Patient Manual i
NEVRO CORP. All questions or concerns about Nevro products 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 Level 20, Tower II, Darling Park 201 Sussex Street, Sydney, NSW 2000 Australia © Copyright 2019, Nevro Corp. All rights reserved.
Explanation of symbols on the product or package labeling. Refer to the product for symbols that apply. Symbol Description SN Serial number LOT Batch code Date of Manufacture Manufacturer Caution Catalog number XX C XX F XX C XXX F Temperature limitation (storage) Consult Electronic Instructions for Use www.nevro.com Non-sterile Non-ionizing radiation Type B Applied Part Type BF Applied Part Do not dispose of this product in the unsorted municipal waste stream.
MR Conditional Conditional MR unsafe 0086 CE Marking of Conformity Authorized representative in the European Community For USA audiences only 11052 Rev E iv
Table of Contents INTRODUCTION...................................................................................... 1 ABOUT CHRONIC PAIN ........................................................................... 1 YOUR SENZA SYSTEM ............................................................................. 2 INDICATIONS ......................................................................................... 4 WARNINGS .....................................................................................
APPENDICES ......................................................................................... 47 Device Specifications ................................................................................. 47 System Components ..................................................................................
INTRODUCTION This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) 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. This booklet presents general information and can help you better communicate with your doctor.
Chronic pain can be intractable, which is the medical term meaning that it is hard to treat. You have probably tried many treatments to control your pain and found that they did not work well or perhaps they did not work at all. INTRACTABLE. Any condition, such as chronic pain, which is very difficult to control or treat effectively. YOUR SENZA SYSTEM The Senza system works by delivering electrical energy from a device to an area around your spine.
If the Senza system is right for you, your doctor will discuss with you the implantation of a battery-powered device after the trial phase. The Senza system components will include: • Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted inside the body (see IPG in the diagram above). • Lead, same as in the trial phase. However, instead of connecting to an external stimulator as occurred during the trial phase, will connect to the implanted IPG.
INDICATIONS The Senza system is not right for everyone. Indications for the use of this device are as follows: The Senza neuromodulation system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. INDICATIONS. Reasons that you should get a device, drug, or treatment.
paresthesia-free therapy and the system must be configured to deliver paresthesia-free stimulation. Stimulation between 1,200 Hz and 10,000 Hz has not been evaluated for safety, effectiveness and perception of paresthesia. Specifically, for stimulation frequencies above 1,200 Hz, amplitudes that produce paresthesias have not been evaluated and therefore it is unknown whether injury may occur.
Heat from Charging – You will have to recharge the battery in your device. Always use the special Charger Belt when recharging. During recharging, the Charging Coil may become warm or even burn you. If you feel warmth or discomfort when recharging the device, stop recharging and contact your doctor. Do not place the charger over an area of skin where you do not feel any sensation.
WARNING: Use of the Senza system adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the Senza system and the other equipment should be observed to verify that they are operating normally. WARNING: Use of accessories other than those specified or provided by Nevro could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Senza system and result in improper operation.
this manual. To avoid unintentionally stopping stimulation, do not open the battery compartment while stimulation is ongoing. • ESD may cause the Charger to stop charging the IPG. If this happens, charging can be resumed by repeating the steps in the “How to Charge the Implantable Pulse Generator” section of this manual. ESD events can be minimized by keeping the charger in the Charger Holster while recharging the IPG.
Computed Tomography (CT) – Please inform your doctor and medical personnel conducting your CT scan that you have an implanted SCS system. You must turn your device off temporarily while the scan is being conducted.
precautions (as identified in the MRI Guidelines located at: http://www.nevro.com/manuals) to prevent patient injury and device damage. Do not take the trial stimulator, patient remote, or charger into the MRI scan room. They are not considered safe for MRI and may be rapidly pulled into the MRI scanner. In doing so, they may strike and injure a person. Before undergoing these or any other procedures, discuss them with your doctor to be sure they are safe for you. LITHOTRIPSY.
• If you suspect that the device is not functioning properly after the use of these therapies or procedures, please contact your doctor. RADIO-FREQUENCY OR MICROWAVE ABLATION – An electrical current produced by a radio/micro wave is used to heat up a small area of nerve tissue, thereby decreasing pain signals from that specific area. Radio-Frequency or Microwave Ablation – Safety has not been established for Radio-Frequency or Microwave Ablation in people who have an implanted neurostimulation system.
PRECAUTIONS Precautions are instructions about your device you should follow to avoid damage to the device, so that it will function correctly and last longer. • Store the Trial Stimulator and Remote Control at normal temperatures in the range of -20°C to 60°C (-4°F to 140° F). • Store the Charger at normal temperatures in the range of 0°C to 45°C (32°F to 113°F). • The operating temperature range for the Patient Remote Control is 10°C to 40°C (50°F to 104°F).
weeks after the surgery. An implanted lead can move from its original location during such movements, which might affect delivery of therapy. In such cases, your system may need to be reprogrammed or the lead may need to be repositioned through another operation. Scuba Diving and Hyperbaric Chambers – Your Senza system is sensitive to high pressure.
