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2BFPM-PERI-1Perimenopause wearable device

identifyher Ltd
Perimenopause wearable device - FCC ID 2BFPM-PERI-1 - identifyher Ltd
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Dec 05, 2024
Application Purpose
Original Equipment
Date of Application
Dec 05, 2024
Equipment Note
Perimenopause wearable device
Frequency Range
2402.00000000 - 2480.00000000
Company
identifyher Ltd
Country
Ireland

Documents & Files

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Users Manual

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Attestation Statements

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

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

Users Manual

User Manual: Perimenopause Wearable Device Congratulations on your purchase of the identifyHer Perimenopausal Symptom Tracker! This innovative device is designed to help women like you going through perimenopause to detect and track your symptoms effectively. Please read this user manual carefully to ensure proper usage and maximum benefit from your device. We want you to get the most out of your experience. Please read this information carefully before using your device and mobile app. Failure to follow the instructions below could result in product damage or malfunction, or even injury. GETTING STARTED Package Contents: • Wearable Sensor Device • Double-sided adhesive patches • Battery x 2 • Charging dock • USB-C cable • User Manual Batteries • You have been provided with TWO batteries to allow for continuous wear of the device. You don’t have to think about taking the device off to charge. Instead you can have one battery charging while the other is worn on the device and then swap when needed. Battery Installation and Removal • Place the sensor device on a flat surface • Take one of the batteries and align the center of the battery with the guide rail at the back of the device. • Gently push the battery along the guide rail until it clicks into place and connects to the device • To remove the battery from the device, gently push on the buttons either side of the device. This will release the battery and you can slide it off the guide rail. SETTING UP YOUR IDENTIFYHER SENSOR Creating an account: • Download and install the identifyHer app from the App Store or Google Play Store. • Create an account o Open the identifyHer app o Confirm you have an identifyHer device o Tap Create an Account o Enter an email and password o Verify your email address by checking your email account o Follow the prompts on-screen to complete setting up your new account. Pair your Device: • After you have created your account, you will be prompted to pair the device • Ensure your phone has Bluetooth turned on • Confirm the battery has been inserted • Follow the on-screen instructions to pair the device with your smartphone via Bluetooth. • Click ‘Find my Device’ • Confirm that you want to pair your phone with the device • The device will be connected automatically during the onboarding process and whenever the battery is replaced. • After successfully connecting the device, you will be asked to confirm you are wearing the device. Instructions on Device placement are provided below. • The app confirms the device is detected • You will be asked additional health related questions to allow you get the most relevant information from your device. Log in after initial account creation • After creating your account, you will be able to log in to your account using your email and password when you open the app. USING THE DEVICE Device Placement: • The sensor is worn under the breast using the double-sided adhesive patch. The device adhesive has a single covering whereas the skin side adhesive has two separate coverings. • Device side adhesive o Once the battery is installed, turn it over with the sensors facing up. o Take one of the adhesives and identify the device side which has one continuous paper covering. o Peel back the adhesive covering and place over the device. Be careful to ensure the adhesive does not overlap with the sensors. o Gently press down on the adhesive to ensure it is in full contact with the device. • Skin side adhesive and placement of the device on the skin o Ensure the skin under the breast is clean and dry before applying the adhesive. o Peel back the small adhesive covering first and then the larger one. o Place the device on the area under the breast as shown in the diagram and gently press against the skin until fully secured, ensuring it sits comfortably against your skin. Daily Use of the Device • Once the device has been placed on the skin, you can go about your daily life and forget about it. • The device does not have an on/off button and remains active once secured to the body and connected through the app. • The device is waterproof and can be worn during exercise, showering, and daily activities. • You will receive a notification on the app when the battery power reaches 20% • To replace the battery, press on the buttons at either side of the device, slide the battery off and insert the fully charged second battery. Remember to charge the battery you removed from the device. • The app will confirm that the new battery has been inserted and is working. • The adhesive has a 7-10 day wear time but can be changed more frequently if desired. • The sensor data is securely transferred via the mobile phone app so it is important to ensure your smartphone has an active internet connection for seamless data transfer. You will be sent a notification if the data has not been transferred. MOBILE APP USAGE Home Dashboard: • Upon opening the app, you will brought to the Home screen containing a dashboard of your daily perimenopause symptoms. • You can view information on the frequency and severity of hot flushes, night sweats, anxiety levels, and sleep efficiency. • If you tap on any of the symptoms, you can access weekly and, by swiping left, monthly symptom trends, detailed reports and insights. • You can return to the daily report by tapping the ‘Home’ button at the bottom of the screen Physical activity • Your daily step count will be reported on the Home dashboard but you can also get more detailed information from the ‘Activity’ tab at the bottom of the screen. • You can monitor changes in step count by looking at weekly or monthly trends • You will get insights about your activity levels and how they relate to your symptoms. Diary • The purpose of the ‘Diary’ tab is to allow you track additional information that could be impacting your symptoms. Now you can track these changes and get valuable insights about managing your symptoms. • You can log a range of symptoms that are not passively …

