Alexander Sowinski

Test report

Otsuka America Pharmaceutical, Inc. 02684 Wearable Sensor for Ambulatory Recording X7902684 X7902684 02684

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Test Report ­ Products Prüfbericht - Produkte

Test Report No.: Prüfbericht-Nr.:
Client Reference No.: Kunden-Referenz-Nr.:

US22NGJU 001 Rev1.0 2361512

Order No.: Auftrags-Nr.:

P00755351 234193356

Order date: Auftragsdatum: 7/6/2022

Page 1 of 62 Seite 1 von 62

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:

Radio Compliance Test Report

Test specification: Prüfgrundlage:
Date of sample receipt: Wareneingangsdatum:
Test sample No: Prüfmuster-Nr.:
Testing period: Prüfzeitraum:
Testing laboratory: Prüflaboratorium:

CFR 47 Part 15.247: 2022 and RSS 247: 2017

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: 11/14/2022 Datum:

Issue Date: 11/14/2022 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

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Remarks Anmerkungen

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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 s ubcontractors 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).

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Product description Produktbeschreibung

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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:

Test sample(s), as well sample information, description, product details and intended usage was provided by customer.

7 Test sample obtaining: Prüfmusterbereitstellung:

 Sending by customer  others:

 Sampling by TÜV Rheinland Group

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Date mm/dd/yy
11/14/2022

Name Rev. 1

Revisions
Page Number of Change N/A

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Describe Change Original Document

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TABLE OF CONTENTS
1 General Information ................................................................................................................. 6 1.1 Scope ............................................................................................................................. 6 1.2 Purpose .......................................................................................................................... 6 1.3 Summary of Test Results ................................................................................................... 6 1.4 Special Accessories .......................................................................................................... 6
2 Laboratory Information ............................................................................................................. 7 2.1 Accreditations & Endorsements........................................................................................... 7 2.2 Test Facilities & EMC Software........................................................................................... 9 2.3 Measurement Uncertainty ................................................................................................ 10 2.4 Calibration Traceability .................................................................................................... 12
3 Product Information................................................................................................................ 13 3.1 Product Description......................................................................................................... 13 3.2 Equipment Configuration.................................................................................................. 13 3.3 Operating Mode.............................................................................................................. 13 3.4 Unique Antenna Connector .............................................................................................. 14
4. Emissions............................................................................................................................. 15 4.1 Output Power Requirements............................................................................................. 15 4.2 DTS Bandwidth (6dB) and Occupied Bandwidth .................................................................. 20 4.3 Peak Power Spectral Density............................................................................................ 28 4.4 Out of Band Emissions: Non-Restricted Bands .................................................................... 33 4.1 Out of Band Emissions: Restricted Band Edge .................................................................... 41 4.2 Transmitter Spurious Emissions ........................................................................................ 44 4.3 AC Conducted Emissions................................................................................................. 55
5 Test Equipment Use List......................................................................................................... 56 5.1 Equipment List ............................................................................................................... 56
6 EMC Test Plan...................................................................................................................... 57 6.1 Introduction.................................................................................................................... 57 6.2 Customer....................................................................................................................... 57 6.3 Equipment Under Test (EUT)............................................................................................ 57 6.4 Test Specifications.......................................................................................................... 61

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1 General Information

1.1 Scope
This report is intended to document the status of conformance with the requirements of the CFR 47 Part 15.247: 2022 and RSS 247: 2017 based on the results of testing performed from October 31, 2022 through November 2, 2022 on Otsuka Patch, Model D-Tect manufactured by Otsuka America Pharmaceutical, Inc. This report only applies to the specific samples tested under the stated test conditions. It is the responsibility of the manufacturer to assure that additional production units of this model are manufactured with identical or EMI equivalent electrical and mechanical components. This report is further inten ded to document changes and modifications to the EUT throughout its life cycle. All documentation will be included as a supplement.

1.2 Purpose
Testing was performed to evaluate the EMC performance of the EUT in accordance with the applicable requirements, procedures, and criteria defined in the application of regulations and application of standards listed in this report. The 2402 MHz to 2480 MHz frequency band for Bluetooth, Low Energy is covered in this document.

1.3 Summary of Test Results

Test
Maximum Output Power
DTS Bandwidth (6dB)
Peak Power Spectral Density
Out of Band Emissions: NonRestricted Out of Band Emissions: Restricted Transmitter Spurious Emissions AC Power Conducted Emission

Table 1 - Summary of Test Results

Test Method ANSI C 63.10 &
C63.4

Worse Case (Measured)

CFR47 15.247 (b), RSS 247 Sect. 5.4 (d)

-8.21 dBm (0.000151 Watts) @ 2402MHz Channel, 1Mbps

CFR47 15.247

(a)(2), RSS 247

0.702MHz @ 2402MHz Channel, 1Mbps

Sect. 5.2 (a)

CFR47 15.247 (e), RSS 247 Sect. 5.2 (b)

-24.35dBm/3kHz @ 2402MHz channel, 1Mbps

CFR47 15.247 (d), RSS 247 Sect.5.5

-38.35dBm @ 2400 MHz, Lower Band Edge

CFR47 15.205, RSS GEN Sect.8.10

-27.11dB margin @ 2380.26 MHz, Average

CFR47 15.209,

CFR47 15.247 (d), -6.25dB Margin @ 168.02MHz, Quasi Peak

RSS-GEN Sect.8.9

CFR47 15.207, RSS-GEN Sect.8.8

N/A- EUT is DC powered

Result Complied Complied Complied Complied Complied Complied
N/A

Note: This test report covers 2402 MHz to 2480 MHz band. Class B limits w ere applied w here applicable.

1.4 Special Accessories
No special accessories were necessary in order to achieve compliance.

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2 Laboratory Information
2.1 Accreditations & Endorsements

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2.1.1 US Federal Communications Commission
TUV Rheinland of North America EMC test facilities located at 1279 Quarry Lane, Ste. A, Pleasanton, CA, 94566, and 5015 Brandin Ct, Fremont, CA. 94538, are recognized by the Commission for performing testing services for the general public on a fee basis. These laboratory test facilities have been fully described in repor ts submitted to and accepted by the FCC (Pleasanton Registration No. US1131, Fremont Registration No. US1131). The laboratory Scopes of Accreditation include Title 47 CFR Parts 15, 18 and 90. The accreditations are updated every three years.

2.1.2 A2LA
TUV Rheinland of North America EMC test facilities are accredited by the American Association for Laboratory Accreditation (A2LA). Thelaboratories have been assessed and accredited by A2LA in accordance with ISO Standard 17025:2017 (Testing Certificate #3331.02). The Scope of Laboratory Accreditation includes emission and immunity testing. The accreditations are updated annually.

2.1.3 Industry Canada
The Pleasanton 5-meter Semi-Anechoic Chamber, Registration No. 2932M-1, has been accepted by Industry Canada to perform testing to 3 and 5 meters based on the test procedures described in ANSI C63.4 -2014. The Fremont 10-meter Semi-Anechoic Chamber, Registration No. 2932D-1, has been accepted by Industry Canada to perform testing to 3 and 10 meters based on the test procedures described in ANSI C63.4-2014.

