Nevro HFX Spinal Cord Stimulation System

Quick Start Guide: Remote Control Patients

Introduction

This guide provides instructions for patients using the Nevro HFX spinal cord stimulation system with a remote control. Your Nevro HFX Care Team will offer guidance on how and when to use your remote control.

Getting Familiar with Your Remote Control

The remote control has several key components:

1. Remote Control ON/OFF Button: Turns the remote control on and off.
2. Stimulation OFF Button: Turns stimulation off.
3. Battery Level Indicator: Shows the remaining battery life.
4. Stimulation Level Indicator (“Ladder Lights”): Displays the current stimulation level.
5. Stimulation Start/Increase Button: Starts stimulation or increases the level.
6. Stimulation Decrease Button: Decreases the stimulation level.
7. Program Indicator: Shows the current program.
8. Program Selection Button: Allows you to cycle through available programs.

Note: For PTRC2300 models, there are 3 programs displayed above the Program Selection Button.

Trial Guidelines (For Trial Patients)

Your remote control is used for all adjustments during the trial period.
Keep the remote control close to your trial device for consistent communication. A beep will sound if there is an open lead.
Check the Stimulation Level Indicator twice daily to ensure your trial device is ON.

Turning Your Remote Control ON and OFF

To Turn ON: Press and hold the Remote Control ON/OFF Button until a long beep is heard (up to 5 seconds).
To Turn OFF: Press the Remote Control ON/OFF Button. Stimulation continues even when the remote is off. The remote will turn off automatically after 2 minutes of inactivity.

Tips:

A successful sync is indicated by at least one LED lighting up and a single beep.
If the remote cannot sync, you will hear 3 beeps, and the lights will turn off. Try moving the remote closer to the device.
Other buttons only function when the remote is ON and connected to the device.

Turning Stimulation ON and Changing Programs

Ensure your remote control is ON. Stimulation is ON by default unless turned OFF.
If the Stimulation Level Indicator is not illuminated, stimulation is OFF.
Press the Stimulation Start/Increase Button to turn stimulation ON to a predetermined level. The device will start at the last active program's level.
To change programs, press the Program Selection Button repeatedly until the desired program number is indicated. Do not press other buttons until the light stops blinking; a single beep confirms the change.
Ensure the light above your program number is brightly illuminated.

Note: If the remote beeps 3 times and the program indicator reverts to the previous program, the change was unsuccessful. Move the remote closer and repeat the steps.

Changing Stimulation Level

Ensure your remote control is ON.
Press the [Increase icon] button to increase stimulation level.
Press the [Decrease icon] button to decrease stimulation level.
Each press of these buttons will result in 1 beep.
The Stimulation Level Indicator shows the current level.

Note: If you attempt to increase or decrease the level beyond the programmed limit, you will hear 2 beeps.

Turning Stimulation OFF

With the remote ON, press the Stimulation OFF Button (located under the battery door) to turn stimulation OFF.
The Stimulation Level Indicator lights will be OFF when stimulation is OFF.
The Stimulation OFF Button only turns stimulation OFF, not ON.

Replacing Batteries

Replace batteries when the remote control beeps 6 times upon turning on, or if it fails to turn on.
Low battery is indicated by 2 or fewer dots on the Battery Level Indicator. Contact your Nevro HFX Care Team to change batteries.
If the remote beeps 10 times upon turning ON, the device batteries are critically low, and stimulation is OFF. Contact your Nevro HFX Care Team to change batteries.

Note: Use only 2 AAA alkaline batteries. Do not use lithium or rechargeable batteries.

Troubleshooting

What You Hear	What You See	What It Means	What to Do
Continuous beeping for 60 seconds.	All Stimulation Level Indicator lights blinking.	Possible loose connection between a lead and the trial device.	Press and hold the ON/OFF Button for up to 5 seconds to dismiss. Contact Nevro HFX Care Team.
Continuous beeping for 60 seconds.	All Battery Level lights blinking.	Trial device battery is low or completely empty.	Press and hold the ON/OFF Button for up to 5 seconds to dismiss. Battery lights will continue to flash. Contact Nevro HFX Care Team.

Nevro HFX Care Team Contact Information

For support, please call 1-844-331-1001, Monday - Friday, 9:00 AM - 5:00 PM.

MRI: Impedance Check Instructions (For Implanted Patients)

Contact your Nevro HFX Care Team before performing an impedance check.

An impedance check is required before your MRI scan.

Refer to the following pages for step-by-step instructions.

Note: Record your current program and level before the impedance check to verify settings.

How to know your impedance check was successful:

Impedances are within the acceptable range.
You hear 1 long beep.
All numbered levels and battery lights on the remote are illuminated solid.

How to know your impedance check was unsuccessful:

You hear 4 short beeps followed by blinking number levels or battery light: Impedances are out of range. Contact Nevro HFX Care Team.
No lights or beeps: The impedance check was not performed. Repeat the "Turn OFF Stimulation and Start an Impedance Check" steps.
You hear 3 beeps: Device is not connected to the remote. Move remote closer and repeat the "Turn OFF Stimulation and Start an Impedance Check" steps.

Post MRI Instructions (For Implanted Patients)

Ensure stimulation remains OFF until after your MRI is complete.

