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KAIXIN ® KX5100 Ultrasonic Diagnostic Instruments User`s Manual

1. Gray Scale 256 Monitor 6 4 LCD Adapter rating 100 240V 50 60Hz 70VA model MW125RA1203F01 Output of Adapter DC12V 3 0A Main device rating DC12V 3 0A Main Unit Dimension approx 326x162x47mm LxWxH Main Unit Weight approx 1 5kg excluding accessories 2 2 Primary Functions O MON NWN BWN N FF RRR Ri Ri Ro i ea O 9 O ANU BWN CO 21 22 23 24 25 26 2T Display Mode B B B B M M 4B M Speed Is 2s 3s 4s 5s 6s 7s 8s Magnification x0 8 x1 0 x1 2 x1 5 1 6 x2 0 x2 4 x3 0 Depth range selection Depth enhancement pan function Local zoom Adjustment of near field far field total gain and dynamic range Single point multi point focusing Frequency conversion Angle width change Frame correlation function Image post processing Edge enhancement Images freeze unfreeze Vertical horizontal flip and B W conversion Pseudo color display Case information image annotation and auto time display Body marks Measurement of distance depth circumference area volume slope heart rate and cycle OB software package including 15 obstetric tables automatic calculation of EDC and fetus weight Puncture guide Image storage Cine loop PAL NTSC Conversion Energy saving Chinese English Switch Obstetric report Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Three Product Outline
2. E E SUCII AS HOT SUNSHINE OR IN THE CAR WIEN ET LL CAUSE THE FIRE OR SZORTEN ITS LIFE AND WORSEN ITS PERF BEYOND TIIS LISTED EV RONME IE MANUAL JT WILL CAUSE THE FIRE OR SHORTEN ERFORMANCE EVEN LEAD TO EXTREME HEAT OR SXPLOSION OR FIRE TRE ANY NATL OR SPICULATE OBJECT AND DO NOT HAMMERBLOW OR TRAMPLE THE BATTERY ON OR FIRE FFERENT MODEL OR DIFFERENT BRAND OR ABNORMAL i OSTON OR FIRE EAD OF WASHING IT AND GET HE E DOCTOR AS SOON AS POSSIZLE A Ordinances or Regulations for disposal Symbol for the marking of electrical and electronics devices according to Directive 2002 96 EC The device accessories and the packaging have to be disposed of waste correctly at the end of the usage Please follow Ultrasonic Diagnostic Instruments User s Manual V1 01 Contents Chapter One Intended Application 0 eee eee 1 Chapter Two Technical Specifications ccc cece ccc nene 2 Chapter Three Product Outline eee 3 3 1 Structure composition of the instrument nana 3 3 2 Name of parts and components sssssssssssseeerrereesssrsssssssreerrrrreesssseesssssse 3 3 3 Patt SOP the Probe ceh e a a a a mun ante de aie e 8 a E E MAD ad 3 3 4 Function keys description ere tie o ie d a ca a T Ua
3. aL I 4 qr r Humidity limitation Temperature limits L0 a poe J e Atmospheric pressure X Marking for the separate collection of ae limitation electrical and electronic equipment 3 Labels Label Description y Danger amp DANGER 1 It may have explosion MIXED LSE WITH FLAMMABLE GAS WILL hazard if used with LEAD TO DANGEROUS EXPLOSION flammable gas NOTICE BEFORE USING THE PROBE 2 Operate the probe with CAREFULLY USE THE PROBE BECAUSE care Read the probe n 1 Pon SITE 10 information inthe GUIDE TO USE AND CLEAN THE PROBE relevant manual for See proper probe use Attention It is prohibited to pull out a IT WILL LEAD TO BAD CONNECTION WITH THE insert the probe frequently PROBE SOCKET TF FREQUENTLY PULL OUT OR INSERT THE PROBE OR LOOSELY LOCK THE BOLT Ultrasonic Diagnostic Instruments User s Manual V1 01 ANY NICK OR PRESS TOWARDS THE LCD WILL LEAD TO THE DAMAGE OF THE LCD Attention It is prohibited to scratch or squeeze the LCD The device should be used only with external AC DC adapter provided by manufacturer Use of other AC DC adapter may cause damaged to the device or cause fire and electric shock hazards Warning The device should be used only with external AC DC adapter provided by manufacturer Use of other AC DC adapter may cause damaged to the device or cause fire and electric shock
4. 7 2 8 Chinese English Switch 1 Press Menu key to enter main menu and press direction keys to move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press Mode Text key to switch between Chinese and English 4 PresslEsc key to quit setting interface 7 3 System Formula Setting Press Menu key to enter main menu and press key to move cursor to SETUP Press direction keys to enter setting interface Press direction keys to move symbol lt to point to Formula Set Press direction keys to select the desired formula aA BW N e Press Enter key to confirm this setting and quit the setting interface Ultrasonic Diagnostic Instruments Formula preset table User s Manual V1 01 preset Options preset Options Preset Options ASUM China ASUM China Hansmann Hadlock Hadlock GS Hellman AC Hansmann Hansmann Rempen Jeanty Tokyo Merz urtz China Shinozuka BPD Merz Hadlock Mercer Osaka Hansmann FT i Paris Jeanty aris ll Rempen FL Merz a Shinozuka Osaka oor Tokyo Paris ae ral ASUM Shinozuka eases China Tokyo Hadiog Hadlock Jeanty EFW a ey Hansmann HL Merz Hansmann Jeanty Osaka Merz CRL Nelson Eriksen Merz2 Osaka TAD Hansmann Osaka Paris Paris Shepard Rempen Hadlock Tokyo Robinson Hansmann Shinozuka HC Jeanty Tokyo Merz 7 4 Mode Selection In real time mode press Mode Text key repeat
5. 3 1 Structure composition of the instrument KX5100 ultrasonic diagnostic instruments are composed of main unit and probe etc 3 2 Name of parts and components Power indicator Charge indicator 09 DC power input port Video signal port Keyboard 1E USB A interface LCD display Probe socket o Y wy a Front View Right View USB B interface o r me Se Top View Scutcheon Battery box Back View Fig KX5100 Main Unit sketch map 3 3 Parts of the probe Take 3 5MHz convex array probe for example Fig Name of 3 5MHz convex array probe parts W Ultrasonic Diagnostic Instruments User s Manual V1 01 Name Function 1 Acoustic lens To convert electric signal to ultrasonic signal based on principle of converse piezoelectric effect The ultrasonic signal after entering the human body is reflected as echo wave and converted to electric signal again The acoustic lens is on the probe surface Supply ultrasonic coupling gel to the acoustic lens surface when performing ultrasonic diagnosis 2 Cable To connect the probe to probe connector 3 Probe connector To connect the probe to ultrasonic dia
6. 7 8 9 10 11 Ultrasonic Diagnostic Instruments User s Manual V1 01 built in mark C 00000mm on the right part of the screen Press SIC key or click right mouse to display at the built in mark A 00000mm the value of the measured area formed by measurement line enclosure Repeat steps 3 4 to complete the multi group data measurement PresslEsc key to quit the measurement status Press Clear key or click the left and right key synchronously to clear all marks and data Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status Circumference area volume measurement with ellipse method In B B B mode choose desired image and freeze it Press Sl key or click left mouse the cursor will show Press direction keys or operate the mouse to move the mark to desired position press I key or click left mouse to set the mark position as the starting point of the measurement Press direction keys or operate the mouse to move the mark to the end point of the measurement Press OIC J key or click middle mouse the elliptic curve appears Press Menu key until the lt J D mark appears on the screen Hold down orkey to change the minor axis of the ellipse so as to satisfy the test area The measured values are displayed at the built in characters C 00000mm A 00000mm V 00000cm on the right part of th
7. 4 In real time mode press Mode Text key to exit B M mode 7 4 5 M Mode 1 In real time mode press Mode Text key to enter M mode 2 Change of M scan mode Press Menu key to enter main menu and press direction keys to move cursor to M DISPLAY and then press direction keys to change the M ultra scan mode Or right click mouse to realize the change of scan mode 3 Change of M speed Press Menu key to enter main menu and press direction keys Oto move cursor to M SPEED and then press direction keys to select the eight kinds of scan speed Or left click mouse to switch between M speeds 4 In real time mode press Mode Text key to exit M mode 7 5 Image Quality Adjustment 7 5 1 Brightness and Contrast Adjustment In the startup default status press direction keys the adjustment bars of brightness and contrast will be displayed on the screen adjust them according to actual need Press direction key to increase brightness and contrast direction key to decrease them press direction keys to select brightness or contrast adjustment Note If direction keys cannot be adjusted when adjust brightness in normal operation mode must be exit current operating condition of direction keys 7 5 2 Total Gain Adjustment In real time mode press Menu key to enter main menu and press direction keys to move cursor to Gain in the display area Press direction keyto increase total gain and direction keyto reduce to
8. 40 2 IV Mode SCI ois c c ra Bad ala ta a aaa e a meets 10 T23 Energy SAVING se UNO e rc cocci aa sewn get aaa aaa ai aaa ta a Bta die ii 10 T 2 4 Characters Brightness Setting rs peir anu t canta ni aia aa ale ro ao ia ea i 10 G2 SOs pital Name Setting nsure nani pita iba ua da oala piete ac dai 050 eg naan atatia adapa ep a 10 Plo Key SOONG Setting surclasat sete pna a te 2 os A Matei d a ati a AI a UD A 11 7 2 7 Compression Curve SEMINO ei pazita tu suds DE O ca data e Cf cal tit sas ana d i a aa neues 11 142 8 Chinese English SAC seca e aie eee i a da Doilea ae lesan aa ta dia 11 7 3 System Formula DELING ces pariat apa tepe gods nedenisnansasereansaseanneraeaer are Ea ai aleea 11 TA Mode Selectii asia a ti nse da ta sake se vois a ra esa EEA at enemas 12 TAI EV WOO mapa atzi pg at of wed haba a ha any eden aa a All 12 KA 2 B B IMO GC arietes osa aise eels anaes Meee ea wa buna armed nears 12 MA SSAB Mode gic fea such coda socggiee yeaa idea Boga ne ones bane a d pei aie O E AETERNE 12 TAA BIM Mode astora ahs ete ri Reverie sed Oa tte tls 30 a aaah o halls 9 a a d ced 12 a P AR Es atit 4 Rey me Care oe rem atata nO oct ene cre rege ra eta ee ee 13 E3 Image Qnalaty gt Adjustments se ore nic a natn it d a eer yes tees oun at pees 13 7 5 1 Brightness and Contrast Adjustment se catea n ca ata a da acea aaa cena da a aden a a 13 1 9 2 Lota Gam Adjustment sarea pa n atata it a au dt 0 a a ai a at oa la d 13 1 9 3 Near F
9. 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Mains power quality shall be that of a typical commercial or hospital environment If the user of this equipment requires continued operation during power mains interruption it is recommended that the equipment be powered from an uninterruptible power supply Conducted RF IEC61000 4 6 Radiated RF IEC61000 4 3 3 Vims 150KHz to 80MHz 3 V m 80MHz to 2 5GHz 1 Vims 3V m Portable and mobile RF communications equipment should be used no closer to any part of this equipment including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 5VP d 1 17VP 80MHz to 800MHz d 2 33VP 800MHz to 2 5GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the complianc level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ke Note 1 Ur is the a c mains voltage prior to application of the test level Note 2 At 80MHz and 800MHz the higher fr
10. Post process Edge Enhancement In real time mode press ES key repeatedly to enter the second vice menu and switch among the focus frame correlation post process edge enhancement and magnification Then press direction keys to select the focus mode frame correlation post process edge enhancement and magnification 7 6 Image Control 7 6 1 Magnification Selection In real time mode press Menu key to enter main menu and move cursor to ZOOM and then press direction keys to choose eight kinds of magnification 7 6 2 Depth Enhancement and Depth Range Selection In real time mode press Ol key s appears in the center of the screen Press direction keys or operate mouse to move image up down or left right so as to observe the images of different depth and width PresslE c key to quit depth enhancement pan status Note Image can not move up and down in the 0 8 magnification In real time mode press J key twice depth selection 1 17cm 2 18cm 3 19cm 4 20cm 5 2lcm 6 22cm 7 23cm 8 24cm are displayed at the bottom of the screen Press direction keys to select corresponding depth at the bottom of the screen press Enter J key to confirm press E key to quit depth range selection Note There is no depth selection function when main unit matching probe which its nominal frequency greater than or equal to 6 5MHz 7 6 3 Local Zoom and Local Additive Color In real time B mode press key a box appears Operate
