: ...o exit the puncture status 8 2 Puncture lead calibration Put the biopsy guide and transducer Acoustical lens under water Make sure the rubber of the transducer is above the water Click calibrate to al...

Страница 52: ...increasingly concerned about the application of ultrasonic technique in diagnosis and may lead to the potential risk of biological effect 9 2 Caution use declaration Although there is no confirmation...

Страница 53: ...he organization micro bubbles increasing vibration and the results diabrosis this reaction is called cavitation MI said the possibility of pressure cavitation effect MI value is obtained by the square...

Страница 54: ...ct 9 4 2 MI TI display instructions TI and MI display on the screen of centre The operator should monitor these index values in the inspection process and to ensure that in the premise of effective di...

Страница 55: ...output limit depending on the selected mode of the probe surface temperature rise and the provisions of the FDA acoustic output of each probe Be careful When you turn on the scanner change transducer...

Страница 56: ...s scanning and non scanning mode the thermal effect with M Doppler Color are closely related The attenuation of the tissue is directly related to the change of the probe and its frequency The image de...

Страница 57: ...play uncertainty The displayed MI and TI values are based on calculations that use a set of acoustic output measurements that were made using a single reference ultrasound system with a single referen...

Страница 58: ...eeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued by FDA in 2008 6 Medical electrical equipment Part 2 37 Particular requirements for the basic safety and essential pe...

Страница 59: ...95 TR 9 627 L11 4Ks TMM Normal B C PW 23 140 24 330 TF 29 421 TR 5 091 L11 4Ks Still Air Normal B C PW 22 380 23 340 TF 34 73 TR 11 390 C8 5Ks TMM Normal B C PW 24 656 25 740 TF 31 553 TR 5 813 C8 5Ks...

Страница 60: ...me Cable length m Whether to shield or not Remarks 1 DC input power cord 1 5 yes 2 C5 2Fs Probe cable 1 5 yes 3 C5 2Ks Probe cable 1 5 yes 4 L11 4Ks Probe cable 1 5 yes 5 L11 4Gs Probe cable 1 5 yes 6...

Страница 61: ...tive radiated power 1 TX power 18 0dBm 1DSSS 14 5dBm 54OFDM 2 RX sensitivity 95 7dBm 1DSSS 74 0dBm 54OFDM 10 The guide and manufacturer s statement are detailed in the following table Table 1 Electrom...

Страница 62: ...r hospital environment Surge IEC 61000 4 5 1 kV Differential mode 2 kV common mode 1 kV Differential mode 2 kV common mode The power quality of the network must be a typical commercial or hospital env...

Страница 63: ...1 2 x P 80 MHz to 800 MHz d 2 3 x P 800 MHz to 2 5GHz Among them P is the rated maximum output power of transmitter manufacturers is a unit of Watt D is the recommended distance the units are in mete...

Страница 64: ...nce between the proposed system and portable mobile RF communication equipment The following suggestions to keep the distance is calculated according to the maximum output power of communication equip...

Страница 65: ...ries of ultrasonic pulses that generate scanning lines that do not follow the same acoustic path Scanning mode Parameter B mode Gain 0 100 tunable Maximal acoustic output 10 100 tunable Depth C5 2Fs p...

Страница 66: ...nces in all homogeneous materials in the parts of the SJ T11363 2006 in the specified limits requires the following The toxic and harmful substances exceeded the limitation of SJ T11363 2006 standard...

Страница 67: ...ut power after attenuation P1 Bounded output power pi Pulse sound pressure square integral pr Peak sparse sound pressure pr a Peak sparse sound pressure Prr Pulse repetition frequency TI Thermal index...

Страница 68: ...94 0 20 0 20 N A Index component value 0 20 N A 0 20 N A Acoustic Parameters 1 56 P mW 25 39 25 39 N A P1x1 mW 14 03 14 03 ZS cm N A Zb cm N A ZMI cm 2 58 ZPII cm 2 58 2 76 2 76 2 76 N A Other Informa...

Страница 69: ...ucer Model C5 2Fs Operating Model M At surface Below surface At surface Below surface Index label Maximum index value Index component value Acoustic Parameters Other Information Operating control cond...

Страница 70: ...omponent value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Table 201 103 Transducer Model C5 2Fs Operating Model B C At surface Below surface At...

Страница 71: ...del C5 2Fs Operating Model B P At surface Below surface At surface Below surface Index label Maximum index value Index component value Acoustic Parameters Other Information Operating control condition...

Страница 72: ...dex component value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Table 201 103 Transducer Model C5 2Ks Operating Model B M At surface Below surfac...

Страница 73: ...value Acoustic Parameters Other Information Operating control conditions Table 201 103 Transducer Model C5 2Ks Operating Model B P At surface Below surface At surface Below surface Index label Maximu...

Страница 74: ...e Index component value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Table 201 103 Transducer Model L11 4Ks Operating Model B At surface Below sur...

Страница 75: ...ponent value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Speed Table 201 103 Transducer Model L11 4Ks Operating Model B C At surface Below surfac...

Страница 76: ...component value Acoustic Parameters Other Information Operating control conditions Table 201 103 Transducer Model L11 4Ks Operating Model PW At surface Below surface At surface Below surface Index la...

Страница 77: ...ndex component value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Table 201 103 Transducer Model L11 4Gs Operating Model B M At surface Below surf...

Страница 78: ...t value Acoustic Parameters Other Information Operating control conditions Table 201 103 Transducer Model L11 4Gs Operating Model B P At surface Below surface At surface Below surface Index label Maxi...

Страница 79: ...ue Index component value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Table 201 103 Transducer Model C8 5Ks Operating Model B At surface Below sur...

Страница 80: ...e Index component value Acoustic Parameters Other Information Operating control conditions Focus mm Depth mm Frequency MHz Speed Table 201 103 Transducer Model C8 5Ks Operating Model B C At surface Be...

Страница 81: ...alue Acoustic Parameters Other Information Operating control conditions Table 201 103 Transducer Model C8 5Ks Operating Model PW At surface Below surface At surface Below surface Index label Maximum i...

Страница 82: ...sites Wuhan Youkey Bio Medical Electronics Co Ltd No 3 6F Unit 1 North Building of Xingye Building Science and Technology Park of Wuhan University University Park Road East Lake Development District W...

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