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Attestation Statements

identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai 120623-17 rev 9 Certification Application Attestation Statements Date: October 31, 2024 American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 To Whom It May Concern: Statement for 47 CFR section 2.911(d)(5)(i) identifyHer Ltd certifies that as of the date of the application the equipment for which authorization is sought is not “covered” equipment 1 prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. If the equipment for which the applicant seeks authorization is produced by any of the entities identified on the current Covered List, including affiliates or subsidiaries of the named companies, the applicant must include an explanation on why the equipment is not “covered” equipment. Additional Explanation: <N/A> Statement for 47 CFR section 2.911(d)(5)(ii) identifyHer Ltd (“the applicant”) certifies that, as of the date of the filing of this application, the applicant is NOT identified on the Covered List (as a specifically named entity or any of its subsidiaries or affiliates – see KDB 986446 Question 5) as an entity producing “covered” equipment. Thank you, By: DONAL O’GORMAN (Signature 2 ) (Print name) 1 - The Commission’s Covered List is published by the Public Safety and Homeland Security Bureau and posted on the Commission’s website. This Covered List, which is periodically updated, identifies particular equipment, produced by particular entities, that constitutes “covered” equipment. https://www.fcc.gov/supplychain/coveredlist . 2 - Letters must be placed on appropriate letterhead. identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai 120623-17 rev 9 Title: COFOUNDER & COO Company: identifyHer Ltd Telephone: +353-87-473-5322

Attestation Statements

TO: ATTE N Desi g Comp FRN: Addre Conta Phone Email: This l e Desig Appli c U.S. A Date: 1 Signe ......... ......... The A mark e The a infor m Appli c Comp Grante FCC I FRN # Conta Street City/P Teleph Email: Applic Date: Sign e American 313 Park A Suite 300 Falls Chu r NTION: FCC gnated U.S. any Name: 003340288 4 ess: 3722 Illin act Person: T e: 708-571-3 : Support@F etter is to co nated U.S. A cant noted b Agent Signa 11/06/2024 ed by (Printe .................. .................. pplicant ack eting and imp pplicant furth mation above cant any name: ee Code: D: #: act Name: t Address: rovince/Zip: hone No: : cant Signat ed by (Printe Certification Avenue rch, VA 2204 C Certificati Agent FCC US Ag e 4 nois Avenue Tim Payne 3148 FCCUSAgen nfirm that w Agent for Se below. ature: ed Name/Tit .................. ........... knowledges t portation OR her acknowl e changes. ture: ed Name/Tit Body, Inc. 46 ion – Sectio ent, LLC e, Saint Char nt.com e (“the Desi g rvice of Proc tle): Tim Pa .................. that they mu R the conclus edges their IDENTIFY H 2BF 2BFPM-PE R 0011357084 DONAL O’G 13 ADELAID DUBLIN/D0 +353-87-47 donal.ogor m 06 th tle): DON on 2.911(d)( rles, IL, 6017 gnated U.S. cess as requ ayne/Manag .................. ust maintain sion of any C responsibilit HER LTD PM RI-1 4 GORMAN DE ROAD 02P950/IREL 35322 man@identif November NAL O’GORM (7) Informat 74, USA Agent) hav e uired by sec ger .................. an agent fo Commission ty to inform t LAND fyher.ai 2024 MAN (COFO tion e accepted t tion 47 CFR .................. r no less tha n-related pro the FCC wh OUNDER & Ph E the responsi R 2.911(d)(7) .................. an one year oceeding invo enever the D COO) identif 13 Ad hone: +353-87 Email: info@ide www.ide 06 th Novem ibility to act a ) on behalf o .................. after termina olving the eq Designated fyHer Ltd delaide Rd Dublin D02P950 Ireland -473-5322 entifyher.ai entifyher.ai mber 2024 as the of the ............ ating all quipment. U.S. Agent