11. 2 3 Energy Saving Setting 1 Press Menu key to enter main menu and press direction keys to move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press direction keys to move symbol lt to point to Sleep 4 Press direction keys to select energy saving time or energy saving close between 1 99 minutes 5 PressEJkey to quit setting interface 7 2 4 Characters Brightness Setting 1 Press Menu key to enter main menu and press direction keys to move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press direction keys to move symbol lt to point to Font Bright 4 Press direction keys to select characters brightness among 160 192 224 and 255 5 PresslEsc key to quit setting interface 7 2 5 Hospital Name Setting 1 Press Menu key to enter main menu and press direction keys Oto move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press direction keys Oto move symbol lt to point to Hospital 4 Press Enter J key the cursor is located above NAME at the same time characters inpu will be shown at the bottom of the screen Caps0123456789abcdefgh Ultrasonic Diagnostic Instruments User s Manual V1 01 Shiftijklmnopqrstuvwxyz Press direction keys or operate mouse to move cursor to point to Caps and then press Enter J key or click left mouse to achieve capital and small letter conversion If the cursor point
12. 75 Power up mode B Mode B Mode B Mode Acoustic initial factor AIF 89 75 93 12 89 75 Initialization mode B Mode B Mode B Mode Acoustic output freeze yes yes yes Ultrasonic Diagnostic Instruments User s Manual V1 01 Appendix A3 Sound Power Output Parameter Disclosure Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment GB 16846 1997 we hereby make our declaration of the relevant acoustic output parameters as follows Xuzhou Kaixin Electronic Instrument Co Ltd Type B Full Digital Ultrasonic Diagnostic Instrument Test Frequency 6 5 MHz Acoustic output data for KX5100 Probe model Probe model 6 5C13A1 Probe No 6 5C64 603001 Mode Parameter B M B M Maximum space averaged acoustic zi 35 33 power output mW Peak negative sound pressure P 1 15 1 15 1 15 Mpa Sound intensity of output beam Iu 0 76 5 07 0 83 mW cm Space peak time averaged sound 3 79 57 77 3 69 intensity output Iota mW cm Focus mode Focus mode Focus mode Syst tti 1 section 1 section 1 section See Depth 10cm Depth 10cm Depth 10cm Scan scope 3 M speed 4s M speed 4s Distance between transducer output end surface and integral dot for 23 23 23 square of the maximum acoustic pressure Lp mm 6dB pulse beam width 1 99 2 65 1 99 Woes ID mm L mm L 3 96 L 3 29 L 3 9
13. Application KX5100 ultrasonic diagnostic instruments are applicable to abdominal viscera include trans vagina gynecologic and obstetric and small parts ultrasonic diagnosis Attention Although ultrasonic diagnostic does not hurt human body do consider the scanning stop time and frequency for pregnant woman and fetus on the basis of ALARA principle N Attention The method below should be followed when the intra cavity probe is used for gynecology and obstetrics Explain the importance and necessity to the subject to get the understanding and coordination 2 Get the bladder calculus no need to fill the bladder 3 Smear the coupling gel on the top of the probe then put condom on it and then put the coupling gel on it again Then place the probe to different position of the uterine cervix and fornix along pelvis axis slowly Use of the rotation tilt pumping the basic approaches of pelvic structure sagittal coronal traverse and other cross sectional profile scanning Pay attention to the scanning depth so that the organ of near filed or the far filed get into the accumulation area for observing If the position of organ is higher the operator can press lower abdomen gently such as bilanual gynecological examination by left hand to make it next to probe and get the best showing Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Two Technical Specifications 2 1 Technical Parameters IA NU BP WN
14. E TE al 4 Chapter Four System Configuration 5 Chapter Five Operation Condition nene 5 Chapter Six System Installation and Check eee 6 6 1 System placement eria e a do le A a li d po at a oda ia 6 6 2 Probe installationen a 19 00 te waa tale Eat 7 6 2 1 Probe COnmeC MOMs anhalt cea de a e aE A ll AEA OE das Dei EE i Ea ata 7 6 2 2 Probe disconnette sg t ede tast ed s aaa ea aa aul ate cree a Mate E la 7 6 3 Install dismantle the battery scoica a as asta ied aaa aaa d o ae dias a laba T 6 4 Connect to video TECOLCEE sasas eresien a i do la e a A do her ti a Se 8 6 5 Connect to the MOUSE sasa She pac e noa ag a ta n lu li ER d ai a Ee 8 6 6 CONNee to the POW ers acini o atatea la a a degli a ata ala ai 0 sale aa idle ata la ala 8 6 7 Probe check before and after Operation c orci atata a 80 pie 0 Bodiu at ne sentences 8 6 8 Main unit check before and after operation ccc eee 8 6 8 1 Inspection before start up ac stase e plan geaca indiu canoes esa daia aaa Aaaa E a Sa Stead 8 6 8 2 Inspection after Start Upin seriis Mea a Sed as ta an e reeds aaa e ER de a i i 9 6 9 SySteM reSt sips spa e Bastia a atata As Au a a a da a d n aa i a a R 9 Chapter Seven Function Operation nenea 10 Tel cStartup and Sh tdo Whi svacrt tities aud i EE ed ti al d ta ta a d ta 10 T2 System Functions Setting sosser tao d alee Mea ie da aa Baa ui 3340 03 alba d de e i ag e a ale a 10 T21 Time Setting sees arma iai al de 0 e bd ta iii at 10
15. User s Manual V1 01 4 PresslEsc key to quit mass dumping status and press key to return to real time status e From U disk to main unit 1 Plug U disk 2 Freeze the image continuously press EEE key until enter PAUSE status 3 Press O C key twice U Disk gt LOCAL Mass Dump prompt display at the bottom of the screen 4 Press Enter key Dumping prompt appears the number behind PAUSE character is the number of file name of mass dumping After finishing mass dumping return to PAUSE status 5 PresslEsc key to quit mass dumping status and press key to return to real time status Explanation 1 Mass dump which is dump images from main unit to DUMP folder in the U disk can also dump the images under the DUMP folder in the U disk to main unit 2 If U disk does not have DUMP folder or DUMP folder does not have images or the images within the DUMP folder are not named by digital 1 100 press Enter key although the screen prompt Dumping the image number is not appeared on the right corner of the screen 7 11 Delete the image 1 Freeze the image press E key to enter reading or saving image status 2 Press Mode Text key to switch LOCAL and U disk identified the location LOCAL or U disk for file need to be deleted 3 Press direction keys to select the image code to be deleted such as 002 4 Press OIC key the
16. and charge free repair service from the day of purchasing the equipment eighteen months for main unit and typical configured probe and six months for other components 2 Within warranty period the company will not be responsible for the following situation 1 Damage or malfunction arising from failing to comply with the instructions of the User s Manual 2 Damage or malfunction caused by falling during moving after purchased 3 Warranty is expired 4 Damage or malfunction due to human factors 5 Damage or malfunction caused by disassembling and assembling alteration and repair without the consent of the company 6 Instrument losses induced by Force Majeure like abnormal power supply fire flood lightning strike earthquake etc 7 Damage or malfunction caused by use of unqualified ultrasonic coupling gel 8 Damage or malfunction caused by use of probe not provided by our company 3 The company will offer repair service for instrument out of warranty but additional fees of materials and repair service will be charged 4 The customer can repair the instrument out of warranty by themselves and if necessary the company can provide circuit diagram and components under customers request Return of Goods Follow the procedure below if you need to return the purchased equipment To obtain the right to return the goods contact local dealer of Kaixin Company indicating serial number of main unit this number is located on the nameplat
17. at bottom right of the display 7 5 8 Focus Adjustment and Control In real time mode and in B B B or 4B mode press Menu key to enter main menu an Ultrasonic Diagnostic Instruments User s Manual V1 01 cursor to Focus and then press direction keys to choose from the four focus modes of stage 1 Full process dynamic focus 2 3 and 4 In real time mode and in B B B B M 4B or M mode press E Ikey to quit menu mode press direction keys Dagain to move the focus up and down Note In B M or M mode only allowed choosing single focus mode 7 5 9 Frame Correlation Adjustment In real time mode press Menu key to enter main menu and press direction keys Oto move cursor to FC in the display area and then press direction keys to realize the switching of four frames correlation 7 5 10 Post process Adjustment In real time mode press Menu key to enter main menu and press direction keys to move cursor to IP in the display area and then press direction keys to obtain four kinds of corrected image Four levels of post process are 0 1 2 and 3 System default is 2 7 5 11 Edge Enhancement Adjustment In real time mode press Menu key to enter main menu and press direction keys Oto move cursor to IE in the display area and then press direction keys to gain four kinds of sharpened images Four levels of edge enhancement are 0 1 2 and 3 System default is 0 7 5 12 Quick Adjustment of Focus Frame Correlation
18. ata iti oat 15 7 6 7 Scan Range Angie Width Change i io iti a i ase ama Malacca an da ile 15 T68 Color CC ONVETSION ro d in 0 aa si at al 70 00 EE d ia 15 1 6 9 livia Ce SE PEG Ze INTEC Ze ste arti cca fetal 8 iG a del a Cit ata AE E Doe rii d ta a data 15 7 7 Puncture guide and lithotripsy positioning line eee 15 7 8 Body Mark and Probe Math sis i icter DA oa a 15 7 9 Image storage and TECAN diss sve cane dvadnras aia pd atata boas ia al seas ea 0 teak ie 17 7 10 Single dump and mass GUMpP ra sista cade ea Sia e iba a aul a la 315 ia 05 aia Ri Da 18 Tell Delete te Aa 2 tars i ae die ati etala etalon a clad ela re tac ere Oc dala a bata clei 3 sati dani 19 T12 Image PENIC ee ca e pa ca aa 0 20 pa a SA es 0 de 5 4 aa ri 19 PAS CNE JOOP i du ennnen lo ot da adu el ae af ina al ee berea 19 TIA Text NP erer eaa a EA tedster ETEA RE de a sive d p aia RU e ca ala 20 Chapter Eight General Measurement eee nenea na 21 8 1 Distance Measurement saca dais e ca aaa aa a a po des ai eevee Ia 21 8 2 Depth Measurements mc aspect Beaten ac a as lear ata c a il 21 8 3 Circumference Area Volume Measurement ns e vcs aaa te sea a did da said td ia a ala ata 21 8 4 Slope Heart rate Cycle Measurements iss ce a cuca ieee eee aa ta ip la a iau o pedala au ven 22 Chapter Nine Obstetric Measurement eee 23 9 1 Measurement and Calculation items sasea cae caca sk cetate Gay Iata a ala ai eae 23 9 2 Fetus growth parameter Measurement es acasa eee ca a
19. calculation of the maximum output power of the communications equipment i 150KHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz sue es d 3 5 P d 1 17 P d 2 33 P transmitter W 0 01 0 35 0 12 0 23 0 1 1 11 0 37 0 74 1 3 50 1 17 2 33 10 11 07 3 69 7 38 100 35 00 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d 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 Notel At 80MHz and 800MHz the separation distance for the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Statement When performing common mode conducted RF disturbance test IEC61000 4 6 trivial radiation stripes may appear on the screen when 1V disturbing voltage is adde That disturbance does not affect the diagnosis Ultrasonic Diagnostic Instruments User s Manual V1 01 Appendix Al Sound Power Output Parameter Disclosure Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment GB 16846 1997 we hereby make our declaration of the relevant acoustic output parameters as follo
