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WED-380

1. S 12 2 S Technicabspeel 13 DP VO CG EE E NE 14 e ale EIE M M n Ms M a a 14 2 6 Equipitient CODSLUPUeTIE M 14 2 62 Standard COMM OUTA ION 14 Ee 14 Chapter d hree JEnstallaliofi 00 16 3 1 Operating environmental requirements 16 2 2 NPAC KAO TS PSC LOIN 16 lt _ 2 3 23 2 lt 2 lt 3 _ 6 16 3 4 Rguipotentral COMMCCHOM 6 __2 22222323322323 2 ____ _ 17 Chapter Four Keyboard and Trackball Operation 18 Fh PN eee A ee EDEN 18 2 2 Ope bavi Ke 18 A e Mure p 24 Chapter Five Operation Procedutes aec etu e ecu tdt dtes db obe cis dubi en bees uni 25 Ss I start4he Cqurptilell caa ce EORUM n Does oO 25
2. ee 52 p 53 TOC omnee rusade EE eegene EE 54 Tr AInstrameonttest and CallDEMU OTI eeben 55 Chapter Eight Transportation Stora 6 parere tees 56 8 1 Environmental Requirements for Transportation and Storage ccc cccsssssssccceeeeeeeeeeeeceeeeeceeeeeeeeeeeeeeeeees 56 ______3_ _2 2C 224 2 222 lt 9 2 99 56 Mae 01i 56 Chapter Nine Malfunction Examination and 2221 42 2 0000000000000000000000004000000000000 57 57 I 9 9 gt 57 Appendix A E ER S a Renee a ema ee cee Se eS 58 ba a ee eee 60 Appendix Gestational 70 2 WED 380 English User Manual V1 3 Manufacturer Information Manufacturer Information Name Shenzhen Well D Medical Electronics Co Ltd Add F12 N F13 New Energy B D Nanhai Ave Nanshan District Shenzhen
3. 25 tu utet t Ced du oe dumm d aM d eue cM ere ee 25 5 4 Routine Measurement usas oc ctam ate 28 Distance measure men __ _ _ __ 28 542 Circumtetence and Area Measure FO IE uicti nee tinet aote Tin d ete odi e Tin ete deed 29 2 49 Volume ona Eege 30 32 5 5 Rett Ventricular Measurement a 32 I M 33 WED 380 English User Manual V1 3 Content 52523 Mitral Valve Measurement ze Cures atu ee 34 Pulmiobaty Vake Measure 6 M 35 3 95 eene Valve Measure Ime IMX e cas uei 36 9 945 Heart late Measurement 55 0 d peo bito 37 5 6 Cine loop and image storage function 38 SX UM mase storage BITTE See 38 Teea NET at ea cise T P 39 25 0 2 Cane 0 0 0 _ _ 3 ____________ _ _ _ _ _ Pint fs 39 Cale UlA O
4. Focus number selection Press this key to lighten up the FPIN on the screen right top press again to change the focus numbers There are two focus at most Press this key to switch between one focus to two Span Focus space selection When set the focus number as two their distance can be adjusted There are 5 levels focus space D2 D3 D4 DS D6 and press this key repeatedly to switch among them circularly er Scan angle selection key Press this key to lighten up the ANGLE on the up right screen press 6 change the scanning angles The angel range is C1 6 20R 5 0MHz ECI I R13 6 5M L3 1 7 5MHz HF linear probe Micro convex Endo cavity EL3 1 7 5MHz Endo rectal C3 1 60R 3 5MHz Convex probe probe probe probe Tips Reduce the angle can improve the image frame rate and increase cine loop frames DR Dynamic range adjusting key WED 380 English User Manual V1 3 23 Chapter Four Keyboard and Trackball Operation Press this key to lighten up DR on the screen top right corner Pres to adjust the dynamic range between 100dB 130dB 118 dB is recommended Adjusting key Press to adjust scan depth between 40mm 240mm The current depth displays at bootom screen see figure 4 1 The depth adjusting range of each probe is given below EL3 1 7 5 MHz C1 6 20R 5 0MHz C3 1 60R 3 5MHz Endo rectal probe ECI 1 13R 6 5MHz Probe mode Micro Convex prob
5. Up down left right black white Distance circumference area volume heart GA FW EDD Date time name sex age doctor hospital name full screen words edit T High speed USB 2 0 device WED 380 English User Manual V1 3 13 Chapter Two System Introduction 2 4 Block Diagram Digital wave bundle Correlation M Mode synthesize AS Processing Address Transmitting Control Video Video Frame B Mode Regulation synchronizat amp Synthesizing RAM Address Crystal Diagram and Gray Read and Oscillator CPU Character Levels Write Control Figure 2 4 Electric principal block diagram 2 5 Basic principle Digital Ultrasonic Diagnostic System works in this following procedure different tissues of human body possess different densities and speeds of transmission of ultrasound 1 different acoustic impedance product of media density and sound speed when piezo chip transductor gets certainly regulated electric impulse it will produce ultrasound with certain frequency when this ultrasound sound energy is injected into human body different organ surfaces will produce reflection echo the different size reflection is received by the transductor which emitted ultrasound and is changed into electric impulse when this electric impulse is amplified demodulated digital scanned shifted and some other handling video standard signal is produced and organ cross sectional images are
6. Appendix C Gestational Table Biparietal diameter BPD Table Set1 Tokyo University Method BPD WEEKS S D BPD WEEKS S D mm w d days mm w d days 7 56 23 0 11 7 58 2920 11 4 60 24 2 12 4 62 25 0 12 0 7 64 25 6 12 6 7 66 26 3 19 Bei T 68 218 13 6 7 70 28 0 13 2 E 29 0 14 0 74 29 5 14 E 8 76 30 1 15 0 78 Sch 16 UD 8 80 92 4 16 S 9 82 33 0 18 0 9 84 34 0 20 59 86 3520 25 id 88 31 0 28 0 90 39 0 25 4 92 42 0 20 i WED 380 English User Manual V1 3 77 Appendix C Gestational Table Biparietal diameter BPD Table Set2 Hadlock F P et al Method WEEKS BPD WEEKS V d days mm w d days 60 24 16 14 11 6 4 16 1222 9 62 29 1 16 18 12 6 9 64 25 6 16 20 13 1 9 66 26 4 16 22 13 4 9 68 16 24 14 1 9 10 28 1 16 26 14 4 9 Ce 28 6 16 28 15 0 9 14 29 9 16 30 15 4 9 16 30 4 22 32 16 0 9 8 01 2 22 34 16 4 9 80 02d 22 36 17 0 9 82 33 0 22 38 17 4 g 84 39 6 22 40 18 1 14 86 34 9 22 42 18 5 14 88 30 4 22 44 19 2 14 90 36 4 24 46 19 6 14 92 925 24 48 20 4 14 94 2622 24 20 14 96 99 1 24 52 21 6 14 98 40 1 24 94 ACD 14 100 41 1 24 29 1 14 58 29 0 14 78 WED 380 English User Manual V1 3 Appendix C Gestational Table Abdominal circumference AC Table Set1 Hadlock F P et al Method AC WEEKS 95 Conf AC WEEKS 95 Conf mm w d Limits mm w d Limits 100 16 9 230 21 9 23 0
7. electromagnetic emission The WED 380 Full Digital Ultrasonic Diagnostic System is intended for use in the electromagnetic environment specified below The customer of the user of the WED 380 Full Digital Ultrasonic Diagnostic Systemshould assure that it is used in such and environment Emission test Compliance Electromagnetic environment guidance The WED 380 Full Digital Ultrasonic Diagnostic System uses RF energy only for its internal function Therefore its RF emissions are RF emissions Group CLSPR 11 very low and are not likely to cause any interference in nearby electronic equipment RF emission CLSPR 11 Harmonic emissions IEC61000 3 2 Voltage Class B Class A The sample WED 380 is suitable for usage in any facility including household and the public low voltage supply network connecting to residence fluctuations Complies flicker emissions IEC 61000 3 3 6 WED 380 English User Manual V1 3 Preface Guidance and manufacture s declaration electromagnetic immunity For EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The WED 380 Full Digital Ultrasonic Diagnostic System is intended for use in the electromagnetic environment specified below The customer or the user of WED 380 Full Digital Ultrasonic Diagnostic System should assure that it is used in such an environment Immunity IEC 60601 Compliance
8. 0434 Temperatura AQ0 C 55 Relative humidity range 10 amp 1006 Atmospheric prassure range SOKPa 108KPa MODEL QTY N W G W MEAS 435x365x463mm Appendix A Lables Diagram Storage and transportation canditian Temperature AD C 55 C 0434 humidity range 1055 1008 Atmospheric prassurme range 5OKPa 1T065KPa MODEL O IlnL L N W G Wi MEAS 435x365x463mm Full Digital Ultrasonic Diagnostic System DC Wellkang Ltd H 29 Harley Mrest LONDON Wi MJE England United kingdoe Telda C20 BBIGS3OS Faresa 200 76811874 http wwwCE markisg com E mail Auth RepirCEmarking org Modification on the above information may not be further notified WED 380 English User Manual V1 3 59 Appendix B Sound Output Specifications Table Appendix B Acoustic output reporting table B mode Nominal frequency 3 5MHz Trans ducer Model C3 1 60R 3 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label Maximum index value P mW Min of Pa Zs lzpta aZs mW cm cm Associated acoustic parameters 5 Nr 2 at max Joe 5 30 Zp fa 1 64 wf Dim of Aaprt IX s s E sg e CH 3 usec rr Hz iicet at max MPa deg at max lpi loa a at max MI W cm Operating Power 80 control conditions Angle Focus position Notes Ca Th
9. 518054 Guangdong P R China Tel 0086 755 26073353 0086 755 26073350 Fax 0086 755 26411198 Email export welld com cn Authorized agency in EU Name Wellkang Ltd Add Suite B 29 Harley Street LONDON WIG 9QR England United Kingdom Tel 44 20 88168300 88168309 79934346 79276844 Fax 44 20 76811874 Web www CE marking com www CE marking org www CEmarking org E mail AuthRep CEmarking org CE mark WED 380 English User Manual V1 3 1 Preface Preface Copyright This publication including pictures and illustrations is property of Shenzhen Well D Medical Electronics Co Ltd and under protection of international copyright law Version V1 3 P N No WED 20 09009E Statement Information in this document are not annotated to change The manufacture shall not state nor observe any warranty basing on this point and definitely give up any implied warranty basing on any special purpose of selling or making benefit Without previous written permission from the producer this document must not be photocopied reproduced or translated into other languages We preserve the right of revision on this document without still further notice Some pictures in this manual which are schematic diagrams for indication only may disaccord with the real object and then the real object should be regarded as the final D i are trade marks of Shenzhen Well D Medical Electronics Co Ltd Any abuse of these trade marks
10. CC WED 380 Full Digital Ultrasound Diagnostic System User Manual SHENZHEN WELL D MEDICAL ELECTRONICS CO LTD Content Content 1 EE M 2 M 2 SIC III C 2 EEN 2 Mates eed ACS UCDO IN enc 2 SALLY 3 4 General TIPS TOF device 03690 desistere di intei 4 General sarety EE 4 Execution Standard 5 22 6 3 3 lt 2 2223 2322 3 33 ___3__ _ _ _ _ _ _ _ _ 10 __ _ 23252625 11 TPC T x C 11 2 Range of Applicaton utate hee da tue uut Dukes 11 IBS rays E 11 Chapter lw Ors y Stemi 12 PAN PPPS ALAIN asso T T m 12 2 2
11. Figure 5 5 Circumference and area measuring sketch Ellipse method and Alare the circumference and area of the first group data C2 and A2 are the circumference and area of the second group data C1 C2 is the ratio of the two circumferences A1 A2 is the ratio of the two areas 5 4 3 Volume measurement Volume can be measured in two ways 1 Volume measurement utilizes 3 axle method to measure 3 groups of distances and then calculate them 30 WED 380 English User Manual V1 3 Chapter Five Operation Procedures Measure To fulfill volume measurement first measure three distances and then press key to get the volume Measure If the measured distance data is less than three groups pressing does not get volume if four distances Measure information are measured when pressing key the result is the value of the first three data D1 D2 D3 Operation procedure take kidney as an example 1 Get the kidney cross section image and profile section image respectively and freeze them 2 Measure the long axis and short axis lengths of kidney cross section with distance measurement method 3 Measure the diameter of kidney profile section with distance measurement method Measure 4 Press key to fulfill volume measurement The volume cost displays at the lower right corner of the screen behind Vm1 as the following figure shows Figure 5 6 Double B mode volume measurement sketch 3 axil metod 2 Utilizes ellipse meas
