
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
Product Manual USA Medications: For use only with Advair ™ HFA or Flovent ™ HFA as indicated on the Hailie ™ sensor label. For more information on all regions see the “Compatible Inhalers” section. 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 including medication reminders. The Hailie sensor is compatible only with the Advair ™ HFA or Flovent ™ 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 has a built-in audiovisual alert to remind you when to take your prescribed medication — and tracks when you did — so you can have confidence you’re following your prescription. 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 AUSSeretide™ MDI 50/25, 125/25, 250/25 mcg Flixotide™ MDI 50, 125, 250 mcg CANAdvair™ HFA 125/25, 250/25 mcg Flovent™ HFA 50, 125, 250 mcg NLDSeretide™ MDI 50/50, 50/125, 50/250 mcg Flixotide™ MDI 50, 125, 250 mcg NZLSeretide™ MDI 50/25, 125/25, 250/25 mcg Flixotide™ MDI 50, 125, 250 mcg HKGSeretide™ MDI 50/25, 125/25, 250/25 mcg Flixotide™ MDI 50, 125, 250 mcg SGPSeretide™ Evohaler™ 50/25, 125/25, 250/25 mcg Flixotide™ Evohaler™ 50, 125, 250 mcg UKSeretide™ Evohaler™ 50/25, 125/25, 250/25 mcg Flixotide™ Evohaler™ 50, 125, 250 mcg USAAdvair™ HFA 45/21, 115/21, 230/21 mcg Flovent™ HFA 44, 110, 220 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. hai…
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EMC Technologies Pty Ltd, 176 Harrick Road, Keilor Park VIC 3042 Australia www.emctech.com.au To: Federal Communications Commission Attention: Certification Officer Date: October 24, 2022 EMC Ref: M2204009 Subject: FCC FILING – FCC ID: PN2-MDI1 (Original certification) Company: Adherium (NZ) Limited Adherium (NZ) limited is applying for original certification the Hailie for GSK pMDI – A small hand- held, battery-powered electronic module which an inhaler is inserted into. 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 • Antenna: Custom PCB trace. 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]
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: 12 October 2022 SUBJECT: FCC Application for (FCC ID: PN2-MDI1) 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 (2.67 x 1.43 x 1.6 in) and does not utilize electronic labeling. The FCC 15.19 compliance statement is be placed in the user manual. Regards, Tara M. Creaven-Capasso VP Quality, Regulatory and Clinical Affairs Adherium (NZ) Ltd.
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: Melbourne 18 October 2022 Confidentiality Request regarding application for certification of FCC ID: PN2-MDI1. 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 1 Schematics 2 Operational Description A1. Hailie for pMDI - Block Diagram.pdf A2. NA0147 - V2.0 - Schematic.pdf A3. NA0149 - V2.0 - SchematicFlex.pdf A4. Hailie for pMDI Operational Description.pdf 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 E2202-1514-5 (Appendix A).pdf E2202-1514-5 (Appendix B).pdf E2202-1514-5 (Appendix C).pdf A5. ND0532 V1 Hailie for pMDI Short Product Manual.pdf Sincerely, Tara M. Creaven-Capasso VP Quality, Regulatory and Clinical Affairs Adherium (NZ) Ltd.
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: 12 October 2022 SUBJECT: FCC Application for (FCC ID:PN2-MDI1) 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 & Clinical Affairs Adherium (NZ) Ltd.
