Nevro HFX iQ Quick Start Guide
For HFX App Patients
Introduction
Pain is a personal experience, impacting individuals in unique ways and often diminishing the quality of life. Nevro offers an intelligent, personalized approach to pain treatment with the HFX iQ system. This system analyzes patient inputs, preferences, and pain experiences to deliver tailored recommendations, drawing from a database of over 80,000 patients. HFX iQ is designed to listen and respond to individual patient needs.
- Trial Stimulator: A device worn externally during the trial period.
- Implantable Pulse Generator (IPG): The primary implanted device.
- Leads: Wires connecting the IPG to electrodes placed near the spinal cord.
- HFX App: The patient application used to manage HFX iQ therapy on a smartphone.
- Charger: Used to recharge the IPG after implantation.
With HFX iQ, patients actively manage their pain relief by providing feedback through the HFX App, enabling direct programming adjustments to the IPG. After answering a few questions about their current pain, medication, and activity levels, patients receive a personalized programming recommendation. Once accepted in the app, therapy is adjusted in real-time directly to the IPG.
For Trial Patients
How to Use Your HFX App
How to download the HFX App
- Open your mobile device and navigate to the App Store.
- Tap the Search icon (?).
- In the search bar, type "HFX iQ" and tap Search.
- Tap on the HFX App and select GET to download.
You will need your existing Apple ID and password to download the app.
Get familiar with your Home screen
The HFX App home screen provides access to key functions:
- Stim ON/OFF Button: Controls stimulation status.
- Therapy Settings: Accesses detailed therapy parameters.
- Change Program Button: Allows selection of different programs.
- Start Assessment: Initiates a pain assessment.
- Battery Indicator: Shows the battery level of the device.
- Connection Status: Indicates the connection between the app and the device.
- Menu Tab: Accesses additional options and settings.
How to change programs
- Tap the Change Program Button (▶️).
- Scroll through the program carousel to select your desired program.
- Scroll the level wheel to adjust the stimulation level.
- Tap Done to save your changes.
Trial guidelines
- Keep your mobile phone close to your trial device for consistent communication.
- All therapy adjustments are made via the HFX App.
- Check the Stim ON/OFF Button on your HFX App twice daily to ensure your trial device is active.
- Use the Favorites feature to bookmark preferred programs for easy access.
How to complete an assessment
The "Start Assessment" button will turn yellow when you are within your assessment window.
Note: The HFX Trial Stimulator is not safe for MRI scans. Consult the Nevro MRI Guidelines Manual for detailed information on MRI safety and conditions for patients with Nevro products.
For Implanted Patients
How to Use Your HFX App
iQ Mode
In iQ Mode, you do not manually adjust program or level settings. Instead, you complete daily pain assessments. Based on your input, HFX iQ provides personalized recommendations to optimize your pain relief.
Your Nevro HFX Care Team will help you determine if iQ Mode or Manual Mode is best for you.
Get familiar with your iQ Mode Home screen
When your device is in iQ Mode, you will see an HFX iQ icon on the app's home screen, which also includes:
- HFX iQ icon: Indicates the device is in iQ Mode.
- Stim ON/OFF Button: Controls stimulation.
- Current Program Setting: Displays the active program.
- Change Program Button: For program adjustments (if applicable).
- Start Assessment: Initiates pain assessment.
- Battery Status: Shows device battery level.
- Connection Status: Confirms app-to-device connection.
- My Progress Tab: Tracks therapy progress.
- Favorites Tab: Accesses saved programs.
- Menu Tab: Navigates to other settings.
How to complete an assessment
The "Start Assessment" button turns yellow when it's time to complete your pain relief assessment.
Implant guidelines
- Regularly charge your mobile phone to monitor your pain relief.
- Enable HFX App notifications for important device updates.
- In iQ Mode, complete pain relief assessments promptly when prompted for optimal results.
- Ensure Bluetooth® is connected when using the HFX app for assessments.
Manual Mode
In Manual Mode, you work with your Nevro HFX Care Team to change programs. You can adjust settings via the program settings screen. Accessing Manual Mode requires a six-digit PIN provided by your Care Team. You can modify program settings, level settings, or both.
