Axonics 1101 User manual

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Sacral Neuromodulation System
Neurostimulator Implant Manual
Model 1101 Neurostimulator
EN
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FR
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NL
English................................................................ 3
Deutsch............................................................. 17
Français............................................................. 33
Español ............................................................. 49
Italiano ............................................................. 65
Nederlands........................................................ 81
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Sacral Neuromodulation System
Neurostimulator Implant Manual
Model 1101 Neurostimulator
Rx only
EN
Axonics®, Axonics Modulation®, Axonics ModulationTechnologies® and Axonics Sacral Neuromodulation System® are trademarks of Axonics ModulationTechnologies,
Inc., registered or pending registration in the U.S. and other countries.
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Table of contents
INTRODUCTION ....................................................................................................6
AXONICS SNM THERAPY FOR URINARY CONTROL .....................................................................6
Indications ......................................................................................................6
Precautions .....................................................................................................6
Cliniciantraining.................................................................................................6
Useinspecicpopulations ........................................................................................6
AXONICS SNM THERAPY FOR BOWEL CONTROL .......................................................................6
Indications ......................................................................................................6
Precautions .....................................................................................................6
Cliniciantraining.................................................................................................6
Useinspecicpopulations ........................................................................................6
CONTRAINDICATIONS ..............................................................................................6
WARNINGS........................................................................................................6
Diathermy ......................................................................................................6
Magnetic Resonance Imaging (MRI) ..............................................................................6
Electromagnetic interference (EMI) ..............................................................................7
Case Damage....................................................................................................7
Eects on other implanted devices ...............................................................................7
Neurostimulator interaction with implanted cardiac devices ......................................................7
PRECAUTIONS .....................................................................................................7
Clinician programming ..........................................................................................7
Patient activities ................................................................................................8
Patient programming and Remote Control .......................................................................8
Storage and Usage Environment .................................................................................8
Sterilization.....................................................................................................9
System implant .................................................................................................9
INDIVIDUALIZATION OF TREATMENT.................................................................................9
ADVERSE EVENTS ..................................................................................................9
PATIENT COUNSELING INFORMATION................................................................................9
COMPONENT DISPOSAL............................................................................................10
DEVICE DESCRIPTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Package contents...............................................................................................10
System registration form and Patient identication card.........................................................10
SPECIFICATIONS ..................................................................................................11
X-RAY IDENTIFICATION ............................................................................................12
NEUROSTIMULATOR IMPLANT PROCEDURE .........................................................................12
Procedure supplies .............................................................................................12
Neurostimulator Preparation ...................................................................................12
Creating the Neurostimulator pocket............................................................................12
Connecting the lead to the Neurostimulator.....................................................................13
Implanting the Neurostimulator ................................................................................14
Completing the implant procedure..............................................................................15
Post-surgery treatment.........................................................................................15
Replacing the Neurostimulator .................................................................................15
LABEL SYMBOLS ..................................................................................................15
WIRELESS COMMUNICATION.......................................................................................16
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INTRODUCTION
Thismanual providesinformationabout theAxonicsSacralNeuromodulation (SNM) SystemNeurostimulator (Model 1101),whichisa partoftheAxonicsSNM System.TheNeurostimulator
is connected to the Axonics tined lead (Model 1201 or 2201).
AXONICS SNM THERAPY 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 signicant
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 specic populations
The safety and eectiveness 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.
AXONICS SNM THERAPY 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 specic populations
The safety and eectiveness 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.
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. Diathermycan 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)
The Axonics SNM System is an MRI Conditional system. Refer to“MRI Guidelines for the Axonics Sacral Neuromodulation System”for more information.
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Additional medical procedures that may aect the Axonics SNM System and should be avoided include:
• Lithotripsy
• Monopolar electrosurgery
• Microwave and Radio-frequency (RF) ablation
• Radiation therapy over the Neurostimulator
• Ultrasound or scanning equipment
Electromagnetic interference (EMI)
Electromagnetic interference is energy generated by equipment found at home, work, or in public that can interfere with the function of the Axonics SNM System.The Axonics SNM System
includes features that provide protection from EMI so that most electrical devices encountered in a normal day are unlikely to aect the operation of the Neurostimulator.While everyday
electrical devices are unlikely to aect the Neurostimulator, there are strong sources of EMI that pose a higher risk, including 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. 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 the Neurostimulator and/or leads that causes damage to surrounding tissue.
