User guide: How it works

Dialoq® works with FlexTouch® to track your doses

While Dialoq® is attached to your FlexTouch® pen, it records and remembers:

• The drug brand name and strength
• The number of units dosed
• The time and date of your doses.

Dialoq® stores up to 1200 doses including your priming doses. Dialoq® is a medical device. Read this user guide before you start using Dialoq® to learn how to use Dialoq® correctly.

Use Dialoq® with your phone

You can export the doses in your Dialoq® to a compatible app on your phone. That way you can keep a digital insulin log.

Export your doses

Dialoq® sends your injected doses and priming doses to the app when you press and release the dose button. Make sure Bluetooth® on your phone is turned on and that the app is open.

Dialoq® overview

Components:

• Dose button
• Dose selector
• Dose counter window
• Attachment knob
• Slide button
• Dialoq® ID and markings (Front/Back)

Need help? Call us at 1-833-4-DIALOQ

Get started: Visit www.mydialoq.com

Getting Started: Step-by-Step

1. 1. Attach Dialoq®

   Description: Check the back of your FlexTouch® pen for a small attachment knob. FlexTouch® pens with this knob are compatible with Dialoq® (see www.mydialoq.com for a list). Attach Dialoq® to your FlexTouch® pen, ensuring the dose counter windows align. Leave Dialoq® on until the pen is empty, then remove it using the slide button on the back before disposing of the pen. Never use excessive force.

2. 2. Download app and pair

   Description: Visit www.mydialoq.com on your phone to download a compatible app. Ensure your phone has internet and Bluetooth® turned on. Avoid pairing in public places for security. Open the app and follow instructions to pair Dialoq®. To pair, ensure the dose selector shows 0 on your FlexTouch® pen. Press and release the dose button on Dialoq®. Verify the Dialoq® ID in the app matches the ID on the back of your Dialoq®. Follow app instructions to complete pairing. If pairing fails, repeat the steps. Pairing is not needed for new pens once initially paired.

3. 3. Use Dialoq® with your FlexTouch® pen

   Description: Always follow your FlexTouch® pen's instructions for correct dosing. Ensure Dialoq® is paired and correctly attached. Turn the dose selector on Dialoq® to choose your dose. Insert the needle into your skin. Press and hold the dose button on Dialoq® until the dose counter shows 0, then count slowly to 6. Dialoq® records the dose size, time, and date. Doses are exported automatically during injection if the app is open, the phone is nearby, and Bluetooth® is on. This can skip step 4.

4. 4. Export doses to app

   Description: Ensure Bluetooth® is on and Dialoq® is attached to your FlexTouch® pen. Open the app on your phone. Check that the pen's dose counter shows 0 (unless currently taking a dose). Press and release the dose button on Dialoq® to export doses. Verify the export was successful in the app. It is recommended to export doses whenever you want to consult your log and at least once a month.

Frequently Asked Questions

Significance of symbols

• ⚠️ [Caution]: Pay special attention to these notes as they are important for safe use of Dialoq®.
• ℹ️ [Info]: Useful information and tips.
• ? [Manufacturer Info]: Name and address of manufacturer.
• ? [Instructions]: Consult instructions for use.
• ?️ [Temperature]: Temperature range.
• ♻️ [Disposal]: The disposal symbol indicates that Dialoq® must not be disposed of with household waste.
• ? [Keep Dry]: Keep dry.
• ? [Batch Number]: Batch no.
• ⚕️ [BF Applied Part]: BF Applied Part.

