Quick Start Guide: HFX App Patients

Introduction

Pain impacts everyone uniquely, affecting passions and time with loved ones. Nevro offers an intelligent, individualized approach to pain treatment. The HFX iQ™ system analyzes patient inputs, preferences, and pain experiences, providing personalized recommendations based on a database of over 80,000 patients. By listening to patients individually, HFX iQ™ responds to their specific needs.

System Components:

• Trial Stimulator: Worn externally during the trial period.
• HFX App: The patient application used to manage the HFX iQ™ therapy.
• Implantable Pulse Generator (IPG): The implanted device.
• Leads: Electrodes connected to the IPG.
• Charger: Used to charge the IPG after implantation.

With HFX iQ™, patients manage their pain relief by providing input via the HFX App, which allows direct programming adjustments to the IPG. After answering four quick questions about current pain, medication, and activity levels on a phone, patients receive a personalized programming recommendation. Accepting this recommendation in the HFX App adjusts therapy in real-time, directly to the IPG.

For Trial Patients

How to Use Your HFX App

How to download the HFX App

1. Open your mobile device from your Home screen. Tap the [blue icon] that says App Store.
2. Tap the [Search icon] on the bottom right side of your screen.
3. In the search bar, type "HFX iQ" and then tap Search.
4. Tap on the HFX App and tap GET to download the app.

You will need your existing Apple ID and password to download the HFX App from the Apple App Store. Alternatively, scan this code [QR code placeholder] to go to the Apple App Store.

Get familiar with your Home screen

The Home screen includes:

• 1. Stim ON/OFF Button: Controls stimulation status.
• 2. Therapy Settings: Displays current therapy settings.
• 3. Change Program Button: Allows selection of different programs.
• 4. Start Assessment: Initiates a pain assessment.
• 5. Battery Indicator: Shows the device's battery level.
• 6. Connection Status: Indicates Bluetooth connection status.
• 7. Menu Tab: Access to further options.

How to change programs

1. Tap the Change Program Button on the lower right of the circle.
2. To change your program setting, scroll through the program carousel until the circle is over the desired program.
3. To change your level setting, scroll through each level on the level wheel until the desired level is selected.
4. Tap Done to save your changes.

Trial guidelines

• Keep your mobile phone close to your trial device as they communicate wirelessly.
• All changes are made using your HFX App.
• When your assessment window is active, the Start Assessment button will turn [yellow button].
• Check the Stim ON/OFF Button on your HFX App twice daily to confirm your trial device is ON.
• Use the Favorites feature (page 13) to save programs that provide the best relief or that you may want to revisit.

For support, please contact your local HFX Care Team or physician.

Note: The HFX Trial Stimulator is unsafe for MRI scans. Refer to the Nevro MRI Guidelines Manual for detailed information on MRI safety and conditions for scanning patients with Nevro products, available at www.nevro.com/manuals.

For Implanted Patients

How to Use Your HFX App

iQ Mode

• In iQ Mode, you do not need to manually adjust program or level settings.
• Complete daily pain assessments during your assessment window. Based on your input, HFX iQ™ will provide a personalized recommendation to optimize or maintain your pain relief.

Your HFX App can operate in two therapy modes: iQ Mode and Manual Mode. Your Nevro HFX Care Team will help you determine the best mode for you.

Get familiar with your iQ Mode Home screen

The iQ Mode Home screen includes:

• 1. HFX iQ icon: Indicates the device is in iQ Mode.
• 2. Stim ON/OFF Button: Controls stimulation status.
• 3. Current Program Setting: Displays the active program.
• 4. Change Program Button: Allows selection of different programs.
• 5. Start Assessment: Initiates a pain assessment.
• 6. Battery Status: Shows the device's battery level.
• 7. Connection Status: Indicates Bluetooth connection status.
• 8. My Progress Tab: Access to progress tracking.
• 9. Favorites Tab: Access to saved favorite programs.
• 10. Menu Tab: Access to further options.

How to complete an assessment

When you are within your window for receiving a personalized therapy recommendation, the Start Assessment button will turn [yellow button].

Implant guidelines

• Regularly charge your mobile phone to monitor your pain relief.
• Enable HFX App notifications to receive important device information.
• In iQ Mode, take your pain relief assessment when prompted for optimal relief.
• Ensure Bluetooth is enabled when using the HFX app to complete assessments.

Manual Mode

You will work with your Nevro HFX Care Team to change programs in this mode. Access to Manual Mode requires a six-digit PIN from your Nevro HFX Care Team. You can change program settings, level settings, or both.

Your HFX App can operate in two therapy modes: iQ Mode and Manual Mode. Your Nevro HFX Care Team will help you determine the best mode for you.

