Polar Electro Active Ice - CAUTIONS AND WARNINGS; Contraindications; Risk Factors for Cold-Induced Injury

CAUTION: To reduce the risk of adverse reactions and malfunction, the Active Ice® System
must be used in accordance with all instructions. Read and follow ALL included
instructions.
Use only under the direction and supervision of a licensed healthcare practitioner.
Patients first need to be assessed by and discuss treatment with their physicians for
contraindications, risk factors, and medical history before using this product. If used
improperly, use of the Active Ice® System could result in serious injury. Supervision may be
necessary to ensure precautions are followed, especially with young children and the elderly.
Adhere strictly to your doctor’s instructions regarding use, treatment times, treatment
frequency, settings, self-assessment and best practices regarding your specific condition.
Contraindications – The Polar Active Ice® System should not be used on patients with the
following conditions, including but not limited to:
• History of cold injury, frostbite, or adverse reactions to cold application
• History of injury or adverse reactions to treatment
• Special care monitoring must be provided for children, patients on prolonged therapy,
unconscious or incapacitated patients, patients with diabetes, and those with poor circulation
• Application areas with compromised local circulation
• Potential wound healing problems, including those from multiple surgical procedures
• Circulatory syndromes such as 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
• Unconsciousness or incoherence due to any reason.
• Polyneuropathy or other nerve damage
Risk Factors for Cold-Induced Injury – Including but not limited to:
• Pathological sensitivity to cold
• Young children and the elderly
• Behaviors that negatively affect circulation, such as poor nutritional habits, using tobacco,
caffeine abuse, and alcohol abuse
• Cognitive impairment and use of medications that negatively impact mental capacity
• Patients with diabetes
• Application area desensitization due to local anesthesia or regional nerve blocks
• Medications that have a negative effect on peripheral vascular circulation: beta adrenergic
blockers and localized epinephrine
• Excessive moisture at the application site
• Hand/wrist or feet/ankle surgery
• Communication barriers that would cause improper use of the system
9
CAUTIONS AND WARNINGS