PRODUCT MANUAL Table of Contents Preparation for First Use Warnings, Cautions, and Notes Smartinhaler Sensor Components Terms and Abbreviations Compatible MDI Devices Installing or Removing an MDI Setting up Bluetooth Communications Delivering a Dose of Medication Reminders Reviewing Smartinhaler Sensor Usage Data Manually Uploading Stored Information Reviewing Battery Level Recharging the Smartinhaler Sensor -
Rechargeable Sensor Only Cleaning the Smartinhaler Sensor and MDI 4 5 5 6 6 6 10 10 12 12 12 13 14 14 Storage Troubleshooting Servicing Disposal Smartinhaler Sensor Intended Use How the Smartinhaler Sensor Works Safety and Usage Information Symbols Warranty Specifications Smartinhaler Sensor Specifications FCC Statement IC Statement RF Exposure Statement Declaration of Conformity 15 15 16 16 16 17 17 18 19 19 20 20 21 22 22 Preparation for First Use Rechargeable Sensor - NF0090 Following manufacture the Smartinhaler sensor is placed in Deep-Sleep mode to conserve battery life. Before first use, place the Smartinhaler sensor on charge for a minimum of 3 hours or until the LED stops flashing green. This will wake the Smartinhaler sensor from Deep-
Sleep mode and the Smartinhaler sensor is ready to use. Non-Rechargeable Sensor - NF0091 Following manufacture, the Smartinhaler sensor is placed in Deep-Sleep mode to conserve battery life. To wake up the Smartinhaler sensor, hold down the Status Button for 3 seconds and then release. Press the Status Button once more to check the battery level. The Smartinhaler sensor LED should flash green prior to first use. Warnings, Cautions, and Notes Warnings identify actions or situations that could lead to personal injury. Take note of all warnings before using the Smartinhaler sensor. Cautions identify actions or situations that could damage the Smartinhaler sensor or other equipment, or affect the accuracy or availability of recorded actuation data. Notes contain advisory information about some aspect of the Smartinhaler sensor or its use. 4 Smartinhaler Sensor Components Key:
1. Use only with this medication 2. Light Emitting Diode (LED) 3. Battery type see Symbols section for more information 4. Status Button (reminder button/battery check button) 5. USB port (only used for NF0090 to recharge battery) Terms and Abbreviations MDI Metered Dose Inhaler. Compatible MDI Devices The Smartinhaler sensor is designed to work only with the MDI and medication indicated on the Smartinhaler sensor label. 5 Installing or Removing an MDI Installation (for non-tethered MDI) To install the Smartinhaler sensor, align the MDI with the back of the Smartinhaler sensor. Push the MDI firmly into the Smartinhaler sensor, ensuring the mouth piece of the MDI goes through the front window on the Smartinhaler sensor. 6 Removal (for non-tethered MDI) While holding each side of the Smartinhaler sensor, gently push the mouthpiece of the MDI to remove the MDI from the Smartinhaler sensor. 7 Installation (for tethered MDI) To install the Smartinhaler sensor, open the MDI cap, and align the MDI with the back of the Smartinhaler sensor. Push the MDI firmly into the Smartinhaler sensor, ensuring the mouth piece of the MDI goes through the front window on the Smartinhaler sensor. Close the MDI cap. 8 Removal (for tethered MDI) Open the MDI cap. While holding each side of the Smartinhaler sensor, gently push the mouthpiece of the MDI to remove the MDI from the Smartinhaler sensor. Close the MDI cap. 9 Setting Up Bluetooth Communications The Smartinhaler sensor must be paired with a compatible Bluetooth smartphone or tablet computer in order to upload stored usage data. Refer to Smartinhaler App on App store or on Google Play for more information. To pair the Smartinhaler 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 Smartinhaler sensor press the Status Button 3 times quickly to enter pairing mode. The LED will flash blue when the Smartinhaler sensor is 3. Follow any prompts on your smartphone or tablet computer to select and accept pairing with the Smartinhaler sensor. The LED will flash green to indicate pairing is successful. in pairing mode. If pairing is not successful within 60 seconds the LED will flash red. The pairing process can be repeated if necessary. The Smartinhaler sensor can only be paired with a single smartphone or tablet computer at a time. Starting the pairing process removes the current paired Smartinhaler sensor. 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 Smartinhaler sensor LED flashes after detecting a medication dose has been actuated. 10 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. To use the Smartinhaler sensor with a spacer, hold the Smartinhaler sensor in one hand with the thumb at the base of the Smartinhaler sensor and the index finger and second finger on top of the medication canister. Use the other hand to support the spacer chamber. The Smartinhaler sensor LED flashes after detecting a medication dose has been actuated. 