Axonics 1601 User manual

Sacral Neuromodulation System
Trial Stimulator Manual
Model 1601
Rx only
Axonics®, Axonics Modulation®, Axonics Modulation Technologies® and
Axonics Sacral Neuromodulation System® are trademarks of Axonics Modulation Technologies, Inc.,
registered or pending registration in the U.S. and other countries.
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Axonics ModulationTechnologies, Inc.
26Technology Drive
Irvine, CA 92618 (USA)
www.axonicsmodulation.com
Tel. [phone]
Fax [phone]
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LABEL SYMBOLS
This section explains the symbols found on the product and packaging.
Symbol Description Symbol Description
AxonicsTrial Stimulator Do not reuse
0 mA
210 µs
14 Hz
Trial Stimulator default waveform with 14
Hz frequency, 0 mA amplitude and 210 µs
pulse width
IP24
Protection from the amount of dust
and splashing water that would
interfere with the operation of the
device.
Product Serial Number Do not use if package is damaged
Manufacturer Authorized representative in the
European community
Product Model Number !USA Rx ONLY
For USA audiences only
Caution: U.S. Federal law restricts this
device for sale by or on the order of
a physician
Manufacturing Date Warning / Caution
Non-ionizing electromagnetic radiation IC Industry Canada certification number
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Symbol Description Symbol Description
Conformité Européenne (European Conformity).
This symbol means that the device fully
complies with AIMD Directive 90/385/EEC
(Notified Body reviewed) and RED 2014/53/EU
(self-certified)
Product cannot be discarded in trash.
See instructions on disposal of the
product.
Refer to instructions for use (Consult
accompanying documents)
IEC 60601-1/EN60601-1, Type BF
Equipment
Temperature limitation Classified by CSA with respect to safety
Humidity limitation
R-NZ
This device complies with all Australian
Communications and Media Authority
(ACMA) regulatory arrangements
and electrical equipment safety
requirements
Pressure limitation FCC ID US Federal Communications
Commission device identification
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TABLE OF CONTENTS
LABEL SYMBOLS ................................3
INTRODUCTION.................................6
Purpose of the trial system....................6
DEVICE DESCRIPTION............................6
Package contents............................7
CONTRAINDICATIONS............................7
WARNINGS.....................................7
Prohibited Medical Procedure .................7
Diathermy..................................7
Magnetic Resonance Imaging (MRI) ............7
Electromagnetic interference (EMI) ............8
Case Damage ...............................8
Effects on other implanted devices.............8
Unauthorized modifications to the Trial
Stimulator ..............................9
PRECAUTIONS ..................................9
Clinician programming .......................9
Electromagnetic interference (EMI) ...........10
Patient activities ...........................12
Patient programming and Remote Control .....13
Storage and Usage Environment..............13
Sterilization ...............................14
System implant ............................14
POTENTIAL ADVERSE EVENTS SUMMARY ..........14
INDIVIDUALIZATION OF TREATMENT..............15
PATIENT COUNSELING INFORMATION .............16
SPECIFICATIONS ...............................17
ACTIVATING THE TRIAL STIMULATOR .............18
CONNECTING THE TRIAL STIMULATOR TO THE TINED
LEAD OR PNE LEAD .............................19
INSERTING TS INTOTHE BELT ....................19
REPLACEMENT AND DISPOSAL ...................20
WIRELESS COMMUNICATION ....................21
CUSTOMER SERVICE ............................22
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INTRODUCTION
This manual provides information about the Axonics Sacral Neuromodulation (SNM) System Trial Stimulator (Model 1601), which is
a part of the Axonics SNM Trial System. TheTrial Stimulator (TS) is used to provide temporary electrical stimulation to the S3 or S4
sacral nerve.There are two types of trials for which theTS is used. For a basic trial, theTS connects to a Peripheral Nerve Evaluation
(PNE) lead to deliver temporary electrical stimulation. For an advanced trial, the TS connects to a tined lead to deliver temporary
electrical stimulation.
Purpose of the trial system
The Axonics SNMTrial System is used for a test period to evaluate if a subject should be treated with the Axonics SNM System.
