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VN5-CPBBlood glucose monitoring system

Ascensia Diabetes Care US Inc.

Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Sep 19, 2024
Application Purpose
Original Equipment
Date of Application
Sep 10, 2024
Equipment Note
Blood glucose monitoring system
Frequency Range
2402.00000000 - 2480.00000000
Company
Ascensia Diabetes Care US Inc.
Country
United States

Documents & Files

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Attestation Statements

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Cover Letter(s)

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Attestation Statements

Date: 7/24/2024 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 §2.911 (d)(5) Attestation FCC ID: VN5-CPB 1. Ascensia Diabetes Care US Inc. (“the applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. 2. Ascensia Diabetes Care US Inc (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing “covered” equipment and is not an affiliate or subsidiary of an entity identified on the Covered List. Sincerely yours, Name: Ben Hostetler Job Title: Global Program Manager - Quality Company Name: Ascensia Diabetes Care US Inc.

Attestation Statements

Date: 7/25/2024 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 §2.911 (d)(7) Agent Designation Attestation FCC ID: VN5-CPB Applicant (Grantee) FRN: 0016907776 To whom it may concern: Ascensia Diabetes Care US Inc. (“t he applicant”) as required by section §2.911(d)(7), will also serve as the agent for service of process for the above referenced FCC ID. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. The applicant further acknowledges their responsibility under CFR 47 §2.929(c) to inform the FCC whenever the agent information changes. U.S. Agent Information: Ben Hostetler Ascensia Diabetes Care US Inc. FCC FRN: 0016907776 5 Wood Hollow Rd. Parsippany, NJ 07054 USA [email protected] Sincerely yours, Ben Hostetler Ascensia Diabetes Care US Inc. 5 Wood Hollow Rd. Parsippany, NJ 07054 USA

Cover Letter(s)

Date: 7/16/2024 UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 USA To whom it may concern: I, the undersigned, hereby authorize UL LLC to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL LLC as our representative, we still recognize that we are responsible to: a) fulfill the requirements for the scope of certification requested, including implementing any appropriate changes requested by UL Verification Services Telecommunications Certification Body (TCB) and / or the FCC; b) supply any and all information needed for the evaluation of the products for which certification is sought; c) make claims regarding certification only in respect of the scope for which certification has been granted; d) not use our product certification in such a manner as to bring the TCB or FCC into disrepute and to not make any statement regarding product certification which the TCB or FCC may consider misleading or unauthorized; e) discontinue use of all advertising matter that contains any reference thereto and complies with any and all actions required by the FCC upon suspension or cancellation of certification; f) use certification only to indicate that products are certified in conformity with specified standards; g) endeavor to ensure that no certificate or report or any part thereof is used in a misleading manner, and any copies of the grants/certificates shall be reproduced in their entirety; h) comply with the requirements of the TCB and FCC, including the use of marks and label information prescribed for the scope of certification, when making reference to product certification in communication media such as documents, brochure or advertisements; i) comply with the requirements for certification, supply any information needed for evaluation of products to be certified and, where applicable, make provision for the participation of observers; j) ensure that products marketed under the scope of the requested certification continue to comply with the certification requirements; k) provide a sample of a production unit for testing within 30 days of the request should this product be selected as part of either the TCB’s or the FCC’s market surveillance requirements; l) keep a record of all complaints relating to product’s compliance with requirements of relevant standard; make records available to UL or FCC when requested; take appropriate action with respect to such complaints and any deficiencies found in the product that affect compliance with requirements for certification; document the actions taken with respect to complaints and/or deficiencies; m) inform the TCB immediately of any changes that may affect its ability to comply with the certification requirements. This authorization is valid until January 16 th , 2025. Sincerely Yours, Ben Hostetler Global Program Manager - Quality Ascensia Diabetes Care US Inc.