20. direction keys or mouse to move the box to place to be enlarged and the selected image to be enlarged Press fale key again to quit local zoom status In the color display the selected image which by above mentioned operation will be enlarged and added color 7 6 4 Image Left right Flip In real time mode and in B B B 4B or B M mode press Menu key to enter main m press direction keys to move cursor to SCAN WAY and then press direction keys realize image horizontal flip Or left click mouse also to realize image horizontal flip The Ultrasonic Diagnostic Instruments User s Manual V1 01 horizontal flip is the change of probe scanning direction The probe scanning direction is indicated by the arrow on the upper left area of the image 7 6 5 Image Up down Flip In real time mode press Menu key to enter main menu and press direction keys to move cursor to IMAGE UP and then press direction keys to realize image vertical flip 7 6 6 Image Negative In real time mode press Menu key to enter main menu and press direction keys to move cursor to IMAGE POS and then press direction keys to realize negative function 7 6 7 Scan Range Angle Width Change In real time mode press Menu key to enter main menu and press direction keys to move cursor to SCAN ANGL and then press direction keys Okto choose angle width convex array for scanning angle and linear array for scanning width 7 6 8 Color Conversion In
21. hard up on its connection Check probe and its cable to ensure they are free of abnormity such as scuffing drop off or contamination If the contaminant is present clean disinfect the contaminated objects as specified in relevant sections No barriers around the intake of equipment See to it that probe has been cleaned disinfected and sterilized else dispose it as specified in relevant sections Check all the ports of the machine for possible damage or blockage Clean the field and environment 6 8 2 Inspection after start up Check the following items after starting the machine l 2 No abnormal voice strange smell and overheating appear Check the machine to ensure a normal start up The power indicator is on and startup picture is shown on the screen The machine will be then automatically set in B mode Check the ultrasonic lens is abnormal heat or not when the probe is in use This can be done by hand touching the probe to feel the temperature of the lens Check image to ensure trouble free display no excessive noise or flickering Check the panel to ensure normal operation condition Check the instrument to ensure that the phenomenon of high local temperature will not appear Z Attention If the overheat ultrasonic lens is placed on the patient s skin heat injury may occur Z Attention Thoroughly clean the coupling gel on the probe surface each time after ultrasonic operation or the coupli
22. hazards Lithium Ion Battery Pack KX5100 Rating 120V 29Wh Lithium Ion Battery Pack KX5100 Rating DC 12 0V 29Wh Limit To Use With KX5000 KX5100 Battery pack is limited to use only with Ultrasonic Diagnostic Instrument Only KX5000 KX5100 ultrasonic diagnostic instrument Attention ATTERY INTO WATER WHICH WILL LEAD TO THE LEAKAGE FXPLOSTON OR FIRE Battery use should note Y NEAR THE BEAT SOURCE SUCH AS FIRE OR EEATER WHICH WILL LZAD TO TEE LEAXNGE EXPLOS the precautions ODE REVERSELY WHICH WILL LEAD TO THE LEAKAGE EXPLOSION OR FIRE PTERY INTO FIRE WICU WILL LEAD TO TE LEAKAGE EXPLOSION OR FIRE E WITH ANY METAL OR LEAD LINE W IC WILL LEAD TO TZE LEAKAGE EXPLOSION OR F MECTANICALLY SIIAAE THE BATTERY WITCH WILL LFAD TO TIE LEAKAGE EXPLOSTON OR F KAGE EXPLOS F RECTLY WICH WILL LEAD i LEAKAGE EXPLOSION OR FIRE NY WAY WHICH WILL LEA 3 LEAKAGE EXPLOSION OR FIRE HEAT SOURCE OR EXTRA HOT E II WELL LEAD TO THE LEAKAGE EXPLOS ON OR FIRE L OR ABNORMAL 0 RN COLORS OMENON HAPPENS TO THE BATTERY S S PARTICULAR SMELL VE WILL L3AD E LEAKAGE SION OR FIRE TICULAR SMELL TAPPENS ITC WILT EAD TO TIE LEAKAGE BXPI
23. instrument may result in biological effect in human body there is possibility that such biological effect is proved to be true in the future Therefore we Shall exercise prudence in applying the diagnostic ultrasound to clinical practice We shall obtain clinical information necessary for the diagnosis with reasonable ultrasound and avoid using high intensity ultrasound for long period of time 10 4 ALARA as low as reasonably achievable principle Application of ultrasound shall be based on the ALARA principle that requires a minimized biological effect free energy output to obtain necessary diagnostic information The ultrasonic energy intensity is related to output power and exposure time Different patients and cases require different ultrasonic intensity Not all diagnosis can be done with extra low ultrasonic energy output The extra low ultrasound power produces poor quality image or weaker Doppler signal that may reduce the diagnostic reliability On the other hand use of sound power larger than diagnostically required makes no more contribution to improvement of the diagnostic information quality and increase the risk of biological effect possibility Therefore user of the diagnostic ultrasound shall be fully aware of the patient s safety and choose a proper output level for a specific purpose based on ALARA principle 10 5 Image control impact on sound power output Change of image control settings may have influence on sound power outpu
24. items BPD Biparietal Diameter CRL Crown Rump Length GS Gestational Sac FL Femur Length HL Humerus Length LV Lumbar Vertebrae TTD Thorax Transverse Diameter APTD Antero posterior Thorax Diameter HC Head Circumference AC Abdominal Circumference FT Foot Length TAD Abdominal Transverse Diameter THD Thorax Height Diameter TCD Transverse Cerebellum Diameter OFD Occipitofrontal Diameter EFW Estimated Fetus Weight EDC Estimated Date of Confinement GA Gestational Age 9 2 Fetus growth parameter measurement The following parameters are common evaluation specification of fetus growth When you measure one of the parameters the system will calculate the GA automatically Z Attention 1 The measured value of GA is the diagnostic GA 2 The formulae of every measurement item have been embedded in main unit 3 Make sure that the measurement is in the effective image area or else it can t calculate right or lead to wrong calculation 9 2 1 Measurement of GA and EDC 9 2 1 1 Measurement of BPD CRL GS FL HL LV TTD APTD FT TAD THD TCD OFD Follow the steps below 1 In B B B mode freeze the desired image 2 Press R key to display the obstetric parameters on the lower part of the screen 3 Press direction keys to select corresponding measurement parameters items BPD CRL GS FL HL LV TTD APTD FT TAD THD TCD OFD Press Etter J key to confirm 4 Press key or click le
25. pare key or click right mouse to set the mark position as the starting point of the measurement Press direction keys or operate the mouse a solid line measurement locus appear on the screen along the moving direction circumference GA and EDC value will be displayed in real time in the right area of the screen press SIC key or click right mouse again to finish the first measurement in the corresponding right area of the screen display the value in square millimeter of the measured area formed by measuring line enclosure Press Esckey to quit the GA measurement Press Clear key or click the left and right key synchronously to clear all marks and data 9 Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status e Measuring HC and AC using elliptic method Follow the steps below l In B B B mode freeze the desired image 2 Press R key to display the obstetric parameters on the lower part of the screen 8 9 10 11 Press direction keys to select measurement parameters in HC AC press Ener J key to confirm Press S key or click left mouse the cursor will show Press direction keys or operate the mouse to move the mark to desired position press I key or click left mouse to set the mark position as the starting point of the measurement Press direction keys or operate the mouse to change the m
26. the probe surface should be covered with a condom every time before diagnose the cavity 5 Do not use the probe packing box to store the probe as the box may become the of contamination 6 The waterproof grade of intra cavity probe is IPX7 immersion depth from p acoustic head to the sheath of probe handle other probes are IPX4 Ultrasonic Diagnostic Instruments User s Manual V1 01 Clean the probe 1 Wear sterilized gloves to prevent possible infection 2 Clean the probe with sterile water to remove all contaminants Do not use brush as it may damage the probe 3 Dry the probe with sterilized cloth or gauze after cleaning Do not dry the probe by heating it Disinfect the probe 1 Wear sterilized gloves to prevent possible infection in the process of disinfection 2 Clean the probe firstly before disinfection and then wipe the probe twice with 75 alcohol 3 Clean the probe with sterile water to remove residual chemicals 4 Clean the water off the probe surface with sterilized cloth or gauze Never dry the probe by heating it ANWarning Do not place the ultrasonic probe connector into water or disinfection sterilization liquid as it may cause electric shock Sterilize the probe 1 Wear sterilized gloves to prevent possible infection in the process of sterilization 2 Clean the probe firstly before sterilization 2 glutaraldehyde disinfectant is recommended for the pro
27. 0 4 2 6 KV contact 8 KV air 6 KV contact 8 KV air Floors shall be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC61000 4 4 2 KV for power supply lines 2 KV for power supply lines Mains power quality shall be that of a typical commercial or hospital environment magnetic field 50 Hz IEC61000 4 8 Surge 1 KV differential 1 KV differential Mains power quality IEC61000 4 5 mode mode shall be that of a typical 2 KV common 2 KV common commercial or hospital mode mode environment Power frequency 3A m 3A m Mains power quality shall be that of a typ commercial or hosp environment Ultrasonic Diagnostic Instruments User s Manual V1 01 Guidance and manufacturer s declaration electromagnetic immunity This equipment is intended for use in the electromagnetic environment specified below Customer or user shall assure that it is used in such an environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guidance Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec lt 5 Ur gt
28. 12 Moist 13 Thunderstorm weather 14 Strong electromagnetic field e g MRI 15 Radiation e g x ray CT 16 Defibrillators or short wave therapy equipn Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Six System Installation and Check Z Warning 1 Do not connect the three core power supply cord to unprotected two core socket or electric shock may occur If breakers and fuse of the mains power socket are identical to those of the this system and they are used to control the current for equipment like life support system the system shall not be connected to such power supply socket as it may cause breaker or fuse to trip and cut off the power supply to the entire premise in case of malfunction or over current with this ultrasonic system All plugs of instruments of this system shall be connected into the power socket with protective earth on the wall and the socket must meet the requirement of power rating of instrument Multiple portable socket outlets can not be used for the system Equipment that connects the signal input part or signal output part must only connect the accessories authorized in this manual and connect the equipment that complies with IEC 60601 1 standard When the instrument connects with more than 3 sets of equipment it may cause the danger of the leakage current accumulation When this system is installed or used around patient try to avoid the patient touching the system If system is w
29. 5 Pulse repetition rate prr kHz N A 4 608 64 10 Scan repetition rate srr Hz 71 42 N A 32 05 Output beam size cm 2 75 0 69 2 75 Arithmetic average acoustic working 5 96 5 84 6 43 frequency fawn MHz Acoustic power on factor APF 100 100 100 Power up mode B Mode B Mode B Mode Acoustic initial factor AIF 100 100 100 Initialization mode B Mode B Mode B Mode Acoustic output freeze yes yes yes Ultrasonic Diagnostic Instruments User s Manual V1 01 Appendix A4 Sound Power Output Parameter Disclosure Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment GB 16846 1997 we hereby make our declaration of the relevant acoustic output parameters as follows Xuzhou Kaixin Electronic Instrument Co Ltd Type B Full Digital Ultrasonic Diagnostic Instrument Test Frequency 7 5 MHz Acoustic output data for KX5100 Probe model Probe model 7 5L40A3 Probe No 7 5L40A3 612002 Parameter B M B M Maximum space averaged acoustic 78 93 73 power output mW Peak negative sound pressure P 2 69 2 69 2 69 Mpa Sound intensity of output beam Iu Lp 3 03 161 mW cm Space peak time averaged sound 23 89 386 04 15 39 intensity output Ispta mW em Focus mode Focus mode Focus mode Sige tti 1 section 1 section 1 section eee Depth 10cm Depth 10cm Depth 10cm Scan scope 3 M speed 1s M s
