2A8KOUVSMARTD60V1Medical Device disinfector with RFID for user registration

1UV Smart D60 | Instructions for Use | Revision 1US Instructions for Use US United states of America To avoid the risk of accidents or damage to the D60, it is essential to read these instructions before it is installed and used. UV Smart D60 2UV Smart D60 | Instructions for Use | Revision 1US Table of contents 1. Introduction ............................................................................................................................................................. 2. Intended Use ........................................................................................................................................................... 2.1. Intended Use 2.2. Intended Medical Indication 2.3. Indications for Use 2.4. Contra-indications for Use 2.5. Intended users 2.6. Intended use environment 2.7. Claimed performance 3. Clinical benefits ....................................................................................................................................................... 4. Residual risks .......................................................................................................................................................... 5. Warnings and precautions ...................................................................................................................................... 5.1. Warnings 5.2. Precautions 6. Product overview ..................................................................................................................................................... 6.1. Packaging content 6.2. Features and dimensions 7. Interface .................................................................................................................................................................... 8. Sounds and lights .................................................................................................................................................... 9. Use ............................................................................................................................................................................. 9.1. Connected and standalone D60 9.2. First time (setup) 9.3. Before every D60 use 9.4. After every D60 use 9.5. Placement of medical equipment guide 9.6. D60 use 9.7. Navigating the D60 menu 9.8. Adding//editing equipment 9.9. Adding/editing users 9.10. Exporting data via USB 10. UV Soft..................................................................................................................................................................... 10.1. First time use 10.2. D60 settings 10.3. Equipment settings 10.4. User settings 10.5. Export 10.6. License 10.7. Server 10.8. Language 10.9. Info 10.10. Exit 11. Maintenance ............................................................................................................................................................ 11.1. Maintenance 11.2. Cleaning 11.3. Calibration 11.4. Yearly validation 11.5. Disposal 12. Problem solving .................................................................................................................................................... 12.1. Problem solving 12.2. Out-of-use 12.3. Broken glass 12.4. Overheating 13. Technical specifications ........................................................................................................................................ 14. Symbols .................................................................................................................................................................. 15. Warranty .................................................................................................................................................................. 16. Contact details ....................................................................................................................................................... 17. Index ........................................................................................................................................................................ 3 5 7 7 8 10 12 13 14 31 39 40 41 42 43 43 44 3UV Smart D60 | Instructions for Use | Revision 1US 1. Introduction The UV Smart D60 is intended to reduce micro-organism count by at least log-4 on outer surfaces of channel- less invasive medical devices 1 within 60 seconds by using UV-C light. The D60 has a disinfection area with 8 lamps, in which medical equipment can be placed. The lamps switch on for 60 seconds during each cycle, in which the micro-organism count on inserted equipment reduces with at least log-4. When applicable, data about the user, equipment and disinfection cycles is stored on the D60 memory. The emitted light used is UV-C, ranging from 100-280nm (peak at 253.7nm). The lamps each have an intensity of 75W. The light is diffusely distributed. The D60 disinfection area is completely sealed off, preventing UV-C light from reaching the user, guaranteeing safe use. UV-C light cannot penetrate the window in the door; only visible light gets through, enabling the user to see inserted equipment and to verify if all the lamps are on during a cycle. When opening the D60 during a disinfection cycle, the UV-C lights switch off automatically. The germicidal effect of UV-C light will not penetrate dirt, debris and grime. To allow the D60 to perform optimally it is required that all medical equipment is cleaned before use, according to the corresponding instructions for use provided by the equipment manufacturer. The UV Smart D60 should be used by trained personnel only. In addition, the Instructions for Use should be read prior to operation. In case they might occur, serious incidents should be reported to UV Smart or your local distributor and competent authority of the member state. The UV Smart D60 is a Risk Group 2 device. This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device do…

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Title UV Smart D60 V1 External foto’s FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 1 of 2 Front view Back view Right side view Left side view Title UV Smart D60 V1 External foto’s FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 2 of 2 Top view with power and ethernet connector Open after successful cycle Open after unsuccessful cycle

Title UV Smart D60 V1 Label FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 1 of 2 Title UV Smart D60 V1 Label FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 2 of 2 Label position Figure 1: Location of Product Sticker.