2.1.4 Japan ­ VCCI
The Voluntary Control Council for Interference by Information Technology Equipment (VCCI) is a group that consists of Information Technology Equipment (ITE) manufacturers and EMC test laboratories. The purpose of the Council is to take voluntary control measures against electromagnetic interference from Information Technology Equipment, and thereby contribute to the development of a socially beneficial and responsible state of affairs in the realm of Information Technology Equipment in Japan. TUV Rheinland of North America EMC test facilities located at 1279 Quarry Lane, Ste. A, Pleasanton, CA, 94566, and 5051 Brandin Ct, Fremont, CA. 94538, have been assessed and approved in accordance with the Regulations for Voluntary Control Measures.
VCCI Registration No. for Pleasanton: A-0399
VCCI Registration No. for Fremont: A-0398

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2.1.5 Acceptance by Mutual Recognition Arrangement

country.

The United States has an established agreement with specific countries under the Asia Pacific Laboratory Accreditation Corporation (APLAC) Mutual Recognition Arrangement. Under this agreement, all TUV Rheinland at 1279 Quarry Ln, Pleasanton, CA 94566 test results and test reports within the scope of the laboratory NIST / A2LA accreditation will be accepted by each member

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2.2 Test Facilities & EMC Software
Test facilities are located at 1279 Quarry Lane, Ste. A, Pleasanton, California 94566, U.S.A. and 5015 Brandin Ct, Fremont, CA. 94538, U.S.A. (Fremont is the Pleasanton Annex).

2.2.1 Emission Test Facility
The Semi-Anechoic Chambers and AC Line Conducted measurement facilities used to collect radiated and conducted emissions data have been constructed in accordance with ANSI C63.7:1992. The Fremont 10 meter semi-anechoic chamber has been measured in accordance with and verified to comply with the theoretical volumetric normalized site attenuation of ANSI C63.4-2014 and SVSWR requirements of CISPR 16-1-4 Consol. Ed. 3.0 (2010-04), at test distances of 3 and 10 meters. This site has been described in reports dated November 1st, 2006, submitted to the FCC, and accepted by letter dated November 28, 2006. The site is listed with the FCC and accredited by A2LA (Testing Certificate #3331.02). The Pleasanton 5 meter semi-anechoic chamber has been verified to comply with the theoretical volumetric normalized site attenuation of ANSI C63.4 -2014 and SVSWR requirements of CISPR 16-1-4 Consol. Ed. 3.0 (2010-04) at a test distance of 3 meters. This site has been described in reports dated November 1st, 2006, submitted to the FCC, and accepted by letter dated November 28, 2006. The site is listed with the FCC and accredited by A2LA (Testing Certificate #3331.02).

2.2.2 Immunity Test Facility
ESD, EFT, Surge, PQF: These tests are performed in an environmentally controlled room with a 3.7 m x 4.8 m x 3.175 mm thick aluminum floor connected to PE ground.
For ESD testing, tabletop equipment is placed on an insulated mat with a surface resistivity of 109 Ohms/square on a 1.6 m x 0.8 m x 0.8 m high non-conductive table with a 3.175 mm aluminum top (Horizontal Coupling Plane). The HCP is connected to the main ground plane via a low impedance ground strap through two 470-k resistors. The Vertical Coupling Plane consists of an aluminum plate 50 cm x 50 cm x 3.175 mm thick. The VCP is connected to the main ground plane via a low impedance ground strap through two 470 -k resistors.
For EFT, Surge, PQF, the HCP and VCP are removed.
RF Field Immunity testing is performed in a 7.3 m x 4.3 m x 4.1 m anechoic chamber.
RF Conducted and Magnetic Field Immunity testing is performed on a 4.8 m x 3.7 m x 3.175 mm thick aluminum ground plane.
All test areas allow a minimum distance of 1 meter from the EUT to walls or conducting objects.

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2.2.3 EMC Software ­ Pleasanton and Fremont

M anufacturer

Name

Ve rsion

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Test Type

Rohde & Schwarz ETS-Lindgren

EMC32 TILE

Agilent

Agilent MXE

ETS-Lindgren
Thermo Electron Keytek Voltech

TILE CEWare32 IEC61000-3

10.40.10 3.4.K.14 @ 4.0.A.5
A.11.02 3.4.K.14
4.00 1.21.07RC2

Radiated Emissions
Radiated & Conducted Emissions
Radiated & Conducted Emissions
Radiated & Conducted Immunity
EFT/Surge/Voltage Dips & Interrupt
Harmonic & Flicker

2.3 Measurement Uncertainty
Two types of measurement uncertainty are expressed in this report, per ISO Guide to the Expression of Uncertainty in Measurement, 1st Edition, 1995.
The Combined Standard Uncertainty is the standard uncertainty of the result of a measurement when that result is obtained from the values of a number of other quantities; it is equal to the positive square root of the sum of the variances or co-variances of these other quantities, weighted according to how the measurement result varies with changes in these quantities. The term standard uncertainty is the result of a measurement expressed as a standard deviation.
The Expanded Uncertainty defines an interval about the result of a measurement that may be expected to encompass a large fraction of the distribution of values that could reasonably be attributed to the measurement. The fraction may be viewed as the coverage probability or level of confidence of the interval.
2.3.1 Sample Calculation ­ radiated & conducted emissions
The field strength is calculated by subtracting the Amplifier Gain and adding the Cable Loss and Antenna Correction Factor to the measured reading. The basic equation is as follows:
Field Strength (dBV/m) = RAW - AMP + CBL + ACF Where: RAW = Measured level before correction (dBV)
AMP = Amplifier Gain (dB) CBL = Cable Loss (dB)
ACF = Antenna Correction Factor (dB/m)
dBV / m
V/m = 10 20 Sample radiated emissions calculation @ 30 MHz Measurement +Antenna Factor­Amplifier Gain+Cable loss=Radiated Emissions (dBuV/m)
25 dBuV/m + 17.5 dB ­ 20 dB + 1.0 dB = 23.5 dBuV/m

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2.3.2 Measurement Uncertainty

M easurement Uncertainty Emissions

Per CISPR 16-4-2

Ulab

Radiated Disturbance @ 10 meters

30 ­ 1,000 MHz

2.25 dB

Radiated Disturbance @ 3 meters

30 ­ 1,000 MHz

2.26 dB

1 ­ 6 GHz

2.12 dB

6 ­ 40 GHz

2.47 dB

Conducted Disturbance @ Mains Terminals

150 kHz ­ 30 MHz

1.09 dB

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Ucispr
4.51 dB
4.52 dB 4.25 dB 4.93 dB
2.18 dB

Voltech PM6000A
The estimated combined standard uncertainty for harmonic current and flicker measurements is ± 5.0%.

Per CISPR 16-4-2 Methods

Measurement Uncertainty Immunity
The estimated combined standard uncertainty for ESD immunity measurements is ± 8.2%.

