User Manual

FCC ID: PN2-STC1

Users Manual

Download: PDF
FCCID_2883594

Preparation for First Use Compatible MDI Devices Installation (for tethered MDI) Removal (for tethered MDI) mode. The LED will flash blue when the The upload of new information will occur Following manufacture the SmartTouch is The SmartTouch is designed to work only To install the SmartTouch, open the MDI cap, Open the MDI cap. While holding each side of SmartTouch is in pairing mode. automatically as long as the SmartTouch placed in Deep-Sleep mode to conserve with the MDI and medication indicated on and align the MDI with the back of the the SmartTouch, gently push the mouthpiece 3) Follow any prompts on your is within range (5 meters or 16 feet) of the SmartTouch. Push the MDI firmly into the of the MDI to remove the MDI from the smartphone or tablet computer to communication device. battery life. To wake up the device, hold the device label. SmartTouch, ensuring the mouth piece of the SmartTouch. Close the MDI cap. down the Status Button for 3 seconds select and accept pairing with the MDI goes through the front window on the and then release. Press the Status Button SmartTouch. The LED will flash green to Note: Refer to the instruction manual for Installing or Removing an MDI SmartTouch. Close the MDI cap. 1 2 once more to check the battery level. The indicate pairing is successful. your specific communication device for Product Manual Installation (for non-tethered MDI) device LED should flash green prior to To install the SmartTouch, align the MDI with 1 2 more information on this process. first use. the back of the SmartTouch. Push the MDI Note: If pairing is not successful within 60 firmly into the SmartTouch, ensuring the seconds the LED will flash red. The Manually Uploading Stored To check if a device is still in Deep-Sleep mouth piece of the MDI goes through the front pairing process can be repeated if Information mode, press the Status Button once. The window on the SmartTouch. necessary. If required to ensure all current data has LED will flash pink if it is still in Deep- Note: The SmartTouch can only be paired 1 2 been transferred, the SmartTouch can Sleep; and green, orange, or red (to with a single smartphone or tablet manually upload information to a paired indicate battery level) if it has previously computer at a time. Starting the pairing Bluetooth smartphone or tablet computer. been awoken from Deep-Sleep. process removes the current paired To manually upload stored information 3 4 device. from the SmartTouch: If you plan to use Smartinhaler Connection Centre™ to review usage Delivering a Dose of Medication 1) Hold down the Status Button until the data, please refer to instructions on Caution: This manual is not intended to LED shows pink, then release. SmartinhalerLive.com before first use. replace the advice provided by a The SmartTouch LED flashes after 3 4 2) The LED will flash pink while the healthcare professional. Directions for detecting a medication dose has been SmartTouch attempts to upload, then Removal (for non-tethered MDI) using prescription medication should be actuated. SmartTouch Components While holding each side of the SmartTouch, flash green if the upload is successful. obtained from a healthcare professional gently push the mouthpiece of the MDI to and followed accordingly. Any questions Reminders Note: The SmartTouch LED will flash red if remove the MDI from the SmartTouch. related to prescription medication should Audio-visual reminders can be set up the upload is not successful. Check the Smart be referred to a healthcare professional. from a Smartinhaler app or via SmartTouch is within range of the Touc 1 2 USE ONLY h Please refer to the labeling provided with Smartinhaler Connection Centre. smartphone or tablet computer, and it has Medic ation WITH Nam Setting Up Bluetooth the inhaler for instructions on use. If enabled, the medication reminders are 0000 e 2 Bluetooth communications enabled. 1 01 Communications generated with increasing frequency for The SmartTouch must be paired with a To use the SmartTouch with a spacer, up to 24 minutes, or until the installed Reviewing the Battery Level 2016 Adheriu Aucklan m (NZ) smar d 1010,Lim ited tinhaNew Zealand compatible Bluetooth smartphone or hold the SmartTouch in one hand with the MDI is actuated. ler.co m tablet computer in order to upload stored The LED on the main face indicates the thumb at the base of the SmartTouch and FCC ID: IC: 205 PN2-STC1 battery level of the SmartTouch after 09-STC 1 usage data. To pair the SmartTouch with a the index finger and second finger on top 3 Upload of SmartTouch Usage medication is actuated, or when the smartphone or tablet computer: of the medication canister. Use the other 1) Follow the instructions on your Data Status Button is pressed: Key hand to support the spacer chamber. The MDI usage history can be smartphone or tablet computer to put it • Green – the battery level is good, and 1. Light Emitting Diode (LED) automatically uploaded via a compatible in pairing mode. the SmartTouch is monitoring 2. Use only with this medication paired smartphone or tablet computer. 2) On the SmartTouch press the Status actuations. 3. Status Button Button 3 times quickly to enter pairing

