Advair™ Diskus™ and Flovent™ Diskus
For use only with
™
Product Manual
For customer support, go to support.hailie.com
This Product Manual will help you
to get the most out of your Hailie™
sensor. Please read the manual
before using the sensor.
Table of Contents
Safety Statement 5
q
1.1 Hailie™ Sensor Intended Use 5
1.2 Important User Information 6
1.3 Warnings and Precautions 6
Hailie™ Sensor Overview 8
w
2.1 What is the Hailie™ Sensor? 8
2.2 Hailie™ Sensor Components 8
2.3 Compatible Inhalers 9
Setting up the Hailie™ Sensor 10
e
3.1 Preparation for First Use 10
3.2 Installing and Removing an Inhaler 10
3.3 Setting up Bluetooth® Communications 12
Using the Hailie™ Sensor 13
r
4.1 Delivering a Dose of Medication 13
4.2 Medication Reminders 14
4.3 Reviewing Inhaler Usage Data 15
4.4 Manually Uploading Stored Information 15
4.5 Reviewing the Battery Level 16
4.6 Recharging the Hailie™ Sensor 16
Maintenance 17
t
5.1 Cleaning the Hailie™ Sensor and Inhaler 17
5.2 Storage 17
Troubleshooting 18
y
Customer Support and Servicing 18
u
7.1 Customer Support 18
7.2 Servicing 19
Disposal 19
i
Warranty 19
o
Technical Information and Symbols 20
a
10.1 Specications 20
10.2 Symbols 21
Regulatory Statements 22
s
11.1 Electromagnetic Compatibility 22
11.2 FCC Statement 23
11.3 Declaration of Conformity 23
4
q Safety Statement
1.1. Hailie™ Sensor Intended Use
The Hailie™ sensor is intended for single patient use in
the home environment as a medication reminder and
electronic data capture accessory for recording usage
of prescribed Inhaler medication. This may be used in
the following applications:
• In clinical trials, where researchers need to know when
a patient has used their trial Inhaler medication.
• In clinical practice, where specialists, general
practitioners, nurses, and educators need to know if a
patient has used their prescribed Inhaler medication.
• In self-management, where patients need to track
their medication use as part of their management plan.
The Hailie™ sensor is compatible only with the
Advair™ Diskus™ and Flovent™ Diskus™ Inhalers.
The Hailie™ sensor is not intended to indicate remaining
quantity of medication in an Inhaler and does not
include a dose counting function.
5
1.2 Important User Information
Warnings identify actions or situations that could
lead to personal injury. Take note of all warnings
before using the Hailie
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.
™
sensor.
1.3 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.
US only: Important instructions for use of the Inhaler
are printed on each side of the Inhaler. The labels
are covered when the Hailie™ sensor is installed. The
labels can be checked at any time by removing the
Hailie™ sensor from the Inhaler, and replacing it after
the labels are checked. Follow the steps in Installing
and Removing an Inhaler.
US only: Read the labels on both sides of the Inhaler
before installing into the Hailie™ sensor.
6
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.
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.
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.
Setup and use of the Hailie™ sensor for patients
under 12 years of age requires assistance from a
parent or caregiver.
To ensure accuracy of Inhaler usage records, only
open the Inhaler when you take your medication,
and always close it again afterwards.
The Hailie™ sensor is a battery-powered electronic
device. Do not immerse the Hailie™ sensor in water. Do
not use the Hailie™ sensor if it is not in good condition.
Take care to not spill liquids on the Hailie™ sensor
or immerse it in water. 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.
7
w Hailie
™
Sensor Overview
2.1 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 audio-visual alert to
remind you when to take your prescribed medication
— and tracks when you did — so you can have
condence you're following your prescription.
2.2 Hailie™ Sensor Components
Front View
8
Back View
Key
1. Reminder Button and Reminder LED
2. Pair Button and Pair LED
3. Battery Button and Battery LED
4. USB Port
5. Clips
6. Serial Number Label
2.3 Compatible Inhalers
The Hailie™ sensor is designed to work only with the Inhaler
and medication indicated on the Hailie™ sensor label.
The compatible Inhalers are:
• GSK Advair™ Diskus™ (100/50, 250/50, 500/50 mcg)
• GSK Flovent™ Diskus™ (50, 100, 250 mcg)
The Hailie™ sensor intended population is identical to
the intended population of the compatible Inhaler.
9
e Setting up the
Hailie™ Sensor
3.1 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. To check if
the Hailie™ sensor is still in Deep-Sleep mode, press
the Pair Button once. The Pair LED will ash white if it
is still in Deep-Sleep.
Before rst use, place the Hailie™ sensor on charge for
up to 8 hours or until the Battery LED stops ashing
green. This will wake the Hailie™ sensor from DeepSleep mode.
