Adherium STOC1 Users Manual

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SmartTouch

All product names and brand names in this document are

No part of this document may be reproduced

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Product specifications may change without notice.

is manufactured by:

contact@smartinhaler.com

Product Manual

NL0034 SmartTouch ProAir Product Manual (US Letter)

trademarks or registered trademarks

or transmitted in any form or by any means,

- v5.1.docx

ProAir Product Manual

of their respective holders.

permission of Nexus6 Ltd.

SmartTouch ProAir Nexus6 Ltd 8 Commerce Street, Suite 205 Auckland 1010 New Zealand Phone +64 9 307 2771 Fax +64 9 307 2773 Email Web www.smartinhaler.com

SmartTouch ProAir

Page 1

NL0034 SmartTouch ProAir Product Manual (US Letter) - v5.1.docx

pMDI

Pressurized Metered Dose Inhaler

Serial number

EU only:

o not dispose of the

US only: Caution

- Federal law restricts

Part Number NL0034 Revision 5.1 Issue Date 23 October 2012 Product Version STOUCHPROAIR

1 Who this Product Manual is intended for

This Product Manual is intended for users of the SmartTouch ProAir device, namely clinical trials investigators, healthcare professionals, patients with respiratory conditions, and patient caregivers.

2 Warnings, Cautions, and Notes

Warnings identify actions or situations that could lead to personal injury. Take note of all

warnings before using the SmartTouch ProAir.

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

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

3 Terms and Abbreviations

4 Symbols

Consult instructions for use

Manufacturer

SmartTouch ProAir or used batteries as unsorted municipal waste.

this device to sale by or on the order of a physician.

Intended Use

is intended for

actuation

In clinical trials, where researchers need to know when a patient has actuated their trial

practice, where specialists, general practitioners, and nurse educators need to

know if a patient has actuated their prescribed pMDI medication.

In self management, where patients need to track their medication

ProAir

is a small battery powered

internal

clock and calendar that is used to log the date and time

registers pMDI actuations.

Components

is designed

NL0034 SmartTouch ProAir Product Manual (US Letter)

lectronic

The SmartTouch

contains an internal electronic

The SmartTouch

Bluetooth

Light Emitting Diode (LED)

Upload Button

- v5.1.docx

5 SmartTouch ProAir

The SmartTouch ProAir device accessory for recording applications:

•

pMDI medication;

• In clinical

•

management plan.

6 How the SmartTouch

The SmartTouch ProAir ProAir is powered by an

ProAir connection.

single-patient use as an e

s of prescribed pMDI usage. This may be use

use

Works

electronic data logger.

non-rechargeable battery, and

of pMDI actuation.

Usage data can be uploaded via a wireless

data capture

in the following

as part of their

7 SmartTouch ProAir

8 Compatible pMDI Devices

The SmartTouch ProAir

Main face

to work with ProAir pMDI.

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NL0034 SmartTouch ProAir Product Manual (US Letter) - v5.1.docx

9 Safety and Usage Information

Warning: The SmartTouch ProAir does not contain a dose counter. Do not use information

collected by the SmartTouch ProAir to determine the number of doses remaining in a medication canister.

Caution: For hygiene and data integrity reasons, do not use the SmartTouch ProAir with more

than one patient.

Caution: Take care to not spill liquids on the SmartTouch ProAir or immerse it in water. Note: The SmartTouch ProAir does not detect or record patient inhalation within the pMDI it

is attached to. The SmartTouch ProAir does not record the quantity of medication delivered by the pMDI.

10 Installing or Removing a pMDI

Installation

To install the SmartTouch ProAir, align the pMDI with the back of the SmartTouch ProAir, and push the pMDI firmly into the SmartTouch, ensuring the mouth piece of the pMDI goes through the front window on the SmartTouch.

Removal

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

NL0034 SmartTouch ProAir Product Manual (US Letter) - v5.1.docx

11 Delivering a Dose of Medication

Caution: This manual does not provide information on how to use prescription pMDI

medication. 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 ProAir inhaler for instructions.

12 Uploading SmartTouch ProAir data

Data logged in the SmartTouch ProAir can be uploaded to the Smartinhaler Connection Center Desktop software for review. Data is transferred to the Connection Center Desktop software via Bluetooth wireless communication.

The Smartinhaler Connection Center Desktop software will need to be already installed onto the computer before data can be reviewed. The software can be downloaded from the SmartinhalerLive website (www.smartinhalerlive.com). Please follow the instructions on the SmartinhalerLive website to download and install the Smartinhaler Connection Center Desktop software.

12.1 Upload via Bluetooth

To upload data stored on the SmartTouch ProAir using Bluetooth communications, firstly click the Upload button on the Connection Center software. Press the Upload button located on the center of the SmartTouch ProAir main face (refer to image in Section 7). The button needs to be held down for 2 seconds before data communications commences. The SmartTouch ProAir searches for a Bluetooth device that it can communicate with, for example, Nexus6’s SmartKey.

