Usage Environment - Axonics 1901 PNE Lead Manual Del Usario

Unexpected changes in stimulation – EMI, postural changes, and other activities may cause a perceived increase
in stimulation. Some patients may find this uncomfortable (a jolting or shocking feeling). Before engaging in activities
where 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 the TS. 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).
Remote Control handling – Patients should avoid immersing the Remote Control in liquid to avoid damaging it.
Patients should also avoid dropping the device or mishandling it in any way that may damage it. Patients should clean
the device with water and a 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 implant the component if any of the following have occurred:
• The storage package or sterile pack has been damaged, pierced, or altered. In this case, sterility cannot be
guaranteed and infection may occur.
• 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 condition for use of the Axonics components:
• Temperature (Lead and accessories): 5 °C to 40 °C
• Humidity (Lead and accessories): 15% to 95%
• Pressure (Lead and accessories): 70 kPa to 106 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 and 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): 15% to 95%
• 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, do not use them until they have
returned to the operating temperature range.
Sterilization
Contents* of this package have been sterilized using ethylene oxide. This device is for single use only and should not
be re-sterilized.
*Non-sterile contents include the PNE Ground Pad and Cable, Needle Stimulation Pad and Cable, and the Basic Trial
Cable.
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. The PNE lead should provide
at least 7 days of service. Unexpected stress, strain, or impact can cause earlier failure. Such 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.
8