Breg POLAR CARE WAVE Instrucciones De Uso página 5

WARNINGS
The Polar Care Wave can be cold enough to cause serious injury, including full skin necrosis. Follow and
carefully read the instructions for use and the cold compression pad fitting instructions (printed on each cold
compression pad) prior to use.
General Warnings
Patients with any of the following cognitive risk factors should only use Polar
Care Wave under direct supervision of a medical professional or caretaker. If
patient has any of the cognitive risk factors below, medical
professional or caretaker should provide skin checks:
Cognitive risk factors • Children under 18 years old and elderly
• Cognitive disabilities
• Communication barriers
• Use of medications that have a negative effect upon mental capacity
• Visually impaired
Discuss treatment
with your licensed Ask your healthcare professional about potential adverse reactions and cold-induced
injuries. Certain medical conditions make cold-induced injury more likely.
healthcare
professional
Do not use this device if you did not receive or do not understand the
instructions. Use only according to your healthcare professional's instructions
regarding the frequency, duration, and settings of cold and compression
application and length of breaks between uses, how and when to inspect the
skin, and total length of treatment.
United States Federal law restricts this device to sale by or on the order of a
Use only as
healthcare professional. The Polar Care Wave and cold compression pads are
prescribed
intended for single patient, multiple use only. Dispensed with a prescription.
The prescription must include:
• The frequency, duration, and settings of the cold and compression
application
• Length of breaks between uses
• How and when to inspect the skin
• Total length of treatment
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WARNING
Warnings continued through page 9.
WARNINGS
General Warnings
Patients vary in sensitivity to cold, regularly inspect the skin under the cold
compression pad (by lifting the edge) as prescribed, typically every 1 to 2
hours. Do not use the Polar Care Wave unit if skins checks are inhibited by a
barrier.
Inspect skin regularly
Stop using and consult your healthcare professional immediately if you
experience any adverse reactions, such as: increased pain, burning, increased
swelling, itching, blisters, increased redness, discoloration, welts, irritation and
other changes in skin appearance, or any other reaction identified by your
healthcare professional.
• Keep tubing and cords away from the neck to avoid risk of strangulation.
•
If a leak or a steady stream of water is flowing from any part of the unit,
tubing or cold compression pad, discontinue use and contact Breg Customer
Care. Excess moisture could result in a slip hazard or unwanted moisture at
an injury site.
• Do not modify, service, or perform unspecified maintenance on this equipment
or accessories. Only use parts and accessories designed for the Polar Care Wave.
• Do not attempt to sterilize Polar Care Wave or cold compression pads by
General safety
any means.
• Set up and use this equipment in a location away from unsupervised
children and pets.
• Do not operate the unit in a heavy dust/lint environment, excessive dust/
lint may cause clogging. Do not leave the unit in direct sunlight, UV light
may damage or discolor the unit.
• Device not intended for use with numbing agents.
NOTICE TO USERS
If any serious incident has occurred in relation to the device, report to Breg and the competent authority
of the Member State in which the user and/or patient is established.
Warnings continued through page 9.
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