Alexander Sowinski
RFx
Otsuka America Pharmaceutical, Inc. 02684 Wearable Sensor for Ambulatory Recording X7902684 X7902684 02684
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02684 Wearable Sensor For Ambulatory Recording by Otsuka America Pharmaceutical
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Document DEVICE REPORT02684-RF-Exposure-Info-Otsuka-America-Pharmaceutical-x7902684-ex-1-4Test Report Products Prüfbericht - Produkte Test Report No.: Prüfbericht-Nr.: Client Reference No.: Kunden-Referenz-Nr.: US225CE4 001 Rev1.0 2361512 Order No.: Auftrags-Nr.: P00755351 234193356 Order date: Auftragsdatum: 7/6/2022 Page 1 of 7 Seite 1 von 7 Client: Auftraggeber: Test item: Prüfgegenstand: Otsuka America Pharmaceutical, Inc. 3956 Point Eden Way Hayward, CA 94545 USA Otsuka Patch Identification/ Type No.: Bezeichnung / Typ-Nr. D-Tect Order content: Auftrags-Inhalt: RF Exposure Report Test specification: Prüfgrundlage: Date of sample receipt: Wareneingangsdatum: Test sample No: Prüfmuster-Nr.: Testing period: Prüfzeitraum: Testing laboratory: Prüflaboratorium: FCC Part 2.1091 10/31/2022 00182, 00196 10/31/2022- 11/2/2022 TUV Rheinland of North America 5015 Brandin Ct. Fremont, CA 94538 See Test Setup Exhibit for Photos Test result*: Prüfergebnis*: tested by: geprüft von: Pass authorized by: / genehmigt von: Date: 11/15/2022 Datum: Issue Date: 11/15/2022 Ausstellungsdatum: Position / Stellung: Others / Sonstiges: Expert Position / Stellung: Expert Condition of the test item at delivery: Zustand des Prüfgegenstandes bei Anlieferung: Test sample complete and undamaged * Legend: * Legende: P(ass) = passed a.m. test specification(s) P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = f ailed a.m. test specification(s) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = not applicable N/A = nicht anwendbar N/T = not tested N/T = nicht getestet This test report only relates to the a. m . test sam ple. Without perm ission of the test center this test report is not perm itted to be duplicated in extracts. This test report does not entitle to carry any test m ark. Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. TÜV Rheinland of North America, Inc., 295 Foster St. Suite 100, Littleton, MA 01460 USA Mail: [email protected] · Web: www.tuv.com EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684 Test Report - Products Prüfbericht - Produkte Test report no.: US225CE4 001 Rev1.0 Prüfbericht-Nr.: Remarks Anmerkungen Page 2 of 7 Seite 2 von 7 1 The equipment used during the specified testing period was calibrated according to our test laboratory calibration program. The equipment fulfils the requirements included in the relevant standards. The traceability of the test equipment used is ensured by compliance with the regulations of our management system. Detailed information regarding test conditions, equipment and measurement uncertainty is available in the test laboratory and could be provided on request. Alle eingesetzten Prüfmittel waren zum angegebenen Prüfzeitraum gemäß eines festgelegten Kalibierungsprogramms unseres Prüfhauses kalibriert. Sie entsprechen den in den Prüfprogrammen hinterlegten Anforderungen. Die Rückverfolgbarkeit der eingesetzten Prüfmittel ist durch die Einhaltung der Regelungen unseres Managementsystems gegeben. Detaillierte Informationen bezüglich Prüfkonditionen, Prüfequipment und Messunsicherheiten sind im Prüflabor vorhanden und k önnen auf Wunsch bereitgestellt werden. 2 As contractually agreed, this document has been signed digitally only. TUV Rheinland has not verified and unable to verify which legal or other pertaining requirements are applicable for this document. Such verification is within the responsibility of the user of this document. Upon request by its client, TUV Rheinland can confirm the validity of the digital signature by a separate document. Such request shall be addressed to our Sales department. An environmental fee for such additional service will be charged. Wie vertraglich vereinbart, wurde dieses Dokument nur digital unterzeichnet. Der TÜV Rheinland hat nicht überprüft, welche rechtlichen oder sonstigen diesbezüglichen Anforderungen für dieses Dokument gelten. Diese Überprüfung liegt in der Verantwortung des Benutzers dieses Dokuments. Auf Verlangen des Kunden k ann der TÜV Rheinland die Gültigkeit der digitalen Signatur durch ein gesondertes Dokument bestätigen. Diese Anfrage ist an unseren Vertrieb zu richten. Eine Umweltgebühr für einen solchen zusätzlichen Service wird erhoben. 3 Test clauses with remark of * are subcontracted to qualified subcontractors and descripted under the respective test clause in the report. Deviations of testing specification(s) or customer requirements are listed in specific test clause in the report. Prüfk lausel mit der Note * wurden an qualifizierte Unterauftragnehmer vergeben und sind unter der jeweiligen Prüfk lausel des Berichts beschrieben. Abweichungen von Prüfspezifikation(en) oder Kundenanforderungen sind in der jeweiligen Prüfklausel im Bericht aufgeführt. 4 The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TÜV Rheinland test mark. The report must not be used by the client to claim product certification, approval, or endorsement by A2LA. 5 Radio Compliance Emissions Test Report. The above product was found to be Compliant to the above test standard(s). EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684 Test Report - Products Prüfbericht - Produkte Test report no .: US225CE4 001 Rev1.0 Prüfbericht-Nr.: Product description Produktbeschreibung Page 3 of 7 Seite 3 von 7 1 Product details: Produk tdetails: The Patch device is a component of the Core Medical Device (CMD) that gathers ingestion, physiological and behavioral metrics from a user.This data is then transmitted to a BLE-enabled gateway device. The data can be accessed by external applications for further processing or displayed directly to a user via a display. 