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KAIXIN ® KX5200 Full Digital Ultrasonic Diagnostic

1. TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan AapnSlem Aaprez om Maximum index value 0 35 0 85 Pra MPa 0 87 P mW 24 0 min of Pa Zs NICA e f Zs cm Associated Zop cm acoustic A cm _ parameters 7 at max Tpi a cm 2 82 deq zb cm i fawe MHz 7 40 7 40 X cm 0 88 REEE NOS 0 80 E 3 ta usec 0 103 prr Hz 4149 One f Prat max lpi MPa 1 57 information de at max Li a Iba aat max MI W em 38 94 Operating Focus 1 E 3 control Focus setting mm 30 30 conditions Frequency Hz 7 5 7 5 Test Mode BM MODE Probe Type 7 5L40E1 TIS TIB Index label MI Non scan TIC Scan gt 7 Non scan April em Aap LEM Maximum index value 0 35 0 85 0 011 0 013 Pra MPa 0 87 P mW 24 2 0 37 0 37 min of Pa Zs moZ W Zs cm Associated Zop cm y acoustic A cm 2 82 patalneleas Z at max Ipi a cm 2 82 deq zb cm 0 68 fawe MHz 7 40 7 40 7 40 7 40 y X cm 0 88 0 88 0 88 Dan Ot Agt iy cm 0 80 0 80 0 80 z ta usec 0 103 prr Hz 64 Ober i prat max lpi MPa 1 57 toe deq at max pi cm 0 57 Tha aat max MI Wiem 38 94 Operating Focus 1 1 1 1 control Focus setting mm 30 30 30 30 conditions Frequency Hz 1D 75 7 5 7 5
2. Full Digital Ultrasonic Diagnostic Instruments Test Mode M MODE User s Manual V1 01 Probe Type 7 5L40E1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan AapnSlem Aap LEM Maximum index value 0 35 0 063 0 030 Pra MPa 0 87 P mW 2 2 2 2 min of Pa Zs NICA l Zs cm Associated Zop cm E acoustic Zo cm 2 82 parameters Z at max pi a cm 2 82 deq zb cm 0 51 fawe MHz 7 40 7 40 7 40 Diet Ace x cm 0 88 0 88 Y cm 0 80 0 80 ta usec 0 103 prr Hz 520 Other i prat max lpi MPa 1 57 eorpu deq at max lpi cm 0 48 Iba aat max MI W em 38 94 Operating Focus l l 1 control Focus setting mm 30 30 30 conditions Frequency Hz 7 5 7 5 LD Test Mode B MODE Probe Type 5 0C20B1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan April em Aap LEM Maximum index value 0 75 0 23 Pra MPa 1 48 P mW 12 4 min of Po Zs eazy Zs cm Associated Zop cm a acoustic A cm parameters Z at max lpi a cm 2 61 des Zb em fawe MHz 3 95 3 95 X cm 0 62 Dnot gy cm 0 73 E ta usec 0 410 prr Hz 4166 Other i prat max lpi MPa 2 11 information de at max L em Iba aa
3. Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Interference may occur in the vicinity of equipment marked with the following symbol 9 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the KX5200 is used exceeds the applicable RF compliance level above the KX5200 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the KX5200 gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT or SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the KX5200
4. to point to Key Sound 4 Press direction keys to select between On and Off 5 Press key to quit setting interface 7 2 7 Compression Curve Setting iF Press key to enter main menu and press direction keys Dto move cursor to Preset 2 Press direction keys to enter setting interface 3 Press direction keys Dto move symbol lt to point to Compression Curve 4 Press direction keys to select compression curve among 00 07 5 Press e key to quit setting interface Note If use 3 5MHz probe it is recommended to choose 05 or 06 if use 5 0MHz probe recommend choose 03 or 04 if use 7 5MHz probe recommend choose 00 or 01 if use 6 5MHz probe recommend choose 01 or 02 7 2 8 Chinese English Setting 1 Press key to enter main menu and press direction keys Dto move cursor to Preset 2 Press direction keys ko enter setting interface 3 Press key to switch between Chinese and English 4 Press hr key to quit setting interface 7 3 System Formula Setting 1 Press key to enter main menu and press keys Dto move cursor to Preset 2 Press direction keys to enter setting interface 3 Press direction keys Dto move symbol lt to point to Formula Set 4 Press direction keys Cto select the desired formula Di Press He key to confirm this setting and quit setting interface Full Digital Ultrasonic Diagnostic Instruments User s Ma
5. 1 Unauthorized components are assembly stretching readjustment 2 Users fail to properly operate the equipment in accordance with the requirements specified in this user s manual 9 The maintenance and servicing of product shall be performed by the trained engineer or by Kaixin Electronic Instrument Company Ltd Product Information Issue date June 15 2011 Version V1 02 Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Limited warranty Repair Service 1 Kaixin offers Type B ultrasound lifetime warranty and charge free repair service from the day of purchasing the equipment eighteen months for main unit and typical configured probe six months for other components 2 The company will not assume free warranty for the following situation 1 Malfunction or damage arising from failing to comply with the instructions of the User s Manual 2 Malfunction or damage caused by falling during moving after purchased 3 Warranty is expired 4 Malfunction or damage due to human factors 5 Damage or malfunction caused by disassembling and assembling alteration and repair without the consent of the company 6 Damage caused 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 instr
6. 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 Z Attention The accuracy of software measurement distance measurement lt 1mm area measurement Imm volume measurement lem heart rate measurement 1bmp time measurement lt 1ms Due to differences in images obtained by each user in different times the actual object for the accuracy of the measurement may be greater than the above mentioned values 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 parameters measurement The following parameters are common evaluation specification of fetus growth When you measure one of the pa
7. 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 Image display is not clear 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 power 11 3 Periodic Safety Check 1 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 Inspect the equipment and accessories for mechanical and functional damage Inspect the safety relevant labels for legibility Inspect the fuse to verify compliance with rated current and breaking characteristics Verify that the device functions properly as described in the instructions for use Test the protection earth resistance according to IEC 60601 1 Limit 0 10 Test the earth leakage current according to IEC 60601 1 Limit NC300uA 300uA for UL SFC 1000u4 Test the touch current according to IEC 60601 1 Limit NC 100uA SFC 500uA Test the patient leakage current according to IEC 60601 1 Limit for a c 100uA for d c
8. 10A Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC 60601 1 Limit for a c 500uA for d c SOUA The leakage current should be never exceed the limit The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests the device has to be repaired 2 Please clean the plug of power cord at least once a year Too much dust on plug may cause the fire 11 4 Please calibrate the device at least once every 12 months Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Twelve Storage and Transportation Storage and Transportation 1 If the instrument is stored over 3 months take out the instrument from the packing case connect it to power supply for 4 hours and then disconnect the power and place it in the case again following the direction indicated by arrows on the package Store the case in the warehouse Do not pile the case The instrument case should have adequate space from ground walls and 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
9. 6 Do not hammerblow throw or mechanically shake the battery which will lead to the leakage explosion or fire 7 Do not insert the battery with nail or other spiculate objects do not hammerblow or trample the battery which will lead to the leakage explosion or fire 8 Do not weld the battery terminal directly which will lead to the leakage explosion or fire 9 Do not disassemble the battery in any way which will lead to the leakage explosion or fire 10 Do not charge the battery near the heat source or extra hot environment which will lead to the leakage explosion or fire 11 Do not put the battery into the microwave oven or pressure vessel which will lead to the leakage explosion or fire 12 Do not mixed use the battery together with one off battery such as dry battery or different capability or different model or different brand battery which will lead to the leakage explosion or fire 13 Do not use the abnormal battery with particular smell or abnormal heat or distortion or turn colors or abnormal phenomena which will lead to the leakage explosion or fire 14 Do stop the charge and pull out the battery from the charger at once if any abnormal phenomenon happens to the battery such as particular smell or abnormal heat or distortion or turn colors Otherwise each of above will lead to the leakage explosion or fire 15 Do remove the battery from the near fire if any leakage or particular smell happens which will
10. depth circumference area volume slope heart rate and cycle 20 OB software package including 15 obstetric tables automatic calculation of EDC and EFW 21 Puncture guide 22 Cine loop 23 PAL NTSC Conversion 24 Energy saving 25 Chinese English Switch 26 Obstetric report Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Three System Outline and Structure 3 1 Structure composition of the instrument KX5200 full digital ultrasonic diagnostic instruments are composed of main unit probe and display etc 3 2 Components name Power indicator Charge indicator Main unit i LCD Video interface Power interface DODOgODO Keyboard Fig KX5200 main unit sketch map 3 3 Parts of the probe Take 3 5MHz convex array probe for example A 4 b Fig Parts name of 3 5MHz convex array probe Name Function To convert electric signal to ultrasonic signal based on principle of converse piezoelectric effect The ultrasonic signal after entering the human body is 1 Acoustic lens reflected as echo wave and converted to electric signal again The acoustic lens is on the probe surface Supply ultrasonic coupling gel to the acoustic lens surface when performing ultrasonic diagnosis 2 Cable To connect the probe to the probe connector 3 Probe connector To connect the probe to ultrasonic diagnostic system 4 Fix
11. 1 32 min of Pa Zs eazy Zs cm Associated Zop cm a acoustic ZA cm 0 97 Parameters Z at max pia cm 1 09 deq zb cm 1 03 fawe MHz 4 48 4 48 4 48 4 48 X cm 0 25 0 25 0 25 Dan Ot Agt iy cm 0 80 0 80 0 80 z ta usec 0 412 prr Hz 64 Ober i prat max lpi MPa 1 10 o aL cm 1 02 Iba aat max MI W em 40 54 Operating Focus 1 1 1 1 control Focus setting mm 10 10 10 10 conditions Frequency Hz 6 5 6 5 6 5 6 5 Full Digital Ultrasonic Diagnostic Instruments Test Mode M MODE User s Manual V1 01 Probe Type 6 5C11E1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan Aapri lt l cm Aap LEM Maximum index value 0 43 0 034 0 086 Pra MPa 091 P mW 1 61 1 61 a min of Po Zs _ lu 0 79 T Zs cm Associated Ze cm acoustic Zo cm 0 97 parameters Z at max Inia cm 1 09 deq zb cm 0 40 E MHz 4 48 a 4 48 z 4 48 R X cm 0 25 0 25 a D fA mot a dota E 0 80 z 0 89 ta usec 0 412 prr Hz 520 ee i prat max lpi MPa 1 10 A deq at max Ij cm 0 39 Iba aat max MI W em 40 54 Operating Focus 1 1 1 control Focus setting mm 10 10 10 conditions Frequency Hz 6 5 6 5 6 5 Appendix B System Blo