• Orange – the battery level is getting Other wireless communications Cautions identify actions or situations that is used to log the date and time of US only: Caution - Federal law Wireless Bluetooth 4.0: Operation is subject to the following two by any means, electronic, mechanical, low. The SmartTouch is still monitoring equipment such as wireless home that could damage the SmartTouch, or MDI actuation. The SmartTouch registers restricts this device to sale by or Technology 2.40 - 2.48 GHz, conditions: photocopying, recording, or otherwise, actuations. network devices, mobile phones, cordless other equipment, or affect the accuracy or MDI actuations. Usage data can be on the order of a physician. 2.5 mW Low Energy 1) This device may not cause interference; without the prior written permission of • Red – the battery is flat. The telephones and their base stations, and availability of compliance data. uploaded via a wireless Bluetooth and Adherium (NZ) Ltd. SmartTouch has stopped monitoring walkie-talkies can affect the SmartTouch. connection. Battery Type Lithium Coin cell, 2) This device must accept any actuations. Increase the separation distance between Notes contain advisory information about Warranty Non-rechargeable interference, including interference that Product specifications may change • No flash – the battery is flat, or the the SmartTouch and any such devices if some aspect of the SmartTouch or its use. The SmartTouch includes a 12 month may cause undesired operation of the without notice. Safety and Usage Information Shelf Life 3 years SmartTouch device has failed, e.g. this could be causing problems. warranty against manufacturing defects device. Warning: To ensure your inhaler functions due to liquid immersion or mechanical from date of first use. This warranty may Service Life 1 year New Zealand Patent No. 614928 Terms and Abbreviations correctly, do not use the SmartTouch with stress. If this does not help, contact the supplier be voided under the following Operating 0 to 40ºC Patents Pending: PCT/NZ2014/000184 MDI Metered Dose Inhaler any other MDI or medication than that Le présent appareil est conforme aux or manufacturer for further assistance. circumstances: damage to the Temperature (32 to 104ºF) and NZ Pat. Appl. No. 703739 indicated on the device label. CNR d'Industrie Canada applicables aux SmartTouch including dropping, water New Zealand Design Appl. No. 419719 Cleaning the SmartTouch and SmartTouch Intended Use Warning: The SmartTouch does not damage resulting from condensation or Storage -20 to 60ºC appareils radio exempts de licence. MDI Servicing The SmartTouch is intended for single- contain a dose counter. Do not use data immersion, tampering, attempts to Temperature (-4 to 140ºF) L'exploitation est autorisée aux deux Check the instructions from the MDI Please contact the supplier or patient use as an electronic data capture collected by the SmartTouch to determine service, or other forms of abuse. manufacturer for keeping the mouthpiece manufacturer for device servicing. Do not accessory for recording actuations of the number of doses remaining in a Operating / 15 to 95% RH conditions suivantes : Wellkang Ltd clean. Keep the SmartTouch clean and attempt to open or service the prescribed MDI usage. This may be used medication canister. Storage (non-condensing) 1) l'appareil ne doit pas produire de 29 Harley Street, Suite B The SmartTouch warranty expires 4 years free of chemicals, steam, water and dust. SmartTouch. Tampering with the device in the following applications: Caution: For hygiene and data integrity Humidity London W1G 9QR from date of manufacture. brouillage, et Clean the SmartTouch by wiping the voids the warranty. reasons, do not use the SmartTouch with United Kingdom more than one patient. 