PATIENT MANUAL Senza® Bluetooth® Trial System Effective November 2020 10000890 Rev B
All questions or concerns about Nevro Corp. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 USA Tel: +1.650.251.0005 Fax: +1.650.251.9415 info@nevro.com MDSS GMBH Schiffgraben 41 D-30175 Hannover Germany Australian Sponsor Emergo Australia 201 Sussex Street, Darling Park, Tower II, Level 20 Sydney, NSW 2000 Australia © Copyright 2020, Nevro Corp. All rights reserved.
CONTENTS 1 EXPLANATION OF SYMBOLS ON THE PRODUCT OR LABELING .......................................................................................... 4 2 INTRODUCTION ................................................................................................................................................................ 7 2.1 2.2 2.3 2.4 ABOUT THIS BOOKLET ................................................................................................................................................
1 EXPLANATION OF SYMBOLS ON THE PRODUCT OR LABELING SYMBOLS DESCRIPTION Serial number Caution Batch number Date of manufacture Manufacturer Expiration date Catalog number Physician only Temperature limit Consult instructions for use 10000890 REV B 4
SYMBOLS DESCRIPTION Consult electronic instructions for use www.nevro.com Sterilized using ethylene oxide Non-sterile IP22 Degree of ingress protection provided by enclosure Keep dry Do not re-use Do not re-sterilize Do not use if package damaged Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. www.nevro.co Magnetic resonance (MR) unsafe m Non-ionizing electromagnetic radiation www.nevro.
SYMBOLS DESCRIPTION Type BF applied part Authorized European representative Medical device Unique device identification Refer to Instruction manual/booklet AAA Battery 10000890 REV B 6
2 INTRODUCTION 2.1 About This Booklet This booklet was written for people who are considering or have received a Nevro ® Senza® BLUETOOTH® enabled Spinal Cord Stimulator (SCS) Trial System to help treat pain. Every person is unique, and your medical needs differ from those of others, even people with the same condition and the same SCS system. For this reason, always talk to your doctor if you have questions about your condition.
2.3 What to Expect with SCS Therapy If you and your doctor decide to proceed with SCS therapy, the first step is a trial phase. Typically, your doctor will first place a lead in your body. This procedure may be done under local anesthetic, so you are awake and aware of what is going on. You may be given medication to help you relax and some numbing medicine for the insertion site. The lead is placed in your body during a minor procedure usually without an incision.
3 DEVICE DESCRIPTION The Senza® Bluetooth® Trial System works by delivering electrical energy from a stimulator to an area around the spine. The system is capable of delivering HF10® therapy, a therapy that does not produce tingling sensations called paresthesia. It is also capable of providing stimulation that produces paresthesia at some therapy settings. For SCS therapy, a patient will typically first go through a trial phase to evaluate the therapy to see if it is right for them. 3.
Battery Compartment Stimulation OFF Button 2 AAA Batteries • Leads: Leads are thin insulated wires that connect to the Trial Stimulator at one end and have small electrodes on the other end placed near the spine. A small amount of electrical energy from the device travels through the leads and to the electrodes near the spine.
4 INSTRUCTIONS FOR USE 4.1 Using the Remote Control 4.1.1 Turning ON the Remote Control Most of the time, your Remote Control will be OFF to help save battery life. The Remote Control needs to be turned ON for it to communicate with the Trial Stimulator. 1. Press and hold the small gray ON / OFF Button on the upper left side of the Remote Control for up to five seconds Remote Control ON / OFF Button 2. If the Remote Control turns ON, you will hear one long beep and it will flash all its lights once. 3.
4.1.3 Turning OFF Stimulation 1. Press and hold the small gray ON / OFF Button on the upper left side of the Remote Control for up to five seconds to turn the Remote Control ON. 2. Press the round red Stimulation OFF Button located inside the Remote Control battery compartment to turn stimulation OFF. The Stimulation is OFF when all stimulation level indicator lights are off. NOTE: Avoid touching the battery when turning off stimulation. Stimulation OFF Button 4.1.4 Turning ON Stimulation 1.
