ZELTIQ CoolSculpting System, Руководство пользователя

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System Overview Contraindications
User Manual 3
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.
CoolSculpting System use 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
The effect of performing a CoolSculpting treatment (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 System of areas with a subcutaneous fat layer thickness of less than 1cm.
Do not use the CoolSculpting System on areas of decreased sensation or perfusion.
Do not use the CoolSculpting System on areas with minimal underlying muscle mass or on areas with
superficially located nerve branches, arteries, or veins.
Do not use the CoolSculpting System on the face, head, genitalia, inguinal creases, axillae, popliteal fossae,
antecubital fossae, hands, or feet.