30. After the prompt disappear the current image is stored in the folder for patient number ID as folder name in the U disk and file name is arranged by the selected saving code that is 4 If user did not enter the number ID the folder name defaults to USER 6 Press Eckey to quit saving status and press key to return to real time mode Explanation 1 Each number ID corresponds to a folder the largest storage for each folder is 100 images 2 Press Mode Text key can select LOCAL or U Disk 3 If you want to use number ID for the folder name must first input number ID and then store image Folder name is made up of underline letters or numbers without spaces 7 9 2 Open image e Open image stored in the main unit 1 Freeze the image 2 Continuously press E key twice a Read prompt appears on lower right corner of the screen 3 Press direction keys to select the image code need to be read out in the LOCAL such as choose 003 4 Press Enter key to appear Wait prompt After the prompt disappear the image stored in frame 003 is read out 5 PresslEckkey to quit reading status and press key to return to real time status e Open image stored in the U disk 1 Plug U disk 2 Freeze the image Ultrasonic Diagnostic Instruments User s Manual V1 01 3 Continuously press E key twice a Read prompt appears on lower right corner of the screen 4 Pr
31. Attention The formulas of fetus weight measurement are all based on estimation Due to differences in development of individual fetuses and quality of images obtained in different times the estimated fetus weight may deviate Therefore besides using more accurate parameters it is advisable to measure the fetus weight in various formulae and average the values Note Select other formulas measuring fetus weight The method and steps are identical with those above 9 3 Obstetric report In frozen status press Menu key to enter main menu and press direction keys to move the cursor to the position REPORT Press direction keys to display obstetric report Press direction keys again to exit obstetric report status Note 1 For measurements done with the given obstetric table the distance gestational week and estimated date of confinement are automatically stored in the corresponding places of the obstetric report 2 When performing fetus weight measurement the system will store the last measurement value only and display the value at the EFW position of the obstetric report 9 4 Measurement items 1 Items measurable in B mode distance depth circumference area volume gestational age GA estimated date of confinement EDC and fetus weight 2 Items measurable in B B mode distance depth circumference area volume gestational age GA estimated date of confinement EDC and fetus weight 3 Items measurable in B M m
32. Diagnostic Instruments User s Manual V1 01 Z Attention Adequate space from rear left and right side of the machine shall be reserved or the machine may malfunction under excessive heat inside the enclosure 6 2 Probe installation Warning 1 The Kaixin ultrasonic probe shall be connected to the dedicated Kaixin ultrasonic system only Select proper probe model according to the relevant instructions of ultrasonic diagnostic system Check the ultrasonic probe and connecting cable after diagnostic operation Use of defective probe may cause electric shock Do not knock or bump the probe or it may be damaged and cause electric shock Unauthorized disassembly of the probe shall be prohibited as it may cause electric shock hazard Attention Turn off the ultrasonic system before disconnecting the probe Disconnecting the probe with system power on may damage the system or probe Before disconnecting the probe place the cable and probe on a stable and leveled position so that the probe may not be damaged or injury person by unexpected fall Freeze the instrument when instrument is start up without operation to increase of service life of probe Repeat available machine time should be more than 5 minutes to avoid turn on off power supply in short time 6 2 1 Probe connection ANWarning Make sure that the probe connecting cable and connector are in normal condition free of cracks or drop Use of defective probe may cause elec
33. Heart Quad Heart Chamber D a YY A N N a Aortic valve M type curve Aorta Minor Axis Bicuspid valve M type curve User s Manual V1 01 a Body Lumbar Female Upper Parts Rear pees Ne Right Left Shoulder Rear Shoulder Rear Uterus Front Uterine Body Transection Breast 2 Neck Front Head Rear Head Top f A Right Arm Left Arm Left Apical Five Ventricle Chamber Major Axis Cross Section rs Large Intestine Ste Ultrasonic Diagnostic Instruments User s Manual V1 01 CN N Za SI ZE Thoracic Testes Knee Joint 1 Knee Joint 2 Foot 1 Foot 2 Hand 1 Hand 2 Cavity 7 9 Image storage and recall 7 9 1 Save image e Storage to main unit 1 Freeze the image 2 Press EF key a Save prompt appears on lower right corner of the screen 3 Press direction keys to select the image code need to be saved in the LOCAL such as choose 003 4 Press Enter key to appear Wait prompt After the prompt disappear the current image is saved in the frame for coded 003 The saved image code is preceded with asterisk 5 PresslEsckey to quit saving status and press key to return to real time status e Storage to U disk 1 Plug U disk 2 Freeze the image 3 Press EF key a Save prompt appears on lower right corner of the screen 4 Press direction keys to select the image code need to be saved in the U disk such as choose 004 5 Press Enter key to appear Wait prompt
34. KAIXIN K NX 5 4 OO Ultrasonic Diagnostic Instruments User s Manual anal XUZHOU KAIXIN Electronic Instrument Co Ultrasonic Diagnostic Instruments User s Manual V1 01 Information for Users Users shall carefully read through this manual and fully understand the text before operating the equipment This manual shall be placed easy of access for future reference otherwise it may cause instrument damage or person injury Intellectual Property Information Xuzhou Kaixin Electronic Instrument Company Ltd hereinafter referred to as Kaixin has the copyright of this user s manual and reserves the right to keep it confidential This user s manual shall be used for the sole purpose of operation maintenance and servicing of Kaixin s products This user s manual and intellectual property right including copyright herewith included is property of Kaixin No persons may use disclose or allow a third party to obtain by any means any of the information contained herein without prior written consent of Kaixin No persons may reproduce this user s manual in whole or in part including but not limited to photography photocopy reprint or translation into any other language without prior written consent of Kaixin KA IXI N This is registered trade mark of Kaixin Company Kaixin is the sole authority for the interpretation of this user s manual Kaixin may revise this manual without prior notice Kaixin may revis
35. aa a oi dr a a dee 3 0 d Dada 23 9 21 Measurement of GA and BDC vor sceneta mec iei tata ea i e aaa ad e 3 a 3 23 9 2 1 1 Measurement of BPD CRL GS FL HL LV TTD APTD FI TAD THD TCD OFD 23 9 2 1 2 Measurement of HC and Aaa retrasa et ratie ati 0 ireala a a daia i 23 9 2 2 Fetus Wed hi m as rement Adi ast a a e e bean Nei i Sea dara pa ie ad 24 Ors OBSCENE TEDOE ciara o aia vata gat sa etate ca uta ostatec gi e ale pa 0 O A 25 94 Measurement TEINS serenos taca odata Pa a la a ia pa A n e ati 25 Chapter Ten Principle of Sound Power nenea 26 Chapter Eleven System Clean and Troubleshooting 27 Ideal Maintenance by serS aeset aere ane E A il aa 20g ei d aa d 27 11 1 1 System clean disinfect and Stertize css cc a taie and aaa de av ata 0 aa ok 27 11 1 2 Use and maintenance for the charging battery eee eee 29 11 2 Troublesh otint sosse a ara Date Acu ala pei E ET ao T rea it atei 30 Chapter Twelve System Maintenance eee 30 Chapter Thirteen Accuracy of Measurement eee 32 Chapter Fourteen Storage and Transportation eee 33 Chapter Fifteen Standard Compliance ciinii cas eo o atare ae nea aa oe gaedes caro o Chapter Sixteen Safety Classification eee nenea 33 Chapter Seventeen Guidance and Manufacturer s Declaration A Appendix A Sound Power Output Parameter Disclosure e cesses eee Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter One Intended
36. ajor axis of the ellipse Press Menu key the lt gt mark appears on the screen hold down or key to change the minor axis of the ellipse so as to satisfy the test area circumference GA and EDC value will be displayed in real time in the right area of the screen Pressf O Jkey or click left mouse to exchange the starting point and end point Press Menu key again to quit the status of changing minor axis Press key or click right mouse to finish the first measurement PresslEsc key to quit the GA measurement Press Clear key or click the left and right key synchronously to clear all marks and data Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 9 2 2 Fetus weight measurement Fetus weight measurement can be done in B B B mode Multi parameter measurement and storage are required as different formulas are applied to the measurement These parameter groups for fetus weight measurement include BPD FTA FL or BPD APTD TTD FL Elliptic method shall be used for area and circumference measurement for the fetus weight measurement The calculation methods for fetus weight measurement are as follows BW N Re In B B B mode freeze the desired image Press R key to display the obstetric parameters on the lower part of the screen Press direction keys to select the 16 EFW parameter f Press Enter Jkey to confirm For example set the calcula
37. be Immerse the sound head part of the probe See sterilization sketch map in liquid for more than 10 hours for sterilization Attention 1 Please carefully read the instructions provided by disinfectant provider about the sterilization liquid concentration and sterilization method as well as the description of the dilution method 2 Glutaraldehyde liquid should use the activator 3 Clean the probe with sterile water to thoroughly remove residual chemicals 4 Clean the water off the probe surface with sterilized cloth Never dry the probe by heating it X Fig Wrong 3 5MHz probe sterilization Fig Correct 3 5MHz probe sterilization Attention 1 Itis a normal phenomenon that color of the acoustic lens may change and color of the probe label may fade away 2 To prevent the infection or the cross infection such cleaning disinfection and sterilization for puncture bracket and probe is very necessary before and after e puncture operation 3 The sterilization times should be minimized as it may lead to degrade of the prol safety and performance Ultrasonic Diagnostic Instruments User s Manual V1 01 4 Clean the probe cable and its connector 1 Clean the probe cable and its connector with soft dry cloth 2 In case of die hard blots clean with soft cloth dipped in moderate detergent and then air dry it 5 Clean the liquid crystal d
38. ceiling of the warehouse 2 Environment requirement Ambient temperature 20 C 55 C Relative humidity 30 93 without condensation Atmospheric pressure 700hPa 1060hPa The warehouse should be well ventilated and free of direct sunlight and corrosive gas 3 Shockproof measures have been taken inside the packing case to allow for transport by air railway land and sea The goods shall not be exposed to poor weather conditions like rain and snow nor shall the goods be placed upside down bumped knocked or over stacked Chapter Fifteen Standard Compliance The compliant standards are listed below 93 42 EEC EN ISO 14971 IEC 60601 1 IEC 60601 1 1 IEC 60601 2 37 IEC 60601 1 4 IEC 60601 1 2 EN 980 EN 1041 IEC 61157 EN ISO 10993 1 EN ISO 10993 5 EN ISO 10993 10 Chapter Sixteen Safety Classification 1 Classified according to electric shock protection type Class I internally powered equipment 2 Classified according to electric shock protection degree Type B applied part 3 Classified according to the degree of protection against ingress of liquid Main unit belong to IPXO equipment 4 Classified according to operation safety in condition of existence of flammable anesthetic mixture with air or oxygen or nitrous oxide It is neither of category AP equipment nor of category APG equipment 5 Classified according to mode of operation Continuous operation equipment 6 Classified according to the protection of radio s