•System damage, which may require surgical replacement due to change in symptom control.
•Operational changes to the Neurostimulator, causing it to turn on or o or to reset the settings, resulting in loss of stimulation or return of symptoms, causing a need for
reprogramming by the clinician.
•Unexpected changes in stimulation, leading to a sudden increase or change 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
The Neurostimulator contains battery chemicals that could cause severe burns if the Neurostimulator case were ruptured or pierced.
Eects on other implanted devices
The eect of the Axonics SNM System on the operation of other implanted devices, such as cardiac devices, other Neurostimulators, and implantable drug pumps, is not known. In
particular, if the Axonics device is implanted close to one of these devices, they may have sensing problems and/or inappropriate device responses. Potential interference issues should be
investigated before surgery by clinicians involved with both devices. The programming of the devices may need to be optimized to provide maximum benet from both devices.
Neurostimulator interaction with implanted cardiac devices
When a patient needs both an Axonics SNM System and an implanted cardiac device (for example, a pacemaker or debrillator), interactions between the two devices should be
discussed by the patients’ physicians involved with both devices (such as the cardiologist, electrophysiologist, urologist, and urogynecologist) before surgery. To reduce potential
interference, the devices should be implanted on opposite sides of the body and as far away from each other as practical.
• The stimulation pulses produced by the Axonics SNM System may interact with cardiac devices that sense cardiac activity, leading to inappropriate behavior of the cardiac device.
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.
• Before disconnecting the stimulation cable or turning the simulation on or o, 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 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 to minimize unintended audible clicks or other sounds.
Programmer interaction with ammable atmospheres – The CP is not intended to be used in the presence of a ammable gas, 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 Neurostimulator and another active implanted device (for example, a pacemaker,
debrillator, or another neurostimulator), 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.
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Telemetry signal disruption from EMI –The Neurostimulator should not be programmed near equipment that may generate electromagnetic interference (EMI) as the equipment
may interfere with the CP or Remote Control’s ability to communicate with the Neurostimulator. If EMI is suspected to be interrupting programming, the CP or Remote Control and the
Neurostimulator should be moved away from the likely source of EMI.
Patient activities
Activities requiring excessive twisting or stretching – Patient activities that may strain the implanted components of the Axonics SNM Systems should be avoided. For example,
movements that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching may cause migration or breakage of the Axonics SNM leads. Lead breakage or
migration may cause loss of stimulation, intermittent stimulation, or stimulation at the fracture site. Additional surgery may be required to replace or reposition the component.
Activities that typically involve these movements include gymnastics, mountain biking, and other vigorous sports. Clinicians should ask their patients about the activities in which they
participate and inform them of the need for restricted activities.
Charging use – If swelling or redness occurs near the Charger attachment site, the patient should contact their clinician before using the Charger again. Swelling or redness may
indicate an infection or an allergic reaction to the Charger adhesive.
Component manipulation by patient (Twiddler’s syndrome) – Clinicians should advise patients to refrain from manipulating the Axonics SNM System through the skin.
Manipulation may cause device damage, lead migration, skin erosion, or uncomfortable stimulation.
Scuba diving or hyperbaric chambers – Pressures below 10 meters (33 feet) of water (or above 200 kPa) could damage the Axonics SNM System. Diving below 10 meters (33 feet) of
water or entering hyperbaric chambers above 200 kPa should be avoided. Patients should discuss the eects of high pressure with their physician before diving or using a hyperbaric chamber.
Skydiving, skiing, or hiking in the mountains – High altitudes should not aect the Neurostimulator. Nevertheless, patients should be cautious with high altitude activities due
to the potential for movements that may put stress on the implanted components. For example, the sudden jerk that occurs when a parachute opens while skydiving may cause lead
breakage or migration, which may require surgery to replace or remove the lead.
Unexpected changes in stimulation – A perceived increase in stimulation may be caused by electromagnetic interference, postural changes, and other activities. Some patients
may nd 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 o the Neurostimulator. Patients should also discuss these activities with their clinician.
