Synapse Biomedical

NeuRx System

NeuRx Diaphragm Pacing System Clinicians Guide Rev A

Clinicians Guide

44 Pages

TABLE OF CONTENTS INTENDED USE ... 5 GENERAL OVERVIEW... 6 WARNINGS AND CAUTIONS ... 6 ELECTROMAGNETIC INTERFERENCE WARNING... 7 FLAMMABILITY WARNING ... 7 PRECAUTIONS... 7 DESCRIPTION OF THE SYSTEM ... 8 PROCEDURE RISKS... 9 PREPARATION FOR PROCEDURE ... 10 Verifying Clinical Station Charge ... 10 OPERATING ROOM PREPARATION/ASSEMBLY ... 10 Preparation of the Electrode Delivery Tools ... 10 Patient Preparation ... 11 Establishing Laparoscopic Ports... 11 Mapping the Diaphragm ... 12 Using the Clinical Station for Mapping the Diaphragm... 14 Implantation ... 16 Routing ... 19 Final Check of Electrodes... 20 Changing Setting on the Clinical Station for Final Intraoperative Check... 20 Blocking ... 22 Apply Strain Relief Boot... 27 ESTABLISHING SETTINGS FOR A PATIENT WITH SPINAL CORD INJURY ... 32 Changing Settings on the Clinical Station... 32 Recommendations for SCI Patient without Sensation ... 34 Suggestions for making adjustments ... 34 Recommendations for SCI Patients with Sensation ... 35 ESTABLISHING SETTINGS FOR A PATIENT WITH ALS ... 36 Changing Settings on the Clinical Station... 36 Programming the NeuRx DPS® External Pulse Generator (EPG) ... 40 Confirming Settings ... 41  3
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File Name: neurx_diaphragm_pacing_system_clinicians_guide_rev_.pdf

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