IPG Location and Patient Manipulation – Do not to twist or rotate the IPG. If the IPG flips over in the body, the Charger may not be able to charge the IPG. Manipulation of the IPG in your body may cause the skin over the IPG to become thinner over time. Infection – If you experience persistent discomfort or excessive redness around the wound areas, please advise your physician. You may need to be checked for infection.
benefits from spinal cord stimulation. Stimulation effectiveness at 10 kHz has been established for one year. ADVERSE EVENTS Adverse events, or side effects, are risks associated with the use of this or any other SCS system. There are adverse events associated with the implant procedure, with stimulation, and with the device itself. Please contact your physician if you experience any adverse events associated with the device.
Possible Adverse Events Associated with the Implanted Device Components • Tissue reaction or allergy to implanted materials • Persistent pain at the lead or IPG implant site(s) • Failure of device components or the battery, including lead breakage or movement (migration), hardware malfunctions, loose connections, electrical shorts, or open circuits and lead insulation breaches • Failure or malfunction, resulting in ineffective pain control or other undesirable changes in stimulation, possibly requiring expl
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.
well for you, you will have an IPG implanted in the body to replace the Trial Stimulator. This trial phase typically lasts several days. For your trial, your doctor has set up a special stimulation program for you. He or she has adjusted the device’s features specifically for you. You will be given the external Trial Stimulator, a Remote Control, and some cables. Using this system, you can test the stimulation system to see how it works for you.
• The Trial Stimulator will lock itself again automatically if you do not press any button on it for a minute or more. Plugging OR Cables into the Trial Stimulator You will receive the Trial Stimulator with OR Cables. A diagram of these cables and the Trial Stimulator appears in the Appendix. To plug them into the Trial Stimulator, follow these steps: 1. Make sure the Trial Stimulator is turned OFF by pressing the red Stimulation OFF Button. 2.
Trial Stimulator Alert If the Trial Stimulator is set up but cannot deliver therapy, it will sound an alert. This alert will sound until you press the red Stimulation OFF Button on the Trial Stimulator. Pressing the red button turns therapy OFF. A frequent reason for the Trial Stimulator alert is one or more loose connections. Check that both OR Cables are properly in place and securely plugged in. If a cable is loose or disconnected, plug it in securely.
How to Change the Batteries in the Trial Stimulator You will regularly need to replace the batteries in your Trial Stimulator. Use only the special Nevro batteries provided. A spare set of batteries will be provided with the Trial Kit. If needed, additional batteries can be obtained from your physician. Typically, batteries last for approximately five days. 1. Turn OFF the Trial Stimulator by pressing the red Stimulation OFF Button on the lower right. 2.
The Remote Control (RC1000) RC1000 The Remote Control communicates wirelessly with the Trial Stimulator when you hold the Remote Control near it. The Remote Control turns itself OFF when it is not in use. To turn it ON, just press the yellow ON/OFF Button on the upper lefthand corner. Once the Remote Control is ON, you can increase or decrease stimulation by pressing the big plus (Stimulation Start/Increase) and minus (Stimulation Decrease) buttons on the front of the Remote Control.
2. Hold it down for up to five seconds. o If the Remote Control turns on, you will hear a long beep. o Lights will flash as the Remote Control tries to establish communication with the Trial Stimulator.
How to Change the Batteries in the Remote Control Make sure the Remote Control is OFF; it turns itself OFF automatically if it is not touched for two minutes. Pushing the yellow ON/OFF Button on the top left corner also turns off the Remote Control. 1. Turn the Remote Control over and remove the battery compartment cover. 2. Remove the two old batteries. 3. Double check that the new batteries are AA alkaline batteries. Do not use any other type of battery. 4.
How to Turn OFF Stimulation If you are using the Trial Stimulator, you can turn stimulation OFF by pressing the round red Stimulation OFF Button on the lower right-hand corner. This button is always active and can be pressed at any time, even if the Trial Stimulator is locked. You can also turn stimulation OFF with the Remote Control, but the Remote Control must be turned ON first (press the yellow ON/OFF Button on the upper left).
Trial Stimulator Remote Control Turn stimulation ON from the Remote Control, first turn the Remote Control on by pressing the yellow ON/OFF Button for up to five seconds. One long beep sounds to tell you the Remote Control is on. Turn stimulation ON: Press the plus sign. The lights will flash when it is stimulating. Once the Remote Control is ON; Turn stimulation ON: press the plus sign. When the device is stimulating, you will see at least one of the LED lights turn on.