39. ction earth resistance according to IEC 60601 1 1988 A1 1991 A2 1995 Limit 0 1Q Test the earth leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 500uA SFC 1000uA Test the enclosure leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 100uA SFC S00uA Test the patient leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit for a c 100A for d c 10A Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC 60601 1 1988 A1 1991 A2 1995 Limit for a c 500A for d c SOpA Probe lt MCU control system m Clock A el H V SYNC Signal y y y y Transmit and conne DSC Signal Display Receive processing synthesis part Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Thirteen Table 13 1 Accuracy in measurement Accuracy of Measurement Parameter Numeric range Deviation M mode image time 1 2 3 4 5 6 7 8s 1s 3 ms 2s 6 ms 3s 9 ms 4s 12ms Ss 15 ms 6s 18 ms 7s 21 ms 8s 24 ms Table 13 2 Two dimensional image measurement Parameter Numeric range Deviation Distance depth Max Value 194mm Wain Soror less st eg Aa P i measured value is less than 40mm 2 Within 7 or less than 1 5 cm when Area Max Value 448 cm measured valu
40. d with asterisk 5 PresslEsc key to quit dumping status and press key to return to real time status e From U disk to main unit 1 Enter number ID after complete it and exit input status 2 Read out the image in the U disk Img with highlight status is displayed on lower right corner of the screen 3 Press Mode Text key a Dump prompt appears on lower right corner of the screen 4 Press direction keys to select the image saving code in the LOCAL such as choose 006 5 Press Enter J key Dump prompt disappears until the Dump re appears the current image can 66399 be dumped in the frame for coded 006 The dumped image code is preceded with asterisk 6 PresslEsc key to quit dumping status and pressBkey to return to real time status Explanation If not enter number ID it will select the image within the system default USER folder The operation steps are 2 6 7 10 2 Mass dump e From main unit to U disk 1 Freeze the image continuously press E key until enter PAUSE status 2 Press OIC J key LOCAL gt U Disk Mass Dump prompt display at the bottom of the 3 Press Enter J key Dumping prompt appears images are mass dumped under the I folder in the U disk and the number behind PAUSE character is the number of file 1 mass dumping After finishing mass dumping return to PAUSE status Ultrasonic Diagnostic Instruments
41. e is less than 16 cm A 2 Within 7 or less than 1 5 cm when Area Ellipse Max Value 360 cm measured value is less than 16 cm Table 13 3 Time motion measurement Parameter Numeric range Deviation A Within 3 or less than 2mm when measured Distance Max Value 194mm Waite ie je a aoa Time Max Value 8s Within 1 Heart rate 8 252 times s Within 3 Slope Max 7250mm s Within 4 Table 13 4 Volume measurement Parameter Numeric range Deviation Wels Max Value 999 cm Within 10 or less than 7cm when measured value is less than 64cm AN Attention In the selected view range the measurement can guarantee the above listed accuracy specification The accuracy specification is based on the system performance in the worst environment or on the real system measurement The accuracy specs above do not include the impact imposed by sound beam error Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Fourteen Storage and Transportation Storage and Transportation 1 If the instrument is stored over 3 months take out the instrument from the packing case connect it to power supply for 4 hours and then disconnect the power and place it in the case again following the direction indicated by arrows on the package Store the case in the warehouse Do not pile the case The instrument case should have adequate space from ground walls and
42. e its technical process without prior notice Kaixin may modify specifications of the product without prior notice Liability and Disclaimer Statement Kaixin does not guarantee the correctness of information contained in this manual Kaixin bears no responsibility for the use of this user s manual including but not limited to responsibilities of implied marketability or merchantability applicable to the product for a particular use Kaixin shall be responsible for the safety reliability and proper performance of this equipment on condition that the assembly extension readjustment modification or service of the equipment herewith related is done by technical personnel authorized or approved by Kaixin Electronic Instrument Company Ltd The electric equipment is consistent with relevant national standards and the equipment is operated in compliance with the operation guidance Kaixin does not guarantee the safety reliability and proper performance of the product in case of the following conditions Equipment or units of which the equipment is formed are disassembled and reassemble extended or readjusted without proper authorization Users fail to properly operate the equipment in accordance with the requirements specified in this user s manual Product Information Issue date June 15 2011 Version V1 02 Ultrasonic Diagnostic Instruments User s Manual V1 01 Limited Warranty Repair Service 1 Kaixin offers Type B lifetime warranty
43. e of main unit Please mark the product model the serial number of main unit and reason to return the product Manufacturer s Information Xuzhou Kaixin Electronic Instrument Co Ltd Kaixin Mansion C 01 Economic Development Zone Xuzhou Jiangsu China Zip Code 221004 Tel 86 516 87732932 87733758 Fax 86 516 87732932 87792848 Website http www kxele com E mail gm01 kxele com Ultrasonic Diagnostic Instruments User s Manual V1 01 Safety Cautions 1 Warning Symbols and Definitions The following warning symbols are used in this manual to indicate safety level and other important items Please remember these symbols and understand the meaning as you read this user s manual These symbols convey specific meanings as detailed in the table below Symbols amp Words Connotation A Indicates an imminent danger that may result in personal death or Danger serious injury if not avoided A Indicates a potential danger that may result in personal injury if not Warning avoided Indicates a potential danger or unexpected use condition that may Z Attention result in light injury or property loss or affecting the use if not avoided AN Indicates that make sure refer to relevant contents in this manual 2 Safety Symbols Symbols Meaning Symbols Meaning e r q R Type B applied part tt Up N AC Power Keep dry DC Power Fragile qr JL Power Indicator Stacking limit by number aci Hen
44. e screen automatically Press O key or click left mouse to exchange the starting point and end point Press Menu key again to quit status of changing minor axis Press key or click right mouse to finish the first measurement Repeat the steps from 3 to 7 to complete the multi group data measurement i PresslEsc key to quit the measurement status Press Clear key or click the left and right key synchronously to clear all marks and data Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 8 4 Slope Heart rate Cycle Measurement The method to measure slope hear rate cycle is identical with distance measurement Note In B M mode if both starting point and end point of the measurement mark fall into the B mode area the value of the refers to distance if starting point and end point of the measurement mark fall into the M mode area the value of the refers to depth if the starting point and end point are in separate areas the will display 66 99 sign or invalid value denotes depth measured in mm millimeter EF denotes slope coefficient measured in mm s millimeter per second HR denotes heart rate measured in times minute times per minute T denotes cycle measured in ms millisecond Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Nine Obstetric Measurement 9 1 Measurement and Calculation
45. edly to realize mode switching of B B B 4B B M and M 7 4 1 B Mode B Mode is the basic operation mode after startup and a single framed B Mode image is displayed 7 4 2 B B Mode 1 In real time mode press Mode Text key to enter B B mode 2 B B image switch Press Menu key to enter main menu and Oe direction keys to move the cursor to B B MODE and then press direction keys to switch image display Or right click mouse to switch image display the selected image is activated and the other one is frozen 3 In real time mode press Mode Text key to exit B B mode 7 4 3 4B Mode 1 In real time mode press Mode Text key to enter 4B mode 2 4B image switch Press Menu key to enter main menu ies a direction keys Oto move the cursor to 4B MODE then press direction keys to switch display among four images Or right click mouse to switch display among four images the selected image is activated and the other three are frozen 3 In real time mode press Mode Text key to exit 4B mode 7 4 4 B M Mode 1 In real time mode press Mode Text key to enter B M mode 2 Change of scan mode Press Menu key to enter main menu and press direction keys move cursor to M DISPLAY and then press direction keys to change the M ultr mode Or right click mouse to realize the change of scan mode Ultrasonic Diagnostic Instruments User s Manual V1 01 3 Move sample line Press direction keys to move sample line
46. ept of Kaixin for support Trouble Correction Power light is off and no screen 1 Check power supply display is present when starting 2 Check power cable and connector the machine 3 Check power adapter Character and gray scale are displayed but no ultrasonic image on the screen Probe is not properly connected Turn off the power and reconnect the probe 1 Check power supply spark interference present 2 Check environment source of interference around the machine such as electric motor ultrasonic atomizer automobile computer or other interference Check power plug socket of the instrument or probe connectors They shall be properly contacted 1 Adjust the total gain near field far field 2 Adjust the brightness and contrast level Intermittent stripe snow or far field interference appears on screen 3 Image display is not clear Control panel malfunction Restart the system by turning off the main unit power Chapter Twelve System Maintenance Warning For optimal performance and personal safety product service should be performed only by qualified service personnel Customers outside China should contact their local factory authorized distributor for service or call Tel 86 516 87732932 87733758 consult the International Trade Dept of Kaixin Z Attention Xuzhou KAIXIN will make available on request circuit diagrams component part lists descriptions calib
47. equency range applies Note 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field 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 accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which this equipment is 1 exceeds the applicable RF compliance level above the equipment should be observe verify normal operation If abnormal performance is observed additional measures ma necessary such as reorienting or relocating the equipment b Over the frequency range 150kHz to 80MHz field strengths should be less than 1V m Ultrasonic Diagnostic Instruments User s Manual V1 01 Recommended separation distance between portable and mobile RF communications equipment and this equipment This equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and suggested distance below is based on
48. ervices Group I Class A equipment Chapter Seventeen Ultrasonic Diagnostic Instruments User s Manual V1 01 Guidance and Manufacturer s Declaration This product complies with EMC test standard EN60601 1 2 Guidance and manufacturer s declaration electromagnetic emission This equipment is intended for use in the electromagnetic environment specified below Customer or user shall assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance This equipment uses RF energy only for piara acts its internal function Therefore its RF CISPR 11 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Cie This equipment is suitable for use in all CISPR 11 ass establishments other than domestic and f those directly connected to the public Harmonic emissions Class A low voltage power supply network that IEC61000 3 2 supplies building used domestic purposes Voltage fluctuation flicker emissions Complies IEC61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity This equipment is intended for use in the electromagnetic environment specified below Customer or user shall assure that it is used in such an environment Immunity test IEC60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC6100