Cover Letter(s)

Date: 8/20/2024 Attn: FCC Office of Engineering and Technology / UL Verification Services TCB Subject: Request for Confidentiality FCC ID: VN5-CPB To Whom It May Concern: Pursuant to the provisions of Sections 0.457 and 0.459 of the Commission’s rules (47 CFR §§ 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. • Schematic Diagram • Block Diagram • Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant short-term confidentiality request on the following attachments until January 16 th , 2025. • External Photos • Internal Photos • Test Setup Photos • User Manual It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards, Ben Hostetler Global Program Manager - Quality Ascensia Diabetes Care US Inc.

ID Label/Location Info

Date: 9/9/2024 To whom it may concern: The below labeling is applicable to the Contour Plus Blue device with FCC ID# VN5-CPB. Both labels are for the same model, with the only difference being the manufacturer SKU # (7035 vs 7036). SKU 7036 will be the commercially available SKU while SKU 7035 is the ‘Free Goods’ SKU. All labels attached to the device are attached with permanent adhesive and not detachable by the end-user. Contour Plus Blue meter back side Manufacturer label location *For example only *For example only Commercially available device label Free goods device label Sincerely Yours, Ben Hostetler Global Program Manager - Quality Ascensia Diabetes Care US Inc.

RF Exposure Info

FCC Part 1 Subpart I FCC Part 2 Subpart J RF EXPOSURE REPORT FOR Contour Plus BLUE Blood Glucose Monitoring System MODEL NAME: 7035 and 7036 FCC ID: VN5-CPB REPORT NUMBER: R14622069-E1 ISSUE DATE: 2024-08-26 Prepared for Ascensia Diabetes Care Holdings AG Peter Merian-Strasse 90 4052 Basel, Switzerland Prepared by UL LLC 12 LABORATORY DR. RESEARCH TRIANGLE PARK, NC 27709 USA TEL: (919) 549-1400 REPORT NO: R14622069-E1 DATE: 2024-08-26 FCC ID: VN5-CPB Page 2 of 7 UL LLC FORM NO: 03-EM-F00858 12 Laboratory Dr., RTP, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC. . Revision History Rev. Issue Date Revisions Revised By V1 2023-06-23 Initial Issue Charles Moody V2 2024-08-26 Revised: Added model designations 7035 and 7036 with a model difference explanation. Jeff Moser REPORT NO: R14622069-E1 DATE: 2024-08-26 FCC ID: VN5-CPB Page 3 of 7 UL LLC FORM NO: 03-EM-F00858 12 Laboratory Dr., RTP, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC. . TABLE OF CONTENTS 1. ATTESTATION OF TEST RESULTS ............................................................................... 4 2. TEST METHODOLOGY .................................................................................................. 5 3. REFERENCES ............................................................................................................... 5 4. FACILITIES AND ACCREDITATION ............................................................................... 5 5. DECISION RULES AND MEASUREMENT UNCERTAINTY............................................. 6 5.1. METROLOGICAL TRACEABILITY .......................................................................... 6 5.2. DECISION RULES .................................................................................................. 6 6. DEVICE UNDER TEST ................................................................................................... 6 7. STANDALONE SAR TEST EXCLUSION CONSIDERATIONS ......................................... 