FCCID.CO- FCC ID Database
HomeCompaniesEquipment ClassesSearch

© 2026 FCC ID Database. All rights reserved.

AboutContactData sourced from FCC public records
  1. Home/
  2. Adherium (NZ) Ltd/
  3. PN2-PRO1

PN2-PRO1The Hailie Sensor is a small battery-powered electronic data logger that attaches to a pMDI inhaler. The Hailie Sensor uses a BLE system to provide wireless communications to a connected App, powered by non-rechargeable coin cell.

Adherium (NZ) Ltd
The Hailie Sensor is a small battery-powered electronic data logger that attaches to a pMDI inhaler. The Hailie Sensor uses a BLE system to provide wireless communications to a connected App, powered by non-rechargeable coin cell. - FCC ID PN2-PRO1 - Adherium (NZ) Ltd
Click to zoom

Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Nov 20, 2022
Application Purpose
Original Equipment
Date of Application
Nov 20, 2022
Equipment Note
The Hailie Sensor is a small battery-powered electronic data logger that attaches to a pMDI inhaler. The Hailie Sensor uses a BLE system to provide wireless communications to a connected App, powered by non-rechargeable coin cell.
Frequency Range
2402.00000000 - 2480.00000000
Company
Adherium (NZ) Ltd
Country
New Zealand

Documents & Files

Select a file to view

Users Manual

↗

Cover Letter(s)

↗
↗
↗
↗

External Photos

↗

ID Label/Location Info

↗

Internal Photos

↗

RF Exposure Info

↗

Test Report

↗
↗

Test Setup Photos

↗

Document Text

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

Users Manual

Product Manual USA Medications: For use only with Teva ProAir ™ HFA or Teva Albuterol Sulfate HFA This Product Manual will help you to get the most out of your Hailie ® sensor. Please read the manual before using the sensor. Hailie ® Sensor Intended Use The Hailie ® sensor is intended for single-patient use in the home environment as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler shake, for prescribed inhaler usage. The Hailie ® sensor may be used in the following applications: in clinical practice or clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management. The Hailie sensor is compatible only with the Teva ProAir ™ HFA or Teva Albuterol Sulfate HFA inhalers. The Hailie ® sensor is not intended to indicate remaining quantity of medication in an Inhaler and does not include a dose counting function. The Hailie sensor is not intended to provide spirometry measurements. Important User Information Warnings identify actions or situations that could lead to personal injury. Take note of all warnings before using the Hailie ® sensor. Precautions identify actions or situations that could damage the Hailie ® sensor or other equipment, or affect the accuracy or availability of recorded usage data. Notes contain advisory information about some aspect of the Hailie ® sensor or its use. Warnings and Precautions To ensure your Inhaler functions correctly, do not use the Hailie ® sensor with any other Inhaler or medication than that indicated on the Hailie ® sensor label. Refer to the labelling provided with the Inhaler for instructions on use. Carry out all steps required to use your Inhaler according to the instructions. The Hailie ® sensor is intended to track medication usage. It is not intended to diagnose your condition or to replace the diagnosis of a licensed physician. This manual does not provide information on how to use prescription medication, and is not intended to replace the advice provided by a health professional. Directions for using prescription medication should be obtained from a health professional and followed accordingly. Any questions related to prescription medication should be referred to a health professional. The Hailie ® sensor does not contain a dose counter. Do not use data collected by the Hailie ® sensor to determine the number of doses remaining in an Inhaler. If your prescribed Inhaler changes, do not use it with this Hailie ® sensor. Only use a Hailie ® sensor that is labelled as compatible with your prescribed Inhaler. Keep the Hailie ® sensor outside MRI scanner rooms. Setup and use of the Hailie ® sensor for patients under 12 years of age requires assistance from a parent or caregiver. The Hailie ® sensor is a battery- powered electronic device. Take care to not spill liquids on the Hailie ® sensor or immerse it in water. Do not use the Hailie ® sensor if it is not in good condition. Do not expose the Hailie ® sensor to excessive perspiration during exercise. For hygiene and data integrity reasons, do not use the Hailie ® sensor with more than one patient. Remove the Hailie ® sensor from the Inhaler before cleaning the Inhaler. User to store the device when not in use and avoid unnecessary shaking or motion to maintain battery service life. What is the Hailie ® Sensor? The Hailie ® sensor is a companion tool that tracks your prescribed medication use and reminds you when to take your prescribed medication. The Hailie ® sensor is a small battery- powered electronic data logger that attaches to an Inhaler. The Hailie ® sensor contains an electronic clock and calendar that is used to log the date and time of Inhaler usage. Usage data can be uploaded via a wireless Bluetooth ® connection. The Hailie ® sensor records parameters of inhaler use, including inspiratory flow and shaking the inhaler before use, which may be used by your doctor to help assess your inhaler usage. Hailie ® Sensor Components Key 1. Door Slide 2. Status Button/Light Emitting Diode (LED) Compatible Inhalers The Hailie ® sensor is designed to work only with the Inhaler and medication indicated on the Hailie ® sensor label. CountryMedication Strength USTeva ProAir™ HFA 90 mcg Teva Albuterol Sulfate HFA 90 mcg Since the time of printing certain information might have changed. For an up to date list of compatible inhalers please refer to www.adherium.com/ compatibility. The Hailie ® sensor intended population is identical to the intended population of the compatible Inhaler. Preparation for First Use Setup and use of the Hailie ® sensor for patients under 12 years of age requires assistance from a parent or caregiver. Following manufacture, the Hailie ® sensor is placed in Deep-Sleep mode to conserve battery life. The Hailie ® sensor must be paired with a compatible Bluetooth ® mobile device in order to sync stored usage data. Download a compatible mobile app to communicate with your sensor. For more information go to support. hailie.com. Ensure Bluetooth ® is enabled on your mobile device. 1. Open the compatible mobile app and follow the prompts to complete the pairing process. 2. Wake up the Hailie ® sensor by pressing the Status Button. 3. The Hailie ® sensor will wake up and the LED will flash green. 4. After 5 seconds the Hailie ® sensor will automatically enter Bluetooth ® pairing mode and the LED will flash blue for 60 seconds. 5. Follow the prompts to complete the pairing process. 6. The LED will flash green to indicate successful pairing. If pairing is not successful within 60 seconds the LED will flash red. The pairing process can be repeated if necessary by pressing the Status Button 3 times quickly to initiate pairing. The Hailie ® sensor can only be paired with a single mobile device at one time. Successful pairing with a new mobile device will remove the curr…

