Adherium STAV1 Users Manual

SmartTouch

Product Manual

Preparation for First Use

Following manufacture the SmartTouch AV is
placed in Deep-Sleep mode to conserve
battery life.

Before rst use place the SmartTouch AV on
charge for 1.5 hours or until the battery
indicator is showing a full charge. This will
wake the device from Deep-Sleep mode.

When SmartTouch AV is fully recharged,
disconnect from the power supply.

If you plan to use Smartinhaler Connection
Centre™ to review usage data, please refer to
instructions on SmartinhalerLive.com before
rst use.

SmartTouch AV Components

MDI

Touch User
Interface

SmartTouch AV

Compatible MDI Devices

The SmartTouch AV is designed to work only
with the MDI and medication indicated on the
device label.

Power
Button

USB Port

Installing or Removing an MDI

1 2

Installation (for non-tethered MDI)

To install the SmartTouch AV, align the MDI with
the back of the SmartTouch AV, and push the
MDI rmly into the SmartTouch AV, ensuring
the mouth piece of the MDI goes through the
front window on the SmartTouch AV.

1 2

Removal (for non-tethered MDI)

While holding each side of the SmartTouch AV,
gently push the mouthpiece of the MDI to
remove the MDI from the SmartTouch AV.

1 2

3 4

Installation (for tethered MDI)

To install the SmartTouch AV, open the MDI
cap, align the MDI with the back of the
SmartTouch AV, and push the MDI rmly into
the SmartTouch AV, ensuring the mouth piece
of the MDI goes through the front window on
the SmartTouch AV, close the MDI cap.

1 2

3 4

Removal (for tethered MDI)

Open the MDI cap, while holding each side of
the SmartTouch AV, gently push the
mouthpiece of the MDI to remove the MDI from
the SmartTouch AV, close the MDI cap.

Delivering a Dose of Medication

Caution: This manual does not provide

information on how to use prescription MDI
medication, and is not intended to replace the
advice provided by a healthcare professional.
Directions for using prescription medication
should be obtained from a healthcare
professional and followed accordingly. Any
questions related to prescription medication
should be referred to a healthcare professional.
Please refer to the labeling provided with the
inhaler for instructions on use.

The SmartTouch AV will show a dose taken
image on its screen after detecting a
medication dose has been actuated. This is
followed by Dose Taken question, which the
user can answer Yes ( ) or No ( ). If no
response is registered the SmartTouch AV will
record as a medication dose.

Navigating the SmartTouch AV Menu

The SmartTouch AV main menu can be
accessed after the SmartTouch AV is switched
on by pressing the power button. You can
navigate to the sub menus of each of the four
icons on the main menu.
The date and time of the internal clock, and
the battery indicator are shown on the top of
the main menu.

Clock Date

& Time

24-Hour

Dashboard

7-Day

Dashboard

Once a menu has been entered, the following
icons can be used to navigate around each
individual page:

Scroll Up

Scroll Down

Battery
Indicator

Chart

Settings

Select

Cancel

Return

24-Hour Dashboard

The 24-Hour Dashboard menu indicates when
the medication was last used and how much
was used in last 24 hours.
Tap the screen to show this information.

Taken last 24 hours indicates the number of
doses taken in the previous 24 hours.

Preventer Only

Adherence today indicates the percentage

adherence with the prescribed dose during the
current day.

Reliever Only

Including Night uses indicates the total

number of doses taken between midnight and
6 am.

7-Day Dashboard

The 7-Day Dashboard menu indicates how
many doses were taken in the last 7 days, the
percentage adherence and when last taken.

Taken last 7 days indicates the number of
doses taken during the last 7 days, including
the current day.

Preventer Only

Adherence last 7 days indicates the

percentage adherence with the prescribed
dose during the last 7 days.

Reliever Only

Including Night uses indicates the total

number of doses taken between midnight and
6 am during the last 7 days.

Chart

The Chart menu displays the total number of
doses actuated by day over the last 7 days,
including the current day. Use the Scroll Down
arrow to view medication usage for previous
weeks.

Settings

The Settings menu allows you to change the
internal clock settings, set reminders, upload
data and pair SmartTouch AV with a
Smartphone.

