Adherium SmartTouch User manual

Product Manual
For use only with Bevespi Aerosphere™
For customer support,
email [e-mail]
or call 1 833 3886 9688.
SmartTouch™

Compatible MDI Devices
Preparation for First Use
Warnings, Cautions, and Notes
SmartTouch™Sensor Components
Terms and Abbreviations
Installing or Removing an MDI
Setting up Bluetooth®Communications
Delivering a Dose of Medication
Reminders
Reviewing SmartTouch™Sensor Usage Data
Manually Uploading Stored Information
Reviewing Battery Level
Cleaning the SmartTouch™Sensor and MDI
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Table of Contents

Compatible MDI Devices
Preparation for First Use
Warnings, Cautions, and Notes
SmartTouch™Sensor Components
Terms and Abbreviations
Installing or Removing an MDI
Setting up Bluetooth®Communications
Delivering a Dose of Medication
Reminders
Reviewing SmartTouch™Sensor Usage Data
Manually Uploading Stored Information
Reviewing Battery Level
Cleaning the SmartTouch™Sensor and MDI
4
4
4
5
5
5
6
7
8
8
8
9
9
Storage
Troubleshooting
Servicing
Disposal
SmartTouch™Sensor Intended Use
How the SmartTouch™Sensor Works
Safety and Usage Information
Symbols
Warranty
Specications
FCC Statement
Declaration of Conformity
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Compatible MDI Devices
The SmartTouch™sensor is designed to work only with
the MDI and medication indicated on the device label:
• For use with Bevespi Aerosphere™MDI.
The SmartTouch™sensor intended population is
identical to the intended population of the Bevespi
Aerosphere™MDI.
Preparation for First Use
Before rst use remove the Battery Saver Pull Tab.
Download a compatible mobile application to
communicate with your sensor. For more information
see www.smartinhaler.com.
Warnings, Cautions, and Notes
Warnings identify actions or situations that could
lead to personal injury. Take note of all warnings
before using the SmartTouch™sensor.
Cautions identify actions or situations that
could damage the SmartTouch™sensor or other
equipment, or affect the accuracy or availability
of recorded actuation data.
Notes contain advisory information about some
aspect of the SmartTouch™sensor or its use.

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SmartTouch™Sensor Components







Terms and Abbreviations
MDI Metered Dose Inhaler.
Installing or Removing an MDI

Key:
1. Door latch
2. Reminder LED
3. Reminder button
4. Pair LED
5. Pair button
6. Battery LED
7. Battery button
8. USB port (not used)

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
Installation
To install the inhaler, open the door of the SmartTouch™
sensor by pulling the Door Latch. Push the MDI into the
SmartTouch™ sensor. Close the door so it clicks into place.
Removal
To remove the inhaler, pull the Door Latch to open
the door of the SmartTouch™ sensor. Pull the MDI to
remove it from the SmartTouch™ sensor. Close the
door so it clicks into place.
Setting Up Bluetooth®Communications
The SmartTouch™sensor must be paired with a
compatible Bluetooth®smartphone or tablet computer
in order to upload stored usage data.
To pair the SmartTouch™sensor with a smartphone or
tablet computer:
1. Follow the instructions on your smartphone or tablet
computer to put it in pairing mode.
2. On the SmartTouch™sensor hold down the Pair
Button for 1 second to enter pairing mode. The Pair
LED will ash blue when the SmartTouch™sensor is
in pairing mode.

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3. Follow any prompts on your smartphone or tablet
computer to select and accept pairing with the
SmartTouch™sensor. The Pair LED will ash green
to indicate pairing is successful.
If pairing is not successful within 60 seconds the
LED will ash red. The pairing process can be
repeated if necessary.
The SmartTouch™ sensor can only be paired with a
single smartphone or tablet computer at one time.
Successful pairing with a new smartphone or tablet
computer will remove the current pairing. If pairing
on the new smartphone or tablet computer fails, the
existing pairing will be retained.
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 SmartTouch™ sensor battery status LED will ash
green, orange, or red depending on battery status.
The ash will occur 3 seconds after the medication
actuation is detected.
This manual does not provide information on how to
use compatible MDI medication and is not intended
to replace the advice provided by a healthcare
professional. Directions for using compatible
medication should be obtained from a healthcare
professional and followed accordingly. Any
questions related to prescription medication should
be referred to a healthcare professional.