When recharging is completed, disconnect the Hailie™
sensor from the power supply. Press the Battery
Button once to check the battery level. The Battery
LED should ash green prior to rst use.
3.2 Installing and Removing an Inhaler
Installation
US Only - Read the
labels on both sides
of the Inhaler before
installing into the
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Hailie™ sensor.
To install the Inhaler hold
the Hailie™ sensor in an
upright position.
Open the Hailie™ sensor
by pushing the clips and
opening the side latches.
Place the Inhaler into
the Hailie™ sensor with
the Inhaler dose counter
facing upwards.
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Close the Hailie™ sensor,
ensuring the clips snap
shut on both sides.
Removal
1. To remove the Inhaler hold the Hailie™ sensor in an
upright position.
2. Open the Hailie™ sensor by pushing the clips and
opening the side latches.
3. Pull the Inhaler to remove it from the Hailie™ sensor.
4. Close the door so it clicks into place.
3.3 Setting Up Bluetooth® Communications
The Hailie™ sensor must be paired with a compatible
Bluetooth® phone or tablet computer 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.
12
The Hailie™ sensor
is ready to pair with
a compatible mobile
app. Follow the
instructions below in
Setting Up Bluetooth®
Communications.
1. Ensure Bluetooth® is enabled on your phone or
tablet computer.
2. Open the compatible mobile app and follow the
prompts to complete the pairing process.
3. On the Hailie™ sensor, hold down the Pair Button
for 1 second to enter pairing mode. The Pair LED
will ash blue when the Hailie™ sensor is in
pairing mode.
4. The Pair LED will ash green to indicate successful
pairing.
If pairing is not successful within 60 seconds the
Pair LED will ash red. The pairing process can be
repeated if necessary.
The Hailie™ sensor can only be paired with a single
phone or tablet computer at one time. Successful
pairing with a new phone or tablet computer will
remove the current pairing. If pairing on the new
phone or tablet computer fails, the existing pairing
will be retained.
r Using the Hailie
™
Sensor
4.1 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 logs Inhaler usage by monitoring
when the Inhaler is opened and closed.
To ensure accuracy of Inhaler usage records, only
open the Inhaler when you take your medication,
and always close it again afterwards.
13
The Hailie™ sensor Battery LED ashes green, orange,
or red (to indicate battery level) 3 seconds after
detecting medication usage and the Inhaler is closed.
If the Battery LED ashes red or if there is no ash,
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.
4.2 Medication Reminders
Audio-visual reminders may be available to 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 cancelled. The Reminder LED ashes green
and the Hailie™ sensor emits a beeping sound when
the reminder alert is triggered.
To cancel the reminder, hold down the Reminder
Button until you hear a beeping sound and the
Reminder LED ashes red.
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4.3 Reviewing Inhaler Usage Data
The Inhaler usage history can be automatically uploaded
via a compatible paired phone or tablet computer.
The upload of new information will occur automatically
as long as the Hailie™ sensor is within range (10 meters
or 32 feet) of the phone or tablet computer with
Bluetooth® enabled.
When travelling ensure your phone or tablet
computer is set to the local time zone for accuracy
of Inhaler usage data.
4.4 Manually Uploading Stored Information
The Hailie™ sensor can manually upload data to a
paired Bluetooth® phone or tablet computer.
1. Hold down the Pair Button for 3 seconds until the
Pair LED shows white, then release.
2. The Pair LED will ash white while the Hailie™
sensor attempts to upload, then ash green if the
upload is successful.
The Hailie™ sensor Pair LED will ash red if the
upload is not successful. Check the Hailie™ sensor is
within range of the paired phone or tablet computer,
and ensure Bluetooth® communications are enabled.
15
4.5 Reviewing the Battery Level
The Battery LED on the Hailie™ sensor indicates the
battery level after detecting medication usage, or when
the Battery Button is pressed once.
LED Colour Battery Status
Green
Orange
Red
No Flash
4.6 Recharging the Hailie™ Sensor
The Hailie™ sensor contains a rechargeable battery that
is recharged via the USB Port. To recharge the Hailie™
sensor, connect it to a computer USB port or USB wall
plug adaptor, using the supplied USB cable or a microUSB cable less than 3 metres (9ft 10in) in length.
When connected to a charging source, the Battery
LED will ash slowly in a colour according to the
battery level. When charging is complete, the Battery
LED will turn off. The Hailie™ sensor should not be
used while charging.
Allow up to 8 hours to fully recharge a Hailie™ sensor
that is displaying a red ashing Battery LED. Charging
times will signicantly increase in temperatures below
10°C (50°F).