Text truncated - open the document above for the full version.

Cover Letter(s)

EMC Technologies Pty Ltd, 176 Harrick Road, Keilor Park VIC 3042 Australia www.emctech.com.au To: Federal Communications Commission Attention: Certification Officer Date: November 17, 2022 EMC Ref: M2206003 Subject: FCC FILING – FCC ID: PN2-PRO1 (Original certification) Company: Adherium (NZ) Limited Adherium (NZ) limited is applying for original certification of the NF0110 Hailie Sensor – A small hand-held, battery-powered data logger that attaches to an inhaler. It reminds the user when medication is due and logs when medication is taken. EUT Transmitter Details: • Type: Bluetooth Low Energy • Operating Freq: 2402 – 2480 MHz • Modulation: GFSK EMC Technologies is acting as agent for Adherium (NZ) Limited in this application. Regards _____________ Shabbir Ahmed CEO EMC Technologies Pty Ltd 176 Harrick Road, Keilor Park, VIC 3042 Australia Ph: +61 3 9365 1000 www.emctech.com.au EMC Technologies Pty Ltd ABN 82 057 105 549 176 Harrick Road, Keilor Park, VIC 3042 Australia Ph: + 613 9365 1000 Fax: + 613 9331 7455 Email: [email protected]

Cover Letter(s)

Adherium (NZ) Limited Level 2, 63 Albert Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 [email protected] www.hailie.com Federal Communications Commission Authorization and Evaluation Division 1435 Oakland Mills Road Columbia, MD 21046 Date: 26 Oct 2022 SUBJECT: FCC Application for (FCC ID: PN2-PRO1) To Whom It May Concern: As per KDB 784748 D01, Section 3, we, the undersigned, hereby request permission to exclude the FCC 15.19 compliance statement from our device. The device is extremely small (2.58 x 1.48 x 1.73 in) and does not utilize electronic labeling. The FCC 15.19 compliance statement is placed in the user manual. Regards, Tara M. Creaven-Capasso VP Quality, Regulatory and Clinical Affairs Adherium (NZ) Ltd.

