XE8CJSMEH-IIWireless CF Card

Capsule Endoscope System User’s Manual ------------ Handheld Wireless Monitor SCIE-OM-01 2 Contents 1 Composition, technical specification and characteristics of Handheld Wireless Monitor ---------------------------------- 3 1.1 Composition of Handheld Wireless Monitor--------------------------------------3 1.2 Technical specification---------------------------------------------------------------6 1.3 Characteristics---------------------------------------------------------------------------6 2 Status indication of Handheld Wireless Monitor----------------------------------7 3 Main interface of Handheld Wireless Monitor OMOM software system-------8 4 Usage of Handheld Wireless Monitor-------------------------------------------------9 4.1 Power on/off Handheld Wireless Monitor-----------------------------------------9 4.2 Reset Handheld Wireless Monitor------------------------------------------------9 4.3 Communication setting--------------------------------------------------------------9 4.4 PDA charge------------------------------------------------------------------------------9 4.5 Proper use of touch pen-----------------------------------------------------------------------------10 4.6 Use of input keyboard and input method-----------------------------------------11 4.7 Set up the operating condition of PDA------------------------------------------11 5 System care and maintenance----------------------------------------------------------12 5.1 Care and maintenance of intelligent capsules------------------------------------12 5.2 Maintenance of image recorder-----------------------------------------------------12 5.3 Care and maintenance of Handheld Wireless Monitor ------------------------13 3 Handheld Wireless Monitor Handheld Wireless Monitor is intended to be used by Medical Staff to control recorder and capsules, monitor corresponding working state in absence of Imaging Workstation. It can make monitor the collected images, save the data and so on. You can set the system through Handheld Wireless Monitor such as downloading and reading the serial number, channel number of capsules, time correction and reading of image recorder. it can control parameters such as sleeping, waking up and exposure of capsules, complete all of the system settings before image analysis. Therefore, medical staff can collect pathological pictures of patients without Imaging Workstation. ： Handheld Wireless Monitor can complete normal work only with recorder and capsules. 1 Composition, technical specification and characteristics of Handheld Wireless Monitor 1.1 Composition of Handheld Wireless Monitor: Handheld Wireless Monitor is composed of PDA and a wireless CF card. The OMOM software can be run on PDA Windows Mobile® 6 Classic operating system, the expansion slots include SDIO and CF card, minimum standards for normal memory: 128MB SDRAM main memory, 256MB flash ROM, video resolution is 640 x 480,65 K color, 16 bit. For example, HPiPAQ212 model of PDA complies with configuration requirements. ：PDA is not developed by our company. Do not charge PDA during use of Handheld Wireless Monitor. 4 Figures： Front Pannel Side Panel 1 5 Side Panel 2 ① Power Switch: Open the power of Handheld Wireless Monitor. ② Bluetooth Indicator: Lights up means wireless functions like Bluetooth have been activated. ③ Charging indicator: Light is orange when charging, green for completion of charge. ④ Reset button: Marked as RESET; restart the system. ⑤ Shortcut key for E-mail: Press this key into management interface of E-mail. ⑥ “OK” key: The function of closing the current window. ⑦ Arrow keys and confirm key. ⑧ Shortcut key of start menu: Click the key to pop-up start menu; ⑨ Agenda management: Press this key to pop-up agenda management interface. ⑩ Wireless CF card: Connector between handheld monitor and recorder which is responsible for the functions to send and receive data. Light sensors (not enabled). External connectors: The operation detail of the connection with computers and charging rules handheld monitor is in section 2.1.3. Charging and data interfaces: Transmit data through the interconnection with computer and other equipments by cable. Earphone port: Audio port. Stylus: Place stylus here. 6 ：The detail description and operation of PDA is presented in the user manual of PDA. 1.2 Technical specification： Technical specification of PDA： Operating system：Windows Mobile® 6 Classic Ambient temperature: 5～40°C Relative humidity: ≤85%(25°C) Weight： 0.2kilograms Mode of operation: Touch Screen Battery: Li-ion battery Storage conditions: Ambient temperature: 0～50°C Relative humidity: ≤85%(25°C) Atmospheric pressure: 70～106Kpa Technical specification of wireless CF card Model： JS-MEH-II Rated voltage： 3.3V DC Rated current： 0.03A Operating temperature： 5～40°C Storage conditions: Ambient temperature: 0～50°C Relative humidity： 75％(25°C) Atmospheric pressure: 70～106Kpa 1.3 Characteristics 7 · Easy operation：The diagnosis includes three steps which are swallowing capsule, recording and observation. · Safe and healthy: Intelligent capsule is provided sterilized and it is only for single use, which can avoid cross-infection. And the diagnosis is non-invasive and painless. Its shell is made of medical polymer materials, which can not be corroded by digestive juice, and it is non-toxic non-irritant to humans and can be safely eliminated from the body. · High-Resolution Image： It can resolve the blind spot during the diagnosis of small intestine. The true color images for whole segment of small intestine are legible and direct (pixels can reach 300,000), which can greatly increase the diagnostic rate of gastrointestinal disease. · As convenient as desired：Patients do not need anesthesia or hospitalization during use of the product, they can move freely, the normal work and life are not affected (Caution: it is unsuitable for engaging in manual labor or strenuous exercise during use of this product.). ·Continuous visible…

