SmartTouch Product Manual Preparation for First Use Following manufacture the SmartTouch AV is placed in Deep-Sleep mode to conserve battery life. Removal (for non-tethered MDI) While holding each side of the SmartTouch AV, gently push the mouthpiece of the MDI to remove the MDI from the SmartTouch AV. 1 3 Before rst use place the SmartTouch AV on charge for 1.5 hours or until the battery indicator is showing a full charge. This will wake the device from Deep-Sleep mode. When SmartTouch AV is fully recharged, disconnect from the power supply. If you plan to use Smartinhaler Connection Centre to review usage data, please refer to instructions on SmartinhalerLive.com before
rst use. SmartTouch AV Components MDI Touch User Interface SmartTouch AV Power Button USB Port 2 4 Compatible MDI Devices The SmartTouch AV is designed to work only with the MDI and medication indicated on the device label. Installing or Removing an MDI 1 2 Installation (for tethered MDI) To install the SmartTouch AV, open the MDI cap, align the MDI with the back of the SmartTouch AV, and push the MDI rmly into the SmartTouch AV, ensuring the mouth piece of the MDI goes through the front window on the SmartTouch AV, close the MDI cap. 1 3 2 4 Installation (for non-tethered MDI) To install the SmartTouch AV, align the MDI with the back of the SmartTouch AV, and push the MDI rmly into the SmartTouch AV, ensuring the mouth piece of the MDI goes through the front window on the SmartTouch AV. 1 2 Removal (for tethered MDI) Open the MDI cap, while holding each side of the SmartTouch AV, gently push the mouthpiece of the MDI to remove the MDI from the SmartTouch AV, close the MDI cap. Delivering a Dose of Medication Caution: This manual does not provide information on how to use prescription MDI medication, and 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. The SmartTouch AV will show a dose taken image on its screen after detecting a medication dose has been actuated. This is followed by Dose Taken question, which the user can answer Yes ( ) or No ( ). If no response is registered the SmartTouch AV will record as a medication dose. Navigating the SmartTouch AV Menu The SmartTouch AV main menu can be accessed after the SmartTouch AV is switched on by pressing the power button. You can navigate to the sub menus of each of the four icons on the main menu. The date and time of the internal clock, and the battery indicator are shown on the top of the main menu. Clock Date
& Time 24-Hour Dashboard 7-Day Dashboard Battery Indicator Chart Settings Once a menu has been entered, the following icons can be used to navigate around each individual page:
Scroll Up Scroll Down Return Select Cancel 24-Hour Dashboard The 24-Hour Dashboard menu indicates when the medication was last used and how much was used in last 24 hours. Tap the screen to show this information. Taken last 24 hours indicates the number of doses taken in the previous 24 hours. Preventer Only Adherence today indicates the percentage adherence with the prescribed dose during the current day. Reliever Only Including Night uses indicates the total number of doses taken between midnight and 6 am. 7-Day Dashboard The 7-Day Dashboard menu indicates how many doses were taken in the last 7 days, the percentage adherence and when last taken. Taken last 7 days indicates the number of doses taken during the last 7 days, including the current day. Preventer Only Adherence last 7 days indicates the percentage adherence with the prescribed dose during the last 7 days. Reliever Only Including Night uses indicates the total number of doses taken between midnight and 6 am during the last 7 days. Chart The Chart menu displays the total number of doses actuated by day over the last 7 days, including the current day. Use the Scroll Down arrow to view medication usage for previous weeks. Settings The Settings menu allows you to change the internal clock settings, set reminders, upload data and pair SmartTouch AV with a Smartphone. Set Clock The Set Clock allows the SmartTouch AV internal clock to be changed. To change the internal clock, navigate to the Set Clock menu. Use the Scroll Up or Scroll Down buttons to change the time zone, press Select to conrm. Use the Scroll Up or Scroll Down buttons to change the date and time value (selection to change ashing). Holding down the Scroll Up or Scroll Down buttons will change the value quickly. Press Select to conrm and move to the next time unit in the order of day, month, year, hour and minute. Reminders Note: The reminder functionality is only available on monitors which are designed for preventer medications. Reminders Sub Menu - On/Off The Reminder On/Off Menu enables or disables the reminder. Press Select to enter the Reminder On/Off screen. Change the Reminder On/Off setting using the Scroll Up or Scroll Down buttons to set it to Play All, Play Selected or Off. Press Select to conrm or Cancel to exit. If enabled, the medication reminder tunes play at the times congured in the Reminder Times screen for up to 25 minutes, or until the installed pMDI is actuated the number of times set in the Doses menu. Reminders Sub Menu Ringtones The Ringtones screen allows an audio reminder tune to be listened to. Press