Axonics SNM System 2501 Operating and maintenance manual

Sacral Neuromodulaon System
Model 2501
Clinician Programmer Manual
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Languages
English..................................................... 1
Deutsch.................................................... 67
Francais.................................................... 133
Espanol.................................................... 199
Italiano.................................................... 265
Nederlands................................................. 331
EN
DE
FR
ES
IT
NL
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Clinician Programmer Manual
Model 2501 Clinician Programmer
EN
!USA Rx ONLY
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Axonics®, Axonics Modulation®, Axonics Modulation Technologies®,
Axonics Sacral Neuromodulation System® and r-SNM®
are trademarks of
Axonics Modulation Technologies, Inc.,
registered or pending registration in theU.S. and other countries.
Refer to the appropriateclinician manuals for additional information on theAxonics SNM System,
including contraindications, warnings, precautions, adverse events, individualization of treatment,
patientselection, and implantprocedures.
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■Introduction .................................5
■Purpose of the Trial System
■Axonics SNM System for Urinary Control...........6
■Indications
■Precautions
■Contraindications
■Axonics SNM System for Bowel Control ...........7
■Indications
■Precautions
■Contraindications
■Precautions ..................................8
■Parameter Adjustment
■Sensitivity to Stimulation
■Programmer Interaction with Flammable
Atmospheres
■Programmer Interaction with OtherActive
Implanted Devices
■Telemetry Signal Disruption from EMI
■Device Specifications ..........................9
■Operating Characteristics
■StorageandUsageEnvironment
■Maintenance
■Handling and Disposal
■Wireless Communication
■Start‐up and General Functions. ................12
■SummaryofClinician Programmer Buttons and
Connections
■Turning the Clinician Programmer On and Off
■Logging-in to the Clinician Programmer
■NavigatingtheHomescreen
■Description of Battery Level Icons and Charging
■Introduction to Clinician Programmer Prompts
■Understanding Impedance Values
■Controlling Stimulation Amplitude
■Test Stimulation During Lead Implantation. .......23
■Foramen NeedleTestStimulation
■PNE Lead TestStimulation
■Define Tined Lead Thresholds
■Programming the Stimulator ...................33
■Connecting toaStimulator
■Patient Device Screen Overview
■Setting Up a NewStimulator
■Viewingthe Status ofaStimulator
■Resetting the Stimulator
■Programming the Stimulator Stimulation Settings
■Home Screen Tools...........................55
■Clinician Programmer Settings
■Reports
■Troubleshooting..............................67
■Issues with the CP display
■Issues Communicating with a Stimulator
■Issues DeliveringStimulation
■Impedance Issue During Lead Implant
■Impedance Issuewith the Stimulator
■Label Symbols................................72
Table of Contents
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Introduction
Thismanual provides information aboutthe Axonics
Sacral Neuromodulation (SNM) System Clinician
Programmer (CP). The CP can be used during
implantation and programming of the following Axonics
SNM System components:
■Axonics Model 1601 Trial Stimulator
■Axonics Model 1901 PNE Lead
■Axonics Model 1201Tined Lead
The CP can provideteststimulation during lead
implantation and can wirelessly communicatewith the
Stimulator tocheckdevicestatus andprogram
the device.
Note: TheCP is requiredto implant aleadorprogramaStimulator.
Confirmtheavailabilityand operationofaCPpriorto beginninga
lead implantprocedure.
Package Contents
■Axonics Model 2501 Clinician Programmer
■Power Supply
■Product Literature
Warning: Do notattemptto modify or service this
product.If there is an issue withtheproduct, please
consult an Axonics representative.
Purpose of the Trial System
The Axonics SNM Trial System is used for a test period to
evaluate if a subject should be treated with the Axonics
SNM System.
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Axonics SNM System for Urinary Control
Indications
Axonics SNM Therapy for urinary control is indicated for
the treatment of urinary retention and the symptoms of
overactivebladder, includingurinaryurgeincontinence
and significant symptoms of urgency-frequency alone or
in combination,inpatients whohave failedorcouldnot
toleratemoreconservative treatments.
Warning: Thistherapyisnotintendedforpatients
with mechanical obstruction such as benign prostatic
hypertrophy, cancer, or urethral stricture.
Precautions
■Clinician Training
■Implanting cliniciansshouldbetrainedonthe
implantation and use of theAxonics SNM System.
■Prescribing cliniciansshouldbeexperienced in
the diagnosisand treatmentof lowerurinarytract
symptoms and should be trained on the use of the
Axonics SNM System.
■Use in Specific Populations
■Thesafetyand effectiveness of thistherapyhasnot
been established for:
■Pregnantwomen
■Pediatricuse (patients undertheage of 16)
■Patients withneurological diseaseorigins, such
as multiple sclerosis or diabetes
■Bilateral stimulation
Contraindications
TheAxonics SNM System is contraindicated for patients
who areunable to operate theAxonics SNMSystem.
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