FCC ID: 2A6BYAKES-11SW Capsule

NaviCam Small Bowel Capsule Endoscopy System User Manual ANKON Technologies Co., Ltd. AKQWO-YF-018 Revision A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 2 Copyright Statement:

The ownership of the User Manual belongs to ANKON Technologies Co., Ltd., and it should not be distributed or reproduced by any means or in any form without prior written permission by ANKON Technologies Co., Ltd.. The User Manual is protected by copyright, and all rights are reserved. ANKON Technologies Co., Ltd. reserves the right to change the User Manual and the products as described herein. Equipment specifications are subject to change without prior notification. Any information contained in the User Manual is not to be considered a proposal, guarantee, commitment or contractual conditions. Warranty ANKON Technologies Co., Ltd. assures that all parts in the NaviCam Small Bowel Capsule Endoscopy System are well-designed, manufactured, packed and tested for prevention of defects, and assumes no responsibility for any accident, loss, damage or cost increase directly or indirectly resulting from use of the ESView platform. ANKON Technologies Co., Ltd. will repair or replace parts within the warranty period, while customer is responsible for all other items including normal wear and team or anything that is out of the control of ANKON Technologies Co., Ltd. , including but not limited to operation, storage, cleaning, misuse, abuse, patient treatment or diagnosis. This warranty replaces any other warranties which may have been implied in verbal or documented form. Modifications by User or Third Party Any and all modifications to the product which are not expressly approved in writing by ANKON Technologies Co., Ltd. will void this warranty in its entirety. Manufacturer: ANKON Technologies Co., Ltd. Address:B3-2,B3-3,D3-4 Biolake,No.666,Hi-Tech Road, East Lake New Technology Development Zone, Wuhan, 430075 Hubei, China CAUTION:

US Federal law restricts this device to sale by or on the order of a physician. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 3 TABLE OF CONTENTS CHAPTER 1:....................................................................................................................... INTRODUCTION5 1.1 1.2 1.3 IMPORTANT INFORMATION................................................................................................................... 5 ABOUT NAVICAM SMALL BOWEL CAPSULE ENDOSCOPY SYSTEM........................................................... 5 1.2.1 Capsule(AKES-11SW/AKES-11SI)....................................................................................... 6 1.2.2 Data Recorder......................................................................................................................... 7 1.2.3 Locator..................................................................................................................................... 9 1.2.4 ESView Software...................................................................................................................10 SUMMARY OF CLINICAL PERFORMANCE.............................................................................................. 10 CHAPTER 2:.................................................. INDICATIONS, CONTRAINDICATIONS AND WARNINGS14 INDICATIONS..................................................................................................................................... 14 2.1 CONTRAINDICATIONS......................................................................................................................... 14 2.2 ADVERSE EVENTS...............................................................................................................................14 2.3 2.4 WARNINGS........................................................................................................................................ 14 CHAPTER 3:.................................................................. ESVIEW SOFTWARE OPERATION INITIATION17 3.1 3.2 3.3 3.4 INSTALLATION................................................................................................................................... 17 UNINSTALLATION...............................................................................................................................20 BASIC SOFTWARE OPERATION............................................................................................................21 SOFTWARE STARTUP.......................................................................................................................... 22 3.4.1 First-time Startup.................................................................................................................22 3.4.2 Regular Startup.....................................................................................................................23 CHAPTER 4:........................................................... ESVIEW SOFTWARE OPERATION INSTRUCTIONS25 4.1 4.2 PATIENT CHECK-IN............................................................................................................................25 REAL TIME VIEWING IN RTDISPLAY INTERFACE.................................................................................. 26 4.2.1 Access Rtdisplay................................................................................................................... 26 4.2.2 Functions of Buttons in the Toolbar.................................................................................. 27 4.2.3 Rtdisplay Image Zoom-in and Out..................................................................................... 28 4.2.4 Data Recorder Status Indicator.......................................................................................... 28 4.3 DATA EXPORT....................................................................................................................................29 IMAGE BROWSING, PROCESSING, AND EDITING, PROSCAN MODE.........................................................31 4.4 4.4.1 Open Video.......................................................................................................................... 31 4.4.2 Video Playback Function....................................................................................................32 4.4.3 Image Browsing.................................................................................................................. 32 4.4.4 Image Tagging..................................................................................................................... 37 4.4.5 Image Remark..................................................................................................................... 39 4.4.6 Thumbnails..........................................................................................................................43 4.4.7 Image Processing................................................................................................................ 45 4.4.8 Browsing Mode................................................................................................................... 49 4.4.9 Option Setting......................................................................................................................50 4.4.10.................................................................................................................... NaviCam ProScan52 ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 4 4.4.11.............................................................................................................................. Add to Atlas56 REPORT GENERATION........................................................................................................................58 4.5 CASE MANAGEMENT..........................................................................................................................62 4.6 CAPSULE ENDOSCOPY ATLAS............................................................................................................. 64 4.7 SOFTWARE HELP............................................................................................................................... 67 4.8 SOFTWARE CONFIGURATION BACKUP/RESTORE................................................................................. 68 4.9 4.10 SOFTWARE EXIT................................................................................................................................ 70 CHAPTER 5:...............................................................................................................USING THE CAPSULE72 CHAPTER 6:................................................................................................ USING THE DATA RECORDER73 6.1 DATA RECORDER(AKR-1).................................................................................................................73 6.1.1 Installation and Use............................................................................................................73 6.1.2 Operation Instructions.......................................................................................................73 6.2 DATA RECORDER (AKRI-1)...............................................................................................................75 6.2.1 Installation and Usage........................................................................................................75 6.2.2 Operation Description........................................................................................................76 CHAPTER 7:.............................................................................................................. USING THE LOCATOR78 7.1 7.2 OPERATION PANEL............................................................................................................................ 78 USE................................................................................................................................................... 78 7.2.1 Turn-on the Capsule........................................................................................................... 78 7.2.2 Locate the Capsule..............................................................................................................79 7.2.3 Turn-off the Locator........................................................................................................... 79 7.2.4 Charge the Locator............................................................................................................. 79 CHAPTER 8:............................................................................................................... TROUBLESHOOTING80 ESVIEW WARNINGS.......................................................................................................................... 80 8.1 CAPSULE............................................................................................................................................80 8.2 8.3 DATA RECORDER............................................................................................................................... 81 LOCATOR........................................................................................................................................... 81 8.4 CHAPTER 9:......................................................................................................................... MAINTENANCE82 9.1 9.2 CLEANING THE DATA RECORDER VEST/BELT-EXAMINATION CLOTH.................................................. 82 CLEANING THE DATA RECORDER AND LOCATOR................................................................................. 82 CHAPTER 10: TECHNICAL SPECIFICATIONS........................................................................................ 83 10.1 DATA RECORDER (AKR-1/AKRI-1)................................................................................................. 83 10.2 CAPSULE(AKES-11SW/AKES-11SI )............................................................................................. 85 10.3 LOCATOR........................................................................................................................................... 87 10.4 ESVIEW SOFTWARE...........................................................................................................................88 10.5 GUIDANCE AND MANUFACTURER'S DECLARATIONS.............................................................................88 10.5.1.......................................................................................................................... Data Recorder88 10.5.2......................................................................................................................................Capsule91 10.5.3......................................................................................................................................Locator94 CHAPTER 11: SYSTEM LABELING...........................................................................................................97 ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 5 CHAPTER 1: INTRODUCTION 1.1 Important Information A thorough understanding of the technical principles, clinical applications and risks associated with the NaviCam Small Bowel Capsule Endoscopy System is necessary before using this product. Read this entire manual before using the system for the first time. Failure to follow instructions could result in damage to the equipment or pollution to environment. CAUTION WARNING Failure to follow instructions could result in injury or even death to operator, patient, or other personnel. To avoid the risk of electric shock, this equipment must only be connected to a power supply that is properly grounded. 1.2 About NaviCam Small Bowel Capsule Endoscopy System The User Manual introduces the use of NaviCam Small Bowel Capsule Endoscopy System (Model:

NS-I, hereinafter referred to as "NaviCam SB System"). The NaviCam SB System is a type of capsule endoscope system. This chapter introduces tip information involved in the quick guide and the User Manual. NaviCam SB System is comprised from the following components:

- Capsule (Model: AKES-11SW, AKES-SI)

- Data Recorder (Model: AKR-1, AKRI-1)

- Locator (Model: AKS-1)

