hailie NF0100 Manuel utilisateur
For use only with
Advair™Diskus™ and Flovent™Diskus™
For customer support, go to support.hailie.com
Product Manual
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
qSafety Statement 5
1.1 Hailie™Sensor Intended Use 5
1.2 Important User Information 6
1.3 Warnings and Precautions 6
wHailie™Sensor Overview 8
2.1 What is the Hailie™Sensor? 8
2.2 Hailie™Sensor Components 8
2.3 Compatible Inhalers 9
eSetting up the Hailie™Sensor 10
3.1 Preparation for First Use 10
3.2 Installing and Removing an Inhaler 10
3.3 Setting up Bluetooth®Communications 12
rUsing the Hailie™Sensor 13
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
4
tMaintenance 17
5.1 Cleaning the Hailie™Sensor and Inhaler 17
5.2 Storage 17
yTroubleshooting 18
uCustomer Support and Servicing 18
7.1 Customer Support 18
7.2 Servicing 19
iDisposal 19
oWarranty 19
aTechnical Information and Symbols 20
10.1 Specications 20
10.2 Symbols 21
sRegulatory Statements 22
11.1 Electromagnetic Compatibility 22
11.2 FCC Statement 23
11.3 Declaration of Conformity 23
5
qSafety 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.
6
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™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.
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.
7
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.
8
wHailie™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
9
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.
10
eSetting 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 Deep-
Sleep 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
Hailie™sensor.
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