Get familiar with your Manual Mode Home screen

The Manual Mode Home screen includes:

• 1. HFX logo: Indicates the device is in Manual Mode.
• 2. Stim ON/OFF Button: Controls stimulation status.
• 3. Current Program Setting: Displays the active program.
• 4. Change Program Button: Allows selection of different programs.
• 5. Start Assessment: Initiates a pain assessment.
• 6. Battery Status: Shows the device's battery level.
• 7. Connection Status: Indicates Bluetooth connection status.
• 8. My Progress Tab: Access to progress tracking.
• 9. Favorites Tab: Access to saved favorite programs.
• 10. Menu Tab: Access to further options.

How to change programs

1. Tap the Change Program Button on the lower right of the circle.
2. To change your program setting, scroll through the program carousel until the circle is over the desired program.
3. To change your level setting, scroll through each level on the level wheel until the desired level is selected.
4. Tap Done to save your changes.

In Manual Mode, your HFX App may offer additional programs, including multi-frequency programs, which can only be accessed and set up by your Nevro HFX Care Team. These programs should only be accessed under your Nevro HFX Care Team's guidance.

How to change group settings

1. At the bottom of the Home screen, tap Menu.
2. Under Advanced Settings, tap Programs.
3. Tap a group of 5 programs from the 6 available groups.
4. When you change the program group, a new program from the new group will start. Tap OK to switch to the new group of programs.

Favorites

Favorites can be used to bookmark programs and settings you use frequently or want to easily return to. Favorites can be current programs or past programs accessed from your History screen. You can personalize Favorites by naming the program and selecting a color.

Get familiar with your Favorites screen

• 1. Add Favorite: Button to add a new favorite.
• 2. Number of available Favorites remaining: Indicates how many more favorites can be saved.
• 3. Name and date of Favorite: Displays the name and date saved for each favorite.

Use the Favorites feature to save programs that provide the best relief or ones you may want to come back to.

MRI Mode

MRI Mode allows you to safely undergo an MRI scan under specific conditions, if your device is eligible. Always check with your care team before entering or exiting MRI Mode.

How to enter MRI Mode

1. From the bottom of your Home screen, tap Menu.
2. Under Advanced Settings, tap MRI Mode.
3. Tap the Enter MRI Mode button.
4. In the pop-up window, tap Enter to confirm and enter MRI Mode. This action will turn OFF stimulation.

How to know you have successfully entered MRI Mode

Your device is in MRI Mode if your screen displays: "Your Stimulator is in MRI Mode."

How to know you have unsuccessfully entered MRI Mode

If you are unsuccessful in entering MRI Mode, a pop-up will appear stating: "Your Stimulator cannot enter MRI Mode at this time. Please contact your physician or HFX Care Team." If this occurs, please contact your Nevro HFX Care Team or your physician.

For video instructions on MRI Mode, scan this code [QR code placeholder] or visit www.NevroHFX.com/en/resources/hfx-app/.

How to exit MRI Mode and turn your stimulation back ON

1. After your MRI is complete, from the MRI Mode screen, tap the Exit MRI Mode button.
2. In the pop-up window, tap Exit to confirm exiting MRI Mode.
3. After successfully exiting MRI Mode, tap Turn On in the pop-up window to reactivate your stimulation. If you wish to turn stimulation ON later, you can return to the Home screen of your HFX App and activate it from there.

Patient MRI Checklist

When your doctor requests an MRI scan:

• Inform your physician that you have an implanted spinal cord stimulator device.
• Locate your patient ID card. If lost, contact your Nevro HFX Care Team for a replacement.

When making your MRI appointment:

Provide the following information to the MRI facility:

• You have a Nevro HFX spinal cord stimulator.
• Details of any other medical device implants you may have.
• A detailed description of your device, including product number, leads, and other implant components (found on your patient ID card).
• Contact information for the physician who implanted your device.
• The Nevro HFX MRI Guidelines (available at Nevro.com/manuals).

This information helps your physician and radiographer determine the safety of the MRI scan.

Preparing for your MRI appointment:

• Contact your Nevro HFX Care Team for a pre-MRI system check before scheduling your MRI scan.
• Before your MRI scan, your Nevro HFX Care Team will assist you in placing your device in MRI Mode using your HFX App. Refer to pages 14-16 or NevroHFX.com/en/resources/hfx-app/ for instructions.
• Ensure your device is fully charged before your MRI scan.

At your MRI appointment:

• Bring your patient ID card and HFX App to the appointment.
• Your radiographer will confirm your device is in MRI Mode before the scan.

After your MRI appointment:

• Click "Exit MRI Mode" and follow the prompts on your HFX App to exit MRI Mode and turn stimulation back ON.
• If using Manual Mode, contact your Nevro HFX Care Team to ensure your device is programmed to your pre-MRI settings.

Do you need help? Please contact your local HFX Care Team.

MRI Guidelines for Your Radiographer

Scan the code [QR code placeholder] for detailed MRI compatibility information or visit Nevro.com/manuals.