Per IEC 61000-4-2

The estimated combined standard uncertainty for radiated immunity measurements is ± 4.10 dB. Per IEC 61000-4-3

The estimated combined standard uncertainty for conducted immunity measurements w ith CDN

is ± 3.66 dB

Per IEC 61000-4-6

The estimated combined standard uncertainty for power frequency magnetic field immunity is ± 2.9%.

Per IEC 61000-4-8

Thermo KeyTek EMC Pro
The estimated combined standard uncertainty for EFT fast transient immunity measurements is ± 2.6%. The estimated combined standard uncertainty for surgeimmunity measurements is ± 2.6%. The estimated combined standard uncertainty for voltage variation and interruption measurements is ± 1.74%.

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M easurement Uncertainty ­ Radio Testing
The estimated combined standard uncertainty for frequency error measurements is ± 3.88 Hz
The estimated combined standard uncertainty for carrier pow er measurements is ± 0.70 dB.

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The estimated combined standard uncertainty for adjacent c hannel pow er measurements is ± 1.47 dB.

The estimated combined standard uncertainty for modulation frequency response measurements is ± 0.46 dB.

The estimated combined standard uncertainty for transmitter conducted emission measurements is ± 2.06 dB

The expanded uncertainty at a level of 95% confidence is obtained by multiplying the combined standard uncertainty by a coverage factor of 2. Compliance criteria are not based on measurement uncertainty.

2.4 Calibration Traceability
All measurement instrumentation is traceable to the National Institute of Standards and Technology (NIST). Measurement method complies with ANSI/NCSL Z540-1-1994 and ISO Standard 17025:2017. Equipment calibration records are kept on file at the test facility.

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3 Product Information

3.1 Product Description
The Otsuka America Pharmaceutical, Inc. Feedback Device consists of a miniaturized, wearable sensor (Otsuka Patch) for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gr avity (body position), and timestamped patient logged events, including events signaled by the co -incidence with, or coingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka America Pharmaceutical, Inc. Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Otsuka America Pharmaceutical, Inc. Feedback Device may be used in any instance where quantifiable analysis of event associated physiological and behavioral metrics is desirable and enables unattended data collection for clinical and research applications.
The Otsuka America Pharmaceutical, Inc. Feedback Device has no items of Essential Performance; there are no specifications or Risk mitigations needed to avoid unacceptable Risks.
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 for further processing or displayed directly to a user via a display.

3.2 Equipment Configuration
A description and justification of the equipme nt configuration is given in the EMC Test Plan. The EUT was tested as described in the EMC Test Plan and was configured and operated in a manner consistent with its intended use. The EUT was connected to rated power and allowed to warm up to normal operating conditions. The placement of the EUT system components was guided by the test standard and selected to represent typical installation conditions.
In the case of a EUT that can operate in more than one configuration, preliminary testing was performed to determine the configuration that produced maximum radiation.
The final configuration was selected to produce worse case radiation and place the EUT in the most susceptible state. There were no deviations from the description of the Equipment Configuration given in the EMC Test Plan.

3.3 Operating Mode
A description and justification of the operation mode is given in the EMC Test Plan.
In the case of a EUT that can operate in more than one state, preliminary testing was performed to determine the operating mode that produced maximum radiation.
The final operating mode was selected to produce worse case radiation and place the EUT in the most susceptible state. There were no deviations from the description of the Operation Mode given in the EMC Test Plan.

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3.4 Unique Antenna Connector
An intentional radiator shall be designed to ensure that no antenna other than that furnished by the responsible party shall be used with the device. The use of a permanently attached antenna or of an antenna that uses a unique coupling to the intentional radiator shall be considered sufficient to comply with the provisions of this Section. The manufacturer may design the unit so that a broken antenna can be replaced by the user, but the use of a standard antenna jack or electrical connector is prohibited. This requirement does not apply to carrier current devices or to devices operated under the provisions of CFR47 Parts 15.211, 15.213, 15.217, 15.219, or 15.221.

3.4.1 Re sults
The Otsuka Patch, Model D-Tect has 1 dedicated Bluetooth Patch antenna that has maximum gain of -10.1dBi. It is not easily accessible to the end user.
It is integrated into the PCB of the device and is not easily accessible to the end user.
Antenna gain measurement results included in D-Tect Bluetooth antenna report provided by Manufacturer.The measured TRP (Total Radiated Power) and EIRP (Effective Isotropic Radiated Power) values for the filled and empty canister cases are shown in Figure 15 of DTect Bluetooth antenna report. For the antenna in free-space, the EIRP value at 2440 MHz (mid-band) is about -18.1 dBm. For the loaded antenna (salt water in canister), the EIRP is about -18.9 dBm. Thus, for the used -8 dBm transmission power, the measured realized antenna gains to be 10.1 dBi (empty canister) and -10.9 dBi (filled canister), respectively. These are average gain values over the full radiation sphere. The difference between the empty and filled canister test cases is only 0.8 dB which shows good immunity to the proximity of lossy materials such as human tissue.

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4. Emissions

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Testing was performed in accordance with CFR 47 Part 15.247: 2022 and RSS 247: 2017. These test methods are listed under the laboratory's A2LA Scope of Accr editation. This test measures the levels emanating from the EUT, thus evaluating the potential for the EUT to cause radio frequency interference to other electronic devices. Procedures described in section 8 of the standard were used.

4.1 Output Power Requirements The maximum output power requirement is the maximum equivalent isotropic radiated power delivering at the transmitting antenna under specified conditions of measurements in the presence of modulation.
The maximum output power and harmonics shall not exceed CFR47 Part 15.247 (b) and RSS 247 Sect. 5.4.(d).
The maximum transmitted power in the frequency band 2400-2483.5 MHz: 1 W

4.1.1 Test Method
Conducted method was used to measure the channel power output. The worst findings were conducted on 3 channels in each operating range per CFR47 Part 15.247(b) and RSS 247 Sect. 5.4(d); 2400 MHz to 2483.5 MHz The worst mode results indicated below.

4.1.2 Test Setup: (Conducted)

Spectrum

EUT

Analyzer

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4.1.3 Results
As originally tested, the EUT was found to be compliant to the requirements of the test standard(s). Worse case data for each mode reported below. Plots of highest power included for low, medium, and high channels.