DEVICE DESCRIPTION
The AxonicsTS (Figure 1) is part of the Axonics SNM System. The TS is a programmable device that is worn on the outside of the
body. The TS delivers electrical stimulation to the sacral nerve via connections to either a permanent or temporary lead.
Figure 1: AxonicsTrial Stimulator (TS).
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Package contents
TheTS package contains the following:
• TS
• Belt
• TS Manual (this document)
The contents of the package are NOT STERILE.The contents of the package are intended for single use only.
CONTRAINDICATIONS
The Axonics SNMTrial System is contraindicated for patients who are unable to operate the Axonics SNM Trial System.
WARNINGS
Prohibited Medical Procedure
Diathermy
Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as diathermy) CANNOT
be performed on patients implanted with the Axonics SNM System. Diathermy can transmit energy through the implanted system,
potentially causing tissue damage at the location of the implanted electrodes, resulting in severe injury.
Magnetic Resonance Imaging (MRI)
An MRI should not be conducted on an individual undergoing a trial period of SNM therapy utilizing the external TS.
Other Medical Procedures
Thefollowingadditional medicalprocedures thatmay adversely affect thepatient orAxonics SNMSystem should be avoidedduring
the trial period:
• Lithotripsy
• Monopolar electro surgery
• Microwave and Radio-frequency (RF) ablation
• Radiation therapy
• Ultrasound or scanning equipment
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Electromagnetic interference (EMI)
EMI is energy that can interfere with the function of the Axonics SNM System. This energy can be generated by equipment found
at home, work, or in public. The Axonics SNM System includes features that provide protection from EMI. Most electrical devices
encounteredina normal day areunlikely toaffect the operationof theTS.While everydayelectrical devices areunlikelyto affect the
TS,thereare strong sourcesofEMI thatmay temporarilyaffect the operation ofyour stimulator, includinganti-theft detectors found
in stores used to detect stolen merchandise. If patients encounter any of these electrical devices, they should walk as far away from
the sides of the anti-theft detector when passing through.
At the Airport, Courthouses, etc.
Ifpatientsencounterwalkthroughmetal detectorsor security archways they should walk-throughata normal pace.Thesedetectors
should not affect the Stimulator. Hand-held security wands should be passed over the Stimulator quickly and should not affect the
stimulator. Full-bodysecurity scanners(millimeter wavescanners)areused bytheTransportation SecurityAdministration(TSA)and
are considered safe in patients that have a stimulator.
Additionally, patients should minimize their exposure by not lingering in the immediate area of the security systems. Some anti-theft
detectorsmaynotbevisible.Ifpatientsfeelpoorly,theyshouldwalkawayfromtheareaandanti-theftdetectorsandsecurity scanners.
Case Damage
TheTrial Stimulator contains battery chemicals that could cause severe burns if the case were ruptured or pierced.
Effects on other implanted devices
The effect of the Axonics SNM System on the operation of other implanted devices is not known. This includes devices such as
cardiac devices, other Neurostimulators, and implantable drug pumps. In particular, if the Axonics device is on the body near one of
these devices, they may have sensing problems and/or inappropriate device responses. Clinicians involved with both devices should
investigate potential interference issues before surgery. The programming of the devices may need to be optimized to provide
maximum benefit from both devices.
Trial Stimulator interaction with implanted cardiac devices
When a patient needs both an Axonics SNM System and an implanted cardiac device, interactions between the two devices should
be discussed by the patients’ physicians before surgery. Such devices may include pacemakers or defibrillators. The physicians
involved may include cardiologists, electrophysiologists, urologists, and urogynecologist. To reduce potential interference, the TS
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should be worn on opposite side of the body. It should also be worn as far away as practical from an implanted cardiac device.
The stimulation pulses produced by the Axonics SNM System may interact with cardiac devices that sense cardiac activity. This may
lead to inappropriate behavior of the cardiac device.
Unauthorized modifications to the Trial Stimulator
No modification of any component of the Axonics SNM System is allowed. Modification may result in more risks and hazards.