Patient programming and Remote Control
Patient access to Remote Control – Patients should carry their Remote Control with them at all times to allow them to adjust the stimulation amplitude and/or turn on/o the
Neurostimulator.
Remote Control may aect other implanted devices – Patients should avoid placing the Remote Control over or near other active implanted medical devices (for example
pacemaker, debrillator and other neurostimulators).
Remote Control handling – To avoid damaging the Remote Control, patients should avoid immersing it in liquid and should clean it with damp soft cloth. Patients should avoid
dropping the device or mishandling it in any way that may damage it.
Remote Control use – Patients should avoid operating the Remote Control when near ammable or explosive gases.
Storage and Usage Environment
Component packaging – Any component that has been compromised in any way should not be implanted. Do not implant the component if any of the following have occurred:
• The storage package or sterile pack has been damaged, pierced, or altered, as sterility cannot be guaranteed, which may lead to infection.
• The component itself shows any signs of damage. The component may not function properly.
• The use-by date has expired. In this case, component sterility cannot be guaranteed and infection may occur.
Usage environment:
The following lists the appropriate temperature, humidity, and pressure usage conditions for use of the Neurostimulator:
• Temperature: 20°C to 45°C
• Pressure:The Neurostimulator should function at up to 10 m (33 ft) underwater (200 kPa) and at altitudes up to 3000 m (10,000 ft) associated with activities like hiking and skydiving
(as low as 70 kPa)
Shipping and Storage environment:
The following lists the appropriate temperature, humidity, and pressure conditions for shipping and storing the Neurostimulator:
• Temperature (short term: 3 days): -10˚C to 55˚C
• Temperature (long term): 20˚C to 30˚C
• Humidity (short term: 3 days): 15% to 95%
• Humidity (long term): 30% to 85%
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• Pressure (short term): 57 kPa to 106 kPa
• Pressure (long term): 70 kPa to 106 kPa
If the Neurostimulator was stored at temperatures outside of this range, it should not be used until it has returned to the operating temperature range.
Sterilization
The contents of this package have been sterilized using ethylene oxide. This device is for single use only and should not be resterilized.
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 voids Axonics warranty coverage.
Component failures – The components of the Axonics SNM System may fail at any time. Such failures, such as electrical shorts, open circuits, and insulation breaches are
unpredictable. Also, the Neurostimulator battery will eventually fail to recharge. The rechargeable Neurostimulator battery should provide at least 15 years of service and with
repeated charging the battery will lose its ability to recharge to its full capacity.This may result in the Neurostimulator requiring more frequent recharging. When stimulator can no
longer be maintained with regular charging, the Neurostimulator may need to be replaced.
Component handling –The components of the Axonics SNM System must be handled withextreme care. They may be damaged by excessive force or sharp instruments, which can
lead to intermittent stimulation or loss of stimulation altogether and may require surgery to replace.
INDIVIDUALIZATION OF TREATMENT
The patient should be fully informed about the risks and benets of SNM therapy, including risks of the surgical procedure, follow-up responsibilities, and self-care requirements. In order
to achieve optimal benets from the therapy, the Axonics SNM System requires a long-term commitment to post-surgical management.
Patient selection – Patients should be carefully selected to ensure they meet the following criteria:
• The patient is an appropriate surgical candidate with 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, including the ability to use the Remote Control, to detect alignment of the Charger, and to understand when charging
is complete.
• If the patient underwent a test stimulation period, he/she received satisfactory results.
• 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 of which may necessitate surgical intervention. These risks 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
• Change in sensation or magnitude of stimulation which has been described as uncomfortable (jolting or shocking) by some patients
• Infection
• Pain or irritation at Neurostimulator and/or lead site
• Seroma, hemorrhage, and/or hematoma
• Suspected lead or Neurostimulator migration or erosion
• Suspected nerve injury (including numbness)
• Suspected technical device malfunction
• Transient electric shock or tingling
• Unintended nerve activation
• Heating or burn at Neurostimulator site
PATIENT COUNSELING INFORMATION
Clinicians should provide the following:
• Information about the components of the Axonics SNM System.
• Instructions for using the Remote Control and Charging System.
