CE-C10-03-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.
CE-C10-03-SMSP01-20220502 V1.0 Contents Introduce ........................................................................................................................................ I Maintenance and repair service ............................................................................................. III Intellectual Property Statement .............................................................................................. III 1 Safety precautions .........................................
CE-C10-03-SMSP01-20220502 V1.0 Image Adjustment ........................................................................................................... 27 4.2.2 BM mode............................................................................................................. 28 4.2.3 C mode ................................................................................................................ 29 4.2.4 PW mode ....................................................................................
CE-C10-03-SMSP01-20220502 V1.0 Production enterprise name: Beijing Konted Medical Technology Co.,Ltd Registered address: Room 111,1F, Building 3, No. 27, Yongwang Road,Daxing Biological Pharmaceutical Industry Base,Daxing District,Beijing,China Production 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 Customer service: Beijing Konted Medical Technology Co.
CE-C10-03-SMSP01-20220502 V1.0 Introduce This manual describes the operation of the Pocket Ultrasound System. In order to ensure the safe operation of the system, please read and understand the contents of the manual before using the system This specification is formulated and explained by KONTED. This manual is published: December 2018，first revised December 2019. KONTED reserves the right to change the contents of the instruction manual without prior notice Important statement! 1.
CE-C10-03-SMSP01-20220502 V1.0 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
CE-C10-03-SMSP01-20220502 V1.0 Maintenance and repair service The main warranty period is 18 months. The warranty period from the date when the product leave the factory. Within the warranty period, the product can enjoy free customer service; but please note that even in the warranty period, due to the reasons on the page "important statement" caused by the products need maintenance, KONTED will charge maintenance services, you need to pay the cost of maintenance and spare parts costs.
CE-C10-03-SMSP01-20220502 V1.0 1 Safety precautions 1.
CE-C10-03-SMSP01-20220502 V1.0 1.3 Safety warning information In order to ensure the safety of the patient and the operator, the following safety rules should be strictly observed in the use of the wireless ultrasonic probe. 1. WARNI NG: 2. 3. 4. 5. 6. 7. 8 9 Do not disassemble the ultrasonic probe, which may cause electric shock. Use the power cord supplied with this unit; use only the power supply provided by US to supply power, the use of other specific power supply (such as UPS, etc.
CE-C10-03-SMSP01-20220502 V1.0 1. CAREF UL： CAU 1 TIO N ： Matters needing attention in clinical examination technology： This equipment can only be operated by qualified medical personnel. This manual does not introduce a clinical examination technique. It is necessary to select the correct inspection techniques according to the professional training knowledge and clinical experience. 2. The equipment can not be checked for a long time. 3.
CE-C10-03-SMSP01-20220502 V1.0 1.4 WARNING Labels The system has a variety of identification to cause the user to pay attention to the potential danger. The symbol on the warning sign security. indicates the precautions for system The instructions explain in detail the meaning of these warning signs. Read the instructions carefully before using the system. 1.
CE-C10-03-SMSP01-20220502 V1.0 2 Product overview 2.1 Intended use It is designed to fulfill following intended uses: Obstetrics、Gynaecology、Abdominal Small Parts (breast, thyroid, testicle, 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.
CE-C10-03-SMSP01-20220502 V1.0 2.3 Product specifications 2.3.1 Imaging mode B mode BM mode C mode PW mode PDI mode 2.3.2 Power condition External power adapter Supply voltage AC : 100 - 240V Power frequency : 50/60Hz Output DC: 5V/2A Internal battery voltage: 3.8V capacity: 2600mAh 2.3.
CE-C10-03-SMSP01-20220502 V1.0 Transport: 1. Do not use or store the system outside the specified environmental conditions. Working: 1. Please ensure that the use of the equipment to master a solid, otherwise, equipment may hurt the patient fall. 2. To ensure that the equipment in a dry environment, the operation of environmental temperature and humidity changes, may lead to liquid condensation in the circuit board, there is the risk of short circuit. WARNI NG： 3.
CE-C10-03-SMSP01-20220502 V1.0 2.4 system configuration The system is mainly composed of probe and application. 2.4.1 Standard configuration Main unit probe: 1 set 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.