PRECAUTIONS
Clinician programming
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
•
Beforedisconnecting the stimulationcable orturning the simulationon oroff,the stimulationamplitude should be decreasedto 0.0 mA
Sensitivity tostimulation– Patientswhoare very sensitive tostimulation, maybe ableto sensethe telemetry signalsassociated
with reprogramming.
Programmer interaction with a cochlear implant – Patients with cochlear implants should keep the external portion of
their cochlear implant as far from the Clinician Programmer (CP) or Remote Control as possible.This will help minimize unintended
audible clicks or other sounds.
Programmer interaction with flammable atmospheres –The CP is not intended to be used in the presence of a flammable
gas.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 TS and another active implanted
devicetheRadio Frequency(RF) signal usedtoprogramanyof thesedevicesmay reset orreprogramtheotherdevices.Thesedevices
include a pacemaker, defibrillator, or another neurostimulator.
Wheneverthesettings forthese devices arechanged,a clinicianfamiliar with eachdevice shouldcheck theprogramsettings ofeach
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.
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Telemetry signal disruption from EMI – The TS should not be programmed near equipment that may generate EMI. The
equipment may interfere with the CP or Remote Control’s ability to communicate with theTS. If EMI is suspected to be interrupting
programming, the CP or Remote Control and the TS should be moved away from the likely source of EMI.
Interference during medical imaging – The TS should be turned off, disconnected, and removed prior to medical imaging
(x-ray, CT). The components of the trial system may distort images or impede the ability to see certain internal structures when
performing imaging tests.
Electromagnetic interference (EMI)
Patients may encounter additional equipment that generates EMI. This equipment is unlikely to affect the Axonics SNM System if
the patients follows these guidelines:
Bone growth stimulators –The external coils of bone growth stimulators should be kept at least 45 cm (18 in) away from the
Axonics SNM System. Do not use a bone growth stimulator if it is not working as intended.
Dental drills and ultrasonic probes – The drill or probe should be kept 15 cm (6 in) away from the Neurostimulator. The
Neurostimulator should be turned off.
Electrolysis – The electrolysis wand should be kept at least 15 cm (6 in) away from the Neurostimulator. The Neurostimulator
should be turned off.
Electromagneticfield devices–Thefollowingequipmentor environmentsshouldbeavoidedorpatientsshould exercisecaution
around:
• Antenna of citizens band (CB) radio or ham radio
• Electric arc welding equipment
• Electric induction heaters such as those used in industry to bend plastic
• Electric steel furnaces
• High-power amateur transmitters
• High-voltage areas (generally safe if outside the fenced area)
• Linear power amplifiers
• Magnetic degaussing equipment
• Magnets or other equipment that generates strong magnetic fields
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• Microwave communication transmitters (generally safe if outside the fenced area)
• Perfusion systems
• Resistance welders
• Television and radio transmitting towers (generally safe if outside the fenced area)
Laser procedures –The laser should not be directed at the Neurostimulator. The Neurostimulator should be turned off.
Psychotherapeutic procedures – Equipment used for psychotherapeutic procedures may induce electrical currents which may
cause heating at the lead electrodes and could result in tissue damage. Equipment that generates electromagnetic interference
(e.g., electroconvulsive therapy,transcranialmagnetic stimulation) duringpsychotherapeuticprocedureshavenot beenestablished
assafe tooperatein apatientwith aNeurostimulator.Inducedelectricalcurrents may causeheating,especially atthe leadelectrode
site, resulting in tissue damage.
Radiation therapy – Neurostimulator operation may be affected by high-radiation exposure. Sources of high-radiation should
not be directed at the Neurostimulator. Neurostimulator damage due to high-radiation exposure may not be immediately evident,
and exposure should be limited using appropriate measures, including shielding and adjusting the beam angle to avoid exposure
to the Neurostimulator.
Transcutaneous electrical nerve stimulation (TENS) – TENS electrodes should not be placed in locations where the TENS
current passes over any component of the Axonics SNM System. Discontinue using TENS if it starts affecting the performance of
the Axonics SNM System.
If a patient thinks that an EMI generating equipment or environment is affecting the function of their Axonics SNM System, the
patient should:
1. Move away from the equipment or object.
2. Turn off the equipment or object. (if possible)
3. Use the patient Remote Control to adjust stimulation if necessary and to confirm the system is functioning appropriately.