Cover Letter(s)

identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai 050222-17 Authority to Act as Agent Date: October 31, 2024 American Certification Body, Inc. 313 Park Avenue Suite 300 Falls Church, VA 22046 To Whom It May Concern: Compliance Engineering Ireland Ltd (Michael Kirby and John McAuley) is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. We also declare that the information provided to the FCC is true and correct to the best of our knowledge (47 CFR 2.911(d)) and we have been informed of the grantee responsibilities (47 CFR 2.909) with regard to certified equipment. Thank you, Agency Agreement Expiration Date: _____12 months_____ By: DONAL O’GORMAN (Signature 1 ) Print name) Title: COFOUNDER AND COO On behalf of: identifyHer Ltd (Company Name) 1 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead. identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai 050222-17 Telephone: +353-87-473-5322

Cover Letter(s)

identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai 050222-17 Request for Confidentiality Date: December 4, 2024 Subject: Confidentiality Request for: FCCID: 2BFPM-PERI-1 IC: 32314-PERI01 Pursuant to FCC 47 CFR 0.457(d) and 0.459 and/or IC RSP-100, Section 12.4, the applicant requests that a part of the subject application(s) be held confidential. Type of Confidentiality Requested Exhibit ☐ Short Term ☒ Permanent Block Diagrams ☐ Short Term --------------------------- External Photos ☐ Short Term ☐ Permanent * 1 Internal Photos ☐ Short Term ☒ Permanent Operation Description/Theory of Operation ☐ Short Term ☒ Permanent Parts List & Placement/BOM ☐ Short Term ☐ Permanent Tune-Up Procedure ☐ Short Term ☒ Permanent Schematics ☐ Short Term --------------------------- Test Setup Photos ☐ Short Term ☐ Permanent * 1 User’s Manual identifyHer Ltd. has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality for FCC Applications: The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public before the requested period has expired. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Short Term Confidentiality for Industry Canada Applications: Starting May 2022, ISED will recognize short term confidentiality on certain exhibits until the intended date of marketing. The applicant requests the exhibits selected above as short term confidential be withheld from public view until: (specify ISED expiration date / date of marketing) . Sincerely, 1 - The asterisked items (*) require further information to be provided to ACB before permanent confidentiality will be extended to these exhibits. Please refer to FCC KDB 726920 and the specific Document link for D01 found at: https://apps.fcc.gov/oetcf/kdb/forms/FTSSearchResultPage.cfm?switch=P&id=41731 and review section II, 3) regarding specific information that must accompany these requests. identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai 050222-17 By: (COFOUNDER & COO) DONAL O’GORMAN (Signature/Title 2 ) (Print name) 2 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

Cover Letter(s)

1/1 identifyHer Ltd 13 Adelaide Rd Dublin D02P950 Ireland Phone: +353-87-473-5322 Email: [email protected] www.identifyher.ai Cover Letter Date: 13 th Jun 2024 Federal Communications Commission Equipment Approval Services P.O. Box 358315 Pittsburgh, PA 15251-5315 FCCID: 2BFPM-PERI-1 To Whom It May Concern: Enclosed, please find a radio application from identifyHer Ltd, requesting the certification of a non-invasive wearable device that detects and tracks the symptoms of perimenopause. The product contains a BLE radio Below is the relevant information regarding the above noted device Standards Applied CFR Title 47, Part 15.247 We have enclosed the completed the application form with the applicable exhibits. If you have any questions or need any additional information, please let me know. Sincerely, By: Donal O’Gorman (Signature) (Print name) Title: Chief Operating Officer [email protected] (Email Address) On behalf of: identifyHer Ltd (Company Name) Telephone: +353-87-4735322

Cover Letter(s)

PRODUCT SPECIFICATION REVISION: ECR/ECN INFORMATION: 2.4GHz/5GHz Ceramic SMT Product Specification SHEET No. B EC No: 1 of 11 DATE: 2018/12/20 DOCUMENT NUMBER: CREATED / REVISED BY: CHECKED BY: APPROVED BY: PS-2119640001 Cooper Zhou2018/12/20 Yuxi Gao 2018/12/20 Stary Song 2018/12/20 TEMPLATE FILENAME: PRODUCT_SPEC[SIZE_A4](V.1).DOC TITLE 2.4GHZ/5GHZ CERAMIC SMT ANTENNA TABLE OF CONTENTS 1.0 SCOPE 2.0 PRODUCT DESCRIPTION 3.0 APPLICABLE DOCUMENTS 4.0 GENERAL SPECIFICATION 5.0 ANTENNA SPECIFICATION 6.0 MECHANICAL REQUIREMENTS 7.0 ENVIRONMENTAL SPECIFICATION 8.0 RECOMMENDED REFLOW CONDITION 9.0 RECOMMENDED FOOTPRINT ON PCB FOR SOLDERING 10.0 PACKING PRODUCT SPECIFICATION REVISION: ECR/ECN INFORMATION: 2.4GHz/5GHz Ceramic SMT Product Specification SHEET No. B EC No: 2 of 11 DATE: 2018/12/20 DOCUMENT NUMBER: CREATED / REVISED BY: CHECKED BY: APPROVED BY: PS-2119640001 Cooper Zhou2018/12/20 Yuxi Gao 2018/12/20 Stary Song 2018/12/20 TEMPLATE FILENAME: PRODUCT_SPEC[SIZE_A4](V.1).DOC 2.4GHZ/5GHZ CERAMIC SMT ANTENNA 1.0 SCOPE This product specification covers the mechanical, electrical and environmental performances specification for 2.4GHz/5GHz Ceramic SMT antenna. 2.0 PRODUCT DESCRIPTION 2.1 PRODUCT NAME AND SERIES NUMBER (S) Product name: 2.4GHz/5GHz Ceramic SMT antenna. Series Number: 211964**** 2.2 DESCRIPTION 211964 is 2.4GHz/5GHz ceramic loop antenna. It works very well when being placed at PCB Center-edge. With applying different matching setup, it supports 2.4GHz single band or 2.4/5GHz dual band. 2.3 FEATURES.  Working frequency 2.4GHz and/or 5GHz with high efficiency (more than 65%)  Antenna size 3.2x1.6x1.2mm, PCB keep-out area 6x4mm  Linear polarization  RoHS Compliant Molex 2119640001 2.4GHz/5GHz Ceramic SMT antenna 3D View PRODUCT SPECIFICATION REVISION: ECR/ECN INFORMATION: 2.4GHz/5GHz Ceramic SMT Product Specification SHEET No. B EC No: 3 of 11 DATE: 2018/12/20 DOCUMENT NUMBER: CREATED / REVISED BY: CHECKED BY: APPROVED BY: PS-2119640001 Cooper Zhou2018/12/20 Yuxi Gao 2018/12/20 Stary Song 2018/12/20 TEMPLATE FILENAME: PRODUCT_SPEC[SIZE_A4](V.1).DOC 2.4 PRODUCT STRUCTURE INFORMATION P/N 2119640001 MECHANICAL STRUCTURE INFORMATION FOR 2119640001 3.0 APPLICABLE DOCUMENTS DOCUMENT NUMBER DESCRIPTION Sale Drawing(SD) SD-2119640001 Mechanical Dimension of the product Application Guide(AS) AS-2119640001 Antenna Application and surrounding Packing Drawing(PK) PK-2119640001 Product packaging specifications PRODUCT SPECIFICATION REVISION: ECR/ECN