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KAIXIN ® KX5000 Ultrasonic Diagnostic Instruments User`s Manual

1. 3 Probe connector To connect the probe to ultrasonic diagnostic system 4 Lod loosen knob o loosen the connection of probe to ultrasonic diagnostic 5 Fix puncture anchor point Fix the puncture bracket 3 4 Function keys description SN pi ing Real time mode function SN Function keys Freeze mode function 1 8 B mode selection 23 Freeze Unfreeze 2 is B B mode selection 241 O Direction keys 3 GE 4B mode selection 25 Distance Depth measurement 4 Bm B M mode selection 26 Measurement scaling 5 m M mode selection 27 O e tek 6 Color conversion 28 Obstetric measurement 7 Local zoom 29 Clear screen Ea eE Seu 9 Puncture guide 31 Ener Enter key confirm Scan direction conversion 01 O Single image dump 32 Text input Switch U disk and Local 11 Image up down flip 33 Delete 12 Negative 34 Quit 13 GO M speed conversion 35 tap pi pidas 14 Angle width change 36 Shift key 15 Post process 37 Space key 16 CE Edge enhancement 38 aD Total gain adjustment 17 Magnification conversion 39 lt D Near field gain adjustment 18 Focus mode selection 40 lt p gt Far field gain adjustment Frame correlation 19 conversion 41 ai D Dynamic range adjustment Mass images dump TARA 21 E a 43 Character Obstetric re 22 Cine loop 44 Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Four System Configuration 4 1 Standard Configuration 1 Main u
2. 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 hazards Lithium Ion Battery Pack KX5000 Rating 120V 32Wh Lithium Ion Battery Pack KX5000 Rating DC 12 0V 32Wh Limit To Use With KX5000 KX5100 Ultrasonic Diagnostic Instrument Only Battery pack is limited to use only with KX5000 KX5100 ultrasonic diagnostic instrument 1 D0 NO BEMOTST OR TER 2 DO NOT USE OR STORE 3 DO NOT CONNECT TIE AN A DO 50 HEAT UP OR T ROI 5 DO NO CONNECT THE AN 6 DO NOT TIAWMERZLOV 7 DO NOT INSERT THE EACH OF WHICH WILL Li 8 D0 NOT PORT 9 00 BLE 10 D0 IE BA DO NO7 sATTERY 2 00 N SE THE TERY 7 S TCO JIOT BECA 18 LE USE THE BATTE T RAPT T OF TFE BATTERY INTO WATER WHICH WILL LEAD TO TEE LSARAGR FXPLOSTON 02 FIRE IE BATTERY NEAR TIE CEAT SOURCE SUCK AS FIRE OR JEATER WICH WILL LEAD TO THE LEAKAGE EXPLOSION GR FIR ODZ AND CATHODE REVERSELY WHICH WILL LEAD TO TE LEAKAGE EXPLOSION 02 FIRE OW CTE SATTERY INTO FIRE WHICH WILL LEAD O TIE LEAKAGE EXPLOSION OR FIRE ODZ AND CATHODE W
3. Ultrasonic Diagnostic Instruments User s Manual V1 01 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 calibration 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 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 r
4. 15 Radiation e g x ray CT 16 Defibrillators or short wave therapy equipme Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Six System Installation and Check NWarning 1 Do not connect the three core power supply cord to unprotected two core socket or electric shock may occur 2 If breakers and fuse of the mains power socket are identical to those of 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 protectively 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 in the patient environment try to avoid the patient touching the system If system is with some unknown defects it may cause danger of electric shock
5. 7 7 5 Dynamic Range Adjustment In real time mode press key press key to increase the value of dynamic and CE key to reduce the value of dynamic range so as to control the dynamic range of th image Ultrasonic Diagnostic Instruments User s Manual V1 01 7 7 6 Frequency Adjustment Frequency conversion In real time mode press key to realize frequency conversion The frequency value is displayed at bottom right of the display place 7 7 7 Focus Adjustment and Control In real time mode and in B B B or 4B mode pressk key to choose from the four focus modes of stage 1 Full process dynamic focus 2 3 and 4 Focus is intelligent in the status of stage 2 3 or 4 the focal position and focal length can not be changed at this time In real time mode and in B B B B M 4B or M mode press direction key to move the focus up and down Note In B M or M mode only allowed choosing single focus mode 7 7 8 Frame Correlation Adjustment In real time mode press key to realize the switching among four kinds of frames correlation 7 7 9 Post process Adjustment In real time mode pressUP key to obtain four kinds of corrected images System default is 2 7 7 10 Edge Enhancement Adjustment In real time mode pressCE key to gain four kinds of sharpened image System default is 0 7 8 Image Control 7 8 1 Magnification Selection In real time mode press Skey to choose eight kinds of magnifications 7 8 2 Depth Enhancement and Depth Range Se
6. Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Two Technical Specifications 2 1 Technical Parameters NNN BP Y NN Gray Scale 256 Monitor 10 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 Size approx 290x245x50mm LxWxH Main Unit Weight approx 2 4kg excluding accessories 2 2 Primary Functions O 0 DU WR NO FF a gt gt 2 2 Bu ea O 9 O ANU BWN kK 9 21 22 23 24 25 26 21 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 sa
7. NWarning 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 It is 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 If the 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 machine on a stable and leveled position 3 Leave adequate space of 20 centimeters as minimum from rear left and right side of the machine AM Attention Adequate space from rear left and right side of the machine shall reserved or the machine may malfunction under e
8. Osaka Paris Rempen Robinson Shinozuka Tokyo FL China Hadlock Hansmann Jeanty Merz Osaka Paris Shinozuka Tokyo AC ASUM Hadlock Hansmann Jeanty Merz Shinozuka FT Mercer Paris HL Jeanty Merz Osaka TAD Eriksen Hansmann Paris HC Hadlock Hansmann Jeanty Merz EFW Campell German Hadlock1 Hadlock2 Hadlock3 Hadlock4 Hansmann Merzl Merz2 Osaka Shepard Tokyo Ultrasonic Diagnostic Instruments User s Manual V1 01 7 6 Mode Selection 7 6 1 B Mode B Mode is the basic operation mode after startup and a single framed B mode image is displayed PressBBlo o elor m key to exit B mode Press key to switch single framed B mode image 7 6 2 B B Mode 1 In real time mode press BB key to enter B B mode 2 B B image switch Press B Bkey to switch left right image display 3 In real time mode preso lol key to exit B B mode 7 6 3 4B Mode 1 In real time mode press lkey to enter 4B mode 2 4B image switch PressBlkey to switch display among four images the selected image is activated and the other three are frozen 3 In real time mode press BoB Jo Mo fm key to exit 4B mode 7 6 4 B M Mode 1 In real time mode press Ikey to enter B M mode 2 Change of scan mode Press Ikey to change the M ultra scan mode 3 Move sample line Press direction key to move sample line 4 In real time mode press B JorE Joo key to e
9. 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 NWarning Do not place the ultrasonic probe connector into water or disinfection sterilization liquid as it may cause electric shock 3 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 probe 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
10. 9 24 Arithmetic average acoustic working 2 85 2 97 2 97 frequency faws MHz Acoustic power on factor APF 100 107 31 100 Acoustic initial factor AIF 100 107 31 100 Power up mode B mode B mode B mode Initialization mode B mode B mode B mode Acoustic output freeze Yes Yes Yes Appendix A2 Sound Power Output Data Disclosure Ultrasonic Diagnostic Instruments User s Manual V1 01 Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment IEC61157 1992 we hereby make our declaration of the relevant acoustic output parameters as follows Product name Ultrasonic diagnostic instruments Manufacturer Xuzhou Kaixin Electronic Instrument Co Ltd China Test frequency 6 5 MHz System model KX5000 Probe model Mode Probe model 6 5C13A1 Probe mark Y6 5C64 511001 B M B M Parameter Maximum space averaged acoustic 1 2 3 3 4 2 power output mW Peak negative sound pressure 0 89 1 07 1 08 P Mpa Sound intensity of tb Lo oun i ensity of output beam lob 0 43 4 82 1 52 mW cm Space peak time average sound 0 75 35 80 3 00 intensity output Ispta mW em System settings Single focus Focus One second Focus One second x 1 0 Zoom 1 2 Zoom 1 2 Distance between transducer output end surface and integrated dot for square of 40 36 36 the maximum acoustic pre