If the patient is unable to eliminate the interference or believes the interference has altered the effectiveness of their therapy, the
patient should contact their clinician.
Sources of strong EMI can result in the following:
• Serious patient injury, resulting from heating of theTrial Stimulator and/or leads.This may damage the surrounding tissue.
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• System damage, which may require surgical replacement due to change in symptom control.
• OperationalchangestotheTrialStimulator,causingit toturnonor offortoresetthe settings, resultingin lossofstimulation
or return of symptoms. Re-programming by the clinician may be needed.
• Unexpected changes in stimulation which may be experienced as a jolting or shocking sensation. While the sensation may
be uncomfortable, the device would not be damaged nor would it cause direct injury to the patient. In rare cases, the change in
stimulation may cause the patient to fall and be injured.
Patient activities
Activities requiring twisting or stretching – Patients should avoid activities that may strain the connections between the
implanted components of the Axonics SNM System and theTS. For example, movements that include bending, twisting, bouncing,
or stretching may pull on the connection between the TS and the lead(s). This may potentially cause movement of the lead or
discomfort and may result in an unsuccessful trial period due to lack of adequate stimulation of the sacral nerve. Clinicians should
asktheir patientsaboutthe activities inwhich theyparticipateandinform themof theneed forrestricting andminimizing activities
during the trial stimulation period.
Componentmanipulation bypatient (Twiddler’ssyndrome) – Cliniciansshould advise patientsto refrainfrommanipulating
thecomponentsoftheAxonicsSNMSystem.Manipulationmaycausedevicedamage,leadmigration,skinerosion,oruncomfortable
stimulation.
Scubadiving orhyperbaricchambers– Patientsshould notscubadiveor use ahyperbaricchamberduring theirtrialstimulation
period.
Skydiving, skiing, or hiking in the mountains – Patients should not sky-dive, ski or go hiking during the trial stimulation
period.
Unexpectedchanges instimulation –EMI, posturalchanges,and otheractivitiesmay causea perceivedincreasein stimulation.
Some patients may find this uncomfortable (a jolting or shocking feeling). Before engaging in activities that receiving a jolt would
be unsafe for the patient or those around them, patients should lower the stimulation amplitude to the lowest setting and turn off
the TS. Patients should also discuss these activities with their clinician.
Showering and bathing during the trial stimulation period – Patients should not expose the TS to water during the trial
stimulation period. They may take sponge baths during the trial stimulation period. However, patients will have to remove the
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TS and keep their lead implant site and their surgical dressings dry. Patients should be advised on avoiding showers and baths by
their physician.
Patient programming and Remote Control
Patient access to Remote Control – Patients should carry their Remote Control with them at all times.This will allow them to
adjust the stimulation amplitude and/or turn on/off theTS.
Remote Control may affect other implanted devices – Patients should avoid placing the Remote Control over or near other
active implanted medical devices (for example: pacemaker, defibrillator and other neurostimulators).
Remote Control handling – Patients should avoid
• Immersing the Remote Control in liquid as this could damage the device.
• Dropping the device or mishandling it in any way that may damage it.
Patients should clean the device with damp soft cloth.
Remote Control use – Patients should avoid operating the Remote Control when near flammable or explosive gases.
Storage and Usage Environment
Component packaging –Do not use the component if any of the following have occurred:
• The storage package has been damaged, pierced, or altered. In this case, sterility cannot be guaranteed and infection may occur.
• The component itself shows any signs of damage.The component may not function properly.
• The use-by date has expired. In this case, component performance cannot be guaranteed.
Usage environment:
The following lists the appropriate temperature, humidity, and pressure usage conditions for use of theTS:
• Temperature: 5 °C to 40 °C
• Humidity: 15% to 95%
• Pressure: 106 kPa to 70 kPa
Shipping and Storage environment:
The following lists the appropriate temperature, humidity, and pressure conditions for shipping and storing theTS:
• Temperature (short term: 3 days): -25 °C to 70 °C
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• Temperature (long term): 20 °C to 30 °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 TS is exposed to extreme temperatures, it may be permanently damaged and should not be used, even if it has returned to a
temperature that is within the specified operating range.
