Viatom C10 Instruction Manual
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Viatom C10 Instruction Manual

Pocket ultrasound system
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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.

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Summary of Contents for Viatom C10

  • Page 1 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.

  • Page 2: Table Of Contents

    CE-C10-03-SMSP01-20220502 V1.0 Contents Introduce ............................I Maintenance and repair service ..................... III Intellectual Property Statement ....................III Safety precautions ........................1 Security classification ..................... 1 Security symbol ....................... 1 Safety warning information ..................... 2 WARNING Labels ......................4 Ultrasound Benefits and Risks ..................4 Ultrasound Benefits ......................
  • Page 3 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 ......................30 4.3 Measurements ........................ 31 4.4 Patient’s information and report ..................32 4.5 DICOM .......................... 33 5 maintenance and inspect ......................34 5.1 Charging the probe ......................
  • Page 4 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...

  • Page 5: Introduce

    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.
  • Page 6 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.

  • Page 7: Maintenance And Repair Service

    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"...

  • Page 8: Safety Precautions

    CE-C10-03-SMSP01-20220502 V1.0 1 Safety precautions 1.1 Security classification  According to the type of anti electric shock： Internal power supply, where the adapter is Class 1;  According to the degree of anti electric shock： Type BF application part;  According to the protection degree of harmful liquid：...

  • Page 9: Safety Warning Information

    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. Do not disassemble the ultrasonic probe, which may cause electric WARNI shock.
  • Page 10 CE-C10-03-SMSP01-20220502 V1.0 Matters needing attention in clinical examination technology： CAREF  This equipment can only be operated by qualified medical personnel. UL：  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.

  • Page 11: Warning Labels

    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 indicates the precautions for system security. The instructions explain in detail the meaning of these warning signs. Read the instructions carefully before using the system.

  • Page 12: Product Overview

    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.

  • Page 13: Product Specifications

    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...
  • Page 14 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...

  • Page 15: System Configuration

    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 ...

  • Page 16: Symbol Description

    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 Symbol Explain number Type BF application part explain：All ultrasonic probes are part of the BF application. Please refer to the instruction manual for this symbol to...
  • Page 17 CE-C10-03-SMSP01-20220502 V1.0 Serial Symbol Explain number Country of manufacture Importer Distributor Medical device Power Voltage Frequency Class II equipment Away from the sunlight Storage temperature limit Upwards...
  • Page 18 CE-C10-03-SMSP01-20220502 V1.0 Serial Symbol Explain number Keep dry Storage humidity limit Stacking layer limit...

  • Page 19: Introduction Of Each Component Of The System

    CE-C10-03-SMSP01-20220502 V1.0 2.6 Introduction of each component of the system number Name Function Control buttons Power switch / freeze /Living button Connect to Android/Windows software/Charging USB Type-C port with USB type-C cable Battery status Battery charge/remaining display Serial number; password of this probe’s wifi...

  • Page 20: Control Panel

    CE-C10-03-SMSP01-20220502 V1.0 2.7 Control panel Control Button Key name Function buttons icon 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;...

  • Page 21: Basic Introduction

    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.

  • Page 22: Android Device

    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.

  • Page 23: Turn On/Off The Probe

    CE-C10-03-SMSP01-20220502 V1.0 3.2 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: Probe And Terminal Connection

    CE-C10-03-SMSP01-20220502 V1.0 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.
  • Page 25 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.
  • Page 26 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.
  • Page 27 CE-C10-03-SMSP01-20220502 V1.0 Android Devices Type-C Windows PC USB 2.0 / 3.0 (Win10) IOS Devices 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.

  • Page 28: Basic Software Interface

    CE-C10-03-SMSP01-20220502 V1.0 3.4 Basic software interface Convex array + Phased array mode: Linear array mode:...

  • Page 29: Detailed Operation Introduction

    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.

  • Page 30: Operation Introduction

    CE-C10-03-SMSP01-20220502 V1.0 4.2 Operation Introduction 4.2.1 B mode 24 15 16 11 12 Item Description Serial number of probe Preset selection The Thermal Index (TI), Mechanical Index Dynamic Range (DR) (MI), and Hz values DICOM Procedures, uploading images to Imaging Enhance (ENH) PACS Mode: B⟺...
  • Page 31 CE-C10-03-SMSP01-20220502 V1.0 B Gain （GN） H: change scanning frequency(F) Biopsy Needle Guide line Live/freeze display To invert the image horizontally or vertically. Mid-line U/D flip, R/L flip Dual screen display mode Depth Scale display (only available for Apple ipad and android...
  • Page 32 CE-C10-03-SMSP01-20220502 V1.0 Color/PDI Mode 1 GN Color Gain ± Click Steer Adjust the deflection 2 Steer angle of color ROI Click PRF Adjust color pulse 3 PRF repetition frequency Click WF Adjusting the filtering frequency of a pulse wave or...

  • Page 33: Selecting Exam Present

    CE-C10-03-SMSP01-20220502 V1.0 Click Steer Adjust the deflection 10 Steer angle of sampling line of linear array probe Change the size of the sampling 11 Volume volume Used to change the spectrum 12 Angle sampling line angle Adjust color pulse repetition...

  • Page 34: Switching Between Imaging Modes

    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 Adjust No.23 Focus Pos To modify gray scale image effect Adjust No.24 ENH Adjust No.25 H...

  • Page 35: Bm Mode

    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.

  • Page 36: C Mode

    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). Parameters display area in color 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...

  • Page 37: Pw Mode

    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.

  • Page 38: Measurements

    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: to freeze the image. 1.Tap 2.Tap to access the measurement tools. Mode Measurement Tools Available Operations Length Measures the length between two points of interest.

  • Page 39: Patient's Information And Report

    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 Data Sheet . Please swipe to the left to browse the pictures/videos and report.

  • Page 40: Dicom

    CE-C10-03-SMSP01-20220502 V1.0 4.5 DICOM ， then press Dicom Settings. 1. Click setting 2. Click , you can search and select patient info in the Worklist Query and Store.

  • Page 41: Maintenance And Inspect

    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.
  • Page 42 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.
  • Page 43 CE-C10-03-SMSP01-20220502 V1.0 ： If the probe will not power on after charging, it could indicate a battery CAUTION failure. Contact Support. 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.

  • Page 44: Replace The Battery

    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.

  • Page 45: Cleaning And Disinfecting The Probe

    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...

  • Page 46: Disinfecting The Probe

    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 instructions, and pay attention to whether the use time of detergent is within the warranty...

  • Page 47: Wear Probe Protection Sleeve

    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.

  • Page 48: Storage

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

  • Page 49: Life Cycle

    CE-C10-03-SMSP01-20220502 V1.0 repair. Equipment failure, Users are not allowed to repair WARNING： 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.constituting the product material over time will gradually aging,...

  • Page 50: Troubleshooting

    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.
  • Page 51 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.

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