Table 2: RF Output Power at the Antenna Port ­ Test Results

Test Date: November 01, 2022

Test By: Rachana Khanduri

Test M ethod: Conducted Measurements Antenna Type: Patch

Power Setting: -8 dBm Max. Antenna Gain: -10.1 dBi

Ambient Temp.: 21 C

Relative Humidity: 37% Bluetooth LE ­ RF Output Power

Data Rate

Ope rating Channel
(M Hz)

M easured Peak Output [Watts]

M easured Peak Output [dBm]

Limit [dBm]

M argin [dB]

2402

0.000151

-8.21

+30.00

-38.21

1Mbps

2440

0.000138

-8.61

+30.00

-38.61

2480

0.000095

-10.20

+30.00

-40.20

2402

0.000149

-8.27

+30.00

-38.27

2Mbps

2440

0.000136

-8.66

+30.00

-38.66

2480

0.000093

-10.31

+30.00

-40.31

Note: The highest power output observed was at 1 Mbps

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F i g u r e 1 : Maximum Conducted Power, 2402 MHz, 1Mbps

F i g u r e 2 : Maximum Conducted Power, 2440MHz, 1Mbps

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F i g u r e 3 : Maximum Conducted Power, 2480MHz, 1Mbps

F i g u r e 4 : Maximum Conducted Power, 2402 MHz, 2Mbps

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F i g u r e 5 : Maximum Conducted Power, 2440MHz, 2Mbps

F i g u r e 6 : Maximum Conducted Power, 2480MHz, 2Mbps

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4.2 DTS Bandwidth (6dB) and Occupied Bandwidth
The occupied bandwidth is measured at an amplitude level reduced fromthe reference level by a specified ratio. The reference level is the level of the highest amplitude signal observed from the transmitter at the fundamental frequency. The 99% bandwidth is the bandwidth in which 99% of the transmitted power occupied. The minimum 6 dB bandwidth shall be at least 500 kHz.

4.2.1 Test Method
The conducted method was used to measure the occupied bandwidth according to ANSI C63.10:2013 Section 11.8. The measurement was performed with modulatio n per CFR47 15.247 (a) (2) and RSS Gen Sect. 6.6. Measurements were performed on the low, middle and high channels of the operating frequency range; 2402 MHz to 2480 MHz.

4.2.2 Te st Se tup: (Conducted)

Spectrum

EUT

Analyzer

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4.2.3 Results
As originally tested, the EUT was found to be compliant to the requirements of the test standard(s).

Table 3: Occupied Bandwidth ­ Test Results

Test Date: November 02, 2022

Test By: Rachana Khanduri

Test M ethod: Conducted Measurements Antenna Type: Patch

Powe r Se tting: -8 dBm Max. Antenna Gain: -10.1 dBi

Ambient Temp.: 21 C

Relative Humidity: 37% Bluetooth LE ­ Occupied Bandwidth

Data Rate

Ope rating Channel
(M Hz) 2402

99% Bandwidth (M Hz)
1.053

6dB (DTS) Bandwidth (M Hz)
0.702

1Mbps

2440

1.053

0.712

2480

1.058

0.702

2402

2.051

0.737

2Mbps

2440

2.051

0.745

2480

2.059

0.745

Note: 1. The narrower bandwidth was measured at 1 Mbps. 2. Emission Designator is 1M05F1DXX based upon the 99% Bandwidth.

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F i g u r e 7 : 2402MHz, 1Mbps, 6dB Bandwidth

F i g u r e 8 : 2440MHz, 1Mbps, 6dB Bandwidth

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F i g u r e 9 : 2480MHz, 1Mbps, 6dB Bandwidth

F i g u r e 1 0 : 2402MHz, 2Mbps, 6dB Bandwidth

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F i g u r e 1 1 : 2440MHz, 2Mbps, 6dB Bandwidth

F i g u r e 1 2 : 2480MHz, 2Mbps, 6dB Bandwidth

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F i g u r e 1 3 : 2402MHz, 1Mbps, 99% Bandwidth

F i g u r e 1 4 : 2440MHz, 1Mbps, 99% Bandwidth

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F i g u r e 1 5 : 2480MHz, 1Mbps, 99% Bandwidth

F i g u r e 1 6 : 2402MHz, 2Mbps, 99% Bandwidth

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F i g u r e 1 7 : 2440MHz, 2Mbps, 99% Bandwidth

F i g u r e 1 8 : 2480MHz, 2Mbps, 99% Bandwidth

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4.3 Peak Power Spectral Density
According to the CFR47 Part 15.247 (e) and RSS 247 Sect.5.2 (b), the power spect ral density conducted from the intentional radiator to the antenna shall not be greater than 8 dBm in any 3 kHz band during any time interval of continuous transmission.

4.3.1 Test Method
The conducted method was used to measure the channel power output per ANS I C63.102013 Section 11.10.2. The measurement was performed with modulation per CFR47 Part 15.247 (e) and RSS 247 Sect.5.2 (b). The worst findings were conducted on 3 channels in each operating frequency range of 2402 MHz to 2480 MHz.
Method PKPSD of "KDB 558074 ­ DTS Measurement Guidance v04" was used.

4.3.2 Te st Se tup: (Conducted)

Spectrum

Analyzer

EUT

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4.3.3 Results
As originally tested, the EUT was found to be compliant to the requirements of the test standard(s).

Table 4: Peak Power Spectral Density ­ Test Results

Test Date: November 02, 2022

Test By: Rachana Khanduri

Test M ethod: Conducted Measurements Antenna Type: Patch

Power Setting: -8 dBm Max. Antenna Gain: -10.1 dBi

Ambie nt Te mp.: 21 C

Relative Humidity: 37%

Bluetooth LE ­ Peak Power Spectral Density

Operating Channel

Data Rate

(M Hz)

Total PSD [dBm/kHz]

Limit [dBm/3kHz]

M argin [dB]

2402

-24.35

8.0dBm /3kHz

-32.35

1Mbps

2440

-24.81

8.0dBm /3kHz

-32.81

2480

-26.66

8.0dBm /3kHz

-34.66

2402

-26.75

8.0dBm /3kHz

-34.75

2Mbps

2440

-27.19

8.0dBm /3kHz

-35.19

2480

-28.90

Note: The highest PSD was observed at 1 Mbps

8.0dBm /3kHz

-36.9o

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F i g u r e 1 9 : 2402 MHz, 1Mbps, PSD

F i g u r e 2 0 : 2440 MHz, 1Mbps, PSD

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F i g u r e 2 1 : 2480MHz, 1Mbps, PSD

F i g u r e 2 2 : 2402 MHz, 2Mbps, PSD

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F i g u r e 2 3 : 2440 MHz, 2Mbps, PSD

F i g u r e 2 4 : 2480MHz, 2Mbps, PSD

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4.4 Out of Band Emissions: Non-Restricted Bands
Transmitter spurious emissions are emissions outside the frequency range of the equipment when the equipment is in transmitting mode; per requirement of CFR47 15.205, 15.209, 15.247(d), RSS-247 Sect. 5.5, RSS-GEN Sect. 8.9 and 8.10.

4.4.1 Test Method
Conducted measurements per ANSI C63.10-2013 Sections 6.10, 11.11, 14.3.3 were used to measure the undesirable emission requirement in non-restricted bands. The measurement was performed with modulation. The measurement was conducted from 30MHz to 26.5GHz on 3 channels in each mode on the EUT. Band edge tests were conducted on the low and high channel of each mode. The worst case measurement of each mode is recorded in this report.

4.4.2 Te st Se tup: (Conducted)

Spectrum Analyzer

EUT

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4.4.3 Results
As originally tested, the EUT was found to be compliant to the requirements of the test standard(s).

