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 Statement5
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1.1 Hailie™ Sensor Intended Use5
1.2 Important User Information6
1.3 Warnings and Precautions6
Hailie™ Sensor Overview8
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2.1 What is the Hailie™ Sensor?8
2.2 Hailie™ Sensor Components8
2.3 Compatible Inhalers9
Setting up the Hailie™ Sensor10
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3.1 Preparation for First Use10
3.2 Installing and Removing an Inhaler10
3.3 Setting up Bluetooth® Communications12
Using the Hailie™ Sensor13
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4.1 Delivering a Dose of Medication13
4.2 Medication Reminders14
4.3 Reviewing Inhaler Usage Data15
4.4 Manually Uploading Stored Information15
4.5 Reviewing the Battery Level16
4.6 Recharging the Hailie™ Sensor16
Maintenance17
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5.1 Cleaning the Hailie™ Sensor and Inhaler17
5.2 Storage17
Troubleshooting18
y
Customer Support and Servicing18
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7.1 Customer Support18
7.2 Servicing19
Disposal19
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Warranty19
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Technical Information and Symbols20
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10.1 Specications20
10.2 Symbols21
Regulatory Statements22
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11.1 Electromagnetic Compatibility22
11.2 FCC Statement23
11.3 Declaration of Conformity23
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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.
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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.
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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
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