12. 50 60 Hz hospital environment magnetic field IEC 61000 4 8 Note Ur is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The KX5200 is intended for use in the electromagnetic environment specified below The customer or the user of KX5200 should assure that it is used in such an environment inane text IEC 60601 test Compliance Electromagnetic environment ty level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the KX5200 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RE 3 Vins 3 V ms Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz qe ES NP outside ISM bands 3 5 Radiated RF 3 V m 3V m d FE VP 80 MHz to 800MHz IEC 61000 4 3 80 MHz to 2 5 GHz 7 d JVP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed transmitters as determined by electromagnetic site survey should less than the compliance level in e frequency range
13. Press He key to appear Wait prompt After the prompt disappear the current image is saved in the frame for coded 003 The saved image code is preceded with asterisk 5 Press E key to quit saving status and press A key to return to real time status eStorage to U disk 1 Plug U disk 2 Freeze the image 3 Press key a Save prompt appears on lower right corner ofthe screen 4 Press direction keys to select the image code need to be saved in the U disk such as choose 004 5 Press He key to appear Wait prompt After the prompt disappear the current image is stored in the folder for patient number ID as folder name in the U disk and file name is arranged by the selected saving code that is 4 If user did not enter the number ID the folder name defaults to USER 6 Press E key to quit saving status and press AE key to return to real time mode Explanation 1 Each number ID corresponds to a folder the largest storage for each folder is 100 images 2 Press key can select LOCAL or U Disk 3 If you want to use number ID for the folder name must first input number ID and then store image Folder name is made up of underline letters or numbers without spaces 7 9 2 Open image e Open image in the main unit 1 Freeze the image 2 Continuously press key twice a Read prompt appears on lower right corner of the screen 3 Press direction key Dto sel
14. The KX5200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the KX5200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the KX5200 as recommended below according to the maximum output power of the communications equipment ais Separation distance according to frequency of transmitter m output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter W d na JVP d E JVP de E JVP 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 2 1 2 23 10 3 7 3 7 1 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affec by absorption and reflection from structures objects and people Appendix A Acoustic Output Data Disclosure Pursuant to the provisions of EN 60601 2 37 2008 Medical electrical equipment Part 2 37 Particular requirements for
15. by digital 1 100 press Jkey although the screen prompt Dumping the image number is not appeared on the right corner of the screen 7 11 Delete the image 1 Freeze the image press key 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 Cto select the image code to be deleted such as 002 ss 4 Press key the image will be deleted will automatically disappear 5 Repeat the 2 3 steps delete other images 6 press ME key to return to real time mode Explanation If you want to delete the images within the folder identified by number ID under the U disk must input ID first before deleting then do as the above steps if did not enter the number ID it would default to delete the images in the USER folder under the U disk 7 12 Image review 1 Freeze the image press key to enter reading or saving image status 2 Press key to enter the function of LOCAL image review images will be automatically played by the fixed time interval 3 Press direction keys Cto select the previous or the next image to review 4 Press Es key to return to frozen status 7 13 Cine loop In real time mode the system is always saving the scanned image The playback images are for a period time images before freeze Freeze the image continuously pres
16. frame correlation continuously adjustable dynamic range linear interpolation digital beam composite digital scan converter DSC pre process post process techniques to make image clear stable high sensitivity and strong resolution Applied part of KX5200 full digital ultrasonic diagnostic instruments is probe its biocompatibility has been proven effectively 1 2 Intended Use KX5200 full digital ultrasonic diagnostic instruments are applicable to ultrasonic diagnose abdominal viscera include trans vagina gynecologic obstetric and small parts AM 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 A Attention The method below should be followed when the intra cavity probe is used for gynecology and obstetrics 1 Explain the importance and necessity to the subject to get the understanding and coordination 2 Get the bladder calculus no need to fill the bladder 3 Smear the coupling gel on the top of the probe then put condom on it and then put the coupling gel on it again Then place the probe to different position of the uterine cervix and fornix along pelvis axis slowly Use of the rotation tilt pumping the basic approaches of pelvic structure sagittal coronal traverse and other cross sectional profile scanning Pay attention to the scanning depth so that the organ of near filed or the f
17. lem Aapr1cm Maximum index value 0 64 0 87 0 01 0 02 Pra MPa 1 12 P mW 58 8 1 06 min of Pa Zs E a i aw 0 63 Zs cm 2 26 Associated Zop cm 224 acoustic Zo cm 3 08 parameters amas Tpi a cm 3 14 deq zb cm 0 58 fat MHz 3 11 3 11 3 11 3 11 Dim of Ap X cm 1 19 1 19 1 19 Y cm 1 48 ta usec 0 467 prr Hz 64 Other i prat max lpi MPa 1 58 iati deq at max Ij cm 0 58 Iba aat max MI W em 74 03 Operating Focus 1 1 1 1 control Focus setting mm 30 30 30 30 conditions Frequency Hz 3 5 3 5 3 5 3 5 Test Mode M MODE Probe Type 3 5C60E1 TIS TIB Index label MI Non scan TIC Scan gt 7 Non scan AapnSlem Aap LEM Maximum index value 0 64 0 18 0 26 Pra MPa 1 12 P mW 22 4 min of Pa Zs a a 1 Zs mW 11 72 Zs cm 2 82 Associated Zop cm 2 24 acoustic ZA cm 3 08 parameters Z at max lpi a cm 3 14 deq zb cm 0 95 faut MHz 3 11 3 11 3 11 X cm 1 19 1 19 Dan Ot Agt iy cm 1 48 1 48 ta usec 0 467 prr Hz 520 Other i prat max lpi MPa 1 58 pano deq at max lpi cm 0 94 Iba at max MI W em 74 03 Operating Focus l l 1 control Focus setting mm 30 30 30 conditions Frequency Hz 3 3 3 5 3 5 Full Digital Ultrasonic Diagnostic Instruments Test Mode B MODE User s Manual V1 01 Probe Type 7 5L40E1
18. 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 Thirteen Standard Compliance The compliant standards are listed below 93 42 EEC EN ISO 14971 2009 EN 60601 1 2006 EN 60601 1 1 2001 EN 60601 2 37 2008 IEC 60601 1 2 2007 N 980 2008 N 1041 2008 N ISO 10993 1 2009 N ISO 10993 5 2009 N ISO 10993 10 2009 oda es Chapter Fourteen Safety Classification 1 Classified according to electric shock protection type Class I internally powered equipment 2 Classified according to electric shock protection degree Type B applied part 3 Classified according to the degree of protection against ingress of liquid Main unit belong to IPXO equipment 4 Classified according to operation safety in condition of existence of flammable anesthetic mixture with air or oxygen or nitrous oxide It is neither of category AP equipment nor of category APG equipment 5 Classified according to mode of operation Continuous operation equipment 6 Classified according to the protection of radio services Group I Class A equipment Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Fifteen Guidance and Manufacturer s Declaration This product complies with EMC test standard IEC 60601 1 2 Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guida
19. the basic safety and essential performance of ultrasonic medical Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 diagnostic and monitoring equipment acoustic output data disclosure as follows Manufacturer Xuzhou Kaixin Electronic Instrument Co Ltd Product Name Full Digital Ultrasonic Diagnostic Instruments Test Mode B MODE Probe Type 3 5C60E1 TIS TIB Index label MI Non scan TIC Scan gt 7 Non scan Aap lem Aap LEM Maximum index value 0 64 0 87 Pra MPa 1 12 P mW 58 6 min of Pa Zs mad i Zs cm Associated Ze cm acoustic Za cm B parameters Z at max lpi a cm 3 14 du 20 cm fawf MHz 3 11 3 11 X cm 1 19 o oy cm 1 48 a z ta usec 0 467 prr Hz 4132 Other i prat max lpi MPa 1 58 information de at max Ty em T Iba aat max MI W em 74 03 Operating Focus 1 1 E E control Focus setting mm 30 30 conditions Frequency Hz 3 5 3 5 Full Digital Ultrasonic Diagnostic Instruments Test Mode BM MODE User s Manual V1 01 Probe Type 3 5C60E1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan Aap
20. to put on your arm the long end through the back ring c Strain the arm band and stick it firmly on the Velcro 3 Instrument hanging on the chest to use Adjustable strap length a Take out the attached straps install the straps on the rings of main unit as fig Hung on the neck or shoulders shown b Adjust the strap length the front strap hung on the neck the back strap fixed on the waist two straps can also adjust to similar length to meet the requirements of the screen visual angle while hanging around the neck to use a strap length Hung on waist 4 Instrument places on the leather lag and hangs on the chest to use Installation a Take out the instrument and accessory install the probe b The probe passes through the oval hole of the leather bag and put the instrument into the leather lag c Install the straps on the rings of leather bag as fig shown d Adjust the strap length the one hung on the neck the other one fixed on the waist you can also use a strap around your neck or diagonal used in your shoulder The benefits of using this method a Self built darkroom for the strong light environments b The protection of leather bag can avoid collisions and pollution in the use process Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 6 2 Probe installation Danger Use together with flammable anaesthetic it may result in explosion AM Attention Probe is highl
21. using it 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 installation Please carefully read through and fully understand the use method before installing the syste check the goods for its completeness according to the packing list furnished This system provi following several usages for the user to select Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 1 Place the instrument on a desktop to use As shown in fig insert the support bracket from the back of the instrument place the instrument on a desktop adjust the angle of the support bracket to adjust the screen visual angle 2 Instrument fixed in the arm to use AM Attention when using the arm band if allergy please consult a doctor immediately and increase protective measures e g Wear gloves before use Armband back ring STL a Lock the arm band as figures from the back of the instrument b Extend your arm into the arm band according to arrow direction or disconnect the arm band
