
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
samplix.com Xdrop ® Sort manual User manual version 4.0, October 2022 Xdrop Sort manual October 2022 2022 samplix.com For Research Use Only. Not for use in diagnostic procedures. Information in this publication is subject to change without notice. It is Samplix’ policy to improve products and protocols as new techniques and components become available. Therefore, Samplix reserves the right to change specifications at any time. Every effort has been made to avoid errors in the text, diagrams, illustrations, figures, and screen captures. However, Samplix assumes no responsibility for any errors or omissions. In no event shall Samplix be liable for any damages in connection with or arising from the use of this publication. Trademarks © Samplix ApS, 2023. All rights reserved. Duplication, public display, public performance, modification, or any other use of all or any portion of this document without the express prior written consent of Samplix is strictly forbidden. Samplix ® and Xdrop ® are registered trademarks of Samplix ApS and may not be used for any purpose without prior written consent of Samplix. All other trademarks are the property of their respective owners. Contact: Samplix ApS Bregnerødvej 96 3460 Birkerød Denmark Samplix Inc. Industrial Rd 733 San Carlos, CA 94070 USA For technical support email [email protected] Learn more about Samplix technology at samplix.com. Xdrop Sort manual v. 4 October 2022 samplix.com 3 Table of Contents Chapter 1: Introduction 4 Instrument safety 6 Maintenance and service 8 Xdrop Sort installation 10 Required items for Xdrop Sort workflows 11 Chapter 2: Xdrop DE20 Cartridge 14 Considerations for DE20 droplet-based assay design 14 Preparing and loading the Xdrop DE20 Cartridge 18 Xdrop DE20 Cartridge storage after use 26 Chapter 3: DE20 droplet sorting 27 Preparing the Xdrop DE20 Sort Cartridge 27 Overview of the droplet view screen 38 Chapter 4: Sort data analysis 45 Analyzing sorting data with Droplet viewer software 45 Tool tips 52 Chapter 5: Xdrop SE85 Cartridge 53 Preparing and loading the Xdrop SE85 Cartridge 54 Xdrop SE85 Cartridge storage after use 60 samplix.com Xdrop Sort manual v. 4 October 2022 Introduction The Xdrop Sort instrument 4 Chapter 1: Introduction The Xdrop Sort instrument Xdrop Sort supports high-resolution analyses of cells and genomes. It uses microfluidics-based technology to encapsulate living mammalian or microbial cells, organelles, long DNA fragments, or other biological material in double- or single-emulsion droplets. Figure 1.1. Xdrop Sort instrument - front and back panel. Touchscreen – to interface the instrument’s software Power Button – to activate instrument LED Indicators – indicates instrument activity status Cartridge Drawer – to load cartridges USB Port – for software update and data collection Exhaust Fan – to cool down instrument Product Sticker – contains instrument serial number Power Connector – to connect power cord On/Off Switch – to turn the instrument on and off Safety warning – to indicate a potential laser radiation hazard samplix.com Xdrop Sort manual v. 4 October 2022 Introduction The Xdrop Sort instrument 5 Intended use The Xdrop Sort Platform is a microfluidic droplet system that enables high-throughput single-cell analysis and genomic applications. The instrument encapsulates cells, DNA, or particles into individual double emulsion droplets, enabling subsequent analysis and fluorescent based sorting. The instrument may be used with a variety of sample types, including microbial cells, mammalian cells and DNA samples. The Xdrop Sort platform is intended for use by trained laboratory personnel in a clean laboratory environment. Components included in shipping box Name Item no. Quantity Notes Xdrop Sort Instrument IN00200-EU 1 instrument Power Cable 1 power cable Country-specific power cable USB Flash Drive 1 USB key Containing operating software Instrument specifications Technical specifications Model Xdrop Sort Dimensions (w x h x d) 25 x 25 x 48 cm 9.8 x 9.8 x 18.9 in Weight 23.5 kg / 51.8 lbs. USB port 1x USB 2.0 port (for data transfer only) Monitor 15.6" LCD touchscreen Operating specifications Input voltage 110–240 V, 50/60 Hz Max current at 230 VAC: 650 mA at 115 VAC: 1.3 A Operating temperature 20 – 25°C Max operating altitude 2000 m Relative humidity (RH) 0 – 75%. Regulatory compliance Overvoltage category Class II Pollution degree of environment 2 Degree of ingress protection (IEC 60529) IP20, Type 1 (UL50E) Electromagnetic compatibility (EMC) IEC 61326-1 Certificates CE, UL, FCC Class A samplix.com Xdrop Sort manual v. 4 October 2022 Introduction Instrument safety 6 Instrument safety Required training Ensure that all personnel involved with the operation of the instrument have: • Received instruction in general safety practices for laboratories. • Received instruction in specific safety practices for the instrument. • Read and understood all related SDSs. Warning Use this product only as described in this manual. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. Chemical safety Read and understand all safety data sheets (SDSs) provided by chemical manufacturers before you use, store, or handle any chemicals or hazardous materials. The following reagents contain Per- and Polyfluoroalkyl Substances (PFAS). Product name Product number Xdrop DE Oil ● REOILSE0700 Xdrop SE Oil ● REOILDEC1900 Droplet break solution ● REBREDESE0195 Large volume droplet break solution ● REBREDESE1250 Wear personal protective equipment (PPE) when handling chemicals. • Do not inhale fumes from chemicals. Use adequate ventilation and close vials immediately after use. • Check regularly for chemical spills or leaks. Follow SDS recommendations for cleaning up spills or leaks. Warning Some of our reagents may contain Per- and Polyfluoroalkyl Substances (PFAS) Always use and dispose these products according to the Safety Data Sheet. Ele…
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Applicant Declaration QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 1 of 1 Original Issue: Jan. 4, 2021 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Legal Business Name Samplix ApS Address Bregnerødvej 96 Grantee Code 2AU86 FCC ID 2AU86XDROPSORT Authorized Contact Name Thomas Kvist Contact Email [email protected] Contact Phone +45 29 88 11 87 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare; a) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. b) in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for: (1) labeling the equipment with the exact FCC ID as specified in this application, (2) compliance statement labeling pursuant to the applicable rules, (3) compliance of the equipment with the applicable technical rules, c) if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC’s technical requirements. d) in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. e) in accordance with ISO 17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements. (1) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. (2) the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. (3) the Applicant shall, upon request by SGS, at the Applicant’s expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. §862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a “party” for these purposes. g) the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Link to the Covered List: Covered List Samplix ApS (“the applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Samplix ApS (“the applicant”) certifies that, as of the date of the filing of the application, the applicant [is not] identified on the Covered list, established pursuant to §1.50002, as an entity producing “covered” equipment. Applicant Signature: Date: September 7, 2023 Print Name: Thomas Kvist Title: Head of Hardware Development *NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database
Samplix ApS Bregnerødvej 96 3460 Birkerød Denmark www.samplix.com cvr: 32 30 93 21 bank: 3409 0011673171 November 24, 2023 To: SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States From: Samplix ApS Bregnerødvej 96 3640 Birkerød Denmark Phone: (+45) 82 30 45 00 VAT: DK32309321 Regarding: Confidentiality Request regarding application for FCC ID 2AU86XDROPSORT LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commission’s rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematics Block Diagrams The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. No short term confidentiality request. Sincerely, Thomas Kvist Head of Hardware Development Samplix ApS Bregnerødvej 96 3640 Birkerød Denmark
Samplix ApS Bregnerødvej 96 3460 Birkerød Denmark www.samplix.com cvr: 32 30 93 21 bank: 3409 0011673171 UNITED STATESDESIGNATED AGENT LETTER Date: September 25, 2023 TO: Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Applicant U.S. designated agent Company Name: Samplix ApS Company Name: Americas Compliance consulting, LLC dba iCertifi #iCertifi” . Grantee Code: 2AU86 FRN: 0033399411 Contact Name: Thomas Kvist Contact Name: Paul Preston Address: Bregnerødvej 96 Address: 1001 SW Disk Drive, Suite 250 City/Province/Zip: Birkerød/Denmark/3460 City/Province/Zip: Bend/Oregon/97702 Telephone: +45 29881187Telephone: 888-885-4575 Fax: NAFax: NA Email: [email protected]: [email protected] Applicable Equipment: FCC ID: 2AU86XDROPSORT ATTN: Director of Certification: We, Samplix ApS and iCertifi. understand and acknowledge the applicants consent and the designated agent’s obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and e-mail of the designated agent listed above. We, Samplix ApS and iCertifi, acknowledge the applicant’s acceptance of its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Applicant U.S. designated agent Name (Printed): Thomas Kvist Name (Printed): Paul Preston Title: Head of Hardware Development Title: President Signature: Signature:
Reference number: HELEM2306000271-1 Page 1 of 13 These test results are valid for the tested unit only. This report shall not be reproduced, except in full, without a written permission of SGS Fimko. Test Report Electromagnetic Compatibility (EMC) HELEM2306000271-1 TESTS ACCORDING TO FCC PART 15 B REQUIREMENTS Equipment Under Test: Droplet Generator and Sorter Trademark: Samplix Model: Xdrop Sort Customer / Manufacturer: Samplix ApS Bregnerødvej 96 3460 Birkerød Denmark FCC Rule Part: FCC CFR 47 Part 15 Subpart B, Class A Date: 6 November 2023 Date: 6 November 2023 Issued by: Checked by: Henri Mäki Rauno Repo Testing Engineer Senior EMC Specialist Reference number: HELEM2306000271-1 Page 2 of 13 Table of Contents TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................................................. 2 GENERAL REMARKS ................................................................................................................................... 3 Disclaimer ................................................................................................................................................. 3 RELEASE HISTORY...................................................................................................................................... 4 PRODUCT DESCRIPTION ............................................................................................................................ 5 Equipment Under Test (EUT) .................................................................................................................... 5 General description ................................................................................................................................... 5 Samples and modifications........................................................................................................................ 5 Ports and cables ....................................................................................................................................... 5 Peripherals ............................................................................................................................................... 5 TEST CONDITION ......................................................................................................................................... 6 EUT Test Conditions During EMC-Testing ................................................................................................. 6 Operation modes ...................................................................................................................................... 6 Emission Measurement Uncertainty .......................................................................................................... 6 SUMMARY OF TESTING .............................................................................................................................. 7 EMISSION TESTS ......................................................................................................................................... 8 Conducted Emissions ............................................................................................................................... 8 Radiated Emissions .................................................................................................................................. 10 TEST EQUIPMENT ....................................................................................................................................... 13 Conducted Emissions ............................................................................................................................... 13 Radiated Emissions .................................................................................................................................. 13 Reference number: HELEM2306000271-1 Page 3 of 13 Disclaimer GENERAL REMARKS Disclaimer This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic format docu- ments, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Condi- tions/Terms-e-Document.aspx Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written ap- proval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only. Reference number: HELEM2306000271-1 Page 4 of 13 Release History RELEASE HISTORY Version Changes Issued 1.0 Initial release 18 October 2023 1.1 Test standards corrected 6 November 2023 Reference number: HELEM2306000271-1 Page 5 of 13 Product Description PRODUCT DESCRIPTION Equipment Under Test (EUT) EUT information General Product Description Droplet Generator and Sorter Trademark Samplix Model Xdrop Sort Type - Serial number SAMXS210004 Power input port type AC, three-wire (L/N/PE) Rated voltage 110 – 240 V Rated current 1.3 A Rated frequency 50 – 60 Hz Rated power - EUT Highest operation freq. 1 GHz (System on Module processor) Hardware Version (if any) - Software Version (if any) - Mechanical size of the EU…
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TEST SETUP PHOTOGRAPHS Page 1 of 2 Project number: HELEM2306000271-1 SGS Fimko Ltd. Takomotie 8, FI-00380 Helsinki Finland t +358 9 6963 361 f +358 9 692 5474 www.sgs.fi Member of SGS Group (Société Générale de Surveillance) Photograph 1: Conducted emissions Photograph 2: Radiated emissions 30 – 1000 MHz TEST SETUP PHOTOGRAPHS Page 2 of 2 Project number: HELEM2306000271-1 SGS Fimko Ltd. Takomotie 8, FI-00380 Helsinki Finland t +358 9 6963 361 f +358 9 692 5474 www.sgs.fi Member of SGS Group (Société Générale de Surveillance) Photograph 3: Radiated emissions 1 – 5 GHz
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15B | - | - |