Also, the clinician should provide each patient with a copy of the Axonics SNM System PatientTherapy Guide and, in particular, review the following sections with him/her:
• Getting the Axonics SNM System
• Living with the Axonics SNM System
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Clinicians should also instruct their patients as follows:
• Patients should tell their healthcare professionals, including their primary doctor and dentist, that they have an implanted neuromodulation system. Patients should bring their
PatientTherapy Guide to all medical and dental appointments in the event that their healthcare professional has any questions regarding any precautions to take to avoid potential
device problems.
• Patients should always carry their Remote Control to allow them to change the stimulation amplitude and/or turn the Neurostimulator on or o.
• 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.
COMPONENT DISPOSAL
The following steps should be taken when the Axonics SNM System is explanted (for example, due to replacement, cessation of therapy, or after patient death) or when disposing of
accessories:
• If possible, the explanted component should be returned to Axonics along with completed paperwork for analysis and disposal.
• The device should not be autoclaved or exposed to ultrasonic cleaners to allow it to be analyzed by Axonics.
• Any components not returned to Axonics should be disposed of according to local regulations. Any potentially contaminated materials should be treated as biohazardous waste.
Note that in some countries, explanting a battery-operated implantable device is mandatory.
Cautions:
• Components that are explanted or that have come into contact with bodily uids should be handled with appropriate biohazard controls. Such components should only be returned
to Axonics in packaging supplied by Axonics.
• The Neurostimulator may explode if subjected to high temperatures; therefore the Neurostimulator should not be incinerated and should be explanted before patient cremation.
• Implantable devices should not be reused after exposure to body tissues or uids because the sterility and functionality of these devices cannot be assured.
DEVICE DESCRIPTION
The Axonics Neurostimulator (Figure 1) is part of the Axonics SNM System. The Neurostimulator is a programmable device that is connected to the Axonics tined lead, which conducts
stimulation pulses to the sacral nerve.
Figure 1. Axonics Neurostimulator.
Package contents
The Neurostimulator package contains the following:
• Neurostimulator
• Torque wrench
• System registration form
• Patient identication card
• Neurostimulator Implant Manual (this document)
The contents of the inner package are STERILE.The contents of the Neurostimulator package are intended for single use only.
System registration form and Patient identication card
The system registration form registers the device and creates a record of the device in Axonics’implant data system.
The patient identication card is also packaged with this device.The patient should carry the identication card at all times.
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SPECIFICATIONS
Table 1 shows the Neurostimulator physical specications. For detailed descriptions and specications for other components and accessories, refer to the product literature packaged
with those devices.
Table 1. Neurostimulator specications
Physical Attributes Height 42 mm
Length 22 mm
Thickness 6 mm
Weight 11 grams
Volume 5.5 cc
Radiopaque identier AXA
Stimulation Characteristics Frequency 2-130 Hz
PulseWidth 60-450 ms
Amplitude 0-12.5 mA
Minimum Amplitude Step Size 0.05 mA
Ramping 0-30 s
Stimulation Mode Continuous or Cycling
Mode of Operation Current-Controlled
Power Source Battery Rechargeable
Power Source 50 mAh (3.6V)
Battery life 15 years (open-ended)*
Note: All dimensions are approximate.
*Battery life estimated at nominal and worst case stimulation settings. Nominal: 1mA, 14 Hz, 210
m s, continuous stimulation,
impedance = 1,600 Ohms.Worst case: 4mA, 14 Hz, 210 m s, continuous stimulation, impedance = 1,600 Ohms.
Table 2 shows the materials used in the Neurostimulator kit components that come in contact with human tissue.
Table 2. Human-Contact Materials
Device Component Material
Neurostimulator Neurostimulator case Titanium-Ceramic
Neurostimulator header Epoxy
Septum and strain relief Silicone
Setscrew Titanium
Adhesive Silicone
Torque wrench Torque wrench handle Polyetherimide
Torque wrench shaft Stainless steel
Note: The Neurostimulator case, which contains the electronics and power source, is hermetically sealed.
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XRAY IDENTIFICATION
The radiopaque marker allows physicians to identify the manufacturer and model number under standard x-ray procedures. For the Axonics Neurostimulator, the designated code is AXA,
which appears as light characters on a black background (Figure 2).
