Medical Notes
Indications:
Treatment and prophylaxis of:
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Epicondylitis humeri radialis ("tennis elbow", epicondylitis lateralis / exterior epicondyle)
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Epicondylitis humeri ulnaris ("golfer's elbow", medial epicondylitis / inner epicondyle)
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Targeted groups of patients:
This product is developed for patients suffering from epicondylitis humeri radialis and/or epicondylitis humeri ulnaris, for aftercare, as well as for prophylaxis at activities straining the affected area.
Contraindications:
The product is not intended for use, or may only be applied after consultation with the doctor at:
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Allergies and / or material incompatibility
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Injured, irritated or damaged skin (within the affected area)
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Sensation and / or circulatory disorders of the hand
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In case of paralysis (for example hemiparesis), oedemas, swellings
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Acute fractures in the area of effect (on or near the elbow, forearm)
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Impaired lymph drainage - including soft tissue swelling of uncertain origin located outside of the area of effect
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The Masalo Cuff develops strong physical forces, which is why this product may only be used on children and young people under medical supervision
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Side effects:
Even if used properly, on the skin may temporarily occur bruising or redness under heavy load of the arm.
Other side effects are not known.
If unexpected additional pain or allergic reactions occur, please consult your doctor immediately.
We must inform you, that any seriuous incident that has occured in relation to the device, which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health should be reported to us and the competent authority of the member state in which you are established.
Exclusion of liability:
Please use the cuff only after consulting your physician. Usage without prior consent is your own sole responsibility.
Any liability for normal wear and tear is excluded. Compensation claims of every kind are excluded. The liability according to the product liability law is not restricted by the above mentioned statements.
Legal marks:
The Masalo Cuff is a medical device regarding regulation 2017/745/EU
State: 09/2023
CE-certificate: yes
Material:
65% polyester, 26% nylon, 6% viscose, 2% elasthane, 1% cotton