Sterilization
The contents of this package are not sterile.This device is for single use only and should not be sterilized.
System implant
Compatibility–Forpropertherapy,useonlyAxonicsSNM components. Theuse ofnon-Axonicscomponentswith theAxonicsSNM
System may result in damage to Axonics components, loss of stimulation, or patient injury.
Use of non-Axonics components will void Axonics warranty coverage.
Component failures –The components of the Axonics SNM System may fail at any time. Failures such as electrical shorts, open
circuits, and insulation breaches are unpredictable. Also, the TS battery will eventually run out and can provide no more than 60
days of stimulation.
Component handling – Handle the components of the Axonics SNM System with extreme care. They may be damaged by
excessive force or sharp instruments. Such damage can lead to intermittent stimulation or loss of stimulation altogether and may
require surgery to replace.
POTENTIAL ADVERSE EVENTS SUMMARY
Implantation and use of the Axonics SNM System incurs risk beyond those normally associated with surgery. Some risks may
necessitate surgical intervention. The risks during the trial stimulation period include, but are not limited to the following:
• Adverse change in voiding function (bladder)
• Allergic or immune system response to the implanted materials that could result in device rejections
• Changein sensationor magnitude ofstimulation which has been described as uncomfortable (jolting or shocking) bysome patients
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• Device fracture/failure
• Device migration
• Electrical shock
• Infection
• Pain or irritation at Stimulator and/or lead site
• Seroma, hemorrhage, and/or hematoma
• Suspected lead migration
• Suspected nerve injury (including numbness)
• Suspected technical device malfunction
• Transient electric shock or tingling
• Unintended nerve activation
• Heating or burn at Stimulator site
• Lack of effectiveness
• Reoperation/Revision
• Undesirable change in pelvic function
INDIVIDUALIZATION OF TREATMENT
Fully inform the patient about the risks and benefits of SNM therapy. This includes risks of the surgical procedure, follow-up
responsibilities,andself-care requirements. Inorder to achieveoptimal benefits fromthe therapy,the AxonicsSNM System requires
a long-term commitment to post-surgical management.
Patient selection – Select the patients carefully to ensure they meet the following criteria:
• The patient is an appropriate surgical candidate. Give special consideration for the lead length, implant depth, and ability to
successfully implant the lead and route the lead to the Neurostimulator
• Thepatientcan properlyoperatetheAxonics SNMSystem.Thisincludesthe abilityto usethe RemoteControl, to detect alignment
of the Charger, and to understand when charging is complete
• The patient does not have a history of sensitivity to stimulation
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PATIENT COUNSELING INFORMATION
Clinicians should provide the following:
• Information about the components of the Axonics SNM System
• Instructions for using the Remote Control
Also, the clinician should provide each patient with a copy of the Axonics SNM System Patient Therapy Guide.The clinician should
review the following sections with him/her:
• Getting the Axonics SNM System
• Living with the Axonics SNM System
Clinicians should also instruct their patients as follows:
• Patients should tell their healthcare professionals, including their primary doctor and dentist, that they have a trial SNM system.
Patientsshould bringtheir PatientTherapyGuide toall medical anddental appointments.Thiswill helpresolveanyquestionsthat
their healthcare professional may have regarding any precautions to take to avoid potential device problems.
• Patients should alwayscarrytheir RemoteControl.This allowspatientsto change the stimulation amplitudeand/or turn theTSon
or off
• Patients should always bring their Remote Control to appointments related to their Axonics SNM System, including all
programming sessions
• Patients should contact their physician if they have any unusual signs or symptoms
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SPECIFICATIONS
Table1 showstheTSphysicalspecifications.Fordetaileddescriptionsand specificationsforother componentsandaccessories,refer
to the product literature packaged with those devices.
