2A36T-GLP806R21-01

GLP systems Track Operations Manual For use with the GLP systems Track Laboratory Automation System, the Track Sample Manager, the Track Workflow Manager, and the Input/Output Module 80003968-101 DRAFT DRAFT 2022-03-11 DRAFT 2022-03-11 Table of contents Read me first................................................................................................................7 General safety information...................................................................................................8 System security.....................................................................................................................9 Customer service................................................................................................................10 Intended use.......................................................................................................................11 Proprietary statement........................................................................................................12 Disclaimers..........................................................................................................................13 GLP systems Track warranty statement for USA customers only.......................................14 GLP systems Track agency approvals..................................................................................15 Intellectual Property statement..........................................................................................17 Key to symbols....................................................................................................................18 Manufacturer and distributor.............................................................................................22 System documentation..............................................................................................23 Organization of the operations manual..............................................................................24 Conventions for the operations manual.............................................................................26 Operations manual description..........................................................................................28 Operations manual use.......................................................................................................29 Section 1: Use or function...........................................................................................31 GLP systems Track overview...............................................................................................32 Communication paths..............................................................................................33 Track overview....................................................................................................................34 Track section............................................................................................................34 Lane elements..........................................................................................................35 CAR overview......................................................................................................................40 CAR design and function..........................................................................................40 Track Sample Manager overview........................................................................................44 Track Workflow Manager overview....................................................................................45 Input/Output Module overview..........................................................................................46 Input/Output Module design and function..............................................................46 RackPorts overview.............................................................................................................55 FlexRacks overview.............................................................................................................56 Section 2: Installation procedures and special requirements......................................57 Transportation, installation, disassembly, and disposal.....................................................58 Track installation......................................................................................................59 Input/Output Module installation requirements.....................................................59 Input/Output Module configuration...................................................................................60 Using drawers with FlexRacks..................................................................................60 Using racks...............................................................................................................64 Section 3: Principles of operation...............................................................................67 General operation...............................................................................................................68 Control system....................................................................................................................70 Track Sample Manager functional description...................................................................71 Workflow..................................................................................................................71 GLP systems Track Operations Manual 80003968-101 DRAFT - 2022-03-11 3 DRAFT 2022-03-11 System monitoring...................................................................................................73 Track Workflow Manager functional description...............................................................75 Section 4: Performance characteristics and specifications..........................................77 Technical data.........................................................................…

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SEE ELECTRONIC REVISION HISTORY REPORT SCALE SIZE DWG NO. REV. DO NOT SCALE DRAWING B SHEET 1 OF 1 1/1 ABBOTT DIAGNOSTIC DIVISIONABBOTT LABORATORIES1921 HURD DRIVE IRVING, TEXAS 75038, USA DWN BY: DATE: APPLIED FINISH: None THREADS CLASS 2A OR 2B REMOVE BURRS AND SHARP EDGES .02 MAX. UNLESS OTHERWISE SPECIFIED: DIMENSIONS IN INCHES TOLERANCES ANGULAR ± 2° 63 .XX ± .02 .XXX ± .010 CONFIDENTIAL INFORMATION CONTAINS TRADE SECRET AND/OR CONFIDENTIAL INFORMATION WHICH IS THE PROPERTY OF ABBOTT LABORATORIES. AS PROVIDED BY 21CFR 20.61, DO NOT DISCLOSE TO THE PUBLIC. TITLE: MATERIAL: 2 S. Goldston 07/14/22 NOTES: UNLESS OTHERWISE SPECIFIED PURCHASED LABEL 1. PRINT PER LABEL CONTENT SHOWN. 2 PRINTING SPECIFICATION: INK COLOR - BLACK BACKGROUND - WHITE MATERIAL - 2mil POLYESTER with 1 mil CLEAR OVERCOAT ADHESIVE - 1.8 mil #350 ACRYLIC LABEL SIZE - 2.0 x 1.0 ± .02 CORNER RADIUS - .05 ± .02 ROLL SIZE - 500, MAX INNER DIE CUT: 1.25 x 0.5 ± .02 4. DIE CUT TO LINER. PERFORATING LINER BETWEEN LABELS IS OPTIONAL. PART NUMBER TO BE PRINTED ON THE WASTE MATRIX. 5. LABEL MUST CONFORM TO UL 969 AND SHALL BE UL APPROVED MATERIAL WITH SUPPLIER NAME AND LABEL NAME OR DESIGNATION ON INSIDE OF ROLL CORE. 6. LABEL MUST BE PROCURED FROM UL AUTHORIZED SUPPLIER. 7. REFERENCE S14913. 8. THIS PART IS A U.L. CRITICAL PART. ANY CHANGES TO THIS PART MUST BE APPROVED BY EMC/SAFETY GROUP. 9. THIS PART/ASSEMBLY SHALL BE COMPLIANT PER THE LATEST REVISION OF ABBOTT SPECIFICATION S205053. 2 3 3 SHEET 1 OF 1 1/1 A LABEL, GLP8 FCC - IC ID 80004979-101 (80004979-101) FCC ID: 2A36T-GLP8 IC: 28384-GLP8