INFORMATION: 2.4GHz/5GHz Ceramic SMT Product Specification SHEET No. B EC No: 4 of 11 DATE: 2018/12/20 DOCUMENT NUMBER: CREATED / REVISED BY: CHECKED BY: APPROVED BY: PS-2119640001 Cooper Zhou2018/12/20 Yuxi Gao 2018/12/20 Stary Song 2018/12/20 TEMPLATE FILENAME: PRODUCT_SPEC[SIZE_A4](V.1).DOC 4.0 GENERAL SPECIFICATION PRODUCT NAME 2.4GHz/5GHz Ceramic SMT antenna PART NUMBER 2119640001 FREQUENCY RANGE 2400~2500MHz or 2400~2500MHz and 5150~5850MHz POLARIZATION Linear IMPEDANCE WITH MATCHING 50 Ohms STORAGE TEMPERATURE -40°C to 85°C RELATIVE HUMIDITY 55%-75% RF POWER 2 Watts ANTENNA TYPE LTCC CERAMIC DIMENSION 3.2x1.6x1.2 mm SINGLE WEIGHT 0.0192g/ pcs Note: if you plan to re-use the products that be taken out from packaging. Suggest to re-pack them within 24 hours by re-seal with vacuum packaging to prevent oxidation. Product should be used within six months of receipt. 5.0 ANTENNA SPECIFICATION All measurements are done of the antenna mounted on reference PCB (40*20*0.8mm) with VNA Agilent E5071C and Over-The-Air (OTA) chamber. 5.0.1 ANTENNA PERFORMANCE Requirements (For Configure 1) Requirements (For Configure 2) P/N 2119640001 FREQUENCY RANGE 2.4-2.5GHz 2.4-2.5GHz 5.15-5.85GHz PEAK GAIN(MAX) 2.7dBi 2.1dBi 2.2dBi AVERAGE TOTAL EFFICIENCY >80% >70% >65% RETURN LOSS < -6 dB < -5 dB < -5 dB Note that the above antenna performance is measured with just the antenna mounted on a reference PCB (40*20*0.8mm) in free space. When implement into the system, the frequency resonant might be off-tune due to the loading of surrounding components especially metal plane. This off-tune can be compensated through matching. Although module manufacturers specify a peak gain limit, it is based on free-space conditions. The peak gain will be degraded by 1 to 2dBi in the actual implementation as the radiation pattern will change due to the surround components. As such, during selection of antenna, you can select one with high peak gain to compensate for the loss. Molex can offer assistant to choose the best location and best tuning in-order to meet this peak gain requirement. PRODUCT SPECIFICATION REVISION: ECR/ECN INFORMATION: 2.4GHz/5GHz Ceramic SMT Product Specification SHEET No. B EC No: 5 of 11 DATE: 2018/12/20 DOCUMENT NUMBER: CREATED / REVISED BY: CHECKED BY: APPROVED BY: PS-2119640001 Cooper Zhou2018/12/20 Yuxi Gao 2018/12/20 Stary Song 2018/12/20 TEMPLATE FILENAME: PRODUCT_SPEC[SIZE_A4](V.1).DOC 6.0 MECHANICAL REQUIREMENTS DESCRIPTION TEST CONDITION TEST RESULT SHEAR FORCE Apply push force on parts soldered on the PCB at the speed rate of 253 mm/minute. Shear force:>10N 7.0 ENVIRONMENTAL SPECIFICATION DESCRIPTION SPECIFICATION HUMIDITY TEST 1. The device under test is kept for 12 hours in an environment with a temperature of 55 degrees and a relating humidity of 95%. Thereafter for 12 Hours in an environment with a temperature of 25 degrees and a relative humidity of 95%. The cycle is repeated until a total of 6 cycles have been completed. Hereafter the conditions are stabilized at room temperature. 2. Parts should meet RF spec before and after test. 3. No cosmetic problem (No bubble issue、No plating peeling off issue、 No mechanical damage.) TEMPERATURE CYCLING TEST 1. The device under test at -40 °C⇔125 °C by 72 cycles, Dwell of 30 min, transition time between Dwell 15 sec (~ 61 min / cycle ) and each item should be measured after exposing them in normal temperature and humidity for 24 h. 2. Part should meet RF spec before and after test. 3. No cosmetic pr…