22. 160 192 224 and 255 i Press key to quit setting interface 7 2 5 Hospital Name Setting 1 Press key to enter main menu and press direction keys Dto move cursor to Preset nA A WN Re 2 Press direction keys to enter setting interface 3 Press direction keys to move symbol lt to point to Hospital 4 Press key the cursor is located above NAME at the same time characters input menu will be shown at the bottom of the screen Caps0123456789abcdefgh Shiftijklmnopqrstuvwxyz Press direction keys or operate mouse to move cursor to point to Caps and then pres Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 click left mouse to achieve capital and small letter conversion If the cursor point to Shift press key or click left mouse again to achieve the conversion between the letter and punctuation 5 Press direction keys to choose numbers or characters and press key to confirm Or operate mouse to click numbers or characters to input 6 If need modify the content press key to quit the character input menu press direction keys to delete input content press key again to retype 7 Press 2 key to save this setting and quit setting interface 7 2 6 Key Sound Setting 1 Press key to enter main menu and press direction keys Dto move cursor to Preset 2 Press direction keys to enter setting interface 3 Press direction keys Dto move symbol lt
23. Axis a Thoracic Cavity Full Digital Ultrasonic Diagnostic Instruments RS Left Front zl MEL QO Right Shoulder Front a Uterine Base Transection Neck Left Lateral O Eyeball 1 Q Fetus Heart 2 E Aortic Arch Major Axis 2 i Testes User s Manual V1 01 SANS Right Butt Front PS A 07 Right Left Shoulder Rear eh Shoulder Rear Ce E SF ADE eee PEE Right Front Left Butt Front Uterine Uterus Rear Appendages 7 a Uterine Liver Transection S 7 E Head Right Head Left Lateral Lateral O Eyeball 2 Lower Limb Front Bilocular Heart Quad Heart ZI ES EE l Bicuspid valve Aorta Minor Axis M type curve Knee Joint 2 Foot 1 Uterus Level D Head Front i Lower Limb Rear Apical Four Chamber Se lt lt S Aortic valve M type curve Foot 2 Uterine Body Uterus Front Transection wg an Breast 2 Neck Front Head Rear Head Top Y Right Arm Left Arm Left Ventricle Apical Five Chamber Major Axis Cross Section Large Intestine Stomach SU AP Knee Joint Hand 1 H Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 7 9 Image storage and recall 7 9 1 Save image eStorage to main unit 1 Freeze the image 2 Press key a Save prompt appears on lower right corner of the screen 3 Press direction keys to select the image code need to be saved in the LOCAL such as choose 003 4
24. KAIXIN Full Digital Ultrasonic Diagnostic KX 52 00 Instruments User s Manual ail xuZHOU KAIXIN ELECTRONIC INSTRUMENT CO Full Digital 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 o KA X f N This is registered trade mark of Kaixin Company Kaixin is the sole authority for the interpretation of this user s manual Kai
25. and press direction keys Dto move cursor to Puncture and then press direction keys to choose line 3 press key to confirm lithotripsy positioning line appears on the screen At the same time the measurement depth of lithotripsy positioning line 0 0mm is shown at the top right corner operate the up down keys to positioning the depth Press E key to quit 7 8 Body Mark and Probe Mark This product 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 frozen status press key to enter main menu and press direction keys Y Oto move cursor to Body Mark press key body marks will be showed in the image area press direction keys to change pages 2 Press direction keys to move to the position of desired body mark press key to confirm the selected body mark 3 Press direction keys or operate mouse to change the probe mark position press key to change probe mark direction 4 Press E key to quit body mark and probe mark status 5 Press E key to quit froze and body mark status The 64 body marks are listed below CH ART i x ys Body Right Body Body Front Body Right Body Left Body Left Lateral Ent Female Upper Parts A tera Mother Front PES Ce Left Shoulder Front 45 Uterine Neck Transection Neck Right Lateral Skull Fontanelle Transection Fetus Heart 9 Aortic Arch Major
26. ar 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 Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Two Technical Specifications 2 1 Technical Data 1 Gray scale 256 2 Monitor 5 7 LCD 3 Adapter ratings 100 240V 50 60Hz 70VA model MW125RA1203F01 4 Output of adapter DC12V 3 0A 5 Main device rating DC12V 3 0A 6 Main Unit Size approx 155x180x80mm LxWxH 7 Weight of main unit approx 1 1kg excluding accessories Warning the device should be combined with provided AC DC adapter as an ME SYSTEM Other adapters are prohibited 2 2 Primary Functions 1 Mode conversion function 2 Magnification conversion function 3 Frequency conversion function 4 Frame correlation function 5 Image post process function 6 Edge enhancement function 7 Image freeze unfreeze 8 Depth range selection function 9 Depth heighten pan function 10 Color display function 11 Local zooming 12 Angle width change 13 Adjustment and display of near field far field total gain and dynamic range 14 Single point multi point focusing 15 Image storage 16 Vertical horizontal reverse and B W conversion 17 Case information image annotation and auto time display 18 Body marks 19 Measurement of distance
27. ast Adjustment In the startup default status press freeze key to unfreeze press ESlkey to quit the current using status the adjustment bars of brightness and contrast will be displayed on the screen by pressing direction keys OO adjust them according to actual need Press direction key to increase brightness and contrast direction key Dto decrease them press direction keys to select brightness or contrast adjustment Note If direction keys cannot be adjusted when adjust brightness in normal operation mode must be exit current operating condition of direction keys 7 5 2 Total Gain Adjustment In real time mode press key to enter main menu and press direction keys Y to move cursor to Gain in the display area Press direction key to increase image total gain and direction key Sto reduce total gain so as to control the total gain of the entire image 7 5 3 Near Field Gain Adjustment In real time mode press key to enter main menu and press direction keys Y Dto move cursor to Near in the display area Press direction key to increase near field gain and direction key Sto reduce near field gain so as to control the gain in near field region 7 5 4 Far Field Gain Adjustment In real time mode press key to enter main menu and press direction keys Y to move cursor to Far in the display area Press direction key to increase far field gain and direction key Sto reduce far field gain so as to control the gain i
28. ck Diagram Keyboard Probe m Microcomputer control system Clock Line field sync signal y y y Transmission DSC Signal amp Reception Collating Process synthesis Display KAIXIN ELECTRONIC XUZHOU KAIXIN ELECTRONIC INSTRUMENT CO LTD Y 2 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 eo ner Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany E Information contained in this manual is subject to change without further notice
29. conditions the battery should be promptly replaced Attention A power indicator will appear X and glitter continually when the electric quantity is too low Connect the main unit to external power supply and recharge the battery or turn off the machine to recharge AM 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 Use pollution degree II to deal witt Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Attention 1 Do not throw the battery into water or be wet which will lead to the battery leakage explosion or fire Do not use or store the battery near the heat source such as fire or heater which will lead to the battery leakage explosion or fire Do not connect the anode and cathode reversely which will lead to the battery leakage explosion or fire Do not heat up or throw the battery into fire which will lead to the leakage explosion or fire Do not connect the anode and cathode with any metal or conductor do not transport or store the battery together with necklaces hairpins or other metal objects which will lead to the leakage explosion or fire
30. creen Presse key or click right mouse to complete the multi group depth measurement Press key to return to the status of distance measurement Continuously press kkey twice to quit the measurement status Press direction keys Y to choose Clear or synchronously click the left and right key of mouse to clear all marks and data Press ME key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status Note Direction keys cannot work in the depth measurement when connecting convex array probe 8 3 Circumference Area Volume Measurement O Circumference area measurement with trace method 1 In B B B mode choose desired image and freeze it the cursor is located in the Measure of display area Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 2 Presse key the measurement methods are showed in the lower left of the screen press direction keys Cto choose Trace press key again the cursor will show 3 Press direction keys or operate mouse to move the mark to desired position press key or click left mouse to set the mark position as the start of the measurement or click right mouse to set the mark position as the starting point of the measurement 4 Press direction keys or operate mouse to move the mark to the end point of the measurement At the same time a locus appears in the direction of o
31. cursor to Preset 2 Press direction keys to enter setting interface 3 Press direction keys Y Cto select Minutes Hours Day Month and Year 4 When setting minutes hours day month and year press direction key to increase value or press direction key to decrease value 5 Presse key to confirm the time setting and quit setting interface 7 2 2 TV Mode Setting E Press key to enter main menu and press direction keys Dto move cursor to Preset Press direction keys to enter setting interface Press direction keys Dto move symbol lt to point to TV mode Press direction keys to realize TV mode conversion between PAL and NTSC Presse key to quit setting interface 7 2 3 Energy Saving Setting nA A WN Re A Press He key to enter main menu and press direction keys Dio move cursor to Preset Press direction keys to enter setting interface Press direction keys Dto move symbol lt to point to Sleep Press direction keys to select energy saving time among 1 99 minutes or select OfP aA A Y N e Press key to quit setting interface 7 2 4 Characters Brightness Setting Presse key to enter main menu and press direction keys Dto move cursor to Preset Press direction keys ko enter setting interface Press direction keys Dto move symbol lt to point to Font Bright Press direction keys Dto select characters brightness among
