Axonics Model 1601, Manual

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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, the TS battery will eventually run out and can provide no more than 60 days of stimulation.
Component handling –
Handle the components of the Axonics SNM System with extreme care.They may be damaged by excessive force or sharp instruments.
Such damage can lead to intermittent stimulation or loss of stimulation altogether and may require surgery to replace.
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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