NaviCam Small Bowel Capsule Endoscopy System 2. Click , when the button icon changes to User Manual P a g e | 50 , the filter browsing mode will be activated (Figure 4-39). In this mode, the software displays only tagged or captured images for further screening. Figure 4-39: Filter Browsing Mode 4.4.9 Option Setting 1. In the main software interface, select “Tool” “Option” to access the option setting interface (Figure 4-40). ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 51 Figure 4-40: Option Setting Interface 2. In the “Department” area, fill in the department information, which will appear in the case report. 3. In the “Export path” area, choose the paths for exported video files and raw data.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 52 User Manual Figure 4-41: Image Preview 5. If the “Add patient info when save images or mp4 videos” option is checked, the patient information will be added to the upper left, upper right, and lower left corners of the save image, as shown in Figure 4-42. Left click to save the current image. Right click to open the folder where the saved images are located.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 53 the image ribbon. – The esophagus, stomach, and small intestine are automatically segmented for the digestive tract image, and different digestive tract segments are marked with different colors on the image ribbon. This NaviCam ProScan feature can only be used when the following 3 conditions are met: 1) Check the "Allow NaviCam ProScan (requires restart)" option, and restart the ESView software to take effect, as shown in Figure 4-43.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 54 User Manual "Recognition success" in the Case Management case list, as shown in Figure 4-44. Figure 4-44: Recognize Progress 3) If suspected positive lesions are found. 1. If the NaviCam ProScan function is not enabled, there will be no ProScan icon displayed on the main interface of ESView.
NaviCam Small Bowel Capsule Endoscopy System 2. P a g e | 55 User Manual When the NaviCam ProScan icon is blue, the images of suspected positive lesions are marked with red on the image color band, and the "First esophagus image", "First stomach image" and "First small bowel image" images are displayed in the image capture area. Mark position and segment color on the image ribbon, as shown in Figure 4-46. Figure 4-46: NaviCam ProScan Total Images Mode 3.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 56 User Manual Figure 4-47: NaviCam ProScan Mode Figure 4-48: NaviCam ProScan Normal Images Mode 4.4.11 Add to Atlas 1. Move the mouse over the image, right click the mouse and select “Add to Atlas” in the pop-up menu (Figure 4-49) to access the add to atlas interface. ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 57 Figure 4-49: Add to Atlas 2. In the add to atlas interface, select an atlas type in the list on the left and fill in the name in the text box on the right, as shown in Figure 4-50. Click “OK” to confirm. Figure 4-50: Add to Atlas Interface 3. In the main software interface, select “Tool” “Capsule endoscopy atlas” to access the capsule endoscopy atlas interface.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 58 Figure 4-51: Capsule Endoscopy Atlas Interface 4.5 Report Generation 1. In the main software interface, click 4-52). to access the report generation interface (Figure Figure 4-52: Report Generation Interface 2. Move the mouse over the captured image area and double click to select images. The selected images will then be added to the report image area. Double click on images in report image area to remove them.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 59 Figure 4-53: Select Images for Report 3. Move the mouse over the timestamp of an image and double click the left mouse button to edit image comment in the text box below the image (Figure 4-54). Figure 4-54: Edit Report Image Comment 4. In the captured image area and report image area, right clicking the mouse button will bring out the edit menu. Click “edit” to add annotation and comments. 5.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 60 Figure 4-55: Report Preview 7. In the report generation interface, click "Save report", choose a directory and click “Save” to save the case report (Figure 4-56). The software saves reports in *.pdf format by default. The user may also choose to save reports in *.doc format (Figure 4-57). After saving, a dialog box will appear to indicate saving success (Figure 4-58).