Table 5: Emissions at the Band-Edge ­ Test Results

Test Date: October 31, 2022

Test By: Rachana Khanduri

Test M ethod: Conducted Measurements Antenna Type: Patch Ambient Temp.: 21 C

Power Setting: -8 dBm Max. Antenna Gain: -10.1 dBi Relative Humidity: 37%

Bluetooth LE ­ Emissions at the Band-Edge

Data Rate 1Mbps

Band Edge Low
High

Ce nter Freq (MHz)
2402

Out of Band Le v el (dBm) -40.97

20dBc Le v el (dBm) -28.94

2480

-41.12

-31.09

M e asured Freq (MHz)
2400.0
2483.5

2Mbps

Low

2402

-38.35

-29.01

2400.0

High

2480

-41.91

-31.13

Note: dBc is defined as the level below the main carrier. The band-edge level must be lower than the 20dBc level.

2483.5

Re sults Pass Pass Pass Pass

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4.4.3.1 Band Edge - conducted

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F i g u r e 2 5 : 2402MHz, 1Mbps, Lower Band Edge

F i g u r e 2 6 : 2480MHz, 1Mbps Upper Band Edge

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F i g u r e 2 7 : 2402MHz, 2Mbps, Lower Band Edge

F i g u r e 2 8 : 2480MHz, 2Mbps Upper Band Edge

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4.4.3.2 Conducted Spurious

Page 37 of 62 Seite 37 von 62

F i g u r e 2 9 : 1Mbps Ref Measurement

F i g u r e 3 0 : Conducted Emissions, 2402 MHz, 1Mbps

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F i g u r e 3 1 : Conducted Emissions, 2440 MHz, 1Mbps

F i g u r e 3 2 : Conducted Emissions, 2480 MHz, 1Mbps

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F i g u r e 3 3 : 2Mbps Ref Measurement

F i g u r e 3 4 : Conducted Emissions, 2402 MHz, 2Mbps

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F i g u r e 3 5 : Conducted Emissions, 2440 MHz, 2Mbps

F i g u r e 3 6 : Conducted Emissions, 2480 MHz, 2Mbps

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4.1 Out of Band Emissions: Restricted Band Edge
Transmitter spurious emissions are emissions outside the frequency range of the equipment when the equipment is in transmitting mode; per requirement of CFR47 15.205, 15.209, 15.247(d), RSS-247 Sect. 5.5, RSS-GEN Sect. 8.9 and 8.10.

4.1.1 Test Method
Radiated measurements per ANSI C63.10-2013 Section 6.10.5 were used to measure the undesirable emission requirement in restricted bands. Peak points were found and RMS Average was taken for each point found. The measurement was pe rformed with modulation. This test was conducted on low and high channels in BLE mode on the EUT. The worst case 1Mbps measurement of each channel is recorded in this report. All channels were tested at highest power settings.RBW is set to 1MHz, VBW is set to 3MHz.

4.1.2 Test Setup

The DUT was stimulated by manufacturer providedtest software that is not available to the end user.

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4.1.3 Test Results Test Conditions: Radiated Measurement, Normal Temperature and Voltage Antenna Type: Patch Power Setting: -8dBm Max. Antenna Gain: -10.1dBi Test Performed by: Rachana Khanduri

Page 42 of 62 Seite 42 von 62

Frequency MaxPeak Average

Lim it Margin Bandw idth Height Pol Azim uth Corr.

(M Hz )

(dBµV/m (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

2380.259200 43.)40

---

74.00 30.60 1000.000 123.0 H 125.0 -3.2

2380.259200 ---

26.89

54.00 27.11 1000.000 123.0 H 125.0 -3.2

2383.036800 42.69

---

74.00 31.31 1000.000 105.0 H 52.0 -3.1

2383.036800 ---

26.88

54.00 27.12 1000.000 105.0 H 52.0 -3.1

2388.177600 42.64

---

74.00 31.36 1000.000 194.0 V 59.0 -3.5

2388.177600 ---

26.52

54.00 27.48 1000.000 194.0 V

59.0 -3.5

2388.928000 43.13

---

74.00 30.87 1000.000 250.0 H 28.0 -3.1

2388.928000 ---

26.88

54.00 27.12 1000.000 250.0 H 28.0 -3.1

Level in dBµV/m

120

110

100

90

80

70

60

50

40

30

20 2300

2320

2340

2360

Frequency in MHz

2380

2400

2412

Preview R esult 1H-PK+ 2.4GH z Low Rest ricted BE Avg

Preview R esult 1V-PK+ Final_R esult PK+

2.4GH z Low Rest ricted BE Pk Final_R esult AVG

F i g u r e 3 7 : Restricted Band Edge, Low, 2402MHz, 1 Mbps

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Frequency MaxPeak Average

Lim it Margin Bandw idth Height Pol Azim uth Corr.

(M Hz )

(dBµV/m (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

2487.088400

-)--

27.15

54.00 26.85 1000.000 250.0 V 270.0 -3.3

2487.088400 46.78

---

74.00 27.22 1000.000 250.0 V 270.0 -3.3

2487.530000 48.16

---

74.00 25.85 1000.000 100.0 H 57.0 -2.9

2487.530000 ---

27.56

54.00 26.44 1000.000 100.0 H 57.0 -2.9

2497.038200 ---

27.74

54.00 26.26 1000.000 106.0 H 180.0 -2.9

2497.038200 43.34

---

74.00 30.66 1000.000 106.0 H 180.0 -2.9

2498.639000 42.83

---

74.00 31.17 1000.000 104.0 V 254.0 -3.3

2498.639000 ---

27.36

54.00 26.64 1000.000 104.0 V 254.0 -3.3

Level in dBµV/m

120 110 100
90 80 70 60 50 40 30 20 2462

2480

2500

Preview R esult 1H-PK+ 2.4GH z H igh R estric ted BE Avg

2520

2540

Frequency in MHz

Preview R esult 1V-PK+ Final_R esult PK+

2560

2580

2600

2.4GH z H igh R estric ted BE Pk Final_R esult AVG

F i g u r e 3 8 : Restricted Band Edge, High, 2480MHz, 1 Mbps

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4.2 Transmitter Spurious Emissions
Transmitter spurious emissions are emissions outside the frequency range of the equipment when the equipment is in transmit mode; per requirement of CFR47 15.205, 15.209, 15.247(d), RSS 247 Sect.5.5, RSS-GEN Sect. 8.9 and 8.10.

4.2.1 Test Methodology
4.2.1.1 Preliminary Test
A test program that controls instrumentation and data logging was used to automate the preliminary RF emission test procedure. The frequency range of interest was divided into sub-ranges to yield a frequency resolution of approximately 120 kHz and provide a reading at each frequency for no more than 12° of turntable rotation. For each frequency sub-range the turntable was rotated 360° while peak emissio n data was recorded and measured over the frequency range of interest in horizontal and vertical antenna polarization's.
Preliminary emission profile testing was performed inside the anechoic chamber. The EUT was placed on a 1.0m x 1.5m non-conductive table 80cm (<1 GHz) and 150cm (>1 GHz) above the floor. The EUT was positioned as shown in the setup photographs. The receiving antenna was placed at a distance of 3m at a fixed height of 1m. Measurement equipment was located outside of the chamber. A video camera was placed inside the chamber to view the EUT.
Pre-scans were performed to determine the worst data rate / chains.