49. ess direction keys to select the image code need to be read out in the U disk such as choose 004 5 Press Enter key to appear Wait prompt After the prompt disappear the image stored in frame 004 is read out 6 PresslEsc key to quit reading status and press key to return to real time status Explanation 1 When reading images it must choose the image code with 2 If you want to read out the images within the folder identified by number ID under the U disk must input ID first before reading then do as the above steps if did not enter the number ID it would default to read out the images in the USER folder under the U disk 3 If has read out the images in the U disk also would like to re read the local image must press key to exit this reading status then press Mode Text key to choose LOCAL and vice versa 7 10 Single dump and mass dump 7 10 1 Single dump e From main unit to U disk 1 Read out the image in the main unit Img with highlight status is displayed on lower right corner of the screen 2 Press Mode Text key a Dump prompt appears on lower right corner of the screen 3 Press direction keys to select the image saving code in the U disk such as choose 005 4 Press Enter key Dump prompt disappears until the Dump re appears the current image can 66399 be dumped in the frame for coded 005 The dumped image code is precede
50. f the IEC60601 1 standard Z Attention Battery is consumable the battery cycle life is based on the times of charge and discharge as unit When the use time reduced significantly compared with normal conditions the battery should be promptly replaced Attention A power indicator will appear X and glitter continually when the electric quantity is too low Connect the main unit to external power supply and recharge the battery or turn off the machine to recharge Z Attention If long term use exrernal power or do not intend to use the equipment within such a period of time please remove the battery to avoid over charging or discharging the battery which will curtail battery life or to reduce other risk Z Attention Don t throw away the exhausted battery anywhere especially throw the fire Please deal with it according to local statutes Note The cautions of using battery see the warning label on the battery in details Ultrasonic Diagnostic Instruments User s Manual V1 01 11 2 Troubleshooting To ensure normal operation users are recommended to prepare a proper maintenance and regular examination plan to regularly check on product safety performance If any abnormity occur timely contact International Trade Dept of Kaixin for support If the following problems occur on starting up the machine try to make corrections following the method in the table If the problem remains unsolved contact International Trade D
51. ft mouse the cursor will show 5 Press direction keys or operate the mouse to move the mark to desired position press 5 4 key or click left mouse to set the mark position as the starting point of the measurement 6 Press direction keys or operate the mouse to move the mark to the end point of the measurement and GA and EDC value to be displayed in real time in the right area of the screen 7 Press O J key or click left mouse to exchange the starting point and end point 8 Press Ole key or click right mouse to finish the first measurement 9 Repeat the steps from 3 to 8 to complete the multi group data measurement 10 PresslEsc key to quit the measurement status 11 Press Clear key or click the left and right key synchronously to clear all marks and data 12 Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 9 2 1 2 Measurement of HC and AC e Measuring HC and AC using area method Follow the steps below 1 In B B B mode freeze the desired image 2 Press R key to display the obstetric parameters on the lower part of the screen 3 Press direction keys Okto select measurement parameters in HC AC press Ener J confirm 4 Press Eh key or click left mouse the cursor will show Ultrasonic Diagnostic Instruments User s Manual V1 01 Press direction keys or operate the mouse to move the mark to desired position press
52. gnostic system 4 Lock loosen knob To lock loosen the connection of probe to ultrasonic diagnostic system 5 Fix puncture anchor point Fix the puncture bracket 4 Function keys description SN Function keys Real time mode function Freeze mode function 1 Mode Text J Mode Selection ean ae Single image dump 2 Ok Dae eo Distance Depth Measurement Depth range selection 3 3 9 Local Zoom Measurement Scaling 4 amp IC Bunche ss Circumference Area Measurement Mass images dump 5 re J Body Mark First vice menu quick selection 6 Fim Obstetrics Measurement Second vice menu quick selection 7 Ei Frequency Conversion Cine loop 8 Clear Clear Screen 9 Ener J Enter Confirm menu 10 Menu Main menu 11 Freeze Unfreeze 12 DAG OO Direction keys 13 Esc Quit Fan rotation control 14 Power switch Annotation 1 1 First vice menu Total gain near field gain far field gain and dynamic range 2 Second vice menu Focus selection frame correlation post process edge enhancement and magnification selection Annotation 2 Boot default fan is rotating in the case of other functions are quitting pressEs key fan will stop rotating Fan will work automatically after 25 minutes stop rotating tin minutes fan rotating again after 10 minutes before closing the fan Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter F
53. hapter Eight General Measurement 8 1 Distance Measurement l 2 3 O OND 10 In B B B or B M mode choose desired image and freeze it Press Sh key or click left mouse the cursor will show Press direction keys or operate the mouse to move the mark to desired position press 3 9 key or click left mouse to set the mark position as the starting point of the distance to be measured Press direction keys or operate the mouse to move the mark to the end point of the measured distance A lighted dotted line appears between the start and the end as the dashed locus of the measurement The measured value is automatically displayed at the built in mark mm on the right side of the screen Press O key or click left mouse repeatedly to exchange the starting point and end point of the measurement Press Sh key or click right mouse to finish the first measurement Repeat the steps 3 6 to complete the multi group data measurement Press Clear key or click the left and right key synchronously to clear all marks and data i PresslEsc key to quit the measurement status Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 8 2 Depth Measurement l 2 3 4 5 6 In B B B B M or M mode choose desired image and freeze it Press O J key twice a dotted line of depth measurement appears on the sc
54. ield Gait ACUSTIC sein oct oboi ia aaa a ata aaa a at 13 To Ac Hat Field Gain Adjustments ese ame arama a a a a a aaa e a ae ae RE 7 5 5 Dynamic Range Adjustments i ccdeneevaeascaheannavasdsanduaudheDasaesdnga see cenmnens 7 5 6 Quick Adjustment of the image gain and dynamic range 7 5 7 Frequency Adjustment Frequency conversion function 7 5 8 Focus Adjustment and Control ea eee oi a acea ta na aaa aaa ee d iute Ultrasonic Diagnostic Instruments User s Manual V1 01 7 5 9 Frame Correlation Adjustments xiccs Seine yacaai ds diessaedars S ei a Si 8 a 14 7 5 10 Post process Adjustment es aa ao aaa era nau sievedssneacneraaiseseas ue 2000 poante Late eer 14 7 5 11 Edge Enhancement Adjustment sate asa iese ia a a act 5 a aia sa Sa 14 7 5 12 Quick Adjustment of Focus Frame Correlation Post process Edge Enhancement 14 TO Image Contr ions scoase aaa satana atatea akg iaca oa des anes teh acts ob e dia os en aaa pl a a 14 KOA Magnification Selection reeniri eraa Ola dead Dalai petala 0 age 03 aa d dia iati 14 7 6 2 Depth Enhancement and Depth Range Selection eee 14 7 6 3 Local Zoom and Local Additive COIOT sive e etate dr a cas ove oil A o la asses eens 14 73044 Image Lettaght EMD cette 5 teat Gran Aurei Nea oem aves aia ae aaa at data da oper a 14 7 6 5 Image Lp do wit Plipwatwaticve sn a atacata et 3 te a 300003 e tai cl a t 15 7 1030 Image Negative mers ala tans cect 3 tm dea a et rape dn e aaa bel ie aaa Beau aia e
55. image will be deleted will automatically disappear 5 Repeat the 2 3 steps delete other images 6 Pressey to return to real time mode Explanation If you want to delete the images within the folder identified by number ID under the U disk must input ID first before deleting then do as the above steps if did not enter the number ID it would default to delete the images in the USER folder under the U disk 7 12 Image review 1 Freeze the image press E key to enter reading or saving image status 2 Press key to enter the function of LOCAL image review images will be automatically played by the fixed time interval 3 Press direction keys to select the previous or the next image to review 4 PresslEckkey to return to frozen status 7 13 Cine loop In real time mode the system is always saving the scanned image The playback images are for a period time images before freeze Freeze the image press E key three times continuously to enter the automatic playback Press E key to enter pause status when playing back Press direction keys or operate mouse to view images frame by frame in pause status Press E key three times continuously again to return to automatic playback status In the process of saving and playback relevant data of image fra saved and played are shown on the lower right corner of the screen PresslEsc key to return to frozen status Ultrasonic Diagnostic Instruments User s Ma
56. isplay Clean the liquid crystal display with dry soft flax Anti static LCD clean cloth for cleaning liquid crystal display is also applicable Z Attention Do not clean the screen with hydrocarbon detergent such as alcohol or OA equipment cleaning media These kinds of liquid may degrade the internal function of the screen 6 Clean the control panel and enclosure Clean the instrument surface with soft dry cloth or with soft cloth dipped in moderate water cleaning media to remove the blots and then dry the instrument with soft dry cloth or with air 7 Clean the video recorder 1 Use the soft dry cloth to wipe the video recorder 2 If it is difficult to wipe away the blemish clean with soft cloth dipped in moderate detergent and then air dry it 11 1 2 Use and maintenance for the charging battery 1 Only the battery provided by Kaixin Company can be used 2 Battery is consumable the battery cycle life is based on the times of charge and discharge as unit When the use time reduced significantly compared with normal conditions the battery should be promptly replaced 3 The full charged battery can be used for 1 5 2 hours the minimum charging time is 3 hours and up to 4 hours over charging or discharging will shorten the battery life 4 The excess high or low temperature will affect the charging and discharging performance and short the battery life and capacity Z Attention Battery charger shall meet the requirements o
57. ith some unknown defects it may cause danger of electric shock Warning When instrument works abnormally do stop working turn off the power and check the reason then contacts the KAIXIN Company about it Turn off power and pull out of the plug from socket after each ultrasonic diagnostic operation Itis forbidden to drag and press the power and probe cables emphatically regularly inspect whether there is pull apart and bareness if there is the phenomena like this turn off power supply immediately and change it for new one It is forbidden to load and unload the probe or move the instrument in galvanic to avoid danger of safety Pull out of the plug from socket after operation in thunderstorm weather to avoid the instrument being damaged by lightening Ifthe temperature changes greatly in short time will cause vapor recovery inside of instrument the case may damage the instrument The instrument is switched completely only by disconnecting the power supply from the wall socket 6 1 System placement Please carefully read through and fully understand the safety cautions before moving and placing the system 1 Unpack the instrument case and check the goods for its completeness according to the packing list furnished 2 Place the base of the machine on a stable and leveled position and then place the machine or 3 Leave adequate space of 20 centimeters as minimum from rear left and right side machine Ultrasonic
