Adherium LPT1 Ellipta DPI Device Instruction Manual

: June 4, 2024
: Adherium

Adherium LPT1 Ellipta DPI Device

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 actions and other parameters, including inspiratory flow, of 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 GSK Breo™/ Relvar™ Ellipta™, GSK Trelegy™ Ellipta™, GSK Incruse™ Ellipta™, GSK Anoro™ Ellipta™, and GSK Arnuity™ Ellipta™ inhalers.

The Hailie® sensor is not intended to indicate the 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 and in this manual.
Refer to the labeling 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 labeled 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.
To ensure the accuracy of inhaler usage records, use the inhaler within 5 minutes of opening the Ellipta™ Cover, and always close it again afterward.
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.

What is the Hailie® Sensor?

A 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 which may be used by your doctor to help assess your inhaler usage.

Hailie® Sensor Components

Key

Ellipta™ Cover
Sensor Arms
Eject Button
Status Button/Light Emitting Diode (LED)

Compatible Inhalers

The Hailie® sensor is designed to work only with the Inhaler type indicated on the Hailie® sensor label.

The compatible Inhalers are

GSK Breo™/Relvar™ Ellipta™ (to treat COPD or Asthma indications)
GSK Trelegy™ Ellipta™ (to treat COPD or Asthma indications)
GSK Incruse™ Ellipta™ (to treat COPD indication only)
GSK Anoro™ Ellipta™ (to treat COPD indication only)
GSK Arnuity™ Ellipta™ (to treat Asthma indication only)

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’s 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 require 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.

Open the compatible mobile app and follow the prompts to complete the pairing process.
Wake up the Hailie® sensor by pressing the Status Button.
The Hailie® sensor will wake up and the LED will flash green.
After 5 seconds the Hailie® sensor will automatically enter Bluetooth® pairing mode and the LED will flash blue for 60 seconds.
Follow the prompts to complete the pairing process.
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 current pairing. If pairing on the new mobile device fails, the existing pairing will be retained.
The Hailie® sensor will re-enter Deep-Sleep mode within 24 hours if no activity occurs.

Installing and Removing an Inhaler

Installation

To install the inhaler, hold the Hailie® sensor in an upright position.
Place the Ellipta™ into the Hailie® sensor.
Gently push and slide the Ellipta™ down until it clicks into position.
The Hailie® sensor is ready to use.

Removal

To remove the inhaler hold the Hailie® sensor facing you in an upright position.
Hold the Sensor Arms and push the Eject Button to release the Ellipta™ from the Hailie® sensor.
Once released, pull the Ellipta™ away to remove it from the Hailie® sensor.
The Hailie® sensor has been successfully removed.

Delivering a Dose of Medication

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 records inhaler usage when the Ellipta™ Cover is opened and closed, as well as by monitoring the flow generated by inhaling the medication.
To ensure accuracy of inhaler usage records, use the inhaler within 5 minutes of opening the Ellipta™ Cover, and always close it again afterward.
The Hailie® sensor LED flashes green, orange or red (to indicate battery level) 3 seconds after detecting the medication usage.
If the LED flashes red or if there is no flash, the Hailie® sensor is not monitoring usage. Check the battery level according to Reviewing the Battery Level.

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 detect or record the quantity of medication delivered by the Inhaler.

Medication Reminders

Audiovisual reminders may be set up from a compatible mobile app. If enabled, the medication reminders are generated on the Hailie® sensor with increasing frequency for up to 24 minutes, until either the prescribed medication dose is taken or the reminder is canceled. The LED flashes green and the Hailie® sensor emits a beeping sound when the reminder alert is triggered. To cancel the reminder, hold down the Status Button until you hear a beeping sound and the LED flashes red.

Reviewing Inhaler Usage Data

The Inhaler usage history can be automatically uploaded via a compatible paired mobile device. The upload of new information will occur automatically as long as the Hailie® sensor is within range (10 meters or 32 feet) of the mobile device with Bluetooth® enabled. When traveling ensure your mobile device is set to the local time zone for accuracy of Inhaler usage logs.