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External Photos

Top Bottom Side view

ID Label/Location Info

9.5mm 14.5mm FRONT VIEW [4:1] CONTENTS PAGES CONTENTS 1 COVER PAGE REVISION HISTORY REV DATE CHANGE DRAWN BY R0 15/MAY/24 FIRST RELEASE EOIN O’MEARA R1 06/JUN/24 ADDED: HVIN, FVIN. UPDATED: FORMAT, LAYOUT. EOIN O’MEARA ITEM NO. PART NUMBER DESCRIPTION QTY. 1 IDH-800-01 REG LABEL 1 1 2 IDH-800-02 REG LABEL 2 1 AA BB CC DD EE FF 8 8 7 7 6 6 5 5 4 4 3 3 2 2 1 1 REGULATORY LABEL R2 SHEET: ISSUE: DOCUMENT: GENTIAN HEALTH BAY 89.3 SHANNON FREE ZONE SHANNON, CO. CLARE 1 OF 1 TITLE: GEN-R&D-DHF-299 MINIMUM WALL 0.50 ± 0.05mm TOLERANCES (UNLESS OTHERWISE STATED) 0.0 ± 0.5mm 0.00 ± 0.1mm 0.000 ± 0.005mm LINEAR (mm) ANGULAR (°) 1 ± 0.5 DEGREES THIRD ANGLE PROJECTION REFER TO ORIGINAL CAD MODEL COLOURS ARE USED FOR ILLUSTRATION ONLY NO ALTERATION PERMITTED WITHOUT PERMISSION COPYRIGHT GENTIAN HEALTH LTD. 2024© DESCRIPTION REFERENCED PARTS INFORMATION ASSY. NUMBER LAMINATED LABEL MATERIAL COLOUR YES R2 REV NO. SCALE: 4:1 REGULATORY LABEL PRINTED COPIES MUST BE VERIFIED FOR CORRECTNESS AGAINST THE APPROVED DOCUMENT IN THE DOCUMENT MANAGEMENT SYSTEM. IDH-AA-08 TZ-221 9mm BLACK ON WHITE FRONT VIEW [1:1] ISED CANADA ID FCC ID FIRMWARE VERSION # REG LABEL 1 REG LABEL 2 ASSEMBLY REF SERIAL NO CE LOGO MARK UKCA LOGO MARK REFER TO MANUAL FCC ID: 2BFPM-PERI-1 h IDH-AA-02 f 1001 FVIN: v1.0.0 IC: 32314-PERI01 HVIN: PERI HARDWARE VERSION ASSEMBLY REF FCCID: 2BFPM-PERI-1 h IDH-AA-02 f 1001 R2 13/NOV/24 UPDATED ISED FORMAT SHANE DWANE FVIN: v1.0 IC: 32314PERI01 HVIN: PERI FCCID: 2BFPM-PERI-1 h IDH-AA-02 f 1001 FVIN: v1.0 IC: 32314PERI01 HVIN: PERI h IDH-AA-02 f 1001 i FCC:2BFPM-PERI-1 IC:32314-PERI-01 FCCID: 2BFPM-PERI-1 h IDH-AA-02 f 1001 FVIN: v1.0 IC: 32314-PERI-01 HVIN: PERI R0R1R2

