YMQ-8051000Apex Reader

FOR INVESTIGATIONAL USE ONLY To be used by qualified investigators only. The performance characteristics of this device have not been established. Part Number: 80 510 00 Revision C INSTRUMENT DE RECHERCHÉ Réservé uniquement á l’usage de chercheurs compétents Les spécifications de rendement de l’instrument n’ont pas été éstablies. Apex Reader User’s Guide Apex Reader User’s Guide 2 Copyright This document discloses subject matter in which AspenBio Pharma, Inc. has certain proprietary rights. Neither receipt nor possession of this document confers or transfers any rights to reproduce, store in a retrieval system, transmit or translate in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from AspenBio Pharma. The information contained in this User’s Guide is subject to change. Illustrations, including software screen illustrations, are representative, and may not reflect the most recently released updates. Copyright © 2010 AspenBio Pharma, Inc. All rights reserved. Distributor The is distributed by: AspenBio Pharma, Inc. 1585 South Perry Street Castle Rock, CO 80104 www.aspenbiopharma.com T: (303) 794-2000 F: (303) 798-8332 Trademarks AspenBio Pharma ® is a registered trademark of AspenBio Pharma, Inc. Apex Reader 3 Contents Introduction........................................................................................... 5 Product Overview............................................................................. 5 Kit Components........................................................................ 6 Reader Features........................................................................ 7 Understanding Labelling Symbols........................................... 9 Understanding Screens and Menus......................................... 9 Product Specifications........................................................... 18 Safety Symbols............................................................................... 19 Safety Information........................................................................... 19 How To Use This Guide.................................................................. 21 Setup..................................................................................................... 23 Supplying Power to the Reader..................................................... 23 Turning On and Configuring the Reader........................................ 24 Turning On the Reader............................................................ 24 Setting the Date and Time...................................................... 25 Installing the Paper................................................................. 27 Adding the First Supervisor User........................................... 29 Connecting to the LIS..................................................................... 33 Setting Up the Network Connection...................................... 33 Providing LIS Settings............................................................ 36 Changing Reader Settings............................................................. 38 Changing the Language.......................................................... 39 Changing Patient ID Settings................................................. 40 Changing the Print Setting..................................................... 43 Changing Security and Power Saving Settings..................... 44 Managing Users.............................................................................. 47 Adding a User.......................................................................... 47 Changing User Information..................................................... 51 Enabling or Disabling a User.................................................. 55 Deleting a User........................................................................ 57 Daily Operations................................................................................ 61 Startup............................................................................................. 61 Turning On the Reader............................................................ 61 Logging In................................................................................ 62 Running Quality Control Checks............................................ 63 Testing a Patient Sample................................................................ 68 Managing Patient Results.............................................................. 72 Viewing Detailed Test Results................................................ 72 Sending Patient Results......................................................... 75 Printing Patient Results.......................................................... 76 Viewing a Result Stored on a Test Cartridge......................... 78 Daily Shutdown............................................................................... 81 Apex Reader User’s Guide 4 Export / Import Features................................................................ 83 Exporting Stored Test Results....................................................... 84 Exporting Raw Test Data............................................................... 86 Importing and Exporting Users...................................................... 87 Exporting a User..................................................................... 87 Exporting All Users................................................................. 89 Importing a User..................................................................... 91 Importing All Users................................................................. 93 Other Features................................................................................... 97 Reviewing Reader Information....................................................... 97 Checking the Software Version.............................................. 97 Reviewing …

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04.08.2010 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Re: Request of Confidentiality Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commission’s Rules, the Applicant hereby requests confidential treatment of information accompanying as outlined below for the following FCC ID: YMQ-8051000 Schematics, Parts List Operation description Block Diagram 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(d)(1)(ii), disclosure of this Application and all accompanying documentation will not be made before the date of the Grant for this Application. Sincerely, Thomas Ring Manager Certification mikes-testingpartners gmbh Ohmstrasse 2-4 94342 Strasskirchen Germany

ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 1 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 Photo documentation of the EuT Apex-Reader ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 2 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 3 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 4 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 11 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 External Power supply ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 12 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 13 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 Internal Batteries ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 14 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 Tag’s and identification card ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 15 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 16 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 Label position

ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 16 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 Label position

ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 5 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 6 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 7 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 8 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 9 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 RFID Module 1 ATTACHMENT A to File No.: T34322 mikes-testingpartners gmbh File No. T34322, page 10 of 16 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.0, 2.2.2009 RFID Module 2