Note: HFX and HFX iQ™ are approved for MRI scans under specific conditions. Different implanted device models and lead types have different approved scanning conditions. Carefully review the Nevro HFX MRI Guidelines with your Nevro HFX Care Team before undergoing an MRI scan.

How to Use Your Charger (Model: CHGR2500)

Get familiar with your charger

• 1. Charging Coil: The part that connects to the device.
• 2. Power Adapter Port: Where the power adapter connects.
• 3. Charger Battery Level Indicator: Shows the charger's battery status.
• 4. Charge Start Button: Initiates the charging process.
• 5. Antenna Strength Indicator: Shows the quality of the connection.
• 6. Device Battery Level Indicator: Shows the implanted device's battery status.

Charging tips

• Charging times may vary based on usage frequency and settings.
• If the Antenna Strength Indicator shows an insufficient connection (indicated by circle lights), slowly reposition the Charging Coil and wait 3 seconds for the indicator to update. Repeat as needed.
• If charging time is shorter than expected, your device might be turned OFF. Ensure your device is ON via your HFX App; the Stim ON Button in the upper right corner of the Home screen confirms this.

Charging reminders

• You can still receive stimulation while charging.
• Do not charge the device while the charger is plugged into the wall. Always remove the power adapter before pressing the Charge Start Button.
• After charging, plug your charger back into the power adapter and then the power adapter into the wall to prepare the charger for the next session.
• Recharge your device regularly to establish a routine, such as nightly.
• The device site may feel warm during charging. If you experience pain or discomfort, stop charging and contact your Nevro HFX Care Team or physician.
• If charging times increase significantly, contact your Nevro HFX Care Team or physician.

How to prepare for charging

1. Place the center of the circular Charging Coil over the top of your device. The diagram shows the top of your device (in the [yellow box]) should be at the center of the Charging Coil.

How to start charging

1. Press the Charge Start Button to turn on the charger. The light on the side (Charger Battery Level Indicator) will illuminate. The charger will beep and search for your device; beeping continues until a connection is made.
2. When at least one lighted circle appears on the Antenna Strength Indicator, a connection is established. More circles indicate a better connection, reducing the likelihood of charging interruption due to movement. If only the middle dot is illuminated, it signifies a poor connection, and the device/charger will not connect.
3. When the charger is in the correct position, the Battery Level Indicator will light up.
4. If the connection is not made, is insufficient, or is lost, slowly reposition the [blue Charging Coil] and repeat the steps under "How to Start Charging."
5. If 10 seconds pass without a connection, the charger will emit 1 long beep and shut OFF. Reposition the Charging Coil and press the Charge Start Button again.
6. Charging is in progress when the Battery Level Indicator and Antenna Strength Indicator circles are lit. The number of lit dots on the Battery Level Indicator increases as charging progresses.
7. If the connection is lost, the charger will beep. Reposition the Charging Coil and repeat the "How to Start Charging" steps.
8. If only the inner dot on the Antenna Strength Indicator is lit, you are not connected to the charger.

What to do when you're done charging

1. When charging is complete, the charger will emit 1 long beep and turn OFF automatically. There is no OFF button. Verify the device battery is fully charged (four dots) using your HFX App.
2. Use your HFX App to confirm your device is turned ON.
3. Plug your charger into the wall socket to ensure it's ready for the next charging session. Connect the power adapter to the charger's Power Adapter Port, then plug the power adapter into the wall socket. The [orange light] indicates the charger is recharging; recharging is complete when the orange light turns OFF.

How to use the charging belt

Once you identify the optimal position for the Charging Coil for a strong connection, use the charger belt to secure its placement on your body during charging.

1. Place the [blue Charging Coil] in the pouch on your charger belt and securely fasten the belt around your waist. Use the [hook and loop] near the pouch to manage the Charging Coil cable.
2. Start charging and adjust the Charging Coil until it connects with your device.
3. If you need to move during charging, insert your charger into the [holster], then clip the holster to your belt or pants.

Important Information

Video instructions are available at www.NevroHFX.com/en/resources/hfx-app/. For comprehensive instructions on accessories, warnings, and precautions, please refer to the Patient Manual.

Rx Only. Patient experiences with the Senza™ spinal cord stimulation (SCS) system, including pain relief and adverse effects, vary by individual. Patients should consult a physician to understand the benefits and risks of SCS treatment. Please refer to the Senza Manual available at www.nevro.com/manuals for complete information, including indications for use, contraindications, warnings/precautions, and adverse effects.

Contact Information:

Nevro Corp.
1800 Bridge Parkway
Redwood City, CA 94065
Phone: 1.650.251.0005 | 1.888.956.3876
Website: www.NevroHFX.com

Trademarks:

SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. © 2024 Nevro Corp. All Rights Reserved.

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