CE-C10-03-SMSP01-20220502 V1.0 2.5 Symbol description This device uses the following symbol identification, the following list shows its meaning. Serial number Symbol Explain 1 Type BF application part explain：All ultrasonic probes are part of the BF application. 2 Please refer to the instruction manual for this symbol to avoid accidents 3 Indicates the product serial number 4 Indicates the manufacture.
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CE-C10-03-SMSP01-20220502 V1.0 2.
CE-C10-03-SMSP01-20220502 V1.0 2.7 Control panel Control buttons Button icon Key name Function 1） When the probe is not turned on, press the key to open the probe; 2） When the probe is in the open state, press the key to close the probe; Power switch / freeze / thaw button 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.
CE-C10-03-SMSP01-20220502 V1.0 3 Basic introduction 3.1 Install software 3.1.1 iPhone/iPad Download the IOS software from App store on your Apple iphone/ipad, the APP name is MY USG. The following lists the requirements: Updates to the App and probe are handled through the Apple App Store. Keep your mobile device’s operating system and the App updated to ensure you have the most up-to-date version.
CE-C10-03-SMSP01-20220502 V1.0 3.1.2 Android device Download the Android software from Google Play store . The App name is MY USG. The following lists the requirements: Updates to the App and probe are handled through the Google play. Keep your mobile device’s operating system and the App updated to ensure you have the most up-to-date version. Android Device Smart phone Smart Tablet 3.1.3 Requirement RAM≥2GB, ROM≥32GB Wi-Fi:（802.
CE-C10-03-SMSP01-20220502 V1.0 3.2 Turn on/off the probe Press the power button icon. to turn on the probe, the indicator will show the battery after ultrasonic examination, Press the power button off the probe, the indicator become black screen.
CE-C10-03-SMSP01-20220502 V1.0 3.3 Probe and Terminal connection Wi-Fi connection: The first time connection between the probe and the smart terminal device need to be entered the Wi-Fi password. After the first time connection, the device will be connected with the probe’s Wi-Fi automatically. uxccbmh000 Note: password is the SN of the probe, but it is the small letter not capital. Probe SN: uxccbmh000 Step1: Turn on the ultrasound transducer and turn on the Wi-Fi on your IOS or Android device.
CE-C10-03-SMSP01-20220502 V1.0 displayed on the App interface. Note: - If you connect the probe to your device successfully, but there is no image on the screen, 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.
CE-C10-03-SMSP01-20220502 V1.0 USB connection： Step1: Pull out the rubber plug on the right side of the probe. Step2: Connect the probe to your smart device by Type-C cable according 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.
CE-C10-03-SMSP01-20220502 V1.0 Android Devices Type-C Windows PC (Win10) IOS Devices USB 2.0 / 3.0 X Apple Lightning / USB-C Note: - If you connect the probe to your device successfully, but there is no image on the screen, please try to press the power button again. - When the probe is 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.
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CE-C10-03-SMSP01-20220502 V1.0 4 Detailed operation introduction 4.1 Introduction to all levels of 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.
CE-C10-03-SMSP01-20220502 V1.0 4.2 Operation Introduction 4.2.
CE-C10-03-SMSP01-20220502 V1.0 8 H: change scanning frequency(F) 20 B Gain （GN） 21 Live/freeze display 9 Biopsy Needle Guide line To invert the image horizontally or vertically.
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CE-C10-03-SMSP01-20220502 V1.0 Switching Between Imaging Modes Tap No.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 Adjust No.23 Focus Pos Adjust No.24 ENH Adjust No.25 H Adjust No.26 DR effect Adjust No.
CE-C10-03-SMSP01-20220502 V1.0 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.
CE-C10-03-SMSP01-20220502 V1.0 4.2.3 C mode 1). Second menu in color mode,click the buttons, the parameter will be changed 2).
CE-C10-03-SMSP01-20220502 V1.0 4.2.4 PW mode 1. Second menu in PW mode,click the buttons, the parameter will be 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.
CE-C10-03-SMSP01-20220502 V1.0 4.3 Measurements General measurements refer to general measurements on images of B/C/PDI mode, M mode, PW mode. To perform a measurement: 1.Tap 2.Tap Mode to to freeze the image. to access the measurement tools. Measurement Tools Available Operations Length Measures the length between two points of interest. B/C/PDI Angle The angle between two intersected planes Area/Circumference Measures the distance between two points of interest.
