This manual introduces Abbott’s Eterna Spinal Cord Stimulator (SCS)‚ the smallest rechargeable SCS system‚ offering advanced pain management through BurstDR technology. It guides safe and effective use.
1.1 Overview of the Abbott Spinal Cord Stimulator System
The Abbott Spinal Cord Stimulator (SCS) system is a advanced neuromodulation device designed to manage chronic pain. It includes the Eterna SCS‚ the smallest rechargeable implantable generator‚ and the NeuroSphere patient controller. The system utilizes Abbott’s proprietary BurstDR and FlexBurst360 stimulation technologies to deliver personalized pain relief. Key components include the implantable neurostimulator‚ leads‚ and external programming devices. The system is MR conditional under specific conditions‚ ensuring safety during MRI scans. It is designed for patients with chronic‚ intractable pain who have not found relief with other treatments.
1.2 Importance of the Manual for Users and Clinicians
The Abbott Spinal Cord Stimulator manual is essential for both patients and healthcare professionals. It provides detailed instructions for the safe and effective use of the system‚ including implantation‚ programming‚ and maintenance. Users gain understanding of device operation‚ troubleshooting‚ and safety guidelines. Clinicians find critical information for surgical procedures‚ parameter adjustments‚ and patient monitoring. The manual also outlines MR conditional scan parameters and adverse effects‚ ensuring compliance with medical standards. It serves as a comprehensive resource to maximize therapeutic outcomes and minimize risks‚ supporting both clinical decision-making and patient independence.
Components of the Abbott Spinal Cord Stimulator
The Abbott Spinal Cord Stimulator system includes a compact neurostimulator‚ implantable leads‚ and an external patient controller. Accessories enhance functionality and patient convenience.
2.1 Description of the Neurostimulator
The Abbott Spinal Cord Stimulator neurostimulator is a compact‚ implantable medical device designed to deliver mild electrical impulses to the spinal cord. It is engineered to manage chronic pain effectively. The device incorporates advanced features like BurstDR stimulation‚ which mimics natural nerve firing patterns‚ enhancing pain relief. The neurostimulator is MR conditional‚ allowing for MRI scans under specific conditions. Its rechargeable design ensures long-term use‚ making it a reliable solution for patients seeking sustained pain management.
2.2 Components of the System
The Abbott Spinal Cord Stimulator system comprises several key components. The neurostimulator‚ a small implantable pulse generator‚ is the core device. It connects to insulated leads placed near the spinal cord to deliver electrical impulses. The system also includes an external patient controller‚ such as the NeuroSphere‚ for adjusting settings. Additionally‚ a charger is provided for replenishing the neurostimulator’s battery. These components work together to provide personalized pain relief‚ with the controller allowing patients to manage their therapy effectively. The design ensures both functionality and patient convenience.
2.3 Accessories and Additional Equipment
Abbott’s Spinal Cord Stimulator system includes accessories like the NeuroSphere patient controller‚ enabling patients to adjust stimulation settings. A rechargeable battery kit ensures the neurostimulator remains powered. Additional equipment comprises surgical tools for implantation and programming devices for clinicians. Protective covers and carrying cases are provided for the controller. These accessories enhance system functionality‚ ensuring safe and effective use. They are designed to support both patients and healthcare providers‚ optimizing the overall treatment experience with Abbott’s SCS technology.
Indications for Use
The Abbott Spinal Cord Stimulator is indicated for managing chronic pain‚ including failed back surgery syndrome‚ and certain refractory pain conditions. It aids in treating pain.
3.1 Chronic Pain Management
The Abbott Spinal Cord Stimulator (SCS) is a highly effective treatment for chronic pain management‚ particularly for patients who have not found relief through other therapies. By delivering mild electrical pulses to the spinal cord‚ the device interrupts pain signals to the brain‚ providing significant relief. It is commonly used for conditions such as failed back surgery syndrome‚ complex regional pain syndrome‚ and chronic lower back pain. The system offers customizable stimulation settings‚ allowing clinicians to tailor therapy to individual patient needs‚ enhancing both comfort and efficacy.
3.2 Specific Conditions Treated by the Device
The Abbott Spinal Cord Stimulator is designed to treat various chronic pain conditions‚ including failed back surgery syndrome (FBSS)‚ complex regional pain syndrome (CRPS)‚ and chronic lower back pain. It is also effective for managing intractable pain in the legs‚ arms‚ and trunk. The device’s advanced technology‚ such as low-dose BurstDR stimulation‚ provides targeted relief for patients who have not responded to other treatments. By addressing these specific conditions‚ the Abbott SCS helps improve mobility and quality of life for individuals suffering from debilitating pain.