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 61 Figure 4-57: Save Report in .doc Format Figure 4-58: Saving Success Dialog Box 8. In the main software interface, select “File”“Saving finding” to access the save finding interface (Figure 4-59). The finding file saves image markings, comments, and other textual information. Subsequently, the user can select “File”“Open finding” in the menu to load video with all the findings again. Figure 4-59: Save Finding Interface 9.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 62 User Manual setting interface. The user can set image zoom scale in the report, image quantity, font size of the comments, whether to print image background, and whether to add patient information in the image. Click “OK” to save report setting changes. Click “Cancel” to exit the interface without saving changes. 4.6 Case Management 1.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 63 3. The software automatically searches two levels of directory under the case data storage path and displays the patient information found in the case list. In the add case data storage path interface (Figure 4-61) click “View setting” to access the view setting interface (Figure 4-62). Drag the mouse or click the “<<” or “>>” buttons to select the data fields to be displayed.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 64 User Manual Figure 4-63: Patient Information Editing Interface 5. Using the tools from the “Inquire” area, the user can filter cases by procedure date, procedure type, capsule SN, patient name, physician name, and exam result. Click the “Refresh” button to update cases. Click the “Reset” button to reset filters and update cases. 4.7 Capsule Endoscopy Atlas 1.
NaviCam Small Bowel Capsule Endoscopy System 2. 3. User Manual P a g e | 65 Figure 4-64: Capsule Endoscopy AtlasInterface Click on the normal anatomy images or typical GI tract lesions in stomach, duodenum, and small intestine. Select the stomach area or lesion type to be compared and view the corresponding normal anatomy images or lesion images, as shown in Figure 4-65.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 66 Figure 4-66: Comparison Between Exam Image and AtlasImage 4. Figure 4-67: Image Comparison Interface After comparison, if the location or lesion of the exam image is confirmed, click the green checkmark in the upper right corner of the image comparison interface to close it. The software will automatically add the name of the atlas image as a comment to the exam image (Figures 4-68 and 4-69). ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 67 Figure 4-68: Confirm ComparisonResult Figure 4-69: Name of Atlas Image Added as a Comment to the Exam Image 4.8 Software Help 1. In the main software interface, select “Help” ”About” to access the software information interface (Figure 4-70). The interface shows the full name, version number, and the manufacturer of the software. ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System 2. User Manual P a g e | 68 Figure 4-70: Software Information Interface In the main software interface, select “Help” “Instruction” in the menu to access the user manual. 4.9 Software Configuration Backup/Restore 1. 2. 3. The software supports configuration file backup and restore. The user can automatically or manually backup the configuration files of the software. The default backup path is D:\ankonConfigBackup\yyyymmdd_hhmmss.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 69 Figure 4-71: Backup Configuration File 4. Figure 4-72: Dialog Box to Confirm Successful Backup of the Configuration Files Select “Help””Restore configuration files” to open the restore configuration file selection interface, select the folder where the configuration files to be restored are located and click “Select Folder”, then click “Confirm” in the pop-up dialog box to confirm configuration file restore.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 70 User Manual Figure 4-74: Restore Configuration File Selection Interface Figure 4-75: Dialog Box to Confirm Configuration FileRestore Figure 4-76: Dialog Box to Confirm Successful Restore 4.10 Software Exit 1. In the main software interface, select “File” “Exit” in the menu or click the button on the upper right corner, then on the pop-up dialog box (Figure 4-77) click “Yes” to exit or “No” to cancel. ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 71 Figure 4-77: Exit Dialog Box 2. If a case report is changed, the user will be presented with the save finding dialog box (Figure 4-78) upon exit, where the user can click “Yes” to save findings, “No” to exit without saving findings, or “Cancel” to cancel exit. Figure 4-78: Save Finding Dialog Box ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 72 User Manual CHAPTER 5: USING THE CAPSULE The capsule is packed in a sealed package. You can directly take the capsule out and activate it as shown in the following figures. The protective cover is used as a fixture and protects the capsule, facilitating its storage and handling before operation. 