CE-C10-03-SMSP01-20220502 V1.0 4.4 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 Please swipe to the left to browse the pictures/videos and report. 32 Data Sheet .
CE-C10-03-SMSP01-20220502 V1.0 4.5 DICOM 1. Click setting 2. Click ， then press Dicom Settings. , you can search and select patient info in the Worklist Query and Store.
CE-C10-03-SMSP01-20220502 V1.0 5 maintenance and inspect 5.1 Charging the probe Charge the probe when the battery is low(one cell battery). When charging, the battery indicator flashes to indicate the current charge level. US suggest the probe should be charged when one cell battery showed. If the 4-cell battery indicator is on and the battery indicator stops blinking, the battery is fully charged. Charging by USB cable: 1. Pull out the rubber plug at the end of the probe. 2.
CE-C10-03-SMSP01-20220502 V1.0 Charging by wireless charging pad: The C10RL/C10UE/C10RQ probe support wireless charging. 1. Disconnect the probe from your mobile device. 2. Connect the Micro USB cable to the wireless charging pad. 3. Connect the USB end of the cable to the wall adapter. 4. Plug the wall adapter into a power outlet. 5. Place the probe onto the white wireless charging pad.
CE-C10-03-SMSP01-20220502 V1.0 CAUTION ： 1 If the probe will not power on after charging, it could indicate a battery failure. Contact Support. 2 A non-medical grade power supply must be used outside of the patient environment so that it is at least 1.5 meters from the patient. 3 The probe battery should be charged at least monthly to ensure proper functionality. 4 It is normal that the probe may feel warm to the touch while charging.
CE-C10-03-SMSP01-20220502 V1.0 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.
CE-C10-03-SMSP01-20220502 V1.0 5.3 Cleaning and Disinfecting the probe Cleaning the probe The operation process is as follows: The following cleaning methods shall be taken immediately after each complete test on the patient to avoid drying of the coupling remaining on the probe, which is not conducive to the cleaning of the probe and to prevent the body and sound head from being corroded by coupling or other reagents .
CE-C10-03-SMSP01-20220502 V1.0 5、Use ultrasonic special wiping paper or lint free cloth dipped with enzyme containing detergent(the usage of specific cleaners should refer to the usage method of cleaner labels and instructions, and pay attention to whether the use time of detergent is within the warranty period of the product) to clean until there is no visible stain on the acoustic head and the acoustic head and its surroundings have been wiped.
CE-C10-03-SMSP01-20220502 V1.0 mixed quaternary ammonium salt content is 200mg / L-1000mg / L, which conforms to the alcohol disinfection solution of double chain quaternary ammonium salt ) for spraying and disinfection . Install the mixed disinfectant reagent into a spray pot with spraying function, and use the spray pot to evenly spray the disinfectant on the surface of the ultrasonic probe and around the ultrasonic probe shell.
CE-C10-03-SMSP01-20220502 V1.0 2. 3. The probe sheath is made of natural latex and talc, which may cause allergic reactions in some people Do not use expired probe sheath. Check the probe sheath for expiration before using the probe sheath Operation procedure (for reference only)： 1.In the protective sleeve or inside the probe surface coated with an appropriate amount of coupling agent, without the use of coupling agent, the image is not clear. 2.
CE-C10-03-SMSP01-20220502 V1.0 repair. WARNING： Equipment failure, Users are not allowed to repair without authorization. Product must be sent back to the company 5.7 Life cycle According to the manufacturer's design, production and other related documents, this type of product life is generally 5 years, it depends on using frequency,it is possible to be used 6-8 years.
CE-C10-03-SMSP01-20220502 V1.0 5.7 Troubleshooting Here lists the troubleshooting issues and resolutions. If you are unable to resolve an issue using Table-1, please note the issue and report it to Support for assistance. Table-1 Troubleshooting Connection issues Display the error password 1. The SN number of the probe is the wifi password, re-enter the password, The password’s letters must be input as small letters, not capital. 2. Try to connect to the probe with type-C cable.
CE-C10-03-SMSP01-20220502 V1.0 Black screen or screen no longer updates 1. Close the App and restart the App. 2. Unplug the probe from the mobile platform (mobile device) and reconnect. Imaging issues 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.