Contraindications and Warnings
The Abbott Spinal Cord Stimulator is not recommended for pregnant or nursing individuals. MRI scans are contraindicated if any part of the device remains implanted. Ensure proper precautions are followed to avoid adverse effects or device malfunction.
4.1 Conditions Where the Device Should Not Be Used
The Abbott Spinal Cord Stimulator is contraindicated in certain conditions. It should not be used in pregnant or nursing individuals‚ as the risks to the fetus or infant are unknown. Patients with ferromagnetic materials in their bodies or those requiring MRI scans under certain conditions may also be ineligible. Additionally‚ individuals with unresolved medical conditions or those who cannot operate the device safely should avoid its use. Always consult the manual for a comprehensive list of contraindications and precautions.
4;2 Adverse Effects and Potential Risks
Common adverse effects of the Abbott Spinal Cord Stimulator include infection‚ tissue damage‚ or discomfort at the implant site. Potential risks may involve device malfunction‚ lead migration‚ or unintended stimulation. In rare cases‚ patients might experience neurological deficits or allergic reactions to the materials. MRI procedures‚ if not performed under specified conditions‚ could cause heating or damage to the device. It is crucial to adhere to the manual’s guidelines and consult a clinician to minimize these risks and ensure safe use of the system.
Implantation Procedure
The Abbott Eterna SCS implantation procedure involves surgically placing the neurostimulator and leads. It requires precise technique to ensure proper device functionality and patient safety.
5.1 Surgical Steps for Implanting the Device
The implantation of the Abbott Eterna SCS involves several precise surgical steps. First‚ the patient is prepared under general anesthesia. The neurosurgeon makes small incisions to insert the leads into the epidural space‚ guided by fluoroscopy. The leads are connected to the neurostimulator‚ which is then implanted in a subcutaneous pocket‚ typically near the abdomen or upper buttock. The procedure requires careful positioning to ensure optimal stimulation and minimize complications.
5.2 Pre- and Post-Operative Care
Pre-operative care involves patient preparation‚ including cleansing and administering antibiotics to minimize infection risks. Post-operative care includes monitoring for complications‚ managing pain‚ and providing wound care instructions. Patients are advised to avoid strenuous activities and follow specific guidelines to ensure proper healing and device functionality. Clinicians emphasize the importance of follow-up appointments for system checks and programming adjustments. Proper care ensures optimal outcomes and minimizes risks associated with the implantation of the Abbott Spinal Cord Stimulator.
Programming the Abbott Spinal Cord Stimulator
Programming involves setting personalized stimulation parameters using Abbott’s advanced technology‚ ensuring optimized pain relief. The system offers a user-friendly interface for clinicians to customize settings effectively.
6.1 Setting Up the Device
Setting up the Abbott Spinal Cord Stimulator involves initializing the neurostimulator and ensuring proper communication with the patient controller. Clinicians power on the device‚ verify battery status‚ and synchronize it with the NeuroSphere Patient Controller. Initial programming is performed to establish baseline settings‚ ensuring the system is customized to the patient’s needs. Proper setup is critical for effective therapy and patient safety. Refer to the user’s guide for detailed instructions on powering up and syncing the system. This step ensures optimal performance and personalized pain management.
6.2 Adjusting Stimulation Parameters
Adjusting stimulation parameters on the Abbott Spinal Cord Stimulator involves customizing settings like amplitude‚ pulse width‚ and frequency to optimize pain relief. Clinicians use the NeuroSphere programmer to tailor stimulation patterns‚ ensuring therapy efficacy. Abbott’s proprietary BurstDR technology allows for microdosing‚ delivering low-dose stimulation for enhanced comfort. Patients can also adjust settings via the patient controller within prescribed limits. Regular follow-ups are essential to refine parameters and ensure continued effectiveness. Refer to the user’s guide for detailed instructions on adjusting settings and utilizing Abbott’s advanced stimulation modes.
MRI Compatibility
The Abbott Spinal Cord Stimulator is MR Conditional‚ allowing MRI scans under specific conditions. Always follow the manual’s guidelines for safe scanning parameters and precautions.
7.1 MR Conditional Scan Parameters
The Abbott Spinal Cord Stimulator is MR Conditional‚ allowing MRI scans under specific conditions. For 1.5T and 3T scanners‚ the system must be in MRI mode. Maximum Spatial Gradient is 3‚200 T/m for 1.5T and 6‚000 T/m for 3T. Whole Body SAR is 3.0 W/kg for 1.5T and 1.5 W/kg for 3T. Always consult the manual for detailed parameters and ensure safe scanning conditions to avoid tissue heating or device damage.
