Foreword
CoolSculpting® Elite
System User Manual
8
CS-UM-CM3-02-EN-D
The effect of performing a
CoolSculpting® Elite
treatment with a vacuum applicator on a
patient who has a hernia in or adjacent to the treatment site has not been studied. The
applicator uses vacuum pressure to draw tissue into the applicator cup during the treatment.
The vacuum pressure may therefore apply pressure on a pre-existing hernia or pre-existing
structurally weak area such as a surgical scar, causing further complications. Physicians
should examine that patient for evidence of pre-existing abdominal or femoral hernia prior to
use of the device.
The system operates at temperatures below 0°C, which can freeze tissue; clinical events that
are common to freezing tissue should be considered.
The use of this device on areas with superficially located nerve branches, arteries, or veins has
not been demonstrated to be safe and effective. Such use may result in injury to the patient.
The effect of performing treatments directly over active implanted devices, such as
pacemakers and defibrillators, is not known.
Patients with chronic pain, sensitivity to cold, or an anxiety disorder may be more prone to pain
or discomfort during the treatment.
Do not use the
CoolSculpting® Elite
on areas with a subcutaneous fat layer thickness of less
than 1cm.
Do not use the
CoolSculpting® Elite
on areas of decreased sensation or perfusion.
Do not use the
CoolSculpting® Elite
on areas with minimal underlying muscle mass or on
areas with superficially located nerve branches, arteries, or veins.
Do not use the
CoolSculpting® Elite
on the face, head, genitalia, inguinal creases, axillae,
popliteal fossae, antecubital fossae, hands, or feet.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
The use of other electronic medical devices on a patient who is undergoing a treatment might
interfere with the correct functioning of the system, possibly resulting in injury to the patient. Do
not use other electronic medical devices on a patient who is undergoing a treatment.
WARNING: Before using the system, read and understand the additional warnings that
are specific to a treatment site within Table 2 on the following page.
