For use only with HandiHaler
™
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 5
1.3 Warnings and Precautions 6
Hailie™ Sensor Overview 7
w
2.1 What is the Hailie™ Sensor? 7
2.2 Hailie™ Sensor Components 8
2.3 Compatible Inhalers 10
Setting up the Hailie™ Sensor 10
e
3.1 Preparation for First Use 10
3.2 Installing and Removing an Inhaler 11
3.3 Setting up Bluetooth
Using the Hailie™ Sensor 14
r
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
®
Communications 13
Maintenance 18
t
5.1 Cleaning the Hailie™ Sensor and Inhaler 18
5.2 Storage 19
Troubleshooting 19
y
Customer Support and Servicing 20
u
7.1 Customer Support 20
7.2 Servicing 20
Disposal 20
i
Warranty 21
o
Technical Information and Symbols 21
a
10.1 Specications 21
10.2 Symbols 23
Regulatory Statements 24
s
11.1 Electromagnetic Compatibility 24
11.2 FCC Statement 25
11.3 Declaration of Conformity 25
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
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.
5
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.
6
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.
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.
7
The Hailie™ sensor is a small battery-powered
™
Installed
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
With the HandiHaler™ installed
8
Without the HandiHaler
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
9
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.
e Setting 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.
10
3.2 Installing and Removing an Inhaler
Installation
US Only - Read the
label on the side
of the HandiHaler™
before installing into
the Hailie™ sensor.
To install the HandiHaler™,
open the HandiHaler™ Dust
Cap.
Rest the HandiHaler™ on top
of the Hailie™ sensor so that
the Piercing Button rests
underneath the Retaining
Fingers.
11
12
Gently push the HandiHaler™
down towards a horizontal
position until both Clips
click into position on the
HandiHaler™ hinge.
Replace the HandiHaler™
Dust Cap.
The Hailie™ sensor is ready
to pair with a compatible
mobile app. Follow the
instructions below in
Setting Up Bluetooth®
Communications.
Removal
Press the Release
Buttons on each side
simultaneously to release
the HandiHaler™.
Gently lift the
HandiHaler™ out of the
Hailie™ sensor.
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.
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 press the Status Button 3
13
times quickly to enter pairing mode. The LEDs will
ash blue when the Hailie™ sensor is in pairing mode.
4. The LEDs will ash green to indicate successful
pairing.
If pairing is not successful within 60 seconds the
LEDs 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 a 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
the sound made by inhaling the medication, when the
Inhaler Dust Cap is opened and closed.
To ensure accuracy of Inhaler usage records, use
the Inhaler within 5 minutes of opening the cap, and
always close again afterwards.
14
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 LEDs ash green, orange or red
(to indicate battery level) 3 seconds after detecting
medication usage and the Dust Cap is closed.
If the LEDs ash 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 LEDs ash green and
the Hailie™ sensor emits a beeping sound when the
reminder alert is triggered.
15
To cancel the reminder, hold down the Status Button
until you hear a beeping sound and the LEDs ash red.
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 Status Button for 3 seconds until the
LEDs show white, then release.
2. The LEDs will ash white while the Hailie™ sensor
attempts to upload, then ash green if the upload is
successful.
The Hailie™ sensor LEDs 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.
16
4.5 Reviewing the Battery Level
The LEDs on the Hailie™ sensor indicate the battery
level after detecting medication usage, or when the
Status Button is pressed once.
LED Colour Battery Status
Green
Orange
Red
No Flash
The battery level is good. The Hailie™
sensor is monitoring Inhaler usage.
The battery level is 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.
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 micro-USB cable less than 3 metres (9ft 10in)
in length.
When connected to a charging source, the LEDs
will ash slowly in a colour according to the battery
level. When charging is complete, the LEDs will turn
off. The Hailie™ sensor should not be used while
charging.
17
Allow up to 4 hours to fully recharge a Hailie™ sensor
that is displaying red ashing LEDs. Charging times
will signicantly increase in temperatures below
10°C (50°F).
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.
18
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.
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.
19
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.
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.
20
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.
a Technical Information
and Symbols
10.1 Specications
Model Number
Usage Log
Precision
Usage Log
Capacity
Internal Clock
Accuracy
NF0101
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.
21
Compatible
with
Wireless
Communication
Battery Type
Shelf Life
Service Life/
Battery Life
Operating
Temperature
Storage
Temperature
Operating /
Storage
Humidity
22
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 85mAh,
Rechargeable
2 years
2 years
0 to 40ºC (32 to 104ºF)
-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
23
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
24
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
25
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 Ltd
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: ND0271
Version: 4
Issue Date: 04 Sep 2018
© 2018 Adherium (NZ) Ltd. All rights reserved.
26
For patent and trade mark information, including thirdparty trademarks, refer to www.adherium.com/ip.
HandiHaler is a trademark of Boehringer Ingelheim
Pharma GmbH & Co. KG.
27
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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