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n – Medical Device – Instructions for Use
Intended use:
Application of cold or heat therapy to affected area.
Intended user: lay person and healthcare professional
Indications: All conditions where hot therapy helps muscles to relax by
promoting blood flow, or cold therapy to decrease swelling by reducing
blood flow. Alternating heat and cold may help reduce exercise-induced
muscle pain.
Contra-indications for hot or cold therapy: Individuals who are sensitive
to temperature extremes, such as those with cardiovascular problems
(e.g. deep vein thrombosis, raynaud’s disease), diabetes, nerve dam
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age, paralysis, skin irritation. If skin is broken, treat wound and apply
(sterile) bandage to the injury before using.
Precautions & Warnings:
Consult a healthcare professional before use.
Do not open the pack. Do not puncture the pack and/or ingest content.
If contents come into contact with eyes or skin: flush with water and
contact a healthcare professional. Never sit, lay or lean against the
pack. Do not fall asleep while using the pack. Do not use along with
sports creams, balms or lotions. Do not apply on sensitive skin are
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as. Always check to make sure pack is not too hot or too cold before
applying. Use the Pack in a soft cloth or over clothing to avoid direct
skin contact; for Soft Touch and Pearl Pack this is not mandatory but
highly recommended. Apply for maximum 20 minutes. Wait at least
20 minutes before re-applying. An overheated pack may cause injury.
Overheating may cause the pack to rupture. Do not use on infants.
How to use:
Reusable. For external use only. For heating times: see
table. Test the product on the body for 2 minutes. If a hotter Pack is
desired, microwave it in (B) seconds increments until the optimum tem
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perature is reached. DO NOT EXCEED THE TOTAL HEATING TIME
INDICATED (C). Do not use in hydrocollator. For freezing times: see
table. For longer product life: use for Hot or Cold, not for both. When
placing the Pack in the freezer, lay it flat, not folded.
Report any serious incident (death, serious deterioration of health,
serious public health threat) to the Manufacturer and your Competent
Authority.
fr – Dispositif médical – Notice d’utilisation
Destination:
Application de la thérapie au froid ou à la chaleur à la zone
touchée. Utilisateur destiné: Profane et professionnel de la santé.
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