SmartTouch Symbicort Product Manual

FCC ID: PN2-SYM1

Users Manual

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FCCID_2979383

4. Battery Check Button 1) Follow the communications device cancelled by holding down the Reminder • No flash – the battery is flat, or the 5. Pair LED instructions to put it in pairing mode. Button. SmartTouch device has failed, e.g. due to 6. Pair Button 2) On the SmartTouch press the Pair Button liquid immersion or mechanical stress. 7. USB Port 3 times to enter pairing mode. Reviewing SmartTouch Usage Data The Pair LED will flash blue when the Symbicort® Compatible MDI Devices SmartTouch is in pairing mode. The MDI usage history can be automatically Cleaning the SmartTouch and MDI uploaded via a compatible paired Check the instructions from the MDI 3) Follow any communications device Product Manual The SmartTouch is designed to work only with the MDI and medication indicated on the prompts to select and accept pairing with communications device such as a manufacturer for keeping the mouthpiece smartphone. clean. Keep the SmartTouch clean and free device label: the SmartTouch. The Pair LED will flash of chemicals, steam, water and dust. Clean • For use with Symbicort® MDIs. green to indicate pairing is successful. The upload of new information will occur the outside plastic enclosure with a lightly automatically as long as the SmartTouch is dampened cloth. Leave it to dry in a warm Note: If pairing is not successful within 60 Installing or Removing an MDI within range (5 meters or 16 feet) of the place that is less than 30°C. seconds the Pair LED will flash red. The communication device. Warning: The SmartTouch is a battery 1 2 pairing process can be repeated if necessary. powered electronic device. Do not immerse Note: The SmartTouch can only be paired with Note: Refer to the instruction manual for your the SmartTouch in water. a single communications device at a time. specific communication device for more Do not use the SmartTouch if it is not in Starting the pairing process removes the information on this process. good condition. current paired device. Manually Uploading Stored Storing the SmartTouch Delivering a Dose of Medication To help maintain battery capacity, store your Caution: This manual does not provide Information If required to ensure all current data has been SmartTouch below 30°C. Keep out of direct information on how to use prescription MDI transferred, the SmartTouch can manually sunlight and avoid extreme temperatures. medication, and is not intended to replace the 3 4 advice provided by a healthcare professional. upload information to a paired Bluetooth Directions for using prescription medication communications device. To manually upload Troubleshooting should be obtained from a healthcare stored information from the SmartTouch: If the SmartTouch is not responding to professional and followed accordingly. Any 1) Hold down the Pair Button for 3 seconds Bluetooth communications, check the questions related to prescription medication until the Pair LED shows white, then SmartTouch battery level as per Reviewing Preparation for First Use release. the Battery Level in this manual. Before first use remove the Battery Saver should be referred to a healthcare professional. Please refer to the labeling 2) The Pair LED will flash white while the Other wireless communications equipment Pull Tab. SmartTouch attempts to upload, then such as wireless home network devices, provided with the inhaler for instructions on use. flash green if the upload is successful. mobile phones, cordless telephones and If you plan to use Smartinhaler Connection their base stations, and walkie-talkies can Center™ to review usage data, please refer Note: The SmartTouch Pair LED will flash red if affect the SmartTouch. Increase the to instructions on SmartinhalerLive.com The SmartTouch LED flashes after detecting a Installation medication dose has been actuated. the upload is not successful. Check the separation distance between the before first use. SmartTouch is within range of the paired SmartTouch and any such devices if this To install the inhaler, open the door of the SmartTouch by pulling the Door Latch. Push communications device, and the could be causing problems. SmartTouch Components Dose Check communications device has Bluetooth® the MDI into the SmartTouch. Close the door You can check if the prescribed dose has so it clicks into place. communications enabled. If this does not help, contact the supplier or been taken within the last 6 hours by pressing manufacturer for further assistance. 1 the Reminder Button once. If the LED flashes 000001 000001 5 Removal green the prescribed dosage has not been Reviewing the Battery Level 2 To remove the inhaler, pull the Door Latch to taken, if the LED flashes red no doses are The LED on the main face indicates the Servicing 3 6 open the door of the SmartTouch. Pull the MDI overdue. battery level of the SmartTouch after Please contact the supplier or manufacturer 7 to remove it from the SmartTouch. Close the medication is actuated, or when the Battery for device servicing. Do not attempt to open 4 Check Button is pressed: or service the SmartTouch. Tampering with door so it clicks into place. Reminders • Green – the battery level is good, and the the device voids the warranty. Audio-visual reminders can be set up from a Setting Up Bluetooth SmartTouch is monitoring actuations. Smartinhaler app or via Smartinhaler • Orange – the battery level is getting low. Disposal Communications Connection Center. The SmartTouch is still monitoring The SmartTouch must be paired with a If enabled, the medication reminders are Dispose or recycle the SmartTouch in Key actuations. compatible Bluetooth communications device generated with increasing frequency for up to accordance with regulations for your 1. Door Latch • Red – the battery is flat. The SmartTouch in order to upload stored usage data. To pair 24 minutes until either the prescribed country, as applicable for electronic devices 2. Light Emitting Diode (LED) has stopped monitoring actuations. the SmartTouch with a communications medication dose is taken or the Reminder is containing a lithium polymer battery. 3. Reminder Button device:

EU only: Do not dispose of the SmartTouch date and time of MDI actuation. The SmartTouch warranty expires 5 years two conditions: electronic, mechanical, photocopying, as unsorted municipal waste. from date of manufacture. 1) This device may not cause harmful recording, or otherwise, without the prior The SmartTouch must be recycled in The SmartTouch registers MDI actuations. interference, and written permission of Adherium (NZ) Ltd. accordance with Directives 2012/19/EU and Usage data can be uploaded via a wireless 2) This device must accept any interference Specifications 2006/66/EC. To arrange for return or disposal Bluetooth connection. received, including interference that may Product specifications may change without of the SmartTouch contact your local Weight 24 grams, excluding MDI cause undesired operation. notice. supplier. Safety and Usage Information Size 41 x 36 x 66mm (L x W x H) Note: The Grantee is not responsible for any Product covered by a NZ Design Application Warning: To ensure your inhaler functions excluding MDI Warnings, Cautions, and Notes correctly, do not use the SmartTouch with any changes or modifications not expressly No. 421072. Warnings identify actions or situations that Actuation Log 1 second approved by the party responsible for Patent pending. other MDI or medication than that indicated could lead to personal injury. Take note of all Precision compliance. Such modifications could void on the device label. warnings before using the SmartTouch. the user’s authority to operate the equipment. Warning: The SmartTouch does not contain a Actuation Log 6144 actuations and device dose counter. Do not use data collected by Capacity status records Cautions identify actions or situations that IC Statement Wellkang Ltd the SmartTouch to determine the number of could damage the SmartTouch, or other Internal Clock ± 1 hour after 12 months This device complies with Industry 29 Harley Street, Suite B doses remaining in a medication canister. equipment, or affect the accuracy or Accuracy Note: the SmartTouch clock Canada’s licence-exempt RSSs. London W1G 9QR Caution: For hygiene and data integrity availability of compliance data. is updated every time data is Operation is subject to the following two United Kingdom reasons, do not use the SmartTouch with more than one patient. uploaded conditions: Notes contain advisory information about 1) This device may not cause interference; Australian Sponsor Caution: Take care to not spill liquids on the some aspect of the SmartTouch or its use. Compatible iOS 7.1 and above, running and Market Access Australia Pty Ltd SmartTouch or immerse it in water. With on: 2) This device must accept any interference, 810 Pacific Highway Note: The SmartTouch does not detect or Terms and Abbreviations • iPhone 4 and later including interference that may cause Gordon NSW 2072 record inhalation by the user. The SmartTouch MDI Metered Dose Inhaler • iPad 3 and later undesired operation of the device. Australia does not record the quantity of medication • iPad mini 1st Gen and delivered by the MDI. later Le présent appareil est conforme aux CNR SmartTouch™ Symbicort is manufactured SmartTouch Intended Use • iPod touch 5th Gen and by: d'Industrie Canada applicables aux appareils The SmartTouch is intended for Symbols later Adherium (NZ) Ltd single-patient use as a medication reminder radio exempts de licence. L'exploitation est Manufacturer: Adherium (NZ) Ltd. Android v4.4 and above autorisée aux deux conditions suivantes : Level 2, 204 Quay Street and electronic data capture accessory for 1) l'appareil ne doit pas produire de brouillage, Auckland 1010 recording actuations of prescribed MDI Wireless Bluetooth 4.0: 2.40-2.48 GHz, Serial Number et New Zealand usage. This may be used in the following Technology 2.5 mW Low Energy 2) l'utilisateur de l'appareil doit accepter tout Phone : +64 9 307 2771 applications: Year of Manufacture Battery Type Lithium Coin Cell, brouillage radioélectrique subi, même si le contact@smartinhaler.com • In clinical trials, where researchers need to Non-rechargeable brouillage est susceptible d'en www.smartinhaler.com know when a patient has actuated their Keep Dry trial MDI medication. compromettre le fonctionnement. Shelf Life 3 years • In clinical practice, where specialists, Non-Rechargeable Device RF Exposure Statement SmartTouch™ Symbicort® Product general practitioners, nurses, and Service Life 1 year EU only: Do not dispose of the This equipment complies with the RSS-102 Manual educators need to know if a patient has SmartTouch as unsorted municipal radiation exposure limits set forth for an Part Number ND0274 actuated their prescribed MDI medication. Battery Life 12 months, depending on waste uncontrolled environment. Version 2 • In self-management, where patients need usage Issue Date 2 March 2016 to track their medication use as part of US only: Caution - Federal law restricts Operating 0 to 40ºC (32 to 104ºF) their management plan. this device to sale by or on the order Temperature Declaration of Conformity of a physician Adherium (NZ) Ltd declares that this Symbicort® is a registered trade mark of The SmartTouch is not intended to indicate Storage -20 to 60ºC (-4 to 140ºF) SmartTouch is in compliance with the AstraZeneca. remaining quantity of medication in an MDI Temperature essential requirements and other relevant Warranty and does not include a dose counting provisions of Directives 1999/5/EC and The SmartTouch includes a 12 month Operating / 15 to 95% RH All product names and brand names in this function. 93/42/EEC. warranty against manufacturing defects from Storage (non-condensing) document are trademarks or registered date of first use. This warranty may be voided Humidity Email contact@smartinhaler.com for a copy of trademarks of their respective holders. How the SmartTouch Works under the following circumstances: damage to the declaration of conformity. The SmartTouch is a small battery- powered the SmartTouch including dropping, water © Copyright Adherium Ltd 2016. All rights electronic data logger that attaches to an damage resulting from condensation or FCC Statement reserved. MDI. The SmartTouch contains an electronic immersion, tampering, attempts to service, or This device complies with Part 15 of the FCC No part of this document may be reproduced clock and calendar that is used to log the other forms of abuse. Rules. Operation is subject to the following or transmitted in any form or by any means,


Document Created: 2016-03-02 16:33:55
Document Modified: 2016-03-02 16:33:55
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