Select to enter the Ringtones screen. Use the Scroll Up or Scroll Down buttons to change the selection. Press Select to preview and select the displayed tune or press Return to exit. Note when Select is pressed for a tone selection, that tune will play at the next reminder time. If Select is not pressed the selection will remain unchanged. Note: When a tune is playing press Select or Return to stop the playback. Reminders Sub Menu - Volume The Volume Menu sets the reminder volume to Normal or Loud. Press Select to enter the Volume screen. Change the Volume setting using the Scroll Up or Scroll Down buttons. Press Select to conrm or Return to exit. Reminders Sub Menu - Times Press Select to congure the Weekday AM/PM and Weekend AM/PM medication reminder times. Use the Scroll Up or Scroll Down buttons to change the time value (selection to change
ashing). Holding down the Scroll Up or Scroll Down buttons will change the value quickly. Press Select to move from the hour value to the minute value and to cycle through the Weekday AM, Weekday PM, Weekend AM, Weekend PM Reminder times. Press Return to exit. Reminders Sub Menu Doses The Doses screen sets the number of doses that will stop the audio reminder while the reminder is playing. Note that if the number of doses indicated is actuated any time in the previous 6 hours before the reminder is scheduled, then the reminder will not play until the next scheduled time is reached. Upload The Upload Menu is used to set up Bluetooth communications with other devices, such as Smartphones. Upload Sub Menu - Upload Now The Upload Now Menu allows the SmartTouch AV to upload the data manually to SmartinhalerLive mobile app. Press Select to enter the Upload Now screen. The data will start to upload and will give a conrmation of Upload Success or Failure. Upload Sub Menu - Pair The Pair Menu allows the SmartTouch AV to Pair with other devices, such as Smartphones. Press Select to enter the Pair screen. The SmartTouch AV will start pairing and will give a conrmation of Pairing Success or Failure. Starting the pairing process removes the current paired device. Locks The Locks Menu enables selected screens to be locked to the user. The default setting is no locked screens. The default lock code is 00000 The master unlock code is 13201 The code must be entered to access the lock menu. Locks Sub Menu - Set Locks Set Lock is used for changing the lock code. A new 5-digit code must be entered twice to complete the set lock process. Locks Sub Menu - Options The Options menu allows the SmartTouch AV reminder and device pairing menus to be lock to the user. Options are:
Reminder Menu (the entire reminder menu) Reminder Doses (the menu where the number of doses is set) Reminder Mode (the menu where the reminder on/off is set) Reminder Times (the menu where the reminder times are set) Device Pairing (pairing of a new device) Reviewing SmartTouch AV Usage Data At a convenient time, the pMDI usage history can be uploaded to www.smartinhalerlive.com for review. This can be done as often as required. However, it is recommended that uploads are performed at least once every month. The SmartTouch AV can store at least one year of medication usage data under normal usage. Note: Refer to the online training at SmartinhalerLive.com for more information on reviewing medication usage. Upload via USB To upload data to SmartinhalerLive.com for review, log in to www.smartinhalerlive.com and download and install the Smartinhaler Connection Center software. Connect the SmartTouch AV to the computer via the USB connection. Follow the instructions on the Connection Center to SmartTouch AV is manufactured by:
Adherium (NZ) Limited 8 Commerce Street, Suite 205 Auckland 1010, New Zealand Phone : +64 9 307 2771 contact@smartinhaler.com www.smartinhaler.com SmartTouch AV Product Manual Part Number ND0026-EN Version Issue Date 4 31 March 2016 All product names and brand names in this document are trademarks or registered trademarks of their respective holders. Copyright Adherium (NZ) Limited 2016. All rights reserved. preview and upload the usage data to www.smartinhalerlive.com. Note: Refer to the instruction manual for SmartinhalerLive.com for more information on downloading and installing the Smartinhaler Connection Center software. Recharging the SmartTouch AV The SmartTouch AV contains an internal rechargeable battery and is recharged via the USB connection. The Battery Indicator is shown on the screen when medication is taken or if the Power Button is pressed. When the Battery Indicator is red, the SmartTouch AV should be recharged. A battery low warning message will be displayed in conjunction with a red battery indicator. To charge the internal battery, connect the SmartTouch AV to a computer USB port or USB wall plug adaptor. When connected to a charging source, the Charging display is shown briey, and a power connection symbol appears on the Battery Indicator with increasing charge level. Charge completion is indicated by a steady Battery Indicator showing full charge. If the battery was at before charging, the SmartTouch AV may have lost its internal date and time settings. After charging, enter the Settings menu to set the SmartTouch AV internal