Take control of your pain therapy. Getting started with Algovita SCS.

Take control of your pain therapy. Getting started with Algovita SCS.

The two-step approach to spinal cord stimulation therapy. You ve talked with your doctor. You ve discussed it with your family. You ve taken the time to consider if spinal cord stimulation (SCS) is right for you and your chronic pain. Now you re ready to take the next step. Before committing to long-term therapy, you will first undergo a trial to see if SCS is right for you. It s a time for you to experience how SCS relieves your pain, how the stimulation feels, and what your life might be like with long-term therapy. Step 1: Trial Phase Preparing for your trial. To prepare for your trial, think about a few ways you d like to measure your trial experience for example, sleeping through the night or being able to walk a few more minutes during the day. Then write these goals down so you can record your progress during the trial. On the day you begin the trial, plan to bring a friend or family member to accompany you home. Also be sure to wear loose, comfortable clothes. Step 1: Trial Phase 1 2

The trial procedure. The trial begins with a minor outpatient procedure, and most people go home shortly after it s complete. Your doctor or nurse will explain the procedure and talk you through what to expect and any possible risks. The procedure generally consists of the following steps: Thin wires called leads will be placed in your back using a special needle. These temporary leads are connected to a trial cable. The temporary leads are secured or taped to your back and covered. The trial cable is connected to your trial stimulator, which is worn outside your body. Your doctor will ask you where you feel the stimulation and what settings give you the greatest relief. Once the procedure is over, you ll go to a recovery room until your doctor releases you to go home. In the recovery room, you will get an Algovita Pocket Programmer and be shown how to control your stimulation during the trial. Leads Trial Stimulator 3 Trial Cable

During the trial. The typical trial period lasts from three days to about a week, depending on your circumstances and your doctor s recommendation. Your doctor will provide you with specific instructions to follow after your procedure. You should avoid certain activities to help keep the leads in place and prevent any complications. No bending, twisting, stretching, or other vigorous activity. No lifting heavy weight (over 5 lbs.). Avoid driving while the stimulation is turned on. Taking a sponge bath instead of a shower or bath during the week. During the trial, it is important to return to as many normal activities as possible, as recommended by your doctor. It s key for you to consider your pain relief and any other effects of the stimulation throughout your day. Also, keep in mind the goals you set for your trial, and take note of how you re progressing: While there are many benefits to an SCS stimulation trial, it s possible for complications to occur. Call your doctor if: You are not experiencing adequate pain relief. You see bleeding, redness, or persistent drainage around an incision. You experience excessive swelling or pain at the incision or area a lead is placed. You experience extreme nausea or a persistent headache that is worse when standing up and better when sitting or lying down. You experience sudden severe pain, leg weakness, spasms, loss of bladder control, or loss of bowel control. The lead becomes disconnected from the trial cable; if the lead breaks, turn the trial stimulator off, and then call your doctor. At the start of your trial, you will receive a Patient Stimulation Trial Manual that you can refer to if you have questions or need a refresher about any aspect of the trial phase. Are you sleeping better or longer at night? Is it easier or less painful to do daily activities? Did your use of pain medication change? It is helpful to keep a daily journal to share with your doctor. You can use the Pain Diary at the end of this booklet to keep track of your pain, as well as to record the effects of different program settings and how stimulation feels during daily activities. 5 6

Step 2: Long-Term Phase Preparing for your permanent implant. The permanent implant procedure is similar to the trial procedure, but there are some differences. Instead of the trial stimulator being worn on the outside of your body, your procedure will include receiving an implantable stimulator. You might also receive new, permanent leads during this time. Step 2: Long-Term Phase After the trial. At the conclusion of your trial, your doctor will remove the trial system. You and your doctor will also discuss your trial experience and determine whether long-term SCS is a good fit for you. If you choose to move forward, you will then schedule a time for the permanent procedure. Just like with your trial, on the day of the implant procedure, bring someone with you who can help you get home. Also be sure to wear loose, comfortable clothes. 7 8

The implant procedure. Implanting your long-term SCS system will involve either an outpatient procedure or a short hospital stay. Your doctor or nurse will explain the procedure and let you know what to expect. You ll then most likely be given medication that will make you drowsy and taken to the procedure room, where: Your doctor might adjust or replace your leads depending upon your trial experience. The doctor will place the stimulator under your skin. Your leads will then be connected to the stimulator. Once the procedure is over, you ll go to a recovery room. A trained SCS professional will teach you how to adjust your stimulation settings and charge your new Algovita device. You will be free to go home when your doctor releases you. You ll be sent home with an Algovita Pocket Programmer and Charging System. 9

