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Indications
The VPULSE is intended to function as an
intermittent, external compression device for
extremities to prevent and reduce complications
of poor circulation. This includes:
• Deep vein thrombosis
• Chronic venous insufficiency
• Venous stasis ulcers
• Post-mastectomy edema and chronic
lymphedema
• Reduction of edema associated with soft tissue
injuries such as burns, postoperative edema,
and ligament sprains
• Localized cold therapy for post-traumatic and
post-surgical medical and/or surgical conditions
• Aid in blood flow back to the heart
• Treatment and assistance in healing of
cutaneous ulceration (wounds), reduction
of wound healing time, enhancement of
arterial circulation (blood flow), reduction
of compartmental pressures, reduction of
edema (swelling), reduction of the need for
anticoagulant (blood thinning) medications
Contraindications: Cold Therapy
Medical professionals and patients should be
aware of situations where cold therapy may
not be appropriate, detrimental to a specific
condition or otherwise contraindicated for use,
including patients with:
• Diabetes
• Cold uticaria
• Cryoglobulinemia
• Raynaud’s syndrome
• Proximal cold hemoglobinuria
• Vasospastic disease
• Cold hypersensitivity
• Compromised local circulation
• History of cold injury, frostbite, or adverse
reactions to local cold application
• Patients who are incoherent due to general
anesthesia, sedation, or coma
• Local tissue infection
• Hand/wrist or feet/ankle surgery with
polyneuropathy
Warnings: Cold Therapy
If the patient has any of the following clinical
risk factors, use of cold therapy may result
in serious cold-induced injury, including full
thickness skin necrosis:
• Pathologic sensitivity to cold
• Behaviors that negatively affect circulation,
including poor nutritional status, smoking
and tobacco use, excessive caffeine use, and
excessive alcohol use
• Cold application area desensitization due to
local anesthesia or regional nerve block
• Taking medications that have a negative effect
on peripheral vascular circulation, including
beta adrenergic blockers and local epinephrine
use (such as in local anesthetics)
If the risk of cold-induced injury outweighs
the benefits of cold therapy, do not prescribe
the VPULSE cold therapy. If you prescribe this
product to patients with risk factors, consider
taking special measures to control the risk, such
as:
• Recommend more frequent skin checks.
• Require more frequent follow-up examinations.
• Use an insulation barrier between the pad and
skin.
• Prescribe shorter durations of application, less
frequent application, or eliminate nighttime
application.
The VPULSE can be cold enough to cause
serious injury including full skin necrosis.
Excessive moisture at the application site due
to excessive bleeding, sweating, or condensation
may increase the risk of serious cold-induced
injury, including full thickness necrosis.
Inspect the skin under the cold therapy pad
(by lifting the edge) as prescribed, typically every
1 to 2 hours. Do not use VPULSE cold therapy
if dressing, wrapping, bracing or casting over
the cold therapy pad prevents skin checks. Stop
using and contact your practitioner immediately
if you experience any adverse reactions, such
as: increased pain, burning, increased swelling,
itching, blisters, increased redness, discoloration,
welts, other changes in skin appearance, or any
other reaction identified by your practitioner
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