Title UV Smart D60 V1 Internal foto’s FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 1 of 4 How to open the D60 V1 RFID antenna (red square) Title UV Smart D60 V1 Internal foto’s FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 2 of 4 Barcode reader in front panel and open electrowall with transformer, ballasts, sensor PCB and on/off switch. RFID Antenna RFID PCB front and back Title UV Smart D60 V1 Internal foto’s FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 3 of 4 J1 header description J2 header description (RS232 version) J3 header description Title UV Smart D60 V1 Internal foto’s FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 4 of 4 J4 UARTO header description

RF Exposure Analysis – SAR Test Exemption – UV Smart D60 FCC ID: 2A8KOUVSMARTD60V1 The UV Smart D60 equipment operates using a 13.56 MHz transmitter. The following FCC Rule Parts and Procedures are applicable: KDB447498 D04 V01 – Interim General RF Exposure Guidance Part 1.1307(b)(3)(i)(A) - Blanket RF exposure exemption (i) Part 1.1307(b)(3)(i)(C) - SAR test exemption (ii) Part 1.1307(b)(3)(i)(B) - SAR test exemption (iii) For the UV Smart D60 Operating Frequency: 13.56 MHz Tx Power max (declared): 53.0 dBμV/m @3m = -42.2 dBm EIRP = -44.35 dBm ERP Measured radiated power – Ref KDB447498 D04 Section 3.1.2 – When an antenna port is not available on the device to support conducted power measurement, e.g.: with built-in integral antennas, the available maximum output power or ERP, whichever is larger, and tolerance allowed for production units shall be used to determine RF exposure test exemption and compliance. Evaluation From Part 1.1307, RF exposure exemption applies if the maximum transmitted power is less than the maximum of the following three criteria: i) Less than 1 mw Blanket exemption. P TH = 0.001 W – §1.1307(b)(3)(i)(A) ii) determination of exemption under the MPE-based §1.1307(b)(3)(i)(C), if i) not met iii) determination of exemption under the SAR-based §1.1307(b)(3)(i)(B) if both i) and ii) are not met; Conclusion The UV Smart D60source-based, time-averaged power is -44.35 dBm. i.e.: less than 1 mW (0 dBm), so complies with the RF exposure blanket exemption in accordance with §1.1307(b)(3)(i)(A).