After the implant. Like your trial procedure, some healing time will be required. Your doctor will provide you with complete instructions, but here are some important things to remember in order to help you heal correctly and prevent any complications. If new leads were implanted, do not stretch your arms over your head. Keep your incision site clean. Check your bandages for any persistent drainage. No bending, twisting, stretching, or other vigorous activity. No lifting heavy weight (over 5 lbs.). No driving with stimulation on. There are many benefits to long-term SCS, but complications can occur. Call your doctor if: You are not receiving adequate pain relief. You see bleeding, redness, or persistent drainage around an incision. You experience excessive swelling or pain at the incision or the area a lead is placed. You experience extreme nausea or a persistent headache that is worse when standing up and better when sitting or lying down. You experience sudden severe pain, leg weakness, spasms, loss of bladder control, or loss of bowel control. Remember that if you need a refresher about any aspect of your permanent system, you will receive a Patient System Manual after your procedure that will guide you through adjusting your stimulation settings and charging, and provide additional information about your system. Using your Algovita SCS System. Algovita is designed to fit into your life. We made it as easy as possible for you, so you have time to focus on the things that really matter. 11 12

Adjusting your stimulation settings. Over time, you and your doctor will work to fine-tune your stimulation settings. You ll also learn how to adjust your therapy on demand using the Pocket Programmer. Remember that SCS is a way to manage your pain, not eliminate it. Your doctor may prescribe other pain management therapies to work with SCS to give you the best possible results. Charging your stimulator. Your stimulator has a rechargeable battery, and charging it is a simple process. How often you ll need to charge your system depends on your settings and other factors. The higher your stimulation settings, the more often you ll need to charge your system. The time it takes to charge also depends upon the battery charge level and how often you recharge. It can range from thirty minutes to several hours. You ll use the Charging System with its attached charging paddle to charge your stimulator. Make charging part of your daily or weekly schedule. Regular charging will help maximize your battery life and also keep charging time down. Remember to charge your Charging System so that you can take it with you when you need it. Talk with your doctor about a recommended routine designed around your level of stimulation. Also contact your doctor if you re having trouble maintaining stimulation with regular charging. 13 14

Pain Relief Diary Pages Life with Algovita SCS. Your doctor may ask you to keep track of your pain in the days before and during your SCS trial procedure. The following pages can be used for tracking purposes and to help you and your doctor evaluate the pain relief that you experience. Pain Relief Diary Pages As you recover, you can really begin to explore what life with Algovita SCS looks and feels like for you. Look back and review your progress since you began the SCS process. For example: Can you go for walks with your dog now? Are you able to spend more time with your family? Have you been taking less pain medication? 15 Congratulations, you ve completed the journey to SCS. Enjoy your new life with less pain. 16

Baseline Pain Daily Diary Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Circle the intensity of your pain when you performed the following activities today. (pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Sleeping: 1 2 3 4 5 6 7 8 9 10 Sitting: 1 2 3 4 5 6 7 8 9 10 Standing: 1 2 3 4 5 6 7 8 9 10 Walking: 1 2 3 4 5 6 7 8 9 10 Notes for Additional Information: 17 18

Trial Stimulation Daily Diary - Day 1 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 19 20

Day 2 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 21 22

Day 3 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 23 24

Day 4 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 25 26

Day 5 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 27 28

Day 6 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 29 30

Day 7 Highlight the areas where you are feeling pain today and indicate the most painful areas by circling them. Date: / / Record the intensity of your pain when you performed the following activities and if it is better or worse than before your trial. (Pain intensity on a scale of 1-10, 1 being no pain, 10 being severe pain) FRONT BACK Activity Pain Intensity Better than Before Trial Sleeping: 1 2 3 4 5 6 7 8 9 10 Yes No Sitting: 1 2 3 4 5 6 7 8 9 10 Yes No Standing: 1 2 3 4 5 6 7 8 9 10 Yes No Walking: 1 2 3 4 5 6 7 8 9 10 Yes No Evaluate your overall sensation of the stimulation. Pleasant: 1 2 3 4 5 6 7 8 9 10 Tolerable: 1 2 3 4 5 6 7 8 9 10 Uncomfortable: 1 2 3 4 5 6 7 8 9 10 Painful: 1 2 3 4 5 6 7 8 9 10 Notes for the day: 31 32

Additional Notes: 33 34

Brief Summary: Product Technical Manuals and Information for Prescribers (IFP) must be consulted prior to use of this product. Indications for Use: The Algovita Spinal Cord Stimulation (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. Contraindications: Diathermy, patients who are poor surgical candidates. Warnings/Precautions: Strong electromagnetic interference (eg, electrocautery, RF or microwave ablation, or MRI) can result in serious patient injury or death, unexpected stimulation, or device malfunction or damage. Rupture or piercing of the neurostimulator many result in severe burns. Safety and effectiveness of SCS have not been established for pediatric patients, for use during pregnancy, or for use with nursing patients. Adverse Events: May include painful stimulation or loss of pain relief, hardware malfunction or migration, allergic response and surgical risks, such as infection, or additional surgery. For full prescribing information, please call Nuvectra at 1.844.727.7897 and/or consult Nuvectra s website at www.nuvectramed.com. Rx Only. April 2016. Algovita is a registered trademark of Nuvectra Corporation. 2016 Nuvectra or its affiliates. All rights reserved. 4AV18EN16