4.2.1.2 Final Test
For each frequency measured, the peak emission was maximized by manipulating the receiving antenna from 1 to 4 meters above the ground plane and placing it at the position that produced the maximum signal strength reading. The turntable was then rotated through 360° while observing the peak signal and placing the EUT at the position that produced maximum radiation. The six highest emissions relative to the limit were measured unless such emissions were more than 20 dB below the limit. If less than six emissions are within 20 dB of the limit, than the noise level of the receiver is measured at frequencies where emissions are expected. Multiples of all oscillator and microprocessor frequencies were also checked.
Final testing was performed on an NSA compliant test site. The EUT was placed on a 1.0m x 1.5m non-conductive table 80cm (<1 GHz) and 150cm (>1 GHz) above the ground plane. The placement of EUT and cables were the same as for preliminary testing and is shown in the setup photographs.

4.2.1.3 Deviations None.

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4.2.2 Test Setup:
All tests were conducted at full power on low, middle, and high channels. The DUT was stimulated by manufacturer provided test software that is not available to the end user.

30MHz-1GHz

1-26.5GHz

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4.2.3 Transmitter Spurious Emission Limit

The spurious emissions of the transmitter shall not exceed the values in CFR47 Part 15.205, 15.209: 2015 and RSS Gen Sect. 8.9 and 8.10: 2014.

------------------------------------------------------------------------

Measurement

Frequency (MHz)

Field strength

distance

(microvolts/meter)

(meters)

------------------------------------------------------------------------

0.009-0.490...................... 2400/F(kHz)

300

0.490-1.705...................... 24000/F(kHz)

30

1.705-30.0....................... 30

30

30-88............................ 100 **

3

88-216........................... 150 **

3

216-960.......................... 200 **

3

Above 960........................ 500

3

4.2.4 Test Results The final measurement data was taken under the worst case operating modes, configurations, and/or cable positions. It also reflects the results including any modifications and/or special accessories listed in Sections 1.4 and test plan. Frequencies below 30MHz and above 18GHz were investigated and no emissions were found above the noise floor. Both horizontal and vertical polarities were investigated. The results show only the worst case. As originally tested, the EUT was found to be compliant to the requirements of the test standard(s).
Note: The 2.4 GHz notch filter was used to protect the front end of the pre -amp.

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4.2.4.1 Measurement Results:

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Fr e que ncy (M Hz )

QuasiPeak Lim it Margin Meas. Tim e Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dB)

(m s )

(k Hz )

(cm )

(deg) (dB/m )

48.049550

24.25

40.00 15.75 10000.0 120.000 100.0 V 95.0 -9.8

143.673600 28.31

43.52 15.21 10000.0 120.000 154.0 H 212.0 -16.3

168.022850 192.046000

37.27 36.89

43.52 6.25 43.52 6.63

10000.0 10000.0

120.000 104.0 H 120.000 100.0 H

215.0 -15.0 215.0 -13.4

503.626800 28.25

46.02 17.77 10000.0 120.000 100.0 V 170.0 -5.9

836.355100 23.29

46.02 22.73 10000.0 120.000 100.0 V 167.0 -1.7

Level in dBµV/m

80

70

60

50

40

30

20

10

0

30 100

200

Preview R esult 1H-PK+ Final_R esult QPK

300

400

500

600

Frequency in MHz

Preview R esult 1V-PK+ Final_R esult PK+

700

800

FCC Part 15 QP

900

1000

F i g u r e 3 9 : Radiated Spurious Emissions 30MHz ­ 1GHz, 2402MHz, 1Mbps

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Fr e que ncy (M Hz )

QuasiPeak Lim it Margin Meas. Tim e Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dB)

(m s )

(k Hz )

(cm )

(deg) (dB/m )

48.160400

23.34

40.00 16.66 10000.0 120.000 100.0 V 287.0 -9.9

143.994200 32.44

43.52 11.08 10000.0 120.000 150.0 H 210.0 -16.4

168.377950 191.891600

37.01 36.76

43.52 6.51 43.52 6.76

10000.0 10000.0

120.000 105.0 H 120.000 100.0 H

214.0 -15.0 221.0 -13.4

416.971300 833.895000

23.64 29.36

46.02 22.38 10000.0 46.02 16.66 10000.0

120.000 105.0 V 120.000 100.0 V

172.0 -8.2 187.0 -1.7

Level in dBµV/m

80

70

60

50

40

30

20

10

0

30 100

200

Preview R esult 1H-PK+ Final_R esult QPK

300

400

500

600

Frequency in MHz

Preview R esult 1V-PK+ Final_R esult PK+

700

800

FCC Part 15 QP

900

1000

F i g u r e 4 0 : Radiated Spurious Emissions 30MHz ­ 1GHz, 2440MHz, 1Mbps

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Fr e que ncy (M Hz )

QuasiPeak Lim it Margin Meas. Tim e Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dB)

(m s )

(k Hz )

(cm )

(deg) (dB/m )

144.157150 32.66

43.52 10.86 10000.0 120.000 150.0 H 207.0 -16.4

168.086950 37.15

43.52 6.37 10000.0 120.000 103.0 H 223.0 -15.0

192.130900 416.827700

36.74 24.01

43.52 6.78 10000.0 46.02 22.01 10000.0

120.000 103.0 H 120.000 105.0 V

227.0 -13.4 216.0 -8.2

519.613650 737.624300

25.62 18.31

46.02 20.40 10000.0 46.02 27.71 10000.0

120.000 100.0 V 120.000 244.0 V

164.0 -5.6 33.0 -2.3

Level in dBµV/m

80

70

60

50

40

30

20

10

0

30 100

200

Preview R esult 1H-PK+ Final_R esult QPK

300

400

500

600

Frequency in MHz

Preview R esult 1V-PK+ Final_R esult PK+

700

800

FCC Part 15 QP

900

1000

F i g u r e 4 1 : Radiated Spurious Emissions 30MHz ­ 1GHz, 2480MHz, 1Mbps

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Fr e que ncy (M Hz )

MaxPeak Average Lim it Margin Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

2479.675000 2479.675000 3192.500000 3192.500000 13551.000000 13551.000000 17267.500000 17267.500000 17435.783000 17435.783000 17798.821000 17798.821000

--35.93
--42.45 52.25
--54.90
--57.07
--59.77
---

16.46 ---
26.54 -----
38.81 ---
41.01 ---
43.63 ---
45.98

54.00 37.54 1000.000 154.0 V 133.0 -3.5 74.00 38.07 1000.000 154.0 V 133.0 -3.5 54.00 27.46 1000.000 150.0 V 212.0 -0.4 74.00 31.55 1000.000 150.0 V 212.0 -0.4 74.00 21.75 1000.000 100.0 V 339.0 18.1 54.00 15.19 1000.000 100.0 V 339.0 18.1 74.00 19.10 1000.000 150.0 H 95.0 22.4 54.00 12.99 1000.000 150.0 H 95.0 22.4 74.00 16.93 1000.000 250.0 H 71.0 23.8 54.00 10.37 1000.000 250.0 H 71.0 23.8 74.00 14.23 1000.000 250.0 H 19.0 26.5 54.00 8.02 1000.000 250.0 H 19.0 26.5