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Reminders
Audio-visual reminders can be set up from the
SmartTouch™app. If enabled, the medication
reminders are generated with increasing frequency
for up to 24 minutes, until either the prescribed
medication dose is taken or the reminder is cancelled.
To cancel the reminder, hold down the Reminder
Button on the SmartTouch™sensor until you hear a
beeping sound and the LED ashes red.
Reviewing SmartTouch™Sensor Usage Data
The MDI usage history can be automatically uploaded
via a compatible paired smartphone or tablet computer.
The upload of new information will occur automatically
if the SmartTouch™sensor is within range (5 meters or
16 feet) of the smartphone or tablet computer.
When travelling ensure your smartphone or tablet
computer is set to the local time zone for accuracy
of MDI actuation logs.
Manually Uploading Stored Information
The SmartTouch™sensor can manually upload
information to a paired Bluetooth®smartphone or
tablet computer.
To manually upload stored usage data from the
SmartTouch™sensor
1. Hold down the Bluetooth®Button for 3 seconds
until the Bluetooth®LED shows white, then release.
2. The Bluetooth®LED will ash white while the
SmartTouch™sensor attempts to upload, then ash
green if the upload is successful.

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The SmartTouch™sensor’s Bluetooth®LED will
ash red if the upload is not successful. Check the
SmartTouch™ sensor is within range of the paired
smartphone or tablet computer, and ensure that
Bluetooth® communications enabled.
Reviewing the Battery Level
The Battery LED indicates the battery level of the
SmartTouch™sensor after medication is actuated, or
when the Battery Check Button is pressed.
Colour Meaning
Green The battery level is good. The
SmartTouch™sensor is monitoring
actuations.
Orange The battery level is low. The SmartTouch™
sensor is still monitoring actuations.
Red The battery is depleted. The SmartTouch™
sensor has stopped monitoring actuations.
No
Flash
The battery is depleted or the
SmartTouch™sensor has failed, e.g. due to
liquid immersion or mechanical stress.
The battery is not rechargeable. Once depleted,
a new SmartTouch™sensor will be required.
Contact Customer Support for more
information.

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Cleaning the SmartTouch™Sensor and MDI
Check the instructions from the MDI manufacturer for
keeping the mouthpiece clean. Keep the SmartTouch™
sensor clean and free of chemicals, steam, water and
dust. Clean the outside plastic enclosure with a lightly
dampened cloth. Check the SmartTouch™sensor is
clean and repeat if necessary. Leave it to dry in a warm
place that is less than 30°C (86°F).
'The SmartTouch™ sensor is battery-powered
and electronic. Do not immerse the SmartTouch™
sensor in water. Do not use the SmartTouch™
sensor if it is not in good condition.
Storage
To help maintain battery capacity, store your
SmartTouch™sensor below 30°C (86° F). Keep out of
direct sunlight and avoid extreme temperatures
Troubleshooting
If the SmartTouch™sensor is not responding to
Bluetooth®communications, check the SmartTouch™
sensor battery level as per Reviewing the Battery Level
in this manual.
Other wireless communications equipment such
as wireless home network devices, mobile phones,
cordless telephones and their base stations, and
walkie-talkies can affect the SmartTouch™sensor, and
should be kept at least 30cm (12in) away.
Increase the separation distance between the
SmartTouch™sensor and any such devices if this could
be causing problems.

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If this does not help, contact Customer Support for
further assistance.
Customer Support
For support on this product, email us at
[e-mail] or call us on +64 9 307
2771. For information about your medical condition
or your medication, contact your healthcare provider.
Servicing
Please contact the Customer Support for SmartTouch™
sensor servicing. Do not attempt to open or service the
SmartTouch™sensor. Tampering with the SmartTouch™
sensor voids the warranty.
Disposal
Dispose or recycle the SmartTouch™sensor in
accordance with regulations for your country, as
applicable for electronic devices containing a lithium
coin-cell battery. Ensure that the inhaler is removed
from the SmartTouch™sensor prior to disposal.
EU only: Do not dispose of the SmartTouch™sensor
as unsorted municipal waste. The SmartTouch™
sensor must be recycled in accordance with Directives
2012/19/EU and 2006/66/EC. To arrange for return or
disposal of the SmartTouch™sensor contact Customer
Support.
SmartTouch™Sensor Intended Use
The SmartTouch™sensor is intended for single
patient use as a medication reminder and electronic
data capture accessory for recording actuations

