2AU7Q-CA1821Readerboard

READERBOARD TMRW-SPC-CUS-005 • VERSION: 01 • IMPLEMENTATION DATE: DD MMM YYYY INSTRUCTIONS FOR USE TMRW READERBOARD TMRW READERBOARD Cryopreservation Identification and Tracking Device DEVICE DESCRIPTION The TMRW RFID ReaderBoard is a custom circuit board component that integrates the TMRW At-the- Robot (ATR) software and Witnessing System. INTENDED USE To read stored information on RFID enabled containers INTENDED USERS The intended users of the RFID Readerboard are laboratory professionals including embryologists, andrologists, clinicians, laboratory technicians, and laboratory management personnel. Patients do not interact with or come into contact with TMRW products. The patient population served is men and women, typically age between the ages of 18 years to 50 years at the time of fertility tissue collection. CONTRAINDICATIONS None. ADVERSE EFFECTS None. STORAGE Store at room temperature. DISPOSAL Discard at an e-waste facility. There are no lithium batteries used to operate, nor are any toxic components used in the manufacturing of the Readerboard. The PCB assembly is lead-free. TMRW Life Sciences, Inc. 250 Hudson, Suite 701 New York, NY, 10013 tmrw.org/contact-us CLIENT SUCCESS Contact for general inquiries into our service or products. Phone: 917-525-3453 E-mail: [email protected] Always use appropriate personal protective equipment (PPE) and follow your laboratory’s standard operating procedures and safety guidelines when working with liquid nitrogen (LN 2 ). The RFID Readerboard requires electricity to function. Use standard caution and care around electrical connections and cords to prevent bodily harm from electrical shock or damage to the machine. Always use proper power and proper electrical compliant connections in accordance with the local electrical code. Figure A: Readerboard With a CryoGrid located in the left CryoBath, and an additional CryoGrid or CryoTransporter located in the right CryoBath (Figure B), refer to the lower screen. If you have additional CryoBeacons for this procedure, repeat Step 2 and Step 3. Wait for the RFID Readerboard to map the CryoBeacons in the CryoGrid and CryoTransporter. Following the arrow on the screen, move the CryoBeacon highlighted in green to the empty location highlighted in green. After a CryoBeacon has been moved, the RFID Readerboard updates the screen to reflect the movement of the CryoBeacon. 01 04 02 03 INSTRUCTIONS FOR USE Medical Product Service GmbH (MPS) Borngasse 20 35619 Braunfels, Germany Note: For specimen vitrification, you can use the CryoTransporter or your preferred cryogenic container. If you choose to use the CryoTransporter for vitrification, the angled slot in the front allows for easy and safe loading of your cryodevice into the CryoBeacon. The CryoTransporter provides sufficient LN 2 depth to plunge cryodevices during vitrification. NOTICE 1. FCC CFR 47 15.19 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. 2. FCC CFR 47 15.21 Caution: any changes or modifications to this device not expressly approved by TMRW Life Sciences, Inc. could void the user’s authority to operate the equipment. 3. FCC CFR 47 15.105 INFORMATION TO THE USER 4. (a) For a Class A digital device or peripheral, the instructions furnished the user shall include the following or similar statement, placed in a prominent location in the text of the manual: Note: This equipment 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. 5. FCC RADIATION EXPOSURE STATEMENT: This device complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. The equipment should be installed and operated with minimum distance of 20cm between the radiator and your body. 6. ISED STATEMENTS This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. Ce dispositif contient les émetteurs/récepteurs autoriser-exempts qui sont conformes au permis RSS exempt du Canada d’innovation, de la Science et de développement économique. L’opération est sujette aux deux conditions suivantes: (1) Ce dispositif peut ne pas causer l’interférence. (2) Ce dispositif doit accepter n’importe quelle interférence, y compris l’interférence qui peut causer le fonctionnement peu désiré du dispositif. CAN ICES-3 (A) / NMB-3 (A) This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de classe A est conforme à la norme canadienne ICES-003. 7. RADIATION EXPOSURE STATEMENT: ISED This equipment complies with ISED radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with greater than 20cm between the radiator and your body. Déclaration d’exposition aux radiations: Cet équipement est conforme aux limites d’exposition aux rayonnements ISED établies pour un environneme…

Text truncated - open the document above for the full version.

250 HUDSON STREET, SUITE 701, NEW YORK, NY 10013 TMRW.ORG December 14, 2020 Nemko USA 2210 Faraday Avenue Suite 150 Carlsbad, CA 92008 REQUEST FOR CONFIDENTIALITY Name of Applicant: TMRW Address: 250 Hudson Street Suite 701 City: New York State: New York FCC ID: 2AU7Q-CA1821 IC: 25647-CA1821 Pursuant to Sections 0.457(d) and 0.459 of the commission’s rules and Industry of Canada per RSP-100 Issue 12 Section 12.4 Regulations, we hereby request that the following documents be held under confidentiality. LONG TERM: 1. Block Diagram 2. Schematics 3. Parts List 4. Operational description Short Term FCC Only - Pursuant to Sections 0.457(d) and 0.459 of the commission’s rules, we hereby request that the following documents be held under confidentiality. SHORT TERM: for the period of 180 days 1. Internal Photos 2. External Photos 3. User Manual The above information contains trade secrets and proprietary information not customarily released to the public. The public disclosure of this information might be harmful to the applicant and provide unjustified benefits to its competitors. Sincerely, Steve Gordon Chief Legal Officer E: [email protected]: 1(973) 981.3685