7 7.1. FCC........................................................................................................................ 7 REPORT NO: R14622069-E1 DATE: 2024-08-26 FCC ID: VN5-CPB Page 4 of 7 UL LLC FORM NO: 03-EM-F00858 12 Laboratory Dr., RTP, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC. . 1. ATTESTATION OF TEST RESULTS COMPANY NAME: Ascensia Diabetes Care Holdings AG Peter Merian-Strasse 90 4052 Basel, Switzerland EUT DESCRIPTION: Contour Plus BLUE Blood Glucose Monitoring System MODEL NAME: 7035 and 7036 SERIAL NUMBER: P403802 SAMPLE RECEIVED DATE: 2023-05-31 DATE TESTED: 2023-06-05 APPLICABLE STANDARDS STANDARD TEST RESULTS FCC PART 1 SUBPART I & PART 2 SUBPART J Complies UL LLC tested the above equipment in accordance with the requirements set forth in the above standards. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. It is the manufacturer's responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. All samples tested were in good operating condition throughout the entire test program. Measurement Uncertainties are published for informational purposes only and were not taken into account unless noted otherwise. This document may not be altered or revised in any way unless done so by UL LLC and all revisions are duly noted in the revisions section. Any alteration of this document not carried out by UL LLC will constitute fraud and shall nullify the document. Approved & Released For UL LLC By: Reviewed By: Prepared By: Michael Antola Brian Kiewra Charles Moody and Jeff Moser Staff Engineer Project Engineer Engineer and Operations Manager Consumer, Medical and IT Segment Consumer, Medical and IT Segment Consumer, Medical and IT Segment UL LLC UL LLC UL LLC REPORT NO: R14622069-E1 DATE: 2024-08-26 FCC ID: VN5-CPB Page 5 of 7 UL LLC FORM NO: 03-EM-F00858 12 Laboratory Dr., RTP, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC. . 2. TEST METHODOLOGY All calculations were made in accordance with FCC Parts 1.1310, 2.1091, 2.1093, KDB 447498 D01 v06, KDB 447498 D03 V01, IEEE Std C95.1-2005, and IEEE Std C95.3-2002. This report contains data provided by the customer which can impact the validity of results. UL LLC is only responsible for the validity of results after the integration of the data provided by the customer Client Provided Data: 1.) Max Declared Avg. Output Power (see section 7.1) 3. REFERENCES Declared maximum average output power is excerpted from client documentation. 4. FACILITIES AND ACCREDITATION UL LLC is accredited by A2LA, certification #0751.06, for all testing performed within the scope of this report. Testing was performed at the locations noted below. Address ISED CABID ISED Company Number FCC Registration ☒ Building 2800 Perimeter Park Dr. Suite B Morrisville, NC 27560, U.S.A US0067 27265 825374 ☐ Building: 12 Laboratory Dr RTP, NC 27709, U.S.A 2180C REPORT NO: R14622069-E1 DATE: 2024-08-26 FCC ID: VN5-CPB Page 6 of 7 UL LLC FORM NO: 03-EM-F00858 12 Laboratory Dr., RTP, NC 27709 TEL: (919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC. . 5. DECISION RULES AND MEASUREMENT UNCERTAINTY 5.1. METROLOGICAL TRACEABILITY The measuring equipment utilized to perform the tests documented in this report has been calibrated in accordance with the manufacturer's recommendations, and is traceable to recognized national standards. 5.2. DECISION RULES For all tests where the applicable U …

