Eighteeth NanoPix1 User Manual
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Eighteeth NanoPix1 User Manual

Intraoral digital imaging sensor
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Intraoral Digital Imaging Sensor
USER MANUAL
Changzhou Sifary Medical Technology Co., Ltd

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Summary of Contents for Eighteeth NanoPix1

  • Page 1 Intraoral Digital Imaging Sensor USER MANUAL Changzhou Sifary Medical Technology Co., Ltd...
  • Page 2 Version: S04 IFU-6935013/S04 Issued: 2020.12.19 Size: 130mmx180mm...

  • Page 3: Table Of Contents

    Table of Contents Table of Contents 1. Scope of Sensor.....................5 2. Symbols........................ 6 3. Introduction......................8 3.1 Scope of Application..................8 3.2 Contraindications...................8 3.3 Safety Instructions..................8 4. Product Installing....................10 4.1 Installation Environment Requirements............10 4.2 Cybersecurity....................10 4.3 Connecting the Sensor to the Computer Terminal........11 4.4 Software Installing..................
  • Page 4 Table of Contents Page 4 / 66...

  • Page 5: Scope Of Sensor

    1 Scope of Sensor 1. Scope of Sensor 1. Sensor 2. USB Flash Driver 3. Sensor Mounting Bracket 4. Disposable Sleeve 5. USB Extension Cable 6. Silicone Protective Cover 7. Handheld Bracket (Optional). Page 5 / 66...

  • Page 6: Symbols

    2 Symbols 2. Symbols If the instructions are not followed properly, the operation may WARNING lead to hazards for the product or the user/patient. Additional information, explanation operation, NOTE performance. Serial number Catalogue number Manufacturer Date of manufacture Lot of manufacture Type BF applied part Dispose of in accordance with the WEEE directive Keep dry...
  • Page 7 2 Symbols IPX8 Protection against liquid Page 7 / 66...

  • Page 8: Introduction

    3 Introduction 3. Introduction 3.1 Scope of Application NanoPix1/NanoPix2 is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygenrich environment.
  • Page 9 (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the NanoPix1/NanoPix2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 10: Product Installing

    4. Product Installing 4. Product Installing 4.1 Installation Environment Requirements Since this product is not equipped with a computer, during the installation of this product, customers need to provide an additional laptop or desktop computer. The specific performance requirements of the computer are as follows: 1.

  • Page 11: Connecting The Sensor To The Computer Terminal

    4. Product Installing 2. Security Software: NanoPix supports anti-virus software and/or use of firewall for proper protection against viruses, malware, and intrusions. The security software should be an effective version that can ensure the security of the computer system. 3. Data Interface and Transfer Protocol: USB2.0 4.
  • Page 12 4. Product Installing Check and ensure the connection between the computer and the sensor is reliable. NOTE All IT components electrically connected to the NanoPix1/NanoPix2 must confirm to IEC 60950-1. Page 12 / 66...

  • Page 13: Software Installing

    4. Product Installing 4.4 Software Installing Make sure the sensor is connected to the computer terminal before installing the software. Step 1: Connect the USB flash driver to the computer and open Step 2: double click .exe file, and then click Step 3: Enter the software installation, wait for...
  • Page 14 4. Product Installing Step 4: The software pops driver installation dialog box, click Step 5: Click Page 14 / 66...
  • Page 15 4. Product Installing Step 6: Accept agreement continue to the next step. Step 7: The software pops up a dialog box on right, click indicate successful driver installation. Page 15 / 66...

  • Page 16: Software Update

    4. Product Installing Step 8: In the last step, the software installation successful dialog box pops up, you can click or close it. 4.5 Software Update If there is an update of NanoPix software, the computer terminal will pop up the following dialog box, users could choose to update it or ignore it.

  • Page 17: Sensor Mounting

    4. Product Installing 4.6 Sensor Mounting It is recommended to use the sensor mounting bracket to place the sensor. The installation method is as follows: Use screws and vias to fix the sensor mounting bracket to the wall. Page 17 / 66...
  • Page 18 4. Product Installing Place unused sensors in the mounting bracket. Page 18 / 66...

  • Page 19: Sensor Protection

    4. Product Installing 4.7 Sensor Protection When the sensor is not in use, it can be wrapped with a silicone protective cover, which has reduced scratches or wears on the sensor receiving board. The sensor silicone protective cover is used as follows: Prepare the sensor and the silicone protective cover Gently...
  • Page 20 4. Product Installing 2. Insert the long side of the sensor into the handheld bracket A in the vertical direction and fix the wire. 3. Use a Disposable Sleeve to cover the sensor and handheld bracket A and then place it in the mouth for imaging.