This report must not be used to claim product certification, approval, or endorsement by A2LA, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. More: https://www.bis.doc.gov/index.php/forms-documents/regulations-docs/14-commerce-country-chart/fileT Abbott Laboratories GLP12153 Switch 90 Divergent FCC 2.1091:2021 13.56 MHz RFID Radio Report: ABBO0088.3, Issue Date: September 14, 2021 CERTIFICATE OF EVALUATION 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: September 14, 2021 Abbott Laboratories EUT: GLP12153 Switch 90 Divergent RF Exposure Evaluation Standards Specification Method FCC 2.1091:2021 FCC 447498 D01 General RF Exposure Guidance v06 Results Method Clause Description Applied Results Comments 7.1 Maximum Permissible Exposure Yes Pass None Deviations From Evaluation Standards None Approved By: Johnny Candelas, Department Manager, EMC Report No. ABBO0088.32/12 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. ABBO0088.33/12 ACCREDITATIONS AND AUTHORIZATIONS 2021.09.01 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Each laboratory is accredited by A2LA to ISO / IEC 17025, and as a product certifier to ISO / IEC 17065 which allows Element to certify transmitters to FCC and IC specifications. Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Recognized as an EU Notified Body validated for the EMCD and RED Directives. United Kingdom BEIS – Recognized by the UK as an Approved Body under the UK Radio Equipment and UK EMC Regulations. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: California Minnesota Oregon Texas Washington Report No. ABBO0088.34/12 FACILITIES 2020.12.15 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 A2LA Lab Code: 3310.04 Lab Code: 3310.05 Lab Code: 3310.02 Lab Code: 3310.03 Lab Code: 3310.06 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. ABBO0088.35/12 PRODUCT DESCRIPTION 2018-07-17 Client and Equipment Under Evaluation Information Company Name: Abbott Laboratories Address: 1921 Hurd Drive City, State, Zip: Irving, TX 75038 Evaluation Requested By: Don Mendell EUT: GLP12153 Switch 90 Divergent Date of Evaluation: September 14, 2021 Information Provided by the Party Requesting the Evaluation Functional Description of the Equipment: Used to switch a CAR from the track into a GLP Module for sample processing. This contains an RFID reader for determining the ID and battery state of the CAR, which contains a passive tag. The maximum product dimension is 20cm Don Mendell, EMC Safety Manager at Abbott Laboratories provided the following information about the duty cycle of the radios: Radio (include radio band if needed) Duty Cycle: over 6 minutes Duty Cycle: over 30 minutes Provide an explanation if the duty cycle is < 100% 13.56 MHz RFID 0.75% 0.…

