2AWE5MOSAIQ125In-vitro diagnostic analyzer system

USER MANUAL MosaiQ 125 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02 FCC ID: 2AWE5MOSAIQ125 SAFETY INSTRUCTIONS / RADIO INTERFERENCE 28 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02 4.6 RADIO INTERFERENCE This section provides information about the risks of radio interference and the safe operation of the MosaiQ 125. The MosaiQ 125 is a Class A digital device in accordance with CISPR 11 and FCC Rules. The MosaiQ 125 complies with the following standards and rules for information concerning radio interference: „IEC 61326-2-6 (Class A for emissions) and IEC 61326-1. „47 CFR Part 15, Subpart B, of the FCC Rules. Electromagnetic Compatibility (EMC) INFO The MosaiQ 125 complies with the emissions and immunity requirements as described in standard IEC 61326-2-6. The MosaiQ 125 has been developed and tested according to CISPR11 Class A. It may cause radio interference in domestic environments. If the MosaiQ 125 causes radio interference, you may need to take measures to eliminate the interference. The electromagnetic environment shall be evaluated before installation and operation of the MosaiQ 125. Do not use the MosaiQ 125 in the proximity of sources with excessive electromagnetic radiation (e.g. unshielded, deliberately operated high frequency sources) since they could interfere with the proper operation of the MosaiQ 125. FCC Statements CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the MosaiQ 125. INFO The MosaiQ 125 has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 4.7 LABORATORY EQUIPMENT WARNING All biological materials must be regarded as being potentially hazardous. All cuts and abrasions on hands must be covered. Gloves and safety glasses should be worn when handling samples and biological materials. CAUTION Strictly follow your laboratory rules regarding protective clothing.

USER MANUALMosaiQ 125 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02 FCC ID: 2AWE5MOSAIQ125 2 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02 Page intentionally left blank 3 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02 TABLE OF CONTENT1. ABOUT THIS MANUAL .............................................................................................................................. ............. 4 2. INTENDED USE .............................................................................................................................. ................................... 12 3. PRIOR TO USE .............................................................................................................................. ...................................... 16 4. SAFETY INSTRUCTIONS .............................................................................................................................. ... 22 5. MOSAIQ 125 PARTS DESCRIPTION AND LOCATION ................................. 29 6. GRAPHICAL USER INTERFACE ............................................................................................................ 47 7. OPERATING INSTRUCTIONS .................................................................................................................. 54 8. SAMPLE LOADING AND TESTING ................................................................................................ 85 9. QUALITY CONTROL .............................................................................................................................. ............... 111 10. MOSAIQ 125 SHUTDOWN .................................................................................................................. 116 11. ADVANCED FUNCTIONS ........................................................................................................................ 118 12. MAINTENANCE .............................................................................................................................. ......................... 128 13. TROUBLESHOOTING AND ERROR OVERVIEW ............................................. 147 14. CYBERSECURITY .............................................................................................................................. .................... 157 15. INSTALLATION AND REMOVAL OF THE MOSAIQ 125 ..................... 163 16. WARRANTY .............................................................................................................................. .................................. 164 17. CONTACT QUOTIENT .............................................................................................................................. ....... 165 18. TECHNICAL DATA ............................................................................................................................... ............... 166 19. INDEX .............................................................................................................................. ........................................................... 171 20. APPENDIX .............................................................................................................................. ......................................... 172 TABLE OF CONTENT 3 4 MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02 1. ABOUT THIS MANUAL1.1 PURPOSE ഩ .............................................................................................................................. ............................................................. ഩ 5 1.2 AUDIENCE ഩ .............................................................................................................................. ......................................................... ഩ 5 1.3 DISCLAIMER ഩ .............................................................................................................................. ................................................. ഩ 5 1.4 HOW TO USE THE USER MANUAL ഩ .................................................................................................... ഩ 5 1.5 GENERAL INFORMATION ഩ .............................................................................................................................. .... ഩ 5 1.6 VERSION ഩ .............................................................................................................................. .............................................................. ഩ 6 1.6.1 EDITION ഩ .............................................................................................................................. ......................................... ഩ 6 1.6.2 SOFTWARE ഩ ............................................................................................................................... ............................... ഩ 6 1.7 TYPOGRAPHICAL CONVENTIONS AND TERMINOLOGY ഩ ....................... ഩ 6 1.7.1 SPECIAL TYPES ഩ .............................................................................................................................. .................... ഩ 6 1.7.2 TERMINOLOGY ഩ .............................................................................................................................. ..................... ഩ 7 1.7.3 CONVENTIONS ഩ .............................................................................................................................. ..................... ഩ 7 1.7.4 LIST OF ACRONYMS ഩ .............................................................................................................................. ...... ഩ 7 1.7.5 DISPLAY OF WARNINGS AND NOTES ഩ ................................................................................ ഩ 9 1.7.6 SYMBOLS ഩ .............................................................................................................................. .........................…