7.2 Safety Precautions for MRI Procedures
Adherence to MRI guidelines is crucial for patient safety. Ensure the Abbott Spinal Cord Stimulator is in MRI mode before scanning. Use the NeuroSphere Patient Controller to confirm settings. Monitor the patient during the procedure and inform MRI staff of the implanted device. Avoid MRI if any leads or components remain post-explant or if the patient is pregnant. Always verify MR Conditional parameters in the manual to prevent potential risks like tissue heating or device malfunction.
Maintenance and Troubleshooting
Regularly recharge the Abbott SCS device to maintain functionality. Monitor battery life and ensure secure connections. Refer to the manual for troubleshooting common issues like loss of stimulation or error messages.
8.1 Recharging the Device
Recharge the Abbott Spinal Cord Stimulator using the provided charging dock. Ensure the device is turned off before charging. The indicator lights will show charging status: green for fully charged and red for low battery. Charge the device regularly to maintain optimal performance. Follow the manual guidelines for recommended charging frequency and duration. Avoid using damaged cables or adapters‚ as they may cause malfunction. If issues arise‚ such as slow charging or no charge‚ consult the troubleshooting section or contact Abbott support.
8.2 Common Issues and Solutions
Common issues with the Abbott Spinal Cord Stimulator include low battery‚ charging malfunctions‚ or unexpected stimulation patterns. If the device is not charging‚ ensure the charger is properly connected and the port is clean. For irregular stimulation‚ check the lead connections or consult the clinician. If the remote control is unresponsive‚ restart it and ensure it is paired correctly. For persistent issues‚ refer to the troubleshooting guide in the manual or contact Abbott support for assistance.
Patient Training and Education
This section provides guidelines for patients and clinicians on proper device usage‚ safety‚ and troubleshooting. Education ensures effective therapy and device management‚ enhancing patient outcomes.
9.1 Understanding the NeuroSphere Patient Controller
The NeuroSphere Patient Controller is a user-friendly interface designed for patients to manage their Abbott Spinal Cord Stimulator. It allows patients to adjust stimulation settings‚ track therapy progress‚ and receive recharge reminders. The controller is compatible with the Eterna SCS system‚ enabling personalized pain management. Patients can use the controller to turn the device on/off‚ adjust intensity‚ and switch programs. This tool empowers patients to take an active role in their therapy. Proper training is essential for safe and effective use.
9.2 Safe Usage Guidelines
Adhering to safety guidelines is crucial for optimal use of the Abbott Spinal Cord Stimulator. Patients should avoid MRI scans unless under specific conditions outlined in the manual. The device should not be used during pregnancy or while nursing. Users must keep the NeuroSphere Controller away from water and extreme temperatures. Regular recharging is essential to maintain functionality. Patients should follow clinician instructions for programming and adjustments. Proper care ensures device longevity and effectiveness in managing chronic pain safely.
Clinical Evidence and Efficacy
Abbott’s SCS systems are supported by extensive clinical trials demonstrating efficacy in pain management. BurstDR stimulation shows significant pain reduction. The Eterna system’s low-dose approach enhances patient satisfaction.
10.1 Studies Supporting the Use of Abbott SCS
Clinical trials demonstrate Abbott’s SCS systems effectively manage chronic pain. The Eterna SCS system‚ featuring BurstDR stimulation‚ has shown significant pain reduction and improved quality of life. FDA-approved studies highlight its safety and efficacy. Patients with chronic back and limb pain reported sustained relief. The system’s low-dose approach minimizes side effects‚ enhancing patient satisfaction. Abbott’s commitment to innovation is supported by robust clinical evidence‚ ensuring the SCS system meets high standards of care and patient outcomes.
10.2 Outcomes and Patient Satisfaction
Patients using Abbott’s SCS systems report significant pain reduction and improved quality of life. Clinical outcomes show high satisfaction rates‚ with many experiencing sustained relief from chronic pain. The Eterna SCS system’s low-dose BurstDR stimulation enhances comfort and minimizes side effects. Patients appreciate the system’s adaptability and ease of use‚ contributing to positive feedback. Abbott’s focus on innovation ensures high patient satisfaction‚ making their SCS systems a trusted choice for chronic pain management.
Regulatory Approvals and Compliance
Abbott’s Eterna SCS system is FDA-approved for chronic pain treatment‚ ensuring compliance with rigorous medical standards and safety protocols‚ adhering to regulatory requirements globally.
11.1 FDA Approvals and Certifications
The Abbott Eterna Spinal Cord Stimulation (SCS) system has received FDA approval for the treatment of chronic pain‚ marking a significant milestone in neuromodulation therapy. This approval underscores Abbott’s commitment to delivering safe and effective solutions. The system utilizes advanced technologies‚ including BurstDR stimulation‚ which has been clinically validated to provide meaningful pain relief. FDA certification ensures that the device meets stringent safety and efficacy standards‚ offering patients and clinicians a reliable option for managing chronic pain conditions. This approval highlights Abbott’s dedication to innovation and patient care.