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Test Report

PHC Corporation Confidential and Proprietary Design Information Document: Antenna Specification Project Thunder Date Aug. 22, 2024 Document Control Number BAB-231113-001 Approver Verifier Author Project Thunder Page 2 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary Revision history Ve r. No. Date Description of Change Author 1 Nov. 13, 23 Initial release H. Isozaki 2 Aug. 22, 24 Added 2.Antenna Measurement H. Isozaki Project Thunder Page 3 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary Table of Contents Revision history .............................................................................................................................. 2 1. Antenna Specification .............................................................................................................. 4 1.1. Antenna External View ......................................................................................................... 4 1.2. Radiation Pattern at 2440MHz ............................................................................................. 5 2. Antenna Measurement ............................................................................................................. 6 2.1. Test Setup Diagram .............................................................................................................. 6 2.2. Test Procedure ...................................................................................................................... 8 2.3. Test Condition ...................................................................................................................... 8 2.4. Result .................................................................................................................................... 9 3. Appendix ................................................................................................................................ 10 3.1. Reference Documents ......................................................................................................... 10 Project Thunder Page 4 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary 1. Antenna Specification Antenna Type Pattern Antenna Note) It is impossible for end users to replace the antenna. Model Name Contour care Contour plus BLUE Contour fit Antenna Gain 0.24dBi at 2440MHz (Mean) 0.57dBi at 2440MHz (Max) Frequency Range 2402MHz to 2480MHz 1.1. Antenna External View Pattern Antenna Length:24mm Project Thunder Page 5 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary 1.2. Radiation Pattern at 2440MHz X-Y Plane Y-Z Plane X-Z Plane Horizontal Vertical Project Thunder Page 6 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary 2. Antenna Measurement 2.1. Test Setup Diagram Figure 1 – Test Block Diagram Project Thunder Page 8 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary This figure is for reference only and is not representative of the meters tested. Figure 5 – Y-Z Plane 2.2. Test Procedure 1. Configure the DUT to operate in RF Test mode CW(*1), Channel 19 - 2440MHz. *1: “RF Test mode CW” is a mode in which the DUT can transmit continuously at 0dBm. 2. Place the DUT on the turntable in the X-Y Plane as shown in Figure 3. 3. Configure the PC Running Software(*2) to acquire the data at resolution of 10 degrees or better. *2: “PC Running Software” is TY2100AM version5.3 made by TOYO corporation. 4. Run the data acquisition software. (The horn antenna changes from “horizontal” to “vertical” automatically.) 5. Repeat steps 3 and 4 for the X-Z Plane and Y-Z Plane as shown in Figure 4 and Figure 5, respectively. 6. Repeat steps 1 through 5 for each DUT. 7. Calculate EIRP and Null of Antenna from measured data. 2.3. Test Condition Item Description Test site PHC laboratory Data Acquisition Software TY2100AM version5.3 Date see below Temperature see below Humidity see below Project Thunder Page 9 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary Name of Test Equipment Part Number PHC ID# Calibration information Spectrum Analyzer N9000A 005450 Calibrated on Aug. 2017 Calibration due Aug. 2018 RF Anechoic Chamber MAB101 005450 - Horn Antenna MDH0118 005450 - Thermometer TR-72U MK0138 Calibrated on Jul. 2017 Calibration due Jul. 2018 The calibration is valid until the end of the month described. 2.4. Result Tester : H.Isozaki Date : 2018/6/18, 2018/6/20 Temperature : 22.6degC, 23.5degC Relative humidity: 58%, 62% S/N Antenna GAIN [dBi] 2440MHz P200372 -0.03 P200373 -0.22 P200374 0.36 P201423 0.57 P201424 0.48 Mean 0.24 Max 0.57 Min -0.22 Project Thunder Page 10 of 10 Document Name Design Information Antenna Specification Document Control No. BAB-231113-001 Ver. No. 2 PHC Corporation Confidential and Proprietary 3. Appendix 3.1. Reference Documents Test Protocol : MATEPM-49130_rev1 (RF Transmission Signal Strength) Test Report : MATEPD-184907-320_rev0 (RF Transmission Signal Strength)