12. pr at max lpi deq at max lpi at max W cm F PIN Operating Power control conditions Angle Focus position Notes This probe is not intended for transcranial or neonatal cephalic use 62 WED 380 English User Manual V1 3 Appendix B Sound Output Specifications Table Acoustic output reporting table M mode Inc B mode Nominal frequency 5 0MHz Transducer Model C1 6 20R 5 0MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label Min of Pa Zs lzpta aZs mW Associated acoustic parameters Z at max Joe deq Zp Other information P at max 1 deg at max lpi cm laa at max MI W cm 119 1 Operating conditions ELE Notes TIS This probe is not intended for transcranial or neonatal cephalic use WED 380 English User Manual V1 3 63 Appendix B Sound Output Specifications Table Acoustic output reporting table B mode Nominal frequency 7 5MHz Transducer Model L3 1 7 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label Associated acoustic parameters deq Zp cm Dim of Aaprt Y ise prr Hz 5649 at lpi MPa information P is deg at max lpi cm Loo at max MI W cm 109 6 Operating control Power conditions Focus position Notes This probe is not intended for transcranial or neon
13. press any key except letter number keys to exit To cancel input you can press any key The name will display after NAME on top of the screen For example input WANG NING then press any non character Zoom key e g to finfish input Press to select 2 PID to put in patient ID 8 characters at most The PID input box is given bellow PLEASE ENTER PID After input press any key except letter number keys to exit To cancel input you can press any key The PID will display after PID on top of the screen Press select 3 AGE to put in patient age 3 characters at most The age input box is given bellow PLEASE ENTER AGE After input press any key except letter number keys to exit To cancel input you can press any key The age will Measure display after AGE on top of the screen For example input 27 then press any non number key e g finfish input Press to select 4 SEX to put in patient sex The input box is given bellow PLEASE ENTER SEX 1 MALE 2 FEMALE 1 2 Press to select 1 MALE and to select 2 FEMALE Press to select 5 COMMENT to enter image notation Move the track ball cursor the you can annotate anywhere in the image When finishing press COMMENT key on the board to end this operation 26 WED 380 English User Manual V1 3 Chapter Five Operation Procedures Press to select 6 TIME to mod
14. to select 6 GAMA to lighten up GM on the up right of the screen There 4 levels GMO GM1 GM2 GM3 press 6 select them circularly Tips This function is set for video output and external devices e g video printer adjustment and is recommended to set at OFF during operation 7 Press to select 7 HISTOGRAM to process histogram statistics as the following procedure At freeze press post process key to display the menu select 7 HISTOGRAM to call out a rectangle window on the image press Measurement key to calculate the gray scale pixel numbers The result displays on screen right as the following figure shows 44 WED 380 English User Manual V1 3 Chapter Five Operation Procedures B ND Figure 5 10 Histogram sketch Horizontal ordinate indicates gray scale degree vertical ordinate indicates number PT indicates total quantity of pixel dots in the rectangular window Gm indicates the corresponding gray scale of the curve at the vertical peak Pm indicate the quantity of pixel dots at Gm gray scale From the above figure in the rectangular area the total number of pixel dots 1s 10000 At dray scale 46 there are 262 dots the most image pixel dots Press select 8 EDGEE to lighten up the EE on the up right screen Then edge enhancement is adjustable There 9 levels EEO EES8 which can be adjusted by pressing This fun
15. 29 9 105 16 1 0 240 28 26 0 30 4 4 4 245 29 9 26 5 30 9 20 250 29 4 21 0 31 4 i 299 29 5 Se rh d 260 30 1 CC T eZ 265 30 4 27 6 33 6 4 210 oL 28 1 34 1 e xi 219 31 4 28 6 34 6 4 85 280 oz 29 Jee 0 0 285 32 4 29 6 6 io 4 290 33 1 30 1 36 1 295 33 4 30 6 36 6 e Se 300 34 1 29 1 905 34 4 31 6 37 6 1 ac 310 I 92 1999 1 4 315 30 4 92 6 36 6 I 8 320 1 6 38 6 4 929 36 4 34 1 39 1 0 2 330 97 1 34 6 39 6 4 335 37 4 30 1 40 1 1 340 38 0 39 6 40 6 349 38 5 36 2 41 2 Se 350 99 1 96 7 41 7 d 29 300 29 9 37 2 42 2 0 D 9 WED 380 English User Manual V1 3 79 SHENZHEN WELL D MEDICAL ELECTRONICS LTD F12 North New Energy B D Nanhai Ave Nanshan District Shenzhen 518054 P R China Tel 0086 755 26073353 Fax 0086 755 26073350 Http www welld com cn www welld net Email export welld com cn Dated in Feb 2009 Version V1 3 PN WED 20 09009E
16. Inc B mode Nominal frequency 7 5MHz Transducer Model EL3 1 7 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD TIS Index label bp Z Associated acoustic Zy parameters deq Zp cm Dim of Aaprt E prr Hz 5681 Other information Pr at max lp MPa deg at max lpi cm I at max W cm 240 0 control conditions Notes a This probe is not intended for transcranial or neonatal cephalic use WED 380 English User Manual V1 3 69 Appendix C Gestational Table Appendix C Gestational Table Head circumference HC Table Set1 Hadlock F P et al Method HC WEEKS HC WEEKS S D mm w d days mm w d days 0 8 210 2924 11 8 217 2220 11 8 224 24 A 15 N 8 291 2054 15 JD 8 238 25 6 15 1 8 245 26 4 15 4 8 292 2 15 0 8 259 28 1 15 E 8 266 29 0 15 6 8 219 29 6 15 8 8 280 30 5 2 6 8 287 31 4 21 22 8 294 32 4 21 6 301 21 308 34 3 21 6 315 29 2 19 4 322 36 3 19 0 329 37 3 19 4 336 38 4 19 24 343 39 4 19 6 350 40 5 19 ES 70 WED 380 English User Manual V1 3 Appendix C Gestational Table Femur length FL Table Set1 Tokyo University Method FL WEEKS D FL WEEKS D mm w d days mm w d days 42 24 5 24 CO 0 44 Z0 29 4 46 26 0 25 1 46 21 0 29 9 20 28 0 29 22 29 0 30 0 94 20 3 30 4 30 2 30 sc 58 31 3 32 60 39 0 38 4 62 3
17. Report Prompt Annotation eYou can press the See key on the report interface and then annotate information in the annotation box but other contents can not be changed e n the obstetrics report 1 2 3 means that biparietal diameter BPD femur length FL Crown rump length CRL and gestational sac GS can be measured at most for three times and AVG is the average value of the three measurement results TOTAL AVG is the average value of the gestational age GA and expected date of delivery EDD ein the obstetrics report fetal weight BPD AC is calculated through the biparietal diameter BPD and abdominal circumference AC and when the measured BPD and AC are unequal to zero fetal weight will display here automatically Report e Press the key to exit the report 5 9 Image processing Image Proc Press key to display the image processing menu as given below It provides image positive negative flip GAMA calibration statistic histogram edge gain and other image processing functions WED 380 English User Manual V1 3 43 Chapter Five Operation Procedures NORMAL SHARPI SHARP2 THI POS NEG GAMA HISTOGRAM EDGEE EXIT 1 Press amp 3 to select NORMAL SHARPI SHARP2 4 Press to switch on or switch off the THI R60 Probe 5 Press select 5 POSI NEGA to change the image polarity as given below Figure 5 9 polarity sketch 6 Press
18. displayed on the monitor 2 6 Equipment constituent 2 6 1 Standard configuration pieces Mainframe C3 1 60R 3 5MHz convex array L3 1 7 5Mhz HF linear probe OR EC1 1 13R 6 5MHz endo vaginal probe PS cable High speed USB cable 2 pieces of fuse tube F2AL250V Coupling gel 250ml User Manual Final examination report Packing List Ah 42 2 12 9 9 6 2 6 2 Optional pieces C1 6 20R 5 0MHz micro convex probe 14 WED 380 English User Manual V1 3 Chapter Two System Introduction EL3 1 7 5MHz endo rectal probe Video printer WED 380 English User Manual V1 3 15 Chapter Three Installation Chapter Three Installation 3 1 Operating environmental requirements a Environment temperature range 5 C 40 C b Relative humidity range lt 80 c Atmosphere pressure range 86KPa 106KPa d Power supply ACII0V 130V 220V 240V 50Hz 60Hz When using avoid strenuous vibration keep it away from devices with high field intense magnetic field or high voltage avoid strong sunlight blazing down on the display keep the device well ventilated moisture proof and dustproof 3 2 Unpacking inspection After unpacking check the device according to Packing List and install it according to requirements and methods described in Installation after affirm that there is no shipping damage 3 3 Installation 1 Check the power supply too see if it is in the expected range then connect the equipment and
19. in this direction Turn for Clear cance 2 press or key to exit the puncture guiding line WED 380 English User Manual V1 3 51 Chapter Seven Check and Maintenance Chapter Seven Check and Maintenance 7 1 Check Check the device power cord and probe cable and waterproof cover if find any damage or breakage must not use the device and replace the broken immediately 7 2 Service life Bases on the manufacturer s design production related files this model s use life is six years The Product s material will gradually aging if the product continually use over the designed use life it may bring the problem of the performance reduced and fault rate raise Note The Discard the device according to local law Do not discard it mixing with other household garbage 7 3 Main unit maintenance Instrumentation environment should accord with 3 1 operation environmental requirement If device enclosure needs cleaning shutdown the device first and then wipe with alcohol sponges Device should not turn on and off frequently When the device does not work for a long time pack the device according to the instructions on the packing Store it properly in the warehouse The storage environment should accord with 8 1 Transportation and storage environmental requirements 7 4 Probe maintenance Probe is an expensive part and frangible Never hit it or drop it on floor When not working place the
20. in the Diastolic Period mm IVSS Thickness of the Interventricular Septum in the Systolic Period mm LVEDV Left Ventricular Volume at the end of the Diastolic Period ml LVESV Left Ventricular Volume at the end of the Systolic Period ml SF Systolic Fraction EF Ejection Fraction SV Heartbeat Volume ml CO ECG Output ml 5 5 2 Aortic Valve Measurement Calculate the aortic valve diameter open size of the aortic valve and the ratio between the aortic valve and left atrium to study the aortic valve Operation Procedure 1 Enter the mode and move the trackball to change the position of the sampling line Press the Freeze key when proper M mode image appears Maasura 2 Press the key and the cardiac measurement menu will appear 3 Press the 2 key to select and a vertical time bar will appear in the M image WED 380 English User Manual V1 3 33 Chapter Five Operation Procedures Confirm 4 Move the time bar to the end of the diastolic period with the trackball and press the key mark the Confirm anterior wall of the aortic valve D1 and the posterior wall of the aortic valve D2 with the key the second time bar will appear after the marking Confirm 5 Move the time bar to the open point of the aortic valve with the trackball and press the key mark the anterior lobe of the aortic valve O1 and posterior lobe of the aortic valve O2 with the same method