58. ng gel may become hardened on the acoustic lens of the probe deteriorating quality of image 6 9 System reset In case of abnormal screen display or system operation try to restart the system by turning on off the main unit power Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Seven Function Operation 7 1 Startup and Shutdown In shutdown mode press key machine starts up power indicatorV lights In startup mode press key machine shuts down power indicator goes out Please note that when shut down the machine the time of pressing key is a rather long than normal pressing key 7 2 System Functions Setting 7 2 1 Time Setting 1 Press Menu key to enter main menu and press direction keys to move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press direction keys Oto select Minutes Hours Day Month and Year 4 When setting minutes hours day month and year press direction keyto increase value or press direction key to decrease value 5 Press Enter key to confirm the time setting and quit setting interface 7 2 2 TV Mode Setting 1 Press Menu key to enter main menu and press direction keys to move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press direction keys Oto move symbol lt to point to TV mode 4 Press direction keys to realize TV mode conversion between PAL and NTSC 5 PresslEsc key to quit setting interface 7
59. nual V1 01 Press key unfreeze and quit playback status Note If the images appear abnormal that is without enough storage time and the images have not been stored full 7 14 Text Input Operation steps 1 2 3 Freeze image Press Mode Text key the cursor is located behind name Press Mode Text key again or right click mouse at the same time characters input menu will be shown at the bottom of the screen Caps0123456789abcdefgh Shitijklmnopqrstuvwxyz Press direction keys DO OOor operate mouse to move cursor to point to Caps and then press Enter key or left click mouse to achieve capital and small letter conversion If the cursor point to Shift press Enter key or left click mouse again to achieve the conversion between the letter and punctuation i i Press direction keys to choose numbers or characters and press Enter key to confirm Or operate mouse to click numbers or characters to input After inputting name press Mode Text key and then press direction keyPto move cursor to serial number and press Mode Text key again to input according to Step 4 After inputting serial number press Mode Text J key and press direction keys to move cursor to image area and press Mode Text key again to input according to Step 4 If need modify the content press Clear key to clear all noted marks and retype PresslEsc key to quit Ultrasonic Diagnostic Instruments User s Manual V1 01 C
60. ode distance or depth slope heart rate and cycle 4 Items measurable in M mode depth slope heart rate and cycle 5 If the display becomes it indicates an invalid measurement value Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Ten Principle of Sound Power 10 1 Biological effect It is generally recognized that ultrasonic diagnosis is safe for human s health So far there has been no report on bodily harm done by ultrasound Nevertheless it is also believed that not all types of ultrasound are absolutely safe Relevant researches have already indicated that high intensity ultrasound is harmful for human body With the development of ultrasonic diagnosis technology in recent years people are more aware of the potential risk in biological effect caused by use of ultrasound and application of ultrasonic diagnostic technology 10 2 Mechanical effect and thermal effect Research indicates that two different ultrasonic properties influence human body one is when ultrasonic subpressure exceed some limited number air pocket forms mechanical effect Another is when tissues absorb ultrasonic appearance of heat energy of ultrasonic may cause thermal effect Two parameters which are mechanical index MI and heat index TI can explain two types of effects influencing level the smaller value of MI TI is the less bioeffect produce 10 3 Prudent use statement Whereas it is not proved that ultrasonic diagnostic
61. ody Mark and Probe Mark This system contains 64 body marks that are divided into two pages when display 32 marks for each page The display operation steps are as follows 1 In image frozen status press 9 key to show the body marks in display area 2 Press direction keys to move to the position of desired body mark press Enter J key to confirm the selected body mark 3 Press direction keys or operate mouse to change the probe mark position press E key to change probe mark direction 4 PresslEsc key to quit body mark and probe mark 5 Press Clear key to clear body mark 6 Press key to unfreeze and quit body mark status The 64 body marks are listed below Body Front Mother Front MT A E Ce Left Shoulder Front 45 Uterine Neck Transection ie Neck Right Lateral e Skull Fontanelle Transection Fetus Heart 1 Aortic Arch Major Axis Body Right et BIR Left Front Na oe QO Right Shoulder Front Uterine Base Transection oe Neck Left Lateral O Eyeball 1 Fetus Heart 2 2 a Te Aortic Arch Major Axis 2 Ultrasonic Diagnostic Instruments KY Body Right Body Left Body Left Lateral Lateral Kat NA ANS LL Right Front Left Butt Front heht Bunt Front Uterine Uterus Rear Uterus Level Appendages A e Uterine Liver Breast 1 Transection a Head Left Lateral Head Front Lower Limb Lower Limb Eyeball 2 Front Rear Apical Four Bilocular
62. our System Configuration 4 1 Standard Configuration 1 Main unit 1 unit 2 3 5MHz convex array probe 1 PC 3 Power adapter 1 PC 4 Internal battery 2 PCS 4 2 Optional parts 1 5 0 MHz micro convex probe 2 6 5 MHz intra cavity probe 3 7 5 MHz high frequency linear array probe 4 Mouse 5 Video recorder P93W S Chapter Five Operation Condition 5 1 Power Supply Adapter rating 100 240V 50 60Hz 70VA Adapter model MW125RA1203F01 Output of Adapter DC12V 3 0A Main device rating DC12V 3 0A 5 2 Operation Environment Ambient temperature 10 C 40 C Relative humidity 30 75 without condensation Atmospheric pressure 700hPa 1060hPa 5 3 Storage and Transport Ambient temperature 20 C 55 C Relative humidity 30 93 without condensation Atmospheric pressure 700hPa 1060hPa Attention The mains voltage varies with different countries or regions Z Warning Avoid using this equipment with high frequency operational equipment or danger may occur Z Danger Do not use this equipment where flammable gas such as anesthetic gas oxygen or hydrogen or flammable liquid such as alcohol are present Failure to do so may result in explosion Z Attention System should be avoided using in following environments 1 Splash 2 No ventilation 3 Direct sunlight 4 Dramatic temperature change 5 Strong shock 6 Close to heat source 7 Chemical medicines 8 Dust 9 Poisonous gas 10 Corrosive gas 11 Rain
63. peed 4s Distance between transducer output end surface and integral dot for A 30 30 30 square of the maximum acoustic pressure Lp mm 6dB pulse beam width 1 24 1 24 I 1 21 Wooe mm L mm L 1 73 L 1 55 LL 1 75 Pulse repetition rate prr kHz N A 4 608 64 10 Scan repetition rate srr Hz 71 42 N A 32 05 Output beam size cm 4 51 1 13 4 51 Arithmetic average acoustic working 4 69 4 69 4 68 frequency fawr MHz Acoustic power on factor APF 100 100 100 Power up mode B Mode B Mode B Mode Acoustic initial factor AIF 100 100 100 Initialization mode B Mode B Mode B Mode Acoustic output freeze yes yes yes KAIXIN ELECTRONIC XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO LTD poe Kaixin Mansion C 01 Economic Development Zone Xuzhou Jiangsu China Zip Code 221004 Tel 86 516 87732932 87733758 Fax 86 5 16 87732932 87792848 Website http www kxele com E mail gm01 kxele com Shanghai International Holding Corp GmbH Europe R Eiffestrasse 80 20537 Hamburg Germany CE 0123 Information contained in this manual is subject to change without further notice
64. power adapter the other end to the mains socket outlet The instrument uses three core power supply It connects with the protective earth line when power plug inserts into its socket Awarning Adapter has no switch The isolation of the system with the MAINS used to unplug the adapter as the intended isolation means The device should be used only with external AC DC adapter provided by Kaixin Company To avoid damaging power adapter or harming people by unexpected fallen make sure the power adapter is placed on the leveled desk 6 7 Probe check before and after operation Before and after ultrasonic diagnosis to check if there are any exceptionally on the surface of the probe or cable jacket such as peeling cracks bulge or if the acoustic lens is reliable disinfected or cleaned 6 8 Main unit check before and after operation 6 8 1 Inspection before start up Check the following items before starting the machine 1 The temperature humidity and atmospheric pressure shall meet the requirements of ope condition 2 No condensation occurs 9 10 Ultrasonic Diagnostic Instruments User s Manual V1 01 No distortion damage or contamination on system and peripheral Clean the parts as specified in relevant sections if the contaminant is present Check the panel LCD and enclosure to ensure they are in good working condition and free of abnormity such as cracks and loosened screws No damage on power cable and
65. ration instructions or other information which will assist the user s appropriately qualified technical personnel to repair those parts of equipment which are designated by the manufacturer as repairable NAttention To ensure the performance and safety of instrument it must be checked after using 1 year When check the instrument please consult the International Trade Dept of Kaixin as they need to have professional technology engineers PERIODIC SAFETY CHECKS For Ultrasonic Diagnostic Instruments 12 1 Seasonal Safety Check 1 Please clean the plug of power cord at least once a year Too much dust on plug may cause the fire 2 The following safety checks should be performed at least every 12 months by a qualified person who has adequate training knowledge and practical experience to perform these tests The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired Inspect the equipment and accessories for mechanical and functional damage 2 Inspect the safety relevant labels for legibility Inspect the fuse to verify compliance with rated current and breaking characteristics 4 Verify that the device functions properly as described in the instructions for use 12 2 The circuit theory chart of KX5100 User s Manual V1 01 Keyboard Test the prote
66. real time mode press Menu key to enter main menu and press direction keys to move cursor to COLOR in the display area and then press direction keys to realize color conversion of eight colors including one kind of black and white 7 6 9 Image Freeze Unfreeze In real time mode press freeze unfreeze key Wor middle mouse key to freeze the image in frozen status pres key or middle mouse key to unfreeze the image 7 7 Puncture guide and lithotripsy positioning line Puncture guide line In real time and B mode press C key two puncture guide lines will be showed on the screen press direction keys to change the angle of the first puncture guide line press direction keys to change the start position of the first puncture guide line Press racy key again to switch the second puncture guide line press direction keys to change the angle of the second puncture guide line press direction keys to change the start position of the second puncture guide line PresslEsckey to quit the puncture guide status Lithotripsy positioning line In real time and B mode press SIC key thrice lithotripsy positioning line appears on the screen At the same time the measurement depth of lithotripsy positioning line 0 0mm is shown at the top right corner operate the up down keys to positioning the depth Repeatedly press CJ key to realize the switch between puncture guide line and lithotripsy positioning line PresslEsc key to quit 7 8 B
