Need help?Do you have a question about the Neuropace RNS System and is the answer not in the manual?
General| Age | 18 years and older |
|---|---|
| Indication | Treatment of drug-resistant epilepsy |
| Seizure Type | Partial onset seizures |
| Therapy | Electrical stimulation |
| Programming | Customizable |
| Stimulation Parameters | Variable frequency, amplitude, and duration |
| Data Collection | Stores seizure data for review |
| Approval | FDA-approved |
Provides contact information for NeuroPace, Inc., including phone, fax, and website.
Outlines the manual's purpose, intended audience, and its contents.
Lists patient criteria, seizure types, and conditions contraindicated for RNS System use.
Covers critical safety information, warnings, and precautions for clinical use and surgical procedures.
Describes the RNS System's function and lists its implantable and external products.
Provides guidelines for handling, sterilization, storage, and disposal of RNS System products.
Explains neurostimulator battery life estimation and factors affecting it.
Describes the patient population and seizure types suitable for RNS System therapy.
Explains methods for precise seizure focus localization and planning lead placement.
Outlines essential training for patients and caregivers on device use and magnet operation.
Provides a high-level view of the implantation process and initial programmer setup.
Details the recommended initial settings for detecting ECoG activity and storing data.
Specifies recommended initial parameters for responsive stimulation therapy.
Covers patient information, pre-surgical antibiotics, and product preparation before surgery.
Visual guide outlining the steps for implanting depth leads, strip leads, and neurostimulator.
Detailed steps for implanting and securing NeuroPace Depth Leads.
Detailed steps for implanting and stabilizing NeuroPace Cortical Strip Leads.
Steps for placing the ferrule and securing the neurostimulator within the craniectomy.
Instructions for tunneling leads and connecting them to the neurostimulator's connector cover.
Guidelines for explanting system components and replacing the neurostimulator.
Steps to access and log into the NeuroPace Programmer software interface.
Explains how to retrieve programmed settings and stored data from the neurostimulator.
Details how to measure electrode impedance to verify lead integrity.
Describes how to measure battery voltage and recommendations for replacement.
Instructions for capturing, viewing, and storing real-time electrocorticogram data.
Guides on labeling implanted leads and configuring electrode assignments for sensing.
Explains how to configure neurostimulator settings to recognize epileptiform activity.
Details how to configure stimulation sequences delivered in response to detected activity.
Instructions for displaying and reviewing programmed settings, event history, and ECoGs.
Recommended step to interrogate the RNS Neurostimulator during follow-up visits.
Review stored ECoGs, test system integrity, and check battery voltage.
Adjust stimulation or detection parameters as needed based on patient response.
Instructions for inspecting and handling damaged NeuroPace products.
Procedures for diagnosing and resolving abnormal lead impedance measurements.
Addresses issues where the neurostimulator cannot fully deliver programmed therapy.
Steps to resolve ECoG signal quality, noise, artifacts, and programmer communication problems.
Addresses rejected measurements, test requests, and neurostimulator resets.
Lists technical specifications for the RNS Neurostimulator device.
Details wireless functions and specifications for leads and system components.
Lists the specifications for the NeuroPace Programmer and Wand Model W-02.
Covers EMI considerations, guidance for medical and public environments.
Lists items included in the NeuroPace RNS Neurostimulator Kit.
Details NeuroPace Depth Lead and Cortical Strip Lead Kits and accessories.
Lists items included in the NeuroPace Programmer and Remote Monitor Kits.
Details kits for craniectomy, cranial prosthesis, connector cover, and ferrule.
To Next Page