1. 2. 3. 4. Figure 5-1: Schematic Diagram of Capsule Activation for Use Tear off the paper cover of the package box.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 73 CHAPTER 6: USING THE DATA RECORDER 6.1 Data Recorder(AKR-1) 6.1.1 Installation and Use The Data Recorder is equipped with 14 sensor arrays, as presented in Figure 6-1. Figure 6-1: Data Recorder ( AKR-1) When in use, the Data Recorder and sensor arrays are embedded into the corresponding examination vest as shown in Figure 6-2. As tested, the working temperature of the data recorder can reach 42℃ tested under 40℃ ambient temperature.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 74 User Manual Figure 6-3 AKR-1 Data Recorder Operation Manual ①: Alarm indicator, yellow; ⑦: Power switch; ②: Run indicator, green; ⑧: USB interface to connect ③④⑤: Battery capacity indicators; ⑨: Charging port. ⑥: Charge indicator, white; Hold down the power switch without releasing until all the five LEDs (marked as ①②③④⑤ in Figure 6-3) are lit up to power on the Data Recorder normally.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 75 these three LEDs will be on and off flashing in a cycle manner. If the white LED charge indicator (marked as in ⑥ in Figure 6-3) keeps lighting up, it indicates that it is under charging (it will be lit up once it is charged regardless of the status of the Data Recorder power). The white LED will automatically turn off when fully charged. WARNING The Data Recorder should be charged only with provided charger.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 76 User Manual AKRI-1 Data Recorder and then put in the pocket of the Host as shown in Figure 6-7. Figure 6- 7 AKRI-1Belt-Examining Cloth Dressing View 6.2.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 77 To power off the AKRI-1 Data Recorder, click the Turn On/Off button in ESView Software Interface. If the AKRI-1 Data Recorder cannot detect the information of the capsule for 30 minutes and cannot connect to the software of Rtdisplay via USB port, it would be automatically power off to save power. If the telecommunication indicator light flashes green, it means the capsule’s data are adequately received.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 78 CHAPTER 7: USING THE LOCATOR 7.1 Operation Panel Figure 7-1 shows functional keys and indicators of the Locator. Figure 7-1: Keys and Indicators of Locator : Scanning indicator, Yellow; 2 : Working indicator, Green; 3 : Infrared light source to activate capsule; 4 : Keys; 1 ⑤: Power Switch; ⑥: Charging port; ⑦: Power switch indicator, white; ⑧: Label plate. 7.2 Use 7.2.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 79 User Manual Figure 7-2: Schematic Diagram of turning-on the Capsule 7.2.2 Locate the Capsule To detect the location of the capsule in a patient using the Locator, perform the following steps: 1. Turn on: Hold the Locator upright, start the Locator by pressing “Power Switch” in the open space without metal objects nearby.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 80 CHAPTER 8: TROUBLESHOOTING 8.
NaviCam Small Bowel Capsule Endoscopy System Problem Real-time image is not transmitted to computer 8.3 Data Recorder Exception Turn the power switch on, and LED or screen are not lit up An image is not transmitted to your computer in real-time 8.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 82 CHAPTER 9: MAINTENANCE 9.1 Cleaning the Data Recorder Vest/Belt-Examination Cloth After each procedure, the examination vest/belt should be sprayed with 70% IPA and then wiped with a clean, dry cloth and air dried for at least 15 minutes. The outer layer of fabric can be washed in water.
NaviCam Small Bowel Capsule Endoscopy System CHAPTER 10: User Manual P a g e | 83 TECHNICAL SPECIFICATIONS 10.1 Data Recorder (Model AKR-1/AKRI-1) Operating performance: Recording time: 8 hours (2fps) Battery type: Lithium battery,3.6-4.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 84 User Manual Modulation Technique: 8-FSK Transmit power: ≤10mW(e.i.r.p.) Adaptor: UE15WCP1-052200SPA for Model AKR-1 Input: 100-240 V a.c ,50/60 Hz, 500 mA Protection class: class II, continuous duty Output: 5.2 V⎓2 A d.c UE10WCP1-050200SPA for Model AKRI-1 Input: 100-240 V a.c , 50/60 Hz, 500 mA Protection class: class II, continuous duty Output: 5.0 V⎓2 A d.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 85 User Manual 10.2 Capsule(Model AKES-11SW/AKES-11SI ) Physical performance: Length: 27 ± 1.0 mm Weight: 4.5 ± 0.5 g Diameter: Material: Optical performance: Illumination: LED flash frequency: Camera: 11.8 ± 0.5mm Biocompatible materials LED 0.
