Eighteeth NanoPix1 User Manual Download Page 66

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Changzhou Sifary Medcial Technology Co., Ltd

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: [email protected]
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. Jian Wang
Dimdi Code: DE/0000048026
E-mail:

[email protected]

Summary of Contents for 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: ...roduction 21 5 1 Login 21 5 2 Software Interface Introduction 22 5 3 The Menu of Tools 23 5 4 Patient Medical Record Menu 27 5 5 Oral X ray Image Acquisition Menu 29 5 6 Oral X ray Image View Menu 32...

Page 4: ...Table of Contents Page 4 66...

Page 5: ...e of Sensor Page 5 66 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 6 7 1 2...

Page 6: ...number Catalogue number Manufacturer Date of manufacture LOT Lot of manufacture Type BF applied part Dispose of in accordance with the WEEE directive Keep dry 55 C 20 C Temperature limitation 80 20 H...

Page 7: ...2 Symbols Page 7 66 IPX8 Protection against liquid...

Page 8: ...akers should use it with caution Pregnant women are prohibited from using it 3 3 Safety Instructions 1 Please read this manual before use 2 The safety regulations and guidelines of NanoPix1 NanoPix2 m...

Page 9: ...MC information In particular do not use the device in the vicinity of fluorescent lamps radio transmitters remote controls and do not use this system near the active HF Surgical Equipment in the hospi...

Page 10: ...GB Hard Disk 64GB Display Resolution 1024 768 or above USB ports USB2 0 1 2 Operating system requirements z Microsoft Windows 7 8 10 32 bit 64 bit 4 2 Cybersecurity 1 Network NanoPix only needs to con...

Page 11: ...l Account Setting NanoPix software adopts account settings when starting and users can open the software only after entering the correct user name and password Encryption and Binding NanoPix is encryp...

Page 12: ...uct Installing Page 12 66 2 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 6...

Page 13: ...connected to the computer terminal before installing the software Step 1 Connect the USB flash driver to the computer and open it Step 2 double click exe file and then click Step 3 Enter the software...

Page 14: ...4 Product Installing Page 14 66 Step 4 The software pops up the driver installation dialog box and click Step 5 Click...

Page 15: ...4 Product Installing Page 15 66 Step 6 Accept the agreement to continue to the next step Step 7 The software pops up a dialog box on the right click to indicate successful driver installation...

Page 16: ...up the following dialog box users could choose to update it or ignore it No network configuration is required and only network connection If the connection is interrupted during the upgrade process p...

Page 17: ...ling Page 17 66 4 6 Sensor Mounting It is recommended to use the sensor mounting bracket to place the sensor The installation method is as follows 1 Use screws and vias to fix the sensor mounting brac...

Page 18: ...4 Product Installing Page 18 66 2 Place unused sensors in the mounting bracket...

Page 19: ...sed as follows 1 Prepare the sensor and the silicone protective cover 2 Gently put the silicone protective cover on the sensor receiving board 4 8 Use of Handheld Bracket When using the Intraoral Digi...

Page 20: ...the sensor and handheld bracket A and then place it in the mouth for imaging The use of handheld bracket B 1 Prepare the sensor and the handheld bracket B 2 Insert the short side of the sensor into th...

Page 21: ...roduction Page 21 66 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 12345...

Page 22: ...ic setting of the software Help User guides PATIENT Patient Medical Record Menu ACQUISITION Oral X ray Image Acquisition Menu VIEWER Oral X ray Image View Menu REPORT Oral Diagnostic Report Menu SEARC...

Page 23: ...y 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 so...

Page 24: ...tting Patient Setting Chart Number setting Patient Name Option Quick Search setting Acquisition Setting General Trigger Mode and Threshold settings Threshold 50uGy 100uGy 200uGy Image Preference Endod...

Page 25: ...Image Lauout Preference Setting 1x1 1x2 2x1 and 2x2 Tools Includes Magnifier size Capture Border Color and Grid settings Mesur a ment Includes Length and Angle settings Annot at ion Includes Draw Lin...

Page 26: ...5 Soft Introduction Page 26 66 Print Includes Paper Header and Footer Preference settings...

Page 27: ...ecord 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...

Page 28: ...Introduction Page 28 66 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 D...

Page 29: ...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 Fl...

Page 30: ...h 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 Offline Sensor is not...

Page 31: ...ival Use to make image mirror up and down NEW STUDY represents the data source IO Sensor data comes from the sensor Import data comes from local TEETH LAYOUT use to determine the age group adult or ch...

Page 32: ...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...

Page 33: ...bine 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 me...

Page 34: ...dontic 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 ima...

Page 35: ...on Page 35 66 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...