PROPOSED AXONICS FIGURE
Figure 2: The Axonics Neurostimulator radiopaque marker, “AXA”.
Figure 2: The Axonics Neurostimulator radiopaque marker,“AXA.”
NEUROSTIMULATOR IMPLANT PROCEDURE
The following section describes the procedure for implanting the Axonics Neurostimulator. This procedure should be performed when an Axonics tined lead has already been implanted.
Procedure supplies
In addition to the general surgical tools required by the physician, the following supplies are needed for the preparation, implantation, programming, and Remote Control pairing of the
Neurostimulator:
• Axonics Neurostimulator (Model 1101)
• Axonics Charging System
• Axonics Clinician Programmer
• Axonics Remote Control
Caution: The user should avoid damaging the Neurostimulator and be especially cautious using sharp instruments as damage to the Neurostimulator may require a surgical
replacement.
Neurostimulator Preparation
Use the Charger to activate the Neurostimulator. Before opening the sterile Neurostimulator package, the Clinician Programmer (CP) should be used to communicate with the
Neurostimulator to verify the ability to communicate and to check battery status. If the Neurostimulator battery is low, the device should be charged through the box before implantation
by using the Charger. Refer to the CP and Charging System Manuals for further instructions.
Creating the Neurostimulator pocket
1. The Neurostimulator will be placed in a subcutaneous pocket at the anterior surface of the muscle in the upper buttock area. Create a small incision, slightly larger than the smaller
dimension of the Neurostimulator, and then bluntly dissect a subcutaneous pocket.
Notes:
• The Neurostimulator should be placed no deeper than 3.0 cm (about 1 in) below the skin and should be parallel to the skin. If the Neurostimulator is too deep or is not parallel to
the skin, charging and/or programming the device may be unsuccessful.
• The Neurostimulator should be implanted horizontally (Figure 3) with the ceramic side farthest from the patient’s midline to facilitate charging and programming.
• For a patient with another neurostimulator already implanted, the neurostimulators should be placed as far away as practical and separated by a minimum of 20 cm (8 in).
Cautions:
• The Neurostimulator implant site should be irrigated with antibiotic solution, and it is recommended that IV antibiotics be administered perioperatively. Do not soak the
Neurostimulator in antibiotic solution as this may aect lead connections.
• The Neurostimulator has been sterilized. The Neurostimulator should not be placed on any non-sterile surface. The Neurostimulator should not be placed on skin. An infection
may require surgical removal of the implanted system.
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PROPOSED AXONICS FIGURE
AX1A150000
Figure 3: Axonics Neurostimulator implantation position.
Figure 3: Axonics Neurostimulator implantation position.
2. Use the tunneling tool to create a tunnel from the lead incision site to the neurostimulator pocket. Refer to the Tined Lead Manual for detailed tunneling and lead implant
instructions.
Connecting the lead to the Neurostimulator
1. The components should be wiped and dried to remove any uids before making the connections. If necessary, use sterile water or a non-ionic antibiotic solution, then wipe dry.
Caution: Failure to completely dry the components could lead to undesired stimulation, intermittent stimulation, or loss of therapy.
2. Ensure that the Neurostimulator connector block is dry and clean.
3. Use the torque wrench to turn the setscrew counterclockwise to back up the setscrew. Do not remove the setscrew from the connector block (Figure 4)
PROPOSED AXONICS FIGURE PROPOSED AXONICS FIGURE
Figure 5: Use the torque wrench to turn the
setscrew counterclockwise to remove
the Neurostimulator setscrew.
Figure 6: Secure the lead by tightening the
setscrew clockwise onto the retention sleeve.
Figure 4: Use the torque wrench to turn the setscrew counterclockwise
to back up the Neurostimulator setscrew and allow for insertion of the lead.
4. Insert the lead into the Neurostimulator connector block until fully seated and the lead cannot be inserted further. Marker D on the lead should be inside the Neurostimulator strain
relief (Figure 5). The retention sleeve on the tined lead should be positioned under the Neurostimulator setscrew.
PROPOSED AXONICS FIGURE
Mrkern D
Figure 4: Insert lead fully into the Neurostimulator connector block.
Figure 5: Insert lead fully into the Neurostimulator connector block.