Manually Uploading Stored Information

The Hailie® sensor can manually upload data to a paired Bluetooth® mobile device.

If an inhaler is installed, ensure the Ellipta™ Cover is in the closed position.
Hold down the Status Button until the LED shows white, then release.
The LED will flash white while the Hailie® sensor attempts to upload, then flash green if the upload is successful.

The Hailie® sensor LED will flash red if the upload is not successful. Check the Hailie® sensor is within range of the paired mobile device and ensure that Bluetooth® communications are enabled.

Reviewing the Battery Level

The LED on the Hailie® sensor indicates the battery level after detecting medication usage, or when the Status Button is pressed once.

LED Colour	Battery Status
Green	The battery level is good. The Hailie® sensor is monitoring

inhaler usage.
Orange| The battery level is low. The Hailie® sensor is still monitoring inhaler usage.
Red| The battery is depleted. The Hailie® sensor has stopped monitoring inhaler usage.
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No Flash| The battery is depleted, or the Hailie® sensor has failed, e.g. due to liquid immersion or mechanical stress.

The battery is not rechargeable. Once depleted, a new Hailie® sensor will be required.

Cleaning the Hailie® Sensor and Inhaler

Check the instructions from the Inhaler manufacturer for keeping the inhaler and mouthpiece clean.

Remove the Hailie® sensor from the inhaler before cleaning the inhaler.

Keep the Hailie® sensor clean and free of chemicals, steam, water and dust. Clean the outside plastic enclosure with a lightly dampened cloth. Check the Hailie® sensor is clean and repeat if necessary. Leave it to dry in a warm place that is less than 30°C (86°F). 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.

The cleaning method is intended to support single-patient use. If the sensor is contaminated by another individual, it is recommended that the Hailie® sensor be discarded and replaced with a new sensor.

Storage

To help maintain battery capacity, store your Hailie® sensor below 30°C (86°F). Keep out of direct sunlight and avoid extreme temperatures. The inhaler medication has its own storage recommendations. Refer to the labeling provided with the inhaler medication.

Troubleshooting

If the Hailie® sensor is not responding to Bluetooth® communications, check the Hailie® sensor battery level as per Reviewing the Battery Level in this manual. Ensure Bluetooth® is enabled in your mobile device. Other wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones, and their base stations, walkie-talkies, and equipment such as contactless payment or anti-theft systems, can affect the Hailie® sensor and should be kept at least 30cm (12in) away.

Increase the separation distance between the Hailie® sensor and any such devices if this could be causing problems. If this does not help, contact the supplier or manufacturer for further assistance.

Customer Support

For support on this product, go to support.hailie.com

For information about your medical condition or your medication, contact your healthcare provider.

EU only: Any serious incident that has occurred in relation to the Hailie® Sensor should be reported to Adherium and the health authority of the EU Member State where it occurred.

A copy of this product manual is available on www.hailie.com/collections /hailie-sensors

Servicing

Contact the supplier or manufacturer for Hailie® sensor servicing. Do not attempt to open or service the Hailie® sensor. Tampering with the Hailie® sensor voids the warranty.

Disposal

Dispose of or recycle the Hailie® sensor in accordance with regulations for your country, as applicable for electronic devices containing a lithium coin cell battery. Ensure that the inhaler is removed from the Hailie® sensor prior to disposal.

EU only: Do not dispose of the Hailie® sensor as unsorted municipal waste. The Hailie® sensor must be recycled in accordance with Directives 2012/19/EU and 2006/66/ EC. To arrange for the return or disposal of the Hailie® sensor contact the supplier.

Warranty

The Hailie® sensor includes a 12-month warranty against manufacturing defects from the date of first use. This warranty may be voided under the following circumstances: damage to the Hailie® sensor including dropping, water damage resulting from condensation or immersion, tampering, attempts to service, or other forms of abuse. The Hailie® sensor warranty expires 4 years from the date of manufacture.