Page 1 of 4 EMC ENGINEERS & LABORATORIES EMC Bayswater Pty Ltd 18/88 Merrindale Drive Croydon South, Victoria, 3136, Australia Telephone: +61 3 9761 5888 Facsimile: +61 3 8761 6547 Email: [email protected] ABN: 49 112 221 333 Photograph Annex A: External - EUT Photographs Adherium (NZ) Limited NF0107 Hailie for GSK pMDI REPORT: E2202-1514-5 Annex A DATE: April, 2022 EMC Bayswater Test Report E2202-1514-5 Annex A Page 2 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photographs Number Photograph Description 1 EUT – External views 2 3 4 5 6 7 EUT – View of sample with temporary DC power supply connection – Radiated method testing 8 Support Equipment – Inhaler EMC Bayswater Test Report E2202-1514-5 Annex A Page 3 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photograph 1 Photograph 2 Photograph 3 Photograph 4 Photograph 5 Photograph 6 EMC Bayswater Test Report E2202-1514-5 Annex A Page 4 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photograph 7 Photograph 8
Page 1 of 4 EMC ENGINEERS & LABORATORIES EMC Bayswater Pty Ltd 18/88 Merrindale Drive Croydon South, Victoria, 3136, Australia Telephone: +61 3 9761 5888 Facsimile: +61 3 8761 6547 Email: [email protected] ABN: 49 112 221 333 Photograph Annex B: Internal - EUT Photographs Adherium (NZ) Limited NF0107 Hailie for GSK pMDI REPORT: E2202-1514-5 Annex B DATE: April, 2022 EMC Bayswater Test Report E2202-1514-5 Annex B Page 2 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photographs Number Photograph Description 1 EUT – Internal views 2 3 4 5 6 7 8 EUT – View of the PCB trace antenna 9 EUT – View of the sample with DC external power supply connection. 10 EUT – View of the sample with temporary SMA antenna port connector and DC external power supply connection for Conducted method testing. EMC Bayswater Test Report E2202-1514-5 Annex B Page 3 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photograph 1 Photograph 2 Photograph 3 Photograph 4 Photograph 5 Photograph 6 EMC Bayswater Test Report E2202-1514-5 Annex B Page 4 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photograph 7 Photograph 8 Photograph 9 Photograph 10
Page 1 of 7 EMC ENGINEERS & LABORATORIES EMC Bayswater Pty Ltd 18/88 Merrindale Drive Croydon South, Victoria, 3136, Australia Telephone: +61 3 9761 5888 Facsimile: +61 3 8761 6547 Email: [email protected] ABN: 49 112 221 333 RF Radiation Exposure Evaluation In accordance with: CFR47 FCC Part 2, Subpart J, 2.1093 FCC KDB 447498 D01 v06 Adherium (NZ) Limited NF0107 Hailie for GSK pMDI FCC ID: PN2-MDI1 REPORT: E2202-1514-6 Rev1 DATE: November, 2022 EMC Bayswater Test Report E2202-1514-6 Rev1 Page 2 of 7 Prepared by: Approved by: 02/11/2022 17:17 Adnan Zaman (EMC Test Engineer) Neville Liyanapatabendige (Manager) Date This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. RF Radiation Exposure Evaluation Report EMC Bayswater Test Report: E2202-1514-6 Rev1 Issue Date: November, 2022 Product: Hailie for GSK pMDI Model No: NF0107 Serial No: Beta 03, Beta 29 FCC ID: PN2-MDI1 Client Details: Mr Igbal Syre Adherium (NZ) Limited Level 2, 63 Albert Street Auckland 1010 New Zealand Phone No: +64 9 307 2771 e-mail: [email protected] Standard(s): CFR47 FCC Part 2, Subpart J, 2.1093 Radiofrequency radiation exposure evaluation: portable devices. FCC KDB 447498 D01 v06 RF EXPOSURE PROCEDURES AND EQUIPMENT AUTHORIZATION POLICIES FOR MOBILE AND PORTABLE DEVICES Results Summary: RF Radiation exposure requirements Complied Test Date(s): 7 th March 2022 Test House (Issued By) EMC Bayswater Pty Ltd 18/88 Merrindale Drive Croydon South Victoria, 3136 Australia FCC Accredited Test Firm Registration number: 527798 FCC Accredited Test Firm Designation number: AU0004 Phone No: +61 3 9761 5888 Email: [email protected] Fax: +61 3 8761 6547 Web: www.emcbayswater.com.au The Adherium (NZ) Limited, NF0107, Hailie for GSK pMDI, measured EIRP is below the SAR exception threshold (5mm distance) and the calculated power density level at a distance of 20cm are below the maximum levels allowed by regulations therefore complied with the requirements of CFR47 FCC Part 2, Subpart J, 2.1093. This is to certify that the necessary evaluations were made by EMC Bayswater Pty Ltd, and that the Adherium (NZ) Limited, NF0107, Hailie for GSK pMDI, has been tested in accordance with requirements contained in the appropriate commission regulations. EMC Bayswater Test Report E2202-1514-6 Rev1 Page 3 of 7 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. RF Radiation Exposure Evaluation for Adherium (NZ) Limited Contents 1. Introduction ................................................................................................................... 4 2. Test Report Revision History ........................................................................................ 4 3. Report Information ........................................................................................................ 4 4. Product Details .............................................................................................................. 5 4.1. Product Sample Details ........................................................................................... 5 4.2. Product description .................................................................................................. 