Foreword
CoolSculpting® Elite
System User Manual
10
CS-UM-CM3-02-EN-D
Precautions
The system is intended for use by a trained physician or by a physician-designated medical
professional.
If the operator observes a potential safety issue or operational abnormality during use, the operator
should stop the treatment immediately and contact ZELTIQ Customer Service (see page 5).
The use of other equipment and supplies with the system has not been tested and may cause
unexpected results.
Adverse Events
Table 3 lists common adverse events that can occur in the treatment area during and after a treatment.
These effects are temporary and generally resolve within days or weeks.
Table 3: Common Adverse Events
When Occurs
Common Side Effects
During a treatment
•
Sensations of pulling, tugging, and mild pinching at treatment site
•
Intense cold, tingling, stinging, aching, cramping
Note:
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
Note:
Numbness can persist up to several weeks after treatment.
•
Sensation of fullness in the back of the throat after submental area treatment