11.2 Compliance with Medical Standards
Abbott’s Eterna SCS system adheres rigorously to international medical standards‚ ensuring safety and efficacy. The device is MR Conditional‚ allowing for MRI scans under specific conditions. It meets FDA guidelines for implantable devices and complies with ISO standards for quality and safety. Regular audits and clinical evaluations confirm its adherence to these regulations‚ providing assurance to both patients and healthcare providers. Compliance with these standards underscores Abbott’s commitment to delivering high-quality‚ reliable medical solutions for chronic pain management. This ensures the device performs optimally and safely for patients worldwide.
Comparison with Other SCS Systems
Abbott’s Eterna SCS stands out as the smallest rechargeable system‚ offering advanced BurstDR and FlexBurst360 technologies for personalized pain relief‚ surpassing competitors in size and therapeutic customization.
12.1 Unique Features of Abbott SCS
Abbott’s Eterna SCS is distinguished by its compact‚ rechargeable design‚ making it the smallest implantable SCS system available. It utilizes proprietary BurstDR and FlexBurst360 technologies‚ delivering personalized pain relief. These features enable microdosing‚ optimizing therapeutic outcomes while minimizing side effects. Additionally‚ Eterna offers MR conditional capabilities‚ ensuring compatibility with certain MRI procedures under specific conditions. Its advanced programming and user-friendly NeuroSphere controller enhance patient and clinician experience‚ setting it apart from other spinal cord stimulation systems on the market.
12.2 Advantages Over Competitor Devices
Abbott’s Eterna SCS stands out for its compact‚ rechargeable design‚ making it the smallest implantable SCS system. Its proprietary BurstDR and FlexBurst360 technologies offer personalized pain relief with microdosing‚ reducing side effects. Eterna also features MR conditional capabilities‚ allowing select MRI procedures. Compared to competitors‚ Abbott’s system combines advanced programming‚ user-friendly controls‚ and enhanced patient outcomes‚ making it a superior choice for chronic pain management. Its innovative design and therapeutic efficacy set it apart in the neuromodulation market‚ providing a more tailored and effective treatment solution.
Future Developments and Innovations
Abbott is advancing spinal cord stimulation with cutting-edge technologies‚ including AI-driven advancements and next-generation devices. These innovations aim to enhance pain relief and improve patient outcomes further.
13.1 Emerging Technologies in SCS
Emerging technologies in spinal cord stimulation include advanced BurstDR microdosing‚ AI-driven personalization‚ and next-gen wireless connectivity. Abbott’s Eterna SCS‚ the smallest rechargeable system‚ integrates these innovations‚ enhancing therapy precision and patient comfort. MR conditional designs and low-dose stimulation are prioritized‚ minimizing risks and improving outcomes. These advancements reflect Abbott’s commitment to revolutionizing pain management through cutting-edge neuromodulation solutions.
13.2 Abbott’s Commitment to Innovation
Abbott’s dedication to innovation is evident in its Eterna Spinal Cord Stimulation system‚ featuring cutting-edge BurstDR technology and a user-friendly NeuroSphere controller. By focusing on patient-centric solutions‚ Abbott ensures continuous improvement in pain management. Their commitment extends to ongoing research and development‚ aiming to enhance treatment efficacy and patient outcomes. Abbott’s advancements underscore their leadership in neuromodulation‚ providing hope for those seeking relief from chronic pain through breakthrough technologies.
The Abbott Spinal Cord Stimulator Manual provides comprehensive guidance for safe and effective use‚ ensuring optimal pain management and improved quality of life for patients.
14.1 Summary of Key Points
The Abbott Spinal Cord Stimulator Manual provides essential guidance for users and clinicians‚ detailing system components‚ indications‚ contraindications‚ and programming. It emphasizes safe usage‚ MRI compatibility‚ and maintenance. The manual highlights Abbott’s commitment to innovation‚ with devices like the Eterna SCS offering advanced pain management. Patient training and clinical evidence are underscored to ensure effective outcomes. This comprehensive resource supports both clinicians and patients in optimizing spinal cord stimulation therapy for chronic pain relief and improved quality of life.
14.2 Final Thoughts on the Abbott Spinal Cord Stimulator Manual
The Abbott Spinal Cord Stimulator Manual serves as a comprehensive guide‚ ensuring safe and effective use of the device. It balances technical details with practical guidance‚ making it invaluable for both patients and clinicians. Abbott’s commitment to innovation‚ as seen in systems like the Eterna SCS‚ underscores their dedication to advancing pain management. This manual not only educates but also empowers users‚ fostering confidence in the technology and its life-enhancing potential for chronic pain relief.