adherium Teva Albuterol Sulfate HFA User Manual

adherium 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.

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 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

1. To install the inhaler, hold the Hailie® sensor in an upright position with the Door Slide open.

2. Push the inhaler from the bottom, goes under the Door of the Hailie® sensor.

3. Press the inhaler into the Hailie® sensor.

4. Slide the Door down so it clicks into place. The Hailie® sensor is ready to use.

The Hailie® sensor will not monitor inhaler use for 5 seconds after the inhaler is installed into the sensor.

Removal
To ensure medication usage is detected, wait for 3 seconds after medication usage before removing the Hailie® sensor.

1.  To remove the inhaler hold the Hailie® sensor in an upright position.
2. Open the Slide Door of the Hailie® sensor by sliding the Door upwards.
3. Pull the inhaler down under the Door to remove it from the Hailie® sensor.
4. Slide the Door down so it clicks into place.

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. To use the Hailie® sensor, hold the Hailie® sensor in one hand with the thumb under the base of the Hailie® sensor and the index finger and second finger on top of the medication canister The Hailie® sensor LED flashes green or orange (to indicate battery level) 3 seconds after detecting the medication usage. 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. To use the Hailie® sensor with a spacer, hold the Hailie® sensor in one hand with the thumb at the base of the Hailie® sensor and the index finger and second finger on top of the medication canister. Use the other hand to support the spacer chamber. If necessary, you may require assistance from another person to hold the spacer chamber for you.

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 travelling 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.

1. Hold down the Status Button until the LED shows white, then release.
2. 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.

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.
No Flash| The battery is depleted, or the Hailie® sensor has failed, e.g. due to liquid immersion or mechanical stress.

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 labelling 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.

EU only: Any serious incident that has occurred in relation to the Hailie® Sensor should be reported to Adenium 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 return or disposal of the Hailie® sensor contact the supplier.

Warranty

The Hailie® sensor includes a 12 month warranty against manufacturing defects from 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 date of manufacture.

Specifications

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.

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 Cells, 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 vapour pressure £ 50 hPa

Symbols

Product Use

| Read manual before use
|

Keep dry

| Non-rechargeable Sensor
|

Temperature limit

|

Humidity limitation

Product Details

| Manufacturer: Achenium (NZ) Limited
|

Serial Number

REF

| ****

Part Number

---|---

#

| ****

Model Number

| ****

Date of Manufacture

| ****

Country of Manufacture

Regulatory Compliance

| AU only: Regulatory compliance mark

| EU only: European conformity mark
|

EU only: Medical Device

****| EU only: Do not dispose Hailie® sensor as unsorted municipal waste

R-NZ

| NZ only: Regulatory compliance mark

UK
CA

| 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

---|---
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

---|---
| 9 V/m: 710, 745,
| 780, 5240, 5500,
Proximity fields| 5785 MHz
from RF wireless

communications

| 27 V/m: 385 MHz
equipment IEC 61000-4-3| 28 V/m: 450, 810,

870, 930, 1720,

| 1845, 1970, 2450
| MHz
Power frequency magnetic fields IEC 61000-4-8|

30 A/m

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

1. This device may not cause harmful interference, and
2. 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. Adenium (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 Netherlands
UK Responsible Person
Emergo Consulting (UK) Limited c/o Cr360 – UL International Compass House, Vision Park Histon Cambridge CB24 9BZ
United Kingdom

Australian Sponsor
Adherium Limited
Collins Square | Tower Four
Level 18, 727 Collins Street Melbourne VIC 3008
Australia Hailie® sensor is manufactured by:
Adherium (NZ) Ltd
63 Albert Street
Auckland 1010
New Zealand
support@hailie.com
www.hailie.com

Hailie® Sensor Product Manual
Part Number : ND0541
Version : 1
Issue Date : 1 July 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 trade mark information, including third-party trademarks, refer to www.adherium.com/ip.
ProAir is a trademark of Teva Respiratory, LLC.
© 2022 Adherium (NZ) Limited. All rights reserved.

References

• The Hailie™ Solution Helps Patients Track Their Inhaler Usage
• Adherium - Adherium
• Adherium - IP
• The Hailie™ Solution Helps Patients Track Their Inhaler Usage
• The Hailie™ Solution Helps Patients Track Their Inhaler Usage

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>