Marker D
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Cautions:
• Avoid pulling the lead body taut when implanted.
• Do not attempt to insert the lead into the Neurostimulator if the setscrew is not suciently retracted as doing so may cause damage to the lead and/or cause the lead to not seat
fully into the connector block.
• Ensure that the setscrew tightens on the retention sleeve, not an electrode. Tightening the setscrew onto the contact could damage the contact, leading to lack of therapy.
5. Fully insert the torque wrench into the hole of the Neurostimulator connector block. Tighten the setscrew by turning the torque wrench clockwise until it clicks (Figure 6).
PROPOSED AXONICS FIGURE PROPOSED AXONICS FIGURE
Figure 5: Use the torque wrench to turn the
setscrew counterclockwise to remove
the Neurostimulator setscrew.
Figure 6: Secure the lead by tightening the
setscrew clockwise onto the retention sleeve.
Figure 6: Secure the lead by tightening the setscrew clockwise onto the retention sleeve.
Cautions:
• Ensure that the torque wrench is fully inserted into the setscrew. Otherwise the setscrew may be damaged, which can result in intermittent or loss of stimulation.
• The torque wrench is designed for single use only and cannot be assured to work appropriately if used for multiple surgeries. Discard the torque wrench after use.
Implanting the Neurostimulator
1. Place the Neurostimulator into the subcutaneous pocket. Ensure that the ceramic side is placed away from the patient’s midline to ensure good communication with the Remote
Control and ease of recharging (Figure 3). The etched writing can face either towards or away from the muscle tissue. Ensure that the lead curves gently away from the
Neurostimulator with no sharp bends.
Note: The Neurostimulator should be placed no deeper than 3.0 cm (about 1 in) below the skin and should be parallel to the skin. If the Neurostimulator is too deep or is not parallel to
the skin, telemetry and/or charging may be unsuccessful.
Caution: Do not coil excess length in front of Neurostimulator. Wrap excess length around the perimeter of the Neurostimulator (Figure 7) or place under the Neurostimulator to
minimize interference with telemetry during programming.
PROPOSED AXONICS FIGURE
Figure 7: Wrap excess lead around or under, but not on top
of, the Neurostimulator.
Figure 7: Wrap excess lead around or under, but not on top of, the Neurostimulator.
2. Use the Clinician Programmer to check the impedances and ensure good function and connectivity of the system.
Notes:
• The Neurostimulator should be in the subcutaneous pocket during system interrogation to ensure proper readings.
• Refer to the Clinician Programming Manual for detailed instruction on checking the system integrity and impedances.
3. Use the suture hole in the header to secure the Neurostimulator to the muscle fascia with non-absorbable silk.
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Completing the implant procedure
1. Close and dress all incisions.
2. Program the patient’s Neurostimulator and Remote Control. Refer to the Clinician Programming Manual formore detailed instruction.
3. Give a Remote Control and patient ID card to the patient.
Caution:The patient must carry the Remote Control at all times to be able to adjust or turn o the Neurostimulator.
4. Complete the system registration paperwork and return to Axonics.
5. Schedule the patient’s follow-up visits at regular intervals to ensure that the stimulation is programmed optimally.
Post-surgery treatment
Administer prophylactic antibiotics for 24 hours.
Replacing the Neurostimulator
1. Carefully open the implant site and remove the Neurostimulator from the subcutaneous pocket. Avoid cutting the tined lead to preserve for connection with the new
Neurostimulator.
2. Clean the Neurostimulator connector block and lead with sterile water. Wipe both dry with sterile gauze.
3. Use the torque wrench to loosen the setscrew in the Neurostimulator connector block by turning it counterclockwise (Figure 4).
4. Gently remove the lead from the Neurostimulator.
Caution: Replace any device that shows signs of damage, pitting, or corrosion.
5. Set aside the explanted components, which should be returned to Axonics.
6. Connect the lead and replacement Neurostimulator according to the steps above.
Return explanted devices to Axonics using materials provided.
LABEL SYMBOLS
This section explains the symbols found on the product and packaging.
