Breg Polar Care Kodiak Gebrauchsanweisung Seite 3

Product Insert Information for Medical Professionals
Guidelines for Use
1. Screen Patients for Contraindications and Risk Factors
Before prescribing cold therapy, always consider the patient's medical history,
particularly any contraindications or risk factors. If not appropriately prescribed,
motorized cold therapy can result in serious cold-induced injury, including full
thickness skin necrosis.
CONTRAINDICATIONS
Patients with any contraindications should not use Polar Care
• History of cold injury, frostbite, or
adverse reactions to local cold
application.
• Patients that are incoherent due
to general anesthesia, sedation, or
coma.
• Application areas with compromised
local circulation or potential wound
healing problems, including localized
compromise due to multiple surgical
procedures.
RISK FACTORS for Cold-Induced Injury
• Pathologic sensitivity to cold.
• Behaviors that negatively effect
circulation, including poor nutritional
status, smoking and tobacco
use, excessive caffeine use, and
excessive alcohol use.
• Patients with cold application
area desensitization due to local
anesthesia or regional nerve blocks.
• Medications that have a negative
effect on peripheral vascular
circulation, including beta
adrenergic blockers and local
epinephrine use (such as in local
anesthetics).
• Circulatory syndromes, including
Raynaud's disease, Buerger's
disease, peripheral vascular disease,
vasospastic disorders, sickle cell
anemia, and hypercoagulable
clotting disorders.
• Local tissue infection.
• Hand/wrist or feet/ankle surgery
with polyneuropathy.
• Diabetic Polyneuropathy.
• Medications that have a negative
effect upon mental capacity.
• Excessive moisture at the
application site due to
excessive bleeding, sweating, or
condensation.
• Diabetes.
• Hand/wrist or feet/ankle surgery.
• Cognitive disabilities.
• Communication barriers.
• Young children and the elderly.
If the risk of cold-induced injury outweighs the benefits of cold therapy, do
not prescribe Breg's Polar Care Cold Therapy. If you prescribe this product to
patients with risk factors, consider taking special measures to control the risk,
such as:
• Recommending more frequent skin checks.
• Requiring more frequent follow-up examinations.
• Using a thicker insulation barrier between the pad and skin.
• Prescribing shorter durations of application, less frequent application, or
eliminating nighttime application.
2. Apply Insulation Barrier and Cold Therapy Pad
Always use an insulation barrier (such as Webril, Kerlix, cast padding, elastic
bandage) between the Cold Therapy Pad and skin. Do not let any part of the
Pad touch skin. If a sterile dressing has been applied to the treatment site that
does not completely cover the skin under the pad, use an additional insulation
barrier. The Pad alone can be too cold to be applied directly to the skin.
Use only Breg Cold Therapy Pads. Other pads may be colder, increasing the risk
of skin injury.
Use only Breg Cold Therapy Pads designed for the body part being treated.
Multi-Use and Rectangle Pads may be used on shoulders, knees, back, and
hips. If the Cold Therapy Pad is placed on a body part that it is not designed for,
or if another brand of pad is used, the skin can get too cold and be injured.
Do not cover the Cold Therapy Pad with dressing, wrapping, bracing or casting
that prevents the patient from checking the skin under the Pad.
3. Provide Prescription and Instructions
Breg Polar Care Cold Therapy units are classified by the FDA as Class II
medical devices that must be prescribed by a physician or licensed healthcare
practitioner. A proper prescription for use must include:
• Frequency and duration of use (and breaks if applicable);
• Frequency and instruction on skin inspections;
• Treatment Period.
Use the Physician Prescription Form on the other side of this document. This
document should be given to the patient (or caregiver) upon discharge or
transfer from the recovery room. Common operating temperatures for patients
without risk factors for extended use (longer than 20 minutes) are 45° to 60° F
(7° to 16° C) for core regions and 50° to 60° F (10° to 16° C) for extremities. When
used with a body part appropriate Cold Therapy Pad and an insulation barrier,
the average operating temperature of the Breg Polar Care Cold Therapy System
will automatically fall within these ranges.
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