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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55
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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66
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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Axonics SNM System for Bowel Control
Indications
Axonics SNM Therapy for bowel control is indicated
forthetreatmentofchronicfecal incontinence in
patients whohave failedorarenotcandidates formore
conservative treatments.
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 fecal incontinence 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 18)
■Patients with progressive, systemic neurological
diseases
■Bilateral stimulation
Contraindications
TheAxonics SNM System is contraindicated for patients
who areunable to operatetheAxonics SNMSystem.
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Precauons
Parameter adjustment – Thesteps below should be
taken to prevent sudden stimulation changes thatlead to
an uncomfortable jolting or shocking feeling:
■Stimulation parameters shouldbe changed in small
increments.
■The stimulation amplitude shouldbe allowed to ramp
to full amplitude slowly.
■Before disconnecting a stimulation cable or turning
stimulation on or off, the stimulation amplitude should
be decreased to 0.0mA.
Sensitivity to Stimulation –Some patients, especially
those that arevery sensitiveto stimulation, may be able
to sense the telemetry signals associated with the CP
communicatingwith the Stimulator.
Programmer Interaction with Flammable Atmospheres
–TheCP is notintendedto beused in thepresence of a
flammable gases,andtheconsequencesofusing theCP
insuchan environment is notknown.
Programmer Interaction with Other Active Implanted
Devices –When apatienthasaStimulatorand an
active implanteddevice(forexample, a pacemaker,
defibrillator, or another Stimulator), the RF signal used
to program any of these devices may reset or reprogram
the other devices.
Whenever the settings for these devices are changed,
aclinician familiar with each deviceshouldcheckthe
program settings of each device before the patientis
released (or as soon as possible). Patients should contact
their physician immediately if they experiencesymptoms
thatarelikelyto be related to thedevices or their
medical condition.
Telemetry Signal Disruption from EMI – The Stimulator
shouldnotbeprogrammed nearequipment that
may generate electromagnetic interference (EMI) as
the equipment may interfere withtheCP’s abilityto
communicate withtheStimulator.If EMI is suspected to
be interruptingprogramming, theCP andtheStimulator
shouldbemoved awayfrom thelikelysource ofEMI.
Unintended Use – TheCP is intendedforuseduring
implantation and programming of theAxonics SNM
System.Itshould onlybeusedwithmanufacturer
providedaccessories.DonotusetheCP for stimulation
orotherpurposes notdescribed in thismanual.
Unintended use can resultin user or patientinjury.
Accidental Electrode Contact – Avoid accidental contact
between connected but unapplied electrodes and
other conductive parts, including thoseconnected to
protectiveearth.
Warning: Shortwave diathermy, microwave
diathermy, or therapeutic ultrasound diathermy
(collectivelydescribedasdiathermy) should notbe
used during implantation of theAxonics SNM System
oronpatients implantedwiththe Axonics SNMSystem.
Diathermy can transmit energy through the CP and
accessoriesortheimplanted system, potentially causing
tissue damageat the location of the surface or implanted
electrodes, resulting in severe injury.
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Device Specifications
Operating Characteristics
Power source: Lithium-ion battery (rechargeable)
External power source: Powerbox EMX30
Input Power: 100 – 240 VAC, 47 – 63 Hz, 0.3 - 0.6 A
OutputPower: 15 V, 2 A
Battery life*: 3 hours per charge; 5-years expected
lifetime
Dimensions: 257 mm(w)x246mm(h) x22 mm (d)
Weight:1125g
Material:
■Housing: Polycarbonate and ABS resin blend
■Buttons: Silicone with polyurethane coating
Screen:Touch-screen, LCD display, 1280x 800 pixels
CP TestStimulation Output:
■MaximumAmplitude: 12.5mA
■Frequency: 14 Hz
■Pulse width: 210 μs
*Note: Batterylifemayvarydependingonfrequencyofuse
Storage and Usage Environment
Usageenvironment
The following lists the appropriate temperature,
humidity, and pressurecondition for use of theAxonics
CP:
■Temperature:5°Cto 35 °C
■Humidity: 15% to 95%
■Pressure: 70 kPa to 106 kPa
Shipping and Storage Environment
The following lists the appropriate temperature,
humidity, and pressurecondition for shipping and
storage of the Axonics CP:
■Temperature (short term: 3 days): -25 oCto70o C
■Temperature (long term): 20 oCto30o C
■Humidity(short term: 3 days): 15% to95%
■Humidity(long term):30% to85%
■Pressure(short term: 3 days): 57 kPa to 106kPa
■Pressure (long term): 70 kPa to 106 kPa
If the CP is stored at temperatures outside of the
operating range, the CP should not be used until it has
come to the operating temperature range.
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1010
Device Specifications
Maintenance
Atleast once a year, the CP should be inspected for
visible damage and should becharged and powered on
to confirm the Log‐In screen is still accessible. Significant
physical damage oraninabilityto power onthedevice
shouldbereported to the manufacturerandthedevice
shouldnotbeused.
Handling and Disposal
■Cleaning: TheCP can be wipedwitha cloth lightly
moistenedwith water.No other cleaning agents should
be used.
■Replacement: If the CP is lost or not working, contact
Axonics.
■Disposal:Donot incineratetheCP as thebattery may
explode. If the CP is no longer needed, contact Axonics
to return thedevice.