32. d point of the measurement at the same time the elliptic curve appears or click middle mouse to appear elliptic curve 5 Press key the lt D gt mark appears on the screen Hold down okey to change the minor axis of the ellipse so as to satisfy the test area The measured values are displayed at the built in characters C 00000mm A 00000mm V 00000 cm on the right part of the screen automatically 6 Press key again to quit the minor axis status Press key or repeatedly click left mouse to exchange the starting point and end point f Press hr key or click right mouse to finish the first measurement Repeat the steps from 3 to 7 to complete the multi group data measurement O 0 N Continuously press key twice to quit the measurement status 10 Press direction keys Dto choose Clear or synchronously click the left and right key of mouse to clear all marks and data 11 Press ME key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 8 4 Slope Heart rate Cycle Measurement The method to measure slope hear rate cycle is identical with distance measurement Note In B M mode if both starting point and end point of the measurement mark fall int B mode area the value of the refers to distance if starting point and end point Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 measurement mark fall into the M mode area the value of the
33. dity 30 93 without condensation Atmospheric pressure 700hPa 1060hPa Attention The mains voltage is varies with different countries or regions Warning 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 15 Radiation e g X ray CT 16 Defibrillators or short wave therapy equipmen Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Six System Installation and Check Warning To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Warning 1 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 premi
34. e eee 15 1 00 Image Freeze Unfree e ns arie sal ile di aa a d le isaac ic e a ae ala aE 15 7 7 Puncture guide and lithotripsy positioning line eee 15 7 8 Body Mark and Probe Marie casa azi o ddr 15 TO image storage and teca eco a AN 17 OPN MS A ii 17 TI OPA e PR ROD a DOR Pe a Rae va IONII Re DE Pet RER RITA PE N RAR Rama 17 7 10 Single dump and mass UA iS 18 TAT Delete the A SS 19 TA Amage TEV IE Wire IA NA A NO 19 A E IN A E A 19 TA VER MUL RAEE TE E E ET EET T 19 Chapter Eight General Measurement ccccccccccccccccccccccccesccccesccccessscoesees 21 8 1 Distance Meas tement soron i oe e at nos E ET EN E TE an 21 8 2 Depth Measurement 2 AI ese AA ARA EA AD 21 8 3 Circumference Area Vohime Measurement nic adn 21 8 4 Slope Heart rate Cycle Measurement RA 22 Chapter Nine Obstetric MEAaSUremen di As eu da 3 23 9 1 Measurement and Calculation MS iii al 23 9 2 Fetus growth parameters MESSI MEME AAA bis 23 9 2 1 Measurement of GA and BDC n eee Deea ia ie ts dau RARA 23 9 2 1 1 Measurement of BPD CRL GS FL HL LV TTD APTD FT TAD THD TCD OFD 23 0 21 2 Measurement of HC and AC cdo 24 9 2 2 Fetus Weight MEA ESSE AT 24 9 3 Obstetric report sorer Ade ne ri alia 03 outa ander anata i ad S at li 25 OA Meas rement Mems ariran a aa ae a as 0 aaa i tad 25 Chapter Ten Principle of Sound Power casca cca e auz AA 26 Chapter Eleven System Maintenant ce scai aia sieves atat asa d e leii aie oala not a cata asia
35. e s acoustic head to the sheath of probe handle others are IPX4 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 Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 damage the probe 3 Dry the probe with sterilized cloth or gauze after cleaning Do not dry the probe by heating it 2 Routinely disinfect the probe 1 Wear sterilized gloves to prevent possible infection in the process of routine disinfection 2 Clean the probe firstly before routine disinfection and then wipe the probe twice with 75 alcohol 3 Clean the probe with sterile water to remove residual chemicals 4 Clean the water off the probe surface with sterilized cloth or gauze Never dry the probe by heating it Warning Do not place the ultrasonic probe connector into water or disinfection as it may cause electric shock 3 Regularly disinfect the probe 1 Wear sterilized gloves to prevent possible infection in the process of regular disinfection 2 Clean the probe firstly before regular disinfection 2 glutaraldehyde disinfectant is recommended for the probe Immerse the sound head part of the probe See regular disinfection sketch map in liquid for more than 10 hours for disinfection M Attention 1 Please carefully read the instructions provided by disinfectant provider about the disinfection liqu
36. e press key and then press direction key to move cursor to ID and pressh key again to input according to Step 4 the number ID only be made up of numbers letters or underlines 6 After inputting ID press key and press direction keys to move cursor to image area and pressh key again to input according to Step 4 7 If need modify the content continuously press ES key twice to quit annotation status press direction keys to select Clear at last press ix key to clear all noted marks and retype 8 Press key to quit Warning after use the device please pull out the power plug from the outlet Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Eight General Measurement 8 1 Distance Measurement 1 Oo OND In B B B or B M mode choose desired image and freeze it the cursor is located in the Measure position of display area Press key the measurement methods are showed in the lower left of the screen press direction keys Cto choose Distance press he key again the cursor will show R 3 A a lt Press direction keys or operate mouse to move the mark to desired position presse key or click left mouse to set the mark position as the starting point of the measurement Press direction keys or operate mouse to move the mark to the end point of the measurement A lighted dotted line appears between the start and the end as th
37. e dashed locus of the measurement The measured value is automatically displayed at the built in mark mm on the right side of the screen Press key or click left mouse repeatedly to exchange the starting point and end point of the measurement f Presse key or click right mouse to finish the first measurement Repeat the steps 3 6 to complete the multi group data measurement Continuously press kkey twice to quit the measurement status Press direction keys Dto choose Clear or synchronously click the left and right key of mouse to clear all marks and data 10 Press E key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 8 2 Depth Measurement 1 ANU yu 8 In B BIB BIM or M mode choose desired image and freeze it the cursor is located in the Measure position of display area Press key the measurement methods are showed in the lower left of the screen press direction keys Cto choose Distance press hekey again the cursor will show i Press key a dotted line of depth measurement appears in the middle of screen press direction key Sor operate the mouse to move the dotted line to desired position press direction keys Y Dor operate the mouse to move the mark to the end point of the measurement the measured value of depth is automatically displayed at the built in mark mm on the right side of the s
38. ect It is generally recognized that ultrasonic diagnosis is safe for human s health So far there has been no report on bodily harm done by ultrasound Nevertheless it is also believed that not all types of ultrasound are absolutely safe Relevant researches have already indicated that high intensity ultrasound is harmful for human body With the development of ultrasonic diagnosis technology in recent years people are more aware of the potential risk in biological effect caused by use of ultrasound and application of ultrasonic diagnostic technology 10 2 Mechanical effect and thermal effect Research indicates that two different ultrasonic properties influence human body one is when ultrasonic sub pressure 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 bio effect 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 ultra
39. ect the image code need to be read out in the LOCAL such as choose 003 4 Press E key to appear Wait prompt After the prompt disappear the image stored in frame 003 is read out 5 Press E key to quit reading status and press AE key to return to real time status e Open image in the U disk 1 Plug U disk Freeze the image 2 3 Continuously press key twice a Read prompt appears on lower right corner of the screen 4 Press direction keys to select the image code need to be read out in the U disk such as choose 004 5 Press Ee key to appear Wait prompt After the prompt disappear the image stored in frame is read out 6 Press E key to quit reading status and press AE key to return to real time status Explanation Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 1 When reading images it must choose the image code with 2 If you want to read out the images within the folder identified by number ID under the U disk must input ID first before reading then do as the above steps if did not enter the number ID it would default to read out the images in the USER folder under the U disk 3 If has read out the images in the U disk also would like to re read the local image must presslEsc key to exit this reading status then press key to choose LOCAL and vice versa 7 10 Single dump and mass dump 7 10 1 Single dump eFrom main
40. en ce 27 Ia EAVES a E DY USE ES 0 a aie Gat ddd oala ea a did ae 27 11 14 System cleaning and dista a ll 27 11 1 2 Use and maintenance for the charging battery eee 29 11 2 Trouble HOMO tana carro ista 30 11 3 Periodic Safety Chi da ata 31 Chapter Twelve Storage and Transportati0N ooooococonccccncnnonanonoccnononaconccnonanononoss 32 Chapter Thirteen Standard Compliance aceia c tate id 32 Chapter Fourteen Safety ClassificatioN ooooocooocccccnoccncncccrccnccccrococccccncccccnoccnoss 32 Chapter Fifteen Guidance and Manufacturer s Declaration scscescescscsecceceees 33 Appendix A Acoustic Output Data Disclosure ooooccooccococonocnccccnonoccnccnonononoconos 36 Appendix B System Block Diagram sessssssssssssossssssssssoosoossesssssesosoeessesseeeee 42 Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter One Overview 1 1 Introduction KX5200 full digital ultrasonic diagnostic instruments are portable equipment which are composed of main unit probe and display In principle it includes microcomputer control parts transmitting parts receiving parts DSC processing parts probe connection parts display parts power part indicator etc KX5200 full digital ultrasonic diagnostic instruments apply microcomputer control which adopt multi point auto focus continuous dynamic variable aperture logarithmic compression TGC control dynamic filtering edge enhancement