2) l'utilisateur de l'appareil doit accepter outside plastic enclosure with a lightly • In clinical trials, where researchers need Specifications dampened cloth. Leave it to dry in a warm Disposal to know when a patient has actuated Caution: Take care to not spill liquids on FCC Statement tout brouillage radioélectrique subi, SmartTouch™ is manufactured by: place that is less than 30°C. Dispose or recycle the SmartTouch in their trial MDI medication. the SmartTouch or immerse it in water. This device complies with Part 15 of the même si le brouillage est susceptible Adherium (NZ) Ltd Actuation Log 1 second Warning: The SmartTouch is a battery accordance with regulations for your • In clinical practice, where specialists, Note: The SmartTouch does not detect or FCC Rules. Operation is subject to the Level 2, 204 Quay Street Precision d'en compromettre le fonctionnement. powered electronic device. Do not country, as applicable for electronic general practitioners, nurses, and record inhalation by the user. The following two conditions: Auckland 1010 immerse the SmartTouch in water. devices containing a lithium coin-cell educators need to know if a patient has SmartTouch does not record the quantity Actuation Log 6140 actuations and 1) This device may not cause harmful New Zealand Do not use the SmartTouch if it is not in battery. actuated their prescribed MDI of medication delivered by the MDI. Capacity device status records interference, and RF Exposure Statement good condition. medication. 2) This device must accept any This equipment complies with the SmartTouch™ (Non-Rechargeable) Symbols Internal Clock ± 1 hour after RSS-102 radiation exposure limits set EU only: Do not dispose of the • In self-management, where patients interference received, including Product Manual Accuracy 12 months. Note: the forth for an uncontrolled environment. Storage SmartTouch as unsorted municipal waste. need to track their medication interference that may cause undesired Part Number ND0002 Manufacturer: Adherium (NZ) Ltd SmartTouch clock is To help maintain battery capacity, store The SmartTouch must be recycled in use as part of their management plan. operation. Version 7 updated every time your SmartTouch below 30°C. Keep out of accordance with Directives 2012/19/EU Serial Number data is uploaded Declaration of Conformity Issue Date 14 January 2016 direct sunlight and avoid extreme and 2006/66/EC. To arrange for return or The SmartTouch is not intended to Note: The Grantee is not responsible for Adherium (NZ) Ltd declares that this temperatures. disposal of the SmartTouch contact your indicate remaining quantity of medication Year of Manufacture Compatible iOS 7.1 and above, any changes or modifications not SmartTouch is in compliance with the local supplier. in an MDI and does not include a dose With running on: expressly approved by the party essential requirements and other relevant Troubleshooting counting function. Keep Dry • iPhone 4 and later responsible for compliance. Such provisions of Directives 1999/5/EC and All product names and brand names in If the SmartTouch is not responding to Warnings, Cautions, and Notes • iPad 3 and later modifications could void the user’s 93/42/EEC. this document are trademarks or Warnings identify actions or situations How the SmartTouch Works Non-Rechargeable Device • iPad mini 1st Gen authority to operate the equipment. Email contact@smartinhaler.com for a registered trademarks of their respective Bluetooth communications, check the SmartTouch battery level as per that could lead to personal injury. Take The SmartTouch is a small battery- and later copy of the declaration of conformity. holders. EU only: Do not dispose of the Reviewing the Battery Level in this note of all warnings before using the powered electronic data logger that • iPod Touch 5th Gen IC Statement SmartTouch as unsorted manual. SmartTouch. attaches to an MDI. The SmartTouch and later This device complies with Industry No part of this document may be © Copyright Adherium (NZ) Ltd 2016. municipal waste contains an electronic clock and calendar Android v4.4 and above Canada’s licence-exempt RSSs. reproduced or transmitted in any form or All rights reserved.


Document Created: 2016-01-15 08:36:28
Document Modified: 2016-01-15 08:36:28
© 2024 FCC.report
This site is not affiliated with or endorsed by the FCC