Three regular beeps means the device cannot accommodate your request. The following may be the reason: • • The Remote Control is too far away from the Trial Stimulator The Remote Control has another problem communicating with the Trial Stimulator Move the Remote Control closer to the Trial Stimulator and try again. Your device is adjustable so that you can find the right level of stimulation to control your pain.
IMPLANTED STIMULATOR PHASE After your Trial Phase using the Trial Stimulator and the Remote Control, you and your doctor will decide if SCS therapy is right for you. During the trial phase, you learned to use the Remote Control. You will use either the same or a similar Remote Control with the IPG. You also learned what it felt like to receive therapy and how it worked to control your pain. It is expected that the therapy will work the same way after the IPG implantation.
RC2500 – 5 Program Remote The Remote Control communicates wirelessly with the IPG when you hold the Remote Control near it. The Remote Control turns itself OFF when it is not in use. To turn it ON, just press the ON/OFF Button on the upper left-hand side. Once the Remote Control is ON, you can increase or decrease stimulation by pressing the ‘up’ (Stimulation Start/Increase) and ‘down’ (Stimulation Decrease) arrow buttons on the front of the Remote Control.
1. Press the small ON/OFF Button on the upper left-hand side of the Remote Control. 2. Hold it down for up to five seconds. o If the Remote Control turns on, you will hear a long beep. o Lights will flash as the Remote Control tries to establish communication with the IPG.
Remote Control Batteries 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. How to Change the Batteries in the Remote Control Make sure the Remote Control is OFF; it turns itself OFF automatically if it is not touched for two minutes.
Adjusting Stimulation Once the Remote Control is ON and has established communication with the IPG, you can use the Remote Control to turn the stimulation ON and OFF, or increase/decrease the strength of the stimulation. How to Turn OFF Stimulation You can turn stimulation OFF with the Remote Control, but the Remote Control must be turned ON first (press the ON/OFF Button on the upper left side). Slide open the back door of the Remote Control slightly till the red Stimulation OFF Button is visible.
How to Turn ON Stimulation To turn stimulation ON, turn on the Remote Control first (use the ON/OFF Button on the upper left) and then turn stimulation ON by pressing the ‘up’ arrow. When the IPG stimulates, it will indicate this by lighting up at least one LED light (Remote Control). Your doctor has set up your stimulation program for you already. When you turn stimulation ON, it will stimulate as programmed.
One single regular beep Two regular beeps Three regular beeps Continuous beeping Stimulation has increased or decreased by one level. You have reached the highest or lowest stimulation level possible. The device cannot respond the way you want. One of the cables on the Trial Stimulator is loose. Three regular beeps means the device cannot accommodate your request.
1. Turn the Remote Control on by pressing and holding the ON/OFF Button on the upper left-hand side for up to five seconds. You will hear one long beep to tell you that the Remote Control is on. 2. Press the green P button to change the stimulation program. The programs go in order (1, 2, 3, 4, 5, then 1, 2, 3, 4, 5, and so on). 3. Stop when light by the desired number is lit. If only one program is available, the number 1 will remain lit and you will not be able to change programs.
Battery Level Indicators (RC1000) The Remote Control also has a Stimulator Battery Level Indicator. The Stimulator Battery Level Indicator on the Remote Control tells you the status of the IPG battery. If you see two or fewer bars, then your IPG needs to be recharged.
Battery Level Indicators (RC2500 – 5 Program Remote) The Remote Control also has a Stimulator Battery Level Indicator. The Stimulator Battery Level Indicator on the Remote Control tells you the status of the IPG battery. If you see two or fewer dots, then your IPG needs to be recharged. How to Charge the Implantable Pulse Generator You can still get stimulation from your device even during charging. Follow these steps to charge the IPG. 1.
WARNING: Never charge your IPG when the Charger is plugged into a wall outlet. Always remove the Power Adaptor before pressing the Charge Start Button. 3. Press the arrow Charge Start Button to turn on the Charger. 4. The Charger will start to look for the IPG. It beeps as it searches. 5. When the Charger finds the IPG, you will see at least two bars on the Antenna Strength Indicator. (If you do not have at least two bars, move the Charging Coil slightly until you get sufficient antenna strength.
The Charger has two battery status bars: The status bar on the left of the arrow button is the battery status of the Charger. The status bar on the right of the arrow button is the battery status of the IPG. 7. Keep the Charging Coil steady in the same position. The Charger will keep charging until the IPG is fully charged (or until the Charger runs out of its own charge). NOTE: If the Charging Coil is moved during the charging session, it may lose communication with the IPG.