67. reen press direction keys or operate the mouse to move the dotted line to desired position press direction keys Wor operate the mouse to move the mark to the end point of the measurement the measured value of depth is automatically displayed at the built in mark mm on the right side of the screen Press O key or click mouse to complete the multi group depth measurement Press Ole key to return to the status of distance measurement Press Clear key or click the left and right key synchronously to clear all marks and data Press key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status Note Direction keys cannot work in the depth measurement when connecting convex array probe 8 3 Circumference Area Volume Measurement 1 2 3 Circumference area measurement with locus method In B B B mode choose desired image and freeze it Press 8 4 key or click left mouse the cursor will show Press direction keys or operate the mouse to move the mark to desired position press SIC key or click right mouse to set the mark position as the starting point of the measurement Press direction keys or operate the mouse to move the mark to the end point measurement At the same time a locus appears in the direction of operation between measurement marks The measured circumference value is displayed automatically O N AU N o
68. t See table below Operation Consequential impact on sound power output The maximum sound power for each probe has been optimized to FDA Change probe standard in order to obtain the best image quality Therefore the sound power varies with the probe change Different parameters are used for B mode and M mode Therefore change of mode may lead to the change of sound power If the mode is Change image mode switched from B to B B or to 4B the sound power will not change as the basic parameters remain the same In most cases sound power output in M mode is larger than that in B mode Image sight scanning Change of scanning angle or width may cause the change of angle or width frequency hence the change of sound power Ultrasonic Diagnostic Instruments User s Manual V1 01 The number of focus influences frame frequency and focus location Number of focus thereby changes the sound power output Change of transmission focus location leads to change of transmission Pocus location level and aperture thereby the change of sound power output Freeze function initiation disables the system elements transmitting Freeze electric energy therefore the system is not able to transmit the ultrasound Change of transmission power will cause the change of system electric T ae sess pics coc output to the probe hence the change of sound power output Change of frequency will lead to the change of
69. t Parameter Disclosure Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment GB 16846 1997 we hereby make our declaration of the relevant acoustic output parameters as follows Xuzhou Kaixin Electronic Instrument Co Ltd Type B Full Digital Ultrasonic Diagnostic Instrument Test Frequency 5 0 MHz Acoustic output data for KX5100 Probe model Probe model 5 0C20A3 Probe No 5 0C6420 605003ASK Mode Parameter B M B M Maximum space averaged acoustic 138 18 9 8 2 power output mW Peak negative sound pressure P 1 66 1 60 1 66 Mpa Sound intensity of output beam Iu 4 00 21 97 2 37 mW cm Space peak time averaged sound 14 14 246 13 10 4 intensity output Ispta mW cm Focus mode Focus mode Focus mode Syst tti 1 section 1 section 1 section Sen Setungs Depth 10cm Depth 10cm Depth 10cm Scan scope 3 M speed 1s M speed 4s Distance between transducer output end surface and integral dot for 30 30 30 square of the maximum acoustic pressure Lp mm 6dB pulse beam width 2 36 2 00 2 00 Woe mm L mm L 4 00 L 3 73 1 3 75 Pulse repetition rate prr kHz N A 4 608 64 10 Scan repetition rate srr Hz 78 37 N A 32 05 Output beam size cm 3 45 0 86 3 45 Arithmetic average acoustic 414 4 15 4 15 working frequency faws MHz Acoustic power on factor APF 89 75 93 12 89
70. tal gain so as to control the total gain of the entire image 7 5 3 Near Field Gain Adjustment In real time mode press Menu key to enter main menu and press direction keys Oto move cursor to Near in the display area Press direction keyto increase near field gain and direction keyto reduce near field gain so as to control the gain in near field region 7 5 4 Far Field Gain Adjustment In real time mode press Menu key to enter main menu and press direction keys Oto move cursor to Far in the display area Press direction keyto increase far field gain and direction keyto reduce far field gain so as to control the gain in far field region 7 5 5 Dynamic Range Adjustment In real time mode press Menu key to enter main menu and press direction keys Oto move cursor to Dyn in the display area Press direction keyto increase the value of dynamic range and direction key to decrease the value of dynamic range so as to control the dynamic range of the entire image 7 5 6 Quick Adjustment of the image gain and dynamic range In real time mode press rey key repeatedly to enter the first vice menu and switch among the total gain near filed gain far field gain and dynamic range Then press direction keys to adjust the total gain near filed gain far field gain and dynamic range 7 5 7 Frequency Adjustment Frequency conversion function In real time mode press Ej key to realize frequency conversion The frequency value is displayed
71. tion formula of fetus weight to Osaka the right area of the screen will appear EFW g 1 MM 2 MM 3 MM Ultrasonic Diagnostic Instruments User s Manual V1 01 At the same time together with relevant parameters 1 BPD 2 FTA 3 FL required for the calculation will be displayed at the bottom of the screen In accordance with the order of shown parameters on the bottom of the screen measure the parameters respectively a Measure BPD with distance measurement method and press Enter J key to confirm The measured value of BPD is saved and displayed at 1 mm position in the EFW zone of the right display area b O Press key to exit BPD measurement status 2 Obtain the desired image and freeze it again 3 Measure FTA with elliptic method of measuring HC AC and press Enter J key to confirm The measured value of FTA is saved and displayed at 2 mm position in the EFW zone of the right display area en Press key to exit FTA measurement status 2 Obtain the desired image and freeze it again 8 Measure FL with distance measurement method and press Enter J key to confirm The measured value of FL is saved and displayed at 3 mm position in the EFW zone of the right display area 5 When values are available for all the selected parameters the EFW value is automatically displayed in EFW g position 6 Press E ckey to quit the measurement status N
72. to Shift press Enter J key or click left mouse again to achieve the conversion between the letter and punctuation 5 Press direction keys to choose numbers or characters and press Enter Jkey to confirm Or operate mouse to click numbers or characters to input 6 If need modify the content press Mode Text key to quit the character input menu press direction keys to delete input content press Mode Text key again to retype 7 PresslEsc key to save this setting and quit setting interface 7 2 6 Key Sound Setting Press Menu key to enter main menu and press direction keys to move cursor to SETUP Press direction keys to enter setting interface Press direction keys to move symbol lt to point to Key Sound Press direction keys to select between On and Off PresslEsc key to quit setting interface 7 2 7 Compression Curve Setting nA BW N Re 1 Press Menu key to enter main menu and press direction keys to move cursor to SETUP 2 Press direction keys to enter setting interface 3 Press direction keys Oto move symbol lt to point to Compression Curve 4 Press direction keys to select compression curve among 00 07 5 PresslEsc key to quit setting interface Note If use 3 5MHz probe it is recommended to choose 05 or 06 if use 5 0MHz probe recommend choose 03 or 04 if use 7 5MHz probe recommend choose 00 or 01 if use 6 5MHz probe recommend choose 01 or 02
73. tric shock 1 Insert the probe connector into the probe socket on the right of the main unit Note the direction of D head 2 Rotate the two probe locking knobs clockwise and lock them 6 2 2 Probe disconnection First turn off the system and then rotate the locking knobs counterclockwise pull out the probe connector vertically 6 3 Install dismantle the battery 1 Install battery Gently push the battery box into the main unit and then screw the fasten bolts 2 Dismantle battery Remove the fasten bolts as shown in Fig Clasp the battery box with finger and withdraw it gently Ultrasonic Diagnostic Instruments User s Manual V1 01 Fasten bolts Fig Install dismantle the battery 6 4 Connect to video recorder 1 Shutdown the system connect the equipotential terminal Y of the video recorder to the earthing 2 Connect the signal connection line to video recorder and the other end to the video output interface on the right of the main unit 3 Insert the power plug jack of the video recorder to its power input socket the other end to the power supply socket 6 5 Connect to the mouse Connect the mouse to USB A interface on the right side of the main unit 6 6 Connect to the power 1 Connect to the power adapter Insert the output plug of adapter into DC input socket which is on the right of main unit 2 Connect to the main power supply Insert the power plug jack furnished with the machine into power input socket of the
74. wave focus Change mayuency characteristic thereby the change of sound power output Restart or turn off on the power will set the system in default mode Ro no oe and change the sound power output Chapter Eleven System Clean and Troubleshooting The system maintenance should be performed by the user and service engineer Users shall be in full charge of maintenance and operation of the system after purchasing the product 11 1 Maintenance by users 11 1 1 System clean disinfect and sterilize Warning Turn off the instrument and pull out the power supply wire before cleaning every instrument of the system It may cause electric shock if clean the system under power is on L Warning There is no any water roof device in the system Do not splash any water or liquor into the system when cleaning or maintaining otherwise it will cause malfunction or electric shock or malfunction Z Attention 1 Probe without cleaning disinfection or sterilization may become the source of contamination so cleaning or disinfection to the probe is very necessary after every ultrasonic diagnosis 2 To prevent possible infection it is advisable to wear sterilized gloves when clean disinfect or sterilize the ultrasonic probe 3 In the process of cleaning disinfection or sterilization avoid probe overheat exceeding 60 C as it may be damaged or deformed under excessive heat 4 To prevent the infection or the cross infection
75. ws Xuzhou Kaixin Electronic Instrument Co Ltd Type B Full Digital Ultrasonic Diagnostic Instrument Test Frequency 3 5MHz Acoustic output data for KX5100 Probe model Probe model 3 5C60A2 Probe No 3 5C80 603024 Mode Parameter B M B M Maximum space averaged acoustic 25 6 43 9 23 power output mW Peak negative sound pressure P 1 30 1 30 1 30 Mpa Sound intensity of output beam Io 277 19 81 2 si mW cm Space peak time averaged sound 9 79 280 70 10 36 intensity output Ispta mW cm Focus mode Focus mode Focus mode Soci ec satin 1 section 1 section 1 section SLEM SEES Depth 17cm Depth 17cm Depth 17cm Scan scope 3 M speed 1s M speed 4s Distance between transducer output end surface and integral dot for 70 70 70 square of the maximum acoustic pressure Lp mm 6dB pulse beam width 3 51 3 98 3 28 Woe ID mm L mm 1 4 54 1 5 19 L 4 95 Pulse repetition rate prr kHz N A 4 608 64 10 Scan repetition rate srr Hz 53 19 N A 32 05 Output beam size cm 9 24 2 18 9 24 Arithmetic average acoustic working 3 05 3 05 3 06 frequency fawn MHz Acoustic power on factor APF 100 100 100 Power up mode B Mode B Mode B Mode Acoustic initial factor AIF 100 100 100 Initialization mode B Mode B Mode B Mode Acoustic output freeze yes yes yes Ultrasonic Diagnostic Instruments User s Manual V1 01 Appendix A2 Sound Power Outpu

KAIXIN ® KX5100 Ultrasonic Diagnostic Instruments User`s Manual

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KAIXIN &reg; KX5100 Ultrasonic Diagnostic Instruments User`s Manual

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KAIXIN ® KX5100 Ultrasonic Diagnostic Instruments User`s Manual