Your HFX App may offer additional multi-frequency programs, accessible only with your Nevro HFX Care Team's setup and guidance.
Get familiar with your Manual Mode Home screen
The Manual Mode home screen displays the HFX logo and includes:
- HFX logo: Indicates the device is in Manual Mode.
- Stim ON/OFF Button: Controls stimulation.
- Current Program Setting: Displays the active program.
- Change Program Button: Allows selection of different programs.
- Start Assessment: Initiates pain assessment.
- Battery Status: Shows device battery level.
- Connection Status: Confirms app-to-device connection.
- My Progress Tab: Tracks therapy progress.
- Favorites Tab: Accesses saved programs.
- Menu Tab: Navigates to other settings.
How to change programs
- Tap the Change Program Button (▶️).
- Scroll through the program carousel to select your desired program.
- Scroll the level wheel to adjust the stimulation level.
- Tap Done to save your changes.
How to change group settings
- From the Home screen, tap the Menu tab (☰).
- Navigate to Advanced Settings and tap Programs.
- Select a group of 5 programs from the available 6 groups.
- Tap OK to switch to the new program group; a new program from that group will start.
Favorites
Get familiar with your Favorites screen
- Add Favorite: Button to save current settings.
- Number of available Favorites remaining: Indicates how many more favorites can be saved.
- Name and date of Favorite: Displays saved program details.
How to use Favorites
Favorites allow you to bookmark frequently used programs and settings for quick access. You can save current or past programs accessed via your progress tab. Personalize favorites by naming them and assigning a color.
Use the Favorites feature to save programs that provide the best relief or that you may want to return to.
MRI Mode
How to enter MRI Mode
- From your Home screen, tap the Menu tab (☰).
- Under Advanced Settings, select MRI Mode.
- Tap the "Enter MRI Mode" button.
- In the confirmation pop-up, tap Enter. This action will turn OFF stimulation.
MRI Mode should only be used under the guidance of your Nevro HFX Care Team. Always consult your team before entering or exiting MRI Mode. If your device is eligible, MRI Mode enables safe MRI scans under specific conditions.
How to know you have successfully entered MRI Mode
Your device is in MRI Mode when the app screen displays: "Your Stimulator is in MRI Mode."
How to know you are unable to enter MRI Mode
If you encounter issues entering MRI Mode, a pop-up will appear stating: "Your Stimulator cannot enter MRI Mode at this time. Please contact your doctor or HFX Care Team." If this occurs, contact your Nevro HFX Care Team or your doctor.
Video Instructions: Scan the QR code or visit www.NevroHFX.com/en/resources/hfx-app/ for video guides.
How to exit MRI Mode and turn your stimulation back ON
- After your MRI is complete, from the MRI Mode screen, tap the "Exit MRI Mode" button.
- In the pop-up window, tap Exit to leave MRI Mode.
- 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 do so from the Home screen of your HFX App.
Patient MRI Checklist
When your doctor requests an MRI scan:
- Inform your doctor that you have an implanted spinal cord stimulator.
- Locate your patient ID card. If lost, contact your Nevro HFX Care Team for a replacement.
When making your MRI appointment:
- Provide the MRI facility with the following information:
- You have a Nevro HFX spinal cord stimulator.
- Details of any other medical device implants.
- A detailed description of your device, including product number, leads, and components (found on your patient ID card).
- Contact information for the doctor who performed your implantation.
- The Nevro HFX MRI Guidelines (available at Nevro.com/manuals).
- This information helps your doctor and radiographer determine your eligibility for an MRI scan.
Preparing for your MRI appointment:
- Contact your Nevro HFX Care Team to confirm your MRI appointment is safely scheduled.
- Your Care Team will assist in placing your device in MRI Mode using your HFX App before the scan.
- Refer to pages 14-16 or NevroHFX.com/en/resources/hfx-app/ for detailed instructions.
Important Reminder: Ensure your device is fully charged before your MRI scan. ?
At your MRI appointment:
- Bring your patient ID card and HFX App.