-ESView Software The NaviCam SB System contains two components, the Capsule and the Data Recorder, which work in different frequencies 2.4GHz, 915MHz. These components are equally used in conjunction with the other components of the NaviCam SB System, namely, the Locator and the ESView software. The relationship between the models of the Capsules and the models of the Data Recorders with their corresponding frequencies is shown in Table1-1. CAUTION Mixing between the Capsule model and Data Recorder model will result ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 6 in a failed examination and could damage the equipment. Table1-1: Relationship between product models and associated frequencies Frequency 2.4GHz 915MHz Capsule Model AKES-11SW AKES-11SI Data Recorder Model AKR-1 AKRI-1 A description of each component is provided below. 1.2.1 Capsule(AKES-11SW/AKES-11SI) The Capsule presented in Figure 1-1, is a capsule endoscope capable of capturing images inside the human digestive tract. This capsule contains a built-in camera, wireless receiving and transmitting unit, LED lights, battery, and a magnet. All components are sealed in a case made of biocompatible materials. Figure 1-1: Capsule (2.4 GHz AKES-11SW, 915MHz AKES-11SI) WARNING Capsule is MR unsafe. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receivingantenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 7 Consult the dealer or an experienced radio/TV technician forhelp. 1.2.2 Data Recorder 1.2.2.1 Data Recorder (AKR-1) The AKR-1 Data Recorder, presented in Figure 1-2, is a portable data receiving unit with built-in rechargeable lithium battery placed inside the examination cloth worn by the patient during examination. It is used for receiving image data wirelessly transmitted from the Capsule. The Data Recorder is charged with an included charger when not in use. Figure 1-2: Data Recorder (2.4 GHz AKR-1) Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. WARNING Never charge the Data Recorder when it is in use by a patient. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 8 Note:

The Data Recorder is used in a hospital environment.as well as in the home healthcare environment, and shall be used by trained personnel or professional personnel. The service life of the battery under the typical condition is 5 years. For the Data Record at low-temperature storage ,which is beyond the operating temperature range, please place them for half an hour or more until warm to operating ambient temperature before using them. And also, for the Data Record at high temperature storage ,which is beyond the operating temperature range, please place them for half an hour or more until cool to operating ambient temperature before using them. 1.2.2.2 Data Recorder (AKRI-1) The AKRI-1 Data Recorder works in the same way as Data Recorder (AKR-1). The AKRI-1 Data Recorder consists of the following three parts as shown in Figure 1- 3 1) Data Recorder Host. 2) Belt-examining cloth (including antenna) and data cable. 3) Charging base. Figure 1- 3 Data Recorder (915MHz AKRI-1) The Data Recorder is charged with an included charger when not in use. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 9 correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. WARNING Do not charge the Data Recorder when it is in use. The battery of the Data Recorder is non-removable and the users shall not replace the battery at discretion. Note:

The Data Recorder is used in a hospital environment.as well as in the home healthcare environment, and shall be used by trained personnel or professional personnel. The service life of the battery under the typical condition is 5 years. For the Data Record at low-temperature storage ,which is beyond the operating temperature range, please place them for half an hour or more until warm to operating ambient temperature before using them. And also, for the Data Record at high temperature storage ,which is beyond the operating temperature range, please place them for half an hour or more until cool to operating ambient temperature before using them. 1.2.3 Locator The Locator, presented in Figure 1-4, is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position. The Locator is charged with an included charger. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 10 Figure 1- 4: Locator WARNING Never charge the Locator when it is in use by a patient. For patient who needs to undergo an MRI test before the expulsion of the capsule has been confirmed, Locator scan should not replace an X-Ray to confirm the absence of capsule in the body. 1.2.4 ESView Software ESView software is the image review software component of the NaviCam SB System . It can be installed on a dedicated image review computer at a hospital, clinic, or doctors office for physicians to review capsule endoscopeimages. The ESView enables the following functions:

Patient check-in Data export Image browsing, processing, and editing, with or without the optional ProScan feature Report generation Case management Capsule endoscopy atlas The minimum operating environment for running ESView software is asfollows:

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 1.3 Summary of Clinical Performance The NaviCam Small Bowel Capsule Endoscopy System was evaluated in two clinical studies: (1) a prospective study, comparing its performance to that of the FDA cleared PillCam SB3 Capsule Endoscopy System (hereafter referred to as PillCam SB System); and (2) a retrospective study to evaluate the performance of the optional ProScan feature of the ESView software. Summaries of both studies are provided below, and the full reports are attached to Section 20.

(1) Performance Evaluation of the AKE-1(NaviCam SB) Capsule Endoscope System in Comparison to the PillCam SB3 Capsule System for the Diagnosis of Small Bowel Diseases This was a prospective, comparative study in 3 sites in China, aimed to evaluate the performance of the NaviCam SB System (trial capsule) when compared to the PillCam SB System (control ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 11 capsule or comparator) for the diagnosis of small bowel diseases. Study primary endpoints included Per Findings analysis, where the recordings obtained with both capsules were independently evaluated and the agreement between findings of both capsules was evaluated; and, Per Subject analysis; where the diagnosis of subjects based on independent interpretation of images obtained with both capsules was evaluated (diagnosis of normal or abnormal per subject). A number of secondary endpoints were also assessed including ease of swallowing the capsule, intestinal transit time, capsule excretion time, diagnostic yield when compared to other standard mucosal imaging procedures, quality of small bowel images, image reading time, and agreement between two or more reviewers with respect to interpretation of the images obtained. The study included adult subjects with symptoms of small bowel diseases or suspected gastrointestinal bleeding. After signing informed consent, subjects who met the study eligibility criteria completed gastrointestinal preparation in advance according to the examination schedule. Before swallowing the capsules, an antifoaming agent (10ml simethicone) with 120ml of water was administered to reduce air bubble formation in the small bowel. Each subject wore the two types of data recorders then swallowed the two types of small bowel capsules approximately 40 minutes apart in a randomized order. Subjects were allowed to drink water 2 hours after swallowing the capsules and eat a small amount of food 4 hours after swallowing the capsules. Upon confirming that the capsules have entered the small bowel, the subjects left the hospital and were instructed to continue wearing the data recorders for 8-10 hours until the power of the capsules were depleted, or the capsules were excreted. The anonymized images acquired by both the trial capsule and comparator were read by two gastroenterologists independently for normal and abnormal interpretation and analysis of lesion type (edema, polyp, hemorrhage, etc.), capsule transit time, reading time and image quality; in cases of disagreement, a third gastroenterologist reviewed the video in question and provided his/her result. A total of 97 subjects were enrolled in the study; 10 subjects were withdrawn or withdrew consent prior to the study procedure. As these subjects did not swallow the capsules, they were excluded from data analysis, therefore, the results from 87 subjects were included in both Per Protocol Set (PPS) analysis and Full Analysis Set (FAS). Primary Efficacy Results:

Per Subject Analysis: Normal versus Abnormal Abnormal rates (NaviCam 73/87 PillCam 68/87) Positive Percent Agreement (PPA) [95% CI]:

Negative Percent Agreement (NPA) [95%CI]

Overall Percent Agreement [95% CI]

Overall percent agreement per Kappa analysis [95% CI] 0.6652 (0.4653, 0.8652) Positive Predictive Value (PPV) [95% CI]

Negative Predictive Value (NPV) [95% CI]

McNemar Test Results 83.91% 78.16%, 97.06% (89.90%, 99.19%) 63.16% (41.04%, 80.85%) 89.66% (81.50%, 94.46%) 90.41% (81.50%, 95.28%) 85.71% (60.06%, 95.99%) X2=2.7778, p=0.0956 ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 12 Per Finding Analysis:

There were no statistically significant differences between the 2 capsules in the detection of vascular tumors/polyps/masses

(p=1.0000), ulcers/ulcerations (p=0.3938), and other lesions (p=0.4669). inflammatory lesions

(p=0.2087),

(p=0.6831), lesions Safety Results:

One case of capsule retention occurred where both NaviCam and PillCam capsules were retained. The incidence of adverse events was 1.15%. No abdominal pain, abdominal distention, nausea, vomiting, headache, obstruction, or other adverse events occurred. In conclusion, the NaviCam SB System and PillCam SB System had a diagnostic overall percent agreement rate of 89.66% (81.50%, 94.46%), and an overall percent agreement Kappa of 0.6652

(0.4653, 0.8652). The results of this comparative study indicate that NaviCam Small Bowel Capsule Endoscopy System performs similarly to the PillCam SB3 Capsule Endoscopy System and provides an effective non-invasive method for the detection of small bowel diseases.

