AXONICS SNM SYSTEM® – Neurostimulator | Recharge-Free, Model 4101 Page 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 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.
• The sterile component was dropped onto a non-sterile surface. In this case, the sterility cannot be guaranteed, and
infection may occur.
Usage Environment:
The following lists the appropriate temperature, humidity, and pressure usage conditions for use of the Neurostimulator:
• Temperature: 20 °C to 45 °C
• Pressure: The Neurostimulator should function at up to 30 m (100 feet) underwater (403 kPa) for up to 60 minutes
and at altitudes up to 3000 m (10,000 feet) 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 conditions for shipping and storing the
Neurostimulator:
• 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
Neurostimulator 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 specified operating 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.
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