User Manual
AXONICS SNM SYSTEM® – Neurosmulator | Rechargeable, Model 5101
6
STORAGE AND USAGE ENVIRONMENT
Component Packaging
Any component that has been compromised in any way should not be implanted; this includes the re-use of non-reusable
product. 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 infecon.
• The component itself shows any signs of damage. The component may not funcon properly.
• The use-by date has expired. In this case, component sterility cannot be guaranteed, and infecon may occur.
• The sterile component was dropped onto a non-sterile surface. In this case, the sterility cannot be guaranteed, and
infecon may occur.
Usage Environment:
The following lists the appropriate temperature, humidity, and pressure usage condions for use of the Neurosmulator:
• Temperature: 20 °C to 45 °C
• Pressure: The Neurosmulator should funcon at up to 10 m (33 feet) underwater (200 kPa) and at altudes up to
3000 m (10,000 feet) associated with acvies like hiking and skydiving (as low as 70 kPa)
Shipping and Storage Environment:
The following lists the appropriate temperature, humidity, and pressure condions for shipping and storing the Neurosmulator:
• Temperature (short term: 3 days): -10
o
C to 55
o
C
• Humidity (short term: 3 days): 15% to 95%
• Pressure (short term): 57 kPa to 106 kPa
If the
Neurosmulator is exposed to extreme temperatures, it may be permanently damaged and should not be used, even
if it has returned to a temperature that is within the specied operang range.
Sterilization
The contents of this package have been sterilized using ethylene oxide. This device is for single use only and should not be
re-sterilized.