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of prescribed MDI usage. This may be used in the
following applications:
• In clinical trials, where researchers need to know when
a patient has actuated their trial MDI medication.
• In clinical practice, where specialists, general
practitioners, nurses, and educators need to know if a
patient has actuated their prescribed MDI medication.
• In self-management, where patients need to track
their medication use as part of their management plan.
The SmartTouch™sensor is compatible only with
Bevespi Aerosphere™MDI.
The SmartTouch™sensor is not intended to indicate
remaining quantity of medication in an MDI and does
not include a dose counting function.
How the SmartTouch™Sensor Works
The SmartTouch™sensor is a small battery-powered
electronic data logger that attaches to an MDI. The
SmartTouch™sensor contains an electronic clock and
calendar that is used to log the date and time of MDI
actuation. The SmartTouch™sensor registers MDI
actuations. Usage data can be uploaded via a wireless
Bluetooth®connection.
Safety and Usage Information
To ensure your inhaler functions correctly, do not
use the SmartTouch™ sensor with any other MDI or
medication than that indicated on the SmartTouch™
sensor label.

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The SmartTouch™sensor does not contain a
dose counter. Do not use data collected by the
SmartTouch™ sensor to determine the number of
doses remaining in a medication canister.
SmartTouch™sensor is not intended to diagnose
your condition or to replace the diagnosis of a
licensed physician.
For hygiene and data integrity reasons, do
not use the SmartTouch™ sensor with more than
one patient.
Take care to not spill liquids on the SmartTouch™
sensor or immerse it in water.
The SmartTouch™sensor does not detect or record
the quantity of medication delivered by the MDI.
Symbols
Manufacturer: Adherium (NZ) Ltd
Serial Number
Year of Manufacture
Keep dry
Non-rechargeable Sensor
EU only: Do not dispose SmartTouch™sensor
as unsorted municipal waste
Warranty
The SmartTouch™sensor includes a 12 month warranty
against manufacturing defects from date of rst use.

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This warranty maybe voided under the following
circumstances: damage to the SmartTouch™sensor
including dropping, water damage resulting from
condensation or immersion, tampering, attempts to
service, or other forms of abuse.
The SmartTouch™sensor warranty expires 4 years from
date of manufacture.
Specications
Model number NF0096
Weight 24 grams, excluding MDI
Size 41 x 36 x 66mm (L x W x H)
excluding MDI
Actuation Log
Precision 1 second
Actuation Log
Capacity
5120 actuations and sensor
status records
Internal Clock
Accuracy
± 1 hour after 12 months
Note: the SmartTouch™sensor
clock is updated every time data
is uploaded.
Compatible
with
iOS or Android smartphone and
tablet devices. Refer to
smartinhaler.com for more
information.
Wireless
Communication
Bluetooth®Low Energy 4.0: 2.40 -
2.48 GHz, 2.5 mW Low Energy
Battery Type Lithium coin cell, non-rechargeable
Shelf Life 3 years
Battery Life/
Service Life 1 year

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Operating
Temperature 0 to 40ºC (32 to 104ºF)
Storage
Temperature -20 to 60ºC (-4 to 140ºF)
Operating /
Storage Humidity
15 to 90% RH (non-condensing)
at water vapour pressure ≤ 50 hPa
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.
Note: The Grantee is not responsible for any changes
or modications not expressly approved by the party
responsible for compliance. Such modications could
void the user’s authority to operate the equipment
Declaration of Conformity
Adherium (NZ) Ltd declares that this SmartTouch™
sensor is in compliance with the essential requirements
and other relevant provisions of Directive 93/42/EEC.
Email [e-mail] for a copy of the
declaration of conformity.
Hereby, Adherium (NZ) Ltd declares that the radio
equipment type SmartTouch™sensor is in compliance
with Directive 2014/53/EU. The full text of the EU
declaration of conformity is available at:
www.smartinhaler.com/RDC
Product specications may change without notice.

Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Australian Sponsor
Adherium Ltd
Level 14, 140 William Street
Melbourne
Victoria 3000
Australia
SmartTouch™sensor is manufactured by:
Adherium (NZ) Ltd
Level 2, 204 Quay Street
Auckland 1010
New Zealand
[e-mail]
www.smartinhaler.com
Made in Thailand
SmartTouch™Sensor Product Manual
Part Number: ND0300
Version: 1
Issue Date: 7 February 2018
© 2018 Adherium (NZ) Ltd. All rights reserved.
For patent and trade mark information, including third-
party trademarks, refer to www.adherium.com/ip.
Bevespi Aerosphere is a trade mark of AstraZeneca AB.