2A6AL-RWR2Digital LightCycler Partitioning Engine

Digital LightCycler ® System User Assistance P ublication version 1.1 Software version 1.0 Draft - Do Not Distribute 2 Roche Diagnostics D igital LightCycler ® System · Software version 1.0 · User Assistance · Publication version 1.1 Publication information Publication version Software version Revision dateChange description 1.01.0February 2022First version 1.11.0September 2022US-specific publication version with added US-specific compliance information. uWhat is new in US-specific publication version 1.1 (13) y Revision history Edition notice This publication is intended for users of the Digital LightCycler ® System. E very effort has been made to ensure that all the information contained in this publication is correct at the time of publishing. However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication. Where to find information The User Assistance contains all information about the product, including the following: • Routine operation • Maintenance • Safety • Troubleshooting information • Software reference • Configuration information • Background information The Safety Guide contains important safety information. You must read the Safety Guide before operating the instruments. The User Guide focuses on routine operation and maintenance. The content is organized according to the normal operation workflow. Privacy notice When you use User Assistance online, viewing events (topics viewed and searches performed) and IP addresses are logged. The data collected is for Roche internal use only and is never forwarded to third parties. It is anonymized, and after one year it is automatically deleted. Viewing events are analyzed to improve User Assistance content and search functionality. IP addresses are used to classify regional behavior. Draft - Do Not Distribute 3 Roche Diagnostics D igital LightCycler ® System · Software version 1.0 · User Assistance · Publication version 1.1 General attention To avoid serious or fatal injury, ensure that you are familiar with the system and safety information before you use the system. rPay particular attention to all safety precautions. rAlways follow the instructions in this publication. rDo not use the instruments in a way that is not described in this publication. rStore all publications in a safe and easily accessible place. Incident reporting rInform your Roche representative and your local competent authority about any serious incidents which may occur when using this product. Training Do not carry out operation tasks or maintenance actions unless you have received training from Roche Diagnostics. Leave tasks that are not described in the user documentation to trained Roche Service representatives. Images The images in this publication have been added exclusively for illustration purposes. Configurable and variable data in screenshots, such as tests, results, or path names visible therein must not be used for laboratory purposes. Warranty Any customer modification to the system renders the warranty or service agreement null and void. For conditions of warranty, contact your local sales representative or refer to your warranty contract partner. Always leave software updates to a Roche Service representative, or perform such updates with their assistance. Copyright © 2022, F. Hoffmann-La Roche Ltd. All rights reserved. License information Digital LightCycler ® System software is protected by contract law, copyright law, and international treaties. Digital LightCycler ® System contains a user license be tween F. Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access the software and use it. Unauthorized use and distribution may result in civil and criminal penalties. Draft - Do Not Distribute 4 Roche Diagnostics D igital LightCycler ® System · Software version 1.0 · User Assistance · Publication version 1.1 Open-source and commercial software Digital LightCycler ® System may include components or modules of commercial or open-source software. For further information on the intellectual property and other warnings, as well as licenses pertaining to the software programs included in Digital LightCycler ® System, refer t o the electronic distribution included with this product. This open-source and commercial software and Digital LightCycler ® System as a whole can constitute a de vice regulated in accordance with applicable law. For more detailed information, refer to the corresponding user documentation and labeling. Note that the respective authorization is no longer valid according to the corresponding legislation should any unauthorized changes be made to Digital LightCycler ® System. Trademarks The following trademarks are acknowledged: LIGHTCYCLER is a trademark of Roche. All other trademarks are the property of their respective owners. Feedback Every effort has been made to ensure that this publication fulfills the intended use. All feedback on any aspect of this publication is welcome and is considered during updates. Contact your Roche representative, should you have any such feedback. Approvals The Digital LightCycler ® System meets the requirements laid down in: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC. Draft - Do Not Distribute 5 Roche Diagnostics D igital LightCycler ® System · Software version 1.0 · User Assistance · Publication…

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DocuSign Envelope ID: A0CB249A-C892-4799-8808-1FAB86F7763C Senior Engineer 23-Sep-2022 Gregor Hotz

