2AYDHKLEEYAIn-vitro diagnostic analyzer system

User Manual EDITION:Date: December 2020 Document no.: 1000027791_B Version 2 SOFTWARE:User Software Version 1.0 TRADEMARKS:Microsoft and Windows are registered trademarks of Microsoft Corporation in the United States and/or other countries. Mozilla and Firefox are registered trademarks of Mozilla Corporation. Adobe, Acrobat and Adobe Reader are registered trademarks of Adobe Systems Incorporated. We reserve the right to make changes in the course of technical development without previous notice. Original Document Copyright © 2020, STRATEC SE. All rights reserved. STRATEC SE Gewerbestraße 37 75217 Birkenfeld Germany Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of STRATEC SE. KLEEYA - User Manual - Version 2TOC-1 TABLE OF CONTENTS 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1 1.1 Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 1.2 Typographical conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 1.2.1 Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2 1.2.2 Display of warnings and notes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3 1.2.3 Used warning symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4 1.2.4 Other symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5 1.2.5 Special types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6 1.3 Qualification for user. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7 1.3.1 Qualification for basic user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7 1.3.2 Additional qualification for advanced user. . . . . . . . . . . . . . . . . . . . . . . .1-7 1.4 Safety instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8 1.4.1 General safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9 1.4.2 Electrical safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11 1.4.3 Biological safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13 1.4.4 Disposal and Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-14 1.5 Positions of safety labels and type label . . . . . . . . . . . . . . . . . . . . . . . . . .1-15 1.6 Radio interferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18 1.7 Cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19 1.7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19 1.7.2 Definition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19 1.7.3 User training and education. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20 1.7.4 Identification of threats and hazards . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20 1.7.5 Unauthorized local access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22 1.7.6 Unauthorized access via the network. . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 1.7.7 Remote access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23 1.7.8 External media and devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24 1.7.9 Security updates of the KleeYa System. . . . . . . . . . . . . . . . . . . . . . . . . .1-26 1.7.10 Privacy of data on the KleeYa System . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27 1.7.11 Incident response. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27 2 Instrument description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1 2.1 Instrument overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1 2.2 Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4 3 Basic functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 3.1 Touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1 3.2 Menu bars (Overview). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2 3.2.1 Top menu bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3 3.2.2 Main menu bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4 3.3 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5 3.3.1 Load or unload Dispense Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7 3.3.2 Load cuvettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18 3.3.3 Load or unload Anchor® Tips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22 3.3.4 Load or unload system liquid main container . . . . . . . . . . . . . . . . . . . .3-29 3.3.5 Load or unload wash buffer main container. . . . . . . . . . . . . . . . . . . . . .3-32 3.3.6 Load or unload solid waste bag. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-37 3.3.7 Load or unload liquid waste main container . . . . . . . . . . . . . . . . . . . . .3-39 TOC-2KleeYa - User Manual - Version 2 3.4 Load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …

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Stratec KleeYa RFID System Description 2021-12-17 1TOSC 12. External Photographs 1.ARS Loading Bay Fig. 1 - Loading Bay with ARS Rack Fig. 2 - ARS Rack with Reagent Integrals Antennas Tag 2.DDCA Modules Fig. 3 - DDCA Modules with Dispense Cartridges Antennas

Stratec KleeYa RFID System Description 2021-12-17 1TOSC 10. Label Format and Location Label: Location:

Stratec KleeYa RFID System Description 2021-12-17 1TOSC 13. Internal Photographs 1. Catridge Carrier CU PCBA with attached RFID Antenna PCBA located in ARS racks 2. DDCA CU PCBA located in DDCA Module Antenna RFID Circuit RFID Circuit Antenna Multiplexer Antenna

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: 2AYDHKLEEYA Model number: KleeYa REF: 9290700001 Manufacturer: Stratec SE Gewerbestraße. 37 75217 Birkenfeld Germany Minimum separation distance 5 mm Opeational frequency 4 MHz 13.56 MHz Maximum EIRP -50.86 dBm (0.00001 mW) -52.86 dBm (0.00000 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 highest ERP of the EUT is 0.00001 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: March 29, 2022 Name: Peter Lukas, Lab Manager FCC SAR Exemption per KDB 447498

