XE8CJSMEC-IISmart Capsule (in-body transmitter)

Capsule Endoscope System User’s Manual ------------ Smart capsule SCIE-OM-01 2 Contents 1 Elements and Specifications --------------------------------------------------- 3 2 Working of smart capsule -------------------------------------------4 3 Activate a capsule----------------------------------------------------5 4 Power-off of a capsule -----------------------------------------------6 5 Recycling of the capsule----------------------------------------------6 6 Environment conditions of the smart capsule--------------------6 7 Maintenance of the smart capsule----------------------------------7 3 Smart capsule Smart capsule is used for taking snap shots and transmitting color image information. The lens, sensor, battery and RF module are enclosed in a capsule shell made of medical polymer material, which cannot be dissolved in human body. 1 Elements and Specifications The functional elements of Smart capsule are sealed in a polymer shell. They are LEDs, lens, image sensor, processor, battery and RF module. A permanent magnet in the holder may keep the capsule switch off in storage and transportation. Serial number and channel code can be read from the outer and inner package box. The appearance of smart capsule package is as below: Specification: Physical Size Diameter 13.0±0.4mm , Length 27.9±0.5mm Weight ≤6g Material Medical polymer material Optical Illumination Six white LED View angle (in air) 120±15° Depth of focus (in air) 0~35mm Resolution (in air) 0.05mm Operating Spec. Max. Sampling rate 2fps ± 10% (QVGA) 0.5fps ± 10% （VGA） Max. Continuous Working Time 8±1h (QVGA/2fps) 4 Voltage 3V DC Current 15 mA Working temperature 0~40 RH (Working) 75% RH (Storage) 80% Storage Temp. 0~50 Atmosphere 100KPa Other Image format 320*240 (QVGA) And 640*480 (VGA) Color type 24-bit true color Sealing IPX7 2 Working of smart capsule Smart capsule is sealed in the package with a permanent magnet to keep it inactive. Once the capsule be pull out from the holder, it will be switched on automatically and read to take snap shot. Patient can swallow only activated capsule in order to start a diagnostic procedure. As the capsule moving along GI tract, it can send image data and received command to and from image recorder. The capsule will stop its work as soon as the battery exhausted. In normal case, it may be excreted within 10-71 hours. From corresponding interface of software, the user may send command to change parameters of a working capsule: Image Format: Image formats can be switch from QVGA to VGA. Sampling Frequency: Under the image format of QVGA, there is three speeds of snapshot for choose: “Fast”, “Normal” and “Slow” corresponding to 2 fps, 1 fps and 0.5 fps. Under the format of VGA, the snap shot speed has only two choices as “Fast” and “Slow” corresponding to 0.5 fps and 0.25 fps. Flash Intensity: Control the brightness of LED grading in 31 levels. The higher the brightness level is, the more the power consumption is, as well as the exposure time gets shorter, the ability to shoot dynamic image is much stronger. Exposure Controlling: Can be selected by Auto or Manual. The function of automatic exposure is to control the average brightness of an image central area around the pre-set lumen value (0-255). When automatic exposure is selected, the user may set the Lumen Value, which can be varies from 1-31. If the brightness is too lower to achieve the set value of Lumen Value, the automatic exposure function will utilize the maximum exposure value. 5 Under the mode of Manual Exposure, the image Lumen Value is disabled. But Exposure Time can be set, namely set the speed of exposure, such as 1/18s (2.0), 1/18s (1.9)....... White Balance: Can be selected by Auto and Manual. Automatic White Balance is to lead capsule to control the increment of R and B automatically. In these two equations as R Av er ag e =R rate *G Average , B Average =B rate *G Average, R rate and B rate are the color temperatures for adjusting image, which can be set by factory setting or the user. Manual White Balance means the increments of R, G and B are completely controlled by the user. Sleep/Wakeup: Capsule standby and stop/recover snap shot. ：The higher flash intensity is set, the more power consumption of a working capsule and the shorter duration hours. We recommend that the level of the flash intensity shall not be set over 12 for a long time in real case. 3 Activate a capsule The inner package of the capsule is equipped with a permanent magnet, which controls the power switch of the capsule. The capsule power circuit will be kept off while it is in the holder of inner package. Pull it out from the holder (no rotating); the capsule power is switched on automatically until the LEDs flash at a rate of 2 times per second. Then the capsule can work normally. ·The user should turn on the image recorder before pull out a capsule. Download serial number and channel code are necessary by software or portable view. ·In case the user pull out capsule before turn on the image recorder, the capsule may flash at a rate of 3 times per second with low brightness. ·Do not activate two capsules with the same channel number at the same time. Otherwise, the capsule may interfere each other. ·If LEDs does not flash or flash with extremely low brightness when the capsule is pulled out, check the channel code first. Once the serial number and channel number are correct and the trouble remains, refer to chapter V for trouble-shooting. ·In case of multi-diagnosis performed at the same time, the capsules must be used with different channels. ：The capsule serial and channel number can be read from its ou5ter package 6 and inner package. ：If capsule fell to the ground accidentally, it is forbidden to ask the patient to swallow it. ：Under the ambient light, snap shots taken by the capsule may be insufficient with the brightness. This is normal. 4 Power-off of a capsule Insert the capsule with its lens towards the holder. Make sure the mark on P…

