FCC ID: 2AJVSPDR0000401 An electronic inhaler add-on module which store and transmit information related to inhaler use (eModule)

< Regulatory You may need to open the app to see notifications. Do not bring your ProAir Digihaler inhaler into an MRI or CT/x-ray scan room. Do not expose your inhaler to other known sources of Electromagnetic Interference (such as diathermy and RF ID systems) The electronic module complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) The electronic module may not cause harmful interference, and

(2) The electronic module must accept any interference received, including interference that may cause undesired operation. Changes or modifications to the electronic module not expressly approved by Teva could void the user's authority to operate the equipment.

Important Notes About ProAir Digihaler If you are having trouble setting up your ProAir Digihaler app, go to ProAirDigihaler.com or call Teva at

(2) This device must accept any interference received, including interference that may cause undesired

Safety:

Electromagnetic Compatibility:

Immunity Test Electrostatic Discharge (ESD)

immunity test

IEC 60601 Test Level

Compliance Level

14

IMPORTANT:

Always close the cap after each inhalation so your inhaler will be ready for you to take your next dose. Do not open the cap unless you are ready for your next dose. You will hear a click sound when the cap is opened fully. If you do not hear the click sound the inhaler may not be activated to give you a dose of medicine. ProAir Digihaler does not have an activation button or medicine canister. When you open the cap, a dose of ProAir Digihaler will be activated for delivery of the medicine. ProAir Digihaler does not need to be wirelessly connected to the mobile application (App) in order for it to work and for you to take your medicine. In general, the technique for administering ProAir Digihaler to children is similar to that for adults. Children should use ProAir Digihaler under adult supervision, as instructed by the patients physician. Do not use a spacer or volume holding chamber with ProAir Digihaler. ProAir Digihaler does not need priming. Do not open the red cap unless you are taking a dose. Repeatedly opening and closing the cap without inhaling a dose will waste the medicine and may damage your inhaler. Your ProAir Digihaler inhaler contains dry powder so it is important that you do not blow or breathe into it. Using your ProAir Digihaler Inhaler:

Important: Make sure the red cap is closed before you start using your inhaler. Your ProAir Digihaler Inhaler When you are ready to use ProAir Digihaler for the rst time, remove the ProAir Digihaler inhaler from the foil pouch. There are 3 main parts of your ProAir Digihaler inhaler including:

the white inhaler with the mouthpiece. See Figure A. the red cap that covers the mouthpiece and vent of the inhaler. See Figure A. the electronic module. See Figure A. There is an electronic module built into the top of the inhaler that records and stores information about inhaler events. The electronic module sends information through Bluetooth wireless technology to a mobile application (App). The electronic module does not control or interfere with delivery of the medicine through the inhaler. There is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. See Figure A. QR code Electronic module Dose counter Vent Mouthpiece Red cap Figure A Your ProAir Digihaler inhaler contains 200 doses (inhalations). See Figure B. The dose counter shows the number of doses left in your inhaler. When there are 20 doses left, the dose counter will change to red and you should rell your prescription or ask your doctor for another prescription. When the dose counter displays 0 your inhaler is empty and you should stop using the inhaler and throw it away. See Figure B. Figure B Step 1. Open Hold the inhaler upright and open the red cap fully until you feel and hear a click. See Figure C. Each time you open the red cap and it clicks, a dose of ProAir Digihaler is ready to be inhaled. Step 2. Inhale Before you inhale, breathe out (exhale) through your mouth and push as much air from your lungs as you can. See Figure E. Do not exhale into the inhaler mouthpiece. Step 3. Close Remember:

Figure C For correct use of ProAir Digihaler, hold the inhaler upright as you open the red cap. See Figure D. Do not hold the inhaler in any other way as you open the red cap. Do not open the red cap until you are ready to take a dose of ProAir Digihaler. Figure E Figure F Put the mouthpiece in your mouth and close your lips tightly around it. See Figure F. Do not block the vent above the mouthpiece with your lips or ngers. See Figure G. Breathe in quickly and deeply through your mouth, to deliver the dose of medicine to your lungs. Vent Figure G Figure H Close the red cap rmly over the mouthpiece. See Figure H. Make sure you close the red cap after each inhalation so that the inhaler will be ready for your next dose. If you need another dose, close the red cap and then repeat steps 1-3. Figure D Remove the inhaler from your mouth. Hold your breath for about 10 seconds or for as long as you comfortably can. Your ProAir Digihaler Inhaler delivers your dose of medicine as a very ne powder that you may or may not taste or feel. Do not take an extra dose from the inhaler even if you do not taste or feel the medicine. Storing your ProAir Digihaler inhaler Store ProAir Digihaler at room temperature between 59F and 77F (15C and 25C). Avoid exposure to extreme heat, cold or humidity. Keep the red cap on the inhaler closed during storage. Keep your ProAir Digihaler inhaler dry and clean at all times. Keep your ProAir Digihaler inhaler and all medicines out of reach of children. Cleaning your ProAir Digihaler inhaler Do not wash or put any part of your ProAir Digihaler inhaler in water. ProAir Digihaler contains a powder and must be kept clean and dry at all times. If the mouthpiece needs cleaning, gently wipe it with a dry cloth or tissue. Replacing your ProAir Digihaler inhaler The counter on the back of your inhaler shows how many doses you have left. When there are 20 doses left, the dose counter color will change to red and you should rell your prescription or ask your doctor for another prescription. When the counter displays 0 your ProAir Digihaler inhaler is empty and you should stop using the inhaler and throw it away. Throw away your ProAir Digihaler inhaler 13 months after removing it from the foil pouch for the rst time, when the dose counter displays 0, or after the expiration date on the package, whichever comes rst. ProAir Digihaler contains a lithium-manganese dioxide battery and should be thrown away (disposed of) in accordance with state and local regulations. Support For instructions on setting up the App, go to www.ProAirDigihaler.com or call Teva at 1-888-603-0788. If you have any questions about ProAir Digihaler, how to use your inhaler, go to www.ProAirDigihaler.com or call 1-888-603-0788. This Instructions for Use has been approved by the U.S. Food and Drug Administration. The Bluetooth word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Teva Respiratory, LLC is under license. Marketed by: Teva Respiratory, LLC, Frazer, PA 19355; Copyright 2017, Teva Respiratory, LLC; All rights reserved. Rev. 013

(PRODHIFU-001 Rev. 12/2018)