Storage And Usage Environment; Sterilization; System Implant; Individualization Of Treatment - Axonics 1201 Mode D'emploi

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 condition for use of the Axonics components:
• Temperature (leads): 20 °C to 45 °C
• Temperature (accessories): 5 °C to 40 °C
• Humidity ( accessories): 15% to 95%
• Pressure (accessories): 70 kPa to 106 kPa
• Pressure (leads): The Leads should function at up to 10 m underwater (200 kPa) and at altitudes up to 3000 m
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 condition for shipping and storage of
Axonics components:
• Temperature (short term: 3 days, Lead): -10˚C to 55˚C
• Temperature (short term: 3 days, accessories): -25˚C to 70˚C
• Temperature (long term, Lead and accessories): 20˚C to 30˚C
• Humidity (short term: 3 days, Lead and accessories): 15% to 95%
• Humidity (long term, Lead and accessories): 30% to 85%
• Pressure (short term: 3 days, Lead and accessories): 57 kPa to 106 kPa
• Pressure (long term, Lead and accessories): 70 kPa to 106 kPa
If the components were stored at temperatures outside of the operating range, these components should not be
used until they have 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. The tined lead should
provide at least 15 years of service, unless unexpected stress, strain, or impact causes earlier failure. Such failures,
such as electrical shorts, open circuits, and insulation breaches are unpredictable. Also, the Neurostimulator battery
will eventually fail to recharge.
Component handling – The components of the Axonics SNM System must be handled with extreme 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 benefits of SNM therapy, including 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 – Patients should be carefully selected to ensure 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.
9