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This report must not be used to claim product certification, approval, or endorsement by A2LA or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. Abbott Laboratories GLP12153 Switch 90 Divergent FCC 15.225:2021 13.56 MHz Radio Report: ABBO0088 Rev. 4, Issue Date: October 3, 2022 CERTIFICATE OF TEST 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: September 2, 2021 Abbott Laboratories EUT: GLP12153 Switch 90 Divergent Radio Equipment Testing Standards Specification Method FCC 15.207:2021 ANSI C63.10:2013 FCC 15.225:2021 Results Method Clause Test Description Applied Results Comments 6.2 Powerline Conducted Emissions Yes Pass 6.4 Field Strength of Fundamental Yes Pass 6.4 Field Strength of Spurious Emissions (Less Than 30 MHz) Yes Pass 6.5 Field Strength of Spurious Emissions (Greater Than 30 MHz) Yes Pass 6.8 Frequency Stability Yes Pass 6.9 Occupied Bandwidth Yes Pass Deviations From Test Standards None Approved By: Adam Bruno, Operations Manager Report No. ABBO0088 Rev. 4EAR-Controlled Data2/41 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 01 Updated standard 2021-09-02 2, 14 and 16 02 Changed Powerline CE spec from Class A to FCC 15.209 2021-09-08 15, 17, 19 and 21 03 Updated block diagram 2022-08-30 7 Updated power settings 2022-08-30 11 Revised comments 2022-08-30 20-22 04 Replaced with "AFL" spectrum analyzer which was used at the time. 2022-10-03 28 Report No. ABBO0088 Rev. 4EAR-Controlled Data3/41 ACCREDITATIONS AND AUTHORIZATIONS 2021.09.01 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Each laboratory is accredited by A2LA to ISO / IEC 17025, and as a product certifier to ISO / IEC 17065 which allows Element to certify transmitters to FCC and IC specifications. Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Recognized as an EU Notified Body validated for the EMCD and RED Directives. United Kingdom BEIS – Recognized by the UK as an Approved Body under the UK Radio Equipment and UK EMC Regulations. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: California Minnesota Oregon Texas Washington Report No. ABBO0088 Rev. 4EAR-Controlled Data4/41 FACILITIES 2020.12.15 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 A2LA Lab Code: 3310.04 Lab Code: 3310.05 Lab Code: 3310.02 Lab Code: 3310.03 Lab Code: 3310.06 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. ABBO0088 Rev. 4EAR-Controlled Data5/41 MEASUREMENT UNCERTAINTY TMU.2015.07.10 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistica…

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photo PSA-ESCI 2021.03.17.0 photos PSA-ESCI 2021.03.17.0 IMG_0295.JPG IMG_0296.JPG _0296 POWERLINE CONDUCTED EMISSIONS photo PSA-ESCI 2021.03.17.0 photos PSA-ESCI 2021.03.17.0 IMG_0297.JPG POWERLINE CONDUCTED EMISSIONS Switch 90 DivergentSwitch 90 Convergent photo PSA-ESCI 2021.03.17.0 photos PSA-ESCI 2021.03.17.0 FF (1).JPG FF (2).JPG -2 RADIATED TESTING photo PSA-ESCI 2021.03.17.0 photos PSA-ESCI 2021.03.17.0 S2 (1).JPG S2 (2).JPG -2 RADIATED TESTING Switch90 Divergent Switch90 Convergent Switch90 Divergent Switch90 Convergent #REF! Direct Connect (1).JPG Direct Connect (2).JPG FREQUENCY STABILITY #REF! Direct Connect (3).JPG Direct Connect (6) Access Point.JPG FREQUENCY STABILITY Switch90 Divergent Direct Connect (1).JPG Direct Connect (2).JPG OCCUPIED BANDWIDTH Direct Connect (3).JPG Direct Connect (6) Access Point.JPG OCCUPIED BANDWIDTH Switch90 Divergent