2 Dimensions / Weight: Maße / Gewicht: 11.3cm x 4.52cm x 0.68cm / 0.011 kg 3 Operating elements: Bedienelemente: 2.9VDC Battery Operated, Transmit bands 2.402-2.480GHz. 4 Equipment / Accessories: Ausstattung / Zubehör: N/A 5 Used materials: Verwendete Materialien: None. 6 Other: Sonstiges: 7 Test sample obtaining: Prüfmusterbereitstellung: Test sample(s), as well sample information, description, product details and intended usage was provided by customer. Sending by customer others: Sampling by TÜV Rheinland Group EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684 Test Report - Products Prüfbericht - Produkte Test report no.: US225CE4 001 Rev1.0 Prüfbericht-Nr.: Date mm/dd/yy 11/15/2022 Name Rev. 1 Revisions Page Number of Change N/A Page 4 of 7 Seite 4 von 7 Describe Change Original Document EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684 Test Report - Products Prüfbericht - Produkte Test report no.: US225CE4 001 Rev1.0 Prüfbericht-Nr.: Page 5 of 7 Seite 5 von 7 TABLE OF CONTENTS 1 Product Information.................................................................................................................. 6 1.1 Product Description........................................................................................................... 6 1.2 Product Specifications ....................................................................................................... 6 2 RF Exposure Test Exemption.................................................................................................... 7 2.1 Purpose .......................................................................................................................... 7 2.2 RF Exposure Limit ............................................................................................................ 7 2.3 Assessment Calculation..................................................................................................... 7 2.4 Conclusion....................................................................................................................... 7 EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684 Test Report - Products Prüfbericht - Produkte Test report no.: US225CE4 001 Rev1.0 Prüfbericht-Nr.: Page 6 of 7 Seite 6 von 7 1 Product Information 1.1 Product Description The Patch device is a component of the Core Medical Device (CMD) that gathers ingestion, physiological and behavioral metrics froma user. This data is then transmitted to a BLE-enabled gateway device. The data can be accessed by external applications f or further processing or displayed directly to a user via a display. 1.2 Product Specifications The information provided in the following table should be listed as it should appear in the final report. Table 1 EUT Specifications* EUT Specification Exposure Type DC Power Input General Population / Uncontrolled Occupational / Controlled 2.9VDC Environment Operating Temperature Range: Multiple Feeds: Product Marketing Name (PMN) Indoor/Outdoor +5 to +40 degrees C Yes and how many No Otsuka Patch Hardware Version Identification Number (HVIN) Firmware Version Identification Number (FVIN) Operating Mode DT3.0 FIRMWARE_VERSION,17,v0.1.4.0 GIT:733 Bluetooth Low Energy Transmitter Frequency Band 2402 - 2480 MHz Power Setting @ Operating Channel Antenna Type -8 dBm (max) Patch Data Rate 1Mbps and 2Mbps Antenna Gain (dBi) -10.1 dBi Modulation Type TX/RX Chain (s) AM FM Other describe: GFSK 1 DSSS OFDM Note: *All EUT specifications are provided by the manufacturer or the TUV direct customer. Information supplied by the customer and can affect the validity of results. EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684 Test Report - Products Prüfbericht - Produkte Test report no.: US225CE4 001 Rev1.0 Prüfbericht-Nr.: 2 RF Exposure Test Exemption Page 7 of 7 Seite 7 von 7 2.1 Purpose In this document, we evaluate the RF Exposure to human body due the intentional transmission from the transmitter (EUT). The limit for RF Exposure Test Exemption specified in FCC 1.1307 is followed. 2.2 RF Exposure Limit 1-mW Test Exemption limit per § 1.1307(b)(3)(i)(A), a single RF source is exempt RF device if the available maximum time-averaged (matched conducted) output power is no more than 1 mW, regardless of separation distance. This exemption applies to all operating configurations and exposure conditions, for the frequency range 100 kHz to 100 GHz, regardless of fixed, mobile, or portable device exposure conditions. This is a standalone exemption, and it cannot be applied in conjunction with any other test exemption. 2.3 Assessment Calculation The maximum output power and antenna gain is declared by the manufacturer and used in this assessment. The minimum RF exposure distance during normal operation is 5mm. Stand Alone Analysis , Frequency Band (MHz) 2402-2480 Operating Freq (MHz) 2402 Max. Conducted Power (dBm) -8.21 Antenna Gain (dBi) -10.1 Max. Conducted Power (mW) 0.151 Exemption Limit (mW) 1 Result (Pass/Fail) Pass 2.4 Conclusion The above result had shown that the device complied with RF Exposure test ememption requirement. EMC_NAM_Report Template_Rev1.0 FCC ID: X7902684
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- X7902684 - Otsuka America Pharmaceutical, Inc. Wearable Sensor for Ambulatory Recording [02684] Microsoft Word 2016; modified using iTextSharp™ 5.5.13.2 ©2000-2020 iText Group NV (AGPL-version)