CoolSculpting® Elite
System User Manual
Foreword
CS-UM-CM3-02-EN-D
7
Mode
Indications
Heating or
cooling
•
Can be used to minimize pain post-trauma and post-surgery.
•
Can be used to provide temporary relief of minor aches, pains, and muscle spasms.
•
The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device
with a patient’s skin by mitigating minor variances in device-to-skin contact.
Massage
(optional
function)
•
Can be used to provide temporary relief of minor muscle aches, pain, and spasm.
•
Can be used to provide temporary improvement in local circulation.
•
Can be used to provide temporary reduction in the appearance of cellulite.
In the United States of America, federal law restricts this device to sale by or on the order
of a physician.
Contraindications
Localized skin cooling is contraindicated in patients who have:
•
Cryoglobulinemia
•
Cold agglutinin disease
•
Paroxysmal cold hemoglobinuria
Warnings
Unauthorized modification or repair of the control unit, its components, or supplies may result
in unsafe conditions and/or impaired performance. No modification of this equipment is allowed
without express authorization from ZELTIQ. Any unauthorized modification or repair will void
the warranty.
The use of the
CoolSculpting® Elite
System has not been studied in children, those who are
pregnant or lactating, or patients with:
•
Known sensitivity to cold such as cold urticaria, Raynaud’s disease, or Chilblains (pernio)
•
Known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol
•
Impaired peripheral circulation in the area to be treated
•
Neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy
•
Impaired skin sensation
•
Open or infected wounds
•
Bleeding disorders or concomitant use of blood thinners
•
Recent surgery or scar tissue in the area to be treated
•
Hernia in or adjacent to the treatment site
•
Skin conditions such as eczema, dermatitis, or rashes in the area to be treated
