Programming Manual

12
10. PACKAGING, STORAGE AND HANDLING
Pulsante® SPG Microstimulator
• The Microstimulator is provided sterile. The Microstimulator is sterilized using ethylene oxide.
• Do not excessively bend the Microstimulator Lead or Bone Fixation Plate. Excessive bending
may damage the integrity of the Microstimulator and may affect device performance.
• Do not attempt to reuse or re-sterilize the Microstimulator. The Microstimulator is intended for
single use only.
• Do not use the Microstimulator if the current date is beyond the labeled “Use by” date.
• Do not use the Microstimulator if the packaging or its contents are damaged or have been
previously opened.
• Do not store the Microstimulator packaging where it may be exposed to water or other liquids,
as moisture may damage the seal integrity of the package materials.
• Store the Microstimulator between –10°C (–14°F) and +55°C (+131°F); temperatures outside
of this range may damage components.
Pulsante® Surgical Tools
• The Surgical Tools are provided sterile. The Surgical Tools are sterilized using ethylene oxide.
• Do not attempt to reuse or re-sterilize the Surgical Tools after surgical use. The Surgical Tools
are intended for single use only.
• Do not use the Surgical Tools if the packaging or its contents are damaged or have been
previously opened.
• Do not store the Surgical Tools’ packaging where it may be exposed to water or moisture.
Pulsante® Remote Controller
• Do not sterilize the Remote Controller.
• Do not store the Remote Controller where it may be exposed to water or other liquids, as
moisture may damage the integrity of the package materials or damage the Remote Controller.
• Do not use the Remote Controller if the packaging or the Remote Controller look damaged.
• The Remote Controller is a sensitive electronic device that may be damaged by rough
handling, including dropping on the ground or being crushed.
• The Remote Controller can be safely stored and operated between 5°C and 40°C. The
Remote Controller can be transported between 20°C and +70°C. Temperatures outside of this
range may reduce battery life.
• Do not connect the USB Port to any other electrical device other than the Charger provided
with the Remote Controller or the Programming USB cable provided with the Programmer
Software.
• The Remote Controller may feel warm when providing therapy. If the patient experiences
discomfort, recommend moving the Remote Controller away from the face slightly and avoid
contact with skin.
• The Remote Controller should not come into contact with skin that is cut or bleeding.
Clinician Programmer
• Do not sterilize the Clinician Programmer.
• Do not store the Clinician Programmer where it may be exposed to water or other liquids, as
moisture may damage the integrity of the package materials or damage the Clinician
Programmer.
• Do not use the Clinician Programmer if the packaging or the Clinician Programmer look
damaged.