11 Reminders Audio-visual reminders can be set up from a Smartinhaler 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. The LED always flashes green when the reminder activates. To cancel the reminder, hold down the status button until the LED flashes red. There will be a beep sound along with the red flash to notify that the reminder is now cancelled. Reviewing Smartinhaler 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 as long as the Smartinhaler sensor is within range (5 meters or 16 feet) of the smartphone or tablet computer. When travelling ensure your communications device is set to the local time zone for accuracy of MDI actuation logs. Manually Uploading Stored Information To ensure all current data has been transferred, the Smartinhaler sensor can manually upload information to a paired Bluetooth smartphone or tablet computer. 12 To manually upload stored usage data from the Smartinhaler sensor 1. Hold down the Status Button until the LED shows white, then release. 2. The LED will flash white while the Smartinhaler upload is successful. sensor attempts to upload, then flash green if the The Smartinhaler sensor LED will flash red if the upload is not successful. Check the Smartinhaler sensor is within range of the paired smartphone or tablet computer, and ensure that Bluetooth communications enabled. Reviewing the Battery Level The LED on the main face indicates the battery level of the Smartinhaler sensor after medication is actuated, or when the Status Button is pressed:
Colour Meaning Green The battery level is good, and the Smartinhaler sensor is monitoring actuations. Orange The battery level is getting low. The Smartinhaler sensor is still monitoring actuations. Red No Flash The battery is dead. The Smartinhaler sensor has stopped monitoring actuations. The battery is dead, or the Smartinhaler sensor has failed, e.g. due to liquid immersion or mechanical stress. 13 Recharging the Smartinhaler Sensor -
NF0090 only The Smartinhaler sensor contains an internal rechargeable battery and is recharged via the USB port. To recharge the Smartinhaler sensor, connect it to a computer USB port or USB wall plug adaptor, using the supplied connector. When connected to a charging source, the LED will flash slowly according to the battery level. When charging is complete, the LED will stop flashing. The Smartinhaler sensor should not be used while charging. Allow up to 3 hours to fully recharge a Smartinhaler sensor that is displaying a red flashing LED. The Smartinhaler sensor should be recharged every 4 months as a minimum to ensure continued battery function. Cleaning the Smartinhaler Sensor and MDI Check the instructions from the MDI manufacturer for keeping the mouthpiece clean. Keep the Smartinhaler sensor clean and free of chemicals, steam, water and dust. Clean the outside plastic enclosure with a lightly dampened cloth. Check the Smartinhaler sensor is clean and repeat if necessary. Leave it to dry in a warm place that is less than 30C (86F). The Smartinhaler sensor is battery-powered and electronic. Do not immerse the Smartinhaler sensor in water. Do not use the Smartinhaler sensor if it is not in good condition. 14 Storage To help maintain battery capacity, store your Smartinhaler sensor below 30C (86 F). Keep out of direct sunlight and avoid extreme temperatures. Troubleshooting If the Smartinhaler sensor is not responding to Bluetooth communications, check the Smartinhaler 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 Smartinhaler sensor, and should be kept at least 30cm (12in) away. Increase the separation distance between the Smartinhaler sensor and any such devices if this could be causing problems. If this does not help, contact the supplier or manufacturer for further assistance. Customer Support For support on this product, email us at support@smartinhaler.com or call us on +64 9 307 2771. For information about your medical condition, please speak to your healthcare provider directly. 15 Servicing Please contact the supplier or manufacturer for Smartinhaler sensor servicing. Do not attempt to open or service the Smartinhaler sensor. Tampering with the Smartinhaler sensor voids the warranty. Disposal Dispose or recycle the Smartinhaler sensor in accordance with regulations for your country, as applicable for electronic devices containing a lithium polymer or lithium primary battery. Ensure that the inhaler is removed from the Smartinhaler sensor prior to disposal. EU only: Do not dispose of the Smartinhaler sensor as unsorted municipal waste. The Smartinhaler sensor must be recycled in accordance with Directives 2012/19/