(2) Retrospective Evaluation to Compare Small Bowel Video Reading by AKE-1 (NaviCam SB) Capsule Endoscopy System with ProScan Feature and PillCam SB3 Capsule System with SBI Feature The goal of this retrospective evaluation was to compare the performance of the NaviCam SB System ESView software with the ProScan feature to this of the PillCam SB System with the SBI feature. The recordings/images used in this study were previously obtained in the prospective study (study (1)) and were analyzed by two independent reviewers for visual comparison of the findings and analysis using ESView software with ProScan and Rapid software with SBI in comparison to the conventional reading previously performed for both systems. Capsule endoscopy videos of 87 subjects were used and included in both the Full Analysis Set

(FAS) and Per Protocol Set (PPS) analyses. The primary endpoint of the study was to evaluate the performance of the NaviCam SB System with the ProScan software feature in comparison with the PillCam SB System SBI feature (per patient analysis). Secondary study endpoints included per findings analysis, image review time, and image review time of NaviCam reading with and without the ProScan feature on. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 13 96.43% (90.02%, 98.78%) 100.00% (43.84%, 10.00%

X2=3.0000, p=0.0833 96.55% 93.10%, 100.00% (95.47%, 100.00%) 50.00% (18.76%, 81.24%) 96.55% (90.35%, 98.82%) Per Subject Analysis: Normal versus Abnormal Abnormal rates (NaviCam 84/87 PillCam 81/87) Positive Percent Agreement (PPA) [95% CI]:

Negative Percent Agreement (NPA) [95%CI]

Overall Percent Agreement [95% CI]

Overall percent agreement per Kappa analysis [95% CI] 0.6506 (0.2866, 1.0000) Positive Predictive Value (PPV) [95% CI]

Negative Predictive Value (NPV) [95% CI]

McNemar Test Results These results demonstrate that the NaviCam SB System and PillCam SB System have good diagnostic consistency. There were no statistically significant differences in the diagnosis of vascular lesions (p=0.4497), inflammatory lesions (p=0.3173, tumors/polyps/masses (p=0.2207), malabsorption (p=1.0000), ulcers/ulcerations (p=0.7963), and other lesions (p=0.0863) between the NaviCam SB and PillCam SB systems. The video review time of the trial capsule was 1.63 min higher than that of the control capsule, and the difference was statistically significant. The difference between the mean reading time of the NaviCam SB with ProScan on and conventional reading (i.e., without ProScan feature on) was

-36.63 min (-46.29 min, -26.72 min) (95% CI), the difference was statistically significant. The results of the analysis of the consistency of the interpretation of the images obtained by two or more reviewers (FAS/PPS) show that the differences between the two groups are not statistically significant. The results of this study showed that the clinical performance of the NaviCam SB System with the ProScan feature and PillCam SB System (with SBI) were similar, and that the NaviCam SB System with ProScan feature on significantly reduced the physician's reading time compared to the reading time of the NaviCam SB System without the ProScan on (21.478.05 vs. 58.1045.28, p<0.0001). ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 14 CHAPTER 2: INDICATIONS, CONTRAINDICATIONS AND WARNINGS 2.1 Indications The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. 2.2 Contraindications The capsules are contraindicated for use under the following conditions:

In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile. In patients with cardiac pacemakers or other implantable electronic medical device. In patients with an easily magnetized metal part. In patients with dysphagia or other swallowing disorders. In pregnant women. Note: The Capsule maybe deployed by using transendoscopic delivery in patients who are unable to ingest the capsule or are known to have prolonged gastric emptying time. Placement into the duodenum is recommended to prevent the patient from vomiting the capsule. Potential adverse events associated with the use of a capsule include injury to a patient caused by delayed excreting or not excreting of capsule, aspiration of the capsule, and interference from strong magnetic field sources. It could be necessary to remove the capsule by intervention. 2.3 Adverse Events 2.4 Warnings A negative or normal result obtained by the capsule does not exclude the presence of pathology and if symptoms persist, further evaluation should be performed. If intestinal fistulas, strictures, or stenosis are suspected, or the patient has had prior abdominal or pelvic surgery, the physician should consider performing an examination to ascertain patency for an object the size of the capsule. The safety of the capsule has not been established in children. The capsule should not be swallowed by patients where a concern for aspiration of the capsule exists (e.g., due to cognitive or neurological deficits or a history of aspiration). In these patients, it is recommended that a capsule endoscopic delivery system be used to ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 15 place the capsule directly in the duodenum. Placement of the capsule in the duodenum will decrease the risk of aspiration of the device [by vomiting] and gastric retention. A thorough understanding of the technical principles, clinical applications and risks associated with the Capsule System is necessary before using this product. Read the entire manual before using the system for the first time. Make sure that only trained personnel or professional personnel, familiar with all operating procedures of the NaviCam SB System, use the system. To prevent the patient from being exposed to unforeseen risks during passage of any capsule, make sure the patient thoroughly understands the procedure, and provide the patient with a copy of the Patient Labeling. A patient with known or suspected delayed gastric emptying (whether disease related or drug induced) could be at increased risk for incomplete the NaviCam SB System. When swallowing the capsule there is a possibility of choking on the capsule. If the patient exhibits any symptoms and/or clinical signs of choking (labored breathing, wheezing, involuntary coughing, etc.), the recommended first-aid procedure should be followed. Keep the capsule away from implants such as pacemakers and other devices that could be affected by proximity to a DC magnetic field. If a child has accidentally swallowed any unused or spent capsule, seek medical attention. Instruct the patient not to sit on bare metal surfaces, such as chairs with metal seating area, during the procedure. Instruct the patient to contact the physician immediately if, after ingesting any capsule, there is any abdominal pain, nausea, or vomiting. Only one capsule should be ingested at a time and only after confirmation that no other capsules or ingestible diagnostic devices remain in the patients body. If, contrary to instructions, a patient ingests more than one capsule, instruct the patient to immediately contact the physician. In patients with unsuspected strictures of the GI tract, any capsule can potentially cause intestinal obstruction resulting in the need for hospitalization and surgery. The safety of this device in patients with significant gastrointestinal diverticular disease is unknown. Final diagnosis based on the capsule images should be made only by physicians who are trained in the interpretation of capsule endoscopy images. If there is reasonable doubt concerning the integrity of the capsule due to dropping, biting, or any other eventuality, the capsule should be deactivated by returning it to its box and it should not be used until consulting with an authorized ANKON Technologies representative. Store all capsules in a safe place, out of the reach of children and infants. Do not use any capsule after its expiration date. Instruct the patient to avoid biting the capsule prior to swallowing. Instruct the patient to wear the data recorder throughout the procedure. After ingesting the capsule and until it is excreted, the patient should not be near any source of powerful electromagnetic fields such as one created near an MRI device. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 16 Undergoing an MRI while the capsule is inside the patient's body may result in serious damage to his/her intestinal tract or abdominal cavity. If the patient did not positively verify the excretion of any capsule from his/her body, he/she should contact the physician for evaluation with the Locator and possible abdominal X-ray before undergoing an MRI examination. A capsule should be ingested only in the presence of authorized medical personnel. The patient should be instructed not to let relatives, neighbors or acquaintances use any capsule without medical attention. If excretion of the capsule from the patient has not been positively verified, and the patient develops unexplained post-procedure abdominal pain, vomiting, or other symptoms of obstruction, he/she should contact the physician for evaluation with the Locator and possible abdominal X-ray examination. Use the system only with components purchased from ANKON Technologies. Use of other components may damage the system and void the warranty. In a small number of cases, the capsules may not image the entire small bowel due to variations in patient GI motility. After ingesting the capsule, the patient should abstain from eating or drinking for another 2 hours. After 2 hours, the patient may drink water. After 4 hours, the patient may have a light snack. After the examination is completed, the patient may return to a normal diet. These instructions related to eating apply unless physician instructs otherwise. The inspection will last for about 8 hours. The physician should instruct the patient when the examination is considered complete. During the examination, the patient should avoid any physical activity that involves sweating and to abstain from bending. The Data Recorder should be treated with utmost care and protection. Sudden movement and banging of the Data Recorder should be avoided. The patient should be instructed not to remove the Data Recorder during the examination. The patient may take his/her usual prescribed medication up until two hours before the examination and resume two hours after capsule ingestion, with water. If the patient is taking any medication that may delay gastric emptying, consider withholding the drug on the day of the test if this is medically acceptable. The capsule is for single use only. Even if other devices meet corresponding national emission standards, the system may still be interfered. The battery of the Data Recorder is not removable, and incorrect replacement will lead to unacceptable risks. Unauthorized personnel are prohibited to replace the lithium battery in the equipment. The users shall not disassembled/modified the Vest/Examination cloth as well as any connection cable by themselves ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 17 CHAPTER 3: ESVIEW SOFTWARE OPERATION INITIATION 3.1 Installation 1. Double click the ESView software installer to install ESView software. The welcome dialog box will pop up (Figure 3-1). Click Next to continue. Figure 3-1: ESView Installation Welcome Dialog Box 2. The Software License Agreement dialog box (Figure 3-2) is displayed. Scroll down to view the agreement in its entirety. Click I Agree to accept. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 18 Figure 3-2: Software License Agreement Dialog Box 3. The dialog box for selecting the destination folder (Figure 3-3) is displayed. The default installation directory is C:\Program Files(x86)\ESView. Click Browse to change the directory. Click Install to continue installation in the selected directory. Figure 3-3: Selection of Installation Directory 4. The dialog box, showing the installation progress (Figure 3-4), is displayed. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 19 Figure 3-4: Installation Progress Dialog Box 5. After ESView software is successfully installed, the Setup Completed! dialog box (Figure 3-5) appears. Click Finish to complete installation. A shortcut to the ESView program is created on the desktop. Figure 3-5: Successful Installation Dialog Box ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 20 3.2 Uninstallation 1. To uninstall the ESView software, from the Windows Start menu, select Programs ESView Uninstall ESView. The uninstallation dialog box (Figure 3-6) appears. Click Uninstall to begin the uninstallation. Figure 3-6: Uninstallation Dialog Box 2. After ESView software is successfully uninstalled, the Uninstall Success! dialog box (Figure 3-7) appears. Click Finish to complete uninstallation. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 21 Figure 3-7: Successful Uninstallation Dialog Box 3.3 Basic Software Operation 1. Connect the data recorder to the PC installed with the ESView software, open the ESView and create a new case, and enter and save the basic information of the patient in the data recorder. 2. After confirming the patient information, turn on the capsule, and the images the capsule is capturing and displayed on the Rtdisplay interface. Check if the capsule image display is normal and if the capsule voltage meets the examination requirements. After confirmation, operate according to the examination manual, and help the patient swallow the capsule. 3. After the examination is complete, connect the data recorder to ESView software and export the image data from the recorder and generate a report after viewing the images. The chart below (Figure 3-8) shows the workflow of the system. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 22 Figure 3-8: NaviCam SB System Workflow 3.4 Software Startup ESView software can be launched by double clicking the ESView shortcut icon on the desktop. The ESView software launch screen (Figure 3-9) will appear. 3.4.1 First-time Startup Figure 3-9: ESView Software Launch Screen When ESView software is launched for the first time on the computer it is installed on, the user ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 23 needs to complete a registration step, using the unique license code received from ANKON, and set up a software password. 1. At first-time launch of ESView software, the registration interface (Figure 3-10) is displayed. The serial number in the top box automatically appears and the user has to enter the license code received from ANKON into the blank box to register the software. Note: ESView software will not function until registration is completed. Figure 3-10: Registration Interface 2. After registration, the user is presented with an UI to set up a login password for ESView software. The user can choose to require the password to be manually entered every time ESView software is launched or have the software automatically fill in the password, i.e., auto login. Note: After logging into the main software interface, the user can select Tools Accounts in the menu to add/delete accounts and change passwords. 3. The user can then proceed to use ESView software. 3.4.2 Regular Startup 1. Use your login credentials to enter into ESView.Figure 3-11 ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 24 Figure 3-11: Login 2. If Microsoft Word 2003 or later version is not installed on the computer, ESView will display a dialog box to alert the user that report generation in Word format will not be supported

