Adherium DSK1 User Manual

Advair™ Diskus™ and Flovent™ Diskus
For use only with
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
Safety Statement 5
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1.1 Hailie™ Sensor Intended Use 5
1.2 Important User Information 6
1.3 Warnings and Precautions 6
Hailie™ Sensor Overview 8
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2.1 What is the Hailie™ Sensor? 8
2.2 Hailie™ Sensor Components 8
2.3 Compatible Inhalers 9
Setting up the Hailie™ Sensor 10
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3.1 Preparation for First Use 10
3.2 Installing and Removing an Inhaler 10
3.3 Setting up Bluetooth® Communications 12
Using the Hailie™ Sensor 13
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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
Maintenance 17
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5.1 Cleaning the Hailie™ Sensor and Inhaler 17
5.2 Storage 17
Troubleshooting 18
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Customer Support and Servicing 18
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7.1 Customer Support 18
7.2 Servicing 19
Disposal 19
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Warranty 19
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Technical Information and Symbols 20
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10.1 Specications 20
10.2 Symbols 21
Regulatory Statements 22
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11.1 Electromagnetic Compatibility 22
11.2 FCC Statement 23
11.3 Declaration of Conformity 23
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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.
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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 condence you're following your prescription.
2.2 Hailie™ Sensor Components
Front View
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