NOTE: The IPG will continue to provide therapy while being recharged. The battery life of the IPG is estimated to be 10 years but the battery life may be more or less depending on the stimulation parameters used. The battery will eventually need to be replaced in a surgical procedure. How to Charge the Charger You should recharge the Charger after every use. The best way to remember to do this is to get into a daily routine of charging the IPG and then recharging the Charger.
Optimizing Charging In order to charge the IPG, the Charging Coil must establish good communication with the IPG. There may be times when you have trouble getting the Charger and the IPG to communicate. If there is no communication at all, the Antenna Strength Indicator will show one single orange bar and beep occasionally. The Charger will eventually turn itself off. 1. Make sure that there is no metal near the Charging Coil.
• Ensure the Charger is charged by viewing the Battery Status indicator on the left side of the Charger. It is recommended that at least two bars are indicated. If no lights are indicated then see “How to Charge the Charger”. • The more bars shown on the Antenna Strength Indicator, the better communication the Charging Coil has with the IPG. The better the communication, the less likely that your charge session will be interrupted.
YOUR PATIENT ID CARD You will receive a temporary patient identification (ID) card during the trial phase. If you have the device implanted, you will get a permanent ID card from Nevro through the mail in several weeks. Carry this patient ID card with you at all times. It identifies you as a device patient and it may be important for you in a medical emergency. If you ever need to go through a security checkpoint, you should show your Patient ID card.
Discuss with your doctor changes in your condition and how you are responding to therapy. TROUBLESHOOTING If you should experience problems with your Senza system, please see if any of these troubleshooting recommendations might address that problem. Many times, 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.
• If you are using the Trial Stimulator, look at the Trial Stimulator to see if the Low Battery Indicator Light (upper left-hand corner) is flashing or lit. If the light is flashing or lit, replace the Trial Stimulator battery. Use only the special batteries provided by Nevro for use in your Trial Stimulator. • Move the Remote Control to make sure it is close enough to the Trial Stimulator or IPG to work. It may be out of range.
• If you notice that the Remote Control is turned off after the three beeps, the IPG battery is low. Recharge the IPG. Troubleshooting the Trial Stimulator If the Trial Stimulator beeps continuously: • • There may be a loose connection. Double check that the OR Cables are in the correct ports (match the colors) and that they are securely inserted. You should feel a click when the cables are inserted the right way. Once you are sure the cables are properly inserted, turn therapy ON again.
If you are trying to recharge the IPG and you have low antenna strength that you cannot improve: • • • Slowly move the Charging Coil slightly. The goal is that the center of the Charging Coil circle is lined up over the top of the implanted device. Wait about three seconds and observe if the antenna strength improves. You may have to do this a few times—make sure your movements are slow and small. You can still charge if you have two bars on the Antenna Strength Indicator.
Stimulation Parameter Ranges The following table summarizes the maximum impedance for which the maximum current of 15 mA can be delivered at the maximum pulse width (1 msec, at a maximum frequency of 400 Hz) and maximum frequency (10,000 Hz, at a maximum pulse width of 30 µsec).
used in accordance with the instructions, may cause harmful interference to radio communications. Changes or modifications of any kind not expressly approved by Nevro could void the user’s authority to operate this device. This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids (i.e.
Flicker emissions IEC 61000-3-3 directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Guidance and Manufacturer’s Declaration - electromagnetic immunity The Senza system is intended for use in the electromagnetic environment specified below. The customer or user of the Senza system should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration - electromagnetic immunity The Senza system is intended for use in the electromagnetic environment specified below. The customer or user of the Senza system should assure that it is used in such an environment.
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range (b) Interference may occur in the vicinity of equipment marked with the symbol shown below: NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
Recommended separation distances between portable and mobile RF communications equipment and the Senza system The Senza system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
System Components TRIAL STIMULATOR AND OR CABLE 2 1. 2. 3. 4. 5. 6. 7. 8. 9. 1 Right Cable Port Left Cable Port Stimulation OFF Button Low Battery Indicator Light Stimulation Increase Button Stimulation Decrease Button Stimulation ON Indicator Light OR Cable, the lead end OR Cable, the Trial Stimulator end 8 9 REMOTE CONTROL (RC1000) 10. 11. 12. 13. 14. 15. 16. 17.
SENZA OMNIA REMOTE CONTROL (RC2500 – 5 Program Remote) 17 10 12 13 11 14 15 16 10. 11. 12. 13. 14. 15. 16. 17.
CHARGER 1. 2. 3. 4. 5. 6. 7. Stimulation OFF Button Antenna Strength Indicator Charger Battery Level Indicator Charge Start Button Implanted Stimulator’s Battery Level Indicator Charging Coil Power Adaptor Port POWER ADAPTOR 8. Power Adaptor Wall Plug 9.
CHARGING BELT CHARGER HOLSTER 11052 Rev E 57
NEVRO CORP. All questions or concerns about Nevro Corp. products 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.