  • Page 21: Software Introduction

    5. Soft Introduction 5. Software Introduction 5.1 Login Click the icon on the desktop to start the software, and its startup interface is as shown in the figure below: UserId Admin(Default) Password 123456(Default) Page 21 / 66...

  • Page 22: Software Interface Introduction

    5. Soft Introduction 5.2 Software Interface Introduction After completing the user login, the software enters the home page interface: File: Use to exit. Tools: Use for the basic setting of the software. Help: User guides. PATIENT: Patient Medical Record Menu. ACQUISITION: Oral X-ray Image Acquisition Menu.

  • Page 23: The Menu Of Tools

    5. Soft Introduction the database. QUICK SEARCH: Use for searching for the recently acquired or recently viewed diagnostic data. Medical record list display area. Use for filtering medical records by date. 5.3 The Menu of Tools The menu of Tools is used for the basic setting of the software Setting: Use for basic setting of the software.
  • Page 24 5. Soft Introduction User Style Setting. Clinic Name setting. Address setting. Phone Number setting Chart Number setting Patient Patient Name Option Setting Quick Search setting. Trigger Mode and Threshold settings Threshold: 50uGy, 100uGy, 200uGy General Image Preference: Acquisition Endodontic; Periodontic;Restorative. Setting Teeth Layout: Adult and Child.
  • Page 25 5. Soft Introduction resolution while displaying, keep the default value. Image Storage path Full Screen setting: On and Off. General Image Lauout Preference Setting: 1x1, 1x2, 2x1 and 2x2. Includes Magnifier size 、 Tools Viewer Capture Border Color Grid Setting settings.
  • Page 26 5. Soft Introduction Print Includes Paper 、 Header and Footer Preference settings. Page 26 / 66...

  • Page 27: Patient Medical Record Menu

    5. Soft Introduction 5.4 Patient Medical Record Menu The main page of Patient Medical Record Menu PATIENT: Click it and enter the Patient Medical Record interface. : Use to create a new medical record. : Use to edit a medical record. : Use to delete a medical record.
  • Page 28 5. Soft Introduction Patient list and thumbnails of selected patients: Right-click the selected thumbnail to quickly execute： 1. Send to the Viewer; 2. Send to Report; 3. Export; 4. Export All; 5. Detail; 6. Delete. Page 28 / 66...

  • Page 29: Oral X-Ray Image Acquisition Menu

    5. Soft Introduction 5.5 Oral X-ray Image Acquisition Menu The main page of Oral X-ray Image Acquisition Menu：IO Sensor ACQUISITION: Click it and enter the oral X-ray Image Acquisition Menu interface. 90CCW: Use to rotate image 90° counterclockwise. 90CW: Use to rotate image 90° clockwise. Flip Horizontal: Use to make image mirror left and right.
  • Page 30 5. Soft Introduction TEETH LAYOUT: use to determine the age group: adult or child. IMAGE PROCESSING: use to process the acquired image data, include Endodontic, Periodontic, Restorative, Smart Contrast, Smart Sharpen, Smooth, Inverse, Colorize, and Reset. BRIGHTNESS & CONTRAST: Manual, Auto and Reset. Sensor Indicator: “Waitting Exposuring”: Indicate that the sensor is connected successfully and can be exposed.
  • Page 31 5. Soft Introduction 90CCW: Use to rotate image 90° counterclockwise. 90CW: Use to rotate image 90° clockwise. Flip Horizontal: Use to make image mirror left and right. Flip Vertival: Use to make image mirror up and down. NEW STUDY: represents the data source. IO Sensor: data comes from the sensor;...

  • Page 32: Oral X-Ray Image View Menu

    5. Soft Introduction 5.6 Oral X-ray Image View Menu The main page of Oral X-ray Image View Menu VIEWER: Click it and enter the Oral X-ray image View Menu interface. 90CCW: Use to rotate image 90° counterclockwise. 90CW: Use to rotate image 90° clockwise. Flip Horizontal: Use to make image mirror left and right.
  • Page 33 5. Soft Introduction Zoom: Combine the mouse wheel to zoom in/out the image. Reset. Length: Measure length. Angle: Measure angle. Draw: Draw a curve. Line: Draw a straight line. Rectangle: Place rectangle. Ellipse: Place ellipse. Memo: Make a memo. Magnify: Local zoom Clear Overlayers Page 33 / 66...
  • Page 34 5. Soft Introduction Capture: Screenshot Grid. IMAGE PROCESSING: use to process the acquired image data, include Endodontic, Periodontic, Restorative, Smart Contrast, Smart Sharpen, Smooth, Inverse, Colorize, and Reset. BRIGHTNESS & CONTRAST: Manual, Auto and Reset. LAYOUT: image layout, use to configure the image display. X-ray image list: Double-click the X-ray image in the list to display it in the display area.