Internal Photos

Battery housing inside test pins visible HR board + temp flex bottom view HR board bottom view HR board top view IDH housing internal Main board bottom view Main board top view Legend on the pcb “Ant 1” shows the location of the Chip antenna (also indicated by red arrow) Temp flex board bottom view Temp flex board top view

RF Exposure Info

TEST SUMMARY 1.0 SAR Evaluation FCC SAR Exclusion Limits Excerpt from 447498 KDB (47498 D01 General RF Exposure Guidance v06) Section 4.3.1 Standalone SAR Test exclusion considerations 4.3.1. Standalone SAR test exclusion considerations 1) The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f (GHz) ] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, 25 where • f (GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculation 26 • The result is rounded to one decimal place for comparison • 3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. 2) At 100 MHz to 6 GHz and for test separation distances > 50 mm, the SAR test exclusion threshold is determined according to the following, and as illustrated in Appendix B: 27 a) [Power allowed at numeric threshold for 50 mm in step 1) + (test separation distance - 50 mm)·( f (MHz) /150)] mW, at 100 MHz to 1500 MHz b) [Power allowed at numeric threshold for 50 mm in step 1) + (test separation distance - 50 mm)·10] mW at > 1500 MHz and ≤ 6 GHz 3) At frequencies below 100 MHz, the following may be considered for SAR test exclusion, and as illustrated in Appendix C: 28 a) The power threshold at the corresponding test separation distance at 100 MHz in step 2) is multiplied by [1 + log(100/f (MHz) )] for test separation distances > 50 mm and < 200 mm b) The power threshold determined by the equation in a) for 50 mm and 100 MHz is multiplied by ½ for test separation distances ≤ 50 mm c) SAR measurement procedures are not established below 100 MHz. When SAR test exclusion cannot be applied, a KDB inquiry is required to determine SAR evaluation requirements for any test results to be acceptable. Report Ref: 24E10961-2a Page 2 of 3 Appendix 1 FCC Head and Body SAR Calculation = [P/D] *[√f(GHz)] where: • f(GHz) is the RF channel transmit frequency in GHz •P = max power of channel including tuneup tolerance mW •D = min separation distance mm •Power and distance are rounded to the nearest mW and mm before calculation25 • The result is rounded to one decimal place for comparison • 3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below Prediction frequency: f 2440 MHz Antenna gain(typical): 2.7 dBi Maximum peak output power at antenna input terminal: P -5.47 dBm Tune up tolerance 0 dB Maximum conducted output power plus Tune up tolerance -5.47 dBm Maximum conducted output power plus Tune up tolerance (rounded to the nearest mW) 0 mW Minimum separation distance: D 5 mm Duty cycle factor (calc over max 30 mins) 0 dB Calculation [(Max. power of channel, including tune up tolerance, mW / min.test separation distance ,mm)]*[√f (GHz)] 0.09 Head and Body SAR 100K-100MHz ;<50mm General pop/Uncontrolled Environment Numeric Threshold for 1g SAR 3 Result meets the SAR test exclusion threshold ==> SAR Test not required 0.1 <= 3 The EUT meets the SAR test exclusion limits for a separation distance of ≤5 mm Test result Pass Report Ref: 24E10961-2a Page 3 of 3 2.0 SAR Evaluation ISED Limit as per IC RSS 102 issue 6 Table 11 Prediction frequency: 2440 MHz Conducted Power at Antenna input: P -5.47 dBm Antenna Gain 2.70 dBi Antenna Gain: G (dBi - 2.15 = dBd) 0.55 dBd Time Averaging Factor: (Taf) 0 dB Tune up tolerance : (Tut) 0 dB ERP dBm (P+G-Taf+Tut) -4.92 dBm ERP mW (P+G-Taf+Tut) 0.32 mW Minimum separation distance: D ≤5 mm Exemption limit for Routine Evaluation SAR : 3.05 mW Head and Body SAR; General pop/Uncontrolled Test Result : EUT meets the SAR Exemption Limit for Routine Evaluation : SAR test not required 0.32 < = 3.05 Pass The EUT meets the SAR test exclusion limits for a separation distance of ≤5 mm End of report