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The battery level is good. The Hailie
sensor is monitoring Inhaler usage.
The battery level is getting low. The
Hailie™ sensor is still monitoring
Inhaler usage.
The battery is depleted. The Hailie™
sensor has stopped monitoring
Inhaler usage.
The battery is depleted, or the Hailie™
sensor has failed, e.g. due to liquid
immersion or mechanical stress.
™
The Hailie™ sensor should be recharged every 4 months
as a minimum to ensure continued battery function.
t Maintenance
5.1 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. Do not immerse the Hailie™
sensor 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.
5.2 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.
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y 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 phone or tablet
computer.
Other wireless communications equipment such
as wireless home network devices, mobile phones,
cordless telephones and their base stations, walkietalkies, 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 Customer Support for
further assistance.
u Customer Support
and Servicing
7.1 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.
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7.2 Servicing
Contact Customer Support for Hailie™ sensor servicing.
Do not attempt to open or service the Hailie™ sensor.
Tampering with the Hailie™ sensor voids the warranty.
i Disposal
Dispose of or recycle the Hailie™ sensor in accordance
with regulations for your country, as applicable for
electronic devices containing a lithium polymer 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 Customer Support.
o Warranty
The Hailie™ sensor includes a 24 month warranty
against manufacturing defects from date of rst 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.
19
a Technical Information
and Symbols
10.1 Specications
Model Number
Usage Log
Precision
Usage Log
Capacity
Internal Clock
Accuracy
Compatible
with
Wireless
Communication
Battery Type
Shelf Life
Service Life
Operating
Temperature
20
NF0100
1 second
5120 usage logs and sensor
status records
± 1 hour after 12 months
Note: the Hailie™ sensor clock
is updated every time data is
uploaded to a compatible
mobile app.
iOS or Android phones and tablet
computers. Go to
support.hailie.com for more
information.
Bluetooth® 4.0: 2.40 - 2.48 GHz,
2.5 mW Low Energy
Lithium Polymer 400mAh,
Rechargeable
2 years
2 years
0 to 40ºC (32 to 104ºF)
Storage
Temperature
Operating /
Storage
Humidity
-20 to 60ºC (-4 to 140ºF)
15 to 90% RH (non-condensing)
at water vapour pressure ≤ 50 hPa
10.2 Symbols
Manufacturer: Adherium (NZ) Ltd
Serial Number
Part Number
Year of Manufacture
Keep dry
Rechargeable Sensor
EU only: Do not dispose Hailie™ sensor as
unsorted municipal waste
EU only: European conformity mark
AU only: Regulatory compliance mark
NZ only: Regulatory compliance mark
Temperature limit
Humidity limitation
21
s Regulatory Statements
11.1 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
Conducted and Radiated
EMICISPR 11
Electrostatic Discharge
IEC 61000-4-2
Radiated RF EM Fields
IEC 61000-4-3
Proximity elds from RF
wireless communications
equipment
IEC 61000-4-3
Power frequency
magnetic elds
IEC 61000-4-8
Voltage dips and
Interruptions
IEC 61000-4-11
22
Compliance Level
Group 1 Class B
± 8 kV contact,
± 2/4/8/15 kV air
10 V/m: 80 - 2700 MHz
9 V/m: 710, 745, 780,
5240, 5500, 5785 MHz
27 V/m: 385 MHz
28 V/m: 450, 810,
870, 930, 1720, 1845,
1970, 2450 MHz
30 A/m
0 % UT : 0.5 cycle
0 % UT : 1 cycle
70 % UT : 25/30
cycles
0 % UT : 250/300
cycles
11.2 FCC Statement
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 dened 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
modications not expressly approved by the party
responsible for compliance. Such modications could
void the user’s authority to operate the equipment.
11.3 Declaration of Conformity
Adherium (NZ) Ltd declares that this Hailie™ sensor
is in compliance with the essential requirements and
other relevant provisions of Directive 93/42/EEC.
Email contact@hailie.com for a copy of the declaration
of conformity.
Hereby, Adherium (NZ) Ltd declares that the radio
equipment type Hailie™ sensor is in compliance
with Directive 2014/53/EU. The full text of the EU
declaration of conformity is available at:
www.hailie.com/RDC
23
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 specications may change without notice.
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
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
Level 2, 204 Quay Street
Auckland 1010
New Zealand
contact@hailie.com
Hailie™ Sensor Product Manual
Part Number: ND0014
Version: 4
Issue Date: 04 Sep 2018
© 2018 Adherium (NZ) Ltd. All rights reserved.
24
For patent and trade mark information, including thirdparty trademarks, refer to www.adherium.com/ip.
Advair, Diskus, and Flovent are trademarks of Glaxo
Group Limited.
25
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.
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