Cover Letter(s)

Adherium (NZ) Limited Level 2, 63 Albert Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 [email protected] www.hailie.com Federal Communications Commission Authorization and Evaluation Division Date: 26 Oct 2022 Confidentiality Request regarding application for certification of FCC ID: PN2-PRO1. Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Exhibit Type File Name Block Diagram Schematics PCBA Schematics Flex Operational Description A1. Hailie for ProAir - Block Diagram.pdf A2. NA0146 – V3.0 – Schematic PCBA A3. NA0148 V2.0 – Schematic Flex A4. Hailie for ProAir Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Pursuant to DA04-1705 June 15, 2004 of the Commission’s public notice, we also request temporary confidential treatment of information accompanying this application as outlined below for a period of 180 days. Exhibit Type File Name External Photos Internal Photos Test Setup Photos Manual S220305-5 Appendix B Ext Photos S220305-5 Appendix C Int Photos S220305-5 Appendix A Test Setup Photos A5. ND0541 V1 Hailie for Teva HFA Product Manual Sincerely, Tara M. Creaven-Capasso VP Quality, Regulatory and Clinical Affairs Adherium (NZ) Ltd.

Cover Letter(s)

Adherium (NZ) Limited Level 2, 63 Albert Street, Auckland 1010, New Zealand PO Box 106-612, Auckland 1143, New Zealand Phone +64 9 307 2771 [email protected] www.hailie.com Federal Communications Commission Authorization and Evaluation Division 1435 Oakland Mills Road Columbia, MD 21046 Date: 26 Oct 2022 SUBJECT: FCC Application for (FCC ID:PN2-PRO1) To Whom It May Concern: We, the undersigned, hereby authorize Shabbir Ahmed at EMC Technologies Pty Ltd to act on our behalf, to apply to the Federal Communications Commission for FCC approval of our equipment. Any and all acts carried out by Shabbir Ahmed at EMC Technologies on our behalf shall have the same effect as acts of our own. This is to advise that we are in full compliance with the Anti- Drug Abuse Act. We, the applicant, are not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 USC853a, and no party to the application is subject to a denial of federal benefits pursuant to that section. Regards, Tara M. Creaven-Capasso VP Quality, Regulatory and Clinical Affairs Adherium (NZ) Ltd.

External Photos

Page 1 of 5 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Accredited for compliance with ISO/IEC 17025.. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme provider reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX B EXTERNAL IDENTIFICATION PHOTOGRAPHS Test Report Number: S220305-5 FCC ID: PN2-PRO1 Tested For: Adherium (NZ) Ltd Device under Test: Hailie Sensor Model Number: NF0110 Issue Date: 10 November 2022 EMC Technologies Pty Ltd reports apply only to the specific samples tested under stated test conditions. It is the manufacturer’s responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. EMC Technologies Pty Ltd shall have no liability for any deductions, inferences or generalisations drawn by the client or others from EMC Technologies Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Technologies Pty Ltd. Appendix B – External Photographs Report No. 220305-5 Page 2 of 5 Accredited for compliance with ISO/IEC 17025.. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme provider reports. This document may only be reproduced in full with exception of Certificate of Compliance REVISION TABLE Version Sec/Para Changed Change Made Date 1 Initial Issue of Document 10/11/2022 Appendix B – External Photographs Report No. 220305-5 Page 3 of 5 Accredited for compliance with ISO/IEC 17025.. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme provider reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX B1 EXTERNAL IDENTIFICATION PHOTOGRAPHS EUT External (Conducted Unit) Appendix B – External Photographs Report No. 220305-5 Page 4 of 5 Accredited for compliance with ISO/IEC 17025.. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme provider reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX B2 EXTERNAL IDENTIFICATION PHOTOGRAPHS EUT External (Radiated Unit) Appendix B – External Photographs Report No. 220305-5 Page 5 of 5 Accredited for compliance with ISO/IEC 17025.. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme provider reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX B3 Photograph of Auxiliary Equipment Dongle EMCT Supplied Laptop -END OF REPORT-

