For additional user manuals related to investigational studies, including the Multiple Sclerosis Pilot Study, please contact your study center.

Indication for Use

The SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs).

Contraindications

There are certain situations in which the SetPoint System should not be used because the risk(s) are greater than the potential benefit(s).

The SetPoint System should not be used:

• If the patient has had certain health procedures that would interfere with how the device works, for example,
  1. If they have had surgery to remove the vagus nerve (vagotomy).
  2. If they have had their spleen removed (splenectomy).
• If you determine that it might not be safe for them to have the surgery, for example,
  1. If they have spine disease in their neck that makes it risky to place a breathing tube (intubate).
  2. If they cannot be safely given anesthesia for surgery.
• If they cannot safely use SetPoint Charger, for example,
  1. If their neck is too large to wear SetPoint Charger.
  2. If they have a pacemaker or a defibrillator implanted.

Warnings & Precautions

It is important that the patient use the SetPoint System safely to avoid injury or damage to the SetPoint System or other devices. Here are some key safety tips:

• Instruct the patient to always present the Patient ID card, prior to undergoing any treatment or diagnostic procedure, to healthcare professionals and providers such as physicians, dentists, imaging technicians (e.g., MRI, X-ray, computerized tomography), estheticians and beauty-care specialists. Failure to present the Patient ID card may result in a treatment or procedure-related complication and/or may damage the SetPoint System. (See Medical Imaging Warnings )
• Instruct the patient not to scuba dive or enter a hyperbaric chamber after receiving the Implant. The safety of high pressure has not been established and these conditions could damage the device.
• Instruct the patient not to use the SetPoint Charger while it is covered (e.g., with a scarf or similar material), in direct sunlight, or in air temperatures exceeding 90 °F (32 °C). If they do, it may cause the Charger to overheat rapidly and shut down prematurely.
• Instruct the patient not to continue to use the SetPoint System beyond its expected service life. The Charger and Docking Station have a 5-year service life. Use after this time can lead to additional risks associated with device deterioration over time. Signs of performance degradation include incomplete Implant charging during the weekly session. The Implant has a 10- year service life, after which time it will stop providing daily stimulation and will no longer recharge. At that time, the Implant will need to be replaced.
• Do not use the SetPoint Charger or Docking Station if any cracks, defects, or breaches are present, or if the product box or Carrying Case are badly damaged. If you do, damaged internal electrical components could alter the Charging or Docking Station function or bypass safety features and result in harm.
• Instruct the patient not to use third-party wireless chargers with the SetPoint Charger or try to charge other devices with the SetPoint Docking Station. Using incompatible accessories with the SetPoint System could lead to device damage or malfunction.
• Instruct the patient not to position the SetPoint Charger around the neck if there are any unhealed wounds. If they do, it increases the risk of infection.
• Instruct the patient not to apply excessive force or rough handling to the SetPoint Charger. If they do, it may damage its internal electrical components, potentially causing malfunction.
• Instruct the patient not to use any cleaning product other than isopropyl alcohol (IPA) wipes to clean the SetPoint Charger. If they do, it could damage the Charger or leave behind harmful or irritating residues.
• Instruct the patient to adhere to local e-waste regulations when disposing of any part of the SetPoint System. If they do not, it can result in environmental contamination with hazardous substances.
• Instruct the patient not to modify or tamper with the SetPoint Charger or Docking Station. If they do, it could alter their function or bypass safety features and result in harm.

Medical Imaging Warnings

There are various types of medical imaging technologies in common use. Although X-rays, computed tomography (CT), ultrasound imaging (sonography), positron emission tomography (PET) are all safe to perform after the patient receives their Implant, it is vital that they always show their Patient ID card to any healthcare professional performing these procedures. Specifically for magnetic resonance imaging (MRI), although they can have scans 2 weeks after implantation, they can only be performed under certain conditions as outlined in SetPoint System Magnetic Resonance Imaging (MRI) Safety Information Manual. This is referred to as MR Conditional and must be discussed with the MRI technician.

The SetPoint Charger and SetPoint Docking Station should never be brought near MRI machines because they are not safe for use in that environment. This is referred to as MR Unsafe.

Medical Procedure Warnings

Instruct the patient to use caution with any medical procedure that introduces electrical current, electromagnetic radiation, or thermal energy into tissues in the neck area. The Implant may absorb, intensify, or reflect these energy sources, resulting in localized heating that could damage the device or nearby nerves and vascular structures. This damage may result in pain or discomfort, loss of vocal cord function, or even possibly life-threatening injury if there is damage to blood vessels. Note that these risks are present whether the Implant is active or suspended. It is vital that they always show their Patient ID card to any healthcare professional performing these procedures so that they can carefully evaluate potential interactions and risks. Before proceeding with any procedure that delivers energy to the tissues surrounding the Implant, the healthcare professional should consider alternatives that avoid energy transfer. Specific examples of higher risk procedures around the implantation site that need to be avoided because they could damage the Implant, cause it to malfunction, and/or result in harm including severe injury:

• Shortwave diathermy, microwave diathermy, ultrasound diathermy or other procedures that induce heat in internal tissues. This does not include diagnostic ultrasound which is permitted.
• Electrosurgery/electrocautery, and ablation techniques that utilize any form of electromagnetic radiation or electrical current to cut, coagulate, or thermally destroy tissues. For electrocautery, do not use within 2 cm of the Implant. If using monopolar electrocautery, place the return pad such that the current path is not across the Implant.
• Transcutaneous electrical nerve stimulation (TENS), electroconvulsive therapy or other procedures that apply electrical current through skin surface electrodes.
• Extracorporeal shock wave lithotripsy or other procedures that use pressure waves or induce mechanical forces to break up internal structures.
• Radiation therapy, including forms of photon beam radiation therapy such as x-rays, gamma rays, proton beam therapy, brachytherapy, stereotactic radiosurgery, cobalt machines, and linear accelerators.

If the patient has had any of the above medical procedures around the implantation site, it is very important that, very soon thereafter, they discuss the procedure with their doctor or rheumatologist managing the SetPoint System in order for them to determine whether verification of Implant functionality is necessary.