ROCHE Digital LightCycler ® Partitioning Engine RFID System Description 2022-08-15 12. External Photographs 1. Partitioning Engine with fluid/liquid bottles compartment Fig. 1 - closed fluid/liquid bottles compartment Fig. 2 - opened fluid/liquid bottles compartment with partitioning fluid and waste bottle Tags Fig. 3 - opened fluid/liquid bottles compartment (PE RFID antennas behind black plastic cover) Antennas

ROCHE Digital LightCycler ® Partitioning Engine RFID System Description 2022-08-15 10. Label Format and Location Labels: Location:

ROCHE Digital LightCycler ® Partitioning Engine RFID System Description 2022-09-01 13. Internal Photographs 1. PE Main CU PCBA (front) RFID Circuit 2. PE Main CU PCBA (back) 3. PE RFID Antenna PCBA (front) 4. PE RFID Antenna PCBA (back) Antennas

ONE WORLD  OUR APPROVAL www.nemko.com KDB 447498 D01 General RF Exposure Guidance v06 (October 23, 2015) 1. Declaration of RF exposure compliance for exemption from routine evaluation limits FCC ID: 2A6AL-RWR2 Model number: Partitioning Engine REF: 10100846 Manufacturer: Roche Molecular Systems Inc. 1080 US Highway 202 South Branchburg, New Jersey, USA Minimum separation distance 5 mm Operational frequency 13.56 MHz Maximum EIRP -57.67 dBm (0.000001 mW) 4.3.1. Standalone SAR test exclusion considerations: Calculation according to KDB 447498 D01, clause 4.3.1: 1.
 [1+log (

 )] x [(Power allowed at numeric threshold for 50 mm in step a) + (50 mm – 50 mm) x (

 )] 2.
 [1+ 0] x [((Power allowed at numeric threshold for 50 mm in step a)) + (0) x (

 )] 3.
 x [Power allowed at numeric threshold for 50 mm in step a] 4.    x   ≤ 3.0 5. max power ≤ .     6. max power ≤ .   √ .
 = 474 mW 7. max power =
 x 474 mW = 237 mW The ERP of the EUT is 0.000001 mW which is less than the maximum allowed power. 2. Attestation ATTESTATION: I attest that the testing was performed or supervised by me; that the test measurements were made in accordance with the above-mentioned departmental standard(s), and that the radio equipment identified in this application has been subject to all applicable test conditions specified in the departmental standards and all of the requirements of the standards have been met. Signature: Date: August 23, 2022 Name: Abdoufataou Salifou, Test Engineer FCC SAR Exemption per KDB 447498