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Quotient Suisse SA, Registered in Switzerland, No. CHE-167.592.818 Business Park Terre Bonne, Route de Crassier 13, 1262 Eysins, Switzerland T +41 22 716 98 00, F +41 22 716 98 01, quotientbd.com Eysins, November 30, 2020 FCC ID: 2AWE5MOSAIQ125 Model: MosaiQ 125 Request for Long-Term Confidentiality Pursuant to Sections 0.457(d) and 0.459 of the Commission’s rules, we hereby request that the following documents be held confidential:  Schematics  Block diagram  Bill of Materials  Operational Description These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated: 11/30/2020 Signed: Printed name: Michael Campbell Title: Head of Regulatory Affairs & Quality On behalf of: Quotient Suisse SA Quotient Suisse SA, Business Park Terre Bonne, Route de Crassier 13, 1262 Eysins, Switzerland Nemko Canada Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2

Quotient Suisse SA, Registered in Switzerland, No. CHE-167.592.818 Business Park Terre Bonne, Route de Crassier 13, 1262 Eysins, Switzerland T +41 22 716 98 00, F +41 22 716 98 01, quotientbd.com Eysins, November 30, 2020 FCC ID: 2AWE5MOSAIQ125 Model: MosaiQ 125 Request for Short-Term Confidentiality Pursuant to Sections 0.457(d) and 0.459 of the Commission’s rules, we hereby request that the following document be held confidential for short-term period: • User Manual MMSURM.0010 • Internal Photos Dated: 11/30/2020 Signed: Printed name: Michael Campbell Title: Head of Regulatory Affairs & Quality On behalf of: Quotient Suisse SA Quotient Suisse SA, Business Park Terre Bonne, Route de Crassier 13, 1262 Eysins, Switzerland Nemko Canada Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2

Quotient Suisse SA, Registered in Switzerland, No. CHE-167.592.818 Business Park Terre Bonne, Route de Crassier 13, 1262 Eysins, Switzerland T +41 22 716 98 00, F +41 22 716 98 01, quotientbd.com Eysins, May 19, 2020 Attn: Director of Certification Authority to Act as Agent FCC On our behalf, I appoint Geremy Bradshaw of Nemko USA, Inc. 2650 FM 407, Suite 145, Box 101, Bartonville, TX 76226, to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in FCC regulations will have affixed to it a label identical to that submitted for approval with this application. In signing this letter, Applicant certifies that neither the applicant nor any party to the application is subject to a denial of Federal benefits, that include 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 47 CFR 1.2002(b) for the definition of a "party" for these purposes. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Quotient Suisse SA – Business Park Terre Bonne – Route de Crassier 13 – 1262 Eysins - Switzerland Dated this 19 Day of May 2020 Agency agreement expiration date: June 01 st , 2021 By: Ed Farrell Signature Printed Title: Chief Operating Officer On behalf of : Quotient Suisse SA Telephone: Michael Campbell +41 22 545 52 46 Head of Regulatory Affairs & Quality Quotient Suisse SA, Business Park Terre Bonne, Route de Crassier 13, 1262 Eysins, Switzerland Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2

Quotient MosaiQ RFID System Description 2020-07-17 1CHKR 12. External Photographs 1. DDCA Modules 2. Consumable Loading 3. Reagent Drawer Station:

Quotient MosaiQ RFID System Description 2020-07-17 1CHKR 13. Internal Photographs 1. DDCA CU PCBA 2. Consumable Loading CU PCBA 3. CL RFID Antenna PCBA 4. Buffer Sensor CU PCBA

TEST REPORT FCC Part 15.225 Report no.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 2 (25) 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 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 ......................................................................................................... 9 3.3 Fundemental Field Strength .................................................................................................... 12 3.4 Spurious emissions (radiated) ................................................................................................. 15 3.5 Transmitter Frequency Stability ............................................................................................... 21 4 Measurement Uncertainty ..................................................................................................... 22 5 LIST OF TEST EQUIPMENT .................................................................................................. 23 6 BLOCK DIAGRAM .................................................................................................................. 24 6.1 Test site radiated emission ...................................................................................................... 24 TEST REPORT FCC Part 15.225 Report no.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 3 (25) 1 TEST INFORMATION 1.1 Test item Name : MosaiQ 125 Model/version : REF: 126001 FCC ID: 2AWE5 MosaiQ 125 Serial number : 5290000126 Software identity and/or version : 02.03 9891 00 COP firmware 1.300.1906.21001 User Software 1.2.1904.18001 Service Software For all firmware versions and article numbers see file: Uniload_5290_Checkscript.txt 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: 52.88 dbμV/m Type of Power Supply : Entire unit: 100 – 240V / 50 – 60Hz RFID Module: 24V DC Antenna Connector : Integral loop antenna Number of antennas: Module 1: 5 identical antennas Module 2: 8 identical antennas Module 3: 8 identical antennas Antenna Diversity Supported : None Desktop Charger : None Description of test item The MosaiQ is a fully automated, floor standing analyzer system for in-vitro diagnostic use. It performs blood type detection and disease testing. The device contains three RFID modules for identifying samples and containers. Module 1 Loading tower: It can control five identical antennas to ensure that a tag is detected. Module 2 DDCA: It can control eight identical antennas to detected different containers. Module 3 Buffer reconstitution module: It can control eight identical antennas to detected different containers. Module 1 and module 3 have the same design, they only contain a different number of antennas. The EUT is a class A device. Class A digital device: A digital device that is marketed for use in a commercial, industrial or business environment, exclusive of a device which is marketed for use by the general public or is intended to be used in the home. TEST REPORT FCC Part 15.225 Report no.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 4 (25) 1.2 Normal test condition Temperature: 19 - 22 °C Relative humidity: 38 - 45 % Normal test voltage: 120V / 60Hz The values are the limit registered during the test period. 1.3 Test Engineer(s) Frederic Hupbauer 1.4 Description of modification for Modification Filing Not applicable. 1.5 Family List Rational Not Applicable. 1.6 Antenna Requirement Is the antenna detachable? Yes No If detachable, is the antenna connector non-standard? Yes No Type of antenna connector: N/A Ref. FCC §15.203 1.7 Worst-Case Configuration and Mode The modules were set to continuus operation and the maximum output level was set in the software. For every module the antenna with the higest output with and without tag was tested. The radiated measurements are tested on three axes. The worst-case-scenario is reported. 1.8 Comme…