calendar and clock to the local date and time. Refer to Set Clock in this manual for more information. Cleaning the SmartTouch AV and MDI Check the instructions from the MDI manufacturer for keeping the mouthpiece clean. Keep the SmartTouch AV clean and free of chemicals, steam, water and dust. Clean the SmartTouch AV by wiping the outside plastic enclosure with a lightly dampened cloth. Leave it to dry in a warm place that is less than 30C. Warning: The SmartTouch AV is a battery powered electronic device. Do not immerse the SmartTouch AV in water. Do not use the SmartTouch AV if it is not in good condition. Storing the SmartTouch AV To help maintain battery capacity, store your SmartTouch AV below 30C. Keep out of direct sunlight and avoid extreme temperatures. Troubleshooting If the SmartTouch AV is not responding to communications, check that the USB cable is plugged in correctly. If this does not help, please 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 AV. Tampering with the device voids the warranty. Disposal Dispose or recycle the SmartTouch AV in accordance with regulations for your country, as applicable for electronic devices containing a lithium polymer battery. EU only: Do not dispose of the SmartTouch AV as unsorted municipal waste. The SmartTouch AV must be recycled in accordance with Directives 2012/19/EU and 2006/66/EC. To arrange for return or disposal of the SmartTouch AV 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 AV. Cautions identify actions or situations that could damage the SmartTouch AV, or other equipment, or affect the accuracy or availability of compliance data. Notes contain advisory information about some aspect of the SmartTouch AV or its use. Terms and Abbreviations MDI Metered Dose Inhaler SmartTouch AV Intended Use The SmartTouch AV is intended for single-patient 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 AV is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function. How the SmartTouch AV Works The SmartTouch AV is a small battery-
powered electronic data logger that attaches to an MDI. The SmartTouch AV contains an electronic clock and calendar that is used to log the date and time of MDI actuation. The SmartTouch AV 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 AV with any other MDI or medication than that indicated on the device label. Warning: The SmartTouch AV does not contain a dose counter. Do not use data collected by the SmartTouch AV to determine the number of doses remaining in a medication canister. Caution: For hygiene and data integrity reasons, do not use the SmartTouch AV with more than one patient. Caution: Take care to not spill liquids on the SmartTouch AV or immerse it in water. Note: The SmartTouch AV does not detect or record inhalation by the user. The SmartTouch AV does not record the quantity of medication delivered by the MDI. Symbols Manufacturer: Adherium (NZ) Limited Serial Number Rechargeable Device Year of Manufacture Keep Dry EU only: Do not dispose of the SmartTouch AV 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 AV includes a 24 month warranty against manufacturing defects from date of rst use. This warranty may be voided under the following circumstances: damage to the SmartTouch AV 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. Specications Weight Size 31 grams, excluding MDI 36 x 41 x 59mm (L x W x H) excluding MDI Actuation Log Resolution 1 second Actuation Log Capacity 3712 actuations and device status records Internal Clock Accuracy 1 hour after 12 months. Note: the SmartTouch AV clock is updated every time data is uploaded Wireless Technology Battery Type Service Life Battery Life Operating Temperature Storage Temperature Operating /
Storage Humidity Bluetooth 4.0:
2.40 - 2.48 GHz, 2.5 mW Low Energy Lithium Polymer 80 mAh rechargeable 2 years 6 weeks on full charge depending on usage 0 to 40C (32 to 104F)
-20 to 60C (-4 to 140F) 15 to 95% RH
(non-condensing) 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 modications not expressly approved by the party responsible for compliance. Such modications could void the users authority to operate the equipment. IC Statement This device complies with Industry Canadas licence-exempt RSSs. 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 prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes :
1) l'appareil ne doit pas produire de brouillage, et 2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme 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 declares that this SmartTouch is in compliance with the essential requirements and other relevant provisions of Directives 1999/5/EC and 93/42/EEC. Email contact@smartinhaler.com for a copy of the declaration of conformity. 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 specications 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 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) Limited. Product specications may change without notice. New Zealand Patent No. 595367 New Zealand Design appl. No. 420386 Patents Pending: EP2758111 and US 2014-0182584 Wellkang Ltd 29 Harley Street, Suite B London W1G 9QR United Kingdom Australian Sponsor Market Access Australia Pty Ltd 810 Pacic Highway Gordon NSW 2072, Australia