41. er output Chapter Eleven System Maintenance The system maintenance should be performed by the user and service engineer Users shall be in full charge of maintenance repair and operation of the system after purchasing the product 11 1 Maintenance by users 11 1 1 System cleaning and disinfection Warning Turn off the instrument and pull out the power supply wire before cleaning every instrument of the system It may cause electric shock if clean the system under power is on Warning There is no any waterproof device in the system Do not splash any water or liquor into the system when cleaning or maintaining otherwise it will cause malfunction or electric shock A Attention Probe without cleaning disinfection 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 cleaning disinfecting the ultrasonic probe In the process of cleaning and disinfection avoid probe overheat exceeding 60 C as it may be deformed or damaged under excessive heat To prevent the infection or the cross infection the intra cavity probe surface should be covered with a condom every time before examination Do not use the probe packing box to store the probe as the box may become the source of contamination The waterproof grade of intra cavity probe is IPX7 immersion depth from prob
42. evsnesevscersseseusvicceossecctenseescscedsieesed s 2 Chapter Three System Outline and Structure ccscecceccscceccccccccccccccsccccecccescsseeseeee 3 3 1 Structure composition of the instruments ld i 3 3 2 Components DAME tada 3 33 WParts of tes POD A 007 nt a A eae naan cake beds 3 3 4 PUNCHON keys description A tases 3 Chapter Four System Configuration e esessssooosesesesssossecosesssssssoossecssssssosoososeseee 4 Chapter Five Operation Condition ie cca soarta alea ate a eroul aia 0030 00 ainu e vai asi no a iara aa 4 Chapter Six System Installation and Check ooooooccccccnoncccnononoconoccononocacocanonononoso 5 Gol AS CA A o e les ens cto Eo Cine 5 6 2 Probe MS Tal LATICO A A es de 7 63 Install dismantles the battery traia NA tie aes pat a rnd eto 7 6 4 Shutter release Installation A a act edu a el 2 8 6 3 Video recorder Instala ia sosise stea a aa tea an ata n a da n A A aaa 8 6 6 Connect tothe MOUSE di 8 6 7 O 8 6 8 Probe check before and after AN A AS 9 6 9 Main unit check before and after operation eee 9 NS A E at E el al ee 9 Chapter Seven Functional Operator rada see o ua eo eors e aaa atace 10 dl Startup amd SHUG Wn 562 tac ate adrenalina o pt l 10 7 2 System Functions SEI sd ante ale atat 10 T2 AMS A NES 10 140005 EV Mod SM A A AA eevee eisce ia uee a 10 Fe 2 3 BNC OY Saving A O Ol acy Lace AA i aul sail ace eg 10 7424 ha rae ers Brightness IO iii 10 1 2 3 Hospital Na
43. 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 enter main menu and press direction keys 4 to move the cursor to the position Report Press direction keys to display obstetric report Press ES key to exit obstetric report status Note 1 For measurements done with the given obstetric table the distance gestational week and estimated date of confinement are automatically stored in the corresponding places of the obstetric report 2 When performing fetus weight measurement the system will store the last measurement value only and display the value at the EFW position of the obstetric report 9 4 Measurement items 1 Items measurable in B mode distance depth circumference area volume gestational age GA estimated date of confinement EDC and fetus weight 2 Items measurable in B B mode distance depth circumference area volume gestational age GA estimated date of confinement EDC and fetus weight 3 Items measurable in B M mode distance or depth slope heart rate and cycle 4 Items measurable in M mode depth slope heart rate and cycle 5 If the display becomes it indicates an invalid measurement value Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Ten Principle of Sound Power 10 1 Biological eff
44. his 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 serious Danger injury if not avoided Warning Indicates a potential danger that may result in personal injury if not avoided Indicates a potential danger or unexpected use condition that may result in A attention light injury or property loss or affecting the use if not avoided A Indicates that make sure refer to relevant contents in this manual 2 Safety Symbols Symbols Meaning Symbols Meaning Paes R Type B applied part ae Keep dry a l A I a Ay Power supply indication bd Fragile 4 DC Power Stacking limit by number Follow instructions for use Temperature limits J q p i 8 L q Up Humidity limitation r 7 3 S O Atmospheric pressure limitation LIOKPa J 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 Local Ordinances or Regulations for disposal E Symbol for the marking of electrical and electronics devices according to a Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Contents Chapter One OVvervieweiiscss ir A AA AAA AAA EA 1 Chapter Two Technical Specifications iiss scsscscisssescccss
45. ic lens for abnormal heat when the probe is in use This can be done by hand touching the probe to feel the temperature of the lens 4 Check the image to ensure trouble free display no excessive noise or flicker 5 Check the control panel to ensure normal operation condition 6 Check the instrument to ensure that the phenomenon of local high temperature will not appear ANWarning Only use the coupling gel that in accordance with MDD regulations A Attention If the overheat acoustic 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 10 System reset In case of abnormal screen display or no working for system operation try to restart the system by turning on off the main unit power Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Seven Functional Operation 7 1 Startup and Shutdown In shutdown status press lkey machine starts up power indicator Y lights In startup status press key machine shuts down power indicatori goes out Please note that when shut down the machine the time of pressing key is a rather long than normal pressing key 7 2 System Functions Setting 7 2 1 Time Setting 1 Press key to enter main menu and press direction keys Dio move
46. ick right mouse to finish the first measurement 8 Repeat the steps from 3 to 7 to complete the multi group data measurement 9 Press E key to quit the obstetric measurement status 10 Press direction keys Y Dto choose Clear or synchronously click the left and right key of mouse to clear all marks and data 11 Press XE key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 9 2 2 Fetus weight measurement Fetus weight measurement can be done in B B B mode Multi parameter measurement and storage are required as different formulas are applied to the measurement These parameter groups for fetus weight measurement include BPD FTA FL or BPD APTD TTD FL Ellipse method shall be used for area and circumference measurement for the fetus weight measurement The calculation methods for fetus weight measurement are as follows 1 In B B B mode freeze the desired image press direction keys Y Dto choose OB in the display area 2 Press Be key to display the obstetric parameters on the lower part of the screen 3 Press direction keys to select the EFW parameter press Ee key to confirm the cursor will show For example set the calculation formula of fetus weight to Osaka the right are screen will appear EFW g 1 mm Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 2 mm 3 mm At the same time together with re
47. id concentration and disinfection 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 Fig Wrong 3 5MHz probe regular disinfection Fig Correct 3 5MHz probe regular disinfection MN Attention 1 It is a normal phenomenon that color of the acoustic lens may change and color of the probe label may fade away 2 To prevent the infection or the cross infection such cleaning disinfection for puncture bracket and probe is very necessary before and after every puncture operation 3 The regular disinfection times should be minimized as it may lead to degrade of the probe safety and performance 4 Clean the probe cable and its connector 1 Clean the probe cable and its connector with soft dry cloth Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 2 In case of die hard blots clean with soft cloth dipped in moderate detergent and then air dry it 5 Clean the LCD screen Clean the liquid crystal display with dry soft flax or anti static LCD clean cloth Attention Do not clean the screen with hydrocarbon detergent for example alcohol etc or OA equipment cleaning media These kinds of liquid may degrade
48. ion key Dto realize color conversion of eight colors including one kind of black and white 7 6 8 Scan Range Angle Width Change In real time B mode press key to enter main menu and press direction keys to move cursor to Angle and then press direction keys to choose angle width convex array for scanning angle and linear array for scanning width 7 6 9 Image Freeze Unfreeze In real time mode press key or middle mouse key to freeze the image in frozen status press ME key or middle mouse key to unfreeze the image 7 7 Puncture guide and lithotripsy positioning line Puncture guide line In real time B mode press key to enter main menu and press direction keys to move cursor to Puncture and then press direction keys to choose line 1 press key to confirm two puncture guide lines appear on the screen press direction keys to change the angle of the first puncture guide line press direction keys Dto change the start position of the first puncture guide line Pres key again to enter main menu and press direction keys Dto move cursor to Puncture and then press direction keys Sto choose line 2 press key to confirm press direction keys to change the angle of the second puncture guide line press direction keys Dto change the start position ofthe second puncture guide line Press Es key to quit the puncture guide status Lithotripsy positioning line In real time B mode press key to enter main menu
49. keys Dto move cursor to Local Zoom in the display area and then press direction keys OO a box appears Press direction keys or operate mouse to move the box to the position to be enlarged the selected image be enlarged Press E lkey to quit local zoom status In the color display the selected image which by above mentioned operation will be enlarged and added color 7 6 4 Image Left right Reverse In real time mode and in B B B 4B or B M mode press key to enter main menu and press direction keys Y to move cursor to H Rev and then press direction keys to realize image horizontal reverse Or left click mouse also to realize image horizontal reverse The image horizontal reverse is the change of probe scanning direction The probe scanning direction is indicated by the arrow on the upper left area of the image 7 6 5 Image Up down Reverse In real time mode press key to enter main menu and press direction keys Do move cursor to V Rev and then press direction keys to realize image vertical reverse 7 6 6 Image Negative In real time mode press key to enter main menu and press direction keys Dto move ci Image POS and then press direction keys to realize negative function Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 7 6 7 Color Selection In real time mode press key to enter main menu and press direction keys to move cursor to Color in the display area and then press direct