5 5. SAR and RF Exposure exception evaluation ............................................................... 6 5.1. SAR exception evaluation ........................................................................................ 6 5.2. RF Exposure Evaluation (MPE) ............................................................................... 7 6. Conclusion ..................................................................................................................... 7 EMC Bayswater Test Report E2202-1514-6 Rev1 Page 4 of 7 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. 1. Introduction RF Radiation Exposure evaluation was performed on a Adherium (NZ) Limited, NF0107, Hailie for GSK pMDI in accordance with CFR47 FCC Part 2, Subpart J, 2.1093. 2. Test Report Revision History ISSUE DATE Description AUTHORISED BY E2202-1514-6 2022-09-29 Original Neville Liyanapatabendige (Manager) E2202-1514-6 Rev1 2022-11-02 • Updated the customer’s address • Corrected the antenna gain as per customer request. RF exposure analysis was updated accordingly. Neville Liyanapatabendige (Manager) 3. Report Information EMC Bayswater Pty Ltd reports apply only to the specific samples tested under the stated test conditions. All samples tested were in good operating condition throughout the entire test program unless otherwise stated. EMC Bayswater Pty Ltd does not in any way guarantees the later performance of the product/equipment. It is the manufacturer's responsibility to ensure that additional production units of the tested model are manufactured with identical electrical and mechanical components. EMC Bayswater Pty Ltd shall have no liability for any deductions, inference or generalisations drawn by the clients or others from EMC Bayswater Pty Ltd issued reports. This report shall not be used to claim, constitute or imply product endorsement by EMC Bayswater Pty Ltd. This report shall not be reproduced except in full, without the written approval of EMC Bayswater Pty Ltd. This document may be altered or revised by EMC Bayswater Pty Ltd personnel only, and shall be noted in the revision section of the document. Any alteration of this document not carried out by EMC Bayswater Pty Ltd will nullify the document. EMC Bayswater Test Report E2202-1514-6 Rev1 Page 5 of 7 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. 4. Product Details 4.1. Product Sample Details The device, as supplied by the client, is described as follows: Product: Hailie for GSK pMDI Model No: NF0107 Variant: None Serial No: Beta 03, Beta 29 Firmware Version: GSK_PMDI_EMCRFTEST_V8.7.dev_B…
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Page 1 of 67 EMC Bayswater Pty Ltd EMC ENGINEERS & LABORATORIES 18/88 Merrindale Drive Croydon South, Victoria, 3136, Australia Telephone: +61 3 9761 5888 Facsimile: +61 3 8761 6547 Email: [email protected] ABN: 49 112 221 333 EMC COMPLIANCE REPORT Certification Test Report In accordance with: CFR47 FCC Part 15, Subpart C, 15.247 Adherium (NZ) Limited NF0107 Hailie for GSK pMDI FCC ID: PN2-MDI1 REPORT: E2202-1514-5 Rev 1 DATE: November, 2022 Accreditation Number: 18553 Accredited for compliance with ISO/IEC 17025 - Testing The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing and calibration reports. This document may not be reproduced except in full without approval from EMC Bayswater, with the exception of the certificate on page 2. EMC Bayswater Test Report E2202-1514-5 Rev 1 Page 2 of 67 Prepared by: Tested by: Approved by: 02/11/2022 16:53 Grishma Khadka (EMC Test Engineer) Adnan Zaman (EMC Test Engineer) Neville Liyanapatabendige (Manager) Date Accreditation number: 18553. The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration and inspection reports. This document may not be reproduced except in full without approval from EMC Bayswater, with the exception of the certificate on page 2. Certificate of Compliance Certification Compliance Report EMC Bayswater Test Report: E2202-1514-5 Rev 1 Issue Date: November, 2022 Test Sample(s): Hailie for GSK pMDI Model No: NF0107 Serial No: Beta 03, Beta 29 FCC ID: PN2-MDI1 Customer Details: Mr. Igbal Syre Adherium (NZ) Limited Level 2, 63 Albert Street Auckland 1010 New Zealand Phone No: +64 9 307 2771 e-mail: [email protected] Test Specification: CFR47 FCC Part 15, Subpart C, 15.247 Results Summary: 15.203 - Antenna requirement Complied 15.247 (a) (2) - 6dB Bandwidth Complied 15.247 (b)(3) – Maximum Output Power Complied 15.247 (d) - Out-of-Band Emissions - – 100kHz, -20dBc Complied 15.247 (d) - Emissions on the Band edge Complied 15.247 (d), 15.209 – Radiated emissions in Restricted bands Complied 15.247 (e) - Power Spectral Density Complied 15.247 (i) - Radio frequency hazard Complied Test Date(s): 22 nd February to 7 th March 2022 Test House (Issued By) EMC Bayswater Pty Ltd 18/88 Merrindale Drive Croydon South Victoria 3136 Australia FCC Accredited Test Firm Registration number: 527798 FCC Accredited Test Firm Designation number: AU0004 Phone No: +61 3 9761 5888 e-mail: [email protected] Fax No: +61 3 8761 6547 Web: www.emcbayswater.com.au/ This is to certify that the necessary measurements were made by EMC Bayswater Pty Ltd, and that the Adherium (NZ) Limited, NF0107, Hailie for GSK pMDI, has been tested in accordance with requirements contained in the appropriate commission regulations. EMC Bayswater Test Report E2202-1514-5 Rev 1 Page 3 of 67 Accreditation number: 18553. The results of the tests, calibrations and/or measurements included in this document are traceable to Australian/national standards. NATA is a signatory to the ILAC Mutual Recognition Arrangement for the mutual recognition of the equivalence of testing, calibration and inspection reports. This document may not be reproduced except in full without approval from EMC Bayswater, with the exception of the certificate on page 2. EMC Compliance Report for Adherium (NZ) Limited Contents 1. Introduction ................................................................................................................... 