EU and 2006/66/EC. To arrange for return or disposal of the Smartinhaler sensor contact your local supplier. Smartinhaler Sensor Intended Use The Smartinhaler sensor is intended for single patient use as a medication reminder and 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 16 The intended MDI is specified on the product label. The Smartinhaler sensor is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function. How the Smartinhaler Sensor Works The Smartinhaler sensor is a small battery-powered electronic data logger that attaches to an MDI. The Smartinhaler sensor contains an electronic clock and calendar that is used to log the date and time of MDI actuation. The Smartinhaler 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 Smartinhaler sensor with any other MDI or medication than that indicated on the Smartinhaler sensor label. The Smartinhaler sensor does not contain a dose counter. Do not use data collected by the Smartinhaler sensor to determine the number of doses remaining in a medication canister. Smartinhaler 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 Smartinhaler sensor with more than one patient. 17 Take care to not spill liquids on the Smartinhaler sensor or immerse it in water. The Smartinhaler sensor does not record the quantity of medication delivered by the MDI. Symbols Manufacturer: Adherium (NZ) Ltd Serial Number Year of Manufacture Keep dry Rechargeable Sensor Non-rechargeable Sensor EU only: Do not dispose Smartinhaler sensor as unsorted municipal waste Warranty The Smartinhaler sensor includes a 12 month warranty against manufacturing defects from date of first use. This warranty maybe voided under the following circumstances: damage to the Smartinhaler sensor including dropping, water damage resulting from condensation or immersion, tampering, attempts to service, or other forms of abuse. 18 The Smartinhaler sensor warranty expires 4 years from date of manufacture. Specifications Model numbers Actuation Log Precision Actuation Log Capacity Internal Clock Accuracy Compatible with Wireless Technology Operating Temperature Storage Temperature Operating /
Storage Humidity NF0090, NF0091 1 second 5120 actuations and sensor status records 1 hour after 12 months. Note: the Smartinhaler sensor clock is updated every time data is uploaded. iOS or Android smartphone and tablet devices. Refer to Apple App store or Google Play store for more information. Bluetooth 4.0: 2.40 - 2.48 GHz, 2.5 mW Low Energy 0 to 40C (32 to 104F)
-20 to 60C (-4 to 140F) 15 to 90% RH (non-condensing) at water vapour pressure 50 hPa 19 Smartinhaler Sensor Specifications Rechargeable Sensor Model Number Battery Type Shelf Life Service Life Lithium Polymer NF0090 2 years 2 years NF0091 Non-rechargeable Sensor Model Number Battery Type Shelf Life Service Life 1 year 3 years Lithium Primary FCC Statement The Smartinhaler sensor complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. The Smartinhaler sensor may not cause harmful 2. The Smartinhaler sensor must accept any may cause undesired operation. interference received, including interference that interference, and The Grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the users authority to operate the equipment. 20 IC Statement
(Non-Rechargeable Sensor Only - NF0091) The Smartinhaler sensor complies with Industry Canadas license-exempt RSSs. Operation is subject to the following two conditions:
interference; and 1. The Smartinhaler sensor may not cause 2. This Smartinhaler sensor must accept any undesired operation of the sensor. interference, including interference that may cause Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:
lappareil ne doit pas produire de brouillage, et lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. 1. 2. 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 declares that this Smartinhaler sensor is in compliance with the essential requirements and other relevant provisions of Directive 93/42/EEC. Email contact@smartinhaler.com for a copy of the declaration of conformity. 21 Hereby, Adherium (NZ) Ltd declares that the radio equipment type Smartinhaler sensor is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:
www.smartinhaler.com/RDC 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 specifications may change without notice. Patent/Design Notice -TBC Emergo Europe Prinsessegracht 20 2514 AP The Haque, The Netherlands Australian Sponsor Adherium Ltd Level 14, 140 William Street Melbourne Victoria 3000 Australia 22 Smartinhaler is manufactured by:
Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland 1010 New Zealand Smartinhaler Product Manual Part Number: ND0400 Version: 1 Issue Date: 19 Jan 2018 All product names and brand names in this document are trademarks or registered trademarks of their respective holders. Copyright Adherium (NZ) Ltd 2018. All rights reserved. 23 Customer Support For support on this product, email us at support@smartinhaler.com or call us on
+64 9 307 2771. For information about your medical condition, please speak to your healthcare provider directly.