TMRW- SP C - CUS - 005 V ERSION: 01 IMPLEMENTATION DATE: D D MMM YYYY TMRW READERBOARD Cryopreservation Identification and Tracking Device READERBOARD DEVICE DESCRIPTION typically age between the ages of 18 years to 50 The TMRW RFID ReaderBoard is a custom circuit years at the time of fertility tissue collection. board component that integrates the TMRW At-the-
Robot (ATR) software and Witnessing System. CONTRAINDICATIONS None. None. INTENDED USE To read stored information on RFID enabled containers ADVERSE EFFECTS INTENDED USERS The intended users of the RFID Readerboard are laboratory professionals including embryologists, andrologists, clinicians, laboratory technicians, and laboratory management personnel. STORAGE Store at room temperature. DISPOSAL Patients do not interact with or come into contact with Discard at an e-waste facility. TMRW products. The patient population served is men and women, any toxic components used in the manufacturing of the There are no lithium batteries used to operate, nor are Readerboard. The PCB assembly is lead-free. Always use appropriate personal protective equipment (PPE) and follow your laboratorys standard operating procedures and safety guidelines when working with liquid nitrogen (LN2). 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. 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: info@tmrw.org INSTRU C TI ONS FOR USE TMRW RE AD ERBOARD Figure A: Readerboard Always use proper power and proper electrical compliant connections in accordance with the local electrical code. INSTRUCTIONS FOR USE 01 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. 03 04 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. NOTICE 1. FCC CFR 47 15.19 If you have additional CryoBeacons for this procedure, repeat Step 2 and Step 3.
(2) this device must accept any interference received, including interference that may cause undesired operation. 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 LN2 depth to plunge cryodevices during vitrification. 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 users authority to operate the equipment. 3. FCC CFR 47 15.105 INFORMATION TO THE USER 6. ISED STATEMENTS This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence exempt RSS(s). Operation is subject to the following two conditions:
Ce dispositif contient les metteurs/rcepteurs autoriser-exempts qui sont conformes au permis RSS exempt du Canada dinnovation, de la Science et de dveloppement conomique. Lopration est sujette aux deux conditions suivantes:
(1) Ce dispositif peut ne pas causer linterfrence.
(2) Ce dispositif doit accepter nimporte quelle interfrence, y compris linterfrence qui peut causer le fonctionnement peu dsir du dispositif. CAN ICES-3 (A) / NMB-3 (A) This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numrique de classe A est conforme la norme canadienne ICES-003. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause interference.
(1) this device may not cause harmful interference, and
(2) This device must accept any interference, including interference that may cause undesired operation of the device. Figure B: CryoGrid and CryoTransporter in CryoBaths 02 Wait for the RFID Readerboard to map the CryoBeacons in the CryoGrid and CryoTransporter. Figure C: Lower Screen - CryoBeacon Error 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. Medical Product Service GmbH (MPS) Borngasse 20 35619 Braunfels, Germany 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 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. Dclaration dexposition aux radiations:
Cet quipement est conforme aux limites dexposition aux rayonnements ISED tablies pour un environnement non contrl. Cet quipement doit tre install et utilis plus de 20 cm entre le radiateur et votre corps. interference in which case the user will be required to correct the interference at his own expense. Innovation, Science and Economic Development Canada ICES 003 Compliance Label: CAN ICES-3 (A)/NMB-3(A)