While communicating, the LED on the top right corner of the main flashes blue. If the LED does not flash after pressing the Upload button, either:

• the battery is flat, or

• the SmartTouch ProAir device has failed, e.g. due to liquid immersion or mechanical

stress.

Caution: Do not initiate wireless Bluetooth communications when travelling on an aircraft.

13 Reviewing SmartTouch ProAir Usage Data on Smartinhaler Connection Center Desktop

NL0034 SmartTouch ProAir Product Manual (US Letter) - v5.1.docx

At a convenient time, the pMDI usage history can be uploaded to the Smartinhaler Connection Center Desktop software for review. This can be done as often as required. However, it is recommended that uploads are performed at least every 6 weeks. The SmartTouch ProAir can store up to one year of medication usage data in its memory.

14 Reviewing the battery level of your SmartTouch ProAir

The SmartTouch ProAir contains an internal non-rechargeable battery. The LED on the top right corner of the main face of the device allows you to review the battery level of the SmartTouch ProAir. The LED on the SmartTouch ProAir flashes one of the following three colours when you actuate the SmartTouch:

• Green – Indicates that the battery level is good, and that the monitoring of actuations is being performed by the SmartTouch ProAir.

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

Note: Do not deploy the SmartTouch ProAir to a new patient if the LED has switched to orange.

• Red – Indicates that the battery is flat. The SmartTouch ProAir has stopped monitoring actuations. Note: Do not deploy the SmartTouch ProAir to a new patient.

• No flash – the battery is flat, or, the SmartTouch ProAir device has failed, e.g. due to liquid immersion or mechanical stress.

The SmartTouch ProAir has a shelf life of 3 years from its Use By date and an active service life of 1 year (at an average daily use of two puffs twice daily).

15 Cleaning the SmartTouch ProAir and pMDI

Keep the SmartTouch ProAir clean and free of chemicals, steam, water and dust. Clean the SmartTouch ProAir 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 ProAir is a battery powered electronic device. Do not submerge the SmartTouch ProAir in water. Do not use the SmartTouch ProAir if it is not in good condition.

16 Storing the SmartTouch ProAir

Store your SmartTouch ProAir below 30°C. Keep out of direct sunlight and avoid extreme temperatures. Keep the SmartTouch ProAir out of reach of children.

NL0034 SmartTouch ProAir Product Manual (US Letter) - v5.1.docx

17 Trouble Shooting

If the SmartTouch ProAir is not responding to communications via Bluetooth, check the SmartTouch ProAir battery level as per section 14 of this manual. If this does not help, contact the supplier or manufacturer for further assistance.

18 Servicing

Please do not attempt to open or service the SmartTouch ProAir. Tampering with the device voids the warranty.

19 Disposal

Dispose or recycle the SmartTouch ProAir in accordance with regulations for your country. EU only: Do not dispose of the SmartTouch ProAir as unsorted municipal waste at the end of the product’s lifetime. The SmartTouch ProAir must be recycled in accordance with the WEEE Directive 2002/96/EC. To arrange for return or disposal of the SmartTouch ProAir contact your local supplier. EU only: Do not dispose of waste batteries as unsorted municipal waste. Device batteries must be recycled in accordance with the Battery Directive 2006/66/EC. Return waste batteries to an appropriate local collection point or contact your local supplier for disposal information.

NL0034 SmartTouch ProAir Product Manual (US Letter) - v5.1.docx

Weight

20 grams including battery, excluding

Size 50mm High × 38mm Wide x 35mm

Actuation Log

1 second

Actuation Log

4096 actuations and device status

Internal

Clock

± 20 minutes

after

12 months

Bluetooth

Bluetooth Low Energy

(BLE)

v4.0

Battery Type

Lithium

Battery Life

3 year shelf life and 1 year service life

Operating

0 to 40 °C (32 to 104 °F)

Operating

25 to 90% at 40 °C (non

condensing)

Storage

20 to 60 °C (

4 to 140 °F)

Storage

25 to 95% at 40 °C (non

condensing)

20 Warranty

The SmartTouch ProAir includes a 24 month warranty against manufacturing defects. 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.

21 Specifications

pMDI

Long excluding the pMDI

resolution

22 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 MODIFICATIONS NOT EXPRESSLY APPROVED BY THE PARTY RESPONSIBLE FOR COMPLIANCE. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY TO OPERATE THE EQUIPMENT.

Capacity

Accuracy

Temperature

Humidity

Temperature

Humidity

records

Note: the SmartTouch ProAir clock is updated every time data is uploaded to Nexus6 software.

Adherium STOC1 Users Manual

Specifications and Main Features

Frequently Asked Questions

User Manual