System Overview
Precautions
User Manual
5
Observe the following warning when treating the upper arm:
Treatment Site
Warning
WARNING: Avoid compression of the ulnar
nerve during treatment of the upper arm.
Ulnar Nerve
Table 2:
Upper Arm Treatment Warning
Precautions
The system is intended for use by a trained physician or a physician-designated medical professional.
If the operator observes a potential safety issue or operational abnormality during use, the treatment should
be terminated and ZELTIQ Customer Service should be contacted promptly.
The use of other equipment and supplies with the system has not been tested and may cause unexpected
results.
Adverse Events
Common Adverse Events
The following effects can occur in the treatment area during and after a treatment. These effects are
temporary and generally resolve within days or weeks.
During a treatment:
•
Sensations of pulling, tugging, and mild pinching at the treatment site.
•
Intense cold, tingling, stinging, aching, cramping. These sensations subside as the area becomes numb.
Immediately after a treatment:
•
Redness and firmness.
•
Transient blanching and/or mild bruising around the edges of the treatment area.
•
Tingling and stinging.
One to two weeks after a treatment:
•
Redness, bruising, and swelling.
•
Tenderness, cramping, and aching.
•
Itching, skin sensitivity, tingling, and numbness. Numbness can persist up to several weeks after a
treatment.
•
Sensation of fullness in the back of the throat after submental area treatment.
Rare Adverse Events
•
Paradoxical hyperplasia: Visibly enlarged tissue volume within the treatment area, which may develop two
to five months after treatment. Surgical intervention may be required.
•
Late-onset pain with a typical onset several days after a treatment and resolution within several weeks.