How your Dialoq® works

• What does Dialoq® record? Dialoq® records the drug brand name and strength, the number of units dosed, and the time and date of all injected and priming doses when attached to a compatible FlexTouch® pen. The pen's dose counter shows selected units. Always keep Dialoq® attached; doses taken without it will not be logged. If unsure about insulin dosage, monitor blood sugar first. Dialoq® is for single use; do not share. Do not stop and resume injections as it may affect dose size detection. Dialoq® records both priming and injected doses.
• Does Dialoq® automatically export my doses to my phone? Yes, Dialoq® automatically exports doses during injection if paired with the app, the app is open, the phone is nearby, and Bluetooth® is on. The export happens upon releasing the dose button. If Dialoq® is not attached to a pen, the log will not update.
• What if I do not export my doses regularly? Dialoq® stores up to 1200 doses. It is recommended to export at least monthly to ensure all doses are in the app. Leaving Dialoq® on the pen until empty ensures all doses are recorded.
• Which information is exported to the app? The exported information includes drug brand name and strength, number of units dosed, time and date of doses, and Dialoq® status information.

Caring for your Dialoq®

• Where do I keep my Dialoq®? Store Dialoq® between 2° C (36° F) and 40° C (104° F) when not attached to the pen. When attached, follow FlexTouch® pen storage instructions. During use, maintain temperatures between 5° C (41° F) and 40° C (104° F), humidity 15%-90% RH, and atmospheric pressure 700-1060 hPa.
• How do I take care of my Dialoq®? Do not attempt to repair or disassemble Dialoq®. Keep it away from dust, dirt, and liquid. Do not attach Dialoq® to a pen with a damaged dose button. Do not modify Dialoq® or insert foreign objects. If damaged, contact 1-833-4-DIALOQ.
• How should I clean Dialoq®? Clean only the outside with a mild detergent on a moistened cloth. Avoid bleaching agents (chlorine, iodine, alcohol) as they can damage the device. Do not wash, soak, or lubricate.
• How long does the battery last? The battery lasts approximately two years with normal use. The app will provide a 30-day warning before it runs out. The battery cannot be replaced or recharged. Export doses before the battery depletes.
• How do I dispose of Dialoq®? Dispose of Dialoq® separately according to local regulations, not with household waste, due to its lithium battery and electronic parts. Packaging materials can be recycled.

Troubleshooting

• What if Dialoq® does not export my doses to the app? Ensure Dialoq® is properly attached, the phone is nearby, Bluetooth® is on, and the app is open. Keep the phone and Dialoq® at least 30 cm (12 in) away from other devices to avoid interference. Check the app for low battery alerts.
• What if I cannot pair Dialoq® with the app? Follow the troubleshooting steps for dose export issues.
• Why does the app not show the medicine or dose amount I expect? This can happen if you stop and resume an injection, split doses between pens, or if Dialoq® registers an error during injection. If unsure about dosage, monitor blood sugar.

Still need help?

Contact your healthcare professional or call 1-833-4-DIALOQ for usage doubts. Visit www.mydialoq.com for support and unexpected events.

Warranty

Dialoq® has a two-year warranty. Novo Nordisk will replace faulty devices returned within two years. The warranty is void for defects arising from use with non-compatible pens, misuse, unauthorized repair, or physical damage.

Classification

• IP 52: 5 indicates dust protection; 2 indicates protection against vertically falling water drops when tilted up to 15 degrees.
• Protection against electrical shock: Type BF Applied Part, internally powered ME Equipment, classified for continuous operation.
• Logging accuracy: Registers doses correctly in over 99% of cases, with +/- 1 increment accuracy for others.

Electromagnetic compatibility

Dialoq® meets IEC 60601-1-2:2014 requirements for home healthcare environments. It complies with FCC Part 15. Operation is subject to conditions preventing harmful interference and accepting received interference. Consult cabin attendants or airlines for Bluetooth® use on airplanes.

Wireless technology

• Frequency Band: 2.4-2.4835 GHz
• Technology: Bluetooth low energy
• Modulation type: Gaussian Frequency Shift Keying (GFSK)
• Output power: 0 dBm

Dialoq® and FlexTouch® are registered trademarks of Novo Nordisk. Bluetooth® is a registered trademark of Bluetooth SIG, Inc. Dialoq® is classified as a device receiver category 3: noncritical communication. Data is collected for device performance improvements and reviewed during maintenance.

© 2020 Novo Nordisk

For information about Dialoq®, contact: 1-833-4-DIALOQ. Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, Attention: Customer Care. Manufactured by: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.