50. lead to the leakage explosion or fire 16 If any leakage splash into eye do not wipe the eye instead of washing it and get help from the doctor as soon as possible Otherwise the eye will be injured 17 Do not use the battery in the extremely hot environment such as hot sunshine or in the car when it is too hot because these will catch fire even worsen its performance and shorten its life 18 If use the battery beyond the listed environment on the manual it will worsen its performance or shorten its life even lead to extreme heat or explosion or fire 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 followine the method in the table If the problem remains unsolved contact International Trade Dept of Ka support Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Trouble Correction Power light is offand 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 but no ultrasonic image on Probe is not properly connected Turn off the power and reconnect the probe the screen
51. levant 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 at 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 D Press E key to exit BPD measurement status 2 Obtain the desired image and freeze it again 3 Measure FTA with ellipse method of measuring HC AC The measured value of FTA is saved and displayed at 2 mm position in the EFW zone of the right display area cO Press A 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 Press E key to quit the measurement status A 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
52. me IMA A A a o ba a E aa ai 10 1 2 0 Key Sound SUING scania ei piat stokes lee 0 00 ai pala ae E dei bn 11 7 2 7 Compression Curve AMA a a 3 e Da a 11 T28 Chinese English SEM airis ca i cd rival 11 T a System A Les 11 Ha Mode Scion Arise tele cutia ua t ds e o e mall tatal 12 TAA B Md lead 12 AZ BIB NO ni A A ia di 12 TA PAB EN 12 TAA B M MOdE e ad Lee al ete deal 12 TAS M MS 13 Ro Image Quality AUSTEN ds 13 7 5 1 Brightness and Contrast AdjusStMeIt ooooocccccoccoccnccnconcnnconcnncnconcncrnnonacncanannnos 13 132 Total Gan ACOs tent cria e at e ana ha ao a 13 7 5 3 Near Field Gain AUS A ol a a aa d A ae a Adus a Ch 13 Td Far Held Gain ASMA A a e da ace nt el 13 7 5 5 Dynamic Range AUS ca aie gli ar lat a d ac a cl d im 13 7 5 6 Frequency Adjustment Frequency conversion eee 7 5 7 Focus Adjustment and Control ic 7 5 8 Frame Correlation Adjustment ceea 7 5 9 Image Post process Adjustment c eee nenea Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 7 5 10 Edge Enhancement Adjustment aa loa tata data ct li da 14 TO ALE COTO Lua ast ati felu cadea 8 aaa i 14 FeO Magmfication SIC CON cp essai ti 14 7 6 2 Depth Range Selection and Depth Enhancement eee 14 7 6 3 Local Zoom and Local Additive Cola A a a e 14 OA Image Leftrieht Rev tl aa 14 0 Image UNA Ri ston ca a atat 3 ta dia aa 14 TOO MN dl ober af atat bit tts 14 TO COLOSIO A a A a 15 7 6 8 Scan Range Angle Width Chang
53. n far field region 7 5 5 Dynamic Range Adjustment In real time mode press key to enter main menu and press direction keys to move cursor to Dyn in the display area Press direction key to increase the value of dynamic range and direction key Sto decrease the value of dynamic range so as to control the dynamic range of the entire image 7 5 6 Frequency Adjustment Frequency conversion In real time mode press e key to enter main menu and press direction keys Y Dto move cursor to Freq in the display area Press direction keys Cto realize frequency conversion 7 5 7 Focus Adjustment and Control In real time mode and in B B B or 4B mode press key to enter main menu and move cursor to F Num and then press direction keys to choose from the four focus modes of stage 1 Full dynamic focus 2 3 and 4 In real time mode and in B B B 4B B M or M mode press ESlkey to quit menu modi direction keys again to move the focus up and down Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Note In B M or M mode only allowed choosing single focus mode 7 5 8 Frame Correlation Adjustment In real time mode press key to enter main menu and press direction keys Y Dto move cursor to Avg in the display area Press direction keys to realize four levels of frame correlation 7 5 9 Image Post process Adjustment In real time mode press key to enter main menu and press direction keys to move curs
54. n unit to U disk Menu 1 Freeze the image continuously press cine loop key until enter PAUSE status 2 Press key LOCAL gt U Disk Mass Dump prompt display at the bottom of the screen 3 Press key Dumping prompt appears images are mass dumped under the DUMP folder in the U disk and the number behind PAUSE character is the number of files name of mass dumping After finishing mass dumping return to PAUSE status 4 Press E key to quit mass dumping status and press ME key to return to real time status e From U disk to main unit 1 Plug U disk 2 Freeze the image continuously press cine loop ke ere until enter PAUSE status 3 Press key twice U Disk gt LOCAL Mass Dump prompt display at the bottom of the screen 4 Press ix key Dumping prompt appears the number behind PAUSE character is the nur files name of mass dumping After finishing mass dumping return to PAUSE status 5 Press E lkey to quit mass dumping status and press key to return to real time status Explanation Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 1 Mass dump which is dump images from main unit to DUMP folder in the U disk can also dump the images under the DUMP folder in the U disk to main unit 2 If U disk does not have DUMP folder or DUMP folder does not have images or the images within the DUMP folder are not named
55. nce and manufacturer s declaration electromagnetic emission The KX5200 is intended for use in the electromagnetic environment specified below The customer of the user of the KX5200 should assure that it is used in such and environment Emission test Compliance Electromagnetic environment guidance gt The KX5200 uses RF energy only for its RF emissions Goi internal function Therefore its RF emissions CISPR 11 P are very low and are not likely to cause any interference in nearby electronic equipment RF emission The KX5200 is suitable for use in all CISPR 11 Class A establishments other than domestic and those 7 a directly connected to a low voltage power Harmonic emissions Class A supply network which supplies buildings used IEC 61000 3 2 for domestic purposes Voltage fluctuations flicker Cia emissions IEC 61000 3 3 i Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immunity The KX5200 is intended for use in the electromagnetic environment specified below The customer or the user of KX5200 should assure that it is used in such an environment Electromagnetic environment Immunity test IEC 60601 test level Compliance level A guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete discharge 8 kV air 8 kV air or ceramic tile If floors are ESD cove
56. nit check before and after operation 6 9 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 Examine the control panel LCD screen and enclosure to ensure they are in good working condition and free of abnormity such as cracks and loosened screws 5 No damage on power cable and hard up on its connection 6 Check probe and its connections to ensure they are free of abnormity such as scuffing drop off or contamination If the contaminant is present clean disinfect the contaminated objects as specified in relevant sections 7 No barriers around the intake of equipment 8 See to it that probe has been cleaned disinfected 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 6 9 2 Inspection after start up Check the following items after starting the machine 1 No abnormal voice strange smell and overheating appear 2 Check the machine to ensure a normal start up The power indication light is on and startup picture is shown on the screen The machine will be then automatically set in B mode 3 Check the acoust
57. nual V1 01 Formula preset table Preset items Options Preset items Options Preset items Options ASUM China ASUM China Hansmann Hadlock Hadlock GS ae AC Hansmann Hansmann empen Jeanty Jeanty Tokyo Merz Kurtz China Shinozuka BPD Hadlock Mercer Merz Hansmann FT Pari Osaka aris Pari rany Campell aris FL Merz p Rempen Osaka German Shinozuka Paris Hadlock1 Tokyo Shinozuka Hadlock2 ASUM Tokyo Hadlock3 China Jeanty EFW Hadlock4 Hadlock HL Merz Hansmann Hansmann Osaka Merzl Jeanty Eriksen Merz2 Nelson TAD Hansmann Osaka ae Osaka Paris Shepard Paris Hadlock Tokyo Rempen HC Hansmann Robinson Jeanty Shinozuka Merz Tokyo 7 4 Mode selection In real time mode press key repeatedly to realize mode switching of B B B 4B B M and M 7 4 1 B Mode B mode is a basic operation mode after startup and a single framed B mode image is displayed 7 4 2 B B Mode 1 In real time mode press key to enter B B mode 2 B B image switch Press key to enter main menu and press direction keys Y Dto move the cursor to B B Mode and then press direction keys to switch image display Or right click mouse to switch image display the selected image is activated and the other one is frozen 3 In real time mode pressh key to exit B B mode 7 4 3 4B Mode 1 In real time mode press key to enter 4B mode 2 4B image switch Press key to enter main menu and pres
58. or to TP in the display area and then press direction keys to obtain corrected image System default is 2 7 5 10 Edge Enhancement Adjustment In real time mode press key to enter main menu and press direction keys to move cursor to Edge in the display area and then press direction keys to gain four levels of sharpened images System default is 0 7 6 Image Control 7 6 1 Magnification Selection In real time mode press key to enter main menu and move cursor to Zoom and then press direction keys to choose eight kinds of magnification 7 6 2 Depth Range Selection and Depth Enhancement In real time mode press key to enter main menu and press direction keys Y Oto move cursor to Depth in the display area and then press direction keys to select depth press E key to quit depth range selection Note There is no depth selection function when main unit matching probe which its nominal frequency greater than or equal to 6 5M Hz In real time mode press key to enter main menu and press direction keys 4 to move cursor to 4 Coe gt Upgrade in the display area and then press direction keys appears on the screen Press direction keys or operate mouse to move image up down or left right so as to observe the images of different depth and width Press Es key to quit depth heighten pan status 7 6 3 Local Zoom and Local Additive Color In real time mode press key to enter main menu and press direction