11. Tt Keep dry E l T T DC Power ha Fragile L JJ o T m O Main unit power OFF Stacking limit by number o Main unit power ON Temperature limits coc j Tr 931 ae aa Marking for the separate collection of Humidity limitation X r f ar ma electrical and electronic equipment io Atmospheric pressure a4 limitation 3 Labels Label Description a A DANGER Danger MIXED USE WITH FLAMMABLE GAS WILL 1 It may have explosion hazard if LEAD TO DANGEROUS EXPLOSION used with flammable gas NOTICE BEFORE USING THE PROBE 2 Operate the probe with care CAREFULLY USE THE PROBE BECAUSE IT IS EXTREMELY SENSITIVE TO SHAKE Read the probe information d PLEASE DO REFER TO THE USER S the relevant manual for proper GUIDE TO USE AND CLEAN THE PROBE STRICTLY probe use Attention IT WILL LEAD TO BAD CONNECTION VITII THE It is prohibited to pull out and in PROBE SOCKET TF FREQUENTLY PULL OUT OR h be ft I INSERT THE PROBE OR LOOSELY LOCK THE BOLT the probe frequently Ultrasonic Diagnostic Instruments User s Manual V 1 01 ANY NICK OR PRESS TOWARDS THE LL LEAD TO THE DAMAGE OF THE WI Attention It is prohibited to scratch or squeeze the LCD NO OBJECT AND NO OUTSIDE FORCE CAN BE PUT ON THE DEVICE CLOSE THE KEYBOARD WH EN MOVE IT Attention Do not place object on the machine Do not apply external force on the machine Close the keyboard before moving the machine
12. down keys or the trackball to positioning the depth Repeatedly presOKkey to realize the switch between puncture guide line and lithotripsy positioning line Press s key to quit 7 10 Body Mark and Probe Mark This system contains 64 body marks that are divided into two pages when display 32 marks for each page The operation steps are as follows 1 In image frozen status press key to show the body marks in display area 2 Press direction key to move to the position of desired body mark presse key to confirm the selected body mark 3 Operate trackball to change the probe mark position press DEE E key ort Ikey Co key to change probe mark direction 4 Press s key to quit body mark and probe mark status 5 Presske key to clear body mark 6 Press key to unfreeze and quit body mark status The 64 body marks are listed below my re Rk amp YB Body Right Body Lumbar Body Front Body Right Body Left Body Left Lateral ateral Female Upper Parts Rear sgh Kf NY Ki NY ASS Nat Nasal ns EAS Mother Front Left Front Right Front Left Butt Front Right Butt Left Shoulder Rear S Front Ultrasonic Diagnostic Instruments User s Manual V1 01 Y E KRA QO SE gt Left Right Shoulder Shoulder Uterine Uterus Rear Uterus Level Uterus Front Uterine Body Appendages Transection Front Front AS fo Uterine Neck UE Base renne Liver Breast 1 Breast 2 Neck Front Transection Transection Transection Da mz So 5 Neck R
13. frequency and focus location Number of focus thereby changes the sound power output Change of transmission focus location leads to change of transmission Focus 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 SransHussion power output to the probe hence the change of sound power output Change of frequency will lead to the change of wave focus characteristic Change frequency thereby the change of sound power output Restart or turn off on the power will set the system in default mode and Restart or turn offon 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 NWarning 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 NWarning There is no any water roof device in the system Do not splash any water or liquor into the system when cleaning or maintaining o
14. into its socket NWarning 1 Adapter has no switch The isolation of the system with the MAINS used to unplug the adapter as the intended isolation means 2 The equipment should be used only with adapter provided by Kaixin Company 3 To avoid damaging power adapter or harming people by unexpected fallen make sure the power adapter is placed on the leveled desk 6 6 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 7 Main unit check before and after operation 6 7 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 operation condition 2 No condensation occurs 3 No distortion damage or contamination on system and peripheral Clean the parts as specified in relevant sections if the contaminant is present 4 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 hard up on its connection 6 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 re
15. measuring line enclosure Press Esckey to quit the measurement status Press Ikey to clear all marks and data 8 Press key to clear all marks and data and quit the measurement status Measuring HC and AC using elliptic method Follow the steps below l 2 3 O OND In B B B 4B mode freeze the desired image Press BOkey to OO the obstetric parameters on the lower part of the screen Press direction keyO to select measureme E Parter in HC AC press Ee key to confirm the cursor will show or press Co key to select the above mentioned measurement parameters Press direction key or operate the trackball to move the mark to desired position press key to set the mark position as the starting point of the measurement Press direction key or operate the trackball to change the major axis of the ellipse hold down lor E key to change the minor axis of the ellipse so as to satisfy the test area circumference G A and EDC value will be displayed in real time in the right area of the screen a Press key to exchange the starting point and end point A Press key to finish the first measurement Press Esckey to quit the measurement status i PressC key to clear all marks and data 10 Press key to 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 4B mode Multi parameter measurement and sto
16. select between On and Off 4 PresslEsc key to quit setting interface 7 4 7 Compression Curve Setting 1 Press ee Jkey to enter setting interface 2 Press direction ke 3 Press direction key Sto select compression curve among 00 07 4 Press Es 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 7 4 8 Chinese English Switch use 6 5MHz probe recommend choose 01 or 02 l PressLsew Jkey to enter setting interface 2 Pressl key to switch between Chinese and English 3 Press s key to quit setting interface 7 5 System Formula Setting l 2 3 4 formula item PressLsew Jkey to enter setting interface Press E key and then press direction key Dto move symbol lt to point to the desired Press direction key Oto select the desired formula PressE Ikey symbol points to TIMESET MENU press Er Ikey to quit setting interface Formula preset table User s Manual V1 01 to move symbol lt to point to Compression Curve Preset items Options Preset items Options Preset items Options BPD ASUM China Hadlock Hansmann Jeanty Kurtz Merz Osaka Paris Rempen Shinozuka Tokyo GS China Hansmann Hellman Rempen Tokyo CRL ASUM China Hadlock Hansmann Jeanty Nelson
17. start up sis it ara Saca Set i soi E ae a E ed EE E EAE AANA 8 6 7 2 Inspection Alt et STAT NUD se cerot a 8 O29 SYSTEM A p a Culina ont i a a Aa oana a a al 2 le al 9 Chapter Seven Function POr A A AA a e Dap a 10 Pl Satu pe and 15 UL AO eiere iati a os 10 TZ Probe Conversions is a es e al oo e to dde cedo 10 Tao image Size PAUSE io 10 7 4 System Functions Setting Sd pa aa patit A aan 10 E A A O 10 TADA Mode A o td th a ol 10 TAD Energy Saving SOU INO cae dna crea aaa aa He a a soi tales aaa ea a een Rad aaa 10 7 4 4 Characters Brightness Series tra 10 TA Hospital NAME Setting ats an cadences a Celica tata E A lia kage aa ata la 10 FAA Sound e bo 11 TAE Compr ssion Curve CO a ld a eul i te a acu at da aa aa 11 T amp S Chinese English Sii a tt a ds ihe 0 a alt 11 To System FORM la Sta dt is A RI AAA 11 TO MOTE SEO aan Md el eo ala 12 TO BM o aa 12 740 2 BABI A O 12 O eso unione A a st a Ra i pl la KEALE a 12 TOA AAA O A IN 12 TOs ME IOS ts e e a ls o do a e ta an tos Da aot a 12 7 7 Image Quality AUS di A A ia 12 7 7 1 Brightness and Contrast AdjustMent ooooooconccconcconccconaconccno naco rca rana seasons 12 T 1412 Total Gam Ad OS ME rs O TAS a pb oaia 12 7 1 3 Neat Field Gam Ad usiment orar aisla Lala F r Field rain Adjustments accesate 0 A Seanad ees 7 7 5 Dynamic Range ACJUSHMeNts vu taia ins ada aa nce ala totes 7 7 6 Frequency Adjustment Frequency conversion nenea Ultrasonic Diagnostic Instruments Use