FCC ID: YMQ-8051000 mikes-testingpartners gmbh File No. T34322-00-01KG, page 1 of 25 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 EMI -- T E S T R E P O R T - FCC Part 15.225 - Test Report No. : T34322-00-01KG 03. August 2010 ______________________________________________________________________________________________ Date of issue Type / Model Name : APEX-Reader Product Description : Laboratory Equipment with RFID Applicant : LRE Medical GmbH Address : Frankfurter Ring 15 80807 München, GERMANY Manufacturer : AspenBio Pharma, Inc. Address : 1585 South Perry Street, Castle Rock Colorado 80104-1931, USA Licence holder : AspenBio Pharma, Inc. Address : 1585 South Perry Street, Castle Rock Colorado 80104-1931, USA Test Result according to the standards listed in clause 1 test standards: POSITIVE The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permission of the test laboratory. DAT-P-207/05-00 Registration No. DAT-P-207/05 FCC ID: YMQ-8051000 mikes-testingpartners gmbh File No. T34322-00-01KG, page 2 of 25 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 Contents 1 TEST STANDARDS 3 2 SUMMARY 4 3 EQUIPMENT UNDER TEST 5 3.1 Photo documentation of the EUT – See attachment A 5 3.2 Power supply system utilised 5 3.3 Short description of the equipment under test (EUT) 5 4 TEST ENVIRONMENT 6 4.1 Address of the test laboratory 6 4.2 Environmental conditions 6 4.3 Statement of the measurement uncertainty 6 4.1 Measurement Protocol for FCC, VCCI and AUSTEL 7 5 TEST CONDITIONS AND RESULTS 8 5.1 Conducted emissions 8 5.2 Field strength of the fundamental wave 12 5.3 Spurious emissions 14 5.4 Frequency tolerance 16 5.5 20 dB Bandwidth 18 5.6 Transmitter spectrum mask 21 5.7 Receiver radiated emissions 24 6 USED TEST EQUIPMENT AND ACCESSORIES 25 FCC ID: YMQ-8051000 mikes-testingpartners gmbh File No. T34322-00-01KG, page 3 of 25 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 1 TEST STANDARDS The tests were performed according to following standards: FCC Rules and Regulations Part 15, Subpart A - General (October, 2009) Part 15, Subpart A, Section 15.31 Measurement standards Part 15, Subpart A, Section 15.33 Frequency range of radiated measurements Part 15, Subpart A, Section 15.35 Measurement detector functions and bandwidths Part 15, Subpart A, Section 15.38 Incorporation by reference FCC Rules and Regulations Part 15, Subpart C - Intentional Radiators (October, 2009) Part 15, Subpart C, Section 15.203 Antenna requirement Part 15, Subpart C, Section 15.204 External radio frequency power amplifiers and antenna modifications Part 15, Subpart C, Section 15.205 Restricted bands of operation Part 15, Subpart C, Section 15.207 Conducted limits Part 15, Subpart C, Section 15.209 Radiated emission limits, general requirements Part 15, Subpart C, Section 15.215 Additional provisions to the general radiated emission limitations Part 15, Subpart C, Section 15.225 Operation within the band 13.110 - 14.010 MHz FCC Rules and Regulations Part 1, Subpart I - Procedures Implementing the National Environmental Policy Act of 1969 Part 1, Subpart I, Section 1.1310 Radiofrequency radiation exposure limits Part 1, Subpart 2, Section 2.1093 Radiofrequency radiation exposure evaluation: portable device OET Bulletin 65, 65A, 65B, 65C Edition 97-01, August 1997 – Evaluating Compliance with FCC Guidelines for Human Exposure to Radio Frequency Electromagnetic Fields. ANSI C63.4: 2009 Methods of Measurement of Radio-Noise Emissions from Low- Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. ANSI C95.1:1992 IEEE Standard for Safety Levels with respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz CISPR 16-4-2: 2003 Uncertainty in EMC measurement CISPR 22: 2005 Information technology equipment EN 55022: 2006 FCC ID: YMQ-8051000 mikes-testingpartners gmbh File No. T34322-00-01KG, page 4 of 25 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 2 SUMMARY GENERAL REMARKS: The EUT includes 2 RFID Modules with identical electronics. Only the form of the PCB and the location is different. The working frequency of the modules is 13.56 MHz. This test report describes the assessment for one RFID Module only. The position of this module is under the key pad and is the “worst case” module. The position of the second module is on the bottom of the unit. The EUT is equipped with an integral antenna. The receiver is permanently co-located within the transmitter. Therefore the receive mode is to short and was tested together with the transmitter in operating mode. There is no standby mode. FINAL ASSESSMENT: The equipment under test fulfills the EMI requirements cited in clause 1 test standards. Date of receipt of test sample : acc. to storage records Testing commenced on : 5 June 2010 Testing concluded on : 16 June 2010 Checked by: Tested by: Thomas Weise Dipl. Ing.(FH) Laboratory Manager Klaus Gegenfurtner Dipl.-Ing.(FH) FCC ID: YMQ-8051000 mikes-testingpartners gmbh File No. T34322-00-01KG, page 5 of 25 Ohmstrasse 2-4 x 94342 STRASSKIRCHEN x GERMANY Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1, 23.4.2009 3 EQUIPMENT UNDER TEST 3.1 Photo documentation of the EUT – See attachment A 3.2 Power supply system utilised Power supply voltage : Battery 6.1 to 8.4 VDC AC 115 V / 60 Hz / 1φ 3.3 Short description of the equipment under test (EUT) The ApexReader is a portable fluorescence instrument used to measure the results of tests by AspenBio Pharma. The reader is designed for use in a laboratory setting. Each test cartridge includes an RFID tag that identfies relevant parameter for evaluating the test results. Number of tes…

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