59. peration between the two measurement marks The measured circumference value is displayed automatically at the built in mark C 00000mm on the right part of the screen Press ite key or click right mouse to display at the built in mark A 00000mm the value of the measured area formed by measurement line enclosure 5 Press E lkey the measurement methods are showed in the lower left of the screen continue to choose Trace to measure 6 Repeat steps 3 4 to complete the multi group data measurement 7 Continuously press kkey twice to quit the measurement status 8 Press direction keys Dto choose Clear or synchronously click the left and right key of mouse to clear all marks and data 9 Press ME key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status O Circumference area volume measurement with ellipse method In B B B mode choose desired image and freeze it the cursor is located in the Measure position of display area 2 Press key the measurement methods are showed in the lower left of the screen press direction keys to choose Ellipse press key again the cursor will show 3 Press direction keys or operate mouse to move the mark to desired position press key or click left mouse to set the mark position as the starting point of the measurement 4 Press direction keys or operate mouse to move the mark to the en
60. puncture anchor point Fix the puncture bracket Warning USB port max loading current 0 3A 3 4 Function keys description SN Function keys Real time mode function Freeze mode function 1 Mode Mode Selection Text Input 2 Enter Enter Confirm menu 3 Menu Main menu Cine loop 4 EA Freeze Unfreeze 5 OOO Direction Keys 6 Esc Quit 7 Power Power switch Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Chapter Four System Configuration 4 1 Typical configuration 1 Main unit 1 unit 2 3 5MHz convex array probe 1PC 3 Power adapter 1PC 4 Internal battery 2 PCS 5 Charger 1 PC 6 Support bracket 1 PC 7 Arm band 1 PC 8 Straps 2 PCS 9 Leather bag 1 PC 10 Shutter release 1 PC 4 2 Optional parts 1 5 0MHz micro convex array probe 2 6 5MHz intra cavity probe 3 7 5 MHz high frequency linear array probe 4 Video recorder P93 W S 5 Mouse 6 Probe holder 7 Plastic seal box Chapter Five Operation Condition 5 1 Power supply Adapter ratings 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 Altitude lt 2000 m Overvoltage Overvoltage Category II 5 3 Storage and Transport Ambient temperature 20 C 55 C Relative humi
61. r end to the video output interface on the left of main unit 3 Insert one end of power plug jack of the video recorder to the power input socket of the video recorder the other end to the power supply socket 6 6 Connect to the mouse Connect the mouse to USB interface on the right side ofthe main unit 6 7 Connect to power 1 Connect to the power adapter Insert the output plug of adapter into DC power input interface which is on the left of main untt 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 NWarning 1 Appliance coupler is intended to be used as disconnecting device please keep appliance coupler easily reached by the operator and use appliance coupler as disconnecting device 2 The device should be used only with power adapter provided by Kaixin Company 3 To avoid damaging power adapter or harming people by unexpected fallen make sur power adapter is placed on the leveled desk warning the operator must not touch SIP SOP and patient simultaneously Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 6 8 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 9 Main u
62. rameters the system will calculate the GA automatically Z Attention 1 The measured value of GA is the diagnostic GA 2 The formulae of every measurement item have been embedded in main unit 3 Make sure that the measurement is in the effective image area or else it can t calculate right or lead to wrong calculation 9 2 1 Measurement of GA and EDC 9 2 1 1 Measurement of BPD CRL GS FL HL LV TTD APTD FT TAD THD TCD OFD Follow the steps below 1 In B B B mode freeze the desired image press direction keys Y Dto choose OB in the display area 2 Press hu key to display the obstetric parameters on the lower part of the screen 3 Press direction keys Dto select corresponding measurement parameters items BPD CRL GS FL HL LV TTD APTD FT TAD THD TCD OFD prese key to confirm the cursor will show 4 Press direction keys or operate mouse to move the mark to desired position press Ee click left mouse to set the mark position as the starting point of the measurement 5 Press direction keys or operate mouse to move the mark to the end point of the measurem GA and EDC value to be displayed in real time in the right area of the screen Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 6 Press key or repeatedly click left mouse to exchange the starting point and end point 7 Press hr key or click right mouse to finish the first measurement 8 Repeat the s
63. red with synthetic material IEC 61000 4 2 the relative humidity should be at least 30 Electrical fast 2 kV for power 1kV for power The RESPONSIBLE ansent supply lines supply lines ORGANIZATION or OPERATOR must take actions IEC 61000 4 4 like installing filter on power supply for KX5200 to reduce environmental levels of the ELECTROMAGNETIC DISTURBANCE so that they are less than or equal to the COMPLIANCE LEVEL listed in column 3 Surge TEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment User s Manual V1 01 Full Digital Ultrasonic Diagnostic Instruments Voltage dips lt 5 Ur lt 5 Ur Mains power quality should be Be op gt 95 dip in Ur gt 95 dip in Ur POS feats short for 0 5 cycle for 0 5 cycle that of a typical commercial or interruptions hospital environment The and voltage ee gyn KX5200 can continue the Oe 60 dip in Ur 60 dip in Ur l variations on for 5 cycles for 5 cycles operation during power mains power supply 70 Ur 70 Ur interruptions due to the usage of input lines 30 dipin Ur 30 dipin Ur battery IEC for 25 cycles for 25 cycles 61000 4 11 lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Power 3A m 3A m Mains power quality should be frequency that of a typical commercial or
64. robe socket at the back of the main unit 6 2 2 Probe disconnection Turn off the system and use probe screwdriver to remove the probe with figure s method and instructions 6 3 Install dismantle the battery 1 Install battery Socket screwdriver Button position on both side of socket According to arrow direction gently insert the socket screwdriver then button up the button position on both side of the socket with your fingers you can remove the probe socket Put the battery into battery storage of main unit cover the Upper cover of battery storage int corresponding position and then toggle the push button in the opposite direction lock the Upper c battery storage Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 2 Dismantle battery According to the direction of the arrow toggle Push button of battery storage removed Upper cover of battery storage as shown in figure take out the battery 6 4 Shutter release installation Install shutter release to shutter release interface Freeze interface as shown in the figure In the operation you can freeze or unfreeze images using shutter release Shutter release 6 5 Video recorder installation 1 Turn off the system connect the equipotential terminal 9 ofthe video recorder to the earthing 2 Connect one end of the video connection line to the video recorder and the othe
65. s direction keys Y Oto move the cursor to 4B Mode then press direction keys to switch display among four images or right click mouse to switch display among four images the selected image is activated and the other three are frozen 3 In real time mode press key to exit 4B mode 7 4 4 B M Mode 1 In real time mode pressheeke to enter B M mode 2 Change ofscan mode Pres tie key to enter main menu and press direction keys to mov cursor to M Mode and then press direction keys to change the M ultra scan mode Or click mouse to realize the change of scan mode 3 Move sample line Press E lkey to quit the current using status for direction keys Press d Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 keys to move sample line 4 In real time mode press key to exit B M mode 7 4 5 M Mode 1 In real time mode press key to enter M mode 2 Change of M scan mode Press key to enter main menu and press direction keys to move cursor to M Mode and then press direction keys to change the M ultra scan mode Or right click mouse to realize the change of scan mode 3 Change of M speed Press key to enter main menu and press direction keys to move cursor to M Speed and then press direction keys Cto select the eight kinds of scan speed Or left click mouse to switch M speeds 4 In real time mode press key to exit M mode 7 5 Image Quality Adjustment 7 5 1 Brightness and Contr
66. s key three times to enter the automatic playback status Press key to enter pause status when playing back Press direction keys or operate mouse to view images frame by frame in pause status Continuously press key three times 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 Press E key to return to frozen status Press ME key unfreeze and quit playback status Note If the images appear abnormal that is without enough storage time and the images have not been stored full 7 14 Text Input Operation steps 1 Freeze image 2 Press key the cursor is located behind name 3 Press key again or right click mouse at the same time characters input menu will be show bottom ofthe screen Caps0123456789abcdefgh Shiftijklmnopqrstuvwxyz Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 Press direction keys or operate mouse to move cursor to point to Caps and then press Ee key or left click mouse to achieve capital and small letter conversion If the cursor point to Shift press i key or left click mouse again to achieve the conversion between the letter and punctuation lt 4 Press direction keys to choose numbers or characters and press her key to confirm Or operate mouse to click numbers or characters to input 5 After inputting nam
67. se in case of malfunction or over current or transient current generated at power on 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 the respective IEC standards IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment If in doubt consult the technical service department or your local representative When this system is installed or used around patient try to avoid the patient touching the system If system is with some unknown defects it may cause danger of electric shock Warning When instrument works abnormally do stop working turn off the power and check the reason then contacts the KAIXIN Company about it Operator in contact with the input output interfaces can not touch patients at the same time 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 stop