Nemko GmbH Reetzstraße 58 D-76327 Pfinztal Tel.: + 49 (0) 7240 – 63 - 0 Fax: + 49 (0) 7240 – 63 - 11 Report No. 455148-01 Template version: B This report consists of 28 numbered pages including this page and shall not be reproduced except in full, without the written approval of the testing laboratory. The results are related to the equipment under test only (type-test). Legal validity is given by the signed document only. FCC TEST REPORT / ISED TEST REPORT Product Partitioning Engine Name and address of the applicant Roche Molecular Systems Inc. 1080 US Highway 202 South Branchburg, New Jersey 08876, USA Name and address of the manufacturer Roche Molecular Systems Inc. 1080 US Highway 202 South Branchburg, New Jersey 08876, USA Model Partitioning Engine REF: 10100846 Rating 100 – 240V Trademark ROCHE Serial number 4361000036 Additional information Radio Frequency Identification (RFID) -13.56MHz. Tested according to FCC Part 15.225 Low Power Transmitter 13.110 - 14.010 MHz Band Industry Canada RSS-210, Issue 10 Low Power Licence-Exempt Radiocommunications Devices Order number 455148 Tested in period 2021-12-20; 2021-12-21 Issue date 2022-08-23 Name and address of the testing laboratory Nemko GmbH Reetzstraße 58 D-76327 Pfinztal Tel.: + 49 (0) 7240 – 63 - 0 Fax: + 49 (0) 7240 – 63 – 11 FCC No: 973501 IC OATS: 10921A Prepared by [F. Hupbauer] Approved by [Dipl.-Ing. P. Lukas] TEST REPORT FCC Part 15.225 Report no.: 455148-01 FCC ID: 2A6AL-RWR2 Nemko GmbH, Reetzstraße 58, 76327 Pfinztal, Germany Page 2 (28) CONTENTS 1 TEST INFORMATION ............................................................................................................... 3 1.1 Test item .................................................................................................................................... 3 1.2 Normal test condition ................................................................................................................. 4 1.3 Test Engineer(s) ........................................................................................................................ 4 1.4 Description of modification for Modification Filing ...................................................................... 4 1.5 Family List Rational ................................................................................................................... 4 1.6 Antenna Requirement ................................................................................................................ 4 1.7 Worst-Case Configuration and Mode ......................................................................................... 4 1.8 Decision criteria ......................................................................................................................... 4 1.9 Comments ................................................................................................................................. 4 2 TEST REPORT SUMMARY ...................................................................................................... 5 2.1 General ...................................................................................................................................... 5 2.2 Test summary ............................................................................................................................ 6 3 TEST RESULTS ........................................................................................................................ 7 3.1 Power Line Conducted Emissions ............................................................................................. 7 3.2 99 % Occupied Bandwidth ....................................................................................................... 11 3.3 Fundemental Field Strength .................................................................................................... 13 3.4 Spurious emissions (radiated) ................................................................................................. 15 3.5 Transmitter Frequency Stability ............................................................................................... 23 4 Measurement Uncertainty ..................................................................................................... 24 5 LIST OF TEST EQUIPMENT................................................................................................... 25 6 BLOCK DIAGRAM .................................................................................................................. 26 6.1 Radiated emissions set-up for frequencies below 1 GHz ........................................................ 26 6.2 Radiated emissions set-up for frequencies above 1 GHz ........................................................ 26 6.3 Power Line Conducted Emissions set-up ................................................................................ 27 6.4 Antenna port set-up ................................................................................................................. 27 TEST REPORT FCC Part 15.225 Report no.: 455148-01 FCC ID: 2A6AL-RWR2 Nemko GmbH, Reetzstraße 58, 76327 Pfinztal, Germany Page 3 (28) 1 TEST INFORMATION 1.1 Test item Name : Partitioning Engine Model/version : REF: 10100846 FCC ID: 2A6AL-RWR2 Serial number : 4361000036 Frequency Range : 13.553-13.567 MHz Number of Channels : 1 Operating Modes : Transmitter Type of Modulation : ASK User Frequency Adjustment : None Maximum field strength @ 3m: 39.71 dbμV/m Type of Power Supply : AC Adapter: 100 – 240 V / 47 – 63 Hz Device: 24 VDC Antenna Connector : Integral loop antenna Number of antennas: 2 identical internal antennas Antenna Diversity Supported : None Desktop Charger : None Description of test item The Partitioning Engine is an IVD system for laboratory use, which distributes sample into the different micro- partitions of a dPCR plate and seals those partitions with silicone oil. The Partitioning Engine is controlled by an …

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Nemko GmbH Reetzstraße 58 D-76327 Pfinztal Tel.: + 49 (0) 7240 – 63 - 0 Fax: + 49 (0) 7240 – 63 - 11 TEST SET-UP PHOTOS TO REPORT NO.: 455148-01 FCC ID: 2A6AL-RWR2 Page 1 (4) Nemko GmbH, Reetzstraße 58, 76327 Pfinztal, Germany TEST SET-UP PHOTOS AC Conducted Spurious Emission TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 455148 FCC ID: 2A6AL-RWR2 Nemko GmbH, Reetzstraße 58, 76327 Pfinztal, Germany Page 2 (4) Radiated Spurious Emissions from 9 kHz to 30MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 455148 FCC ID: 2A6AL-RWR2 Nemko GmbH, Reetzstraße 58, 76327 Pfinztal, Germany Page 3 (4) Radiated Spurious Emission from 30 MHz to 200 MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 455148 FCC ID: 2A6AL-RWR2 Nemko GmbH, Reetzstraße 58, 76327 Pfinztal, Germany Page 4 (4) Radiated Spurious Emission from 200 MHz to 1000 MHz