How to turn stimulation ON after your MRI:

Exit Impedance Check Mode: Press and hold the Remote Control ON/OFF Button for 5 seconds until all lights turn OFF.
Turn your remote control ON again. It will return to normal mode.
Press the Stimulation Start/Increase Button once to turn stimulation ON.

Illuminated number levels indicate stimulation is ON. You can adjust program settings as needed.

Note: Do not turn stimulation back ON until your MRI is completed.

How to Change Groups (For PTRC2500/PTRC3000 - 5 Program Users Only)

Contact your Nevro HFX Care Team before accessing these settings.

Enter Group Change Mode: Press and hold the Program Selection Button for at least 3 seconds. A long beep confirms entry.
A blinking light above the Stimulation Start/Increase Button indicates the current group number.
Use the [Up arrow] or [Down arrow] buttons to select your desired group number.
Confirm the new group: Press and hold the Program Selection Button again for at least 3 seconds. A long beep confirms the change.

Note: Changes are not saved if not confirmed within 60 seconds. The remote displays the current group number when changing programs.

To activate a program change, press the Program Selection Button once. The current group number will be illuminated. Press the Program Selection Button a second time to move to the next program.

How to Use Your Charger (CHRG2500)

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. Battery Level Indicator: Shows the device's battery status.

Charging Tips:

Charging times vary.
If the Charging Coil has a poor connection (indicated by Antenna Strength Indicator lights), reposition the coil slowly and wait for the indicator to update (up to 3 seconds).
If charging is faster than expected, ensure your device is turned ON via the remote control.
Stimulation is ON when the remote is ON and the corresponding lights are illuminated.

Charging Reminders:

You can receive stimulation while charging.
Do not charge while the charger is plugged into the wall. Always unplug the power adapter from the wall before pressing the Charge Start Button.
Plug the charger back into the power adapter and then into the wall to prepare for the next session.
Recharge regularly as part of a routine.
The device site may become warm during charging. If you experience pain or discomfort, stop charging and contact Nevro HFX Care Team.
If charging times increase significantly, contact Nevro HFX Care Team.

How to Prepare for Charging:

Place the center of the circular Charging Coil over your device. The diagram shows the top of the device (yellow box) centered on the coil.

How to Start Charging:

Press the Charge Start Button to turn ON the charger. The Charger Battery Level Indicator will light up. The charger will beep and search for your device.
A connection is made when at least one circle on the Antenna Strength Indicator lights up. More circles indicate a better connection.
When the charger is correctly positioned, the Battery Level Indicator will light up.

Note: If the connection is insufficient or lost, reposition the Charging Coil slowly and repeat the steps. If only the inner dot on the Antenna Strength Indicator is lit, you are not connected.

What to Do When You're Done Charging:

A long beep indicates charging is complete, and the charger turns OFF automatically. Check the device battery level (four dots indicate full charge).
Use your remote control to confirm your device is ON.
Plug your charger into the wall socket to ensure it's ready for the next session.
Connect the power adapter to the charger's Power Adapter Port, then plug into the wall socket. An orange light indicates recharging; it turns OFF when complete.

How to Use the Charging Belt:

Once you know the optimal placement for the Charging Coil, use the charger belt to secure it on your body.
Place the Charging Coil in the belt's pouch and attach the belt around your waist. Use the hook-and-loop closure to secure the cable.
Start charging and move the Charging Coil until it connects with your device.
For mobility during charging, insert the charger into the holster and clip it to your belt or pants.

Patient MRI Checklist

When Your Doctor Requests an MRI Scan:

Inform your physician 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:

Confirmation of your Nevro HFX spinal cord stimulator.
Details of any other medical implants.
A description of your device, including product number, leads, and components (found on patient ID card).
Contact information for your implanting physician.
The Nevro HFX MRI Guidelines (available at Nevro.com/manuals).

Preparing for Your MRI Appointment:

Contact your Nevro HFX Care Team to confirm MRI safety.
Your Nevro HFX Care Team will assist with device preparation, including an impedance check.
Refer to pages 13-15 or NevroHFX.com/resources for instructions.

Important: Ensure your device is fully charged before your MRI scan.

At Your MRI Appointment:

Bring your patient ID card and remote control.
Your MRI Tech will confirm impedance check results.
Turn your stimulation OFF using your remote control.

After Your MRI Appointment:

Turn your stimulation back ON by pressing the Stimulation Start/Increase Button after turning your remote control ON (refer to page 16).
Contact your Nevro HFX Care Team to ensure your device is programmed to your pre-MRI settings.

Note: HFX and HFX iQ are approved for MRI scans under specific conditions. Consult your Nevro HFX Care Team for details regarding your specific device and lead type.

Resources

Your Nevro HFX Care Team Contact Information:

We offer dedicated support throughout your journey. Please call 1-844-331-1001, Monday - Friday, 9:00 AM - 5:00 PM.

Video Instructions:

Scan the QR code or visit NevroHFX.com/resources.

MRI Guidelines for Your MRI Tech:

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

Important Information:

Rx Only: Patient experiences with the Senza® spinal cord stimulation (SCS) system vary. Please see www.NevroHFX.com/safety for complete safety information, indications for use, and contraindications.

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

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