Set Clock

The Set Clock allows the SmartTouch AV
internal clock to be changed.

To change the internal clock, navigate to the

Set Clock menu. Use the Scroll Up or Scroll
Down buttons to change the time zone, press
Select to conrm. Use the Scroll Up or Scroll
Down buttons to change the date and time

value (selection to change ashing). Holding
down the Scroll Up or Scroll Down buttons will
change the value quickly. Press Select to
conrm and move to the next time unit in the
order of day, month, year, hour and minute.

Reminders

Note: The reminder functionality is only

available on monitors which are designed for
preventer medications.

Reminders Sub Menu - On/Off

The Reminder On/Off Menu enables or
disables the reminder. Press Select to enter the
Reminder On/Off screen.
Change the Reminder On/Off setting using
the Scroll Up or Scroll Down buttons to set it
to Play All, Play Selected or Off. Press Select
to conrm or Cancel to exit.

If enabled, the medication reminder tunes play
at the times congured in the Reminder
Times screen for up to 25 minutes, or until the
installed pMDI is actuated the number of times
set in the “Doses” menu.

Reminders Sub Menu – Ringtones

The Ringtones screen allows an audio
reminder tune to be listened to. Press Select to
enter the Ringtones screen.
Use the Scroll Up or Scroll Down buttons to
change the selection. Press Select to preview
and select the displayed tune or press Return
to exit. Note when Select is pressed for a tone
selection, that tune will play at the next
reminder time. If Select is not pressed the
selection will remain unchanged.

Note: When a tune is playing press Select or

Return to stop the playback.

Reminders Sub Menu - Volume

The Volume Menu sets the reminder volume to
Normal or Loud. Press Select to enter the
Volume screen.
Change the Volume setting using the Scroll Up
or Scroll Down buttons. Press Select to
conrm or Return to exit.

Reminders Sub Menu - Times

Press Select to congure the Weekday AM/PM
and Weekend AM/PM medication reminder
times.

Use the Scroll Up or Scroll Down buttons to
change the time value (selection to change
ashing). Holding down the Scroll Up or Scroll
Down buttons will change the value quickly.
Press Select to move from the hour value to
the minute value and to cycle through the
Weekday AM, Weekday PM, Weekend AM,
Weekend PM Reminder times. Press Return to
exit.

Reminders Sub Menu – Doses

The Doses screen sets the number of doses
that will stop the audio reminder while the
reminder is playing. Note that if the number of
doses indicated is actuated any time in the
previous 6 hours before the reminder is
scheduled, then the reminder will not play until
the next scheduled time is reached.

Upload

The Upload Menu is used to set up Bluetooth
communications with other devices, such as
Smartphones.

Upload Sub Menu - Upload Now

The Upload Now Menu allows the SmartTouch
AV to upload the data manually to
SmartinhalerLive mobile app.
Press Select to enter the Upload Now screen.
The data will start to upload and will give a
conrmation of Upload Success or Failure.

Upload Sub Menu - Pair

The Pair Menu allows the SmartTouch AV to
Pair with other devices, such as
Smartphones.
Press Select to enter the Pair screen. The
SmartTouch AV will start pairing and will give
a conrmation of Pairing Success or Failure.

Starting the pairing process removes the
current paired device.

Locks

The Locks Menu enables selected screens to
be locked to the user. The default setting is
no locked screens.

The default lock code is 00000
The master unlock code is 13201
The code must be entered to access the lock
menu.

Locks Sub Menu - Set Locks

Set Lock is used for changing the lock code.
A new 5-digit code must be entered twice to
complete the set lock process.

Locks Sub Menu - Options

The Options menu allows the SmartTouch AV
reminder and device pairing menus to be lock
to the user.

Options are:

• Reminder Menu (the entire reminder menu)

• Reminder Doses (the menu where the
number of doses is set)

• Reminder Mode (the menu where the
reminder on/off is set)

• Reminder Times (the menu where the
reminder times are set)

• Device Pairing (pairing of a new device)

Reviewing SmartTouch AV Usage
Data

At a convenient time, the pMDI usage history
can be uploaded to
www.smartinhalerlive.com for review. This can
be done as often as required. However, it is
recommended that uploads are performed at
least once every month. The SmartTouch AV
can store at least one year of medication
usage data under normal usage.