5 2. Test Report Revision History ........................................................................................ 5 3. Report Information ........................................................................................................ 5 4. Summary of Results ...................................................................................................... 5 5. Product Sample Details ................................................................................................. 6 5.1. EUT Description........................................................................................................ 6 5.2. Product description ................................................................................................... 6 5.3. Support Equipment ................................................................................................... 7 5.4. Product operating modes .......................................................................................... 7 5.5. Product operating mode for testing ........................................................................... 7 5.6. Configuration ............................................................................................................ 7 5.7. Modifications ............................................................................................................. 8 6. Test Facility & Equipment ............................................................................................. 8 6.1. Test Facility .............................................................................................................. 8 6.2. Test Equipment ........................................................................................................ 8 7. Referenced Standards ................................................................................................... 9 8. Referenced Documents ................................................................................................. 9 9. Antenna Requirement – FCC Part 15.203 ....................................................................10 9.1. Requirements ..................................…
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NF0107 Hailie™ for GSK pMDI Sensors FCC ID: PN2-MDI1 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 bandwidth using GFSK modulation. An omnidirectional antenna is implemented in copper as part of the flexible printed circuit board and is used for both transmit and receive. Total PCB Antenna Length = 1.56 + 16.756 + 0.999 + 13.807 = 33.1 mm Antenna Style = Folded Monopole Antenna Type = Omni-directional NF0107 Hailie™ for GSK pMDI Sensors FCC ID: PN2-MDI1 Copyright © Adherium (NZ) Ltd 2020 EMC – Antenna RF Test Results Product Test Result NF0107 NF0107 Conducted power after matching network -7.9dBm NF0107 NF0107 Radiated Power (EIRP) -17.1dBm Antenna Gain Antenna Gain = Radiated Power – Conducted Power (−17.1 dBm) − (−7.9 dBm) = −9.2 dBi Gain
Page 1 of 4 EMC ENGINEERS & LABORATORIES EMC Bayswater Pty Ltd 18/88 Merrindale Drive Croydon South, Victoria, 3136, Australia Telephone: +61 3 9761 5888 Facsimile: +61 3 8761 6547 Email: [email protected] ABN: 49 112 221 333 Photograph Annex C: Test Configuration Photographs Adherium (NZ) Limited NF0107 Hailie for GSK pMDI REPORT: E2202-1514-5 Annex C DATE: April, 2022 EMC Bayswater Test Report E2202-1514-5 Annex C Page 2 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photographs Number Photograph Description 1 Radiated measurements – EUT X Orientation 2 Radiated measurements – EUT Y Orientation 3 Radiated measurements – EUT Z Orientation 4 Radiated measurements – 9kHz to 30MHz – X Antenna orientation 5 Radiated measurements – 9kHz to 30MHz – Y Antenna orientation 6 Radiated measurements – 9kHz to 30MHz – Z Antenna orientation 7 Radiated measurements – below 1GHz 8 Radiated measurements – above 1GHz 9 Conducted measurements EMC Bayswater Test Report E2202-1514-5 Annex C Page 3 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photograph 1 Photograph 2 Photograph 3 Photograph 4 Photograph 5 Photograph 6 EMC Bayswater Test Report E2202-1514-5 Annex C Page 4 of 4 This document may not be reproduced, except in full, without written approval from EMC Bayswater Pty Ltd. Photograph 7 Photograph 8 Photograph 9
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 100.00 µW |

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.
Equipment Class
DTS - Digital Transmission System
Hallie Sensor (for Breztri Aerosphere) is a device to log medication use of a metered dose inhaler
Equipment Class
DTS - Digital Transmission System
Data logger for inhaled medication
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter