hailie NF0101 User manual

Product Manual
For use only with HandiHaler™
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
qSafety Statement 5
1.1 Hailie™Sensor Intended Use 5
1.2 Important User Information 5
1.3 Warnings and Precautions 6
wHailie™Sensor Overview 7
2.1 What is the Hailie™Sensor? 7
2.2 Hailie™Sensor Components 8
2.3 Compatible Inhalers 10
eSetting up the Hailie™Sensor 10
3.1 Preparation for First Use 10
3.2 Installing and Removing an Inhaler 11
3.3 Setting up Bluetooth®Communications 13
rUsing the Hailie™Sensor 14
4.1 Delivering a Dose of Medication 14
4.2 Medication Reminders 15
4.3 Reviewing Inhaler Usage Data 16
4.4 Manually Uploading Stored Information 16
4.5 Reviewing the Battery Level 17
4.6 Recharging the Hailie™Sensor 17

4
tMaintenance 18
5.1 Cleaning the Hailie™Sensor and Inhaler 18
5.2 Storage 19
yTroubleshooting 19
uCustomer Support and Servicing 20
7.1 Customer Support 20
7.2 Servicing 20
iDisposal 20
oWarranty 21
aTechnical Information and Symbols 21
10.1 Specications 21
10.2 Symbols 23
sRegulatory Statements 24
11.1 Electromagnetic Compatibility 24
11.2 FCC Statement 25
11.3 Declaration of Conformity 25

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
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
HandiHaler™Inhaler.
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.

6
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
HandiHaler™are printed on the front of the Inhaler.
The label is covered when the Hailie™ sensor is
installed. The label can be checked at any time by
removing the Hailie™sensor from the HandiHaler™,
and replacing it after the label is checked. Follow
the steps in Installing and Removing an Inhaler.
US only: Read the label on the front of the
HandiHaler™before installing into the Hailie™sensor.
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.

7
To ensure accuracy of Inhaler usage records, use
the Inhaler within 5 minutes of opening the cap, and
always close it again afterwards.
Take note of the following to prevent triggering
a false usage record. Avoid using the sensor in
excessively noisy environments. Do not handle the
sensor excessively or slide it across a table, while
the cap is open.
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.
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.

8
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
condence you're following your prescription.
2.2 Hailie™Sensor Components
With the HandiHaler™installed












Without the HandiHaler™

With the HandiHaler™Installed

9
Without the HandiHaler™












Without the HandiHaler™

With the HandiHaler™Installed












Without the HandiHaler™

With the HandiHaler™Installed
Key
1. HandiHaler™ Dust Cap 6. HandiHaler™Piercing
2. Clips Button
3. Release Buttons 7. Status Button
4. USB Port 8. LED
5. Retaining Fingers

10
2.3 Compatible Inhalers
The Hailie™sensor is designed to work only with the
HandiHaler™Inhaler as indicated on the Hailie™
sensor label.
The Hailie™sensor intended population is identical to
the intended population of the compatible Inhaler.
eSetting up the
Hailie™Sensor
3.1 Preparation for First Use
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 Status Button once. The LEDs will ash white if it is
still in Deep-Sleep.
Before rst use, place the Hailie™sensor on charge for
up to 4 hours or until the LEDs stop 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 Status Button
once more to check the battery level. The LEDs should
ash green prior to rst use.