Symbol Description Symbol Description
Axonics Neurostimulator Refer to instructions for use (Consult accompanying documents)
Temperature limitation
AxonicsTorqueWrench Humidity limitation
Pressure limitation
Neurostimulator default waveform with 14 Hz frequency, 0 mA
amplitude and 210 m s pulse width
Do not reuse
Sterilized using Ethylene oxide
Neurostimulator default electrode conguration:
Electrode 0: Negative (-)
Electrode 1: O (0)
Electrode 2: O (0)
Electrode 3: Positive (+)
Case: O (0)
Use by
Do not use if package is damaged
Do not resterilize
(& 5(3
Authorized representative in the European community
Product Serial Number Open here
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Manufacturer !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
Product Model Number Warning / Caution
Manufacturing Date Product Literature
Non ionizing electromagnetic radiation Magnetic Resonance (MR) Conditional
0086
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)
IC Industry Canada certication number
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
WIRLESS COMMUNICATION
Model: 1101
IC: 20225-X
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 maybe 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 licence-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 modications to the Neurostimulator are not authorized by Axonics could void FCC and IC certication and negate the user’s authority to use the product.
Quality of Wireless Service:This device operates in the 402-405 MHz frequency and the maximum eective radiated power of the Neurostimulator communication is below the limit of 25
µW ERP/EIRP as specied in EU: EN ETSI 301-839 and USA: FCC 47 CFR Part 95; Subpart I. The Remote Control, Clinician Programmer, or Charger have to be within 1 meter from the implant
for successful communication.
Wireless Security: The Neurostimulator can only communicate with a single Remote Control that is paired to it using the Clinician Programmer. Any Axonics Clinician Programmer or
Charger can communicate with a Neurostimulator. Additional mechanisms exist to ensure the integrity of radio data
Wireless Security: The Neurostimulator can only communicate with a single Remote Control that is paired to it using the Clinician Programmer. Any Axonics Clinician Programmer or
Charger can communicate with a Neurostimulator. Additional mechanisms exist to ensure the integrity of radio data.
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Sakrales Neuromodulationssystem
Neurostimulatorimplantat-Handbuch
Neurostimulator-Modell 1101
Rx Only
DE
Axonics®, Axonics Modulation®, Axonics ModulationTechnologies® und Axonics Sacral Neuromodulation System® sind Marken von Axonics Modulation
Technologies, Inc. eingetragen oder angemeldet in den USA und anderen Ländern.
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Inhalt
EINFÜHRUNG.....................................................................................................20
AXONICS SNM THERAPIE ZUR BLASENKONTROLLE ...................................................................20
Indikationen ...................................................................................................20
Vorsichtsmaßnahmen ..........................................................................................20
SchulungvonÄrzten...........................................................................................20
VerwendungbeibestimmtenPatientengruppen...................................................................20
AXONICS SNM THERAPIE ZUR DARMKONTROLLE.....................................................................20
Indikationen ...................................................................................................20
Vorsichtsmaßnahmen ..........................................................................................20
SchulungvonÄrzten...........................................................................................20
VerwendungbeibestimmtenPatientengruppen...................................................................20
KONTRAINDIKATIONEN............................................................................................20
WARNHINWEISE..................................................................................................20
Diathermie.....................................................................................................20
Magnetresonanztomograe (MRT)..............................................................................21
Elektromagnetische Störung (EMI) ..............................................................................21
Gehäuseschäden ...............................................................................................21
Auswirkung auf andere implantierte Geräte.....................................................................21
VORSICHTSMAßNAHMEN..........................................................................................21
Klinische Programmierung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Patientenaktivitäten ...........................................................................................22
Programmieren durch den Patienten und Fernbedienung........................................................22
Lagerungs- und Betriebsumgebung.............................................................................23
Sterilisierung. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Systemimplantat...............................................................................................23
INDIVIDUELLE ANPASSUNG DER BEHANDLUNG......................................................................23
UNERWÜNSCHTE EREIGNISSE......................................................................................24
INFORMATIONEN ZUR BERATUNG DES PATIENTEN ...................................................................24
ENTSORGUNG VON KOMPONENTEN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
BESCHREIBUNG DES GERÄTS.......................................................................................25
Packungsinhalt.................................................................................................25
Systemregistrierungsformular und Patientenausweis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
TECHNISCHE DATEN ...............................................................................................25
RÖNTGENKENNZEICHNUNG........................................................................................26
IMPLANTATIONSVERFAHREN FÜR DEN NEUROSTIMULATOR ..........................................................27
Material für das Verfahren ......................................................................................27
Präparation des Neurostimulators ..............................................................................27
Anfertigen einer Tasche für den Neurostimulator ................................................................27
Anschluss der Elektrode an den Neurostimulator.................................................................29
Implantation des Neurostimulators .............................................................................30
Fertigstellen der Implantation..................................................................................30
Behandlung nach der Operation ................................................................................30
Auswechseln des Neurostimulators..............................................................................30
BESCHREIBUNG DER SYMBOLE.....................................................................................30
DRAHTLOSE KOMMUNIKATION.....................................................................................31
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EINFÜHRUNG
Dieses Handbuch enthält Informationen über den Axonics Sakrales Neuromodulationssystem (SNM) Neurostimulator (Modell 1101), der Teil des Axonics SNM Systems ist.Der
Neurostimulator ist mit der AxonicsVerankerungselektrode (Modell 1201 oder 2201) verbunden.