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Ident. Nr.: FC-2002-392655 Date: 2020-03-12 EMV Testzentrum 392655TRFFCC.doc page 2 of 35 Index of the test report: 1 General information .............................................................................................. 5 1.1 Description of Equipment under test (EUT) ............................................................................. 5 1.2 Internal frequency .................................................................................................................... 5 1.3 Equipment configuration .......................................................................................................... 5 1.3.1 Assembly of EUT ................................................................................................................. 5 1.3.2 EUT software during test ..................................................................................................... 5 1.4 Operating status (OS) .............................................................................................................. 6 1.5 Project history .......................................................................................................................... 6 1.6 Labelling information ............................................................................................................... 7 1.7 Test equipment ........................................................................................................................ 7 1.8 definitions limit class ................................................................................................................ 8 1.9 General .................................................................................................................................... 9 2 Test Report Summary......................................................................................... 10 2.1 Standards .............................................................................................................................. 10 2.2 Results ................................................................................................................................... 10 3 Measurement of conducted emission ................................................................. 11 3.1 Standards .............................................................................................................................. 11 3.2 Measurement equipment ....................................................................................................... 11 3.3 Test set-up ............................................................................................................................. 12 3.4 Test methods and limits ......................................................................................................... 12 3.5 Subpart B: FCC Part 15.107 / ICES-003 class A limit values ............................................... 12 3.6 Settings receiver .................................................................................................................... 13 3.7 Climatic conditions ................................................................................................................. 13 3.8 Test result .............................................................................................................................. 13 3.9 Diagrams and tables .............................................................................................................. 13 3.9.1 Diagram 392655-6EC ........................................................................................................ 13 3.9.2 Table Final Measurements 392655-6EC_fin QP ............................................................... 14 3.9.3 Table Final Measurements 392655-6EC_fin AV ............................................................... 14 Ident. Nr.: FC-2002-392655 Date: 2020-03-12 EMV Testzentrum 392655TRFFCC.doc page 3 of 35 4 Measurement of radiated field ............................................................................ 15 4.1 Standards .............................................................................................................................. 15 4.2 Measurement equipment ....................................................................................................... 15 4.3 Test set-up ............................................................................................................................. 15 4.4 Test method and limits .......................................................................................................... 16 4.5 Subpart B: FCC Part 15.109 / ICES-003 class A limit values ............................................... 17 4.6 Settings receiver .................................................................................................................... 17 4.7 Climatic conditions ................................................................................................................. 17 4.8 Internal generated or used frequency for unintentional radiators .......................................... 17 4.9 Test result .............................................................................................................................. 18 4.10 Diagrams and tables .............................................................................................................. 18 4.10.1 Diagram 392655-1ER .................................................................................................... 18 4.10.2 Table Final measurements 392655-1ER QP ................................................................ 18 5 Measurement of radiated field ............................................................................ 20 5.1 Standards .............................................................................................................................. 20 5.2 Measurement equipment ................................…

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Nemko GmbH & Co. KG Reetzstraße 58 D-76327 Pfinztal Tel.: + 49 (0) 7240 – 63 - 0 Fax: + 49 (0) 7240 – 63 - 11 TEST SET-UP PHOTOS TO REPORT NO.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Page 1 (4) Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany PHOTOS OF TEST SET-UP Conducted emission TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 2 (4) Radiated < 30MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 3 (4) Radiated emission 30 MHz - 200 MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 389668-01 FCC ID: 2AWE5 MosaiQ 125 Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 4 (4) Radiated emission 200 MHz - 1000 MHz