Page 36: ...int 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 im...

Page 37: ...6 Operating Instructions Page 37 66 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 38: ...ons Page 38 66 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 pa...

Page 39: ...ations please refer to Chapter 4 8 6 Click Optional place the transmitter of the X ray generator directly on the receiving surface of the sensor ensure the receptor of the sensor can efficiently recei...

Page 40: ...g 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 2 Before step 6 mak...

Page 41: ...tructions Page 41 66 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 acquis...

Page 42: ...6 Operating Instructions Page 42 66 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 43: ...ating Instructions Page 43 66 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 s...

Page 44: ...The user can optimize the acquired X ray image in the VIEW interface WARNING Please read the following warning carefully before using Besides the optimization of the software the image quality is also...

Page 45: ...ording 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 i...

Page 46: ...Page 46 66 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 s...

Page 47: ...e exposure trigger threshold through software Tools Settings Acquisition Trigger setting The operation steps could refer to chapter 5 3 In our test the exposure source parameter used is 60kV 1mA and i...

Page 48: ...Pediatric X ray exposure condition can be changed by the expert s judgment 2 For X ray protection All X ray equipment for Dental Intra oral Radiography used with NanoPix1 NanoPix2 must conform to IEC...

Page 49: ...there is no maximum number of allowable reprocessing The device should no longer be reused in case of signs of material degradation In case of damage the device should be reprocessed before sending ba...

Page 50: ...ve the used disposable sleeve Disconnect all plug connections Put the sensor and USB Extension Cable in container for transportation WARNING Make sure that used sleeves are disposed of as infected was...

Page 51: ...Make sure no liquid penetrates the sensor through the USB cable or connectors otherwise it will damage the internal parts 3 When cleaning the cable hold the sensor with one hand and wipe with the othe...

Page 52: ...ge the components or wipe them with any of the following functional water acidic electrolyzed water strong alkaline solution or ozone water medical agents glutaral etc or any other special types of wa...

Page 53: ...40 C x emptying The automated cleaning processes have been validated by using 0 5 neodisher MediClean forte Dr Weigert Note Acc to EN ISO 17664 no manual reprocessing methods are required for these d...

Page 54: ...n an appropriate packaging material for sterilization WARNING z Check the validity period of pouch given by the manufacturer to determine the shelf life z Use pouches which resist to a temperature up...

Page 55: ...validity period Reprocessing validation study information The above mentioned reprocessing process cleaning disinfection sterilization has been successfully validated Refer to test reports NOTE The in...

Page 56: ...ection 5 3 Close and reopen the software Unplug the sensor and plug it in again The X ray image is dim and textured Exposure time is too short increase exposure time The selected acquisition mode does...

Page 57: ...ent moves during exposure The head of the generator is unstable The image is white The receiver of the sensor is not in the X ray direction Insufficient X ray dose The sensor is not connected or impro...

Page 58: ...V Data interface USB2 0 Electrical safety class Depend on the computer terminal that the sensor is connected to Protection against liquid particular matter IP68 Intraoral part of sensor IPX8 USB cable...

Page 59: ...low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The NanoPix1 NanoPix2 is suitable for use in all establishments including domestic establi...

Page 60: ...oors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transients bursts IEC 61000 4 4 2kV 100kHz repetition frequency 2kV 100kHz repetition frequency Mai...

Page 61: ...ns interruptions it is recommended that devices be powered form an uninterruptible power supply or a battery Rated Power frequency magnetic field IEC 61000 4 8 30 A m 50Hz or 60Hz 30 A m 50Hz or 60Hz...

Page 62: ...ecommended minimum separation distances 3 V Portable and mobile RF communications equipment should be used no closer to any part of the NanoPix1 NanoPix2 including cables than the recommended separati...

Page 63: ...should help keep a minimum distance between RF wireless communications equipment and the NanoPix1 NanoPix2 as recommended below Test freq uenc y MH z Band MHz Service Modulation Maximum power W Distan...

Page 64: ...ecreased electromagnetic immunity of NanoPix1 NanoPix2 and result in improper operation Cable information Cable Name Cable Length m Shielded or not Remark Communication line 2 80 Yes USB extension cab...

Page 65: ...rebuild or adjust the affected parts Maintenance MANUFACTURE will provide circuit diagrams component part lists descriptions calibration instructions to assist to SERVICE PERSONNEL in parts repair Dis...

Page 66: ...angzhou City 213000 Jiangsu P R China Tel 86 0519 85962691 Fax 86 0519 85962691 Email ivy sifary com Web www eighteeth com E C REP Name Caretechion GmbH Add Niederrheinstr 71 40474 Duesseldorf Germany...

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