TMRW Readerboard Views Note: Readerboard is assembled into the TMRW Platform. It is located under a console top where operator has limited access and no controls. Photos of the Readboard in its final assembly are difficult to obtain, therefore models are provide to help locate photo views. View Model Photo Top Stand alone: In final assembly: Bottom Front No direct photo possible when assembled into console. Test configuration for reference: Back No direct photo possible when assembled. Readerboard attached to well outside of console for reference: Zoom on label: Left (cross- section) Right

LABEL LOCATION Label Location

ONE WORLD  OUR APPR OVAL 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: 2AU7Q-CA1821 Model number: CA1821 Manufacturer: TMRW Life Sciences, Inc 4.3.1. Standalone SAR test exclusion considerations: During normal operation, user extremities can come within 20 cm of the internal antenna and therefore product is considered as “Portable”. Using Appendix C approximate SAR exclusion table. The device is a 13.56MHz RFID transmitter operation at less than 44.18 dBμV/m at 3m or -51.05 dBm. Per KDB 447498 D01 4.31 c) 2) appendix C. 1) Linear interpolation for 13.56MHz the SAR exclusion level is approximately 461.55mW 2) The actual transmitter is -51.05 dBm or 7.85E-6mW 3) 7.85e-6mW <<<<<<< 461mW Power and distance are rounded to the nearest mW and mm before calculation The result is rounded to one decimal place for comparison The calculation is below the threshold, therefore the product exempt from the SAR test requirements 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: December 7, 2020 Name: Chip Fleury SAR Exclusion

www.nemko.com FCC 15C - §15.225 & RSSS.docx; Date: March 2020 Nemko USA Inc., a testing laboratory, is accredited by NVLAP. The tests included in this report are within the scope of this accreditation. O N E W O R L D O U R A P P R O V A L Test report 400689-2R3TRFWL Date of issue: September 8, 2020 Applicant: TMRW Life Sciences, Inc. Product: Readerboard Model: CA1821 FCC ID: 2AU7Q-CA1821 IC: 25647-CA1821 Specifications:  FCC 47 CFR Part 15, Subpart C – §15.225 Operation within the band 13.110-14.010 MHz  RSS-210, Issue 10, December 2019 License-Exempt Radio Apparatus: Category I Equipment  RSS-Gen, Issue 5, Amendment 1, March 2019 General Requirements for Compliance of Radio Apparatus Report reference ID: 400689-2R3TRFWL Page 2 of 29 Test location Company name Nemko USA, Inc. Address 2210 Faraday Ave, Suite 150 City Carlsbad Province California Postal code 92008 Country USA Telephone +1 760 444 3500 Website www.nemko.com FCC Site Number Test Firm Registration Number: 392943 Designation Number: US5058 ISED Test Site 2040B-3 Tested by David Hewitt, EMC Specialist Reviewed by James Cunningham, Wireless Supervisor Review date September 8, 2020 Reviewer signature Limits of responsibility Note that the results contained in this report relate only to the items tested and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This test report has been completed in accordance with the requirements of ISO/IEC 17025. All results contain in this report are within Nemko USA’s ISO/IEC 17025 accreditation. This report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. Copyright notification Nemko USA Inc. authorizes the applicant to reproduce this report provided it is reproduced in its entirety and for use by the company’s employees only. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko USA Inc. accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. © Nemko USA Inc. Report reference ID: 400689-2R3TRFWL Page 3 of 29 Table of contents Table of contents .......................................................................................................................................................................................................... 3 Section 1. Report summary ................................................................................................................................................................................. 4 1.1 Applicant and manufacturer ................................................................................................................................................................................................ 4 1.2 Test specifications ................................................................................................................................................................................................................. 4 1.3 Test methods ......................................................................................................................................................................................................................... 4 1.4 Statement of compliance ..................................................................................................................................................................................................... 4 1.5 Exclusions .............................................................................................................................................................................................................................. 4 1.6 Test report revision history .................................................................................................................................................................................................. 4 Section 2. Summary of test results ....................................................................................................................................................................... 5 2.1 FCC Part 15 Subpart C, general requirements test results................................................................................................................................................. 5 2.2 FCC Part 15 Subpart C, intentional radiators test results................................................................................................................................................... 5 2.3 IC RSS-GEN, Issue 5, test results........................................................................................................................................................................................... 5 2.4 IC RSS-210, Issue 10, test results ......................................................................................................................................................................................... 5 Section 3. Equipment under test (EUT) details ..................................................................................................................................................... 6 3.1 Sample information .............................................................................................................................................................................................................. 6 3.2 EUT information .................................................................................................................................................................................................................... 6 3.3 Technical information ...........................................................................................................…

Text truncated - open the document above for the full version.

Report reference ID: 400689-3TRFWL (WL Test Setup Photos) Model: RFID Readerboard Assembly Section 1. Test Setup Photos 1.1 Conducted emissions setup Report reference ID: 400689-3TRFWL (WL Test Setup Photos) Model: RFID Readerboard Assembly 1.2 Radiated emissions 9 kHz – 30 MHz Report reference ID: 400689-3TRFWL (WL Test Setup Photos) Model: RFID Readerboard Assembly 1.3 Radiated emissions 30 – 1000 MHz Report reference ID: 400689-3TRFWL (WL Test Setup Photos) Model: RFID Readerboard Assembly 1.4 Radiated emissions 1 – 18 GHz Report reference ID: 400689-3TRFWL (WL Test Setup Photos) Model: RFID Readerboard Assembly 1.5 Wireless bench setup