Note: Refer to the online training at

SmartinhalerLive.com for more information on
reviewing medication usage.

Upload via USB

To upload data to SmartinhalerLive.com for
review, log in to www.smartinhalerlive.com
and download and install the Smartinhaler
Connection Center software.
Connect the SmartTouch AV to the computer
via the USB connection. Follow the
instructions on the Connection Center to

preview and upload the usage data to
www.smartinhalerlive.com.

Note: Refer to the instruction manual for

SmartinhalerLive.com for more information on
downloading and installing the Smartinhaler
Connection Center software.

Recharging the SmartTouch AV

The SmartTouch AV contains an internal
rechargeable battery and is recharged via the
USB connection. The Battery Indicator is
shown on the screen when medication is
taken or if the Power Button is pressed. When
the Battery Indicator is red, the SmartTouch
AV should be recharged. A battery low
warning message will be displayed in
conjunction with a red battery indicator.

To charge the internal battery, connect the
SmartTouch AV to a computer USB port or
USB wall plug adaptor.
When connected to a charging source, the
Charging display is shown briey, and a
power connection symbol appears on the
Battery Indicator with increasing charge level.
Charge completion is indicated by a steady
Battery Indicator showing full charge.

If the battery was at before charging, the
SmartTouch AV may have lost its internal date
and time settings. After charging, enter the
Settings menu to set the SmartTouch AV
internal calendar and clock to the local date
and time. Refer to Set Clock in this manual for
more information.

Cleaning the SmartTouch AV and
MDI

Check the instructions from the MDI
manufacturer for keeping the mouthpiece
clean. Keep the SmartTouch AV clean and
free of chemicals, steam, water and dust.

Clean the SmartTouch AV by wiping the
outside plastic enclosure with a lightly
dampened cloth. Leave it to dry in a warm
place that is less than 30°C.

Warning: The SmartTouch AV is a battery

powered electronic device. Do not immerse
the SmartTouch AV in water.
Do not use the SmartTouch AV if it is not in
good condition.

Storing the SmartTouch AV

To help maintain battery capacity, store your
SmartTouch AV below 30°C. Keep out of
direct sunlight and avoid extreme
temperatures.

Troubleshooting

If the SmartTouch AV is not responding to
communications, check that the USB cable is
plugged in correctly. If this does not help,
please contact the supplier or manufacturer
for further assistance.

Servicing

Please contact the supplier or manufacturer for
device servicing. Do not attempt to open or
service the SmartTouch AV. Tampering with the
device voids the warranty.

Disposal

Dispose or recycle the SmartTouch AV in
accordance with regulations for your country,
as applicable for electronic devices containing
a lithium polymer battery.

EU only: Do not dispose of the SmartTouch AV
as unsorted municipal waste.
The SmartTouch AV must be recycled in
accordance with Directives 2012/19/EU and
2006/66/EC. To arrange for return or disposal of
the SmartTouch AV contact your local supplier.

Warnings, Cautions, and Notes

Warnings identify actions or situations that

could lead to personal injury. Take note of all
warnings before using the SmartTouch AV.

Cautions identify actions or situations that
could damage the SmartTouch AV, or other
equipment, or affect the accuracy or
availability of compliance data.

Notes contain advisory information about
some aspect of the SmartTouch AV or its use.

Terms and Abbreviations

MDI Metered Dose Inhaler

SmartTouch AV Intended Use

The SmartTouch AV is intended for
single-patient use as an electronic data
capture accessory for recording actuations 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 AV is not intended to indicate
remaining quantity of medication in an MDI
and does not include a dose counting function.

How the SmartTouch AV Works

The SmartTouch AV is a small battery­powered electronic data logger that attaches
to an MDI. The SmartTouch AV contains an
electronic clock and calendar that is used to
log the date and time of MDI actuation. The
SmartTouch AV registers MDI actuations.
Usage data can be uploaded via a wireless
Bluetooth connection.

