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Package contents
The TS 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.
CONTRAINDICATIONS
The Axonics SNM Trial System is contraindicated for patients who are unable to operate the Axonics SNM Trial System.
WARNINGS
Prohibited Medical Procedure
Diathermy
Shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (collectively described as diathermy) CANNOT
be performed 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.
Other Medical Procedures
The following additional medical procedures that may adversely affect the patient or 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
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