18. Complies emissions 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 IEC61000 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 1 KV for power supply lines It s recommended the use of filters on power input lines Surge IEC61000 4 5 1 KV differential mode 2 KV common mode 1 KV differential mode 2 KV common mode Mains power quality shall be that ofa typical commercial or hospital environment Power frequency magnetic field 50 Hz IEC61000 4 8 3A m 3A m Mains power quality should be that of a typical commercial or hospital 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 us
19. ITH ANY METAL OR LEAD LINE WHICH WILL LEAD 20 THE LEAKAGE EXPLOSION OR FIRE IOW OR MECIANTCALLY SHAKE TUE BATTERY WETCIL WILL LEAD TO THE LEAR APLOST N CR FIRE ATTERY WITH ANY NAIL OR SPICULATS OBJECT AND DO NOT HAMMERBLOW OR TRAMPLE TEE BATTERY AD TO TZE LEARAGS EXPLOSION OR FIRS Oli TIE BATTERY DIRECTLY WILC WILL LEAD TO THE LEAXAGE EXPLOSION OR FIRE BAT TRE REN RAD TO TIIE LEAKAGE 2XPLOSION OR FIRE Y INTO OR FIRE DIFFERENT CAPABILITY OR DIFFERENT MODEL OR DIFFERENT BRAND WITH PARTICULAR SMELL OR ABNORMAL HEAT OR DISTORTION OR TURN COLORS ETP ANY ABNORWAL PHENOMENON TAPPENS TO THE BATTERY SUCIAS PARTICULAR SMELL OR APNORMAL 5 OTHERWISE EACH OF ABOVE WILL LEAD 10 THE LEAKAGS EXPLOSION OR FIRE FIRE IF AM LEAKAGE 02 PARTICULAR SHELL JAPPENS LEAD TO TLE LEAKAGE EXPLOSION OR FIRE TS LISE AND WORSE O NOT WIPE THE EVE INSTEAD OP MASSING IT AND GZT HEL FROM THE DOCTOR AS SON AS POSSIBLE IN TEE SXTREMELY HOT ENVIRONMENT SUCII AS LOT SUNSHINE OR IN THE CAR WEEN SE WILL CAUSE THE FIRE OR SHORTEN ITS LIFE AND WORSEN ITS PERFORMANCE D THE LISTED ENVIROMENT ON THE MANUAL IT WILL CAUSE THE FIRE OR ScORTSN ORMANCE EVEN LEAD TO SATRENE H2 T OR EXPLOSION OR FI
20. KAIXIN KX 5 OOO Ultrasonic Diagnostic Instruments User s Manual e 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 IX N This is registered trade mark of Kaixin Company Kaixin 1s the sole authority for the interpretation of this user s manual Kaixin may revise this manual without prior notice Kaixin may revise its technica
21. RE Attention Battery use should note the precautions E 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 Lo Ultrasonic Diagnostic Instruments User s Manual V1 01 Contents Chapter One Intended Application eee 1 Chapter Two Technical Specifications eee 2 Chapter Three Product Outline aceea iiss dp aa aa cata aaa da matale aaa A e da 3 3 1 Structure composition of the mstrument td ole agate AA AAA 3 3 2 Name of parts and Componente e cai alai atata aa in 3 3 3 Parts of the P16 DE ns ma aas toaca e ea aaa ta at d acacia d e i 3 3A Fonction Keys descriptioti dd A i a E a iS 4 Chapter Four System Configuration eee 5 Chapter Five Operation Condition eee ne 5 Chapter Six System Installation and Check eee 6 Gl System placements Deron e asa Pale E EN E E EA Acad a ie 6 6 2 Probe installation eeuna A aie ta ata aaa ts zei odia 7 Al A A A VR a a tu 7 6 2 2 Probe disconnection niteen ist T 6 3 Install Dismantle the Dat a T 6 4 Connect to video recordet aa 8 6 5 Connect tothe POWEL co sea aa oaia a aa oi al R ce agree AS 8 6 6 Probe check before and after Operations seis acea a a ci atata n ip a ea da a 8 6 7 Main unit check before and after Opera a aie o uda due 8 6 1 1 Inspection before
22. aration distance in meters m Field strengths 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 fr A NA i Note1 Ur is the a c mains voltage prior to application of the test level Note2 At 80MHz and 800MHz the higher frequency range applies Note3 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 transmitter an electromagnetic site survey should be considered If the measured field strength in the location in which this equipment is used excec applicable RF compliance level above the equipment should be observed to verify 1 operation If abnormal performance is observed additional measures may be necessar 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 portabl
23. attery 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 1 5 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 AM Attention Battery charger shall meet the requirements of 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 Z Attention Main unit will power off automatically 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 Attention Don t throw away the exhausted battery anywhere especially throw it in the fire Please deal with it according to local statutes Note The cautions of using battery see th
24. de the system is always saving the scanned image The playback images are for a period time images before freeze Freeze the image press key three times continuously to enter the automatic playbacl PressDkey to enter pause status when playing back Press direction key or operate tr Ultrasonic Diagnostic Instruments User s Manual V1 01 to view images frame by frame in pause status Press key three times continuously again to return to automatic playback status In the process of saving and playback relevant data of image frames saved and played are shown on the lower right corner of the screen PresslEsc key to return to frozen status 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 16 Text Input Operation steps 1 Freeze image 2 Presse key the cursor is located behind NAME users may enter the name as desirable Press key to convert the capital and small letter a Caps mark appears on lower right corner of the screen when capitalization Press Ikey to convert the shift annotation a Shift mark appears on lower right corner of the screen when annotate the special characters Press See key to enter space Press_ key to delete the previous character 3 After inputting name press direction koto move cursor to ID and input the number as desirable 4 After inputting s
25. displayed in real time in the right area of the screen Press key to exchange the starting point and end point f Press key to finish the first measurement Repeat the steps from 3 to 8 to complete the multi group data measurement PresslEsc key to quit the measurement status 10 Pressf key to clear all marks and data 11 Press key to clear all marks and data and quit the measurement status Oo OND 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 4B mode freeze the desired image 2 Press key to display the obstetric parameters on the lower part of the screen Ultrasonic Diagnostic Instruments User s Manual V1 01 3 Press direction key kto select measureme Eie in HC AC press Ee Jkey to confirm the cursor will show or press Co key to select the above mentioned measurement parameters Press direction key or operate the trackball to move the mark to desired position press key to set the mark position as the starting point of the measurement Press direction key or operate the trackball a solid line measurement locus appear on the screen along the moving direction circumference G A and EDC value will be displayed in real time in the right area of the screen press Okey 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
26. e 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 this equipment as recommended below according to the maximum output power of the communications equipment ee 150KHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz agate di d 3 5 P d 1 174P d 2 33VP 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 watt W according to the transmitter manufacturer Notel At 80 MHz and 800 MHz 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 disturbi