(Figure 3-12). Figure 3-12: Dialog Box Alerting that Word Format Report Is Not Supported Note: All other functions of ESView software will not be affected. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 25 CHAPTER 4: ESVIEW SOFTWARE OPERATION INSTRUCTIONS The main ESView software interface, where the user can browse and annotate images, is shown in Figure 4-1. The user can also use the menu or buttons to access interfaces for patient check-in, data export, medical record management, and report generation, etc. 4.1 Patient Check-in Figure 4-1: Main ESView Software Interface In the main software interface, select ToolCheck-in in the menu to launch the patient check-in interface (Figure 4-2), where the user can enter patient information and save it to the data recorder. Eventually the patient information will be exported together with the patient image data from the data recorder to the computer. The data recorder should be connected to the computer via USB before patient check-in. Only one patient information can be saved in the data recorder at a time. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 26 Figure 4-2: Patient Check-in Interface The patient information already stored in the data recorder can be retrieved and displayed in the information entry area by clicking the Read record button. The Clear button can be used to clear patient information in the entry area. After entering the patient information, click OK button to save the patient information to the data recorder, or click Cancel button to exit the patient check-in interface without saving. 4.2 Real Time Viewing in Rtdisplay Interface 4.2.1 Access Rtdisplay 1. In the main software interface, select ToolRtdisplay in the menu to launch the real-time display interface as shown in Figure 4-3. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 27 Figure 4-3: Rtdisplay Interface 2. 3. In the Rtdisplay interface, images captured by the capsule endoscope inside the digestive tract can be real-time displayed and its running status can be adjusted. The Data Recorder should be connected to your computer via USB for Rtdisplay. If the Data Recorder is not properly connected, buttons on the toolbar area are disabled, and "Connection to data recorder failed" in red will be shown at the connection status display area on the status bar. If the Data Recorder is correctly connected, buttons on the toolbar are available, and

"Connected to data recorder " in black will be shown at the connection status display area on the status bar. 4.2.2 Functions of Buttons in the Toolbar The functions of the toolbar buttons are detailed in Table 4-1 below. Table 4-1: Rtdisplay View Button Function Icon Function Shut down Data Recorder Shut down capsule endoscope Pause capsule endoscope ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 28 4.2.3 Rtdisplay Image Zoom-in and Out 1. Image zoom-in and out can be realized by mouse scrolling, then scaled to x% will be displayed in upper right corner of the image to represent current scaling factor, as shown in Figure 4-4. 2. To restore original size of the displayed image without any zoom in or out, double click the Figure 4-4: Zoom Function image display area. 4.2.4 Data Recorder Status Indicator 1. Two LED status indicators are located in the lower right bottom of the Data Recorder. The left one indicates work status (Green)

, and the right one indicates warning (red)

. 2. Meaning of status indicators:

a) Green LED flashes, red LED does not light indicates image data from capsule ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 29 b) Green LED does not light, red LED lights indicates no signal from capsule endoscope endoscope has been received. has been received. c) Green LED does not light, red LED flashes indicates capsule endoscope signal has been received, but no image data has been received. 4.3 Data Export 1. In the main software interface, select ToolData export in the menu to access the data export interface (Figure 4-5) Figure 4-5: Data Export Interface 2. The data export interface is mainly used to export image data captured by the capsule endoscope to the computer. This interface supports two export modes. One is quick export, which exports the data as a raw data file with suffix *.ankon. *.ankon files cannot be opened by ESView until being parsed to video files. The quick export mode is applicable when it is needed to export image data of the last patient quickly and prepare the data recorder for the next examination. The other export mode is direct export, which exports and parses the data as a video file that can be opened by ESView software. 3. To use the direct export mode, select Export and convert data into video file and click Start export. The image data will be exported from the data recorder as a video file that can be directly opened by ESView. 4. To use the quick export mode, select Export data as RAW file and click Start export. The image data will be exported from the data recorder as a raw data file with suffix *.ankon. To convert raw data file to video file, select Convert existing RAW file into video files and click ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 30 Start export, then select a RAW file in the raw data file selection interface (Figure 4-6) and generate the video file. Figure 4-6: RAW Data File Selection Interface 5. The data recorder should be connected to the computer via USB when exporting data, otherwise, an alert will appear on the data export interface to remind the user to connect the data recorder to the computer (Figure 4-7). Figure 4-7: Data Recorder Not Connected Alert 6. If Shutdown computer when finishing is checked, the computer will automatically shut down after data export finishes. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 31 4.4 Image Browsing, Processing, and Editing, ProScan mode 4.4.1 Open Video 1. In the main software interface, select FileOpen video to access the patient data file selection interface (Figure 4-8). The default path is the data export path. Figure 4-8: Patient Data File Selection Interface 2. Select a patient folder and open the *.acpi file under the folder. The software will automatically load image data in this folder, and the image data will be displayed in the main software interface (Figure 4-9). Figure 4-9: Main Software Interface After Opening Image Data 3. To open recently opened videos, select File Recent video select video path in the menu. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 32 4.4.2 Video Playback Function 1. In the main software interface, click the forward or backward playback button (Figure 4-10) to play the loaded video in forward or backward direction. 2. To stop video playback, click the pause button (Figure 4-11). Figure 4-10: Video Playback Buttons Figure 4-11: Pause Playback Button 4.4.3 Image Browsing 1. Click the

,and buttons to access single-image display mode, two-image ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 33 display mode, transverse four-image display mode, array four-image display mode, and multi-image display mode, respectively, as shown in Figures 4-12 to 4-16. The display mode can also be switched by selecting a display mode in the Display menu. Figure 4-12: Single-Image Display Mode Figure 4-13: Two-Image Display Mode ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 34 Figure 4-14: Transverse Four-Image Display Mode Figure 4-15: Array Four-Image Display Mode ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 35 Figure 4-16: Multi-Image Display Mode 2. Use the playback speed slider to adjust the video playback speed. Click to play video in forward direction. Click to play video in backward direction. Click to display the next image frame. Click to display the previous image frame. Click to display the last image frame. Click to display the first image frame. 3. In single-image and two-image display mode, click to enlarge image display, and click to shrink the image display. In other display modes, the enlargement function is unavailable. In such case, click to switch to the single-image display mode. Figure 4-17 shows the single-image enlargement mode and Figure 4-18 shows two-image enlargement mode. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 36 Figure 4-17: Single-Image Enlargement Mode Figure 4-18: Two-Image Enlargement Mode 4. Click to access the image processing control panel, as shown in Figure 4-19. Drag the corresponding sliders to adjust definition, brightness, and color. Checking the Saturation box and then drag the sliders below to adjust saturation. The image can also be processed using the software's built-in algorithms, including denoise, distortion correction, and image enhancement. It is important to note that if any one of the four options (Image denoise, Distortion correction, Enhance-ICCI, Enhance-RGB) at the bottom is selected, the adjustment of definition, brightness, and color will be disabled, and the image is automatically ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 37 processed by the corresponding algorithm. Click to undo all the image processing. Figure 4-19: Image Processing Control Panel 5. When the icon of the button next to the time window shows as

