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SPR Therapeutics, Inc. SPRINT PNS System User Manual

SPR Therapeutics, Inc. SPRINT PNS System
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1 | SPRINT
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PNS System – Clinician Instruction for Use [L0090-MAN-000 Rev F]
Clinician Instructions for Use

Questions and Answers:

SPR Therapeutics, Inc. SPRINT PNS System Specifications

General IconGeneral
CategoryMedical Equipment
ManufacturerSPR Therapeutics, Inc.
Stimulation DurationUp to 60 days
FDA StatusFDA Cleared
TypePeripheral Nerve Stimulation (PNS) System
Stimulation ParametersAdjustable frequency, pulse width, and amplitude
IndicationTreatment of chronic pain and post-operative pain

Summary

Introduction to SPRINT PNS System

Indications for Use

Details approved uses for the SPRINT PNS System in the back and extremities.

Contraindications

Lists conditions where the SPRINT PNS System should not be used.

Warnings

Highlights critical safety precautions and potential risks associated with system use.

Precautions

Outlines necessary safety measures and steps to prevent adverse events during use.

MRI Safety Information

Explains safety guidelines and restrictions related to MRI procedures with the system.

SPRINT PNS System Overview

System Components

Lists and describes all sterile and non-sterile components of the SPRINT PNS System.

Programming Tools Overview

Describes the Hand-Held Remote and Clinical Programmer for system operation.

Procedure Preparation for SPRINT PNS

Procedural Precautions

Key considerations and warnings before starting the lead placement procedure.

Gather Components

Lists all necessary components and supplies for lead placement.

Assemble Sterile Procedure Tray

Details supplies and steps for preparing a sterile environment for the procedure.

Prepare the Patient Case

Ensures the patient case contains all required items for patient use.

Prepare MicroLead Exit Site

Steps for cleaning and preparing the skin insertion site for the MicroLead.

MicroLead Placement and System Setup

Identify Lead Placement Target

Guides on locating the target nerve using the OnePass Introducer system.

Testing Stimulation

Procedures for testing stimulation with the Stimulating Probe or Needle.

Confirm Location & Place MicroLead

Steps for confirming lead position and safely deploying the MicroLead.

Establishing Therapy Settings

Process for setting up therapy parameters for patient use.

Patient Counseling for SPRINT PNS

System Use at Home

Guidance for patients on using the system at home.

MicroLead Exit Site Care

Instructions for patients on caring for the lead exit site.

Air Travel Guidelines

Information regarding travel with the SPRINT PNS System, especially battery compliance.

Usage Log

How to access and interpret the system's usage and error log.

End of Treatment for SPRINT PNS

MicroLead(s) Withdrawal

Step-by-step guide for safely removing the MicroLead(s).

System Disposal

Guidelines for proper disposal of system components.

Clinical Programmer Optional Features

Optional Features

Details advanced features like Direct Parameter Control and Fine Resolution.

SPRINT PNS Technical Specifications

Technical Description

Overview of the SPRINT PNS System's technical design and function.

Specifications

Detailed technical specifications for system components and operating parameters.

SPRINT PNS Symbols and Messages

Hand-Held Remote Symbols

Explains symbols and messages displayed on the Hand-Held Remote.

Pulse Generator Lights and Tones

Describes the lights and audio signals from the Pulse Generator.

Clinician Programmer Symbols

Explains symbols and messages on the Clinical Programmer interface.

Label Symbols

Details symbols found on product labels and packaging.

MicroLead Placement Near Peripheral Nerves

General Objectives and Overview

Outlines goals and general approach for lead placement near nerves.

Percutaneous Insertion Site Considerations

Factors to consider when choosing the insertion site for the MicroLead.

SPRINT PNS Limited Warranty

Return Product Procedure

Instructions for returning defective products for warranty claims.

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