Level in dBµV/m

80

70

60

50

40

30

20

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0

1

2

4

6

8

10

12

14

16

18

Frequency in GHz

Preview R esult 1H-PK+ FCC Part 15 AVG

Preview R esult 1V-PK+ Final_R esult PK+

FCC Part 15 PK Final_R esult AVG

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Fr e que ncy (M Hz )

MaxPeak Average Lim it Margin Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

1596.180000 1596.180000 3185.839000 3185.839000 13520.815971 13520.815971 17441.645000 17441.645000 17567.358971 17567.358971 17936.999029 17936.999029

50.57 ---
42.25 ---
52.22 ---
56.04 -----
58.64 ---
58.93

--26.76
--24.78
--38.88
--42.67 45.31
--45.47
---

74.00 23.43 1000.000 154.0 V 239.0 -6.5 54.00 27.24 1000.000 154.0 V 239.0 -6.5 74.00 31.75 1000.000 250.0 V 207.0 -0.4 54.00 29.22 1000.000 250.0 V 207.0 -0.4 74.00 21.78 1000.000 235.0 V 22.0 18.0 54.00 15.12 1000.000 235.0 V 22.0 18.0 74.00 17.96 1000.000 104.0 V 240.0 23.0 54.00 11.33 1000.000 104.0 V 240.0 23.0 54.00 8.69 1000.000 104.0 H 203.0 25.0 74.00 15.36 1000.000 104.0 H 203.0 25.0 54.00 8.53 1000.000 250.0 H 52.0 26.3 74.00 15.07 1000.000 250.0 H 52.0 26.3

Level in dBµV/m

80

70

60

50

40

30

20

10

0

1

2

4

6

8

10

12

14

16

18

Frequency in GHz

Preview R esult 1H-PK+ FCC Part 15 AVG

Preview R esult 1V-PK+ Final_R esult PK+

FCC Part 15 PK Final_R esult AVG

F i g u r e 4 3 : Radiated Spurious Emissions 1GHz - 18GHz, 2440MHz, 1Mbps

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Fr e que ncy (M Hz )

MaxPeak Average Lim it Margin Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

1598.031000 1598.031000 3189.386971 3189.386971 13529.248000 13529.248000 17454.023000 17454.023000 17565.131000 17565.131000 17873.484029 17873.484029

--49.90 39.76
--53.11
----56.29 59.74 --59.46 ---

17.79 -----
19.24 ---
39.32 43.15
----45.35 --46.16

54.00 36.21 1000.000 103.0 V 195.0 -6.5 74.00 24.10 1000.000 103.0 V 195.0 -6.5 74.00 34.24 1000.000 103.0 V 234.0 -0.4 54.00 34.76 1000.000 103.0 V 234.0 -0.4 74.00 20.89 1000.000 100.0 H 209.0 18.2 54.00 14.68 1000.000 100.0 H 209.0 18.2 54.00 10.85 1000.000 100.0 V 58.0 23.1 74.00 17.71 1000.000 100.0 V 58.0 23.1 74.00 14.26 1000.000 150.0 H 288.0 25.0 54.00 8.65 1000.000 150.0 H 288.0 25.0 74.00 14.54 1000.000 155.0 H -1.0 26.8 54.00 7.84 1000.000 155.0 H -1.0 26.8

Level in dBµV/m

80

70

60

50

40

30

20

10

0

1

2

4

6

8

10

12

14

16

18

Frequency in GHz

Preview R esult 1H-PK+ FCC Part 15 AVG

Preview R esult 1V-PK+ Final_R esult PK+

FCC Part 15 PK Final_R esult AVG

F i g u r e 4 4 : Radiated Spurious Emissions 1GHz - 18GHz, 2480MHz, 1Mbps

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Fr e que ncy (M Hz )

MaxPeak Average Lim it Margin Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

18298.042971 18298.042971 18984.250000 18984.250000 20907.000000 20907.000000 22000.372029 22000.372029

47.92 -----
48.34 48.06
----49.46

--34.54 34.27
----34.68 35.95 ---

74.00 26.08 1000.000 106.0 H 205.0 -2.7 54.00 19.46 1000.000 106.0 H 205.0 -2.7 54.00 19.73 1000.000 103.0 H 164.0 -1.8 74.00 25.66 1000.000 103.0 H 164.0 -1.8 74.00 25.94 1000.000 100.0 H 158.0 0.5 54.00 19.32 1000.000 100.0 H 158.0 0.5 54.00 18.05 1000.000 100.0 V 214.0 0.8 74.00 24.54 1000.000 100.0 V 214.0 0.8

Level in dBµV/m

80

70

60

50

40

30

20

10

0

18

19

20

Preview R esult 1H-PK+ FCC Part 15 AVG

21

22

23

Frequency in GHz

Preview R esult 1V-PK+ Final_R esult PK+

24

25

FCC Part 15 PK Final_R esult AVG

26 26.5

F i g u r e 4 5 : Radiated Spurious Emissions 18GHz ­ 26.5GHz, 2402MHz, 1Mbps

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Fr e que ncy (M Hz )

MaxPeak Average Lim it Margin Bandw idth Height Pol Azim uth Corr.

(dBµV/m ) (dBµV/m ) (dBµV/m ) (dB)

(k Hz )

(cm )

(deg) (dB/m )

18016.532000 18016.532000 18753.099971 18753.099971 19563.066000 19563.066000 23664.827029 23664.827029

48.93 ---
47.40 -----
47.55 ---
48.72

--34.86
--34.52 34.26
--34.69
---

74.00 25.07 1000.000 105.0 H 225.0 -3.2 54.00 19.14 1000.000 105.0 H 225.0 -3.2 74.00 26.60 1000.000 105.0 V 265.0 -2.2 54.00 19.48 1000.000 105.0 V 265.0 -2.2 54.00 19.74 1000.000 100.0 H 146.0 -1.0 74.00 26.45 1000.000 100.0 H 146.0 -1.0 54.00 19.31 1000.000 155.0 V 230.0 1.5 74.00 25.28 1000.000 155.0 V 230.0 1.5

Level in dBµV/m

80

70

60

50

40

30

20

10

0

18

19

20

Preview R esult 1H-PK+ FCC Part 15 AVG

21

22

23

Frequency in GHz

Preview R esult 1V-PK+ Final_R esult PK+

24

25

FCC Part 15 PK Final_R esult AVG

26 26.5

F i g u r e 4 6 : Radiated Spurious Emissions 18GHz ­ 26.5GHz, 2480MHz, 1Mbps

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4.3 AC Conducted Emissions
Testing was performed in accordance with ANSI C63.10: 2013. These test methods are listed under the laboratory's A2LA Scope of Accreditation. This test measures the levels emanating from the EUT's AC input port, thus evaluating the potential for the EUT to cause radio frequency interference to other electronic devices. The AC conducted emissions of equipment under test shall not exceed the values in CFR47 Part 15.207: 2021 and RSS Gen: 2019 Sect. 8.8.