Specifications

Model number	NF0106
Usage Log Precision	1 second

Usage Log Capacity

| 5120 usage logs and sensor status records

Internal Clock Accuracy

| ± 1 hour after 12 months

Note: the Hailie® sensor clock is updated every time data is

uploaded to a compatible mobile app.

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Compatible with

| iOS or Android mobile devices. Go to support.hailie.com for more information.

Wireless Technology

| Bluetooth ® 4.0: 2.40 – 2.48 GHz,

1.0 mW Low Energy

Battery Type

| Lithium Coin Cell, Non-Rechargeable
Shelf Life| 3 years
Service Life| 1 year
Operating Temperature|

0 to 40ºC (32 to 104ºF)

Storage Temperature| -20 to 60ºC (-4 to 140ºF)
Operating /Storage Humidity| 15 to 90% RH (non-condensing) at water vapor pressure £ 50 hPa

Symbols

Product Use

Read manual before use

|

Keep dry

|

Non-rechargeable Sensor

|

Temperature limit

|

Humidity limitation

|

Product Details

| Manufacturer: Adherium (NZ) Limited
|

Serial Number

|

Part Number

|

Model Number

|

Date of Manufacture

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|

Country of Manufacture

Regulatory Compliance

|

AU only: Regulatory compliance mark

CE

|

EU only: European conformity mark

MD|

EU only: Medical Device

| EU only: Do not dispose Hailie® sensor as unsorted municipal waste
| NZ only: Regulatory compliance mark
|

UK only: UK conformity mark

Electromagnetic Compatibility

The Hailie® sensor does not perform any clinical function where loss or degradation would result in unacceptable risk.

Emissions / Immunity Test and Standard|

Compliance Level

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Radiated EMI CISPR 11|

Group 1 Class B

Electrostatic Discharge IEC 61000-4-2| ± 8 kV contact,

± 2/4/8/15 kV air

Radiated RF EM Fields IEC 61000-4-3|

10 V/m: 80 – 2700 MHz

30 A/m

FCC Statement (US)

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired operation.

“Harmful interference” is defined by FCC as any emission, radiation or induction that endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with FCC rules.

The Grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the user’s authority to operate the equipment.

Declaration of Conformity (EU)

Adherium (NZ) Ltd declares that this Hailie® sensor is in compliance with the General Safety & Performance Requirements and other relevant provisions of Regulation EU 2017/745.

Adherium (NZ) Ltd declares that the radio equipment type Hailie® sensor is in compliance with Directive 2014/53/EU.

EU Declarations of Conformity are available at: www.adherium.com/EUDoC

EU 2017/745, 2014/53/EU, 2011/65/EU

Contact Information

Emergo Europe

Prinsessegracht 20 2514 AP The Hague, The Netherland

UK Responsible Person

Emergo Consulting (UK) Limited
ADDRESS: c/o Cr360 – UL International Compass House, Vision Park Histon Cambridge CB24 9BZ United Kingdom

Australian Sponsor

Adherium Limited Collins Square
ADDRESS: Tower Four Level 18, 727 Collins Street Melbourne VIC 3008 Australia

Hailie® sensor is manufactured by

Adherium (NZ) Ltd
ADDRESS: 16 Kingston Street Auckland 1010 New Zealand
support@hailie.com
www.hailie.com

Hailie® Sensor Product Manual

Part Number: ND0537
Version: 1
Issue Date: 12 January 2022

No part of this document may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of Adherium (NZ) Ltd. Product specifications may change without notice.

For patent and trademark information, including third-party trademarks, refer to www.adherium.com/ip

Breo™, Relvar™, Trelegy™, Incruse™, Anoro™, Arnuity™, and Ellipta™ are trademarks of Glaxo Group Limited.