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CE-C10-03-SMSP01-20220502 V1.0

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Serial

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Symbol

Explain

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Country of manufacture

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Importer

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Distributor

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Medical device

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UDI

18

Power

Voltage

Frequency

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Class II equipment

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Away from the sunlight

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Storage temperature limit

22

Upwards

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Summary of Contents for C10

Page 1: ...3 SMSP01 20220502 V1 0 Pocket Ultrasound System C10 Instruction Manual V1 1N IMPORTANT Read and understand this manual before operating the equipment After reading keep this manual in an easily accessible place ...

Page 2: ... 4 system configuration 8 2 4 1 Standard configuration 8 2 4 2 Components 8 Transducer Type 8 2 5 Symbol description 9 2 6 Introduction of each component of the system 12 2 7 Control panel 13 3 Basic introduction 14 3 1 Install software 14 3 1 1 iPhone iPad 14 3 1 2 Android device 15 3 1 3 Windows device 15 3 2 Turn on off the probe 16 3 3 Probe and Terminal connection 17 3 4 Basic software interf...

Page 3: ...atient s information and report 32 4 5 DICOM 33 5 maintenance and inspect 34 5 1 Charging the probe 34 5 2 Replace the battery 37 5 3 Cleaning and Disinfecting the probe 38 Cleaning the probe 38 Disinfecting the probe 39 5 4 Wear probe protection sleeve 40 5 5 Storage 41 5 6 Inspect 41 5 7 Life cycle 42 5 7 Troubleshooting 43 ...

Page 4: ...ical Pharmaceutical Industry Base Daxing District Beijing China Zip code 102629 Tel 8610 60219113 Fax 8610 60219213 Customer service Beijing Konted Medical Technology Co Ltd Address Room 111 1F Building 3 No 27 Yongwang Road Daxing Biological Pharmaceutical Industry Base Daxing District Beijing China Zip code 102629 Tel 8610 60219113 Fax 8610 60219213 Product Pocket Ultrasound System Model C10 Aut...

Page 5: ...osis and the doctor is responsible for the diagnosis process 4 Quality assurance does not include the following even within the warranty period 1 Damage or loss caused by improper installation or environmental conditions that do not meet the requirements 2 Damage or loss caused by the supply voltage exceeding the specified range 3 Damage or loss of equipment or components purchased not from KONTED...

Page 6: ...for body worn Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruct...

Page 7: ...re that you must familiarize yourself with the operating instructions before use and operate and use it in strict accordance with the requirements and methods of operation of the operating instructions The Company does not assume any responsibility for safety reliability and performance assurance due to any abnormality caused by operation use maintenance and storage in accordance with the requirem...

Page 8: ...l liquid The system probe is IPX5 the probe head is IPX7 According to the degree of safety in the presence of flammable anesthetic gas mixed with air or oxygen nitrous oxide two According to the working mode Continuous working equipment 1 2 Security symbol Security symbol Detailed description Type BF application part Description all the ultrasonic probes are part of the BF application Be careful i...

Page 9: ...ecked for safety do not let the probe by the impact of damaged ultrasound probe may cause the patient to be shocked 5 Before performing an ultrasound check check the surroundings to ensure safe use within the environment Do not operate the unit in an environment with flammable or explosive liquids vapors or gases such as oxygen or hydrogen 6 Be sure to wear a sterile probe case on the probe when p...

Page 10: ...r natural rubber allergy 7 For in vivo transducers in a single fault condition the surface temperature rise shall not exceed 43 C CAU TIO N 1 In order to prevent abnormal probe function read the following safety precautions After each ultrasonic examination the ultrasonic coupling agent on the surface of the probe should be thoroughly erased Otherwise the ultrasonic coupling agent will be solidifi...

Page 11: ...ound imaging has been used for over twenty years and there have been no known long term negative side effects associated with this technology Ultrasound Benefits Portability Cost effectiveness Multiple diagnostic uses Immediate results Safety record Ultrasound Risks Ultrasonic waves can heat the tissues slightly It is normal that the probe may feel warm to the touch while charging If you remove th...

Page 12: ...ticle etc Cardiology Peripheral Vascular Muscular Skeletal Nerve Urology Orthopedic Angiography Physical Examinations Digestion Paediatrics Paracentesis 2 2 Contraindication The product is not suitable for the examination of the organs containing gas such as the stomach and intestines etc when burned burned or damaged in the surface of the human body it can not be used in this part ...

Page 13: ...power adapter Supply voltage AC 100 240V Power frequency 50 60Hz Output DC 5V 2A Internal battery voltage 3 8V capacity 2600mAh 2 3 3 environment condition work environment Storage and transportation environment ambient temperature 0 40 0 45 relative humidity 30 85 No condensation 30 95 No condensation atmospheric pressure 70KPa 106KPa 70KPa 106KPa ...

Page 14: ... flammable or explosive liquids vapors or gases such as oxygen or hydrogen Equipment failure or fan motor sparks may be electronically detonated of these substances A Please ensure that the environment before use if the detection of flammable substances in the environment please do not plug in the power or open the system B Use the real time detection environment to detect flammable substances aft...

Page 15: ... Type C Cable 1 set Wireless charger 1 set Black handbag 1 set Plug American Standard or British Standard Plug Accessory Operation manual 2 4 2 Components Transducer Type Transducer model Type of Transducer Intended use Applicable site Wireless charging C10 3 in 1 type Gynecology and obstetrics abdominal kidney Small organ carotid artery Msk Cardiac body surface ...

Page 16: ...es that the system is protected against the effects of immersion in water to depth between 15 cm and 1 meter 6 Safety mark on behalf of the product has been in line with European standards for safety health environmental health and other standards and directives 7 Indicates the date of manufacture 8 Indicates that the device must be collected separately for disposal Follow proper disposal procedur...

Page 17: ...1 0 10 Serial number Symbol Explain 13 Country of manufacture 14 Importer 15 Distributor 16 Medical device 17 UDI 18 Power Voltage Frequency 19 Class II equipment 20 Away from the sunlight 21 Storage temperature limit 22 Upwards ...

Page 18: ...CE C10 03 SMSP01 20220502 V1 0 11 Serial number Symbol Explain 23 Keep dry 24 Storage humidity limit 25 Stacking layer limit ...

Page 19: ... software Charging with USB type C cable 3 Battery status Battery charge remaining display 4 SN Serial number password of this probe s wifi 5 Wireless charging symbol Face to wireless charger 6 Convex probe Convex probe Phased probe 7 Linear probe Linear probe 8 Type C cable Connect to Android Windows software Charging with USB type C cable 9 Fast Charger The wireless charging pad 1 2 3 6 4 5 7 8 ...

Page 20: ...n state press the key to close the probe 3 When the probe is in the scanning state press the key to freeze the screen image 4 In the frozen state press the button to thaw the screen image the probe continues to scan the image 5 Press and hold for 3 seconds to switch the scanning mode Convex array probe linear array probe Press the button and hold for 3 seconds to switch the scanning mode Convex ar...

Page 21: ... 4th 5th 6th 7th 8th iPad mini 3th 4th iPad Pro 1th 2th 3th 4th PC Note MY USG App is available for download and use on an iphone ipad device not support Apple PC Do not use the MY USG App on a mobile device that does not meet minimum requirements Using the APP on a mobile device that does not meet the minimum requirements may affect performance and image quality possibly resulting in misdiagnosis...

Page 22: ...2GB Wi Fi 802 11n 20MHz 5G USB connector type Type C Android version 8 0 or newer Smart Tablet Windows Device Requirement Operating System PC RAM 4GB Wi Fi 802 11n 20MHz 5G CPU 1GHz up to 3 6GHz Inter i3 i5 i7 Recommended Brand Lenovo HP Dell Acer ASUS It is recommended to use laptops manufactured after 2017 Windows10 64 bit or newer Smart Tablet RAM 4GB ROM 16GB Wi Fi 802 11n 20MHz 5G USB connect...

Page 23: ... Turn on off the probe Press the power button to turn on the probe the indicator will show the battery icon after ultrasonic examination Press the power button and hold for 5 seconds to turn off the probe the indicator become black screen ...

Page 24: ...e password is the SN of the probe but it is the small letter not capital Step1 Turn on the ultrasound transducer and turn on the Wi Fi on your IOS or Android device Step2 Search the list of networks for the SSID with the suffix UX 8C A000 Step3 Enter the Wi Fi password this Wi Fi password is the serial number of the probe but it is the small letter not capital Step4 To open the MY USG App on your ...

Page 25: ...reen please try to press the power button again The password s letters must be input as small letters not capital When the probe is connected to mobile device A if you want to change mobile device B to connect with the probe please disconnect the probe from the mobile device A firstly The probe only can be connected to one mobile device at the same time ...

Page 26: ...rding to the picture above The A end and B end of the cable can not be inserted reversely The A end must be fully inserted into the probe and the B end must be fully inserted into the smart device Step3 To open the MY USG App on your mobile device s home screen when the probe connect to your mobile device successfully The UX 8C A000 will be displayed on the App interface A B ...

Page 27: ... connected to the device successfully the probe charging indicator will automatically flash and charge the probe The probe can be connected to an Android Windows device via Type C cable iPad iPhone only can be connected via Wi Fi not support Type C cable connection The probe can be used while charging X Android Devices Windows PC Win10 IOS Devices Type C USB 2 0 3 0 Apple Lightning USB C ...

Page 28: ...CE C10 03 SMSP01 20220502 V1 0 21 3 4 Basic software interface Convex array Phased array mode Linear array mode ...

Page 29: ...menu The menu in this system is divided into first level second level 4 1 1 First level menu 1 Preset button 2 Hidden menu for parameters 4 1 2 Introduction to the second level menu The 2 level menu is controlled by clicking on the corresponding item of the 1 menu This is the 2 level menu in Color mode ...

Page 30: ...l Index TI Mechanical Index MI and Hz values 3 Imaging Enhance ENH 15 DICOM Procedures uploading images to PACS 4 Mode B B M Color PDI Dual click to switch scanning mode 16 Body Mark 5 Freeze Live button 17 APP version number 6 Mode PW 18 Show patient information 7 Focus Position 19 Full screen 18 19 20 21 22 23 11 12 13 14 17 24 15 16 20 8 12 3 1 2 3 4 5 6 7 8 9 10 2 7 ...

Page 31: ...id pad device 11 8 TGC adjust gains of different depth 12 Depth adjust depth by swiping the button D 24 New patient new report 23 Dual screen display mode Click button to switch the dual screen single screen mode Click the left right screens to switch freely and you can switch B BM Color PW mode at the same time 24 New patient new report a Enter new patient info click OK b Scan now then Freeze ima...

Page 32: ...ltering frequency of a pulse wave or continuous wave Doppler low frequency signal 5 Tap and drag the green box to move the Color ROI 6 Use the arrows provided to adjust the angle and size 7 Invert Color Red Blue invert 8 Slide the Color PDI menu bar First select Color mode Then switch to PW mode only available for convex probe of dual head serial USG probe PW Mode 9 GN PW Gain 1 2 3 4 5 6 7 8 B Co...

Page 33: ...ency 14 Tap and drag the green line 15Baselin e Move the velocity scale 16 Slide the PW menu bar 17 Flow mod e ON OFF Automatic blood flow measurement Step1 select vessel flow preset Step2 enter PW mode produce a uniform spectrum Step3 click Flow mode ON Step4 Freeze the PW image then will show the result automatically only available for linear probe of dual head serial USG probe Selecting Exam Pr...

Page 34: ...22 Mode to select the imaging modes Image Adjustment Requirement Available Operations To modify the brightness Adjust No 10 Gain Adjust No 19 8TGC To modify gray scale image effect Adjust No 23 Focus Pos Adjust No 24 ENH Adjust No 25 H Adjust No 26 DR Zoom Adjust No 4 Depth ...

Page 35: ...E C10 03 SMSP01 20220502 V1 0 28 4 2 2 BM mode In BM mode click the cursor two times it will change green you can adjust the position of the M sampling line by moving the following marks with your finger ...

Page 36: ...lor mode 3 Click this button this button will be changed to button named size the can be adjust the size in this status as below 4 Increase or reduce the color gain 5 Steer afterglow adjustment 6 PRF Adjust color pulse repetition frequency 7 WF adjusting the filtering frequency of a pulse wave or continuous wave Doppler low frequency signal 5 4 1 6 7 3 2 ...

Page 37: ...changed 2 Parameters display area in PW mode 3 PW gain Increase or reduce the pulse gain 4 Steer afterglow adjustment 5 Angle real time scanning state used to change the spectrum sampling line angle 6 Sampling volume change the size of the sampling volume 7 PRF Adjust color pulse repetition frequency 6 3 1 4 5 7 2 ...

Page 38: ...he image Distance Measures the distance between two points of interest GA CRL BPD GS FL HC AC EFW BPD FL Only for present Obstetric M Heart Rate 5 Measures the time of tow cardiac cycles and calculates the heart rate in M mode image Time The time interval between any two points Distance The vertical distance between two points PW Velocity Calculate the velocity of the point in Doppler spectrum wav...

Page 39: ...Patient s information and report 1 Click ID on the patient information enter the patient data input box 2 After editing the report click to save the report to the Data Sheet Please swipe to the left to browse the pictures videos and report ...

Page 40: ...CE C10 03 SMSP01 20220502 V1 0 33 4 5 DICOM 1 Click setting then press Dicom Settings 2 Click you can search and select patient info in the Worklist Query and Store ...

Page 41: ...harging by USB cable 1 Pull out the rubber plug at the end of the probe 2 Use our USB Type C charging cable to connect the probe and wall adapter or other USB port that can provide the power supply such as a portable charger as shown below 3 Plug the wall adapter into a power outlet Note You can perform imaging while the probe is charging by Power Bank Just connect the probe to mobile device by Wi...

Page 42: ...Place the probe onto the white wireless charging pad Note You can not perform imaging while the probe is charging by wireless charging pad Make sure to place the probe on the charging pad so that it lies flat on the charging pad on a flat surface Do not hang the charging pad or hang the probe from the charging pad Ensure that the probe is properly placed on the charging pad so that the probe s bat...

Page 43: ...t is normal that the probe may feel warm to the touch while charging If you remove the probe from the charging pad before or immediately after charging is complete it is recommended that you allow the probe to cool down before use Since the system limits patient contact temperature and will not scan at or above 43 C 109 F allowing the probe to cool down before use will optimize scan time performan...

Page 44: ...CE C10 03 SMSP01 20220502 V1 0 37 5 2 Replace the battery The battery of USB Wi Fi probe can t be replaced If the probe cannot be charged or the probe cannot be turned on please contact us ...

Page 45: ...ment the wiping paper shall be soft non abrasive disposable paper towel or clean lint free soft cloth to wipe the acoustic head Gently wipe the paper or soft lint free cloth along the wide side of the vocal head to the other end if the wiping force is too large it may cause the depression of the vocal head and make the machine unusable The wiping direction should be in accordance with the Repeated...

Page 46: ...ultrasonic instruments or a clean lint free soft cloth The same lint free soft cloth used before is no longer used to wipe the entire body and the vocal head and wipe the residual water stains on the acoustic head until all the residual water stains on the body are wiped clean 8 Place the whole machine in the air with humidity 60 temperature 40 and 15 fine particles 3 5ug m Ventilation and drying ...

Page 47: ...ps of the machine body are completely wiped and disinfected 3 Take a new piece of special wiping paper or clean lint free soft cloth for ultrasonic instrument wipe the whole body and the acoustic head again and wipe it from the acoustic head to the body until all the disinfection reagent residues on the body are wiped clean 4 Check whether there are residual stains or water stains on the body and ...

Page 48: ...s do not pull too far 3 With the rope to ensure the protection of security 4 Check the protective sleeve to ensure no damage 5 5 Storage When not using the probe please place the probe in a suitable package to avoid the impact of violent impact on the probe And to avoid contact with the probe too high temperature suitable storage temperature 0 40 5 6 Inspect Frequently check the probe cable if fou...

Page 49: ...ars constituting the product material over time will gradually aging continue to use the products beyond the life of the post may cause performance degradation and failure rate is significantly high WARNING Equipment failure Users are not allowed to repair without authorization Product must be sent back to the company WARNING The manufacturer will not be held responsible for the risks arising from...

Page 50: ...ly The A end must be fully inserted into the probe and the B end must be fully inserted into the smart device 2 Try to connect the probe with the other side of the type C A port interface Probe issues Probe can not be charged by cable 1 The A end must be fully inserted into the probe and the B end must be fully inserted into the smart device 2 Charge the probe for 1h with wireless charger 3 If not...

Page 51: ...sues Image degradation or occurrence of image artifacts Make sure you are using the appropriate preset and the depth is appropriate for the anatomy being scanned Image quality degraded 1 Make sure you are using enough approved ultrasound gel If quality does not improve 2 If not work contact Support Image is nor clear 1 Adjust the image parameters follow the page 24 2 Use enough ultrasound Gel ...

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