ID Label/Location Info

For use only with Teva ProAir™ HFA or Teva Albuterol Sulphate HFA 0000000 Emergo Europe BV 2514 AP The Hague The Netherlands Adherium (NZ) Limited Auckland 1010, New Zealand www.hailie.com (01)09421032180439 (21)0000000 FCC ID: PN2-PRO1 NF0110 Made in Thailand Key: Die line GS1 Data-matrix Barcode format: <FNC1>010942103218043921NNNNNNN Where: <FNC1> is the GS1 Function 1 Symbol Character 0942103218043 is the GTIN Number 9 is the Check Digit NNNNNNN is the Serial Number Data Matrix Barcode Settings: 18X18 GS1 Compatible Big Serial Number Helvetica Neue LT Std 75 Bold 10.5pt Small Serial Number Helvetica Neue LT Std 67 Medium Condensed 4pt Be sure the number matches with the Big Serial Number Data matrix barcode 5mm x 5mm 29.1 55.1

Internal Photos

Page 1 of 4 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Accredited for compliance with ISO/IEC 17025 – Testing NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme providers reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX D INTERNAL IDENTIFICATION PHOTOGRAPHS External Antenna Unit Test Report Number: S220305-5 FCC ID: PN2-PRO1 Tested For: Adherium (NZ) Ltd Device under Test: Hailie Sensor Model Number: NF0110 Issue Date: 10 November 2022 EMC Technologies Pty Ltd reports apply only to the specific samples tested under stated test conditions. It is the manufacturer’s responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. EMC Technologies Pty Ltd shall have no liability for any deductions, inferences or generalisations drawn by the client or others from EMC Technologies Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Technologies Pty Ltd. Appendix D – Internal Identification Photographs Report No. S220305-5 Page 2 of 4 Accredited for compliance with ISO/IEC 17025 – Testing NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme providers reports. This document may only be reproduced in full with exception of Certificate of Compliance REVISION TABLE Version Sec/Para Changed Change Made Date 1 Initial Issue of Document 10/11/2022 Appendix D – Internal Identification Photographs Report No. S220305-5 Page 3 of 4 Accredited for compliance with ISO/IEC 17025 – Testing NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme providers reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX D1 INTERNAL IDENTIFICATION PHOTOGRAPHS EUT Internal (Conducted Unit) Appendix D – Internal Identification Photographs Report No. S220305-5 Page 4 of 4 Accredited for compliance with ISO/IEC 17025 – Testing NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration, inspection and proficiency testing scheme providers reports. This document may only be reproduced in full with exception of Certificate of Compliance APPENDIX D2 INTERNAL IDENTIFICATION PHOTOGRAPHS EUT Internal (Radiated Unit)