27. e 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 nameplate
28. e warning label on the battery in details 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 Dept of Kaixin for support Trouble Correction Power light is off and no screen 1 Check power supply display is present when starting the 2 Check power cable and connector machine 3 Check power adapter Character and gray scale are displayed b t no uliasonic miedo Probe is not properly connected Turn off the power and reconnect the probe the screen 1 Check power supply spark interference present 2 Check environment source of interference around the Intermittent stripe snow or far field machine such as electric motor ultrasonic atomizer interference appears on screen automobile computer or other interference 3 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 Control panel malfunction Restart the system by turning off the main unit pow Image display is not clear
29. ed 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 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 ofa typical commercial or hospital environment If the equipment requires continued operation during power mains interruptions it is recommended that this 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 5GH 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 d 2 33VP 80MHz to 800MHz 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 sep
30. en press direction keys Dor operate the trackball to move the dotted line to desired position press direction keys Mor operate the trackball 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 3 Press key to complete the multi group depth measurement 4 Press key to return to the status of distance measurement 5 PresslEsc key to quit the measurement status 6 PressC key to clear all marks and data 7 Press key to clear all marks and data and quit the measurement status Note Direction keys Oeannot work in the depth measurement when connecting convex array probe 8 3 Circumference Area Volume Measurement O Circumference area measurement with locus method l PA 3 In B B B 4B mode choose desired image and freeze it Press Pkey the cursor will show Press direction key or operate the trackball to move the mark to desired position press key to set the mark position as the starting point of the measurement Press direction key or operate the trackball to move the mark to the end point measurement A locus appears in the direction of operation between the two measu Ultrasonic Diagnostic Instruments User s Manual V1 01 marks The measured circumference value is displayed automatically at the built in mark C 00000mm on the right part of the
31. eneral Measurement eee nenea ees 20 Gel Distance MAME on 20 8 2 Depth Measurement fara EE ta a ei IDE oaia aia ate 2 00 8 3 CirenmierencelAreal o lime Measurement a din O a dates aia Dat 9 2 8 4 Slope Heart rate Cycle O Pau NN NA NI IO A ae MN i Chapter Nine Obstetric Measurement eee 22 9 1 Measurement and Calculation Hess ld 9 2 Fetus growth parameter measurements si ca ca irita ana oda idas 22 9 2 1 Measurement of GA and BDC siana ea apa ap tau ce neds bee bo atata aia ca i apa 22 9 2 1 1 Measurement of BPD CRL GS FL HL LV TTD APTD FI TAD THD TCD OFD 22 9 2 12 Meastrementol HC and AC A ies 22 902 2 Fet s weight Mea ET areri stieni eat nt pap a cit ia a aae 23 O 24 9 4 Measurement items a ones dead 24 Chapter Ten Principle of Sound POWer ita 25 Chapter Eleven System Clean and ee eee Se ee eee ey et ee 26 11 1 Maintenance by users Dee a be bare a S 11 1 1 System clean disinfect nd sterilize iii sasiu eset obtain ue Atak irre sie att 26 11 1 2 Use and maintenance for the charging battery ccc eee 29 14 27 Tro bl shootihg ernan nnise gan a o ae ard atat ala atata laica 29 Chapter Twelve System Maintenance eee 30 Chapter Thirteen Accuracy of Measurement eee eee 31 Chapter Fourteen Storage and O tS ae ihe et NUN E 32 Chapter Fifteen Standard Compliance Chapter Sixteen Safety Classification E ETTE Chapter Seventeen Guidance and Manufacturer S Declaration e Appendix A Sound Po
32. epaired Inspect the equipment and accessories for mechanical and functional damage 2 Inspect the safety relevant labels for legibility 3 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 5 Test the protection earth resistance according to IEC 60601 1 1988 A1 1991 A2 1995 Limit 0 10 6 Test the earth leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 500uA SFC 100014 2 Test the enclosure leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit NC 1001A SFC SO0uA Test the patient leakage current according to IEC 60601 1 1988 A1 1991 A2 1995 Limit for a c 100uA for d c 10uA 9 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 SOWA 12 2 The circuit theory chart of KX5000 Keyboard Fe ota MCU control system N aa y H V SYNC Signal Y Transmit and mol DSC Signal Display Receives For Collating processing synthesis part Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Thirteen Accuracy of Measurement Table 13 1 Accuracy in measurement Parameter Numeric range Dev
33. erial number press direction key or operate trackball to move cursor to image area and input according to the need 5 Press Esckey to quit Presst Ikey to clear all noted marks Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Eight General Measurement 8 1 Distance Measurement 1 In B B B 4B or B M mode choose desired image and freeze it Oo NDA U 10 i Press key the cursor will show Press direction key or operate the trackball to move the mark to desired position press key to set the mark position as the starting point of the distance to be measured Press direction key or operate the trackball 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 A Press key to exchange the starting point and end point of the measurement E Press key to finish the first measurement Repeat the steps 3 6 to complete the multi group data measurement A PresslEsc key to quit the measurement status E PressC key to clear all marks and data Press key to clear all marks and data and quit the measurement status 8 2 Depth Measurement 1 In B mode choose desired image and freeze it 2 Press key twice a dotted line of depth measurement appears on the scre
34. ey to enter setting interface 2 Press direction key Do move symbol lt to point to Sleep 3 Press direction key Sto select energy saving time or energy saving close between 1 99 minutes 4 PresslE key to quit setting interface If operation of trackball or any other key is not activated for a period specified by this energy saving setup the system will automatically enter the energy saving status Press any key or operate the trackball to bring the system back to normal operation status 7 4 4 Characters Brightness Setting 1 Press Set Jkey to enter setting interface 2 Press direction key to move symbol lt to point to Font Bright 3 Press direction key Sto select characters brightness among 160 192 224 and 255 4 Press s key to quit setting interface 7 4 5 Hospital Name Setting 1 Press se key to enter setting interface 2 Press direction key to move symbol lt to point to Hospital 3 Press direction key to move cursor 4 Press characters key to input if error occurs during the character input press Ikey t delete the characters or press direction key Okto move the cursor to the wrong char to retype again Ultrasonic Diagnostic Instruments 5 Press Ee key twice to confirm and quit setting interface 7 4 6 Key Sound Setting 1 PressL se key to enter setting interface 2 Press direction key to move symbol lt to point to Key Sound 3 Press direction key to
