Axonics Model 1601 User manual

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Sacral Neuromodulation System
Trial Stimulator Manual
Model 1601
EN
DE
FR
ES
IT
NL
English....................................................................................3
Deutsch.................................................................................21
Français................................................................................. 39
Español ................................................................................. 59
Italiano .................................................................................79
Nederlands............................................................................99
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Sacral Neuromodulation System
Trial Stimulator Manual
Model 1601
Rx only
EN
Axonics®, Axonics Modulation®, Axonics Modulation Technologies®, Axonics Sacral Neuromodulation System® and r-SNM® are
trademarks of Axonics ModulationTechnologies, Inc., registered or pending registration in the U.S. and other countries.
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Table of contents
TABLE OF CONTENTS.......................................................................................................................................................................... 5
INTRODUCTION.................................................................................................................................................................................. 6
PURPOSE OF THE TRIAL SYSTEM......................................................................................................................................................... 6
CONTRAINDICATIONS......................................................................................................................................................................... 6
WARNINGS ........................................................................................................................................................................................ 6
PRECAUTIONS.................................................................................................................................................................................... 7
INDIVIDUALIZATION OF TREATMENT ................................................................................................................................................ 11
ADVERSE EVENTS............................................................................................................................................................................. 11
PATIENT COUNSELING INFORMATION............................................................................................................................................... 11
DEVICE DESCRIPTION....................................................................................................................................................................... 12
SPECIFICATIONS............................................................................................................................................................................... 13
ACTIVATING THETRIAL STIMULATOR ................................................................................................................................................ 14
CONNECTINGTHETRIAL STIMULATORTOTHE TINED LEAD OR PNE LEAD........................................................................................... 15
INSERTINGTRIAL STIMULATOR INTOTHE BELT................................................................................................................................. 16
REPLACEMENT AND DISPOSAL......................................................................................................................................................... 16
LABEL SYMBOLS.............................................................................................................................................................................. 17
WIRELESS COMMUNICATION............................................................................................................................................................ 18
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INTRODUCTION
Thismanualprovidesinformationaboutthe Axonics Sacral Neuromodulation(SNM) SystemTrialStimulator (Model 1601), whichis a
part of the Axonics SNM Trial System. TheTrial Stimulator (TS) is used to provide temporary electrical stimulation to the sacral nerve.
There are two types of trials for which the TS is used. For a basic trial, the TS connects to a Peripheral Nerve Evaluation (PNE) lead to
delivertemporary electrical stimulation. Foran advanced trial, theTSconnects to a tinedlead 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.
CONTRAINDICATIONS
The Axonics SNMTrial System is contraindicated for patients who are unable to operate the Axonics SNMTrial System.
WARNINGS
Diathermy
Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as diathermy) should
not be used 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.
The following additional medical procedures that may affect the Axonics SNM System should be avoided during the trial period:
• Lithotripsy
• Monopolar electro surgery
• Microwave and Radio-frequency (RF) ablation
• Radiation therapy
• Ultrasound or scanning equipment
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
encountered in a normal day are unlikely to affect the operation of the TS. While everyday electrical devices are unlikely to affect
the TS, there are strong sources of EMI that pose a higher risk. These include theft detectors, security gates, and security wands. If
patients encounter any of these electrical devices, they should walk as far away from the sides of the device when passing through.
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Additionally, patients should minimize their exposure to these devices by not lingering in the immediate area of the device. 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.
• System damage, which may require surgical replacement due to change in symptom control.
• OperationalchangestotheTrialStimulator,causingittoturn on or o ortoresetthesettings,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.
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
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
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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 the stimulation cable or turning the simulation on or off, the stimulation amplitude should be decreased to
0.0 mA
Sensitivity to stimulation –
Patients who are very sensitive to stimulation, may be able to sense the telemetry signals associated 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 aTS and another active implanted device, the Radio Frequency (RF) signal used to program any of these devices
may reset or reprogram the other devices.These devices include a pacemaker, defibrillator, or another neurostimulator.
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 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.
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
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the TS. 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 ask their patients about the activities in which they participate
and inform them of the need for restricting and minimizing activities during the trial stimulation period.
Component manipulation by patient (Twiddler’s syndrome) –
Clinicians should advise patients to refrain from manipulating the components of the Axonics SNM System. Manipulation may cause
device damage, lead migration, skin erosion, or uncomfortable stimulation.
Scuba diving or hyperbaric chambers –
Patients should not scuba dive or use a hyperbaric chamber during their trial stimulation period.
Skydiving, skiing, or hiking in the mountains –
Patients should not sky-dive, ski or go hiking during the trial stimulation period.
Unexpected changes in stimulation –
EMI,posturalchanges,and other activitiesmaycauseaperceivedincreaseinstimulation.Some patientsmayfindthisuncomfortable
(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 theTS. 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 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 the TS.
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).
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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.
• 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 oC to 70 oC
• Temperature (long term): 20 oC to 30 oC
• 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 was stored at temperatures outside of this range, do not use it until it has returned to the operating temperature range.
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Sterilization
The contents of this package are not sterile.This device is for single use only and should not be sterilized.
System implant
Compatibility –
For proper therapy, use only Axonics SNM components.The use of non-Axonics components with the Axonics SNM 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, theTS 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.
