User Manual

AXONICS SNM SYSTEM® – Neurosmulator | Rechargeable, Model 5101
5
INTRODUCTION
This manual provides informaon about the Axonics Sacral Neuromodulaon (SNM) System Neurosmulator
(Model 5101), which is a part of the Axonics SNM System. The Neurosmulator is connected to the Axonics Tined
Lead (Model 1201 or 2201).
INDICATIONS, WARNINGS, AND PRECAUTIONS
• Refer to Indicaons for Use insert for indicaons and contraindicaons.
• Refer to Informaon for Prescribers and Paents booklet for warnings, precauons, adverse events, paent selecon
and clinical summary.
• Refer to MRI guidelines for informaon on MRI compability and requirements.
Note: The above inserts can be found at
www.axonics.com/eIFU
DEVICE DESCRIPTION
The Axonics Rechargeable Neurosmulator (Figure 1) is part of the Axonics SNM System. The Neurosmulator is a
programmable device that is connected to the Axonics Tined Lead, which conducts smulaon pulses to the sacral nerve.
Figure 1: Axonics Rechargeable Neurosmulator.
Package Contents
The Neurosmulator package contains the following:
• Neurosmulator
• Torque wrench
• System registraon form
• Paent idencaon card
• Product Insert with Indicaons for Use
The contents of the inner package are STERILE.
The contents of the Neurosmulator package are intended for single use only.
System Registration Form and Patient Identification Card
The system registraon form registers the device and creates a record of the device in Axonics’ implant data system.
The paent idencaon card is also packaged with this device. The paent should carry the idencaon card at all mes.