35. 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 puncture operation 3 The sterilization times should be minimized as it may lead to degrade of the pr 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 display Clean the liquid crystal display with dry soft flax Anti static LCD clean cloth for cleaning liquid crystal display is also applicable 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 Z Attention Prohibit using sharp objects to touch the LCD screen and prohibit g p obj pressing or squeezing against the LCD screen 6 Clean the trackball NAttention Trackball should be cleaned regularly or because of dust stains etc resulting in the non flexible use of trackball e Dismantle trackball Respectively hold down the both sides of sealing cover with middle fingers of left hand and right hand or hold down the two grooves of the cover with two small screwdriver and then forced rotate it cloc
36. g 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 services Group I Class A equipment Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Seventeen Guidance and Manufacturer s Declaration This product complies with EMC test standard EN60601 1 2 Guidance and manufacturers 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 RF emissions Group 1 This equipment uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A This equipment is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to the public low voltage Harmonic emissions Class A power supply network that supplies building IEC61000 3 2 used domestic purposes Voltage fluctuation flicker
37. ght corner of the screen i Press key to switch LOCAL and U disk choose LOCAL Press direction key Oto select the image code to be read out such as 002 Press fe key the image stored in frame 002 is read out a Press key Dump xxx prompt appears on lower right corner of the screen Press direction key to select the current image stored code such as 001 E Press E key system enter the dump status at this time Dump 001 prompt disappeared until finishing the dump the Dump 001 prompt will be displayed again l PresslEsc key to quit dumping status and pressBkoy to return to real time mode U disk gt LOCAL Enter the number ID after completed it exit the enter status such as ID is 111 Freeze the image Continuously press key twice a Read prompt appears on lower right corner of the screen Press direction key Oto select the image code to be read out such as 001 Press key the image stored in frame 001 of the 111 folder under the U disk is read out 6 Press amp ke Dump xxx prompt appears on lower right corner of the screen y p prompt app g 9 Press direction key Sto select the current image stored code such as 002 y Press fe key system enter the dump status at this time Dump 002 prompt disappeared until finishing the dump the Dump 002 prompt wi
38. iation 1s 3 ms 2s 6 ms 3s 9 ms 4s 12ms Ss 15 ms 6s 18 ms 7s 21 ms 8s 24 ms M mode image time 1 2 3 4 5 6 7 8s Table 13 2 Two dimensional image measurement Parameter Numeric range Deviation Within 3 or less than 2mm when measured Distance depth Max Value 194mm values less than 40 rin Within 7 or less than 1 5 cm when measured 2 Area Max Value 448 cm value is less than 16 cm Within 7 or less than 1 5 cm when measured 2 Area Ellipse Max Value360 cm value is less than 16 cm Table 13 3 Time motion measurement Parameter Numeric range Deviation Distance Max Value 194mm ed dd de cata Ain MC casare 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 Within 10 or less than 7cm when measured value is less than 64cm Volume Max Value 999 cm QM 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 T
39. ight Neck Den Head Right Head Left Lateral Head Front Head Rear Head Top Lateral Lateral Lateral D 3 a E if f r Skull Fontanelle Eyeball 1 Eyeball 2 howe ap Lower Timb Right Arm Left Arm Front Rear Transection Left Apical Four Apical Five Ventricle Fetus Heart 1 Fetus Heart 2 Bilocular Heart Quad Heart Chamber Chamber Major Axis Cross Section E ee A MM YY A A oo AL o Ne Aortic Arch Aortic Arch Aorta Minor Bicuspid valve Aortic valve Parse test Stomach Major Axis1 Major Axis 2 Axis M type curve M type curve 8 ma Testes Knee Joint 1 Knee Joint 2 Foot 1 Foot 2 Hand 1 Hand 2 7 11 Image storage and recall 7 11 1 Save the image e Storage to main unit 1 Freeze the image 2 Press Dey a Save prompt appears on lower right corner of the screen 3 Press direction key Oto select the current image saving code such as 003 Ultrasonic Diagnostic Instruments User s Manual V1 01 Eh HAU NK u 6 Press Ec key to store the current image to the frame coded 003 The saved image code is ETE preceded with asterisk PresslEsc key to quit saving status and press Prey to return to real time mode Storage to U disk Plug U disk Freeze the image E Press Dkey a Save prompt appears on lower right corner of the screen Press direction key to select the current image saving code such as 003 Press fe Jkey to appear Wait prompt After vanish the p
40. ime mode press key to realize image vertical flip 7 8 6 Image Negative In real time mode press key to realize negative function Ultrasonic Diagnostic Instruments User s Manual V1 01 7 8 7 Scan Range Angle Width Change In real time mode press Okey to choose angle width convex array for scanning angle and linear array for scanning width 7 8 8 Color Selection In real time mode pressC key to realize eight kinds of colors image conversion including one kind of black and white 7 8 9 Image Freeze Unfreeze In real time mode scape ey to freeze the image in frozen status press key to unfreeze the image 7 9 Puncture guide and lithotripsy positioning line Puncture guide line In real time and B mode pressOkey two puncture guide lines will be showed on the screen press direction key to change the angle of the first puncture guide line press direction key to change the start position of the first puncture guide line Press Qkey again to switch the second puncture guide line press direction ke to change the angle of the second puncture guide line press direction key Dto change the start position of the second puncture guide line Press Es key to quit the puncture guide status Lithotripsy positioning line In real time and B mode press Okey 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
41. irection 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 4 Fasten bolts Fig Install dismantle the battery Ultrasonic Diagnostic Instruments User s Manual V1 01 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 power 1 Connect to the power adapter Insert the output plug of adapter into DC power input port 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 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
42. isk e Open image in the U disk l 2 3 4 X Freeze the image Continuously press key twice a Read prompt appears on lower right corner of the screen Press key to switch LOCAL and U disk choose U disk Press fe key the image stored in frame 003 is read out PresslEsc key to quit reading image status and press key to return to real time mode Note 1 When reading images it must choose the image code with 2 Read out the image you can do Color switch IP switch negative switch operations 3 If you want to read out the images within the folder identified by numbe under the U disk must input ID first before reading then do as the abov Ultrasonic Diagnostic Instruments User s Manual V1 01 if did not enter the number ID it would default to read out the images in the USER folder under the U disk 4 If has read out the images in the U disk also would like to re read the local image must press Es key to exit this reading status then press key to choose LOCAL and vice versa 7 12 Single image dump and mass images dump 7 12 1 Single image dump Note Single image dump is bidirectional that is images can transfer from U disk gt e 1 A DQO ui Bb WW wv Me o Eh LOCAL or from LOCAL gt U disk LOCAL gt U disk Freeze the image Continuously press key twice a Read prompt appears on lower ri