Table 1. TS specifications
Physical Attributes Height 45 mm
Length 45 mm
Thickness 12.5 mm
Weight 20 grams
Volume 25 cc
IP Rating IP24
Case material Polycarbonate/ABS
Stimulation Characteristics Frequency 2-130 Hz
PulseWidth 60-450 µs
Amplitude 0-12.5 mA
Minimum Amplitude Step Size 0.05 mA
Ramping 0-30 s
# of Programs 2
Mode of Operation Current-Controlled
Power Source Battery Lithium-ion (non-rechargeable)
Size 27 mm x 25 mm x 5.2 mm
Weight 4.5 grams
Expected Battery life* Nominal: 60 days
Worst case: 45 days
Note: All dimensions are approximate.
*Battery life estimated at nominal and worst case stimulation settings.
Nominal: 1 mA, 14 Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms
Worst case: 4 mA, 14Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms
TheTS may be wiped with a cloth lightly dampened with sterile water or isopropyl alcohol.
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ACTIVATING THE TRIAL STIMULATOR
The following section describes the process for activating the TS for delivering stimulation. This should be performed when an
Axonics lead has already been implanted and a Clinician Programmer is available.
1. Press the button on the back of the TS (Figure 2).The green light next to the button will start to flash.The green light will flash
for 90 seconds.
a. If you connect a CP to theTS before 90 seconds expires, the TS will remain active and can be programmed. After programming
is complete and theTS is disconnected from the CP, the green light will not be on. However, theTS will remain active.
b. IfaCP doesnot connect totheTS,theTSwill returntohibernate mode. Itcan be turnedon again by pressingthe buttonon the
back of the TS.
Notes:
• Ifa redlightflashes thereis an errorwith theTS.Connectthe CPfor detailed errorinformation.Refer tothe CPmanual fordetailed
troubleshooting information.
• Ifthereisnoflashing light whenyoupressthebutton,try pressingthebuttonagain.Confirmyouarepressingthebuttonasshown
in Figure 2. If there is no light after multiple attempts at pressing the button, do not use this TS. Activate a new TS. If the issue
persists with a new TS, contact Axonics.
Figure 2: Activate theTS by pressing the button on the back of the stimulator
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CONNECTING THE TRIAL STIMULATORTO THE TINED LEAD OR PNE LEAD
Thefollowingsectiondescribes theprocessfor connecting theTStothe cablesused toconnect tothe tinedlead orthe PNE lead.This
should be performed when an Axonics lead has already been implanted and the appropriate cables are available. For a trial using
thePNE lead,the BasicTrial Cableshould be connectedtotheTS.For a trial usingthe tinedlead, a PercutaneousExtension (PE)cable
should be connected to theTS.
1. Alignthe raised baseon theTS connectorwith the raisedbar on theBasicTrialCableor the greycolored bar on the PE(Figure 3).
2. Press the connectors together to connect the Basic Trial Cable or PE to the extension of theTS (Figure 3).
3. Use the CP to check the TS impedances to verify theTS and cable is connected correctly.
Notes:
• There will not be any gap between the connectors when fully inserted.
• Use the CP to check the electrode impedances to confirm that the cables are connected.
Figure 3: Align the raised grey bar on theTS with the raised bar on the Basic Trial Cable (shown) or the grey line
on the PE (not shown). Plug the BasicTrial Cable or PE fully into the extension of theTS.
INSERTING TS INTOTHE BELT
The following section describes the placing theTS into the provided belt.This procedure should be performed when an Axonics lead
has already been implanted.
1. Fitthebeltaroundthepatient’swaist.Fastenandadjust thebeltwidthas necessary(Figure4).Thebeltshouldbe worn such that
it is comfortable for the patient.The pouch for theTS is located above the patient’s hip.
2. Slide the TS into the pouch on the belt. Position theTS extension looped around the TS (Figure 5).TheTS is fully inserted when it
passes the narrow point of the pouch.
3. Coil any excess cable and place it in the pouch.
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Figure 4: Fasten the belt on the patient’s body and adjust the width as necessary.
Figure 5: Insert the TS into the pouch on the belt.
REPLACEMENT AND DISPOSAL
Replacement: If theTS is lost, visibly damaged, or not working, the patient should contact their physician to get a newTS.
Disposal: At the end of a trial stim period, the patient should return the TS to their physician. If return is not possible, the patient
should follow local government rules to dispose of the TS.
Warning: Do not throw theTS in a fire as the battery may explode.
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