, the time window and the thumbnail time display show image absolute time. Click

, the button icon will change to

, and the time window and the thumbnail time display will show image relative time. Click

, and the button icon will change back to

. The absolute time is the wall clock time when the image is captured by the capsule endoscope, the relative time is the time difference between the image and the first captured image. 4.4.4 Image Tagging 1. Move the mouse over the image to be tagged and right click on the image. In the pop- up menu (Figure 4-20), select Select the first esophagus image, Select the first stomach image, Select the first small intestine image, Select the first large intestine image, or Select the last digestive tract image to tag the image as a landmark of the digestive tract. When an image is tagged, the colors in the progress bar will change automatically according to the position of the tagged image, separating the images by different sites of the digestive tract. The information in the status bar also changes automatically. The tagged images will appear in the bottom thumbnail area ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 38 Figure 4-20: Image Tagging 2. In addition to tagging an image, the user can also capture an image. Move the mouse over the image to be captured and right click on the image, then select Capture image in the pop-up menu to capture the image (Figure 4-21). An alternative way to capture an image is to double click on the image. The captured image will also appear in the bottom thumbnail area. If the current image is already tagged, such as first esophagus image, the image capture function is disabled. Figure 4-21: Image Capture 3. To cancel image tagging or remove an image from the captured image set, click on the image thumbnail in the thumbnail area to select the image, move the mouse over the image and ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 39 right click on the image then select "Cancel select" in the pop-up menu (Figure 4-22). The image will be removed from the thumbnail area and the colors in the progress bar will be updated accordingly. Figure 4-22: Cancel Image Tagging or Capture 1. Move the mouse over the image you want to add a remark to and right click on the image. Select Add remark in the pop-up menu (Figure 4-23) or click to access the add remark 4.4.5 Image Remark interface (Figure 4-24). ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 40 Figure 4-23: Add Remark Through Pop-Up Menu Figure 4-24: Add Remark Interface 2. In the add remark interface, click to add arrow markings. When the icon changes to

, the user can add an arrow on the image by left clicking to set the start point and holding the left mouse button and dragging to set the endpoint. Click to add circular markings. When the icon changes to

, the user can add a circle on the image by left clicking to set ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 41 the center and holding the left mouse button and dragging to change its size (Figure 4-25). Click to undo the previous marking and click to undo all markings. The markings will be reflected on the images in the thumbnail area. Figure 4-25: Add Markings 3. Click to select the first tagged or captured image, click to select the previous tagged or captured image, click to select the next tagged or captured image, and click to select the last tagged or captured image. Alternatively, the user can move the mouse over an image and scroll over images to select the desired image. Table 4- 2 Description of buttons in the Add Remark Interface Button Function Description Add arrow remark Add circle remark Add rectangle remark Measure lesion length Add text remark ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 42 Button Function Description Set remark color Remove the previous remark Remove all remarks Display the first selected image Display the previous selected image Display the next selected image Display the last selected image Image Setting Add text notes 4. Click to access the add comment interface (Figure 4-26). The user can enter textual descriptions to the image into the comment text box in two ways:

Input manually; or Double click one of the expressions in the Frequently used comment list, a built-in list in ESView software. The user can also add or remove entries in the list. The added comments will be reflected on the images in the thumbnail area. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 43 Figure 4-26: Add Remark Interface 5. As previously described, clicking brings up the image processing control panel (Figure 4-27). The sliders and checkboxes function the same as those in the image processing control panel described previously. Figure 4-27: Image Processing Control Panel 6. Click to exit the add remark interface. 4.4.6 Thumbnails shown in Figure 4-28. 1. Thumbnails of the tagged and captured images are displayed in the thumbnail area, as ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 44 Figure 4-28: Thumbnail Display Area 2. In the thumbnail display area, move the mouse over the image to add remark to and right click on the image, then select Add remark in the pop-up menu (Figure 4-29) to add remark to the corresponding image using the add remark interface shown in Figure 4-26. Figure 4-29: Add Remark to Thumbnail 3. In the thumbnail display area, right click on a thumbnail, then select Cancel mark in the pop-up menu to remove the thumbnail from the thumbnail area, as shown in Figure 4-30. Multiple thumbnails can be removed together by left clicking the thumbnails to be deleted while holding down the Ctrl key or by holding down the left mouse button and dragging the mouse to select multiple thumbnails, and then right clicking to select Cancel mark from the ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 45 pop-up menu. Figure 4-30: Thumbnail Cancel Mark 4. To go to a specific landmark and display the image in the main display area, in the thumbnail display area right click on a thumbnail and select Jump to the first esophagus image, Jump to the first stomach image, Jump to the first small intestine image, Jump to the first large intestine image, or Jump to the last digestive tract image in the pop-up menu. Alternatively, move the mouse over a thumbnail and then double click the left mouse button to display the corresponding image in the main display area. 4.4.7 Image Processing 1. Clicking will bring up the image processing control panel (Figure 4-31). The user can adjust image definition, brightness, and color by using the corresponding sliders. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 46 Figure 4-31: Image Processing Control Panel 2. ESView software is equipped with image denoise algorithm. Check the Image denoise box and the effect as shown in Figure 4-32. To undo the denoising, uncheck the Image denoise box. 3. Check the Distortion Correction box to correct image distortion (Figure 4-33). Figure 4-32: Image Denoise ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 47 4. Check the Enhance - ICCI box to achieve the post-processing effect (Figure 4-34). Figure 4-33: Distortion Correction 5. Check the Enhance - RGB box to achieve the post-processing effect (Figure 4-35). Figure 4-34: Image Enhancement - ICCI ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 48 6. Use the saturation adjustment sliders to adjust image saturation (Figure 4-36). Figure 4-35: Image Enhancement - RGB Figure 4-36: Image Saturation Adjustment 7. Use the definition and brightness sliders to adjust the definition and brightness of the image

(Figure 4-37). ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 49 Figure 4-37: Definition and Brightness Adjustment 4.4.8 Browsing Mode 1. Click

, when the button icon changes to

, the similarity browsing mode will be activated (Figure 4-38). In this mode, the software displays only one image for all the adjacent similar images, reducing number of images to be browsed. Experiments show that the number of images is reduced by approximately 50%. Figure 4-38: Similarity Browsing Mode ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1

NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 50 2. Click

, when the button icon changes to

, 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. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 51 Figure 4-40: Option Setting Interface 2. 3. 4. In the Department area, fill in the department information, which will appear in the case report. In the Export path area, choose the paths for exported video files and raw data. If the Delete RAW files after exported option is checked and the data is exported to video file using the direct export mode, then after export, the related RAW files in the RAW file path will be automatically deleted to save space. In the Others area, if the Display image preview when mouse hovers over the time progress bar option is checked, as the mouse moves over the progress bar, the preview of the image corresponding to the mouse location will be displayed in a floating window if the mouse stops for about 1 second, as shown in Figure 4-41. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 52 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. If the Open the finding file when opening the video images option is checked, then the user can open the last saved finding file when opening the patient video. Figure 4-42: Saved Image Showing Patient Information 4.4.10 NaviCam ProScan NaviCam ProScan feature contains two main functions:

Images of suspected positive lesions (including four kinds: lymphangiectasia Inflammation/erosion/bleeding/ulcerpolyp/bulging or lymphoid follicular hyperplasia and diverticulum) are automatically marked, and the image position is marked in red on ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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. Figure 4-43: ProScan Feature Option 2) Use "Export and convert data into video file" or "Convert existing RAW file into video files" to export data. After exporting, check "Recognize Progress" as 100% and "Recognize Status" as ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 54