1. Press and hold the small gray ON / OFF Button on the upper left side of the Remote Control for up to five seconds to turn the Remote Control ON. 2. To increase stimulation strength, press the Stimulation Increase Button repeatedly until you reach the stimulation strength you want. To decrease the stimulation strength, press the Stimulation Down Button.
programs. 4.1.7 Changing the Batteries in the Remote Control Your Remote Control should come with batteries already installed. It uses two AAA alkaline batteries. Never use any other type of battery with your Remote Control because this could damage the device. WARNING: Use only two AAA alkaline batteries in the Remote Control. Any other type of battery could damage the device. Make sure the Remote Control is OFF; it turns itself OFF automatically if no buttons are pressed for two minutes.
4.1.8 Understanding Signals from the Remote Control Your Remote Control will beep and light up to keep you informed about your Senza® Bluetooth® Trial System status. The following table provides the most common signals you will see and hear from your Remote Control. If you encounter something that is not shown here, Refer to the Troubleshooting Section of this manual, or contact your doctor. What You Hear What You See What It Means One single soft beep No change in lights.
4.2 ABOUT THE TRIAL STIMULATOR The Trial Stimulator is an externally worn SCS device that delivers therapy, stops delivering therapy, increases or decreases therapy intensity, or changes therapy types (“programs”) in response to commands that you send it using the Remote Control. You should avoid interacting directly with the Trial Stimulator, touching it, or applying pressure to it, as these activities could cause the Trial Stimulator that is attached to your body to come loose.
Battery Level What You See What It Means 2 lights on 50% battery capacity remaining. 1 light on 25% battery capacity remaining. All lights blinking The Trial Stimulator battery is low or completely empty. Refer to the Troubleshooting Section of this manual. 4.2.2 Replacing the Trial Stimulator Battery Your Trial Stimulator has a battery that can be replaced by your doctor if necessary. Do not attempt to replace the battery in the Trial Stimulator yourself.
5 TROUBLESHOOTING If you experience any problem with your Senza® Bluetooth® Trial System, please see if any of these troubleshooting recommendations might address that problem. Often, problems with the device turn out to have simple solutions. If you cannot fix your problem with these recommendations, or if you are having a problem not described here, contact your doctor. 5.1 Troubleshooting Therapy 5.1.1 If therapy has stopped: • Check that therapy has not been inadvertently turned OFF.
What You Hear Six beeps What You See All lights are off What It Means The Remote Control batteries are low. • Replace the batteries in the Remote Control (see “Using the Remote Control”). Normally, batteries should be replaced at least once a month. When replacing batteries, replace both at the same time and check that the orientation of the batteries is correct. • Move the Remote Control closer to the Trial Stimulator. The Remote Control may be out of range. 5.2.
5.2.3 If Remote Control is beeping continuously and/or all the Stimulation Level Indicator lights on the Remote Control are blinking: • If the Remote Control is beeping continuously and/or the Stimulation Level Indicator lights are blinking, there may be a loose connection between a lead and the Trial Stimulator.
days) of therapy left. You may continue to use your Trial Stimulator but should schedule an appointment with your doctor to have your battery replaced. • If the Remote Control beeps 10 times when you turn it ON, the Trial Stimulator battery is completely empty, and therapy has been turned OFF. You will not be able to use your Trial Stimulator until the battery is replaced. What You Hear Ten beeps • What You See All lights are off What It Means The Trial Stimulator battery is completely empty.
6 ASK YOUR DOCTOR SCS therapy has helped many people, but you must be willing to share information with your doctor for best results. Keep the name and phone number of your doctor and/or healthcare professional (technician) near you, at home, and at work, so that you or others can get in touch with him or her quickly if need be.
7 PATIENT IDENTIFICATION CARD Patients will be provided with a temporary Patient Identification (ID) Card during the trial phase. Patients should always carry their Patient ID Card with them. The card identifies someone as a device patient, and it may be important for the patient in a medical emergency. If a patient ever needs to go through a security checkpoint, they should show their Patient ID Card. Patients should let their doctor know if they move or their personal information changes.
8 ADDITIONAL INFORMATION Refer to the Clinical Summary (P/N 12057) for additional information regarding clinical studies of the Senza System and safety and effectiveness data. Refer to the Information for Prescribers (P/N 10001045) for indications, contraindications, warnings, warnings about other medical treatments, precautions, adverse events, technical specifications, and security features and declarations. The Trial Stimulator is unsafe for an MRI.
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NEVRO CORP. All questions or concerns about Nevro Corp. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 USA Tel: +1.650.251.0005 Fax: +1.650.251.9415 Email: info@nevro.
