Adherium SHD1 User Manual
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
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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
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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
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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
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5.1 Cleaning the Hailie™ Sensor and Inhaler 18
5.2 Storage 19
Troubleshooting 19
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Customer Support and Servicing 20
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7.1 Customer Support 20
7.2 Servicing 20
Disposal 20
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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
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