"Recognition success" in the Case Management case list, as shown in Figure 4-44. 3) If suspected positive lesions are found. Figure 4-44: Recognize Progress 1. If the NaviCam ProScan function is not enabled, there will be no ProScan icon displayed on the main interface of ESView. If the NaviCam ProScan function is enabled but the data has not been automatically identified and processed by ProScan, the ProScan icon can be displayed by selecting File Open Video. The icon will appear gray, as shown in Figure 4-45. Only after the above three conditions are met, the ProScan icon displayed by opening the data will turn blue. Figure 4-45: NaviCam ProScan function is enabled ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 55 2. 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. When the NaviCam ProScan icon is blue, the default is Total Images Mode, click to switch to NaviCam ProScan Mode, the button color changes to orange, click to Normal Images Mode, the color changes to green, as shown in Figure 4-47 and Figure to switch 4-48, click to switch back to Total Images Mode. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 56 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. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 57 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 4-49: Add to Atlas 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. Select a landmark of the digestive tract, for instance Esophagus, in the left column, the images added in steps 1-2 will be displayed, as shown in Figure 4-51. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 58 Figure 4-51: Capsule Endoscopy Atlas Interface 4.5 Report Generation 4-52). 1. In the main software interface, click 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. The Select all or Clear buttons can be used to select all captured images for report or remove all images from report (Figure 4-53). ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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. The text boxes in the report generation interface can be used to input information that will be displayed in the case report. Similar to the add comment interface, the user can manually input or use useful expressions to add information. If Microsoft Word is installed, click Preview report button to open Microsoft Word and access the report preview, as shown in Figure 4-55. 6. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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). Click OK to complete report saving or click Open to open the saved report. Figure 4-56: Save Report in .pdf Format ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 61 Figure 4-57: Save Report in .doc Format 8. Figure 4-58: Saving Success Dialog Box In the main software interface, select FileSaving 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 FileOpen finding in the menu to load video with all the findings again. 9. In the report generation interface, click the Report setting button to access the report Figure 4-59: Save Finding Interface ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 62 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. In the main software interface, select Tool Case management to access the case management interface (Figure 4-60). The software will automatically add the data export path to the case data storage path. Figure 4-60: Case Management Interface 2. Click to access the add case data storage path interface (Figure 4-61). Click Add, Delete, or Rename button to add, delete, or rename the case data storage path. Click Save to save changes in settings or click Cancel to cancel changes. Figure 4-61: Add Case Data Storage Path Interface ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/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. The date fields in the Available Column box will not be shown in the case management interface, while the data fields in the Used Column box will be displayed. Figure 4-62: View Setting Interface 4. In the case management interface (shown in Figure 4-60), select a case and click to open the case video and load the finding file. Click to open the case video, click to open the recently saved report, click to access the patient information editing interface

(Figure 4-63), where you can change patient data. Alternatively, in the main software interface, open a video file and select FileEdit patient info to access the patient information editing interface. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 64 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. In the main software interface with an opened video, double click one image in the thumbnail area and select Tool Capsule endoscopy atlas to access the capsule endoscope atlas interface (Figure 4-64). ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 65 Figure 4-64: Capsule Endoscopy AtlasInterface 2. 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. Figure 4-65: Normal Anatomy Images of Small Bowel 3. On the atlas image to be compared, right click and select Compare in the pop-up menu to open the image comparison interface and compare the selected exam image with the atlas image, as shown in Figures 4-66 and 4-67. The image scaling factor can be changed by dragging the slider or scrolling the mouse. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 66 Figure 4-66: Comparison Between Exam Image and AtlasImage Figure 4-67: Image Comparison Interface 4. 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. AKQWO-YF-018 Rev A/1 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. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 68 Figure 4-70: Software Information Interface 2. In the main software interface, select Help Instruction in the menu to access the user manual. 4.9 Software Configuration Backup/Restore 1. 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. The user can manually restore the backup configuration files. 2. During initialization, the software will check if there are backup configuration files for the 3. day. If not, it will automatically backup one. Select Help Backup configuration files in the menu to manually backup the configuration files once. If the backup is successful, a dialog box confirming successful backup will appear (Figures 4-71 and 4-72). ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 69 Figure 4-71: Backup Configuration File Figure 4-72: Dialog Box to Confirm Successful Backup of the Configuration Files 4. Select HelpRestore 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. A dialog box will pop up to confirm the successful restore, as shown in Figures 4-73 to 4-76. Figure 4-73: Restore Configuration FileManually ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 70 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. AKQWO-YF-018 Rev A/1 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. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 72 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. Figure 5-1: Schematic Diagram of Capsule Activation for Use 1. Tear off the paper cover of the package box. 2. Remove the capsule with fixture from the cup and remove the upper part. 3. Remove the capsule. 4. Activate the capsule with light irradiated from the Locator. WARNING The capsule must be removed and activated before ingestion and operation. ingestion. damaged. The capsule should only be stored in the original package before The capsule is provided sterile. Do not use a capsule if package is Disposal of capsules should be done according to local regulation for disposal of electronic products. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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. Since the data recorder does not contact patient skin directly, the temperature will not cause burn or other hazard to patients and operators, and the contact duration can be longer than 10 minutes. Figure 6-2: AKR-1 Data Recorder Vest WARNING Data Recorder AKR-1 can only be used with Capsule AKES-11SW. 6.1.2 Operation Instructions Related marks and position of power switch, USB interface, LED, keys on the Data Recorder are shown in Figure 6-3. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 74 Figure 6-3 AKR-1 Data Recorder Operation Manual

: Alarm indicator, yellow;

: Run indicator, green;

: Battery capacity indicators; : Charging port.

: Charge indicator, white;

: Power switch;

: USB interface to connect Hold down the power switch without releasing until all the five LEDs (marked as in Figure 6-3) are lit up to power on the Data Recorder normally. Click the related button in the ESView to power the Data Recorder off. If the Data Recorder is not connected to the computer via USB, and therefore no capsule information is detected for a consecutive 15 minutes, it will automatically power off to save energy. If the yellow LED alarm indicator (marked as in Figure 6-3 with word alarm under it) is always on, it indicates that no capsule is detected. If on/off continues flashing, it indicates that the capsule is present, however the upper-level software has not yet issued a command to let the capsule capture images. The green LED run indicator (marked as in Figure 6-3 with word run under it) will be lit up once it receives the image information from the capsule and off again quickly; it will light up again once it receives the next image information and then off again. The received image information captured by the capsule will also be marked accordingly. The green LED battery capacity indicators (marked as in Figure 6-3, with battery capacity icon under it, three lattices, two lattices and one lattice specifically) indicate current battery capacity. It is 90% when LEDs are all lit up, more than 70% when LEDs are lit up, and 40% when LED is lit up. If only LED is on/off flashing, the remaining battery capacity is very limited. If the Data Recorder is powered on and being charged, ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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 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. Charging can only be performed by the physician/operator. Patients shall not have access to the adaptor. 6.2 Data Recorder (AKRI-1) 6.2.1Installation and Usage The (AKRI-1) Data Recorder is composed of Host, Belt-examining cloth and Charging Base, as shown in Figures 6- 4, 6- 5, and 6- 6 respectively. Figure 6- 4: AKRI-1 Data Recorder Host Figure 6- 5: AKRI-1 Belt-Examining Cloth Figure 6- 6: AKRI-1 Charging Base WARNING Data Recorder AKRI-1 can only be used with Capsule AKES-11SI. The port in the small pocket of the Belt-Examining Cloth is inserted into the right port of the ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 76 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 6.2.2 Operation Description Through the display of the indicators, interactive operation of the buttons, interface on the Host to realize AKRI-1 Data Recorder function , including the following:

The LED indicator light, On/Off button, screen display button, USB port, belt port, screen on the AKRI-1 Data Recorder, and the power-on indicator light, data port, power port on the base. All of the equipment corresponding identifications and positions are as shown in Figure 6- 8.

(1) Charging Indicator Light

(2) Status Indicator Light

(3) Telecommunication Indicator Light

(4) Power-on Button

(5) Screen Control Button

(6) Display Screen

(7) USB port

(8) Power-on Indicator Light on Base

(9) Data port on Base

(10) Power port on Base Figure 6- 8: Operation Panel of AKRI-1 Data Recorder 6.2.2.1 Description of Indicator Light Press and hold the Power-on button for 3 seconds to boot the AKRI-1 Data Recorder. At this time, it will display the current state on the Display Screen. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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 capsules data are adequately received. If the telecommunication indicator light flashes yellow, it means some abnormalities occurred, but the capsules data has been received. If the telecommunication indicator light does not flash, it means no capsules data have been received. The Status Indicator Light is should be green. It will turn yellow in the following situations:

(1) Low Battery;

(2) Belt not Connected;

(3) Other Equipment Exception. The Charging Indicator Light remains on when power is on and turns off if power is disconnected. If the Data Recorder is not full charged, the Charging Indicator Light will flash yellow, if it is fully charged, the Charging Indicator Light will flash green. Press the Screen Display button to light the screen for 30s. If it is pressed again during the display, it will count the time again to display for 30s. The information displayed on the screen is as follows:

Row 1: (1) Telecommunication Status Icon. (2) Battery Icon: Battery charge level. Row 2: (1) Wireless Channel. (2) The Pattern State of Small Intestine. Row 3: Check-in state/Time of Examination. It will display No Entry if not entered. Otherwise, it will display the time of examination. Row 4: Error Information. If there have no error information, no display will appear. The base can charge and transmit data. The Power-on Indicator Light will flash green when the power port of the base is powered-on. It can transmit data when the base is connected to the computer via data port. WARNING The Data Recorder should be charged only with provided charger. Charging can only be performed by the physician/operator. Patients shall not have access to the adaptor. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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 1 : Scanning indicator, Yellow;

2 : Working indicator, Green;

3 : Infrared light source to activate capsule; : Power switch indicator, white;

4 : Keys;

: Power Switch;

: Charging port;