Test Report

TEST REPORT Report Number: R14622069-E2 Applicant : Ascensia Diabetes Care Holdings AG Peter Merian-Strasse 90 4052 Basel, Switzerland Model : 7035 and 7036 FCC ID : VN5-CPB IC : 7347A-9 EUT Description : Contour Plus BLUE Blood Glucose Monitoring System Test Standard(s) : FCC 47 CFR PART 15 SUBPART C: 2024 ISED RSS-247 ISSUE 3: 2023 ISED RSS-GEN ISSUE 5 + A2: 2021 Date Of Issue: 2024-08-26 Prepared by: UL LLC 12 Laboratory Dr. Research Triangle Park, NC 27709 U.S.A. TEL: (919) 549-1400 REPORT NO: R14622069-E2 DATE: 2024-08-26 FCC ID: VN5-CPB IC: 7347A-9 Page 2 of 39 UL LLC 2800 Suite Perimeter Park Dr. Suite B, Morrisville, NC 27560; USA TEL:(919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC REPORT REVISION HISTORY Rev. Issue Date Revisions Revised By V1 2023-06-23 Initial Issue Charles Moody V2 2024-08-26 Revised: FCC reference to 2024, RSS-247 to Issue 3, Antenna Gain to 0.57 dBi and model designations to 7035 and 7036. Added Model difference section. Jeff Moser REPORT NO: R14622069-E2 DATE: 2024-08-26 FCC ID: VN5-CPB IC: 7347A-9 Page 3 of 39 UL LLC 2800 Suite Perimeter Park Dr. Suite B, Morrisville, NC 27560; USA TEL:(919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC TABLE OF CONTENTS REPORT REVISION HISTORY .............................................................................................. 2 TABLE OF CONTENTS ......................................................................................................... 3 1. ATTESTATION OF TEST RESULTS ............................................................................... 5 2. TEST RESULTS SUMMARY ........................................................................................... 6 3. TEST METHODOLOGY .................................................................................................. 6 4. FACILITIES AND ACCREDITATION ............................................................................... 6 5. DECISION RULES AND MEASUREMENT UNCERTAINTY............................................. 7 5.1. METROLOGICAL TRACEABILITY .......................................................................... 7 5.2. DECISION RULES .................................................................................................. 7 5.3. MEASUREMENT UNCERTAINTY ........................................................................... 7 5.4. SAMPLE CALCULATION ........................................................................................ 7 6. EQUIPMENT UNDER TEST ............................................................................................ 8 6.1. EUT DESCRIPTION ................................................................................................ 8 6.2. MODEL DIFFERENCES.......................................................................................... 8 6.3. MAXIMUM OUTPUT POWER ................................................................................. 8 6.4. DESCRIPTION OF AVAILABLE ANTENNAS ........................................................... 8 6.5. SOFTWARE AND FIRMWARE ................................................................................ 8 6.6. WORST-CASE CONFIGURATION AND MODE ....................................................... 9 6.7. DESCRIPTION OF TEST SETUP ............................................................................ 9 7. MEASUREMENT METHOD .......................................................................................... 10 8. TEST AND MEASUREMENT EQUIPMENT ................................................................... 11 9. ANTENNA PORT TEST RESULTS ............................................................................... 13 9.1. ON TIME AND DUTY CYCLE ................................................................................ 13 9.2. 99% BANDWIDTH ................................................................................................ 14 9.2.1. BLE (1Mbps) ................................................................................................. 14 9.3. 6 dB BANDWIDTH ................................................................................................ 15 9.3.1. BLE (1Mbps) ................................................................................................. 15 9.4. OUTPUT POWER ................................................................................................. 16 9.4.1. BLE (1Mbps) ................................................................................................. 16 9.5. AVERAGE POWER .............................................................................................. 17 9.5.1. BLE (1Mbps) ................................................................................................. 17 9.6. POWER SPECTRAL DENSITY ............................................................................. 18 REPORT NO: R14622069-E2 DATE: 2024-08-26 FCC ID: VN5-CPB IC: 7347A-9 Page 4 of 39 UL LLC 2800 Suite Perimeter Park Dr. Suite B, Morrisville, NC 27560; USA TEL:(919) 549-1400 This report shall not be reproduced except in full, without the written approval of UL LLC 9.6.1. BLE (1Mbps) ................................................................................................. 18 9.7. CONDUCTED SPURIOUS EMISSIONS ................................................................ 19 9.7.1. BLE (1Mbps) ................................................................................................. 20 10. RADIATED TEST RESULTS .................................................................................... 21 10.1. LIMITS AND PROCEDURE ................................................................................... 21 10.2. TRANSMITTER ABOVE 1 GHz ............................................................................. 23 10.2.1. BLE (1Mbps) ....................................................................…

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Contact Information

Applicant

Ben Hostetler(Global Program Team - Quality Lead)
[email protected]574-314-9618Fax: 574-314-9618

Test Firm

UL LLCSteven Thompson
[email protected]919 549 1430

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz1.00 mW
Confidentiality
Long Term
Grant Notes
Power output listed is conducted.

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Equipment Class

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CGMT01 - FCC ID VN5-CGMT01 - Ascensia Diabetes Care US Inc.
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Equipment Class

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