4.3.1 Test Methodology
A test program that controls instrumentation and data logging was used to automate the AC Power Line Conducted emission test procedure. The frequency range of interest was divided into sub-ranges such as to yield a frequency resolution of 9 kHz. Each phase and neutral of the AC power line were measured with respect to ground. Measurements were performed using a set of 50H / 50 LISNs.
The setup photographs clearly identify which site was used. The vertical ground plane used in the semi-anechoic chamber is a 2m x 2m solid aluminum frame and panel, and it is bonded to the horizontal ground plane.
In the case of tabletop equipment, the EUT is placed on a 1.0m x 1.5m non -conductive table 80cm above the ground plane and 40cm from a vertical ground reference plane. The rear of the EUT was positioned flush with the backside of the table and directly over the LISNs. The power and I/O cables were routed over the edge of the table and bundled approximately 40cm from the ground plane. Support equipment was powered from a separate LISN.

4.3.1.1 Deviations There were no deviations from this test methodology.

4.3.2 Test Results Test is not applicable since the EUT is DC powered by a battery.

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5 Test Equipment Use List

Page 56 of 62 Seite 56 von 62

5.1 Equipment List

Equipment

Manufacturer

Analyzer/EMI Receiver Rohde & Schwarz

Trilog Antenna

Schwarzbeck; Huber+Suhner

Preamplifier, 30MHz ­ Rohde & Schwarz 8 GHz

Horn, 1-18GHz

EMCO

Preamplifier, 1-18GHz Rohde & Schwarz

Model # ESW, 2Hz-
44GHz VULB 9163
TS-PR8 3115
TS-PR18

Serial/Inst #
5000-032800025 01218:
111218A

Last Cal

Next Cal

mm/dd/yyyy mm/dd/yyyy

03/06/2022 03/06/2023

07/08/2022 07/08/2024

102352

03/14/2022 03/14/2023

9402-4226 3545.7008.03

07/29/2021 02/23/2022

07/29/2023 02/23/2023

Horn, 18-40GHz

Rohde & Schwarz

180-442-KF

132596-01 04/17/2022 06/17/2023

Preamplifier, 18 ­ 40GHz
Spectrum Analyzer
1.6 GHz Low Pass Filter
2.4GHz Band Pass Filter

Rohde & Schwarz Rohde & Schwarz
K&L Microwave Micro-Tronics

TS-PR1840
FSU26.5 8L120-X16000/09135-0249
BRM50702

100067 200050 UA691-35
009

04/04/2022 04/04/2023
03/05/2022 03/05/2023 N/A (See Note) N/A (See Note)

Note: Equipment is characterized before use.

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6 EMC Test Plan

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6.1 Introduction
This section provides a description of the Equipment Under Test (EUT), configurations, operating conditions, and performance acceptance criteria. It is an overview o f information provided by the manufacturer (information supplied by the customer and can affect the validity of results) so that the test laboratory may perform the requested testing.

6.2 Customer
The information in the following tables is required, as it should appear in the final test report. Table 6 ­ Customer Information

Company Name Otsuka America Pharmaceutical, Inc.

Addre ss

3956 Point Eden Way

City, State, Zip Hayward, CA 94545

Country

U.S.A.

Table 7 ­ Contact Information

Name

Jim Hutchison

E-mail

[email protected]

Phone

(650) 394-6316

6.3 Equipment Under Test (EUT)

The information provided in the following table should be listed as it should appear in the final report. For those products that have only a model name, list the model number as non-applicable and viceversa.

Table 8 ­ EUT Designation

Product Name

Otsuka Patch

Model No.

D-Tect

Product Description

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 BLEenabled gateway device. The data can be accessed by external applications for further processingor displayed directly to a user via a display.

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6.3.1 Product Specifications The information provided in the following table should be listed as it should appear in the final report. Table 9 ­ EUT Specifications*
EUT Specification

DC Power Input

2.9VDC

Environment Operating Temperature Range: Multiple Feeds:
Product Marketing Name (PMN) Hardware Version Identification Number (HVIN) Firmware Version Identification Number (FVIN) Operating Mode

Indoor/Outdoor +5 to +40 degrees C
Yes and how many No Otsuka Patch
DT3.0
FIRMWARE_VERSION,17,v0.1.4.0 GIT:733 Bluetooth Low Energy

Transmitter Frequency Band Power Setting @ Operating Channel Antenna Type Antenna Gain (dBi)
Modulation Type

2402 to 2480 MHz

-8 dBm (max)

Patch Antenna

-10.1 dBi

AM

FM

Other describe: GFSK

DSSS

OFDM

Date Rate

1 Mbps and 2 Mbps

TX/RX Chain (s) Directional Gain Type Type of Equipment

1

Uncorrelated

No Beam-Forming

Other describe:

Table Top Wall-mount Floor standing cabinet

Other:

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.

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Table 10: Antenna Information

Numbe r 1

Antenna Type Patch

De scription Internal

Page 59 of 62 Seite 59 von 62
Max Gain (dBi) -10.1

Table 11: Interface Specifications

Inte rface Type

Cabled with what Is the cable

type of cable?

shie lded?

USB Cable 6 pin connector

Yes

M aximum pote ntial length of the cable ?
Metric: <3.0m

Metallic (M), Coax (C),
Fiber (F), or Not
Applicable ?
N/A

Note: Cable required for EUT configuration for regulatory test mode. 6pin to USB cable not utilized within final product. EUT powered by battery during test.

Table 12: Accessory Equipment

Equipment Manufacturer

N/A

N/A

Note: None.

M odel N/A

Se rial N/A

Comme nt N/A

Table 13: Ancillary Equipment (used for test purposes only)

Equipment Manufacturer

M odel

Se rial

Laptop

Dell XPS

Note: None.

P91F

H6WKBK3

Used for
Setup EUT operating channels via USB connection to EUT

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6.3.2 Configuration(s)

Laptop

USB Cable

Page 60 of 62 Seite 60 von 62
2.4 GHz
EUT

Figure 47: Block Diagram of EUT Setup - Radiated
Note: 1. The EUT was connected to the USB Port of the supporting laptop for configuration and control. 2. SMA cable was in place of the antenna for conducted measurement test purposes only.

Table 14: Description of Sample used for Testing

De v ice

Sample Model Numbe r

Configuration

Otsuka Patch Model: D-Tect

00196

Radiated Sample

00182

Conducted Sample

Used For
Radiated Emissions, Radiated Band Edge
Transmit Power, Occupied Bandwidth, Out of Band Emission, PSD

Table 15: Description of Test Configuration used for Radiated Measurement.

De v ice

Ante nna

Mode

Setup Description

Otsuka Patch Model: D-Tect

Patch

Transmit/ Receive

EUT Flat

Note: EUT was tested on its X-Axis as this was worse case

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6.4 Test Specifications
The information provided in the following table should be provided as you would like the product to be evaluated if different from the requirements of the standard.

Table 16 - Test Specifications

Emissions and Immunity

Standard

Re quirement

CFR 47 Part 15.247: 2022

All

RSS 247 Issue 2, 2017

All

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