: Label plate. 7.2 Use 7.2.1 Turn-on the Capsule Before starting the Capsule, press the Power Switch to activate the Locator. Once the Locator is on, the working indicator will flash. Place the Capsule front case opposite to the start infrared light source of the Capsule. Press and hold the INIT Button to align the open position of the Capsule. The Capsule LED will start blinking after the Capsule is opened normally. The Capsule is activated as shown in Figure 7-2. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 79 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. Once the Locator has started, the working indicator will flash at a frequency of once per second, and the scanning indicator will be off. 2. Locating: Use the Locator to move gently in the detection area. Once the Locator is near the capsule, the scanning indicator will light up. When the scanning indicator stays on, it indicates that the capsule is right below the scanning indicator. 7.2.3 Turn-off the Locator Press and hold the Power Switch for more than 5 seconds and the Locator will shut down. All the indicators will be off after the shutdown. The Locator will automatically shut down after 10 minutes without any operation. 7.2.4 Charge the Locator The Locator uses a battery to supply power. When the battery voltage is low, the flashing frequency of the working indicator will get lower. When the flashing changes to one time per three seconds, the Locator needs to charge through the power port. During the charging process, the charging indicator is always on, and is automatically turned off after being fully charged. WARNING The Locator can only be charged using a charger that comes with the unit. Charging can only be performed by the physician/operator. Patients shall not have access to the adaptor. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 80 Warning Message Cause Action Recording fails Add patient information again Record added Click Confirm to exit the dialog box Record changed Click Confirm to exit the dialog box CHAPTER 8: TROUBLESHOOTING 8.1 ESView Warnings Fails to add patient information Complete addition of patient information Save change of patient information Cancel change of patient information Confirm cancel Delete patient information Confirm deletion Click Confirm to confirm cancel, or click Cancel to undo it Click Confirm to confirm deletion, or click Cancel to undo it Add case completed Record added Click Confirm to exit the dialog box Delete case information Confirm deletion Connection error Data export warning Cannot connect to the data recorder, need to check if USB is connected properly Data export is not completed Exit video view Exit video view Confirm exit Confirm exit Print error Printer error Click Confirm to confirm deletion, or click Cancel to undo it Click Confirm and reconnect the data recorder to USB Click Yes to stop data export or No to continue export Click Yes to exit the image browser, click No or Cancel to undo it Click Confirm to exit the software or Cancel to undo it Check printer power and printer settings 8.2 Capsule Problem When activating capsule, LED light does not lit up Cause Battery has no power or capsule damaged Capsule is not activated Equipment failure Action Replace the capsule Warning: replacement of Activate the capsule again Contact technical support personnel ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 81 Problem Cause Real-time image is not transmitted to computer Transmission problems with Data Recorder Capsule is not activated Action See below actions Activate the capsule using the Locator 8.3 Data Recorder Exception Possible Cause Action Low battery Charge the system for 8 hours Turn the power switch on, and LED or screen are not lit up Device malfunction An image is not transmitted to your computer in real-time The capsule is not activated Signal transceiver of the recorder is invalid 8.4 Locator Problem Possible Cause Turn the power switch on, and LED not lit up Cannot activate the capsule The battery is dead Device malfunction Capsule malfunction Device malfunction Contact a technical support staff Use Locator to activate the capsule Contact a technical support staff Action Charge the system again for 8 hours Contact technical support staff Contact technical support staff Contact technical support staff WARNING If problem cannot be addressed with the above actions, please contact ANKON Technologies Customer Support. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 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. For the vest, the inside layer that contains the antenna and cables is not washable, it is not in direct contact with the human body and does not require cleaning. The Data Recorder vest/belt should be cleaned as follows:

1. Take the Data Recorder out of the vest/belt. 2. Remove the outer layer of fabric and immerse it in warm water with neutral soap for 20 minutes. 3. Gently rub and then dry it. CAUTION Do not dry clean or iron the vest. 9.2 Cleaning the Data Recorder and Locator The Data Recorder and Locator should be manually cleaned after every use by wiping the equipment surface gently with a cotton ball lightly dipped in 70% isopropyl alcohol and let it dry for 15 minutes. Note:

As the equipment is equipped with batteries inside, please use a cotton ball dipped with 70%

isopropyl alcohol and then squeeze excessive alcohol from the cotton ball before using it for wiping to avoid alcohol flowing into the equipment through the seams when wiping the edges of the equipment. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 83 CHAPTER 10: TECHNICAL SPECIFICATIONS 10.1 Data Recorder (Model AKR-1/AKRI-1) Operating performance:

Recording time:

Storage capacity:

Battery type:

8 hours (2fps) 4 GB Lithium battery,3.6-4.2 VDC,2500 mAh 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 Limit0% ~90%

Pressure Limit700 hPa~1060 hPa Safety type:

Built-in power supply type BF continuous running equipment Degrees of protection provided by enclosures:

IP22 Shelf Life of AKR-1/AKRI-15 years RF Performance 2.4GHz AKR-1 Frequency:

Bandwidth:

Modulation:

915MHz AKRI-1 Frequency Range:

Bandwidth:

2400~2483.5 MHz 3 MHz GFSK 902MHz-928MHz 4 MHz Emission Power:

10 mW(e.i.r.p) ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 84 Modulation Technique:

Transmit power:

8-FSK 10mW(e.i.r.p.) UE15WCP1-052200SPA for Model AKR-1 Adaptor:

Input:

Output:

Protection 100-240 V a.c ,50/60 Hz, 500 mA 5.2 V2 A d.c class: class II, continuous duty UE10WCP1-050200SPA for Model AKRI-1 Input:

Output:

Protection class:

100-240 V a.c , 50/60 Hz, 500 mA 5.0 V2 A d.c class II, continuous duty Note: The data recorder incorporates a built-in RF module, while the module is completely shut down by software during operation. FCC ID:

Data RecorderAKR-1 FCC ID2A6BYAKR-1 Data RecorderAKRI-1FCC ID2A6BYAKRI-1 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. CAUTION WARNING is operating. 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. The user shall avoid using RFID technology near the device while it ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 85 10.2 Capsule(Model AKES-11SW/AKES-11SI ) Physical performance:

27 1.0 mm 11.8 0.5mm 4.5 0.5 g Biocompatible materials Length:

Diameter:

Weight:

Material:

Camera:

FOV:

Optical performance:

Illumination:

LED flash frequency:

0.5~6 Hz adjustable LED 1 piece FOV(entrance pupil):

FOV(distal window):

12015%

16010%

DOF:

Resolving power:

0 mm~30 mm 6 lp/mm Image performance:

Frame rate:

Image resolution:

0.5~6 fps adjustable 480*480 adjustable Magnetic field performance:

Surface magnetic field strength:

2000 Gs Capsule's non-optic bottom magnetic induction intensity:

96 Gs~360 Gs Operating performance:

Operating time:

Battery type:

Rated voltage:

Safety type:

Silver oxide cell35 mAh 8 hours 3V DC Built-in continuous running equipment supply power type BF ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 86 Chemical safety:

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 Limit0% ~90%

Pressure Limit700 hPa~1060 hPa Degrees of waterproof:

IPX8 Emission Power:

10mW(e.i.r.p) RF Performance 2.4GHz AKES-11SW Frequency:

Bandwidth:

Modulation:

915MHz AKES-11SI Frequency Range:

Bandwidth:

Modulation Technique:

Transmit power:

2400~2483.5MHz 3MHz GFSK 902MHz-928MHz 4MHz 8-FSK 10mW(e.i.r.p.) FCC ID:

Capsule(AKES-11SW ) FCC ID: 2A6BYAKES-11SW Capsule(AKES-11SI ) FCC ID: 2A6BYAKES-11SI 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. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 87 CAUTION WARNING is operating. 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. The user shall avoid using RFID technology near the device while it 10.3 Locator (Model AKS-1) Locating performance:

Probing distance:

150 mm Operating performance:

Battery type:

Safety type:

Grade of waterproof:

Lithium battery, 3.6-4.2 V DC, ,2500mAh power Built-in continuous running equipment IPX 0 supply type BF 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 Limit0% ~90%

Pressure Limit700 hPa~1060 hPa UE15WCP1-052200SPA for Model AKS-1 Adaptor:

Input:

Output:

100-240 V a.c, 50/60 Hz, 500 mA 5.2 V2 A d.c ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 88 Protection class:

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 10.5 Guidance and Manufacturer's Declarations NaviCam Small Bowel Capsule Endoscopy System complies with the requirements of IEC 60601-1-2:2014, EN 60601 1-2:2015. 10.5.1 Data Recorder Guidance and manufacturers declaration - electronicemissions 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. Emissions test Compliance Radiated emissions CISPR 11 Conducted emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage fluctuations and flicker emissions IEC 61000-3-3 Group 1 Class A N/A N/A Electromagnetic environment - guidance its The Data Recorder uses RF internal for energy only function. RF its Therefore, emissions are very low and are not any to interference in nearby electronic equipment. cause likely The harmonic current test and The voltage fluctuation and flick test are the Data not necessary because Recorder be connected to the PUBLIC MAINS NETWORK. intended isnt to ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 89 Guidance and manufacturers 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance 8 kV contact discharge 2~15 kV air discharge 8 kV Horizontal Coupling 8 kV Vertical Coupling Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 2 kV for power supply Mains power quality should 8 kV Electrostatic discharge IEC 61000-4-2 contact discharge 2~15 kV air discharge 8 kV Horizontal Coupling 8 kV Vertical Coupling 2 kV for power supply Lines 1 kV for input/output Lines 0.5 kV, 1 kV line(s) to line(s) 0.5 kV, 1 kV, 2 kV line(s) to earth 0.5 kV, 1 kV, 2 kV line(s) to earth Voltage dips Voltage dips 0% UT; 0.5 cycle 0% UT; 0.5 cycle At 0, 45, 90, 135, At 0, 45, 90, 135, 180, 225, 270 ,315 180, 225, 270 ,315 0% UT; 1 cycle and 70%

