ReActiv8 Safety Information
EU Only
Carefully read all contraindications, warnings, precautions, considerations for patient selection and instructions before use. Follow all operating, maintenance, and installation procedures as described in this manual. Failure to do so may result in patient or operator harm.
Safety may be compromised if the procedures used to operate and maintain the ReActiv8 system are different than those specified in the manuals. Anyone who performs the procedures must be appropriately trained and qualified.
Intended Purpose/Indications for Use: ReActiv8 is an adjunct to medical management of Chronic Low Back Pain for relief of pain in adults who have attempted at least medical management and physical therapy.
Contraindications: ReActiv8 is contraindicated for patients who are unable to operate the system or unsuitable for ReActiv8 implant surgery.
Warnings:
Electromagnetic Interference (EMI): Electromagnetic interference from electrical or magnetic fields generated by equipment found in the home, work, medical or public environments may interact with or disrupt the function and operation of ReActiv8.
Magnetic Resonance Imaging (MRI): The ReActiv8 Implantable Pulse Generator (IPG) and implantable leads are MR Conditional devices with demonstrated safety in the MR environment only within specified conditions. Refer to the
document ReActiv8 System Magnetic Resonance Imaging (MRI) Guidelines at www.mainstaymedical.com/resources for an up-to-date list of approved MR Conditional components, model numbers and required conditions for safe use in the MR Environment.
Diathermy therapy: Safety of diathermy with an implanted ReActiv8 has not been evaluated. Do not use short – wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a ReActiv8.
Defibrillation/cardioversion: When a patient is in ventricular or atrial fibrillation, the first consideration is patient survival. External defibrillation or cardioversion can damage the ReActiv8 IPG. It may also cause induced currents in the leads that can injure the patient.
Electrocautery and radio frequency (RF) ablation: Electro-surgery devices should not be used in close proximity to the ReActiv8 IPG or Lead(s). Contact between a lead and the electrosurgical instrument can cause direct stimulation of a nerve and can result in severe injury to the patient.
ReActiv8 interaction with other active implantable devices: Safety of the ReActiv8 system has not been evaluated when used in combination with active implantable devices (e.g. pacemaker, defibrillator, spinal cord stimulation).
Case damage: If the ReActiv8 IPG case is pierced or ruptured, severe burns could result from exposure to battery chemicals.
