YMQ-8048000RFID Reader

Page 1 ASPECT Reader ™ User Guide - English AW201127 Rev. 1 UG0001 - EN 2 ASPECT Reader User Guide Before You Begin Several important sources of information are available to help get you started and to refer to as needed to ensure accurate test results. Before using this system, read this entire User Guide and the package insert that comes with the ASPECT-PLUS ™ ST2 corresponding test. Take special note of throughout this User Guide. Important Safety Instructions F Follow proper infection control guidelines for handling all blood samples and anything that comes in contact with blood. F All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. F Users should adhere to standard precautions when handling or using this device. For more information, refer to “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007”, http: www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html ASPECT Reader SERIAL NUMBER: Distributor to Call When Ordering Supplies NAME: CONTACT INFORMATION: To reorder supplies, contact your Critical Diagnostics distributor: Product NamePart NumberDescription ASPECT-PLUS ST2 TestPLUS0001ST2 Test Cassettes (20 cassettes) ASPECT ReaderREAD0001Complete reader system ASPECT Reader PaperPAP0001Paper roll for ASPECT Reader (5 rolls) ST2 ControlsLQC0001ST2 liquid quality controls, high and low (2 high, 2 low) Electronic Quality ControlEQC0001ASPECT Reader EQC cassette (1 cassette) ASPECT Reader User Guide 3 User Guide Overview INTRODUCTION contains a brief description of the features and theory of operation of the ASPECT Reader. It also contains some basic information about interface controls such as keyboard keys and data entry fields and their use in the software. INSTALLATION contains information about the unpacking and set up, as well as specifications and warranty information about the reader. INITIAL SET-UP contains information about setting up general reader settings, LIS and Network settings, as well as setting up user access rights and viewing and/or printing error logs. OPERATION contains detailed information about running samples on the ASPECT Reader and menu items found under the Operator icon. REVIEW DATA contains information about reviewing patient results, as well as viewing liquid and electronic quality control results. Information about printing results and sending patient results, liquid and electronic quality control results to a LIS system is contained in this chapter. CONTROLS contains information about setting up and running controls. MAINTENANCE contains information about routine maintenance of the ASPECT Reader. TROUBLESHOOTING contains information about troubleshooting the reader. 4 ASPECT Reader User Guide TABLE OF CONTENTS INTRODUCTION.................................................................................................................................................................6 Welcome ............................................................................................................................................................................6 System Overview ................................................................................................................................................................6 Intended Use .......................................................................................................................................................6 Principles of Measurement ...................................................................................................................................6 Data Entry Fields .................................................................................................................................................6 System Specifications Table ..................................................................................................................................7 Warnings, Precautions, Limitations .......................................................................................................................7 Symbols ..............................................................................................................................................................8-10 INSTALLATION ...................................................................................................................................................................10 Reader ...............................................................................................................................................................................11 Accessories .........................................................................................................................................................................11 Installation .........................................................................................................................................................................12-13 INITIAL SET-UP ..................................................................................................................................................................13 Main Menu .........................................................................................................................................................................13 General Reader Settings ......................................................................................................................................................14 Language ...........................................................................................................................................................................14 Default Settings ...............................................................................................................................................................…

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Ersteller: U. Rodemeier Revision: 04 Erstelldatum: 03.08.01 Datum: 11.05.07 Seite 1 von 1 Request for Confidentiality PHOENIX TESTLAB GmbH Date: 2014-10-09 Product Certification Königswinkel 10 D 32825 Blomberg RE: Certification Application FCC ID: YMQ-8048000 Confidentiality Request Pursuant to Sections 0.457 and 0.459 of the Commission’s Rule, the applicant hereby requests confidential treatment of information accompanying this application as outlined below:  Block diagram  Schematics diagram  Functional description The above 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. The applicant understands that pursuant to rule 0.457, disclosure of this application and all accompanying documentation will not be made before the date of the GRANT for this application. Thank you for your attention in this matter. Applicant’s Company address: EMV Testhaus GmbH Gustav Hertz Str. 35 94315 Straubing Signature: Job Title and Dept.: Christian Kiermeier

EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 1 of 15 1 Annex B – EUT pictures 1.1 List of Pictures Picture 1: EUT- front, left ................................................................................................... 2 Picture 2: EUT- front, right ................................................................................................. 2 Picture 3: EUT- back ......................................................................................................... 3 Picture 4: EUT - open housing, top .................................................................................... 3 Picture 5: EUT - open housing, bottom .............................................................................. 4 Picture 6: EUT - open housing, bottom, without cartridge drawer ...................................... 4 Picture 7: PCB RFID reader (top)– User ........................................................................... 5 Picture 8: PCB RFID reader (bottom) – User ..................................................................... 6 Picture 9: PCB RFID reader (top) – Cartridge ................................................................... 7 Picture 10: PCB RFID reader (top) – Cartridge ................................................................. 8 Picture 11: Main PCB (top) ................................................................................................ 9 Picture 12: Main PCB (bottom) .......................................................................................... 9 Picture 13: Main PCB (top) ............................................................................................... 10 Picture 14: Main PCB (bottom) ......................................................................................... 11 Picture 15: PCB (top) ........................................................................................................ 12 Picture 15: PCB (top) ........................................................................................................ 12 Picture 16: PCB (bottom) .................................................................................................. 13 Picture 17: User tag ........................................................................................................... 14 Picture 18: Cartridge tag .................................................................................................... 15 Picture 19: EUT - power supply ......................................................................................... 15 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 2 of 15 Picture 1: EUT- front, left Picture 2: EUT- front, right EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 3 of 15 Picture 3: EUT- back Picture 4: EUT - open housing, top EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 4 of 15 Picture 5: EUT - open housing, bottom Picture 6: EUT - open housing, bottom, without cartridge drawer EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 5 of 15 Picture 7: PCB RFID reader (top)– User EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 6 of 15 Picture 8: PCB RFID reader (bottom) – User EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 7 of 15 Picture 9: PCB RFID reader (top) – Cartridge EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 8 of 15 Picture 10: PCB RFID reader (top) – Cartridge EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 9 of 15 Picture 11: Main PCB (top) Picture 12: Main PCB (bottom) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 10 of 15 Picture 13: Main PCB (top) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 11 of 15 Picture 14: Main PCB (bottom) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 12 of 15 Picture 15: PCB (top) Picture 16: PCB (top) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 13 of 15 Picture 17: PCB (bottom) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 14 of 15 Picture 18: User tag EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 15 of 15 Picture 19: Cartridge tag Picture 20: EUT - power supply

FCC Label: Position of FCC label: FCC Label

EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 1 of 15 1 Annex B – EUT pictures 1.1 List of Pictures Picture 1: EUT- front, left ................................................................................................... 2 Picture 2: EUT- front, right ................................................................................................. 2 Picture 3: EUT- back ......................................................................................................... 3 Picture 4: EUT - open housing, top .................................................................................... 3 Picture 5: EUT - open housing, bottom .............................................................................. 4 Picture 6: EUT - open housing, bottom, without cartridge drawer ...................................... 4 Picture 7: PCB RFID reader (top)– User ........................................................................... 5 Picture 8: PCB RFID reader (bottom) – User ..................................................................... 6 Picture 9: PCB RFID reader (top) – Cartridge ................................................................... 7 Picture 10: PCB RFID reader (top) – Cartridge ................................................................. 8 Picture 11: Main PCB (top) ................................................................................................ 9 Picture 12: Main PCB (bottom) .......................................................................................... 9 Picture 13: Main PCB (top) ............................................................................................... 10 Picture 14: Main PCB (bottom) ......................................................................................... 11 Picture 15: PCB (top) ........................................................................................................ 12 Picture 15: PCB (top) ........................................................................................................ 12 Picture 16: PCB (bottom) .................................................................................................. 13 Picture 17: User tag ........................................................................................................... 14 Picture 18: Cartridge tag .................................................................................................... 15 Picture 19: EUT - power supply ......................................................................................... 15 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 2 of 15 Picture 1: EUT- front, left Picture 2: EUT- front, right EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 3 of 15 Picture 3: EUT- back Picture 4: EUT - open housing, top EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 4 of 15 Picture 5: EUT - open housing, bottom Picture 6: EUT - open housing, bottom, without cartridge drawer EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 5 of 15 Picture 7: PCB RFID reader (top)– User EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 6 of 15 Picture 8: PCB RFID reader (bottom) – User EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 7 of 15 Picture 9: PCB RFID reader (top) – Cartridge EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 8 of 15 Picture 10: PCB RFID reader (top) – Cartridge EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 9 of 15 Picture 11: Main PCB (top) Picture 12: Main PCB (bottom) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 10 of 15 Picture 13: Main PCB (top) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 11 of 15 Picture 14: Main PCB (bottom) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 12 of 15 Picture 15: PCB (top) Picture 16: PCB (top) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 13 of 15 Picture 17: PCB (bottom) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 14 of 15 Picture 18: User tag EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex B Page 15 of 15 Picture 19: Cartridge tag Picture 20: EUT - power supply

