Breg VPULSE Manual Del Usuario página 3

Symbols
The Caution or Warning symbol precedes an
operational step that could cause damage to
the user or instrument if the patient does not
take certain precautions. Cautions or Warnings
are located in the main text, are preceded
by a Caution or Warning statement and are
accompanied by this symbol in the left margin.
Symbol ISO 7010-M002: refer to the Users
Manual for instructions for product usage.
This device is offered for sale by or on the
order of a licenced healthcare practitioner. Use
only as prescribed.
Medical Device Safety Symbol IEC 60417-5333:
Type BF Applied part complying with IEC
60601-1 to provide protection against electric
shock. The part of the device in contact with
the patient is floating from earth ground.
Protected against spraying water.
Medical Device Symbol IEC 60417-5031: The
product operates from direct current.
Medical Device Symbol IEC 60417-5172: Class
II Equipment.
Medical Device Symbol IEC 60417-5570:
Unlocking, Handle.
Medical Device Symbol IEC 60417-5569:
Locking, Handle.
Minimum water reservoir fill line. Step 1 of
filling the water reservoir.
Maximum ice reservoir fill line. Step 2 of filling
the water reservoir. Note that either ice or
the VPULSE Ice Bottles can be used for cold
therapy.
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Cold therapy enable function.
Start /Stop the therapy session.
Dynamic compression therapy enable function.
Sequential compression therapy enable
function.
Follow local governing ordinances and recy-
cling plans regarding disposal or recycling of
device components. If unclear, please refer to
Breg for proper disposition of this product.
Manufactured by Breg, Inc.
This product conforms to the directive 93/42
2797
EEC for medical devices. The identification
number of the Notified Body is 2797.
Date of manufacture, year XXXX, week YY.
Single patient multiple use.
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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