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ELECTRICAL SAFETY
• When using or cleaning the Polar Care Wave, avoid flammables and oxidizers.
Flammables
Do not use in places with flammable vapors or gases (e.g., flammable
anesthetics), high oxygen concentrations, or other oxidizers (e.g., nitrous oxide).
• Even though the Polar Care unit is designed to hold and pump water, the
electrical components of the unit and power supply must be kept dry.
• Do not handle the power supply or electrical cord with wet hands.
Keep electrical
• Always keep the unit in a place where the connections will not fall into water
components dry
(e.g., a tub, sink, etc.).
and free of debris
• If the electrical connections fall into water, do not touch any part of the product.
• Unplug only at dry electrical connections.
• Use only the power supply provided with the Breg Polar Care Wave unit.
Power supply
Model number is listed in Electrical Specification section on page 20.
• Keep the cord and power supply away from heated surfaces.
• Never operate this product if it has a damaged cord, power supply, or plug,
which could result in electric shock.
• If the cord, power supply, or plug is damaged, unplug and contact Breg
Customer Care.
• This Polar Care Wave unit may cause electromagnetic or other interference with
Electromagnetic
interference and
other electrical devices. Avoid using the Polar Care Wave unit adjacent to or
stacked on other equipment because it could result in improper operation of the
emissions
unit or the other equipment.
• Portable RF communications equipment should be used no closer than 12
inches (30 cm) to any part of the Polar Care Wave unit, doing so may result
in product performance degradation.
• Using accessories or a power supply other than those provided could result in
increased electromagnetic emissions or decreased electromagnetic immunity
of the unit and can result in unit malfunction.
Disposal
This product contains electrical components and can not be discarded in standard waste.
Dispose of product according to local regulations.
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DISCHARGE REMINDERS FOR HEALTHCARE PROFESSIONALS
Follow these reminders prior to discharging the patient from facility care to home use.
1.
Patient Screen. Screen the patient for any contraindications and/or applicable warnings. If the
patient has any contraindications (see Contraindications), do not dispense Breg's Polar Care
Wave to the patient. If any of the warnings apply to the patient (see Warnings), determine the
appropriateness of application of Breg's Polar Care to that patient.
Instructions For Use. Instruct the patient on how to properly use Breg's Polar Care Wave. Review the
2.
Operating Instructions in this document and affixed to the unit with each patient.
3.
Prescription. Instruct the patient regarding the healthcare professional's prescribed protocol: frequency,
compression level, temperature level and duration of use, length of breaks between uses, how and
when to inspect the skin, and total length of treatment. A protocol template is included in this document
(see page 24) to fill in and provide to the patient. The duration of application, temperature and
compression level may vary depending upon the patient. If the patient does not experience pain relief,
the physician may increase the duration of application and/or adjust temperature and compression
levels. As the application duration is increased, the frequency of the skin inspections should increase
(see Warnings). Instruct the patient to take breaks by turning off the unit for a specified period of time.
Potential For Injury. Inform the patient that improper use can result in serious skin injury, including
4.
full thickness skin necrosis. Emphasize the importance of following the prescribed protocol, proper
cold compression pad application, and skin inspection.
5.
Proper Cold compression Pad Application. Instruct the patient to use only the Breg Polar Care Wave
cold compression pad designed for the body part being treated; other pads may not connect or may
be colder, increasing the risk of serious cold-induced injury, including full thickness skin necrosis. Do
not use the Polar Care Wave unit if skin checks are inhibited by a barrier.
Skin Inspection. Instruct the patient to inspect the skin receiving treatment per the practitioner's
6.
instructions, typically every 1 to 2 hours. Do not use the Polar Care Wave unit if skin checks are
inhibited by a barrier.
7.
Discontinue. Instruct the patient to stop using Breg Polar Care Wave and consult his/her healthcare
professional immediately if he/she experiences any adverse reactions, such as: increased pain,
burning, increased swelling, itching, blisters, increased redness, discoloration, welts, or other
changes in skin appearance.
8.
Documentation. Provide the patient 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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