43. kwise remove the cover and take out the trackball As follows Sealing Cover Ball l Trackball shelf Rotate Fig l Fig 2 O Clean the trackball D Clean the trackball shelf lightly with dry soft flax or anti static LCD clean cloth generally 2 In case of die hard blots clean with soft cloth dipped in moderate detergent and then air dry it e Clean the trackball shelf Clean the trackball shelf lightly with dry soft flax or anti static LCD clean cloth e Install trackball Place the sealing cover into the trackball shelf respectively hold down the both sides of sealing cover with middle fingers of left hand and right hand or hold down the two grooves of the cover with two small screwdriver and then forced rotate it Counterclockwise to lock the cover When locking the two grooves of the sealing cover are in the horizontal line 7 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 8 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 de and then air dry it Ultrasonic Diagnostic Instruments User s Manual V1 01 11 1 2 Use and maintenance for the charging battery 1 Only the battery provided by Kaixin Company can be used 2 B
44. l 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 and charge fre
45. lection In real time mode press key e appears in the center of the screen Press direction key or operate trackball to move image up down or left right so as to observe the images of different depth and width Press s key to quit depth enhancement pan status Note When the selected depth of the image is greater than the showed depth image can be moved up and down In real time mode press key depth range 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 A e key to select corresponding depth at the bottom of the screen presslEs lt lkey to quit depth range selection Note There is no depth range selection function when main unit matching probe which its nominal frequency greater than or equal to 6 5MHz 7 8 3 Local Zoom and Local Additive Color In B mode pressDkey a box appears Press direction key or operate trackball to move the box to place to be enlarged and the selected image to be enlarged PressQDkey 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 8 4 Image Left right Flip In real time mode and in B B B 4B or B M mode press key to realize image horizontal flip The image 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 8 5 Image Up down Flip In real t
46. levant sections 7 No barriers around the intake of equipment 8 See to it that probe has been cleaned disinfected and sterilized else dispose it as specified in relevant sections 9 Check all the ports of the machine for possible damage or blockage 10 Clean the field and environment Nn 6 7 2 Inspection after start up Check the following items after starting the machine Ultrasonic Diagnostic Instruments User s Manual V1 01 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 3 Check the ultrasonic lens is abnormal heat or not when the probe is in use This can be done Ne by hand touching the probe to feel the temperature of the lens 4 Check image to ensure trouble free display no excessive noise or flickering 5 Check the panel to ensure normal operation condition 6 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 AM Attention Thoroughly clean the coupling gel on the probe surface each time after ultrasonic operation or the coupling gel may become hardened on the acoustic lens of the probe deteriorating quality of image 6 8 System reset In case of abnormal screen display or system
47. ll be displayed again PresslEsc key to quit dumping status and pressBkey to return to real time mode Note If not enter number ID it will select the image within the system default USER folder The operation steps are 2 9 7 12 2 Mass images dump l de LOCAL gt U disk Freeze the image Press key LOCAL gt U Disk Mass Dump prompt display at the bottom of the screen Press E key all the images stored in the LOCAL are mass dumped to the DUMP folder of U disk at the same time the number of dumped images shows on the lowe Ultrasonic Diagnostic Instruments User s Manual V1 01 of the screen after finishing mass dumping the prompt information will automatically vanish Press key to return to real time mode U disk gt LOCAL Freeze the image i Press key LOCAL gt U Disk Mass Dump prompt display at the bottom of the screen press key again to switch U Disk gt LOCAL Mass Dump 3 Press key all the images stored in the DUMP folder of U disk are mass dumped to the LOCAL at the same time the number of dumped images shows on the lower right of the screen after finishing mass dumping the prompt information will automatically vanish 4 Press Bkoy to return to real time mode Note 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 no
48. ng voltage is added That disturbance does not affect the diagnosis User s Manual V1 01 Ultrasonic Diagnostic Instruments Appendix A1 Sound Power Output Data Disclosure Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment IEC61157 1992 we hereby make our declaration of the relevant acoustic output parameters as follows Product name Ultrasonic diagnostic instruments Manufacturer Xuzhou Kaixin Electronic Instrument Co Ltd China Test frequency 3 5 MHz System model KX5000 Probe model Probe model 3 5C60A2 Probe mark Y3 5C80 511001 Mode B M B M Parameter Maxi d ti aximum space averaged acoustic 255 29 3 30 5 power output mW Peak negative sound pressure 1 32 1 23 1 32 P Mpa Sound intensity of output beam Iob ae eres 270 13 44 3 30 mW cm S k ti erage sound e aE es 5 5 159 75 6 2 intensity output Lspta mW cm A Single focus Single focus Single focus System settings x 1 0 x 1 0 x 1 0 Distance between transducer output d fi dint ted dot fi end surface an 1 egrated do We 60 60 60 square of the maximum acoustic pressure Lp mm 6dB pulse beam width Wa mm 2 55 1D 7 57 2 55 Ma L 6 03 LL 3 50 L 6 03 1 mm e 0 064 Pulse repetition rate prr kHz N A 4 60 M mode 31 84 Scan mode rate srr Hz 22 93 N A B mode Output beam size cm 9 24 2 18
49. nit 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 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 NAttention The mains voltage varies with different countries or regions ANWarning Avoid using this equipment with high frequency operational equipment or danger may occur 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 MN 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 12 Moist 13 Thunderstorm weather 14 Strong electromagnetic field e g MRI
50. 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 Indicates a potential danger that may result in personal injury if not N Warning avoided Indicates a potential danger or unexpected use condition that may NAttention 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 Is q A j Type B applied part tt Up O j rn a N AC Power
51. 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 Toggle the power switch of main unit towards instrument starts up toggle the power switch towardsO instrument shuts down 7 2 Probe Conversion In real time mode press key can realize probe conversion 7 3 Image Size Adjustment l Press Set Jkey to enter setting interface 2 PressE gt key to realize the image size conversion between the normal and full screen status 3 PresslEsckey to quit setting interface Note When display full screen no color output 7 4 System Functions Setting 7 4 1 Time Setting l Press Set key to enter setting interface 2 Press direction key Do select Minutes Hours Day Month and Year 3 When setting minutes hours day month and year press direction key to increase value or press direction key Sto decrease value 4 Presse Jkey press seu key again to confirm the time setting and quit setting interface 5 PresslEsckey to give up the time setting and quit setting interface 7 4 2 TV Mode Setting l Press se key to enter setting interface 2 Press direction key to move symbol lt to point to TV mode 3 Press direction key to realize TV mode conversion between PAL and NTSC 4 Press s key to quit setting interface 7 4 3 Energy Saving Setting l PressL Set Jk