Safety and Usage Information

Warning: To ensure your inhaler functions

correctly, do not use the SmartTouch AV with
any other MDI or medication than that
indicated on the device label.

Warning: The SmartTouch AV does not contain

a dose counter. Do not use data collected by
the SmartTouch AV to determine the number of
doses remaining in a medication canister.

Caution: For hygiene and data integrity

reasons, do not use the SmartTouch AV with
more than one patient.

Caution: Take care to not spill liquids on the

SmartTouch AV or immerse it in water.

Note: The SmartTouch AV does not detect or

record inhalation by the user. The SmartTouch
AV does not record the quantity of medication
delivered by the MDI.

Symbols

Manufacturer: Adherium (NZ) Limited

Serial Number

Rechargeable Device

Year of Manufacture

Keep Dry

EU only: Do not dispose of the
SmartTouch AV as unsorted
municipal waste

US only: Caution - Federal law
restricts this device to sale by or on
the order of a physician.

Warranty

The SmartTouch AV 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 SmartTouch AV including dropping, water
damage resulting from condensation or
immersion, tampering, attempts to service, or
other forms of abuse.

The SmartTouch warranty expires 4 years from
date of manufacture.

Specications

Weight

Size

Actuation Log
Resolution

Actuation Log
Capacity

31 grams, excluding MDI

36 x 41 x 59mm (L x W x H)
excluding MDI

1 second

3712 actuations and device
status records

Internal Clock
Accuracy

Wireless
Technology

Battery Type

± 1 hour after 12 months.

Note: the SmartTouch AV
clock is updated every time
data is uploaded

Bluetooth 4.0:

2.40 - 2.48 GHz,

2.5 mW Low Energy

Lithium Polymer 80 mAh
rechargeable

2 yearsService Life

Battery Life

Temperature

Temperature

Operating /
Storage
Humidity

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.

IC Statement

This device complies with Industry
Canada’s licence-exempt RSSs.
Operation is subject to the following two
conditions:

1) This device may not cause interference;
and

2) This device must accept any
interference, including interference that
may cause undesired operation of the
device.

Le présent appareil est conforme aux CNR
d'Industrie Canada applicables aux appareils
radio exempts de licence. L'exploitation est
autorisée aux deux conditions suivantes :

1) l'appareil ne doit pas produire de
brouillage, et

2) l'utilisateur de l'appareil doit accepter
tout brouillage radioélectrique subi,

6 weeks on full charge
depending on usage

0 to 40ºC (32 to 104ºF)Operating

-20 to 60ºC (-4 to 140ºF)Storage

15 to 95% RH
(non-condensing)

même si le brouillage est susceptible
d'en compromettre le fonctionnement.

RF Exposure Statement

This equipment complies with the RSS-102
radiation exposure limits set forth for an
uncontrolled environment.

Declaration of Conformity

Adherium (NZ) Ltd
SmartTouch is in compliance with the essential
requirements and other relevant provisions of
Directives 1999/5/EC and 93/42/EEC.
Email [e-mail] for a copy of
the declaration of conformity.

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 specications may change without
notice.

New Zealand Patent No. 614928
Patents Pending: PCT/NZ2014/000184 and NZ
Pat. Appl. No. 703739
New Zealand Design Appl. No. 419719

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) Limited.

Product specications may change without
notice.

New Zealand Patent No. 595367
New Zealand Design appl. No. 420386
Patents Pending: EP2758111 and
US 2014-0182584

Wellkang Ltd
29 Harley Street, Suite B
London W1G 9QR
United Kingdom

Australian Sponsor

Market Access Australia Pty Ltd
810 Pacic Highway
Gordon NSW 2072, Australia

declares that this

SmartTouch™ AV is manufactured by:

Adherium (NZ) Limited

8 Commerce Street, Suite 205
Auckland 1010, New Zealand
Phone : [phone]
[e-mail]
www.smartinhaler.com

SmartTouch™ AV Product Manual

Part Number ND0026-EN
Version 4
Issue Date 31 March 2016

All product names and brand names in this
document are trademarks or registered
trademarks of their respective holders.

© Copyright Adherium (NZ) Limited 2016.
All rights reserved.