68. sound and avoid using high intensity ultrasound for long period of time 10 4 LARA as low as reasonably achievable principle Application of ultrasound shall be based on the ALARA principle that requires a minimized biological effect free energy output to obtain necessary diagnostic information The ultrasonic energy intensity is related to output power and exposure time Different patients and cases require different ultrasonic intensity Not all diagnosis can be done with extra low ultrasonic energy output The extra low ultrasound power produces poor quality image or weaker Doppler signal that may reduce the diagnostic reliability On the other hand use of sound power larger than diagnostically required makes no more contribution to improvement of the diagnostic information quality and increase the risk of biological effect possibility Therefore user of the diagnostic ultrasound shall be fully aware of the patient s safety and choose a proper output level for a specific purpose based on ALARA principle 10 5 Factors impacting sound power There are various factors that may have impact on sound power output These factors include generation condition focus transmission frequency transmission voltage for piezoelectric element scanning condition and control settings 10 6 Image control impact on sound power output Change of image control settings may have influence on sound power output See table below Operation Consequen
69. teps from 3 to 7 to complete the multi group data measurement 9 Press ES key to quit the measurement status 10 Press direction keys Dto choose Clear or synchronously click the left and right key of mouse to clear all marks and data 11 Press AE key or click the middle mouse to unfreeze clear all marks and data and quit the measurement status 9 2 1 2 Measurement of HC and AC Measure HC and AC using ellipse method Follow the steps below 1 In B B B mode freeze the desired image press direction keys Dto choose OB in the display area 2 Presse key to display the obstetric parameters on the lower part of the screen 3 Press direction keys to select measurement parameters in HC AC then pressie key to confirm the cursor will show 4 Press direction keys or operate mouse to move the mark to desired position press key or click right mouse to set the mark position as the starting point of the measurement 5 Press direction keys or operate mouse to change the major axis of the ellipse Press key the lt D mark appears on the screen hold down okey to change the minor axis of the ellipse so as to satisfy the test circumference area volume G A and EDC value will be displayed in real time in the right area ofthe screen 6 Press key again to quit the minor axis status Press key or repeatedly click left mouse to exchange the starting point and end point 7 Press Enter key or cl
70. the internal function of the screen 6 Clean the control panel shell Clean the instrument surface with soft dry cloth or with soft cloth dipped in moderate water cleaning media to remove the blots and then dry the instrument with soft dry cloth or with air 7 Clean the video recorder 1 Use the soft dry cloth to wipe the video recorder 2 If it is difficult to wipe away the blemish clean with soft cloth dipped in moderate detergent and then air dry it 11 1 2 Use and maintenance for the rechargable battery 1 2 Only use charger and battery model CNLB 01 provided by KaiXin Company The output port of adapter plugs into the input port of charger to charge the minimum charging time is 3 hours and up to 4 hours Over charging or discharging will shorten the battery life the full charged battery can be used for 2 3 hours 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 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 AM 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
71. tial impact on sound power output The maximum sound power for each probe has been optimized to FDA standard Change probe 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 cha Change image mode may lead to the change of sound power If the mode is switched fro mode B B or to 4B the sound power will not change as the basic parameters rem same In most cases sound power output in M mode is larger than that in B Full Digital Ultrasonic Diagnostic Instruments User s Manual V1 01 The number of focus influences frame frequency and focus location thereby N ff umber of focus changes the sound power output Change of transmission focus location leads to change of transmission level and Focus location i aperture thereby the change of sound power output Freeze function initiation disables the system elements transmitting electric Freeze j energy therefore the system is not able to transmit the ultrasound Transmission Change of transmission power will cause the change of system electric output to power the probe hence the change of sound power output Change of frequency will lead to the change of wave focus characteristic thereby Change frequency the change of sound power output Restart or turn Restart or turn offon the power will set the system in default mode and change offon the sound pow
72. tmax MI W em 119 37 Operating Focus 1 1 control Focus setting mm 20 20 conditions Frequency Hz 5 0 5 0 Full Digital Ultrasonic Diagnostic Instruments Test Mode BM MODE User s Manual V1 01 Probe Type 5 0C20B1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan AapnSlem Apr om Maximum index value 0 75 0 24 0 024 0 024 Pra MPa 1 48 P mW 12 6 1 29 1 29 min of Pa Zs mag i Zs cm Associated Zop cm acoustic Z cm 2 48 parameters Z at max lpi a cm 2 61 deq zb cm 0 47 fawe MHz 3 95 3 95 3 95 3 95 X cm 0 62 0 62 0 62 DA T enn 0 73 0 73 0 73 p ta usec 0 410 prr Hz 64 Other i prat max lpi MPa 2 11 iati deq at max Ij cm 0 47 Iba aat max MI W em 119 37 Operating Focus l 1 l 1 control Focus setting mm 20 20 20 20 conditions Frequency Hz 5 0 5 0 5 0 5 0 Test Mode M MODE Probe Type 5 0C20B1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan Aap lem Aaprez om Maximum index value 0 75 0 19 0 74 Pra MPa 1 48 P mW 10 4 10 4 min of Po Zs eazy Zs cm Associated Zop cm a acoustic Fa cm 2 48 parameters Z at max lpi a cm 2 61 deq zb cm 0 15 fawe MH
73. ument 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 Warning Only manufacturer is permitted to repair the device So if the device is in abnormal condition do not use it and send it to manufacturer 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 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 Instructions concerned For the changes of appearance this manual is subject to change without further notice Full Digital 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 t
74. unit to U disk 1 Read out the image in the main unit Img with highlight status is displayed on lower right corner of the screen 2 Press key a Dump prompt appears on lower right corner of the screen 3 Press direction keys Cto select the image saving code in the U disk such as choose 005 4 Press key Dump prompt disappears until the Dump re appears the current image can be 663699 dumped in the frame for coded 005 The dumped image code is preceded with asterisk 5 Press E key to quit dumping status and press key to return to real time status eFrom U disk to main unit 1 Enter the number ID after completed it exit the enter status 2 Read out the image in the U disk Img with highlight status is displayed on lower right corner of the screen 3 Press key a Dump prompt appears on lower right corner of the screen 4 Press direction keys Cto select the image saving code in the LOCAL such as choose 006 5 Presse key Dump prompt disappears until the Dump re appears the current image can be 66399 dumped in the frame for coded 006 The dumped image code is preceded with asterisk 6 Press E key to quit dumping status and press ME key to return to real time status Note If not enter number ID it will select the image within the system default USER folder The operation steps are 2 6 7 10 2 Mass dump eFrom mai
75. xin may revise this manual without prior notice Kaixin may revise its technical process without prior notice Kaixin may modify specifications of the product without prior notice Liability and Disclaimer Statement 1 This user s manual contains warnings for predictable dangers Users shall also exercise care at any time to be aware of the dangers unforeseen in this manual Kaixin shall not be liable for the damages and losses arising out of neglecting to follow the operation instructions herein described 2 This user s manual shall be furnished with the machine so that operating and managerial personnel can refer to it any time as necessary Once the managerial personnel of the system changes it shall hand over this user s manual 3 Medical personnel qualified with professional qualifications only to use this system 4 This product is intended to provide clinical diagnostic data for the doctor The doctor in charge of the diagnosis shall be responsible for the diagnostic process Kaixin shall not be liable for any problems arising out of the process 5 User shall be fully responsible for the maintenance and management of this product after purchasing this product 6 Do not modify this equipment without authorization of the manufacturer 7 Deal with the exhausted product according to the local statute 8 Kaixin shall not be liable for the safety reliability and operational state of the product in case of the following conditions
76. y sensitive to shake be used with caution About probe s use and cleaning the details see the relevant sections 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 2 Check the ultrasonic probe and connecting cable after diagnostic operation Use of defective probe may cause electric shock 3 Do not knock or bump the probe or it may be damaged and cause electric shock 4 Unauthorized disassembly of the probe shall be prohibited as it may cause electric shock hazard N Attention 1 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 Before connecting or using the probe 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 Insert the probe connector into the p
77. z 3 95 3 95 3 95 X cm 0 62 0 62 Dan Ot Agt iy cm 0 73 a 0 73 2 ta usec 0 410 prr Hz 520 Other i prat max lpi MPa 2 11 pano deq at max lpi cm 0 15 Iba cat max MI W em 119 37 Operating Focus 1 l 1 control Focus setting mm 20 20 20 conditions Frequency Hz 5 0 5 0 5 0 Full Digital Ultrasonic Diagnostic Instruments Test Mode B MODE User s Manual V1 01 Probe Type 6 5C11E1 TIS TIB Index label MI Non scan TIC Scan 7 7 Non scan Aapri lt l em Aap om Maximum index value 0 43 0 22 Pra MPa 0 91 P mW 10 6 min of Pa Zs ayy f Zs cm Associated Zop cm acoustic A cm _ parameters 7 at max Inia cm 1 09 de Zb cm fat MHz 4 48 4 48 X cm 0 25 A En 0 80 E z y ta usec 0 412 prr Hz 4166 One f prat max lpi MPa 1 10 information de at max Li ai Tha aat max MI Wiem 40 54 Operating Focus E 3 control Focus setting mm 10 10 conditions Frequency Hz 6 5 6 5 Test Mode BM MODE Probe Type 6 5C11E1 TIS TIB Index label MI Non scan TIC Scan gt 7 Non scan Aap lem Aap LEM Maximum index value 0 43 0 26 0 028 0 021 Pra MPa 0 91 P mW 12 2 1 32

KAIXIN ® KX5200 Full Digital Ultrasonic Diagnostic

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KAIXIN &reg; KX5200 Full Digital Ultrasonic Diagnostic

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KAIXIN ® KX5200 Full Digital Ultrasonic Diagnostic