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, and self-care requirements. In order to achieve optimal benefits from the therapy, the Axonics SNM 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
• The patient can properly operate the Axonics SNM System. This includes the ability to use the Remote Control, to detect alignment
of the Charger, and to understand when charging is complete
• The patient does not have a history of sensitivity to stimulation
ADVERSE EVENTS
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 (bowel and/or bladder)
• Allergic or immune system response to the implanted materials that could result in device rejections
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• Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients
• Infection
• Suspected lead migration
• Suspected nerve injury (including numbness)
• Suspected technical device malfunction
• Transient electric shock or tingling
• Unintended nerve activation
PATIENT COUNSELING INFORMATION
Clinicians should provide the following:
• Information about the components of the Axonics SNMSystem
• 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.
Patients should bring their Patient Therapy Guide to all medical and dental appointments. This will help resolve any questions
that their healthcare professional may have regarding any precautions to take to avoid potential device problems.
• Patients should always carry their Remote Control. This allows patients to change the stimulation amplitude and/or turn theTS
on 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
DEVICE DESCRIPTION
The AxonicsTS (Figure 1) is part of the Axonics SNM System. TheTS is a programmable device that is worn on the outside of the body.
TheTS delivers electrical stimulation to the sacral nerve via connections to either a permanent or temporary lead.
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Figure 1: AxonicsTrial Stimulator (TS).
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.
Specifications
Table 1 shows theTS physical specifications. For detailed descriptions and specifications for other components and accessories, refer
to the product literature packaged with those devices.
Table 1. TS specications
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
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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: 1mA, 14 Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms
Worst case: 4mA, 14Hz, 210 µs, continuous stimulation, impedance = 1,600 Ohms
TheTS may be wiped with a cloth lightly dampened with sterile water or isopropyl alcohol.
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 theTS (Figure 2).The green light next to the button will start to flash. The green light will flash
for 90 seconds.
a. IfyouconnectaCPtotheTSbefore90 seconds expires,theTSwill remain active and can be programmed.Afterprogramming
is complete and theTS is disconnected from the CP, the green light will not be on. However, the TS will remain active.
b. If a CP does not connect to theTS, the TSwill return to hibernate mode. It can be turned on again by pressing the button on
the back of theTS.
Notes:
• If a red light flashes there is an error with the TS. Connect the CP for detailed error information. Refer to the CP manual for detailed
troubleshooting information.
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• If there is no flashing light when you press the button, try pressing the button again. Confirm you are pressing the button as
shown in Figure 2. If there is no light after multiple attempts at pressing the button, do not use this TS. Activate a newTS. If the
issue persists with a new TS, contact Axonics.
Figure 2: Activate theTS by pressing the button on the back of the stimulator
Connecting the Trial Stimulator to the Tined Lead or PNE Lead
The following section describes the process for connecting the TS to the cables used to connect to the tined lead or the PNE lead. This
should be performed when an Axonics lead has already been implanted and the appropriate cables are available. For a trial using
the PNE lead, the BasicTrial Cable should be connected to the TS. For a trial using the tined lead, a Percutaneous Extension (PE) cable
should be connected to theTS.
1.
Align the raised base on theTS connector with the raised bar on the Basic Trial Cable or the grey colored bar on the PE (Figure 3).
2. Press the connectors together to connect the Basic Trial Cable or PE to the extension of the TS (Figure 3).
3. Use the CP to check theTS 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.
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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 the TS.
Inserting TS into the 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. Fit the belt around the patient’s waist. Fasten and adjust the belt width as necessary (Figure 4).The belt should be worn such
that it is comfortable for the patient.The pouch for the TS is located above the patient’s hip.
2. Slide theTS 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.
Figure 4: Fasten the belt on the patient’s body and adjust the width as necessary
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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.
LABEL SYMBOLS
This section explains the symbols found on the product and packaging.
Symbol Description Symbol Description
AxonicsTrial Stimulator Do not reuse
0mA
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
For USA audiences only
Caution: U.S. Federal law restricts this device for
sale by or on the order of a physician
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Manufacturing Date Warning / Caution
Non ionizing electromagnetic radiation IC Industry Canada certication number
Conformité Européenne (European Conformity). This
symbol means that the device fully complies with
AIMD Directive 90/385/EEC (Notied Body reviewed)
and RED 2014/53/EU (self-certied)
Product cannot be discarded in trash. See
instructions on disposal of the product.
Refer to instructions for use (Consultaccompanying
documents) IEC 60601-1/EN60601-1, Type BF Equipment
Temperature limitation Classied by CSA with respect to safety
Humidity limitation
This device complies with all applicable Radio
Spectrum Management’s (RSM) and Australian
Communications and Media Authority (ACMA)
regulatory arrangements and applicable
electrical equipment safety requirements
Pressure limitation
WIRELESS COMMUNICATION
Model: 1601
IC: 20225-E
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
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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.
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 theTS are not authorized by Axonics could void FCC and IC certification and negate the user’s
authority to use the product.
Quality of Wireless Service: This device operates in 401-402 MHz and 405-406 MHz frequency and the maximum effective radiated
power of theTS communication is below the limit of 25 µW ERP/ERIP as specified in EU: EN ETSI 302-537 and USA: FCC 47 CFR Part
95; Subpart I. The Remote Control or Clinician Programmer have to be within 1 meter from the TS for successful communication.
Wireless Security: The TS can only communicate with a single Remote Control that is paired to it using the Clinician Programmer.
Any Axonics Clinician Programmer can communicate with aTS. Additional mechanisms exist to ensure the integrity of radio data.
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