User's Manual
NaviCam Small Bowel Capsule Endoscopy System
User Manual P a g e |
10
ANKON Technologies Co., Ltd. AKQWO-YF-018 Rev A/1
Figure 1- 4: Locator
WARNING
Never charge the Locator when it is in use by a patient.
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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 doctor’s
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