Test Report

Report Ref: 24E10961-1b Page 1 of 37 Compliance Engineering Ireland Ltd Clonross Lane, Derrockstown, Dunshaughlin Co. Meath, Ireland A85 XN59 Ph +353 1 8017000 , 8256722 www.cei.ie Project Num 24E10961-1b Quotation Q24-0902-1 Prepared For Gentian Health Ltd Company Address Bay 89.3, Shannon Free Zone, Shannon, Co. Clare, Ireland V14 E177 Contact Mark Butler Contact Email Gentian Health Ltd Prepared By [email protected] Test Lab Address Compliance Engineering Ireland Tested By Joy Dalayap Test Report By Michael Kirby FCC Designation Number IE0002 IC Site Registration IE0001 Date 30 th Oct 2024 EUT Description Sensor with Bluetooth Low Energy FCC ID 2BFPM-PERI-1 IC ID 32314-PERI01 Authorised by Paul Reilly Authorised Signature: This report supersedes 24E10961-1b Report Ref: 24E10961-1b Page 2 of 37 TEST SUMMARY The equipment complies with the requirements according to the following standards. FCC 15.247 Section RSS-247 Section TEST PARAMETERS Test Result 15.247 (a)2 RSS-247 5.2a 6dB bandwidth Pass 15.247 (e) RSS-247 5.2b Power Spectral Density Pass 15.247 (b)3 RSS-247 5.4d Output power Conducted Pass 15.247 (d) RSS-247 5.5 Conducted Spurious Emissions Pass 15.205 15.209 RSS Gen 8.9 RSS Gen 8.10 Radiated Spurious Emissions Pass RSS Gen 6.7 99% bandwidth Pass RSS 247 Issue 3 Aug 2023 RSS-Gen Issue 5 Apr 2018 + Amd1 Mar 2019 + Amd2 Feb 2021 This report shall not be reproduced except in full, without the written approval of Compliance Engineering Ireland Ltd. Report Ref: 24E10961-1b Page 3 of 37 Exhibit A – Technical Report Table of Contents 1.0 EUT DESCRIPTION ................................................................................................................................ 4 1.1 EUT OPERATION ..................................................................................................................................... 5 1.2 MODIFICATIONS ...........…

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Contact Information

Applicant

Donal O'Gorman(Cofounder and COO)
[email protected]00353874735322Fax: 00353874735322

Technical Contact

Gentian Health LtdDarren Sherin
[email protected]01135361704986

Bay 81/82 · Shannon · Ireland

Non-Technical Contact

identifyHer LtdDonal O'Gorman
[email protected]011353874735322

Test Firm

Compliance Engineering Ireland Ltd. (CEI)John McAuley
[email protected]+353 1 8017000Fax: +353 1 8256733

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz280.00 µW
Confidentiality
Long Term
Grant Notes
Power output listed is conducted. The antenna(s) used for this transmitter must not be co-located with any other transmitters except in accordance with FCC multi-transmitter product procedures. Grantee must provide installation and operating instructions for complying with FCC multi-transmitter product procedures and RF exposure compliance. This filing meets the KDB publication 447498 requirements for portable RF exposure conditions.

Other Applications from identifyher Ltd

Wearable Bio-sensor - FCC ID 2BFPM-PERI-2 - identifyher Ltd
2BFPM-PERI-2

Wearable Bio-sensor

Feb 03, 2026

Equipment Class

DTS - Digital Transmission System