  • Page 35: Oral Diagnostic Report Menu

    5. Soft Introduction 5.7 Oral Diagnostic Report Menu The main page of Oral Diagnostic Report Menu Report: Click it and enter the Oral Diagnostic Report Menu interface. New report Add page Delete page Add image box Add text box Page 35 / 66...
  • Page 36 5. Soft Introduction Print Print Setting Fit horizontal Fit vertical TEMPLATE: Use to select a template for generating a medical record report. REPORT HISTORY: Use to save the generated report and import the existing report. X-ray image list The display area of the report. Page 36 / 66...

  • Page 37: Operating Instructions

    6 Operating Instructions 6. Operating Instructions 6.1 Acquiring Oral X-ray Image 1. Open NanoPix software. 2. Click , create a new medical record or select an existing medical record. Page 37 / 66...
  • Page 38 6 Operating Instructions 3. Click , enter the oral X-ray image acquisition interface, and make sure the sensor is connected successfully( the is ready). 4. Make sure that the NEW STUDY is IO Sensor ， and determine the patient's TEETH LAYOUT Page 38 / 66...
  • Page 39 6 Operating Instructions 5. Use the handheld bracket to fix the sensor and a Disposable Sleeve to cover the sensor and handheld bracket and then place it in the mouth for imaging. For specific operations, please refer to Chapter 4.8. 6.
  • Page 40 6 Operating Instructions 7. Checks the image quality, if it is not good, adjust the X-ray transmitter parameters(refer to chapter 7), repeat step 5-6. WARNING Please read the following warning carefully before using: 1. Before starting the experiment, please keep the sensor receiving board clean and wrap it with a disposable sleeve before putting it in the patient's mouth.

  • Page 41: Importing Existing Oral X-Ray Images

    6 Operating Instructions 6.2 Importing Existing Oral X-ray Images 1. Open NanoPix software. 2. Click , create a new medical record or select an existing medical record. 3. Click , enter the oral X-ray image acquisition interface. Page 41 / 66...
  • Page 42 6 Operating Instructions 4. Make sure that the NEW STUDY is Import , and click to import existing X-ray images( jpeg, png, bmp, jpg, and dcm file). 5. Save X-ray images to the database. Page 42 / 66...
  • Page 43 6 Operating Instructions WARNING Please read the following warning carefully before using: Make sure to save the X-ray image to the database after finishing step 4. In other words, make sure to do step 5. Page 43 / 66...

  • Page 44: Image Quality Optimization

    6 Operating Instructions 6.3 Image Quality Optimization The image quality optimization currently supported by NanoPix includes IMAGE PROCESSING(Endodontic, Periodontic, Restorative),Smart Sharpen, Smooth, Inverse, Colorize, Reset, BRIGHTNESS&CONTRA(Manual, Auto, Reset). user optimize acquired X-ray image VIEW interface. WARNING Please read the following warning carefully before using: Besides the optimization of the software, the image quality is also related to the Dose / Exposure time.
  • Page 45 6 Operating Instructions 2. Optimize the acquired X-ray images according to section 6.3 (optional). 3. Click the report to enter the oral diagnostic report interface, select the report template ; Select the picture frame and double-click the right X-ray image to fill the image box; Double-click the text box and input the patient's diagnosis results.
  • Page 46 6 Operating Instructions 4. According to the actual needs, use the upper toolbar to edit the report, including creating a new report, adding a page, deleting a page, adding an image box, adding text box (optional); Finally, save and print the report. Page 46 / 66...

  • Page 47: Recommended X-Ray Source Parameters And Exposure Time

    7 Recommended X-ray Source Parameters and Exposure Time 7. Recommended X-ray Source Parameters and Exposure Time exposure Dose 60kVp 60kVp 65kVp time (µGy) Patient Adult Adult Adult 28cm 28cm 28cm Intra Oral No filter X-ray Unit Approximate exposure time(second) Incisor 300~500 0.12~0.2 0.1~0.2...
  • Page 48 2. For X-ray protection: All X-ray equipment for Dental Intra-oral Radiography used with NanoPix1/NanoPix2 must conform to IEC 60601-2-65:2012. The rules for dental radiography still apply to digital X-ray systems. Please continue to use protection for your patients.

  • Page 49: Maintenance

    8 Maintenance 8. Maintenance 8.1 Foreword For hygiene and sanitary safety purpose, the sensor must be cleaned and disinfected even if the disposable sleeve is used. The silicone protective cover and handheld bracket can be steam sterilized, and they should be cleaned, disinfected and sterilized before each usage to prevent any contamination.

  • Page 50: Disinfection Components

    8 Maintenance Do not use bleach or chloride disinfectant materials. 8.3 Disinfection components Disinfection components USB Extension Cable Sensor Sensor Mounting Bracket WARNING Before first use, after each use and whenever there is a risk of contamination, disinfect the above components. Reprocessing Instructions Preparation before cleaning: Immediately after using, remove the used disposable sleeve.