The test result refers exclusively to the tested model. This test report may not be copied or published in a part without the written authorization of the accreditation agency and/or EMV TESTHAUS GmbH Revision: 1.0 Customer: Esterline | LRE Medical GmbH Georg-Brauchle-Ring 89 80992 München Tel.: +49 89 354803-0 Fax: +49 89 354803-67 RF test report 140206-AU01+W02  Esterline | LRE Medical GmbH Laboratory Equipment with RFID Aspect-Reader™ EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Aspect-Reader™ Laboratory Equipment with RFID 140561-AU01+W01 Page 2 of 42 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Tel.: +49 9421 56868-0 Fax: +49 9421 56868-100 Email: [email protected] Accreditation: FCC facility registration number: 221458 Test Firm Type “2.948 listed”: Valid until 2017-04-22 Test Firm Type “accredited”: Valid until 2015-06-11 MRA US-EU, FCC designation number: DE0010 BnetzA-CAB-02/21-02/04 Valid until 2018-11-27 Industry Canada test site number: 3472A-1 Registration expiry date: 2015-10-02 Test Laboratory: EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany The technical accuracy is guaranteed through the quality management of the EMV TESTHAUS GmbH EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Aspect-Reader™ Laboratory Equipment with RFID 140561-AU01+W01 Page 3 of 42 Table of contents 1 Test regulations ........................................................................................................................ 5 2 Equipment under Test (EUT) .................................................................................................... 6 3 AC power line conducted emissions ......................................................................................... 9 4 Radiated emission measurement (<1 GHz) ............................................................................ 17 5 Radiated emission measurement (>1 GHz) ............................................................................ 29 6 Carrier frequency stability ....................................................................................................... 30 7 Bandwidths ............................................................................................................................. 34 8 Equipment calibration status ................................................................................................... 39 9 Measurement uncertainty ....................................................................................................... 40 10 Summary ................................................................................................................................ 41 11 Revision History...................................................................................................................... 42 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Aspect-Reader™ Laboratory Equipment with RFID 140561-AU01+W01 Page 4 of 42 List of pictures Picture 1: Outline of conducted emission test setup ................................................................. 10 Picture 2: Graphic - Conducted emission on mains, phase 1 (without termination) ................... 11 Picture 3: Table - Conducted emission on mains, phase 1 (without termination) ...................... 12 Picture 4: Graphic - Conducted emission on mains, neutral (without termination) ..................... 13 Picture 5: Table - Conducted emission on mains, neutral (without termination) ........................ 14 Picture 6: Graphic - Conducted emission on mains, phase 1 (with termination 50 Ω) ............... 15 Picture 7: Graphic - Conducted emission on mains, neutral (with termination 50 Ω) ................. 16 Picture 8: Test setup for radiated emission measurement (< 30 MHz) ...................................... 20 Picture 9: Test setup for radiated emission measurement (< 1 GHz) ........................................ 20 Picture 10: Radiated emission 9 kHz – 30 MHz @ 3m distance (13.56 MHz) ........................... 22 Picture 11: Radiated emission 30 MHz - 1000MHz @ 3m distance .......................................... 26 Picture 12: Spectrum mask for 13.56 MHz @ 3m distance ....................................................... 28 Picture 13: Test setup for carrier frequency stability measurement ........................................... 31 Picture 14: Occupied bandwidth (99 %) .................................................................................... 36 Picture 15: -6 dB emission bandwidth ....................................................................................... 37 Picture 16: -20 dB emission bandwidth ..................................................................................... 38 List of tables Table 1: Equipment calibration status ....................................................................................... 39 Table 2: Measurement uncertainty ........................................................................................... 40 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Aspect-Reader™ Laboratory Equipment with RFID 140561-AU01+W01 Page 5 of 42 1 Test regulations 47 CFR Part 2: 10-2013 Code of Federal Regulations Part 2 (Frequency allocation and radio treaty matters; General rules and regulations) of the Federal Communication Commission (FCC) 47 CFR Part 15: 10-2013 Code of Federal Regulations Part 15 (Radio Frequency Devices) of the Federal Communication Commission (FCC) ANSI C63.4: September 2009 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 ICES-003 Issue 5, August 2012 Spectrum Management and Telecommunications Interference-Causing Equipment…

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EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex A Page 1 of 6 1 Annex A – Test setup 1.1 List of Pictures Picture 1: EUT position 1 ................................................................................................... 2 Picture 2: EUT position 2 ................................................................................................... 2 Picture 3: EUT position 3 ................................................................................................... 3 Picture 4: test setup radiated emission test 9 kHz - 30 MHz ............................................. 3 Picture 5: EUT test setup radiated emission test 30 MHz - 1 GHz .................................... 4 Picture 6: EUT test setup in open area test site (front view) .............................................. 4 Picture 7: EUT test setup in open area test site (rear view) ............................................... 5 Picture 8: EUT test setup conducted measurements (front view) ...................................... 5 Picture 8: EUT test setup conducted measurements (rear view) ....................................... 6 Picture 9: EUT test setup carrier frequency stability .......................................................... 6 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex A Page 2 of 6 Picture 1: EUT position 1 Picture 2: EUT position 2 EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex A Page 3 of 6 Picture 3: EUT position 3 Picture 4: test setup radiated emission test 9 kHz - 30 MHz EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex A Page 4 of 6 Picture 5: EUT test setup radiated emission test 30 MHz - 1 GHz Picture 6: EUT test setup in open area test site (front view) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex A Page 5 of 6 Picture 7: EUT test setup in open area test site (rear view) Picture 8: EUT test setup conducted measurements (front view) EMV TESTHAUS GmbH Gustav-Hertz-Straße 35 94315 Straubing Germany Revision: 1.0 Esterline | LRE Medical GmbH Laboratory Equipment with RFID 140561-AU01+W01 Annex A Page 6 of 6 Picture 9: EUT test setup conducted measurements (rear view) Picture 10: EUT test setup carrier frequency stability