21. on the front panel 2 Adjust the 8 level TGC and the total gain knob on the front panel 3 Clean the screen optical filter Unclear near field 1 Adjust the total gain knob on the front panel and the 8 level TGC 2 Adjust the focus position to the near field Unclear far field 1 Adjust the total gain knob on the front panel and the 8 level TGC 2 Adjust the focus number space and position to set the focus in the far field WED 380 English User Manual V1 3 57 Appendix A Labels Diagram Appendix A Labels Diagram 1 WED 380 Main unit name plate diagram R WED 380 Full Digital Ultrasonic Diagnostic System Power Supply AC110V 130V 220V 240V 50Hz 60Hz Power Consumption 100VA SHENZHEN WELL D MEDICAL ELECTRONICS CO LTD C es MADE IN CHINA S F 1 North New Energy Bldg Nanhai Ave Nanshan District shenzhen 518054 China 2 WED 380 device probe label diagram adi C3 1160R13 5MHz 3 WED 380 device optional probe nameplate diagram C1 6 20R 5 0MHz EC1 1 6 5MHz d 13 1 7 5 2 58 WED 380 English User Manual V1 3 4 WED 380 Packing diagram Full Digital Ultrasonic Diagnostic System w Shenzhen Welt D Medical Electronics Co n I1II I 2 New Energy Hldg Nanhai Avd Nanshan Metric Shenzhen Guangdong 518054 IER China OI DN TUE EL Far Digi 755 2541 1 158 http com cn E mailcsport rwelld con cn Storage ard transportation condition
22. 4 0 42 22 64 39 0 46 9 66 36 5 20 9 68 38 0 D7 229 70 40 0 64 0 2 40 2 64 0 WED 380 English User Manual V1 3 71 Appendix C Gestational Table i FL mm Table Set2 Hadlock F P et al Method WEEKS w d CO 0 4 sch 9 id 0 4 1 4 22 0 9 18 1 29 4 Femur length FL S D FL days mm A6 48 50 92 04 56 58 60 62 64 66 68 70 12 T4 76 78 80 82 WED 380 English User Manual V1 3 WEEKS w d 20 26 26 Z2 28 29 30 ol 32 33 34 34 35 36 37 38 39 40 42 2 1 6 O n OF Ca OF oa oOo oq N gt A S D days 15 15 15 15 15 15 Al 21 21 21 21 21 21 22 22 22 22 22 22 Appendix C Gestational Table Crown rump length CRL Table Set1 Tokyo University Method CRL WEEKS S D mm w d days 6 7 54 12 4 7 6 7 56 25 7 58 13 0 7 7 60 13 1 1 62 19 2 8 7 64 19 9 7 8 7 66 13 4 7 9 7 68 15 5 7 9 7 70 13 6 7 9 T T2 14 0 8 9 7 74 14 1 8 10 7 76 14 2 8 10 7 78 14 3 8 10 7 80 14 4 8 10 7 82 14 5 Ek 7 84 14 6 8 Ek 7 86 15 0 8 E 7 88 1551 14 t1 90 15 2 14 LI 7 92 15 39 14 127 94 15 4 14 12 96 15 5 14 12 7 98 15 6 14 12 100 16 0 14 WED 380 English User Manual V1 3 73 Appendix C Gestational Table Crown rump length CRL Table Set2 Hadlock F P et al Method CRL
23. Electromagnetic environment guidance test test level level Portable and mobile RF communications equipment should be used no closer to any part of the WED 380 Full Digital Ultrasonic Diagnostic System including cables than the advised separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 3 5 iv J JP Conducted 3Vrms 1V T RF 150 kHz to P 80 MHz to 800 MHz L IEC 80 MHz EM 800 MHz to 2 5GHz E 61000 4 6 Where is the maximum output power rating of the transmitter in watts W according to the transmitter Radiated RF 3V m manufacturer and d is the recommended separation distance IEC 80 MHz to in meters m 61000 4 3 2 5GHz 3V m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the gompliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Dol At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Feld strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accu
24. M duda 40 2 2 2 232 2 2 2 223_ lt _ _ ___3 323233 22 222 __ _ 42 PROCESS MNO 43 9 JTOP t HEET DEET 45 3 11 Vapinam examination geen 45 9412 d misc DEDE qose lt lt _ _____ _ _ 46 Sols MACS Ove OMe RN hen renee eegenen 46 S FA Sh tdoitn tie _ 2323322 _____ 46 Chapter Six Operating Instruction for Function of Puncture 47 6 Pixatiomol Punctute PFrame and Ree 47 02 Selecion ol P nchire Needle EE 48 Call outthe Puncttire Gudime e eee 49 6 4 Calibration Of Puncture screened 49 6S Insertion or Puncture Needle I 50 ROS HI _2 _ 51 Chapter Seven Check and Natntenance su e 52 FM GT e T A Q 52 _ _ ____ _ _ __ _ _ _ _ gt 52 dec NS PATINA OIE TMP ATIC Chote se Sans ees 52 Jd Probe manehan Eaa
25. V1 3 Chapter Five Operation Procedures 4 Mark the following mitral valve waves with the same method E E Wave F F Wave 5 After the marking finishes the measurement results will display on the right side of the screen automatically Mitral Valve Measurement DE lt EX gt Distance from Point D to E on the Y Axis mm EF lt EX gt Distance from Point E to F on the Y Axis mm DE lt TM gt DE Time second EF lt TM gt EFTime second DE lt SL gt slope Point E on the Y Axis Point D on the Y Axis Point F on the X Axis Point D on the X Axis mm second EF lt SL gt slope Point E on the Y Axis Point F on the Y Axis Point F on the X Axis Point E on the X Axis mm second 5 5 4 Pulmonary Valve Measurement In this measurement it is a characteristic calculation parameter Calculate the pulmonary valve according to the following point marking position A Maximum Downward Position of the Valve of the Atrial Systolic Period B Start Point of the Ventricular Systolic Period C Maximum Open Point of the Lobule E1 Start Point of the Ventricular Diastolic Period E2 Complete Close Point of the Valve F Start Point of the Atrial Systolic Period Mark the above points with the method described above when the marking finishes the measurement results will display on the right side of the screen automatically WED 380 English User Manual V1 3 35 Chapter Five Operation Procedures Pulmonary V
26. WEEKS I CRL WEEKS mm w d days w d N N 255 A e OQO AA N O 952 W e e e e re o Co ES E keck N Fe AS 9 0 I 512 a 9 1 4 pal 2 E 572 2d es 9 Ki e NM N N Ke E OQ 09 09 01 OT A Ol Et A A A A A 02 CO COS e 2 4 9 6 1 p 4 re 0 1 gt 4 74 WED 380 English User Manual V1 3 Appendix C Gestational Table Gestational Sac GS Table Set1 Tokyo University Method GS WEEKS GS WEEKS D mm w d days mm w d days 42 9 1 14 4 0 4 1 44 9 9 14 4 4 46 9 4 14 9 0 48 10 0 15 9 1 20 10 1 15 9 4 02 10 3 15 6 0 94 10 4 15 6 1 10 6 15 6 6 58 ER 16 7 1 60 11 3 16 lso 62 11 4 16 1 4 64 11 6 16 8 0 66 11 8 16 8 1 68 12 41 17 8 3 8 6 WED 380 English User Manual V1 3 75 Appendix C Gestational Table Gestational Sac GS Table Set2 Hadlock F P et al Method GS WEEKS WEEKS I mm w d days mm w d days 9 6 6 6 6 Tis 6 d ie 8 8 8 8 8 9 9 9 e ee Xe Jo GE gt 76 WED 380 English User Manual V1 3
27. alve Measurement A lt DEP gt Depth The distance from point F to point A is the distance from the start point of the atrial systolic period to the maximum downward position of the pulmonary valve The distance from point F to A on the Y axis 1s the maximum movement range of the pulmonary valve in the atrial systolic period A lt DEP gt Depth AY FY mm AY is point A on the Y axis and FY is point F on the Y axis EF lt SL gt Slope When the initial blood flow from the atrium E1 is the start point of the ventricular diastolic period and F is the inflow start point of the atrial systolic period EF lt SL gt Slope FY E1Y FX E1X mm second FY is point F on the Y axis E1Y is point El on the Y axis FX is point F on the X axis and is point El on the X axis BC lt DS gt BC is the open part of the pulmonary valve in the ventricular systolic period and the part on the Y axis Diameter the movement distance of lobule when the pulmonary valve open to the maximum BC lt DS gt diameter CY BY mm CY is point C on the Y axis and BY is point B on the Y axis BC lt SL gt Slope BC lt SL gt Slope CY BY CX BX mm second CY is point C on the Y axis BY is point B on the Y axis CX is point C on the X axis and BX is point B on the X axis RVET Ejection Time of the Right Ventricular Ejection time of the right ventricular is the time from point B to E2 of the opening of the pulmonary valve RVET E2X BX secon
28. any preset control or switch unless operate as per instructions in the manual 4 If there is device failure please shut down the device at once and contact for Shenzhen Well D Medical Electronics Co Ltd or their authorized agent 5 If it is needed to connect the device with other company s electronic or mechanical devices please contact Shenzhen Well D Medical Electronics Co Ltd before connection 6 Device operation storage and transportation environment Environmental requirements on normal operation a Environment temperature range 5 C 40 C b Relative humidity range lt 80 c Atmosphere pressure range 86KPa 106KPa Environment requirements on device storage and transportation 4 WED 380 English User Manual V1 3 Preface a Environment temperature range 40 C 55 C b Relative humidity range 10 100 Atmosphere pressure range 5OKPa 106KPa 7 Ultrasound might cause hazard on human body so long time radiation should be avoided Refer to appendix B for sound output parameters 8 Please use standard power cord as the input line of the network power supply for the adapter to reduce risk 9 Shenzhen Well D Medical Electronics Co Ltd shall not take any responsibility for any risk resulted from propelled unauthorized re fitment by the users 10 The power supply plug is the standard three pins plug its protective grounding pin terminal should be connected with the protective gro
29. appears on the screen Move the cursor to the start point of this measurement by controlling the trackball press Ref key again to confirm the start point Move another cursor to the end of this measurement press Cancel to fulfill the measurement and exit Tips 28 WED 380 English User Manual V1 3 Chapter Five Operation Procedures Press Ref key repeatedly to switch between the start and end points of the measurement Go on measuring just repeat step 1 4 to get at most 4 groups of distance measurement The measuring results display on the screen right as the following figure shows Figure 5 3 Distance measurement sketch The four groups of data are D1 D2 D3 D4 among them D1 D2 is the ratio of D1 and D2 D3 D4 1s the ratio of D3 and D4 5 4 2 Circumference and Area Measurement The circumference and area can be measured in two ways AIC Press key to display this menu as given below Put in I FREEHAND 2 ELLIPSE Option 1 is FREEHAND measuring method and option 2 is ELLIPSE measuring method a Freehand method operation 1 5 key to select freehand method and call out the measuring cursor move the cursor to the start point of the measurement Reference 2 Press key and move the cursor along the edge of the measurement area to the end point by controlling the trackball Reference 3 Press key again to end the measuring of circumference and area AIC 4 Press key and rep
30. atal cephalic use 64 WED 380 English User Manual V1 3 Appendix B Sound Output Specifications Table Acoustic output reporting table M mode Inc B mode Nominal frequency 7 5MHz Transducer Model L3 1 7 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD TIS Index label EN bp Z Associated acoustic Zy parameters deq Zp cm Dim of Aaprt E prr Hz 5681 Other information Prat max lp MPa deg at max lpi cm I at max Wicm 109 7 control Notes This probe is not intended for transcranial or neonatal cephalic use WED 380 English User Manual V1 3 65 Appendix B Sound Output Specifications Table Acoustic output reporting table B mode Nominal frequency 6 5MHz Transducer Model EC1 1 13R 6 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label Maximum index value mW U Min of Pa Zs lzptasaZs mW cm N N o Associated acoustic parameters N o Z at max Joe 2 48 deq Zb MHZ awf f Dim of Aaprt 5 e lt ised rr Hz 4807 at Ip deg at max lpi cm r at max W cm F PIN Operating Power control conditions Angle Focus position Notes This probe is not intended for transcranial or neonatal cephalic use 66 WED 380 English User Manual V1 3 Appendix B Sound Outp