- Your radiographer will confirm your device is in MRI Mode prior to the scan.
After your MRI appointment:
- Follow the prompts on your HFX App to "Exit MRI Mode" and turn your 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 QR code or visit Nevro.com/manuals for detailed MRI compatibility information.
Note: HFX and HFX iQ are approved for MRI scans under specific conditions. Different device models and lead types may have varying approved scanning conditions. Always review the Nevro HFX MRI Guidelines with your Nevro HFX Care Team before undergoing an MRI scan.
How to Use Your Charger (CHGR2500)
Get familiar with your charger
- Charging Coil: The part that connects to the device.
- Power Adapter Port: Where the power adapter connects.
- Charger Battery Level Indicator: Shows the charger's battery status.
- Charge Start Button: Initiates the charging process.
- Antenna Strength Indicator: Indicates the quality of the connection.
- Device Battery Level Indicator: Shows the implanted device's battery status.
Charging tips
- Charging times can vary based on usage frequency and settings.
- If the Charging Coil connection is poor (indicated by Antenna Strength Indicator lights), reposition the coil slowly and wait 3 seconds for the lights to update. Repeat if necessary.
- If charging is faster than expected, your device might be turned OFF. Ensure your device is ON via the HFX App; the "Stim ON" button on 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 the charger back into the power adapter and then into the wall to prepare for the next session.
- Establish a routine for recharging your device, 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 doctor.
- If charging times increase significantly, contact your Nevro HFX Care Team or doctor.
How to prepare for charging
- Place the center of the circular Charging Coil over the top of your device. The device's top should align with the center of the coil for optimal charging.
How to start charging
- Press the Charge Start Button to turn on the charger. The Charger Battery Level Indicator will light up, confirming it's ON. The charger will beep as it searches for your device.
- A connection is made when the outer ring of the indicator circle appears. More illuminated circles indicate a better connection, reducing the likelihood of interruption by movement. A single middle dot indicates a poor connection.
- Once the charger is correctly positioned, the Battery Level Indicator will light up.
If a connection is not made, is insufficient, or is lost, reposition the Charging Coil slowly and repeat the "How to Start Charging" steps. If no connection is made within 10 seconds, the charger will beep once and shut OFF. Reposition the coil and press the Charge Start Button again.
Charging is in progress when the Battery Level Indicator and Antenna Strength Indicator lights are illuminated. The number of lit dots on the Battery Level Indicator increases as charging progresses.
If the connection is lost, the charger will beep. Reposition the Charging Coil and repeat the "How to Start Charging" steps. 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
- Upon completion, the charger will emit one long beep and turn OFF automatically. There is no manual OFF button. Verify the device battery is fully charged (indicated by four dots).
- Use your HFX App to confirm your device is turned ON.
- Plug your charger into the wall socket to ensure it's ready for your next charging session.
- To connect to the wall socket, attach the power adapter to the charger's Power Adapter Port, then plug the adapter into the wall. An orange light indicates the charger is recharging; this light turns OFF when recharging is complete.
How to use the charging belt
Once you've identified the optimal position for the Charging Coil for a strong connection, use the charger belt to secure its placement on your body.
- Place the blue Charging Coil into the pouch on your charger belt and securely fasten the belt around your waist. Use the hook-and-loop closure to secure the Charging Coil cable.
- Start charging and adjust the Charging Coil until it connects with your device.
- To allow movement during charging, insert your charger into the holster and clip the holster to your belt or pants.
Important Information
Video instructions are available at www.NevroHFX.com/en/resources/hfx-app/. For complete instructions on accessories, warnings, and precautions, please refer to the Patient Manual.
Rx Only. Patient experiences with the Senza® spinal cord stimulation (SCS) system can vary individually, including the amount of pain relief. Adverse effects associated with SCS implant surgery or use also vary by patient. Patients should consult a doctor to understand the benefits and risks of SCS treatment. Please refer to the Senza Manual available at www.nevro.com/manuals for comprehensive information, including indications for use, contraindications, warnings, precautions, and adverse effects.
Nevro Corp.
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www.NevroHFX.com
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Notes
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