  • Page 51: Autoclavable Components

    8 Maintenance 2. Wipe off the sensor, USB extension cable and mounting bracket surface with a cloth soaked in isopropyl alcohol (70%) to disinfect them completely and thoroughly at least twice. Carefully follow the disinfecting solution manufacturer’s recommended contact time. 3.
  • Page 52 8 Maintenance 1. Only the above components can be autoclaved. 2. Before first use and after each use, sterilize the above components. Reprocessing Instructions Preparation at the Point of Use: 1. Disconnect the silicone protective cover and handheld bracket before cleaning.
  • Page 53 8 Maintenance Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to be given to automated reprocessing methods, especially due to the better standardizing potential and industrial safety. Automated Cleaning: Carefully put the components into the washer-disinfector on a tray and set the parameters as follows, then start the program: 4 min pre-washing with cold water (<40°C);...
  • Page 54 8 Maintenance sterilized immediately. A manual disinfection is not recommended. Drying: Automated Drying: Drying the components through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air. Functional Testing, Maintenance: Visual inspection for cleanliness of the components and reassembling.
  • Page 55 8 Maintenance Use only this recommended sterilization procedure. Control the efficiency (packaging integrity, no humidity, color change of sterilization indicators, physicochemical integrators, digital records of cycles parameters). Waiting for cooling before touching. Storage: Storage of sterilized components in a dry, clean and dust free environment at modest temperatures, refer to label and instructions for use.

  • Page 56: Troubleshooting

    9 Troubleshooting 9. Troubleshooting When a problem or malfunction occurs, please check the machine with the table below before contacting the dealer to quickly eliminate common problems or malfunctions. If the problem or malfunction is not solved, please contact the dealer.
  • Page 57 9 Troubleshooting screen display. The patient moves during exposure. The X-ray image is blurred The head of the generator is unstable. The receiver of the sensor is not in the X-ray direction. Insufficient X-ray dose. The image is white The sensor is not connected or improperly connected. Check the high-voltage generator to ensure that it emits X-rays.

  • Page 58: Technical Data

    10 Technical Data 10. Technical Data Manufacturer Changzhou Sifary Medical Technology Co., Ltd □ □ NanoPix1 / NanoPix2 Model 19.6cm x 14.4cm x 3.4cm±1cm(Package) Dimensions 0.4kg ± 10% Weight NanoPix1: 20x30mm Effective imaging area NanoPix2: 26x36mm Power 1.5W Max Sensor technology...

  • Page 59: Emc Tables

    11. EMC Tables Guidance and manufacturer’s declaration – electromagnetic emissions The NanoPix1/NanoPix2 is intended for use in the electromagnetic environment specified below. The customer or the user of the NanoPix1/NanoPix2 should assure that it is used in such an environment. Electromagnetic...
  • Page 60 11 EMC Tables Immunity test 60601 Compliance Electromagnetic test level level environment - guidance Electrostatic discharge Floors should be wood, (ESD) IEC 61000-4-2 contact contact concrete or ceramic tile. If floors are covered with +/- 2 kV, +/- 4 +/- 2 kV, +/- 4 synthetic material, the kV, +/- 8 kV, kV, +/- 8 kV,...
  • Page 61 Note: UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz Guidance and manufacturer’s declaration – electromagnetic immunity The NanoPix1/NanoPix2 is intended for use in the electromagnetic environment specified below. The customer or the user of the NanoPix1/NanoPix2 should assure that it is used in such an environment. Page...
  • Page 62 IEC 61000-4-6 MHz, 6 V in equipment should be used bands no closer to any part of the be-tween 0.15 NanoPix1/NanoPix2, including cables, than the MHz, 80 % AM recommended separation at 1 kHz distance calculated from the equation applicable to frequency transmitter.
  • Page 63 When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected. The NanoPix1/NanoPix2 has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2014.
  • Page 64 2.80 USB extension cable 0.13 Use of NanoPix1/NanoPix2 adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, NanoPix1/NanoPix2 and the other equipment should be observed to verify that they are operating normally.

  • Page 65: Statement

    12 Statement 12. Statement Expected Service Life The expected service life of NanoPix series products is 5 years. Warranty MANUFACTURER hereby warrants NanoPix series products against defects in material and the workmanship under normal usage and service for a period of 24 months from the date of installation.
  • Page 66 Add: NO.99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, 213000 Jiangsu, P.R. China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: ivy@sifary.com Web: www.eighteeth.com E C R EP Name: Caretechion GmbH Add: Niederrheinstr. 71, 40474 Duesseldorf, Germany Tel: +49 211 3003 6618 Fax: +49 211 3003 6619 Contact Person: Mr.

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