31. bove mentioned numbers or letters for notation OB table OB Table Press this key to display the OB table and press the number keys to carry out the corresponding function WED 380 English User Manual V1 3 19 Chapter Four Keyboard and Trackball Operation Image Proc Image Post process menu Press this key to display image post process menu and press the number keys to carry out the corresponding function RESET Reset Press this key to restart the system when malfunction and misoperation make the system DEAD unable to start the system by pressing any other key M Volocity E Frame correlation factors regulation M mode velocity option This key has two functions At B M mode enter real time state press this key to adjust the refresh velocity of M mode image There are four levels 3 005 2 505 2 00S 1 25S At mode There are four levels 6 005 5 00S 4 005 2 50S Press this key repeatedly to set the velocity circularly The current velocity appears on the right of the screen At B B and modes enter real time state press this key to lighten up the FM AVG on the screen right top And then press e adjust the parameters of frame correlation factors The system provides 8 factors 0 25 0 35 0 45 0 50 0 65 0 75 0 85 0 95 Press this key continuously the factors 1s set circularly The current parameter appears on the right top of the screen see figu
32. c System as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz For transmitters rated at a maximum output power not listed above the recommended separation distanced in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 8 WED 380 English User Manual V1 3 Preface Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The WED 380 Full Digital Ultrasonic Diagnostic System is intended for use in the electromagnetic environment specified below The customer or the user of WED 380 Full Digital Ultrasonic Diagnostic System should assure that it is used in such an environment Electromagnetic environment Immunity test IEC 60601 test level Compliance level guidance Electrostatic 6kV contact 6kV
33. contact Floors should be wood concrete or discharge ESD 8 kV air 8 kV air ceramic tile If floors are covered IEC61000 4 2 with synthetic material the relative humidity should be at least 30 Electrical fast 2kV for power supply 2kV for power Mains power quality should be that of transient burst lines supply lines a typical commercial or hospital IEC 61000 4 4 1kV for input output environment lines Surge 1kV dofferemtoal mode 1kV Mains power quality should be that of IEC 61000 4 5 2kV common dofferemtoal a typical commercial or hospital mode mode environment Voltage dips short lt 5 UT lt 5 UT Mains power quality should be that of interruptions and 2 9595 dip in UT 2 959 dip in a typical commercial or hospital voltage variations on for 0 5 cycle UT environment If the user of the power supply input WED 380 Full Digital Ultrasonic lines 40 UT 40 UT Diagnostic System requires continued IEC 61000 4 11 60 dip in UT 60 dip in UT operation during power mains for 5 cycle for 5 cycle interruptions it is recommended that the WED 380 Full Digital Ultrasonic 709 UT Diagnostic System be powered from 30 dip in UT an uninterruptible power supply or a for 25 cycle battery lt 5 U 295 dip in U for 5 sec Power frequency 3A m 3A m Power frequency magnetic fields 50Hz magnetic should be at levels characteristic of a field IEC 61000 4 8 typical location in a typical commercial or hospital env
34. ction is a special item and recommended to set at OFF during operation Press to select 9 EXIT to exit the menu 5 10 Per rectum examination procedure 1 Empty the rectum before inspection after cleansing enema the patient take left lateral position put some coupling gel around the endo rectal probe tip and put on the rubber sleeve one time use 2 During inspection ask the patient to release the anus or take defecating then breathe deeply to cooperate doctor s inspection The first is anus digital examination to know the position size texture of the lesion and see if it is painful when pressing it and if there is blood on the finger 3 Put the probe into anus about 2 3cm slowly take a close look at the image then go deep into the recta gradually and check each position At the same time press gut gently by putting hand on pubes at lower rump to enhance image definition 5 11 Vaginam examination procedure 1 Preparation before inspection It is different from ultrasonic examination per abdomen no need to suffuse the bladder But please tell the patient that it is needed to put the probe into her vagina Explain the course and WED 380 English User Manual V1 3 45 Chapter Five Operation Procedures 2 3 4 5 advantages of per vaginam ultrasonic examination and release her tension Patient posture Take the posture of bladder lithotripsy Scanning method Put some coupling gel into the dispo
35. d E2X is point E2 on the X axis and BX is point B on the X axis 5 5 5 Tricuspid Valve Measurement Tricuspid valve measurement is similar to mitral valve measurement and the following three points are used for 36 D Open point of the tricuspid valve and the end of the systolic period of the right ventricular E Maximum Point of the Tricuspid Valve Orifice F The tricuspid valve closes completely Mark the above points with the method described above when the marking finishes the measurement results WED 380 English User Manual V1 3 Chapter Five Operation Procedures will display on the right side of the screen automatically Tricuspid Valve Measurement DE lt EX gt Distance from point D right ventricular in the front of the tricuspid valve orifice to point E maximum tricuspid valve orifice mm EF lt EX gt Distance from point E to point F on the Y axis mm DE lt TM gt DE time second EF lt TM gt FF time second DE lt SL gt Slope Point E on the Y axis Point D on the Y axis Point F on the X axis Point D on the X axis mm second EF lt SL gt Slope Point E on the Y axis Point F on the Y axis Point F on the X axis Point E on the X axis mm second 5 5 6 Heart Rate Measurement Operation Procedure Freeze 1 Enter the B M mode move the trackball to change the position of the sampling line press the key when proper M mode image appears Maasura 2 Pre
36. diac wall diameter of the right ventricular diameter of the left ventricular thickness of the posterior wall of the left ventricular thickness of the interventricular septum volume of the left ventricular heartbeat flow ECG output systolic fraction and ejection fraction Operation Procedure 32 1 Enter the mode and move the trackball to change the position of the sampling lime Press the Freeze key when the proper M mode image appears Measure 2 Press the key and the cardiac measurement menu will appear 3 Press the key to select LV lt VF gt a vertical time bar will appear in the M image Confirm 4 Move the time bar with the trackball to the end of the diastolic period and press the key mark the Confirm anterior wall of the right ventricular D1 with the key Some mark points of the diastolic period are described as follows and mark the following several points with the same method D2 Posterior Wall of the Right Ventricular in the Diastolic Period D3 Anterior Wall of the Interventricular Septum in the Diastolic Period D4 Posterior Wall of the Interventricular Septum the Diastolic Period D5 Endocardium of the Posterior Wall of the Left Ventricular in the Diastolic Period D6 Epicardium in the Diastolic Period 5 D6 After marking the second time bar will appear move the time bar to the end of the diastolic period Confirm with the trackball and press the ke
37. dominal wall gently to make them approach the probe Limitation Endo vaginal probe adopts high frequency probe mostly the focal area is within 10cm Cysts out the range of 10cm can not be observed well thus abdomen examination is necessary to cover the shortage 12 Image print Connect the VIDEO IN port of the video printer to the VIDEO OUT port on rear panel of the equipment then operate according to video printer operation manual 5 13 Image upload to computer Connect the USB communication port of the equipment to the computer s USB port The high speed USB2 0 mouthpiece can upload images to the computer at current time In 5 the accompanying disc there USB device driver and software 14 Shut down the equipment Turn power off Tips It would be better to unplug the AC supply if do not use the equipment for a long time 46 Note Must not plug or unplug the power plug when the equipment is not shut down If it needs to switch on the equipment immediately after just shutdown please wait for 2 or 3 minutes to avoid breaking the equipment WED 380 English User Manual V1 3 Chapter Six Operating Instruction for Function of Puncture Guide Chapter Six Operating Instruction for Function of Puncture Guide Note The puncture operation should be performed under the real time status 6 1 Fixation of Puncture Frame and Probe 1 Put the probe aside then loosen the fixing screw nut o
38. e L3 1 7 5MHz Endo cavity probe convex probe HF linear probe Depth range 70 240 40 90 80 150 50 120 mm Table 4 1 Probes and their depth adjusting range Zoom Zoom key At real time or freeze state press this key to display or close sampling windows and zooming window Reference Move zooming window and sampling window by trackball Press Key to switch the current window Tips Change the sizes of zooming window and sampling window by pressing keys at the same time The windows change pro rata The maximum size of zooming window 5 a quarter of the image display area of the screen ES Freeze Press this key to switch between freeze and real time display 4 3 Track ball Track ball is fast convenient in operation In this equipment the track ball functions at Image freeze key e Move measuring mark during measurement e Select menu items during menu operation e Move cursor at annotation e Move the sampling line at BM mode e Control movie playback one frame by frame at cine loop mode e Move the sampling window and zooming window at zooming state eHistogram statistic mode Move the statistic sampling window Tips e Do not press too much when operating the trackball e Keep the ball surface clean 24 WED 380 English User Manual V1 3 Chapter Five Operation Procedures Chapter Five Operation Procedures 5 1 Start the equipment Switch on the equipment indicator light on t
39. e head after every use Do not clean the probe with a surgical brash neither soft brash Only soft cloth can be used fo clean it Note Do not press the probe on the patient too long to avoid discomfort 7 5 Cleansing 1 V the enclosure needs cleaning wipe it with soft dry cloths and then wipe gently with sponge dipped with 75 medical alcohol 2 When the inner part of the equipment needs cleaning power off the equipment first and open the enclosure and vacuum it WED 380 English User Manual V1 3 53 Chapter Seven Check and Maintenance 7 6 Correct usage of probe In order to prolong probe s service life and obtain optimum performance follow these instructions 1 Periodic inspection on probe cable socket and acoustic window Shutdown the device first and then connect or disconnect the probe Do not drop probe or flint body and never hit the probe acoustic window otherwise probe should be damaged Put the probe in the probe box when it 1s not in use Never heat the probe Never bend or pull probe cable otherwise the internal connection should be broken Use coupling gel only on probe header and then clean probe CONN tn d Inspect probe acoustical window enclosure and cable seriously after probe cleaning Never use the probe again if any crack or breakage is found 54 WED 380 English User Manual V1 3 Chapter Seven Check and Maintenance 7 7 Instrument test and cal
