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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