Adherium STC1 User Manual

Product Manual

Preparation for First Use

Following manufacture the SmartTouch is
placed in Deep-Sleep mode to conserve
battery life. To wake up the device, hold
down the Status Button for 3 seconds
and then release. Press the Status Button
once more to check the battery level. The
device LED should ash green prior to
rst use.

To check if a device is still in Deep-Sleep
mode, press the Status Button once. The
LED will ash pink if it is still in Deep­Sleep; and green, orange, or red (to
indicate battery level) if it has previously
been awoken from Deep-Sleep.

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

SmartTouch Components

SmartTouch

USE ONLY WITH

Medication Name

1

2016

Adherium (NZ) Limited
Auckland 1010, New Zealand

smartinhaler.com

Key

1. Light Emitting Diode (LED)

2. Use only with this medication

3. Status Button

000001

FCC ID: PN2-STC1
IC: 20509-STC1

2

3

Compatible MDI Devices

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

Installing or Removing an MDI

Installation (for non-tethered MDI)

To install the SmartTouch, align the MDI with
the back of the SmartTouch. Push the MDI
rmly into the SmartTouch, ensuring the
mouth piece of the MDI goes through the front
window on the SmartTouch.

1

Removal (for non-tethered MDI)

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

1 2

2

Installation (for tethered MDI)

To install the SmartTouch, open the MDI cap,
and align the MDI with the back of the
SmartTouch. Push the MDI rmly into the
SmartTouch, ensuring the mouth piece of the
MDI goes through the front window on the
SmartTouch. Close the MDI cap.

1 2

3 4

Removal (for tethered MDI)

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

1 2

3 4

Setting Up Bluetooth
Communications

The SmartTouch must be paired with a
compatible Bluetooth smartphone or
tablet computer in order to upload stored
usage data. To pair the SmartTouch with a
smartphone or tablet computer:

Follow the instructions on your

1)
smartphone or tablet computer to put it
in pairing mode.
On the SmartTouch press the Status

2)
Button 3 times quickly to enter pairing

mode. The LED will ash blue when the
SmartTouch is in pairing mode.

3)

Follow any prompts on your
smartphone or tablet computer to
select and accept pairing with the
SmartTouch. The LED will ash green to
indicate pairing is successful.

Note: If pairing is not successful within 60

seconds the LED will ash red. The
pairing process can be repeated if
necessary.

Note: The SmartTouch can only be paired

with a single smartphone or tablet
computer at a time. Starting the pairing
process removes the current paired
device.

Delivering a Dose of Medication

Caution: This manual 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.

To use the SmartTouch with a spacer,
hold the SmartTouch in one hand with the
thumb at the base of the SmartTouch and
the index nger and second nger on top
of the medication canister. Use the other
hand to support the spacer chamber.

The SmartTouch LED ashes after
detecting a medication dose has been
actuated.

Reminders

Audio-visual reminders can be set up
from a Smartinhaler app or via
Smartinhaler Connection Centre.
If enabled, the medication reminders are
generated with increasing frequency for
up to 24 minutes, or until the installed
MDI is actuated.

Upload of SmartTouch 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 as long as the SmartTouch
is within range (5 meters or 16 feet) of the
communication device.

Note: Refer to the instruction manual for

your specic communication device for
more information on this process.

Manually Uploading Stored
Information

If required to ensure all current data has
been transferred, the SmartTouch can
manually upload information to a paired
Bluetooth smartphone or tablet computer.
To manually upload stored information
from the SmartTouch:

1)

Hold down the Status Button until the
LED shows pink, then release.

2)

The LED will ash pink while the
SmartTouch attempts to upload, then
ash green if the upload is successful.

Note: The SmartTouch LED will ash red if

the upload is not successful. Check the
SmartTouch is within range of the
smartphone or tablet computer, and it has
Bluetooth communications enabled.

Reviewing the Battery Level

The LED on the main face indicates the
battery level of the SmartTouch after
medication is actuated, or when the
Status Button is pressed:

• Green – the battery level is good, and
the SmartTouch is monitoring
actuations.

• Orange – the battery level is getting
low. The SmartTouch is still monitoring
actuations.

• Red – the battery is at. The
SmartTouch has stopped monitoring
actuations.

• No ash – the battery is at, or the
SmartTouch device has failed, e.g.
due to liquid immersion or mechanical
stress.

Cleaning the SmartTouch and
MDI

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

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

Storage

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

Troubleshooting

If the SmartTouch is not responding to
Bluetooth communications, check the
SmartTouch 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.
Increase the separation distance between
the SmartTouch and any such devices if
this could be causing problems.

If this does not help, 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. Tampering with the device
voids the warranty.

Disposal

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

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

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

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

Terms and Abbreviations

MDI Metered Dose Inhaler

SmartTouch Intended Use

The SmartTouch is intended for single­patient 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 is not intended to
indicate remaining quantity of medication
in an MDI and does not include a dose
counting function.

How the SmartTouch Works

The SmartTouch is a small battery­powered electronic data logger that
attaches to an MDI. The SmartTouch
contains an electronic clock and calendar

that is used to log the date and time of
MDI actuation. The SmartTouch 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 with
any other MDI or medication than that
indicated on the device label.

Warning: The SmartTouch does not

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

Caution: For hygiene and data integrity

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

Caution: Take care to not spill liquids on

the SmartTouch or immerse it in water.

Note: The SmartTouch does not detect or

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

Symbols

Manufacturer: Adherium (NZ) Ltd

Serial Number

Year of Manufacture

Keep Dry

Non-Rechargeable Device

EU only: Do not dispose of the
SmartTouch 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 includes a 12 month
warranty against manufacturing defects
from date of rst use. This warranty may
be voided under the following
circumstances: damage to the
SmartTouch 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

Actuation Log
Precision

Actuation Log
Capacity

Internal Clock
Accuracy

Compatible
With

1 second

6140 actuations and
device status records

± 1 hour after
12 months. Note: the

SmartTouch clock is
updated every time
data is uploaded

iOS 7.1 and above,
running on:

• iPhone 4 and later

• iPad 3 and later

• iPad mini 1
and later

• iPod Touch 5
and later
Android v4.4 and above

st

Gen

th

Gen

Wireless
Technology

Battery Type

Operating
Temperature

Storage
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.

Bluetooth 4.0:

2.40 - 2.48 GHz,

2.5 mW Low Energy

Lithium Coin cell,
Non-rechargeable

3 yearsShelf Life

1 yearService Life

0 to 40ºC
(32 to 104ºF)

-20 to 60ºC
(-4 to 140ºF)

15 to 95% RH
(non-condensing)

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,

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

declares that this

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

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

SmartTouch™ is manufactured by:

Adherium (NZ) Ltd

Level 2, 204 Quay Street
Auckland 1010
New Zealand

SmartTouch™ (Non-Rechargeable)
Product Manual

Part Number ND0002
Version 7
Issue Date 14 January 2016

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

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