52. pta mW cm Single focus Focus One second Focus One second System settings x 1 0 Zoom 1 6 Zoom 1 6 Distance between transducer output end surface and integrated dot for 40 30 30 square of the maximum acoustic pressure Lp mm Wopo mm 1 57 1 25 1 38 6dB pulse beam width L mm L 1 58 L 1 52 L 1 54 Pulse repetition rate prr kHz N A 4 608 0 064 Scan mode rate srr Hz 33 33 N A 31 94 Output beam size cm 4 51 1 13 4 51 Arithmetic average acoustic working 5 54 5 52 5 51 frequency faw MHz Acoustic power on factor APF 100 100 57 98 86 Acoustic initial factor AIF 100 100 57 98 86 Power up mode B mode B mode B mode Initialization mode B mode B mode B mode Acoustic output freeze Yes Yes Yes Ultrasonic Diagnostic Instruments Appendix A4 Sound Power Output Data Disclosure User s Manual V1 01 Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment IEC61157 1992 we hereby make our declaration of the relevant acoustic output parameters as follows Product name Ultrasonic diagnostic instruments Manufacturer Xuzhou Kaixin Electronic Instrument Co Ltd China Test frequency 5 0 MHz System model KX5000 Probe model Mode Probe model 5 0C20A3 Probe mark Y5 0C20 511001 B M B M Parameter Maximum space averaged acoustic 2 9 3 5 3 4 power output mW Peak negative so
53. r s Manual V1 01 7 1 1 Focus Adjustment and Controla it 13 7 7 8 Frame Correlation Adjustment sec e aaa ca ii ie ca cc tl es pala do aie ae d aa ata a aa aa d 13 TLD Post process Adjustment ceia tota aste A a ea 30 au A 13 7 7 10 Edge Enhancement Adjustnient ce casate ta a aaa ea ta arat ear 3 dias 13 e Image Controls a it at ale aa o a aa a died tu sala at a al 13 T 8 L Magnification Selections il Ai a al ali 13 7 8 2 Depth Enhancement and Depth range selection eee 13 7 8 3 Local Zoom and Local Additive Color eee 13 1 34 image BETTIS Wb EP o o o Ethan 13 18 3 Image Up dom Pl ARAN e rie 13 150 maga Neda o 13 7 8 7 Scan Range Angle Width Change mercante 14 78 8 Color SClCHON i apara iasa atare ani atata An ati ada 0 E ARTE AARET n ah 3 ba RA 14 1502 Image Eteeze LINTESEZE i sc pet iau iarna ataca aaa azi ri a d a iaca aan el 14 7 9 Puncture guide and lithotripsy positioning line eee 14 710 Body Mark and Probe Mark da NA a 14 deL Image storage and te edn dare Oil mit 0 e 0 a i ie SA lt e Sb aa 15 d lol le Save LIC A RN 15 VA Open he imager cc pe ae i pe dala 000 de E ued baad 16 7 12 Single image dump and mass images dump cccececeece ence eee eee enne eens 17 TAS Delete ANS IMATE etch e at d alesse ea D aia de bt 18 AAA MASS SREVICW ia 18 Pel CMe OOPS atentate eta atata oaie EEEE ihe meee Seta d nearest A 18 Wo Ox REM AMO yas creas tal ete de a atata ca a ei nl ea petala 0 19 Chapter Eight G
54. rage 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 l 2 3 In B B B 4B mode freeze the desired image Press 2 key twice to display the second group obstetric parameters on the lower part of the screen Press direction key Oto select the 6 EFW parameter press Ee key to confirm or press Jkey to select the above mentioned measurement parameters For example set the calculation 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 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 measurement method The measu
55. ransportation 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 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 accordin
56. red value of FTA is saved and displayed at 2 mm position in the EFW zone of the right display area c D Press key to exit FTA measurement status 2 Obtain the desired image and freeze it again 3 Measure FL with distance measurement method The measured value of FL is saved and displayed at 3 mm position in the EFW zone of the right display area 4 When values are available for all the selected parameters the EFW value is automatically displayed in EFW g position 5 PressEs key to quit the current measurement status press Es key again to quit EFW measurement status 6 Pressl key to clear all marks and data Ze Press key to clear all marks and data and quit the measurement status N 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 key to display obstetric report Pres key again to exit obstetric report status Note 1 2 For measurements done with the given obstetric table the distance gestational week and estima
57. rompt 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 3 If user did not enter the number ID the folder name defaults to USER PresslEsc key to quit saving status and press Okey to return to real time mode Note 1 Each folder can store 100 images 2 Press 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 11 2 Open the image e Open image in the main unit 1 2 N aA Freeze the image Continuously press key twice a Read prompt appears on lower right corner of the screen Press key to switch LOCAL and U disk choose LOCAL Press direction key to select the image code to be read out such as 003 A Press fe key the image stored in frame 003 is read out PresslEsc key to quit reading image status and press key to return to real time mode Note 1 When reading images it must choose the image code with 2 Read out the local image you can do Color switch IP switch negative switch operations 3 If has read out the local image also would like to re read images in the U disk must press s key to exit this reading status then press key to choose U d
58. s 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 4B mode freeze the desired image La Press key to display the first group obstetric parameters on the lower part of the screen I BPD 2 CRL 3 GS 4FL 5 HL 6LV 7 TTD 8 APTD 9 HC 0 AC press key again to display the second group obstetric parameters on the lower part of the screen 1 FT 2 TAD 3 THD 4 TCD 5 OFD 6 EFW 3 Press direction key to select corresponding measurement parameters items BPD CRL GS FL HL LV TTD APTD FT TAD THD TCD OFD press E Jkey to confirm the cursor will show or press BaB key to select the above mentioned measurement parameters 4 Press direction key or operate the trackball to move the mark to desired position press key to set the mark position as the starting point of the measurement 5 Press direction key or operate the trackball to move the mark to the end point of the measurement and G A and EDC value to be
59. screen Press key 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 E Press s key to quit the measurement status i Pressf key to clear all marks and data f Press key to clear all marks and data and quit the measurement status Circumference area volume measurement with ellipse method In B B B 4B mode choose desired image and freeze it Press key the cursor will show Press direction key or operate the trackball to move the mark to desired position WN p ADU press key to set the mark position as the starting point of the measurement 4 Press direction key or operate the trackball to move the mark to the end point of the measurement Press Okey the elliptic curve appears 5 Hold down Jor key to change the minor axis of the ellipse so as to satisfy the test area The measured values are displayed automatically at the built in characters C 00000mm A 00000mm V 00000cm on the right part of the screen E Press key to exchange the starting point and end point i Press key to finish the first measurement Repeat the steps from 3 to 7 to complete the multi group data measurement O ON DD PresslEsc key to quit the measurement status 10 PressC key to clear all marks and data 11 Press key to clear all marks and data and quit the meas
60. sonic 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 TT is the less bioeffect produce 10 3 Prudent use statement Whereas it is not proved that ultrasonic diagnostic 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