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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 FCC ID Label and Location

EXHIBIT C - EUT INTERNAL PHOTOGRAPHS EUT – Cover off View EUT – Main Board Top View EUT – Main Board Bottom View EUT – Battery 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: XE8CJSMEC-II Model: JS-MEC-II Report Type: Original Report Product Type: 2.4 GHz Transceiver (Smart Capsule) Test Engineer: Cookies Bu Report Number: RSC09052551 Report Date: 2009-07-09 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: XE8CJSMEC-II Report No.: RSC09052551 Page 2 of 15 FCC Part15.249 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 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) & §15.109- 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 ..............................................................................................................14 APPLICABLE STANDARD............................................................................................................................................14 MEASUREMENT UNCERTAINTY..................................................................................................................................14 TEST EQUIPMENT SETUP............................................................................................................................................14 TEST PROCEDURE.......................................................................................................…

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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: XE8CJSMEC-II Model: JS-MEC-II Report Type: Original Report Product Type: 2.4 GHz Transceiver (Smart Capsule) Test Engineer: Cookies Bu Report Number: RSC09052551 Rev. A Report Date: 2009-12-21 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: XE8CJSMEC-II Report No.: RSC09052551 Rev. A Page 2 of 16 FCC Part15.249 Test Report TABLE OF CONTENTS GENERAL INFORMATION.......................................................................................................................................4 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT) .....................................................................................4 OBJECTIVE...................................................................................................................................................................4 RELATED SUBMITTAL(S)/GRANT(S).............................................................................................................................4 TEST METHODOLOGY..................................................................................................................................................4 TEST FACILITY.............................................................................................................................................................5 SYSTEM TEST CONFIGURATION ..........................................................................................................................6 JUSTIFICATION.............................................................................................................................................................6 EQUIPMENT MODIFICATIONS.......................................................................................................................................6 CONFIGURATION OF TEST SETUP.................................................................................................................................6 BLOCK DIAGRAM OF TEST SETUP................................................................................................................................6 SUMMARY OF TEST RESULTS...............................................................................................................................7 FCC §15.203 - ANTENNA REQUIREMENT.............................................................................................................8 APPLICABLE STANDARD..............................................................................................................................................8 ANTENNA CONNECTOR CONSTRUCTION......................................................................................................................8 FCC §15.205, §15.209, §15.109 & §15.249 - RADIATED EMISSIONS ...................................................................9 APPLICABLE STANDARD..............................................................................................................................................9 MEASUREMENT UNCERTAINTY....................................................................................................................................9 TEST EQUIPMENT SETUP..............................................................................................................................................9 EUT SETUP................................................................................................................................................................10 TEST EQUIPMENT LIST AND DETAILS.........................................................................................................................10 TEST PROCEDURE......................................................................................................................................................11 CORRECTED AMPLITUDE & MARGIN CALCULATION.................................................................................................11 TEST RESULTS SUMMARY..........................................................................................................................................11 TEST DATA................................................................................................................................................................12 FCC §15.249(D) – OUT OF BAND EMISSIONS .....................................................................................................15 APPLICABLE STANDARD............................................................................................................................................15 MEASUREMENT UNCERTAINTY..................................................................................................................................15 TEST EQUIPMENT SETUP............................................................................................................................................15 TEST PROCEDURE..........................................................................................…

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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)

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)