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EXHIBIT B - EUT EXTERNAL PHOTOGRAPHS EUT – Front View EUT – Rear View EUT – Side View

EXHIBIT A - FCC ID LABELING AND LOCATION

EXHIBIT C - EUT INTERNAL PHOTOGRAPHS EUT – with Battery View EUT – Battery View EUT – Cover off View 1 EUT – Cover off View 2 EUT – Main Board Top View EUT – Main Board Bottom View Antenna

Note: This test report is prepared for the customer shown above and for the device described herein. It may not be duplicated or used in part without prior written consent from Bay Area Compliance Laboratories Corp. (Shenzhen). This report must not be used by the customer to claim product certification, approval, or endorsement by NVLAP*, NIST, or any agency of the Federal Government. * This report may contain data that are not covered by the NVLAP accreditation and are marked with an asterisk “*” (Rev. FCC PART 15.249 MEASUREMENT AND TEST REPORT For Chongqing Jinshan Science & Technology (Group) Co., Ltd. No.18, Nishang Road, LiangLu Industrial City, Yubei District, Chongqing, P.R. of China FCC ID: XE8CJSMEH-II Model: JS-MEH-II Report Type: Original Report Product Type: Wireless CF Card Test Engineer: Cookies Bu Report Number: RSC09052552 Report Date: 2009-07-10 Reviewed By: Merry Zhao EMC Engineer Prepared By: Bay Area Compliance Laboratories Corp. (Shenzhen) 6/F, the 3rd Phase of WanLi Industrial Building, ShiHua Road, FuTian Free Trade Zone Shenzhen, Guangdong, China Tel: +86-755-33320018 Fax: +86-755-33320008 Chongqing Jinshan Science & Technology (Group) Co., Ltd. FCC ID: XE8CJSMEH-II Report No.: RSC09052552 Page 2 of 16 FCC Part 15.249 Test Report TABLE OF CONTENTS GENERAL INFORMATION.......................................................................................................................................3 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT) .....................................................................................3 OBJECTIVE...................................................................................................................................................................3 RELATED SUBMITTAL(S)/GRANT(S).............................................................................................................................3 TEST METHODOLOGY..................................................................................................................................................4 TEST FACILITY.............................................................................................................................................................4 SYSTEM TEST CONFIGURATION ..........................................................................................................................5 JUSTIFICATION.............................................................................................................................................................5 EQUIPMENT MODIFICATIONS.......................................................................................................................................5 LOCAL SUPPORT EQUIPMENT LIST AND DETAILS........................................................................................................5 CONFIGURATION OF TEST SETUP.................................................................................................................................5 BLOCK DIAGRAM OF TEST SETUP................................................................................................................................5 SUMMARY OF TEST RESULTS...............................................................................................................................6 §15.203 - ANTENNA REQUIREMENT......................................................................................................................7 APPLICABLE STANDARD..............................................................................................................................................7 ANTENNA CONNECTOR CONSTRUCTION......................................................................................................................7 §15.205(A) §15.209(A) §15.249(A) §15.249(D) §15.35§15.109 - RADIATED EMISSIONS ....................................8 APPLICABLE STANDARD..............................................................................................................................................8 MEASUREMENT UNCERTAINTY....................................................................................................................................8 TEST EQUIPMENT SETUP..............................................................................................................................................8 EUT SETUP..................................................................................................................................................................9 TEST EQUIPMENT LIST AND DETAILS...........................................................................................................................9 TEST PROCEDURE......................................................................................................................................................10 CORRECTED AMPLITUDE & MARGIN CALCULATION.................................................................................................10 TEST RESULTS SUMMARY..........................................................................................................................................10 TEST DATA................................................................................................................................................................11 §15.249(D) – OUT OF BAND EMISSIONS ..............................................................................................................15 APPLICABLE STANDARD............................................................................................................................................15 TEST PROCEDURE......................................................................................................................................................15 MEASUREMENT UNCERTAINTY........................................................................................................................…

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EXHIBIT D - TEST SETUP PHOTOGRAPHS Radiated Emissions - Front View (Below 1 GHz) Radiated Emissions - Rear View (Below 1 GHz) Radiated Emissions - Front View (Above 1 GHz) Radiated Emissions - Rear View (Above 1 GHz)