Nemko GmbH & Co. KG Reetzstraße 58 D-76327 Pfinztal Tel.: + 49 (0) 7240 – 63 - 0 Fax: + 49 (0) 7240 – 63 - 11 Report No. 406069-01 Template version: B This report consists of 27 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 handwritten signed document only. nemko.com/de FCC TEST REPORT / ISED TEST REPORT Product KleeYa Name and address of the applicant Stratec SE Gewerbestraße 37 D – 75217 Birkenfeld (Germany) Name and address of the manufacturer Stratec SE Gewerbestraße 37 D – 75217 Birkenfeld (Germany) Model KleeYa REF: 9290700001 Rating 100 – 240V Trademark STRATEC Serial number 9070000033 Additional information Radio Frequency Identification (RFID) -13.56MHz Radio device - 4 MHz Tested according to FCC Part 15.225 Low Power Transmitter, Operation in the band 13.110 - 14.010 MHz FCC Part 15.223 Operation in the band 1.705–10 MHz Industry Canada RSS-210, Issue 10 Low Power Licence-Exempt Radiocommunications Devices Order number 406069 Tested in period 2020-10-19 – 2020-10-23 Issue date 2021-11-06 Name and address of the testing laboratory Nemko GmbH & Co. KG 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.: 406069-01 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 2 (27) CONTENTS 1 TEST INFORMATION ............................................................................................................... 3 1.1 Test item .................................................................................................................................... 3 1.2 Normal test condition ................................................................................................................. 5 1.3 Test Engineer(s) ........................................................................................................................ 5 1.4 Description of modification for Modification Filing ...................................................................... 5 1.5 Family List Rational ................................................................................................................... 5 1.6 Antenna Requirement ................................................................................................................ 5 1.7 Worst-Case Configuration and Mode ......................................................................................... 5 1.8 Comments ................................................................................................................................. 5 2 TEST REPORT SUMMARY ...................................................................................................... 6 2.1 General ...................................................................................................................................... 6 2.2 Test summary ............................................................................................................................ 7 3 TEST RESULTS ........................................................................................................................ 8 3.1 Power Line Conducted Emissions ............................................................................................. 8 3.2 99 % Occupied Bandwidth ....................................................................................................... 12 3.3 Fundemental Field Strength .................................................................................................... 15 3.4 Spurious emissions (radiated) ................................................................................................. 17 3.5 Transmitter Frequency Stability ............................................................................................... 23 4 Measurement Uncertainty ..................................................................................................... 24 5 LIST OF TEST EQUIPMENT .................................................................................................. 25 6 BLOCK DIAGRAM .................................................................................................................. 26 6.1 Test site radiated emission ...................................................................................................... 26 TEST REPORT FCC Part 15.225 Report no.: 406069-01 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 3 (27) 1 TEST INFORMATION 1.1 Test item Name : KleeYa Model/version : REF: 9290700001 FCC ID: 2AYDHKLEEYA Serial number : 9070000033 Type of Power Supply : Entire unit: 100 – 240V / 50 – 60Hz RFID Module: 24V DC RFID 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: 42.52 dbμV/m Antenna Connector : Integral loop antenna Number of antennas: Module 1: 16 identical antennas Module 2: 2 identical antennas Antenna Diversity Supported : None 4 MHz Radio Module Frequency Range : 4 MHz Number of Channels: 1 Operating Modes : Transmitter User Frequency Adjustment : None Maximum field strength @ 3m: 46.52 dbμV/m Antenna Connector : Integral loop antenna Number of antennas: Module 3: 8 identical antennas Antenna Diversity Supported : None TEST REPORT FCC Part 15.225 Report no.: 406069-01 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 4 (27) Description of test item The KleeYa system is a fully automated, non-patient contact immunoassay analyzer system for in-vitro diagnostic use. The main parts of the system are the pipettor, the measurement chamber with reagent dispensers (DDCA), …

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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.:406069-01 FCC ID:2AYDHKLEEYA Page 1 (5) Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany TEST SET-UP PHOTOS AC Conducted Spurious Emission TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 406069 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 2 (5) Radiated Spurious Emissions from 9 kHz to 30MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 406069 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 3 (5) Radiated Spurious Emission from 30 MHz to 200 MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 406069 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 4 (5) Radiated Spurious Emission from 200 MHz to 1000 MHz TEST SET-UP PHOTOS FCC Part 15.225 TO REPORT NO.: 406069 FCC ID: 2AYDHKLEEYA Nemko GmbH & Co. KG, Reetzstraße 58, 76327 Pfinztal, Germany Page 5 (5) Radiated Spurious Emission above 1GHz