61. ssure Lp mm Wpo mm 1D 1 17 2 50 2 50 6dB pulse beam width L mm 1 2 50 1 2 97 1 2 30 Pulse repetition rate prr kHz N A 4 629 0 064 Scan mode rate srr Hz 32 89 N A 31 94 Output beam size cm 2 75 0 684 2 15 Arithmetic average acoustic working 3 89 3 93 3 93 frequency faw MHz Acoustic power on factor APF 100 100 93 100 Acoustic initial factor AIF 100 100 93 100 Power up mode B mode B mode B mode 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 Data Disclosure Pursuant to the pertinent provisions of Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment IEC61157 1992 we hereby make our declaration of the relevant acoustic output parameters as follows Product name Ultrasonic diagnostic instruments Manufacturer Xuzhou Kaixin Electronic Instrument Co Ltd China Test frequency 7 5 MHz System model KX5000 Probe model Probe model 7 5L40A3 Probe mark Y7 5L40 511001 Parameter B M B M Maximum space averaged acoustic 1 8 12 8 13 2 power output mW Peak negative sound pressure 1 18 1 73 1 76 P Mpa Sound intensity of tb Tob oun E ensity of output beam Iob 0 39 11 32 2 99 mW cm Space peak time average sound j gt 2 2 133 75 7 61 intensity output Ls
62. t 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 E Ikey although the screen prompt Dumping the image number is not appeared on the right corner of the screen N 0 gt 7 13 Delete the image 1 Freeze the image RE to enter reading or saving image status 2 Press key to switch LOCAL and U disk identified the location LOCAL or U disk for file need to be deleted 3 Press direction key to select the image code to be deleted such as 002 4 Press Jkey the image will be deleted will automatically disappear 5 Repeat the 2 3 steps delete other images 6 Press key to return to real time mode Note 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 14 Image review 1 Freeze the image press 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 key Sto select the previous or the next image to review 4 Press Es key to return to frozen status 7 15 Cine loop In real time mo
63. ted date of confinement are automatically stored in the corresponding places of the obstetric report 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 4B mode distance circumference area volume gestational age GA estimated date of confinement EDC and fetus weight 4 Items measurable in B M mode distance or depth slope heart rate and cycle 5 Items measurable in M mode depth slope heart rate and cycle 6 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 ultra
64. therwise it will cause malfunction or electric shock or malfunction AM 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 To prevent possible infection it is advisable to wear sterilized gloves when clean disinfect or sterilize the ultrasonic probe In the process of cleaning disinfection or sterilization avoid probe overheat exceeding 60 C as it may be damaged or deformed under excessive heat To prevent the infection or the cross infection the probe surface should be covered with a condom every time before diagnose the cavity Do not use the probe packing box to store the probe as the box may becom source of contamination 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 1 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 2 Disinfect the probe 1 Wear sterilized gloves to prevent possible infection in the process of disinfection 2 Clean the probe firstly before disinfection
65. 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 output 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 n Change image mode switched from B to B B or to 4B the sound power will not change basic parameters remain the same In most cases sound power ot M mode is larger than that in B mode Ultrasonic Diagnostic Instruments User s Manual V1 01 The number of focus influences frame
66. und pressure 0 82 0 95 0 95 P Mpa Sound intensity of output beam Iob EE TA 0 84 4 05 0 98 mW cm Space peak time average sound 1 5 57 46 2 64 intensity output Ispta mW em System settings Single focus Focus One second Focus One second x 1 0 Zoom 1 2 Zoom 1 2 Distance between transducer output end surface and integrated dot for i 40 37 37 square of the maximum acoustic pressure Lp mm Wppo mm ID 3 39 2 76 2 96 6dB pulse beam width L mm 1 2 95 L 3 46 L 3 75 Pulse repetition rate prr kHz N A 4 629 0 064 Scan mode rate srr Hz 32 25 N A 31 94 Output beam size cm 3 45 0 863 3 45 Arithmetic average acoustic working 4 09 4 07 4 09 frequency faw MHz Acoustic power on factor APF 100 100 100 Acoustic initial factor AIF 100 100 100 Power up mode B mode B mode B mode Initialization mode B mode B mode B mode Acoustic output freeze Yes Yes Yes KAIXIN ELECTRONIC XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO LTD pr 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 Shanghai International Holding Corp GmbH Europe R Eiffestrasse 80 20537 Hamburg Germany Css Information contained in this manual is subject to change without further notice
67. urement 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 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 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 parameter
68. ving Chinese English Switch Obstetric report Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Three Product Outline 3 1 Structure composition of the instrument KX5000 ultrasonic diagnostic instruments are composed of main unit and probe etc 3 2 Name of parts and components Charge Electric quantity indicator Slide button AAA AOS LCD display Keyboard CO E Power indicator a CT mE e e 3 MW gt Video signal port ya interface e socket tE E C UI pos 0000000000 J Power switch DC power input port Fig KX5000 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 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 h wave and converted to electric signal again The acoustic is on the probe surface Supply ultrasonic coupling gel 1 acoustic lens surface when performing ultrasonic diagnosi 2 Cable To connect the probe to probe connector Ultrasonic Diagnostic Instruments User s Manual V1 01
69. wer Output Parameter Disclosure Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter One Intended Application KX5000 ultrasonic diagnostic instruments are applicable to abdominal viscera include trans vagina gynecologic and obstetric and small parts ultrasonic diagnosis AN 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 Z 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 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
70. xcessive heat inside the enck Ultrasonic Diagnostic Instruments User s Manual V1 01 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 NAttention 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 electric shock 1 Insert the probe connector into the probe socket at the back of the main unit Note the d
71. xit B M mode 7 6 5 M Mode 1 In real time mode press key to enter M mode 2 Change of M scan mode Press Ukey to change the M ultra scan mode 3 Change of M speed Press key to select the eight kinds of scan speed 4 In real time mode press B Joro Ho key to exit M mode 7 7 Image Quality Adjustment 7 7 1 Brightness and Contrast Adjustment In the startup default status the adjustment bars of brightness and contrast will be displayed on the screen by pressing direction keyO adjust them according to actual need Press direction keyto increase brightness and contrast direction key Sto decrease them press direction keys to select brightness or contrast adjustment Press Es key to quit adjustment status Note If direction key Oeannot be adjusted when adjust brightness in normal operation mode must be exit current operating condition of direction keys 7 7 2 Total Gain Adjustment Gain In real time mode press Dkey press key to increase image total gain and key to reduce image total gain so as to control the total gain of the entire image 7 7 3 Near Field Gain Adjustment In real time mode press 1 Okey press key to increase near field gain and key to reduce near field gain so as to control the gain in near field region 7 7 4 Far Field Gain Adjustment In real time mode press lt key press key to increase far field gain and key to reduce far field gain so as to control the gain in far field region

KAIXIN ® KX5000 Ultrasonic Diagnostic Instruments User`s Manual

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KAIXIN &reg; KX5000 Ultrasonic Diagnostic Instruments User`s Manual

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KAIXIN ® KX5000 Ultrasonic Diagnostic Instruments User`s Manual