A3LLABGEOPA20Immunology Analyser

For proper use of the analyzer, please refer to the product manual. PA20 User Manual Version 1.0 IVD SAMSUNG ELECTRONICS CO., LTD. 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Distribution in USA : Nexus Dx, Inc., A Subsidiary of Samsung Electronics Co., Ltd., 6759 Mesa Ridge Road, San Diego, CA 92121 USA / Tel : 858-410-4600, Fax : 858-410-4700, www.nexus-dx.com BCA-PA20 2 Copyright © Copyright Reserved 2012 Samsung Electronics Co., Ltd The hardware/software mentioned in this user manual is protected by copyright law. Except for a copy of the User Manual for normal use, making a partial or whole copy of it without written permission by Samsung Electronics is strictly prohibited by copyright law. The content and specifications of this user manual are subject to change without prior notice. Correct Disposal of This Product (Waste Electrical & Electronic Equipment) (Applicable in countries with separate collection systems) This marking on the product, accessories or literature indicates that the product and its electronic accessories (e.g. charger, headset, USB cable) should not be disposed of with other household waste at the end of their working life. To prevent possible harm to the environment or human health from uncontrolled waste disposal, please separate these items from other types of waste and recycle them responsibly to promote the sustainable reuse of material resources. Household users should contact either the retailer where they purchased this product, or their local government office, for details of where and how they can take these items for environmentally safe recycling. Business users should contact their supplier and check the terms and conditions of the purchase contract. This product and its electronic accessories should not be mixed with other commercial wastes for disposal. 3 1. Safety Warnings and Caution ........................ 7 User’s Manual and Labeled Symbols ................................. 9 Cautions for system installation ....................................... 11 Cautions for system move ................................................. 12 Cautions before use ............................................................ 12 Cautions during use ............................................................ 13 Precautions Before Testing ................................................ 14 Preparing to Test Samples .........................................................................14 Cautions for storage and maintenance after use .......... 15 2. Introduction .................................................17 Intended Use ........................................................................ 18 Introduction ......................................................................... 19 Operating Principle ............................................................. 20 What’s in the box ................................................................. 20 Box contents...................................................................................................20 Sold separately ..............................................................................................21 Introduction of features ..................................................... 22 Front (Right) ...................................................................................................22 Front (Left) ......................................................................................................23 Back ...................................................................................................................24 3. Installation ....................................................25 Installation ............................................................................ 26 Replacing printer paper ..................................................... 27 Table of Contents 4 Samsung LABGEO PA20 Table of Contents Disc ......................................................................................... 29 Handling and Storage of the Disc .................................... 30 Adding the sample to the Disc .......................................... 31 4. Analyzing ......................................................35 Analyzing .............................................................................. 36 Turning power on .........................................................................................36 Preparing analysis ........................................................................................40 Canceling analysis in progress ................................................................43 Analysis completed ....................................................................................45 Viewing analysis results .............................................................................47 Viewing results ..................................................................... 48 Viewing results of patient’s analysis ......................................................50 Viewing QC results .......................................................................................52 Searching results ..........................................................................................54 Printing results ..............................................................................................56 Transferring results ......................................................................................61 Deleting results .............................................................................................63 Quality control ..................................................................... 65 Starting quality control ..............................................................................65 Analyzer settings (General User Settings) ...................... 69 Display settings ................................................................... 71 Calibration (touch screen calibration) ........…

Text truncated - open the document above for the full version.

DATE : July 26, 2012 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Nemko Korea Co., Ltd. (155 & 159, Osan-Ro, Mohyeon-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do 449-852 KOREA, REPUBLIC OF) to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the Federal Communications Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Samsung Electronics Co., Ltd.( 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea). Dated this 26 Day of July 20 12 Agency agreement expiration date: December , 2012 By: Sang Kyung, Ra Signature Printed Title: General Mana ger On behalf of : Samsung Electronics Co., Ltd. Telephone: 310-900-5250

129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, KOREA Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road, Columbia, MD 21046 Date: July 26, 2012 RE: Request of confidentiality for FCC ID: A3LLABGEOPA20 To Whom It May Concern: Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules (CFR 47), and Sectio 552 (b) (4) of the Freedom of Information Act, SAMSUNG ELECTRONICS CO.,LTD. Hereby requests confidentiality and treatment of certain information accompanying this application. The materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. We are also hereby request Short-Term Confidentiality for 180 day after the grant as outlined in Public Notice DA 04-1705. This provision will give SAMSUNG ELECTRONICS CO.,LTD. Temporary confidentiality of commercially sensitive information prior to product release. The requested Permanent and Short-Term Confidential exhibits are listed as follows: PERMANENT AND SHORT-TERM CONFIDENTIAL LIST Exhibit Description PERMANENT 1 Block Diagram 2 Operational Description 3 Schematics SHORT-TERM 4 External Photos 5 Internal Photos 6 Test-Setup Photos 7 Users Manual The Applicant understands that pursuant to Rule 0.457, disclosure of this application and all accompanying documentations, where applicable, will not be made public before the date of the Grant for this application. Sincerely, Name : Sang Kyung, Ra Title : General Manager Company : Samsung Electronics Co., Ltd.

Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 70 of 95 APPENDIX C – EUT PHOTOGRAPHS Front View of EUT Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 71 of 95 Rear View of EUT

Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 67 of 95 APPENDIX A – LABELLING REQUIREMENTS The sample label shown shall be permanently affixed at a conspicuous location on the device and be readily visible to the user at the time of purchase.  Label Location of EUT Labelling Requirements

Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 72 of 95 Inside View of EUT Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 73 of 95 Front View of USB BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 74 of 95 Rear View of USB BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 75 of 95 Front View of MAIN BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 76 of 95 Rear View of MAIN BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 77 of 95 Front View of RFID BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 78 of 95 Front View of RFID BOARD without shield can Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 79 of 95 Rear View of RFID BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 80 of 95 Front View of POWER BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 81 of 95 Rear View of POWER BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 82 of 95 Front View of LASER_MOVING BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 83 of 95 Rear View of LASER_MOVING BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 84 of 95 Front View of PMT BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 85 of 95 Rear View of PMT BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 86 of 95 Front View of DSP BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 87 of 95 Rear View of DSP BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 88 of 95 Front View of DETECTOR BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 89 of 95 Rear View of DETECTOR BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 90 of 95 Front View of LCD BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 91 of 95 Rear View of LCD BOARD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 92 of 95 Front View of LCD Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 93 of 95 Rear View of LCD

Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 94 of 95 APPENDIX D – Maximum Permissible Exposure RF Exposure Limit According to FCC 1.1310: The criteria listed in the following table shall be used to evaluate the Environmental of human exposure to radio frequency (RF) radiation as specified in 1.1307(b) Limits for Maximum Permissible Exposure (MPE) FrequencyElectric FieldMagnetic Field Power Density Averaging Time Range(MHz)Strength(V/m)Strength(A/m) (mW/cm 2 ) (Minutes) 30 - 30061.40.16316 300 - 1500......F/3006 1500 - 100000......56 30 - 30027.50.0730.230 300 - 1500......F/150030 1500 - 100000......130 (A) Limits for occupational / Contral Exposure (B) Limits for General Population / Uncontrolled Exposure F = Frequency (MHz) Fries formula Fries transmission formula : Pd = (Pout * G) / (4 * π* r²) r = √((Pout * G) / 4 * π* Pd)) Where Pd = Power density in ㎽/㎠ Pout = Output power to antenna in ㎽ G = Gain of antenna in linear scale π= 3.1416 r = Distance between observation point center of the radiator in cm Pd is the limit of MPE, 1 ㎽/㎠. If we know the Maximum Gain of the antenna and the total power input to the antenna, through the calculation, we will know the Maximum distance r where the MPE limit is reached and Power density at prediction frequency. Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 95 of 95 Test Result : 2.4 GHz band The maximum antenna gain is 0 dBi. Maximum peak output power at antenna input terminal:21.70 (dBm) Maximum peak output power at antenna input terminal:147.91 (mW) Antenna gain(typical):0.00 (dBi) Maximum antenna gain:1.00 (numeric) Prediction distance:20 (cm) Prediction frequency:2438 (MHz) MPE limit for uncontrolled exposure at prediction frequency:1 (mW/cm^2) Maximum allowable antenna gain:14.30 (dBi) Maximum Distance:3.43 (cm) Power density at prediction frequency : 0.029426(mW/cm^2) Test result: PASS

Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 2 of 95 TABLE OF CONTENTS 1. Scope 4 2. Introduction (Site Description) 5 2.1 Test facility 5 2.2 Accreditation and listing 6 3. Test Conditions & EUT Information 7 3.1 Operation During Test 7 3.2 Support Equipment 8 3.3 Setup Drawing 8 3.4 EUT Information 9 4. Summary of Test Results 10 5. Recommendation / Conclusion 11 6. Antenna Requirements 11 7. Description of Test 12 7.1 Conducted Emissions 12 7.2 Radiated Emissions 13 7.3 6 dB Bandwidth 14 7.4 Maximum Peak Output Power 15 7.5 Peak Power Spectral Density 16 7.6 Conducted Spurious Emissions 17 8. Test Data 18 8.1 Conducted Emissions 18 8.2 Radiated Emissions 21 8.3 6 dB Modulated Bandwidth 22 8.4 Peak Power Output 28 8.5 Power Spectral Density 34 8.6 Conducted Spurious Emissions 40 Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 3 of 95 8.7 Radiated Spurious Emissions 53 9 Accuracy of Measurement 64 10. Test Equipment 66 Appendix A: Labelling Requirement 67 Appendix B: Photographs of Test Set-up 68 Appendix C: EUT Photographs 70 Appendix D: Maximum Permissible Exposure 94 Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 4 of 95 1. SCOPE Measurement and determination of electromagnetic emissions (EME) of radio frequency devices including intentional and/or unintentional radiators for compliance with the technical rules and regulations of the Federal Communications Commission under FCC part 15 and IC RSS-210. Responsible Party : Contact Person : Manufacturer : Samsung Electronics Co., Ltd. Mr. Dongwook. Shin Samsung Electronics Co., Ltd. 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea 443-742  FCC ID: A3LLABGEOPA20  Model: Samsung LABGEO PA20  Brand Name: SAMSUNG  EUT Type: Immunology Analyser  Classification: FCC part 15 Spread Spectrum Transmitter  Applied Standard: FCC 47 CFR Part 15 subpart C  Test Procedure(s): ANSI C63.4-2003 and FCC guidance of 558074 dated January 18, 2012 entitled “Guidance for Performing Compliance Measurements on Digital Transmission System (DTS) Operating Under §15.247”  Dates of Test: June 15, 2012 ~ July 24, 2012  Place of Tests: Nemko Korea Co., Ltd. Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 5 of 95 2. INTRODUCTION 2.1 Test facility The measurement procedure described in American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz (ANSI C63.4-2003) was used in determining radiated and conducted emissions emanating from Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 These measurement tests were conducted at Nemko Korea Co., Ltd. EMC Laboratory. The site address is 155 & 159, Osan-Ro, Mohyeon-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, 449-852 KOREA, REPUBLIC OF. The area of Nemko Korea Corporation Ltd. EMC Test Site is located in a mountain area at 80 km (48 miles) southeast and Incheon International Airport (Incheon Airport), 30 km (18miles) south-southeast from central Seoul. It is located in the valley surrounded by mountains in all directions where ambient radio signal conditions are quiet and a favorable area to measure the radio frequency interference on open field test site for the computing and ISM devices manufactures. The detailed description of the measurement facility was found to be in compliance with the requirements of §2.948 according to ANSI C63.4 2003. Fig. 1. The map above shows the Seoul in Korea vicinity area. The map also shows Nemko Korea Corporation Ltd. EMC Lab. and Incheon Airport. Nemko Korea Co., Ltd. EMC Lab. 155 & 159, Osan-Ro, Mohyeon- Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, 449-852 KOREA, REPUBLIC OF Tel)+82-31-330-1700 Fax)+82-31-322-2332 Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 6 of 95 2.2 Accreditation and listing Accreditation type Accreditation number FCC part 15/18 Filing site Registration No. 97992 CAB Accreditation for DOC Designation No. KR0026 KOLAS Accredited Lab. (Korea Laboratory Accreditation Scheme) Registration No. 155 Canada IC Registered site Site No. 2040E VCCI registration site(RE/CE/Telecom CE) Member No. 2118 EMC CBTL - KCC(RRL)Designated Lab. Registration No. KR0026 SASO registered Lab and Certification Body Registration No. 2008-15 Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 7 of 95 3. TEST CONDITIONS & EUT INFORMATION 3.1 Operation During Test The EUT is the SISO transceiver supporting the 802.11b/g/n mode. During the test, the EUT was connected to laptop PC and then a test program was executed to operate EUT continuously. The EUT was tested at the lowest channel, middle channel and the highest channel with the maximum output power in accordance with the manufacturer’s specifications. The worst data were recorded in the report. Table of test modes Test Items Mode Data rate (Mbps) Conducted Emissions 802.11g 54 Radiated Emissions 802.11g 54 6 dB Bandwidth 802.11b 11 802.11g 54 802.11n MCS7 Peak Output Power 802.11b 11 802.11g 54 802.11n MCS7 Peak Power Spectral Density 802.11b 11 802.11g 54 802.11n MCS7 Conducted Spurious Emission, Radiated Spurious Emission, Band edge Emission 802.11b 11 802.11g 54 802.11n MCS7 Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 8 of 95 3.2 Support Equipment Immunology Analyser (EUT) Samsung Electronics Co., Ltd. Model : Samsung LABGEO PA20 1.5 m unshielded Power cable FCC ID: A3LLABGEOPA20 S/N: N/A Notebook Computer Samsung Electronics Co., Ltd. Model : NT-RF510 S/N : ZZVL93EB301744D Adaptor Chicony Power Technology co., Ltd Model : A10-090P1A 2.0 m unshielded Power cable S/N : CNBA440021…

Text truncated - open the document above for the full version.

Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 68 of 95 APPENDIX B – PHOTOGRAPHS OF TEST SET-UP The Conducted Test Picture and Radiated Test Picture and show the worst-case configuration and cable placement.  Conducted Test Picture(Front)  Conducted Test Picture(Rear) Test Report No.: NK-12-R-073 FCC and IC Certification Samsung Electronics Co., Ltd. FCC ID : A3LLABGEOPA20 Page 69 of 95  Radiated Test Picture (Front)  Radiated Test Picture (Rear)