RF Exposure Info

Page 1 of 8 EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au Accredited for compliance with ISO/IEC 17025. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, medical testing, calibration, inspection and proficiency testing scheme providers reports. Except for the Certificate of Compliance, this document must only be reproduced in full. FCC SAR EXEMPTION REPORT REPORT NUMBER: S220305-6 TEST STANDARD: FCC KDB 447498 D01 FCC ID: PN2-PRO1 CLIENT: ADHERIUM (NZ) LTD DEVICE: HAILIE SENSOR MODEL: NF0110 DATE OF ISSUE: 14/10/2022 EMC Technologies Pty Ltd reports apply only to the specific samples tested under stated test conditions. It is the manufacturer’s responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. EMC Technologies Pty Ltd shall have no liability for any deductions, inferences or generalisations drawn by the client or others from EMC Technologies Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Technologies Pty Ltd. Page 2 of 8 Report No. S220305-6 Except for the Certificate of Compliance, this document must only be reproduced in full. REVISION TABLE Version Sec/Para Changed Change Made Date 1 Initial issue of document 14/10/2022 Page 3 of 8 Report No. S220305-6 Except for the Certificate of Compliance, this document must only be reproduced in full. CONTENTS Introduction ......................................................................................................................... 5 1.1 Laboratory Overview .................................................................................................. 5 1.2 Test Laboratory/Accreditations .................................................................................. 5 Device Details ..................................................................................................................... 5 *Refer to report S220305-5, section 3.5. ............................................................................ 5 SAR TEST EXCLUSION THRESHOLD FOR 100MHz to 6GHz and ≤50mm ................... 6 Uncertainty ......................................................................................................................... 7 ASsumptions in this Assessment ....................................................................................... 7 EVALUATION RESULT ..................................................................................................... 8 Conclusion .......................................................................................................................... 8 Page 4 of 8 Report No. S220305-6 Except for the Certificate of Compliance, this document must only be reproduced in full. FCC SAR EXEMPTION REPORT Device: Hailie Sensor Model Number: NF0110 Serial Number: 773DEMC2 Manufacturer: Adherium (NZ) Ltd Tested for: Adherium (NZ) Ltd Address: Level 2, 63 Albert Street Auckland, New Zealand 1010 Phone Number: +61 430 348 565 Contact: Igbal Syre Email: [email protected] FCC ID: FCC ID: PN2-PRO1 Standards: FCC KDB 447498 D01 General RF Exposure Guidance v6.0 Mobile and Portable Devices RF Exposure Procedures and Equipment Authorization Policies. Result: Based on an assessment of the documentation provided the Hailie Sensor, Model NF0110 exempted from SAR evaluation. Refer to Report S220305-6 for full details Assessment Date: 11 May 2022 Issue Date: 14 October 2022 Assessment Engineer: Dong Feng Authorised Signatory: Emad Mansour EMC Technologies Pty Ltd Issued by: EMC Technologies Pty. Ltd., Unit 3, 87 Station Road, Seven Hills, NSW, 2147, Australia. Phone: +61 2 9624 2777 E-mail: [email protected] Web: www.emctech.com.au Page 5 of 8 Report No. S220305-6 Except for the Certificate of Compliance, this document must only be reproduced in full. INTRODUCTION The transmitter was assessed against FCC KDB 447498 D01 General RF Exposure Guidance v6.0 . This report shows the SAR exclusion on the Hailie Sensor, Model NF0110, in accordance with FCC KDB 447498 D01 clause 4.3.1, The test sample was provided by the Client. The conclusion herein is based on the information provided by the client. 1.1 Laboratory Overview EMC Technologies Pty. Ltd. is an independently owned Australian company that is NATA accredited to ISO 17025 for both testing and calibration and ISO 17020 for Inspection. – Accreditation Number 5292. 1.2 Test Laboratory/Accreditations Inspection were performed at EMC Technologies' laboratory in Seven Hills, NSW, Australia. Table 1-1: Accreditations for Conformity Assessment Country/Region Body Australia/New Zealand NATA Accreditation Number: 5292 Europe European Union Notified Body Number: 0819 USA FCC Designation Number: AU0002 (Syd) Canada ISED Canada Company Number: 4207A (Syd) Japan VCCI Company Number: 785 Taiwan BSMI Lab Code SL2-IN-E-5001R DEVICE DETAILS (Information supplied by the Client) Manufacturer: Adherium (NZ) Ltd Test Sample: Hailie Sensor Model Number: NF0110 Serial Number: 773DEMC2 Transmit parameters were provided by the customer and are shown below: Table 2-1: Transmitter Parameters Frequency Band: 2.400-2.4835GHz ISM band (Bluetooth Low Energy) Modulation: GFSK (1Mb/s) Operating Frequency: 2.4 GHz Nominal Power: 1.0 mW Antenna type and gain: Internal Omnidirectional 1dBi Peak Output Power: -5.8 dbm *Refer to report S220305-5, section 3.5. Page 6 of 8 Report No. S220305-6 Except for the Certificate of Compliance, this document must only be reproduced in full. SAR TEST EXCLUSION THRESHOLD FOR 100MHZ TO 6GHZ AND ≤50MM Table1: SAR test exclusion threshold 100 MHz- 6GHz Frequency (MHz) 5 10 15 20 25 mm 150 39 77 116 155 194 SAR Test Exclusion Thr…

Text truncated - open the document above for the full version.