40. e may change 5 7 Obstetrics calculation The equipment can calculate gestation age expected date of delivery according to 7 parameters such as BPD FL AC HC CRL GS first day of the last menses Therein BPD can be used to calculate fetus weight OBtable At freeze state Press key to display obstetrics table menu as given below TOKYO I BPD FW 21 L 3 AC 4 5 CRL 6 GS 7 LMP 8 EXIT Figure 5 8 Obstetrics table menu sketch Press to select I BPD FW then measure the distance according to distance measurement method the corresponding obstetrical table data display on screen right As below BPD 06 1 mm G A 24W 2D EDD 06 04 23 FW 0490 g BPD Biparietal diameter G A Gestation sac EDD Expected date of delivery FW Fetus weight Press to select 2 FL then measure the distance according to distance measurement method the corresponding obstetrical table data display on screen right As below FL 05 1mm GA 28W 0D EDD 06 03 27 FL 40 WED 380 English User Manual V1 3 Femur length Chapter Five Operation Procedures Press to select 3 AC then measure the AC use the Circumference and Area Measurement the corresponding obstetrical table data display on screen right As below AC 265mm G A 30W 4D EDD 0 7 07 06 AC Abdomeninal circumference Press select 4 HC then measure the HC use the Circumference and Area Measuremen
41. eat the above steps 2 3 to process another measurement Two groups of data can be measured at most And the measuring results display on the screen right as given below Figure 5 4 Circumference and area measuring sketch Freehand method WED 380 English User Manual V1 3 29 Chapter Five Operation Procedures and Alare the circumference and area of the first group data C2 and A2 are the circumference and area of the second group data C1 C2 is the ratio of the two circumferences A1 A2 is the ratio of the two areas b Ellipse measuring method 1 At freeze state Press key to select Ellipse method an ellipse measuring mark display the screen which is named the measured area can be moved to any place on the image by trackball Confirm 2 Press key then move the trackball to change the size of this measured area Move trackball left and right the measured area shrinks or enlarges horizontally Move trackball up and down to shrink or enlarge the measured area vertically Tips Confirm Press key repeatedly to shift between moving the mark and adjust the size by trackball Reference 3 Press key Move trackball to adjust the angle of the measured area Cancel 4 Press key to finish measuring AIC 5 Press key and repeat the above steps 2 4 to process another measurement Two group s data can be measured at most And the measuring results display on the screen right as given below
42. er disappears When an image is saved the system enters freeze mode press lt Freeze The equipment can store 64 images at most and these images will be automatically numbered as per their saving key to return to real time state Save order For example There are images from number 01 20 press key then the currently saved image is Save numbered 21 When the memory is full 1 e there are already 64 images then pressing key will display the following tips 38 WED 380 English User Manual V1 3 Chapter Five Operation Procedures STORAGE IS FULL ERASE NO 01 1 Yes 2 No Tips replace the stored image numbered 01 press 1 to replace it with current saved image press 2 to exit this operation Select No to give up saving image When pressing Save again the system will remind you if you want to cover image numbered 02 reason by analogy in turn Tips When the image memory is full if some stored image is loaded then when processing saving the system will remind you if you want to delete this loaded image and save the current there 5 6 2 Stored image recall Recall At real time or freeze press key to display the following dialog box Please put in image number put in the stored image number e g 01 then press any key except numbers and letters Press eee backspace key to clear the mistakes and input again to load the first image On the screen left bottom 01 64 means 01 is t
43. he panel turns on and the start interface shows on screen Press any key except key to enter the state of scanning Adjust the display brightness contrast TGC and overall gain GAIN to acquire a satisfying visual effect Figure 5 1 Start interface 5 2 Diagnosis Apply some coupling gel on the diagnoses part and press the probe acoustical window on this part closely The section sonogram of the tissue will display on the screen move the probe slightly and find the proper depth and optimum position at the same time adjust the brightness contrast overall gain GAIN 8 TGC to acquire the best section sonogram of the part Tips Adjust the total gain GAIN knob slowly Note 1 Do not press the probe too much to avoid breaking the probe or causing discomfort 2 Do use proper probe and frequency for the target part 5 3 Notation Annotation ABC Press to activate notation menu NAME PID AGE SEX COMMENT TIME HOSP DOCT LANGUAGE ERASE OBTABLE EXIT IL 2 3 4 9 6 T 8 9 A B Figure 5 2 Notation menu WED 380 English User Manual V1 3 25 Chapter Five Operation Procedures Press numeral key to select 1 NAME to enter patient name 15 characters at most can be put in letter Backspace number or space press to delete mistake The same in the following cases Then an name input box will appear on screen as follows PLEASE ENTER NAME After input
44. he serial number and 64 15 the total amount of stored images in the memory Press e to load other images Freeze Press key to return to real time or freeze state Repeat the above steps to load other images Tips You can not load any image from an empty memory area The input number should be from 01 to 64 when the input number is more than 64 the system Will not take any operation 5 6 3 Cine loop function After starting up system enters real time state first collect cine loop images it will last for 30 seconds Cine 1 Switch the equipment into freeze mode Press Se key to playbacks images in circulation 2 During playback press e to enter manual playback Press to play forward and backward And Cine Loop press key to return to auto playback mode 3 When playback at B B B mode switch between B B to play the cine in difference windows Freeze i 4 To exit cine loop press key WED 380 English User Manual V1 3 39 Chapter Five Operation Procedures Tips After changing image scanning mode probe or display mode cine loop can not be processed immediately Normally cine loop can be done 30 seconds after scanning At cine loop mode roll trackball can play cine by single frame When roll trackball up cine Is played from small number to big roll it down the reverse Press Cine loop key to go on auto playback Replace probe or change the scan angle the cine loop fram
45. ibration 1 Check the leakage current of the device annually referring to the following data Standard Test Items Requirements Continuous leakage current under normal temperature uA Dielectric endurance temperature V Leakage current to Normal Shell Single Malfunction a Single Malfunction 4000V 1 min No flashover No breakdown under normal 2 Test the software of obstetrics area and circumference measurement please refer to Appendix C for detailed data WED 380 English User Manual V1 3 55 Chapter Eight Transportation and Storage Chapter Eight Transportation and Storage 8 1 Environmental Requirements for Transportation and Storage Environmental temperature 40 C 55 C Relative humidity 10 100 Atmospheric pressure bOKPa 106KPa 8 2 Transportation All marks printed on the packing box are in accordance with the requirements of GB191 2000 Packing Storage and Transportation Marks Simple shockproof installations are made in the packing box which adapt to voyage railway highway and steamship transportation Avoid rain inversion and impact 8 3 Storage When the device is stored for more than 6 months take out the device from the packing box Electrify the device for 4 hours and then put the device into the packing box according to the instructions sated on the packing box Do not crisscross piling devices or keep the device to floor wall and ceiling Keep
46. ify the system time and date The time and date input box is given bellow Y Y MM DD HH MM SS For example the time is 2006 9 22 9 35 30 then put in Y Y MM DD 060922 HH MM SS 093530 Press to select 7 HOSP to put in hospital name in letter or number at most 18 characters The hospital name input box is given bellow PLEASE ENTER HOSP After input press any key except letter number to exit To cancel input you can press any key The hospital name will display after Hospital at the bottom of the screen see figure 4 1 shows Press to select 8 DOCT to put in doctor s name in letter or number at most 14characters The doctor name input box is given bellow PLEASE ENTER DOCT 9 LANGUAGE Preinstall function Press to select A ERASE to clear out image storage The remind box is given bellow ERASE ALL STORAGE Le YES s Press number key to confirm clearance When processing a word ERASING displays on the upper WED 380 English User Manual V1 3 27 Chapter Five Operation Procedures left screen to indicate that system is processing clearing and no other operation can be done When the reminder disappears the image storage 15 cleared Press to give up and exit B Press to select B OBTABLE to put in obstetric table The system is built in two OB tables TOKYO HADLOCK Table TOKYO 1s suitable for Asian and Table HADLOCK is s
47. inspection on organs containing gas such as lungs etc It is recommended not to check the parts with wounds or acute inflammation to avoid cross infection Patient in the following situations are not allowed to be checked with EC1 1 and EL3 1 probes vaginal infection such as trichomonal vaginitis colpomycosis venereal disease etc the unmarried vagina deformity menstrual period postmenopausal vagina atrophy difficulty in per vagina ultrasonic examination colporrhagia Pyrilamine placenta previa etc 10 WED 380 English User Manual V1 3 Chapter One Summary Chapter One Summary 1 1 Features This equipment is high resolution linear convex ultrasound scanning diagnostic equipment It adopts micro computer control and digital scan converter DSC digital beam forming DBF real time dynamic aperture RDA real time dynamic receiving apodization real time Dynamic receiving focusing DRF Digital frequency Scan DFS 8 segments TGC frame correlation technologies to endue its image with clarity stability and high resolution There are four display modes B B B B M M 4B And 256 gray scale The system can process real time image display freeze save load zoom up and down flip left and right flip black and white flip and capacity cine loop Multi level scanning depth angle dynamic range acoustic power frame correlation factor regulation and focus number focal space focus position etc It offers more than 40 b
48. ironment NOTE is the a c mains voltage prior to application of the test level WED 380 English User Manual V1 3 9 Preface Warning When WED 380 works in strong electromagnetic environment exceeding its statement its image might be interfered and the diagnoses could be influenced At this time please stop operating until the EMC interference is removed Warning When WED 380 works at the state of overlapping or paralleling with other equipments there might be unexpected EMC problems If it must work close to other equipments please observe carefully and check if some equipment ts influenced by unexpected EM coupling Warning Replacement of non standard probe parts may cause unexpected EMC problem Note Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 60601 1 1 Everybody who connects additional equipment to the signal input or signal output part configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC60601 1 IF in doubt consult the technical service department or your local representative Contraindication The equipment is not suitable for