AXONICS SNM THERAPIE ZUR BLASENKONTROLLE
Indikationen
Die Axonics SNM Therapie zur Blasenkontrolle ist indiziert zur Behandlung von Harnretention und Symptomen einer überaktiven Blase mit Dranginkontinenz und maßgeblichen
Symptomen von Drang und Häugkeit alleine oder in Kombination bei Patienten, die konservativereTherapien ausprobiert, diese jedoch nicht vertragen bzw. nicht angesprochen haben.
Achtung: DieseTherapie ist nicht für Patienten bestimmt, bei denen eine Obstruktion vorliegt, z. B. gutartige Prostatahyperplasie, Krebs oder Harnröhrenverengung.
Vorsichtsmaßnahmen
Schulung von Ärzten
Implantierende Ärzte müssen in der Implantation und der Anwendung des Axonics SNM-Systems geschult sein.
Verschreibende Ärzte müssen in der Diagnose und Behandlung von Symptomen des unteren Harntrakts erfahren und in der Anwendung des Axonics SNM Systems geschult sein.
Verwendung bei bestimmten Patientengruppen
Die Sicherheit und Wirksamkeit dieserTherapie ist unter folgenden Umständen nicht belegt:
• Schwangere Frauen
• Anwendung bei Kindern (Patienten von unter 16 Jahren)
• Patienten mit neurologischer Krankheitsursache, z. B. multipler Sklerose oder Diabetes
• Bilaterale Stimulation
AXONICS SNM THERAPIE ZUR DARMKONTROLLE
Indikationen
Die Axonics SNM Therapie zur Darmkontrolle ist indiziert zur Behandlung chronischer Stuhlinkontinenz bei Patienten, die für konservativere Behandlungen nicht infrage kommen oder
nicht darauf angesprochen haben.
Vorsichtsmaßnahmen
Schulung von Ärzten
Implantierende Ärzte müssen in der Implantation und der Anwendung des Axonics SNM Systems geschult sein.
Verschreibende Ärzte müssen in der Diagnose und Behandlung von Stuhlinkontinenz erfahren und in der Anwendung des Axonics SNM Systems geschultsein.
Verwendung bei bestimmten Patientengruppen
Die Sicherheit und Wirksamkeit dieserTherapie ist unter folgenden Umständen nicht belegt:
• Schwangere Frauen
• Anwendung bei Kindern (Patienten von unter 18 Jahren)
• Patienten mit progressiven, systemischen neurologischen Erkrankungen
• Bilaterale Stimulation
KONTRAINDIKATIONEN
Das Axonics SNM System ist kontraindiziert bei Patienten, die das Axonics SNM System nicht bedienen können.
WARNHINWEISE
Diathermie
Kurzwellen-Diathermie, Mikrowellen-Diathermie oder therapeutische Ultraschall-Diathermie (zusammen Diathermie genannt) sollte nicht bei Patienten verwendet werden, denen ein
Axonics SNM System implantiert wurde. Bei Diathermie kann Energie durch das implantierte System übertragen werden, was Gewebeschäden an der Stelle der implantierten Elektroden
und dadurch schwereVerletzungen verursachen kann.
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