VN5-CGMT01CGMT01

CGM Quick Reference Guide Power/back button Front buttons USB plug Home screen Test strip port USB cap CGM Quick Reference Guide CGM Quick Reference Guide 270 75 11:32 AM 1:32 PM mg/dL 118

WTD 12.7.3 FCC Compliance Opinion BAYE0011 Information about the Applicant Grantee (Company Name) Bayer Healthcare Diabetes Care LLC FCC Contact Person Kevin Chang Address 555 White Plains Road City, State, Zip Tarrytown, New York 10591 Job Number BAYE0011 Model CGMT01 FCC ID VN5-CGMT01 Agent Robert A Bruce, PhD Approval Type Original Equipment Class DXX Part 15, Low Power Communication Device Transmitter Rule Part 15.249 Overview The model CGMT01 is a low power transmitter operating in the 2.4 GHz band under FCC rule part 15.249. The CGMT01 is part of a Continuous Glucose Monitoring System, which allows individuals to track changes in tissue glucose levels as part of a Diabetes management regimen. The CGMT01 is a body worn transmitter which communicates with and sends data to a transceiver/monitor. The monitor then store and displays the data received. Confidentiality requested for allowed files. Request is properly addressed and referenced. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 10/26/2012

Bayer CGMT01 External Photographs Page 1 of 1 External Photographs

Bayer CGMT01 Label and Location Page 1 of 1 Label and Location A label is attached to the top surface of the CGMT01 housing as shown in Figure 2 and External Photographs. The label drawing is shown below (Figure 1). Due to space constraints, the required FCC statements are included in the User’s Manual. The characters used in the FCC ID on the label are 1.5 mm in height. Figure 1 CGMT01 Label Figure 2 Label Location 20 mm 12 mm

Bayer CGMT01 Antenna Information Page 1 of 1 Antenna Information The CGMT01 transmits using a half-wave folded dipole antenna. The antenna is fabricated from stamped sheet metal and is insert-molded into the top plastic housing of the device. The ends of the antenna are bent 90 degrees to allow it to fit within the device housing. Refer to the antenna drawing (Figure 1) below for details of the antenna construction. The antenna is permanently affixed to the transmitter and it is not possible to fit alternative antennas to the device. As a dipole, the antenna is designed to provide a gain of approximately 2.3 dBi or 0 dBd. Figure 1 Exploded View, Antenna Molded into Plastic Housing Antenna

Bayer Healthcare LLC CGMT01 Transmitter (RSA) FCC 15.249:2012 Report #: BAYE0011 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington WTD 12.5.23 CERTIFICATE OF TEST Last Date of Test: October 5, 2012 Bayer Healthcare LLC Model: CGMT01 Transmitter (RSA) Emissions Test Description Specification Test Method Pass/Fail Field Strength of Fundamental FCC 15.249:2012 ANSI C63.10:2009 Pass Field Strength of Harmonics FCC 15.249:2012 ANSI C63.10:2009 Pass Deviations From Test Standards None Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200630-0 Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 22975 NW Evergreen Parkway, Suite 400 Hillsboro, OR 97124 Phone: (503) 844-4066 Fax: 844-3826 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834D-1). This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2012.05.24 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2012.08.03 LOCATIONS Oregon Labs EV01-EV12 22975 NW Evergreen Pkwy, #400 Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-OC13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs WA01-WA04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-MN08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs SU01-SU07 14128 339 th Ave. SE Sultan, WA 98294 (360) 793-8675 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834C-1 WTD 12.5.23 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Information Company Name: Bayer Healthcare LLC Address: 27700 SW 95th Avenue City, State, Zip: Wilsonville, OR 97070 Test Requested By: Bob Bruce Model: CGMT01 Transmitter (RSA) First Date of Test: October 01, 2012 Last Date of Test: October 05, 2012 Receipt Date of Samples: September 21, 2012 Equipment Design Stage: Production Equipment Condition: No Damage Information Provided by the Party Requesting the Test Functional Description of the EUT (Equipment Under Test): Radio transceiver operating in the 2.4 GHz band. The transceiver is contained in a body-worn sensor device (RSA) providing digitized glucose levels to a remote handheld. Testing Objective: Seeking TCB authorization under FCC Part 15.249 WTD 12.5.23 CONFIGURATIONS Configuration BAYE0011- 3 EUT Description Manufacturer Model/Part Number Serial Number RSA Low Channel Tx Bayer Healthcare LLC CGMT01 Transmitter (RSA)/70058-00 Rev B 11F00282 RSA Mid Channel Tx Bayer Healthcare LLC CGMT01 Transmitter (RSA)/70058-00 Rev B 11F00489 RSA High Channel Tx Bayer Healthcare LLC CGMT01 Transmitter (RSA)/70058-00 Rev B 11F00160 WTD 12.5.23 MODIFICATIONS Equipment Modifications Item Date Test Modification Note Disposition of EUT 1 10/1/2012 Field Strength of Fundamental Tested as delivered to Test Station. No EMI suppression devices were added or modified during this test. EUT remained at Northwest EMC following the test. 2 10/5/2012 Field Strength of Harmonics Tested as delivered to Test Station. No EMI suppression devices were added or modified during this test. Scheduled testing was completed. description TEST DESCRIPTION PSA-ESCI 2012.08.08 DUTY CYCLE The Duty Cycle (x) were measured for each of the EUT operating modes. The measurements were made using a zero span on the spectrum analyzer to see the pulses in the time domain. The transmit power was set to its default maximum. The duty cycle was measured radiated in the RF chamber. The…

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

photo BAYE0011 SRE 006.JPG BAYE0011 SRE 002.JPG FIELD STRENGTH OF FUNDAMENTAL PSA-ESCI 2012.09.10 photo BAYE0011 SRE 003.JPG FIELD STRENGTH OF FUNDAMENTAL PSA-ESCI 2012.09.10 photo BAYE0011 SRE 006.JPG BAYE0011 SRE 002.JPG FIELD STRENGTH OF HARMONICS PSA-ESCI 2012.09.10 photo BAYE0011 SRE 003.JPG FIELD STRENGTH OF HARMONICS PSA-ESCI 2012.09.10