49. is probe is not intended for transcranial or neonatal cephalic use 60 WED 380 English User Manual V1 3 Appendix B Sound Output Specifications Table Acoustic output reporting table M mode Inc B mode Nominal frequency 3 5MHz Transducer Model C3 1 60R 3 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label TIC Maximum index value 089 049 1 0 11 mW Min of Pa Zs lzpta aZs mW N cm N Associated acoustic parameters N 5 3 5 30 2 at max deq Zb fawt MHz 3 3 Dim of Aaprt use prr Hz 4166 Tuum p at max lp MPa deg at max loi laa at max Wicm 203 9 Operating control Angle conditions Focus position ER 3 Notes This probe is not intended for transcranial or neonatal cephalic use WED 380 English User Manual V1 3 61 Appendix B Sound Output Specifications Table Acoustic output reporting table B mode Nominal frequency 5 0MHz Transducer Model C1 6 20R 5 0MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label Maximum index value mW U Min of Pa Zs lzptasaZs mW cm N N o Associated acoustic parameters N Oo lo 318 2 98 Z at max deq Zp e MHz awf f Dim of Aaprt lt X s s e r CH 3 Hz 4784
50. lator unit then turn the puncture needle guard in ward for 180 WED 380 English User Manual V1 3 49 Chapter Six Operating Instruction for Function of Puncture Guide degree Thus the puncture angle can be adjusted by the angle regulator unit on the puncture frame Turn for 180 degree Needle guard Angle regulator unit 2 Please ensure that each type of angle should be identical with the detent Detent Angle 25 409 559 70 The puncture needle angle should also be identical with the angle of puncture guiding line Puncture needle Detent angle Screw nut for angle fixation GL A Screw nut for 7 puncture needle guard fixation K Guiding line es 6 Screw nut for tightness control of angle regulator unit 6 5 Insertion of Puncture Needle 1 Please ensure that the tissue for puncture is on the puncture guiding line first Then adjust the angle and insert the puncture needle slowly in the direction of needle guard 50 WED 380 English User Manual V1 3 Chapter Six Operating Instruction for Function of Puncture Guide Puncture needle Hepatic cyst Guiding lin 2 Please do not move the probe when inserting the puncture needle for ensuring the accuracy of the puncture operation 6 6 After Puncture 1 Turn the puncture needle guard outward for 180 degree to make the rabbet of the puncture needle guard outward then remove the probe from it Remove probe
51. maconr Dynamic range Gray level bar FREECE Figure 4 1 Equipment interface illustration 4 2 Operating keyboard Figure 4 2 Operating keyboard sketch H Alphabet keys Press these keys at annotation mode to put in characters at the cursor position 18 WED 380 English User Manual V1 3 Chapter Four Keyboard and Trackball Operation Among the alphabet keys there are some keys with dual functions Total gain control key There are four steps 25 30 35 40 Press this key to set them circularly In real time status single B mode press this key to recall penetration sampling line Space Space key At annotation press this key to input space after cursor G Backspace Backspace key At annotation press this key to delete the input characters 0 BS gt Number Numbers are used for time date settings age notation and function menu and selection There are the following dual functions keys Press this key to move cursor or sampling line left Press this key to move cursor or sampling line right Control the cursor moving speed by direction keys Clear Clear Press this key to clear off the measuring marks notation data and measurement results on the image When some menu is displayed it can not be cleared until the current task 1s finished Annotation Notation Press this key to display the notation menu and press the a
52. n the puncture frame Fixing screw nut of puncture frame WED 380 English User Manual V1 3 47 Chapter Six Operating Instruction for Function of Puncture Guide 2 Mount the puncture frame on the probe Please note the direction mark of the probe 3 Buckle on the puncture frame and turn over the probe then fasten the fixing screw nut of the puncture frame Please ensure fixing slot of puncture frame positioned to projecting portion of the probe Fixing screw nur of puncture frame 6 2 Selection of Puncture Needles The puncture needles can be divided into 3 specification numbers such as No 7 No 9 and No 12 You can choose the proper puncture needle and needle guard based on the practical need Please ensure that the specification number of selected puncture needle should be consistent with the selected needle guard 48 WED 380 English User Manual V1 3 Chapter Six Operating Instruction for Function of Puncture Guide Puncture needle Puncture needle guard 6 3 Call out the Puncture Guding Line P Under the real time estate single B mode press key the screen will display the PT Sampling line it calls puncture lead line the trackball or left right direction keys can move to confirm the position if want to exit please Clear Cancel press or key Angle Puncture guiding line 6 4 Calibration of Puncture Line 1 Fix the selected puncture needle on the angle regu
53. ody marks Date clock display Name sex age doctor hospital annotation Distance circumference area volume heart rate measurement preset two obstetric tables to measure GA FW and EDD Many probes are optional for clinic diagnosis demands PAL D and VGA video output offers connection to external video image printer and big display and other equipments High speed USB port provides real time image transfer to the PC Adoption of folded soft push keyboard and trackball provides immediate convenient and flexible operation The equipment is jet molding enclosure and potable structure the usage of non industrial frequency transformer switching power supply programmable parts FPGA and surface mounting technology SMT make the whole unit highly compact The equipment consists of the main unit and electronic convex array probe Standard configuration 15 C3 1 60R 3 5MHz convex array probe And L3 1 7 5Mhz high frequency linear array probe C1 6 20R 5 0MHz micro convex probe EC1 1 13R 6 5MHz endo vaginal and EL3 1 7 5MHz endo rectal probe for option 1 2 Range of application Application in abdominal Obstetric Cardiac small parts sonography 1 3 Safety classification According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide WED 380 not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide Acco
54. onsible for losses damages or injuries caused by delayed service request When there is problem with the products please contact Shenzhen Well D Medical Electronics Co Ltd and explain the device model serial number date of purchase and the problem Matters need Attention To ensure operational safety and long term stable equipment performance please read this operation manual closely and understand the device functions operation and maintenance at all points before operating the device especially contents of Warning Caution and Note 2 WED 380 English User Manual V1 3 Preface Misoperation or inobservance of the instructions given by manufacturer or its agents may result in device damage or personal injury The following convention works through this manual to lay special emphasis on some information Warning Stands for neglect of it will cause severe personal injury death or realized property loss Caution Stands for neglect of it will cause slight personal injury or property damage Note to remind user of installation operation or maintenance information These information is very significant but with no risk Any warning against dangers shall not be contained in NOTE Safety labels Device labels explanation device Note Refer to accompanying documents Turn on general supply O Disconnect general supply Signal output Vy Equipotential IPX7 Watertight
55. probe in the Freeze Please use medical ultrasound coupling gel during diagnoses The water prevention level is IPX7 so do not let box and press key to set the probe at freeze state water exceed the acoustic window see figure 7 1 7 2 7 3 7 4 7 5 Do daily inspection on the probe enclosure to see if it is cracked and avoid liquid leakage to spoil the inner components Check the probe regularly to see if it is filled with clean medical castor oil lest the existing air bubbles influence the image quality If air bubbles appear turn the probe oil filler hole up and screw off the sealing screw turn the probe slowly to drive the air bubbles to the screw hole infuse a little bit of castor oil into the screw hole with syringe with a needle vent the air bubbles and fasten the sealing screw and finally clean the oil stain on the probe surface NS 155mm LL Figure 7 1 60R 3 5MHz convex probe water proof sketch Figure 7 2 Endocavity probe water proof sketch 52 WED 380 English User Manual V1 3 Chapter Seven Check and Maintenance Figure 7 3 7 5MHz HF linear probe water proof sketch Figure 7 4 20R 5 0MHz convex probe water tight sketch 1 225mm L Figure 7 5 7 5MHz rectal probe water proof sketch Once the probe is connected to the main unit do not remove it at will to avoid poor contact Note Probe might be damaged due to long time covered coupling gel Clean the prob
56. proof I Risky voltage eA USB port Ca VOA ou Packing and transportation labels explanation 0A ome Dro 5 WED 380 English User Manual V1 3 3 Preface System labels diagram Refer to Appendix A for device labels General tips for device operation In operation 1 Heat radiation holes are strictly prohibited to be covered 2 After closedown do not switch on the device within 2 3 minutes 3 On scanning if any abnormal case is found stop scanning immediately and shut down the device 4 Patient is not allowed to touch any non application parts 5 Do not press the keyboard too much in case the equipment be damaged After operation 1 Power off the device 2 Pull out the plug from power supply socket instead of pulling the cable 3 Clean off the coupling gel on the probe with soft medical sterilized tampon 4 put the probe into its box General Safety Message Safety of the operator and patients and reliability of the device are taken into consideration during designing and producing the following safety precaution must be implemented 1 The device shall be operated by qualified operating staff or under their instructions 2 Do not open the device and change the parameters without permission If necessary please turn to for Shenzhen Well D Medical Electronics Co Ltd or its authorized agent for service 3 The device has already been regulated into its optimal performance Do not adjust
57. racy 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 WED 380 Full Digital Ultrasonic Diagnostic Systemis used exceeds the applicable RF compliance level above the WED 380 Full Digital Ultrasonic Diagnostic System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the WED 380 Full Digital Ultrasonic Diagnostic System b frequency range 150 kHz to 80 MHz field strengths should be less than 0 5V m WED 380 English User Manual V1 3 7 Preface Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the WED 380 Full Digital Ultrasonic Diagnostic System The WED 380 Full Digital Ultrasonic Diagnostic System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the WED 380 Full Digital Ultrasonic Diagnostic System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the WED 380 Full Digital Ultrasonic Diagnosti