UT; 25/30 cycles Single phase: at 0 0% UT; 1 cycle and 70%

UT; 25/30 cycles Single phase: at 0 Voltage 0% UT; 250/300 cycle interruptions Voltage interruptions 0%

UT; 250/300 cycle 30 A/m 30 A/m 50 Hz or 60 Hz 50 Hz or 60 Hz Electrical fast transient/burst IEC 61000-4-4 Surge IEC/EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input Lines IEC 61000-4-11 Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8 be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Data Recorder requires continued operation during power mains interruptions, it is recommended that the Data Recorder be powered from an un-interruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the AC mains voltage prior to application of the test level. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 90 Guidance and manufacturers 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. Immunity test Compliance level Electromagnetic IEC 60601 test level environment -

guidance Portable and mobile RF communications equipment should be used no closer to any part of the Data Recorder, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Conducte d RF IEC 61000-4-

6 Radiated RF IEC 61000-4-3 3 V 3 V 150 kHz 80 MHz 150 kHz 80 MHz 6 V in ISM bands between 150 kHz and 80 MHz 6 V in ISM bands between 150 kHz and 80 MHz 80% AM at 1 kHz 80% AM at 1 kHz 3 V/m 3 V/m 80 MHz 2.7 GHz 80 MHz 2.7 GHz 80% AM at 1 kHz 80% AM at 1 kHz ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 91 10.5.2 Capsule Guidance and manufacturers 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. Emissions test Compliance Electromagnetic environment - guidance Group 1 N/A N/A The Capsules uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. for are use suitable Capsules The in all establishments including domestic establishments and those directly connected to the public low-

voltage power supplies buildings used for domestic purposes. supply network that Conducted Class B Radiated emissions CISPR 11 emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage fluctuations and flicker emissions IEC 61000-3-3 Guidance and manufacturers 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 IEC 60601 test level Compliance level Electromagnetic environment -

guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrostatic discharge IEC 61000-4-2 8 kV 8 kV contact discharge 2~15 kV air discharge 8 kV Horizontal Coupling 8 kV Vertical contact discharge 2~15 kV air discharge 8 kV Horizontal Coupling 8 kV Vertical Coupling Coupling ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 92 Guidance and manufacturers 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. N/A N/A N/A N/A N/A N/A Electrical fast transient/burst IEC 61000-4-4 Surge IEC/EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input Lines IEC 61000-4-11 2 kV for power supply Lines 1 kV for input/output Lines 0.5 kV, 1 kV line(s) to line(s) 0.5 kV, 1 kV, 2 kV line(s) to earth Voltage dips 0% UT; 0.5 cycle At 0, 45, 90, 135,180, 225, 270 and 315 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase:

at 0 Voltage interruptions:

0% UT; 250/300 cycle Power frequency 30 A/m 30 A/m 50 Hz or 60 Hz 50 Hz or 60 Hz

(50/60 Hz) magnetic field IEC 61000-4-8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the AC mains voltage prior to application of the test level. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 93 Guidance and manufacturers 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 Compliance level Electromagnetic IEC 60601 test level environment -

guidance Portable and mobile RF communications equipment should be used no closer to any part of a Capsule, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 V N/A N/A IEC 61000-4-6 150 kHz 80 MHz 6 V in ISM bands between 150 kHz and 80 MHz 80% AM at 1 kHz Radiated RF IEC 61000-4-3 3 V/m 3 V/m 80 MHz 2.7 GHz 80 MHz 2.7 GHz 80% AM at 1 kHz 80% AM at 1 kHz Mains power quality should be that of a typical commercial or hospital environment. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 94 Guidance and manufacturers 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. Compliance Electromagnetic environment - guidance Group 1 Class A N/A N/A The Locator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The harmonic current test and The voltage fluctuation and flick test are not necessary because the Locator isnt intended to be connected to the PUBLIC MAINS NETWORK. 10.5.3 Locator Emissions test Radiated emissions CISPR 11 Conducted emissions CISPR 11 Harmonic Emissions IEC 61000-3-2 Voltage fluctuations and flicker emissions IEC 61000-3-3 Guidance and manufacturers 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. Immunity test IEC 60601 test level Compliance level Electrostatic discharge IEC 61000-4-2 8 kV contact discharge 2~15 kV air discharge 8 kV Horizontal Coupling 8 kV Vertical Coupling 8 kV contact discharge 2~15 kV air discharge 8 kV Horizontal Coupling 8 kV Vertical Coupling Electrical transient/burst fast IEC 61000-4-4 2 kV for power supply Lines 1 kV for input/output Lines 2 kV for power supply Lines Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 95 Guidance and manufacturers 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. Surge IEC/EN 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input Lines IEC 61000-4-11 0.5 kV, 1 kV line(s) to line(s) 0.5 kV, 1 kV, 2 kV line(s) to earth 0.5 kV, 1 kV, 2 kV line(s) to earth Voltage dips Voltage dips 0% UT; 0.5 cycle 0% UT; 0.5 cycle At 0, 45, 90, 135, At 0, 45, 90, 135, 180, 225, 270 and 180, 225, 270 and 315 315 0% UT; 1 cycle and 70% UT; 25/30 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0 cycles Single phase: at 0 Voltage interruptions Voltage interruptions 0% UT; 250/300 0% UT; 250/300 cycle 30 A/m cycle 30 A/m 50 Hz or 60 Hz 50 Hz or 60 Hz Power frequency

(50/60 Hz) magnetic Field IEC 61000-4-8 Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Data Recorder requires continued operation during power mains interruptions, it is recommended that the Locator be powered from an un-

interruptible power supply or a battery. Power frequency magnetic fields Should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the AC mains voltage prior to application of the test level. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 96 Guidance and manufacturers 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 Compliance level IEC 60601 test level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Locator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 3 V 3 V 150 kHz 80 MHz 150 kHz 80 MHz Mains power quality should be that of a typical commercial or hospital environment. 6 V in ISM bands between 150 kHz and 80 MHz 80% AM at 1 kHz 6 V in ISM bands between 150 kHz and 80 MHz 80% AM at 1 kHz Radiated RF IEC 61000-4-3 3 V/m 3 V/m 80 MHz 2.7 GHz 80 MHz 2.7 GHz 80% AM at 1 kHz 80% AM at 1 kHz Mains power quality should be that of a typical commercial or hospital environment. ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 97 CHAPTER 11:

SYSTEM LABELING Followings are labels of the system components:

Symbol Description STERILE EO Sterilized using ethylene oxide Serial Number Manufacturer Date of Manufacture Type BF Applied Part Do not re-use 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 should not be disposed of with household waste. Please ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 98 Symbol Description recycle where facilities exist. Check with your local Authority or retailer for recycling advice. Nameplate of Data RecorderAKR-1 Nameplate of Locator

( AKS-1) Nameplate of Data RecorderAKRI-1 Keep dry This Side Up Stacking Limit (Not Exceed 3 Layers) Temperature Limit

(transport and storage)

-25~70 Humidity Limit

(transport and storage) 0%~90%

ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1 NaviCam Small Bowel Capsule Endoscopy System User Manual P a g e | 99 Symbol Description Pressure Limit 700hPa~1060hPa ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1

Label:

Label location:

PS: capsule is too small to be printed the FCC ID, so the FCC ID is printed on the package and user manual.

ANKON Technologies Co., Ltd. Date: 4/21/2022 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern:

I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to:

a) comply with the relevant provisions of the certification program;

b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;

Cc) make claims regarding certification only in respect of the scope for which certification has been granted;

d) do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;

e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;

f) use certification only to indicate the products are certified as being in conformity with specified standards;

g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;

h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;

1) keep a record of all complaints made known to us relating to the products compliance with requirements of the relevant standard and to make these records available to the when requested;

)) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;

k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by:

Wongmi Zhu Company Name: ANKON Technologies Co., Ltd. Contact Name: Wangmi Zhu Title of Person : RA Address: B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road, East Lake New Technology Development Zone, Wuhan, 430075 Hubei, China

ANKON Technologies Co., Ltd. Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: 2ZA6BY AKES-11SW To Whom It May Concern:

Pursuant to the provisions of Sections 0.457 and 0.459 of the Commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Company Name: ANKON Technologies Co., Ltd. Contact Name: Wangmi Zhu Title of Person : RA Address: B3-2, B3-3, D3-4 Biolake, No.666, Hi-Tech Road, East Lake New Technology Development Zone, Wuhan, 430075 Hubei, China