VN5-CGMM01CGMM01

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

WTD 12.7.3 FCC Compliance Opinion BAYE0008 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 BAYE0008 Model CGMM01 FCC ID VN5-CGMM01 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 CGMM01 is a low power transmitter operating in the 2.4 GHz band under FCC rule part 15.249. The CGMM01 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 CGmm01 is a handheld monitor which communicates with and receives data from a transmitter, which it then stores and displays graphically. 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 CGMM01 External Photographs Page 1 of 2 External Photographs Bayer CGMM01 External Photographs Page 2 of 2

Bayer CGMM01 Label and Location Page 1 of 1 Label and Location A label is attached to the bottom surface of the CGMM01 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 CGMM01 Internal Photographs Page 1 of 6 Internal Photographs Bayer CGMM01 Internal Photographs Page 2 of 6 Bayer CGMM01 Internal Photographs Page 3 of 6 Radio Antenna Bayer CGMM01 Internal Photographs Page 4 of 6 Bayer CGMM01 Internal Photographs Page 5 of 6 Bayer CGMM01 Internal Photographs Page 6 of 6

Bayer CGMM01 Antenna Information Page 1 of 1 Antenna Information The CGMM01 transmits using a loop antenna. The antenna is fabricated on the RF daughter PCB as shown in Figure 1 below and the Internal Photographs. Antenna impedance matching is provided by components C518, C519, C524 and The antenna is permanently affixed to the internal transmitter circuit board and it is not possible to fit alternative antennas to the device. As a short loop, the antenna is expected to provide a gain slightly less than a half-wave dipole or 0 dBd. Figure 1 Antenna Detail

Bayer Healthcare LLC Bayer CGMM01 Monitor (Bald Eagle ACMU) FCC 15.249:2012 FCC 15.207:2012 Report #: BAYE0008 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: September 25, 2012 Bayer Healthcare LLC Model: Bayer CGMM01 Monitor (Bald Eagle ACMU) 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 AC Powerline Conducted Emissions FCC 15.207:2012 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: Bayer CGMM01 Monitor (Bald Eagle ACMU) First Date of Test: September 18, 2012 Last Date of Test: September 25, 2012 Receipt Date of Samples: September 18, 2012 Equipment Design Stage: Prototype 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 monitor (ACMU). Testing Objective: Seeking TCB authorization under 15.249 WTD 12.5.23 CONFIGURATIONS Configuration BAYE0008- 1 Software/Firmware Running during test Description Version ACMU RF Test Software bald-RF-EV13-PRT(Bayer).dfu EUT Description Manufacturer Model/Part Number Serial Number ACMU Monitor Bayer Healthcare LLC CGMM01 Monitor PP00475 ACMU Monitor Bayer Healthcare LLC CGMM01 Monitor PP00473 Configuration BAYE0008- 2 Software/Firmware Running during test Description Version ACMU RF Test Software bald-RF-EV13-PRT(Bayer).dfu EUT Description Manufacturer Model/Part Number Serial Number ACMU Monitor Bayer Healthcare LLC CGMM01 Monitor PP00473 Peripherals in test setup boundary Description Manufacturer Model/Part Number Serial Number DC Power Supply Dell DA90PS-00 CN-0XD757-48661-6BI-MCKA Laptop Computer Dell Inspiron 6000 DZ88H81 Cables Cable Type Shield Length (m) Ferrite Connection 1 Connection 2 AC Power No 1.8m No DC Power Supply AC Mains DC Power No 1.8m Yes DC Power Supply Laptop Computer PA = Cable is permanently attached to the device. Shielding and/or presence of ferrite may be unknown. WTD 12.5.23 MODI…

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photo FF BAYE0008 003.JPG FF BAYE0008 004.JPG FIELD STRENGTH OF FUNDEMENTAL PSA-ESCI 2012.08.08 photo FF BAYE0008 001.JPG FIELD STRENGTH OF FUNDEMENTAL PSA-ESCI 2012.08.08 photo SRE BAYE0008 004.JPG SRE BAYE0008 001.JPG FIELD STRENGTH OF HARMONICS PSA-ESCI 2012.09.10 photo SRE BAYE0008 003.JPG FIELD STRENGTH OF HARMONICS PSA-ESCI 2012.09.10 photo CE BAYE0008 005.JPG CE BAYE0008 001.JPG AC POWERLINE CONDUCTED EMISSIONS PSA-ESCI 2012.09.10 photo CE BAYE0008 004.JPG AC POWERLINE CONDUCTED EMISSIONS PSA-ESCI 2012.09.10