58. rding to the mode of operation Continuous operation According to the degree of protection against harmful ingress of water as detailed in the current edition of IEC 529 Main unit is general equipment the probe is enclosed equipment protected against the effects of immersion IPX7 According to the type of protection against electric shock Class equipment energized from an external electrical power source equipment According to the degree of protection against electric shock Type B WED 380 English User Manual V1 3 1 Chapter Two System Introduction Chapter Two System Introduction 2 1 Appearance Figure 2 1 Appearance dimension sketch 2 2 Panel Figure 2 3 Back panel sketch 12 WED 380 English User Manual V1 3 Chapter Two System Introduction 2 3 Technical specification Model WED 380 EL3 1 7 5MHz C3 1 60R 3 5MHz endo rectal probe C1 6 20R 5 0MHz ECI 1 13R 6 5MHz micro convex endo vaginal probe probe Probe convex array L3 1 7 5Mhz HF linear probe Display depth mm 240 max 16 levels adjustable Resolution lt 2 depth lt 80 lt 1 lt 3 lt 1 lt 3 depth lt 60 depth lt 60 depth lt 40 80 lt depth lt 130 lt 2 depth lt 80 lt lt 1 lt 1 lt 3 depth lt 80 depth lt 60 depth lt 40 80 lt depth lt 130 position Display mode B B BIM M 4B mm A Axial
59. re 4 1 Probe S Switch between probes This equipment is fitted with two probe connectors A B Press this key to switch the probes The current probe model appears on the right top of the screen see figure 4 1 The probe model and their codes are CA60R C3 1 60R 3 5MHz convex probe CA2ZOR C1 6 20R 5 0M Hz convex probe ECI 1 13R 6 5MHz endo cavity probe LA40 L3 1 7 5MHz linear probe or EL3 1 7 5MHz endo rectal probe Tips 2 The device can automatically identify probes When it is connected with two probes The system default working probe is the one connecting to socket A Please shut down the system first before replacing probes Restart the system it can realize automatic identification save Save image At real time of freeze press this key to save the current image refer to 5 6 1 Image Saving for details Recall Load image Press this key to recall the stored image refer to 5 6 2 Image loading for details 20 WED 380 English User Manual V1 3 Chapter Four Keyboard and Trackball Operation up Image up down Press this key to flip image up and down As given below Figure 4 3 Image up and down flip sketch UR Image left right Press this key to flip image left and right As given below Figure 4 4 Image left and right flip sketch Freg uency Probe frequency switch Press this key to change the working frequency of the probe The frequency of each probe is gi
60. sable sterilizing plastic jacket or a condom and then cover it on probe apply some coupling gel the cover and separate the nymphae with left hand to expose vaginal orifice hold the probe with right hand and put it into the vagina gently can check The position of probe in vagina will influence the image definition In general put the probe closely against vagina vault or cervix Sometimes it 1s depending so move or rotate the probe for a better known of the cavum pelvis For the moment there is no hard and fast rule for image position The near field can be the upper as well as the lower Please identify the image direction As same as per abdomen ultrasonic examination first take vertical section scanning and check the uterine position size outline and each stool section muscle wall and endomembrane echo state as well as cervix vertical section Wiggle the probe right and left to display the two ovaries image Then contra rotate probe 90 to scan the uterine and two appendices cross section Since most of per vaginam ultrasonic examinations are taken on average examining table instead of special gynecologic examining table probe operation might be influenced Some measures can be taken for example for some fatty woman or with anteposition of uterus ask her to hold fists and put it under the hips to raise the rump which is better for probe operation and complete observation Sometimes the target organs are in a higher position press the ab
61. ss the key and the cardiac measurement menu will appear 3 Press the 9 key to select a vertical time bar appears the image Confirm 4 Move the time bar to the first wave peak with the trackball and press the key the second time bar appears 5 Move the time bar to the third wave peak with the trackball and press the w key 6 The measurement finishes and the measurement results will display on the right side of the screen WED 380 English User Manual V1 3 37 Chapter Five Operation Procedures Heart Rate Measurement TM Time second HR Heart Rate times minute Tips N Patient Please identify the functions of gt key Press key delete measuring marks results press gt key to clear off all annotation notes including Doctor name age and sex and measuring marks results as well as report data 2 3 You can fulfill measurement by operating 2 2 direction keys as well as trackball 5 6 Cine loop and image storage function The system provides memory for Cine loop and image storage respectively 5 6 1 Image storage function Save When getting a satisfying image press to save the current image At the same time the current stored image serial number automatically displays at top left corner of the image area Such as SAVING 05 When image saving finishes the serial numb
62. t the corresponding obstetrical table data display on screen right As below HC 23 6mm G A 25W 1D EDD 07 08 13 HC Head circumference Press to select 5 CRL then measure the distance according to distance measurement method the corresponding obstetrical table data display on screen right As below CRL 032mm GA 10W 4D EDD 06 07 29 CRL Crown rump length Press to select 6 GS then measure the distance according to distance measurement method the corresponding obstetrical table data display on screen right As below GS 035mm GA 08W 0D EDD 06 08 17 GS Gestation sac Press to select 7 First day of last menses a reminder displays Put in the first date of the last menses MM DD This reminder ask to put in the first date of the pregnant woman s last menses in the date format MM DD For WED 380 English User Manual V1 3 41 Chapter Five Operation Procedures example May 11 put in 05 11 When the correct date is put measuring result will displays at EDD on screen right in the format of YY MM DD for example 07 02 21 means that the expected date of delivery is on February 21 2007 Note In expected date of delivery calculation the system date must be correct The default standard pregnancy period in the system Is 40 weeks In last menses method measuring if the time interval between the input date and the system date exceeds 40 weeks the inward date will no
63. t be accepted and need to be put in again Under the condition of item 1 if the inward date is bigger than the current system date it will be regarded as the date of the last year After measurement press Clear key to clear the screen for the next measurement Otherwise Press to select 8 Exit to exit OB table 5 8 Report The equipment will store the patient information diagnosis annotation measurement result and hospital data time doctor and some other information in the report page with the diagnosis The abdominal cardiac obstetrics and urological reports will generate automatically according to different measurement items and store the last measurement results Freeze When the corresponding measurement finishes press the key to enter the freeze state then press the Report key and the report menu will display 1 ABDOMEN 2 CARDIAC 3 UROLOGY Enter the corresponding number key to enter the related report and press any key to exit this menu Abdominal Report Urological Report a 1 gt E d Dk Prices kat h wh CA OD p APS enel Cardiac Report 42 WED 380 English User Manual V1 3 Chapter Five Operation Procedures l5 f 5 cU 1 LUE II ORI el Lal J e 1 1 gt H H P END rm 64 e xm eof 4 r RE A CH Obstetrics
64. the third time bar will appear after the marking Confirm 6 Move the time bar to the close point of the aortic valve with the trackball and press the key mark the posterior wall of the aortic valve C1 and posterior lobe arterial wall C2 7 When all the measurements finish the calculation results of the aortic valve will display on the right side of the screen Diastolic Period Aortic Valve 2 an Measurement an 02 Aortic Root Diameter at the end of the Diastolic Period mm LA Dhiameter of the Left Ventricular at the end of the Systolic Period mm AVO Distance between the Aortic Anterior Lobe and Posterior Lobe and the Open Point of the Aortic Valve mm LAR Left Atrium Aorta Ratio LVET Left Ventricular Ejection Time second 5 5 3 Mitral Valve Measurement The research of the mitral valve allows the user to estimate the D E and E F displacement D E and E F slope D E and E F time on the D wave E wave and F wave under the M mode and BM mode Operation Procedure 1 Enter the B M mode and move the trackball to change the position of the sampling line with the trackball Freeze press the key when the proper M mode image appears Measure 2 Press the key and the cardiac measurement menu will appear 3 Press the 3 key to select move the cursor to the wave position of the M mode image area Confirm press the key mark D 34 WED 380 English User Manual
65. the power socket with the cable see figure 2 3 2 A 96 core connector is used for electronic convex array probe see figure 3 1 3 Connection of 96 coreconnector First switch the locker on the probe connector to OPEN position the connector localization pin with the hole on the socket then plug in the connector and switch the locker to LOCK When the locker is moved to OPEN unplug the connector to remove the probe from the main unit Localization Localization Figure 3 1 96 core probe connection sketch 16 WED 380 English User Manual V1 3 Chapter Three Installation Note Avoid by all means unplugging or plugging the probe connector at state of log on in case the probe and main unit be damaged Once the probe is connected with the main unit do not unplug nor plug it at discretion in case poor contact happen 3 4 Equipotential connection 4 Equipment back panel SZ Equipotential terminal See the figure Equipotential line Equipotential terminal Other device v WED 380 English User Manual V1 3 17 Chapter Four Keyboard and Trackball Operation Chapter Four Keyboard and Trackball Operation 4 1 Screen display Rane 2 NN CT PID SEX Taria Focus no amp space x 1 P POER 8 Scan direction Scan angel TANGLE 66 Total gainAcoustic Ege enhancement LE Ga