NaviCam Small Bowel Capsule Endoscopy System Chemical safety: User Manual P a g e | 86 Resistance to dissolve when pH ranges from 2-8 Environmental operating conditions a temperature range to +5 ℃to +40 ℃ a relative humidity range of 15% to 90%, non-condensing but no requiring a water vapour partial presssure greater than 50 hPa and An atmospheric pressuer range of 700 hPa to 1060 hPa Environmental conditions of transport and storage Temperature Limit：-25 ℃~70 ℃ Humidity Limit：0% ~90% Pressure Limit：
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 87 CAUTION The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. WARNING The user shall avoid using RFID technology near the device while it is operating. 10.
NaviCam Small Bowel Capsule Endoscopy System Protection class: P a g e | 88 User Manual class II, continuous duty 10.4 ESView Software ESView software runs on the PC. - CPU: Intel Core i3 2.0GHz or later - GPU:rtx4000 or later - Monitor: Resolution 1920*1080 or higher - HDD: 250GB or above - Memory: 8GB or above - USB Port: 2 or more - Operating System: Windows 7 or above 10.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 89 User Manual Guidance and manufacturer’s declaration - electromagnetic immunity The Data Recorder is intended for use in the electromagnetic environment specifiedbelow. The user of the Data Recorder should assure that it is used in such anenvironment.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 90 User Manual Guidance and manufacturer’s declaration - electromagneticimmunity The Data Recorder is intended for use in the electromagnetic environment specifiedbelow. The user of the Data Recorder should assure that it is used in such anenvironment.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 91 User Manual 10.5.2 Capsule Guidance and manufacturer’s declaration - electronicemissions The Capsules are intended for use in the electromagneticenvironment specified below. The user of the Capsules should assure that it is used insuch an environment.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 92 User Manual Guidance and manufacturer’s declaration - electromagneticimmunity The Capsules are intended for use in the electromagnetic environment specified below. The user of the Capsules should assure that it is used in such an environment. Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply Lines ±1 kV for input/output Lines ±0.5 kV, ±1 kV line(s) to line(s) ±0.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 93 User Manual Guidance and manufacturer’s declaration - electromagneticimmunity The Capsules are intended for use in the electromagnetic environment specified below. The user of the Capsules should assure that it is used in such an environment. Immunity test Conducted RF IEC 60601 test level 3V IEC 61000-4-6 150 kHz – 80 MHz Radiated RF 3 V/m IEC 61000-4-3 ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 94 User Manual 10.5.3 Locator Guidance and manufacturer’s declaration - electronic emissions The Locator is intended for use in the electromagnetic environment specified below. The user of the Locator should assure that it is used in such an environment.
NaviCam Small Bowel Capsule Endoscopy System P a g e | 95 User Manual Guidance and manufacturer’s declaration - electromagneticimmunity The Locator is intended for use in the electromagnetic environment specified below. The user of the Locator should assure that it is used in such an environment. ±0.5 kV, ±1 kV, ±2 kV ±0.5 kV, ±1 kV line(s) to Surge Mains power quality line(s) IEC/EN should be that of a line(s) to earth ±0.5 kV, ±1 kV, ±2 kV 61000-4-5 typical commercial or hospital environment.
NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 96 Guidance and manufacturer’s declaration - electromagnetic immunity The Locator is intended for use in the electromagnetic environment specified below. The of the Locator should assure that it is used in such an environment. Immunity test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System CHAPTER 11: P a g e | 97 User Manual SYSTEM LABELING Followings are labels of the system components: Symbol Serial Number Description Manufacturer Date of Manufacture Type BF Applied Part Do not re-use STERILE EO Sterilized using ethylene oxide IP Code(10m,2h) Batch Code Use by Non-ionizing electromagnetic radiation Do not use if package is damaged Refer to instruction manual/booklet Caution Symbol for “ENVIRONMENT PROTECTION – Waste electrical products
NaviCam Small Bowel Capsule Endoscopy System Symbol User Manual P a g e | 98 Description recycle where facilities exist. Check with your local Authority or retailer for recycling advice.” Nameplate of Data Recorder（AKR-1） Nameplate of Locator ( AKS-1) Nameplate of Data Recorder（AKRI-1） Keep dry This Side Up Stacking Limit (Not Exceed 3 Layers) ANKON Technologies Co., Ltd.
NaviCam Small Bowel Capsule Endoscopy System Symbol P a g e | 99 User Manual Description Pressure Limit 700hPa~1060hPa ANKON Technologies Co., Ltd.