Test Report

FCC ID: PN2-PRO1 Page 1 of 59 Report No. S220305-5 This document may only be reproduced in full with exception of Certificate of Compliance EMC Technologies Pty. Ltd. ABN 82 057 105 549 Melbourne 176 Harrick Road Keilor Park, Vic 3042 Tel: +61 3 9365 1000 Sydney Unit 3/87 Station Road Seven Hills, NSW 2147 Tel: +61 2 9624 2777 Email: [email protected] Web: www.emctech.com.au RADIO REPORT FOR CERTIFICATION to 47 CFR Part 15 Subpart C (Section 15.247) Test Report Number: S220305-5 FCC ID: PN2-PRO1 Tested For: Adherium (NZ) Ltd Device under Test: Hailie Sensor Model Number: NF0110 Issue Date: 16 November 2022 EMC Technologies Pty Ltd reports apply only to the specific samples tested under stated test conditions. It is the manufacturer’s responsibility to assure that additional production units of this model are manufactured with identical electrical and mechanical components. EMC Technologies Pty Ltd shall have no liability for any deductions, inferences or generalisations drawn by the client or others from EMC Technologies Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Technologies Pty Ltd. FCC ID: PN2-PRO1 Page 2 of 59 Report No. S220305-5 This document may only be reproduced in full with exception of Certificate of Compliance RADIO REPORT FOR CERTIFICATION 47 CFR Part 15 Subpart C (Section 15.247) CONTENTS 1.0 INTRODUCTION 2.0 GENERAL INFORMATION 3.0 TEST RESULTS 3.1 §15.203 Antenna Requirement 3.2 §15.205 Restricted Bands of Operation 3.3 §15.209 Radiated Emission Limits; General Requirements 3.4 §15.247(a) DTS Bandwidth 3.5 §15.247(b) Peak Output Power 3.6 §15.247(d) Out of Band Emissions 3.7 §15.247(e) Power Spectral Density 3.8 §2.1049 Occupied bandwidth – 99% power 4.0 COMPLIANCE STATEMENT 5.0 MEASUREMENT UNCERTAINTY FCC ID: PN2-PRO1 Page 3 of 59 Report No. S220305-5 This document may only be reproduced in full with exception of Certificate of Compliance REVISION TABLE Version Change Made Date 1 Initial issue of document 16 November 2022 FCC ID: PN2-PRO1 Page 4 of 59 Report No. S220305-5 This document may only be reproduced in full with exception of Certificate of Compliance RADIO REPORT Device under Test: Hailie Sensor Model Number: NF0110 Serial Number: 773DEMC2 FCC ID: PN2-PRO1 Manufacturer: Adherium (NZ) Ltd Tested for: Adherium (NZ) Ltd Address: Level 2, 63 Albert Street, Auckland New Zealand 1010 Phone: +61 430 348 565 Contact: Igbal Syre Email: [email protected] Standards: 47 CFR Part 15 – Radio Frequency Devices Subpart C – Intentional Radiators Section 15.247 – Operation within the bands 902-928 MHz, 2400- 2483.5 MHz, and 5725-5850 MHz Result: The Hailie Sensor complied with the applicable requirements of the above standards. Refer to Report S220305-5 for full details. Test Date(s): 26 April 2022 to 11 May 2022 Issue Date: 16 November 2022 Attestation: I hereby certify that the Hailie Sensor described herein was tested as described in this report and that the data included is that which was obtained during such testing. Test Engineer: Dong Feng Authorised Signatory: Wilson Xiao Lead Engineer- Radio EMC Technologies Pty Ltd Issued by: EMC Technologies Pty. Ltd., Unit 3, 87 Station Road, Seven Hills, NSW, 2147, Australia. Phone: +61 2 9624 2777 E-mail: [email protected] Web: www.emctech.com.au FCC ID: PN2-PRO1 Page 5 of 59 Report No. S220305-5 This document may only be reproduced in full with exception of Certificate of Compliance RADIO REPORT FOR CERTIFICATION to 47 CFR Part 15 Subpart C (section 15.247) 1.0 Introduction Radio tests were performed on Hailie Sensor with Model Number: NF0110, in accordance with the applicable requirements of 47 CFR, Part 15 Subpart C – Section 15.247 operating within the band: 2400 MHz to 2483.5 MHz. 1.1 Test Procedure Radio measurements were performed in accordance with the appropriate procedures of ANSI C63.10: 2013 and KDB 558074 v05r02 - Guidance for Performing Compliance Measurements on Digital Transmission Systems (DTS) Operating Under §15.247. The measurement instrumentation conformed to the requirements of ANSI C63.2: 2016. 1.2 Summary of 47 CFR Part 15 Subpart C Results Section FCC Part 15 Subpart C Test Performed Results 3.1 15.203 Antenna requirement Complied 3.2 15.205 Restricted bands of operation Complied 3.3 15.209 Radiated emissions limits; general requirements Complied 3.4 15.247 (a) Channel Bandwidth Complied 3.5 15.247 (b) Peak Output Power Complied 3.6 15.247 (d) Out of Band Emissions Complied 3.7 15.247 (e) Peak Power Spectral Density Complied 3.8 2.1049 Occupied Bandwidth 913.46 kHz 1.3 Modifications No modifications were performed on EUT to comply with the standard. FCC ID: PN2-PRO1 Page 6 of 59 Report No. S220305-5 This document may only be reproduced in full with exception of Certificate of Compliance 2.0 GENERAL INFORMATION (Information supplied by the Client) 2.1 EUT (Transmitter) Details Frequency Band: 2.400-2.4835GHz ISM band (Bluetooth Low Energy) Modulation: GFSK (1Mb/s) Operating Frequency: 2.4 GHz Nominal Power: 1.0 mW Antenna type and gain: Internal Omnidirectional 1dBi 2.2 EUT (Host) Details Manufacturer: Adherium (NZ) Limited Device Under Test: Hailie Sensor Model Number: NF0110 Highest Internal Frequency: 2.48GHz 2.3 EUT Description The EUT is a medication usage monitor and reminder for use with Metered Dose Inhaler. 2.4 Test Sample Operation Mode Mode No. Description 1 Continuous transmitting on low channel (2402 MHz) 2 Continuous transmitting on mid channel (2440 MHz) 3 Continuous transmitting on high channel (2480 MHz) 2.5 Facility 2.5.1 General EMC Technologies Pty Ltd has been accredited as a Conformity Assessment Body (CAB) by Australian Communications and Media Authority (ACMA) under the APECTEL MRA and is designated to perform compliance testing on equipment subject to Declaration of Conformity (DoC) and Certification under Parts 15 and 18 of the FCC Commission’s rules – Designation number AU0002. Measurements in th…