66. the repository ventilative Avoid direct sunshine and caustic gas 56 WED 380 English User Manual V1 3 Chapter Nine Malfunction Examination and Troubleshooting Chapter Nine Malfunction Examination and Troubleshooting 9 1 Examination Examine whether the supply power is in normal state The power line of the main frame has been properly connected and inserted in the electric socket Examine whether the probe has been connected to the device correctly 9 2 Troubleshooting Replacement of fuse Position the driver into the slot on the fuse cap and press it then contra rotate it to loose the cap Take off the fuse tube protective tube and replace it then put back the cap and take the reverse measure to fix the cap and fasten it Fuse specification 5x20 F2AL250V Troubleshooting see the following diagram Se Malfunction phenomena Troubleshooting Open power switch of the device with no 1 Examine power supply signal appeared on the screen and the 2 Examine supply line and plug indicator light is not on 3 Examine whether the fuse 15 burned out 4 Examine the lightness adjusting knob of the monitor Discontinuous striae and snow appear on 1 Examine power supply strike fire interfere of the the screen other devices 2 Environmental examination Electric and magnetic field interfere 3 Examine power and probe plugs whether they are well connected Unclear image display l Adjust the brightness and contrast knobs
67. uitable for European The remind box is given bellow PLEASE ENTER OBTABLE TOKYO 2 HADLOCK 1 2 Press to select TOKYO press to select HADLOCK Press to select EXIT to exit comment menu Tips When image storage erasing is in process system reminds Erasing please do not take other operations in case the equipment is damaged The trackball can be used for operating the menu when the menu displays move the trackball up and down to select the items when the selected item is lightened press confirm to enter it N Patient key functions 1 At real time or freeze state press this key to clear off the measuring marks comments measurement results in image area and doctor name patient name age and sex 2 At report interface clear off all the information and measurement results except Hospital and sex 5 4 Routine Measurement Distance circumference area and volume can be measured by controlling the direction keys or trackball Unit of distance and circumference is mm unit of area 1s mm volume is cm There are four measuring marks corresponding to measurement display DI x D2 X D3 D4 In circumference area measurement there two measuring marks corresponding to measurement display CI Al x C2 A2 5 4 1 Distance measurement Operation steps Press DIST key and the first cursor appears on the screen Press Ref key the second cursor
68. unding line of the main power Execution Standard Safety e Safety Standard Standard Number Standard Name IEC60601 1 1988 Medical Electronic Device Part I General safety requirements A1 1991 A2 1995 Medical Electronic Device Part I to II General Safety Requirement Parallel IEC60601 1 2 2004 PE Standard Requirement and Testing of Electromagnetism Compatibility Medical Electronic Device Section I to IV A Program controlled Medical IEC60601 1 4 2000 Electronic System Medical Electronic Device Specialized Safety Requirements for Medical IEC60601 2 37 2004 N Ultrasound Diagnosis and Custodial Care Facility Requirements for the Declaration of the Acoustic Output of Medical Ultrasound IEC61157 1992 Diagnostic Apparatus e EMC Electromagnetic Compatibility Standard Standard Number Standard Name IEC60601 1 2 2001 Electromagnetic Compatibility for Medical Systems comprised of IEC61000 4 2 2001 Electrostatic Discharge Immunity IEC61000 4 3 2002 Radiated Field Immunity IEC61000 4 4 2 2001 Electrical Fast Transient Burst Immunity WED 380 English User Manual V1 3 5 Preface EMC statement WED 380 shall not affect the basic performance of radio service and other equipments and can work well in its stated electromagnetic environment Guidance and manufacture s declaration electromagnetic emissions For all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration
69. uring method to measure 2 groups of areas and then calculate them Operation procedure take kidney as an example 1 Get the kidney cross section image and profile section image respectively and freeze them 2 Measure the circumference and area of kidney cross and profile section with circumference and area measuring method Cancel 3 Press key to fulfill volume measurement The volume value will be calculated automatically and displays on screen right behind Vm1 as the following figure shows Figure 5 7 Double B mode volume measurement sketch Ellipse method Tips If only a group of circumference and area are measured Volume will not be displayed WED 380 English User Manual V1 3 31 Chapter Five Operation Procedures 5 5 Cardiac Measurement Measure Obtain the satisfied image under the B M or M mode and freeze Press the key and the cardiac measurement menu will appear LV lt VF gt 1 Left Ventricular AV 2 Aortic Valve MV 3 Mitral Valve PV 4 Pulmonary Valve TV 5 Tricuspid Valve HR 6 Heart Rate 7 Exit 5 5 1 Left Ventricular Measurement By measuring the diastolic period and systolic period posterior wall of the right ventricular anterior wall of the interventricular septum posterior wall of the interventricular septum endocardium of the posterior wall of the left ventricular epicardium to calculate the diastolic period and systolic period respectively thickness of the left car
70. ut Specifications Table Acoustic output reporting table M mode Inc B mode Nominal frequency 6 5MHz Transducer Model EC1 1 13R 6 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label MPa Min of Pa Zs lzpta aZs mW Associated acoustic parameters Z at max Joe deq Zp Other information P at max 1 deg at max lpi cm TIC 1 41 laa at max MI W cm 124 1 F PIN Operating conditions ge Notes This probe is not intended for transcranial neonatal cephalic use WED 380 English User Manual V1 3 67 Appendix B Sound Output Specifications Table Acoustic output reporting table B mode Nominal frequency 7 5MHz Transducer Model EL3 1 7 5MHz Manufactured By SHENZHEN WELL D MEDICAL ELECTRONIC CO LTD Index label Maximum index value mW U Min of Pa Zs lzptasaZs mW cm N N o Associated acoustic parameters N o Z at max Joe 2 50 deq Zb f MHz awf Dim of Aaprt 5 e lt ised rr Hz 5681 pr at max lpi MPa deg at max lpi cm r at max W cm F PIN Operating control Power conditions Focus position Notes Ca This probe is not intended for transcranial or neonatal cephalic use 68 WED 380 English User Manual V1 3 Appendix B Sound Output Specifications Table Acoustic output reporting table M mode
71. ven bellow CA60R 2 5MHz 3 5MHz 5 0MHz C3 1 60R 3 5MHz convex probe CA20R 4 5 2 5 0MHz 5 5MHz C1 6 20R 5 0MHz convex probe CAI3R 5 5MHz 6 5MHz 7 5MHz EC1 1 R13 6 5MHz endo cavity probe 40 6 5 7 5MHz 8 5MHz CL3 1 7 5MHz HF linear probe or EL3 1 7 5MHz endo rectal probe The current probe frequency displays on the up right of the screen see figure 4 1 Measure Measurement For volume fetus weight measurement and histogram see 5 4 for details Body Mark Body mark At B B B B M 4B modes press this key to active body mark There are 40 body marks press this key repeatedly to display these marks circularly 1 Abdomen JU Al y Body front 99 Body front F Body back WED 380 English User Manual V1 3 21 Chapter Four Keyboard and Trackball Operation x f E Body left side Body right side 2 Obstetric E Mother F EEN Gr COSS aye Fes 990 on 094090066 C WV BERL I w ri 4 Cr cine Loop Cine loop At freeze state press this key to enter cine loop refer to 5 6 3 Cine Loop for details DIST Reference AIG Measurement operation For distance circumference area volume measurement operating Refer to chapter 5 Confirm Confirmation For menu selection when operating by trackball Confirm the contents when noting At real time or freeze press this ke
72. without permission will be sued to assume legal responsibility according to laws Manufacturer s warranty Shenzhen Well D Medical Electronics Co Ltd assumes the responsibility for device security reliability and performance only under the preconditions that the disassembly assembly and maintenance of the device are all performed by its assigned professional and the device is used strictly in compliance with the operation manual Shenzhen Well D Medical Electronics Co Ltd ensures a guarantee period within a year and a half since the delivery day and promises there is no problem with the new device in material and technology Within the warranty period Shenzhen Well D Medical Electronics Co Ltd will maintain the device and replace the parts of non man made damages free of charge But will not repair or replace the device surface if it is damaged This guarantee is only available for failures occurred when the device is operated compliance with the operation manual And the guaranteed device can only be used in the prescribed range given in manual This guarantee excludes losses or damages caused by external reasons such as thunder struck earthquake theft unsuitable use or abuse and refitting the device Shenzhen Well D Medical Electronics Co Ltd shall not be responsible for damages caused by other devices or arbitrary connection to other devices Shenzhen Well D Medical Electronics Co Ltd shall not be resp
73. y and mark the anterior wall of the right ventricular S1 of the systolic period with the w key Some mark points of the diastolic period are described as follows and mark the following several points with the same method S2 Posterior Wall of the Right Ventricular in the Systolic Period S3 Anterior Wall of the Interventricular Septum in the Systolic Period WED 380 English User Manual V1 3 Chapter Five Operation Procedures S4 Posterior Wall of the Interventricular Septum the Systolic Period S5 Endocardium of the Posterior Wall of the Left Ventricular in the Systolic Period S6 Epicardium in the Systolic Period 6 S6 After the marking finishes the measurement results will display on the right side of the screen automatically Diastolic Period Systolic Period Left Ventricular Measurement RHWD Thickness of the Right Cardiac Wall in the Diastolic Period mm RHWS Thickness of the Right Cardiac Wall in the Systolic Period mm RVD Right Ventricular Diameter the Diastolic Period mm RVS Right Ventricular Diameter in the Systolic Period mm LVDD Left Ventricular Diameter in the Diastolic Period mm LVDS Left Ventricular Diameter the Systolic Period mm PLVWD Thickness of the Posterior Wall of the Left Ventricular in the Diastolic Period mm PLVWS Thickness of the Posterior Wall of the Left Ventricular in the Systolic Period mm IVSD Thickness of the Interventricular Septum
74. y to display body mark B display model At any state press this key to enter B mode default mode is single B at starting up Double B display mode key Press this key to enter BB mode And there will be two B mode images displayed on the screen One of them is a Frozen image and the other is a real time image Repress this key can make the two images switch between the states of Frozen or real time Press Freeze key to freeze these two images 11 BM M mode display key Press this key to enter mode B mode and M mode images will display on the screen at the same time or B M for short B mode real time image is on the left and M mode real time image is on the right 22 WED 380 English User Manual V1 3 Chapter Four Keyboard and Trackball Operation Press this key again to enter M mode then M mode image will be displayed on the screen Press this key to convert from BM to M M to BM E SE 4B display Press this key to enter 4B mode and display 4B mode images One is real time the other three are frozen images Press this key repeatedly to switch each image between freeze and real time circularly Press freeze key to get four Frozen images keys are used to adjust focus position dynamic range scanning angle zoom cine loop refer to Chapter 5 Operation Procedures Single B mode BB mode BM mode M mode 4B mode Figure 4 5 Four display modes sketch

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