UL INTERNATIONAL GERMANY GMBH Hedelfinger Str. 61 70327 Stuttgart, Germany [email protected] TEST REPORT Test Report No. : UL-RPT-RP-13935019-316-FCC Applicant : UV Smart Technologies B.V. Model No. : D60 V1 FCC ID : 2A8KOUVSMARTD60V1 Technology : RFID 13.56 MHz Test Standard(s) : FCC Parts 15.207, 15.209(a) & 15.225 For details of applied tests refer to test result summary 1. This test report shall not be reproduced in full or partial, without the written approval of UL International Germany GmbH. 2. The results in this report apply only to the sample tested. 3. The test results in this report are traceable to the national or international standards. 4. Test Report Version 1.0 5. Result of the tested sample: PASS _________________________ _________________________ Prepared by: Sercan, Usta Approved by: Rachid Acharkaoui Title: Project Engineer Title: Operations Manager Date: 01 December 2022 Date: 01 December 2022 This laboratory is accredited by DAkkS. The tests reported herein have been performed in accordance with its’ terms of accreditation. UL INTERNATIONAL GERMANY GMBH TEST REPORT NO: UL-RPT-RP-14390360-316-FCC TEST REPORT VERSION 1.0 ISSUE DATE: 01 DECEMBER 2022 Page 2 of 41 FCC 15.225 - Template Ver. 1.5 This page has been left intentionally blank. UL INTERNATIONAL GERMANY GMBH TEST REPORT NO: UL-RPT-RP-14390360-316-FCC TEST REPORT VERSION 1.0 ISSUE DATE: 01 DECEMBER 2022 Page 3 of 41 FCC 15.225 - Template Ver. 1.5 Table of Contents 1. Customer Information .............................................................................................................. 4 1.1. Applicant Information 4 1.2. Manufacturer Information 4 2. Summary of Testing ................................................................................................................. 5 2.1. General Information 5 Applied Standards 5 Location 5 Date information 5 2.2. Summary of Test Results 6 Note(s): 6 2.3. Methods and Procedures 6 2.4. Deviations from the Test Specification 6 3. Equipment Under Test (EUT) .................................................................................................. 7 3.1. Identification of Equipment Under Test (EUT) 7 3.2. Description of EUT 7 3.3. Modifications Incorporated in the EUT 7 3.4. Additional Information Related to Testing 8 3.5. Support Equipment 8 A. Support Equipment (In-house) 8 B. . Support Equipment (Manufacturer supplied) 8 4. Operation and Monitoring of the EUT during Testing ........................................................... 9 4.1. Operating Modes 9 4.2. Configuration and Peripherals 9 5. Measurements, Examinations and Derived Results ............................................................ 10 5.1. General Comments 10 5.2. Test Results 11 5.2.1. Transmitter AC Conducted Spurious Emissions 11 5.2.2. Transmitter 20 dB Bandwidth 17 5.2.3. Transmitter Fundamental Field Strength & Spectrum Mask 19 5.2.4. Transmitter Radiated Spurious Emissions 25 5.2.5. Transmitter Frequency Stability (Temperature & Voltage Variation) 31 6. Measurement Uncertainty ..................................................................................................... 35 7. Used equipment ..................................................................................................................... 36 8. Open-Area-Test Site comparison .......................................................................................... 37 9. Report Revision History ........................................................................................................ 41 UL INTERNATIONAL GERMANY GMBH TEST REPORT NO: UL-RPT-RP-14390360-316-FCC TEST REPORT VERSION 1.0 ISSUE DATE: 01 DECEMBER 2022 Page 4 of 41 FCC 15.225 - Template Ver. 1.5 1. Customer Information 1.1.Applicant Information Company Name: UV Smart Technologies B.V. Company Address: Patrijsweg 74, Rijswijk, The Netherlands Contact Person: Koen van der Kouwe Contact E-Mail Address: [email protected] Contact Phone No.: 085 060 9800 1.2.Manufacturer Information Company Name: UV Smart Technologies B.V. Company Address: Patrijsweg 74, Rijswijk, The Netherlands Contact Person: Koen van der Kouwe Contact E-Mail Address: [email protected] Contact Phone No.: 085 060 9800 UL INTERNATIONAL GERMANY GMBH TEST REPORT NO: UL-RPT-RP-14390360-316-FCC TEST REPORT VERSION 1.0 ISSUE DATE: 01 DECEMBER 2022 Page 5 of 41 FCC 15.225 - Template Ver. 1.5 2. Summary of Testing 2.1. General Information Applied Standards Specification Reference: 47CFR15.225 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart C (Radio Frequency Devices) - Section 15.225 Specification Reference: 47CFR15.207 and 47CFR15.209 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart C (Intentional Radiators) - Sections 15.207 and 15.209 Location Location of Testing: UL International Germany GmbH Hedelfinger Str. 61 70327 Stuttgart Germany Test Firm Registration: 399704 Date information Order Date: 24 June 2022 EUT arrived: 13 September 2022 Test Dates: 23 September 2022 to 28 September 2022 EUT returned: -/- UL INTERNATIONAL GERMANY GMBH TEST REPORT NO: UL-RPT-RP-14390360-316-FCC TEST REPORT VERSION 1.0 ISSUE DATE: 01 DECEMBER 2022 Page 6 of 41 FCC 15.225 - Template Ver. 1.5 2.2.Summary of Test Results Clause Measurement Complied Did not comply Not performed Not applicable Part 15.207 Transmitter AC Conducted Emissions ☒ ☐ ☐ ☐ Part 15.215(c) Transmitter 20 dB Bandwidth ☒ ☐ ☐ ☐ Part 15.225(a)(b)(c)(d) Transmitter Fundamental Field Strength & Spectrum Mask (continued) ☒ ☐ ☐ ☐ Part 15.209(a)/ 15.225(d) Transmitter Radiated Emissions ☒ ☐ ☐ ☐ Part 15.225(e) Transmitter Frequency Stability (Temperature & Voltage Variation) ☒ ☐ ☐ ☐ Note(s): 2.3. Methods and Procedures Reference: ANSI C63.4-2014 Title: American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to…

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Title UV Smart D60 Antenna details FCC Author Koen van der Kouwe Document ID DOC- TBD Revision 0 SOP-03-8 FRM Memorandum; Rev. 2; DOC-206; CO-229 UV Smart Confidential Document Page 1 of 1 1. Antenna used MUX RFID external antenna 13.56 MHz V1.0

UV Smart Technologies B.V. FCC ID: 2A8KOUVSMARTD60V1 UL-RPT-RP-14390360-316 UL International Germany GmbH 1 Test Setup Photographs for the HVIN: 1.5/ PMN: D60 V1 1.Radiated Emissions: Photo 1 Radiated Test Setup-9 kHz – 30 MHz Photo 2 Radiated Test Setup-9 kHz – 30 MHz UV Smart Technologies B.V. FCC ID: 2A8KOUVSMARTD60V1 UL-RPT-RP-14390360-316 UL International Germany GmbH 2 Photo 3 Radiated Test Setup-30 MHz – 1 GHz Photo 4 Radiated Test Setup-30 MHz – 1 GHz UV Smart Technologies B.V. FCC ID: 2A8KOUVSMARTD60V1 UL-RPT-RP-14390360-316 UL International Germany GmbH 3 2.Test Setup - Frequency Stability: Photo 5 Test Setup - Frequency Stability ( Temperature & Voltage Variation) Photo 6 Test Setup - Frequency Stability ( Temperature & Voltage Variation) UV Smart Technologies B.V. FCC ID: 2A8KOUVSMARTD60V1 UL-RPT-RP-14390360-316 UL International Germany GmbH 4 3.AC Conducted Emissions: Photo 7 AC Conducted Test Setup Photo 8 AC Conducted Test Setup