Text truncated - open the document above for the full version.

Test Report

NF0110 Hailie™ for Teva ProAir Sensors FCC ID: PN2-PRO1 Copyright © Adherium (NZ) Ltd 2020 Antenna Description - RF Antenna The Hailie™ Sensor uses a 2.4GHz radio frequency antenna to communicate using the Bluetooth Low Energy protocol. The antenna is driven by the Nordic nRF52832 microcontroller, which is configured to operate at 1.0 mW (0dBm) output power at 2.40 - 2.48 GHz on 40 channels of 2MHz …

Text truncated - open the document above for the full version.

Contact Information

Applicant

Tara Creaven-Capasso(Vice Pres Clinical, Quality & Regulatory Affairs)
[email protected]093072771Fax: 093072771

Test Firm

EMC Technologies Pty. Ltd.Tracy Newman
[email protected]61296242777Fax: 61298384050

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz300.00 µW
Confidentiality
Long Term
Grant Notes
Power listed is conducted.

Other Applications from Adherium (NZ) Ltd

The HailieTM Sensor is a small battery-powered electronic data logger that attaches to a pMDI inhaler. The HailieTM Sensor uses a BLE system to provide wireless communications to a connected App, powered by non-rechargeable coin cell - FCC ID PN2-MDI1 - Adherium (NZ) Ltd
PN2-MDI1

The HailieTM Sensor is a small battery-powered electronic data logger that attaches to a pMDI inhaler. The HailieTM Sensor uses a BLE system to provide wireless communications to a connected App, powered by non-rechargeable coin cell

Nov 08, 2022

Equipment Class

DTS - Digital Transmission System
Hallie Sensor (for Breztri Aerosphere) is a device to log medication use of a metered dose inhaler - FCC ID PN2-BZT1 - Adherium (NZ) Ltd
PN2-BZT1

Hallie Sensor (for Breztri Aerosphere) is a device to log medication use of a metered dose inhaler

Jul 19, 2020

Equipment Class

DTS - Digital Transmission System
Data logger for inhaled medication - FCC ID PN2-STC1 - Adherium (NZ) Ltd
PN2-STC1

Data logger for inhaled medication

Jan 24, 2016

Equipment Class

DXX - Part 15 Low Power Communication Device Transmitter