Wireless Communication
■Radiofrequency telemetry
■Model: 2501
■IC: 20225-C
■Qualityof WirelessService:
■Thisdevice operates inthe401-406MHzfrequency
and the maximum effective radiated power is
belowthelimitof 25 µWERP/EIRP as specified in
EU:ENETSI 301-839andENETSI 302-537 andUSA:
FCC 47 CFR Part 95;SubpartI. TheCPhas to be
within 1 meterfrom the Stimulator forsuccessful
communication.
■Wireless Security:
■Any CPcan communicate with a Stimulator.
Additionalmechanismsexist toensure theintegrity
of radio data.
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1111
Device Specifications
FCC Compliance
Thisdevicecomplies with part 15 of the FCC Rules.
Operation is subjectto thefollowing two conditions:
(1)This devicemaynotcause harmful interference, and
(2) this device mustaccept anyinterference received,
including interference that may cause undesired
operation.
This transmitter is authorized by rule under the Medical
DeviceRadio communication Service(inpart95of the
FCC Rules) and must not cause harmful interference to
stations operating in the 400.150–406.000 MHz band in
the Meteorological Aids (i.e., transmitters and receivers
used to communicateweather data), the Meteorological
Satellite, or the Earth Exploration Satellite Services
andmustaccept interference thatmaybe causedby
such stations, including interference that may cause
undesiredoperation. This transmittershallbe usedonly
in accordance with the FCC Rules governing the Medical
DeviceRadio Communication Service.Analog and
digital voice communications are prohibited. Although
this transmitter has been approved by the Federal
Communications Commission, thereisnoguarantee
thatit will notreceive interference or that any particular
transmission from this transmitterwill befreefrom
interference.
Note: FCCComplianceinformationcanbeaccessedontheCP inthe
ClinicianProgrammer Settingsscreen.
IC Compliance
Thisdevicecomplies with Industry Canada license-
exemptRSS standard(s). Operation is subjectto the
followingtwo conditions: (1) this devicemaynotcause
interference, and (2) this device must accept any
interference, including interference that may cause
undesiredoperation of thisdevice.
FCC and IC Compliance
This device may not interferewith stations operating in
the 400.150–406.000 MHz band in the Meteorological
Aids, Meteorological Satellite, and Earth Exploration
Satellite Services andmustaccept anyinterference
received, including interference that may cause
undesired operation.
Note: Changesandmodifications totheClinicianProgrammerare
notauthorized byAxonics and could voidFCCandIC certification
andnegatetheuser’sauthorityto usetheproduct.
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Start Up and General Funcons
Thissectiondescribes the processof startingup theClinicianProgrammer (CP) andprovides instructions onseveral
key CP functions that areencountered in multiple screens when using the CP.
Thefollowing sections include:
•Getting Started
•Summary of CP Buttons and Connections
•Turning the CP on and off
•Logging-in to the CP
•Navigatingthe Homescreen
•General functions
•Description of Battery Level Icons and Charging
•Introduction to Clinician Programmer Prompts
•Understanding Impedance Values
•Controlling Stimulation Amplitude
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Summary of CP Buttons and Connections
The CP has two physical buttons:
1Power Button– turns theCPonand off.
2Stimulation Button – turns teststimulation on and off
(select screens only)
The CPhas a Connector Panel with plugsfor thecables
that are used withthe CP. The symbols onthe Connector
Panel indicate which cable should be used with each plug:
3EMG Channel 1
4EMG Ground
5EMG Channel 2
6Tined Lead TestStimulation
7Stimulation Ground
8Foramen NeedleTestStimulation
9Power Input
The purposes and uses of these buttons and connections
are described throughout this manual
Note:EMGfunctionality( 3,4,5) is notavailableinthismodelof
theAxonics ClinicianProgrammer.
1
2
3
4
5
6
7
8 9
3 4 5 6 7 8 9
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Turning the Clinician Programmer On and O
Turning On the CP
•Pressandholdthepowerbutton ( 1)toturnontheCP.
•TheCPscreen will showthe Axonics logoastheCPstarts up.
•The CP will proceed to the password protected Log‐In screen.
Turning Off the CP
•From any CP screen,pressandholdthepowerbutton
(1)toturnofftheCP
1
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Logging‐in to the Clinician Programmer
•WhentheCP is turned on, it will
start-up at the Log‐In screen.
•By default, the “ADMIN” user
name will appear on the Log‐In
screen ( 1).
•Press “ADMIN” to log in using that
user name.
•Press the down arrow to the
right of the user name to select
a different user name ( 2).There
will notbeadown arrowifno
additional user names exist.
•A short listofnames will appear
when thedown arrowispressed.
•Press auser name to selectitto
log in ( 3).
•More names can be accessed by
scrolling up and downthelistusing
the arrows on theright( 4).
•A keypad will appearwhenauser
name is selected.
•Enter the 4-digit passcode
associated with the selecteduser
name to log-in to the CP.
•Press “Cancel” to switch user
names( 5).
Note: TheCPwill automaticallylog-out auser after30minutesof inactivity.
1
234
4
5
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Navigating the Home Screen
The Homescreen will appear aftersuccessful log-in to theCP.
The Home screen provides access to themain functions of the
CP, including:
1Lead Placement – Deliver teststimulation during a lead
placement procedure.
2Connect to Patient Device – Check the status of and
program a Stimulator.
3CP Settings - Change CP settings, including default
stimulation settings.
4Reports List-View, save,andmanageCP reports.
Additional information about each of these functions is included
in the following sections of this manual.
5,6These buttons are for use by the Manufacturer only.
2
1
3
4 5 6
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