Product features:

EpiPoint elbow brace
Pain-relieving epicondylitis brace for irritated tendon insertions

Intended purpose:
EpiPoint is a medical device. It is an orthosis for the targeted relief of tendon insertions at the elbow.

Indications:

• Epicondylitis lateralis humeri (inflammation of the muscle origin, tennis elbow)
• Medial epicondylitis of the humerus (inflammation of the muscle origin, golfer's and pitcher's elbow)
• Prevention/Relapse prevention

Application risks:

• EpiPoint is a prescription product. If it has been prescribed to you by a doctor, be sure to discuss its use and duration of treatment with them. In any case, instruction from the healthcare professional who provided you with the product is required.
• If your symptoms worsen or you notice any unusual changes in yourself, please consult your doctor immediately.
• Product liability is excluded in the event of improper or unintended use.
• The EpiPoint device must not be modified without authorization.
• If you experience any defects in the product or wear and tear on individual parts, please contact your specialist retailer.
• Do not allow the product to come into contact with greasy and acidic agents, ointments, and lotions.
• The product is most effective during physical activity. It should be removed during extended periods of rest (e.g., sleeping, prolonged sitting).

Contains natural rubber latex (elastodiene), which may cause skin irritation in cases of hypersensitivity. Remove the brace if you experience any allergic reactions.

Contraindications:
Systemic side effects are not currently known. Proper use/application is required. All externally applied aids – bandages and orthoses – can, if applied too tightly, cause local pressure sores or, in rare cases, constrict blood vessels or nerves. Hypersensitivity reactions of clinical significance are not currently known. In the following conditions, the application and wearing of such an aid is only recommended after consulting your doctor:

• Skin diseases/&ndash%%%injuries in the treated area of ​​the body, especially in cases of inflammation%%% as well as raised scars with swelling, redness and increased warmth.
• Sensory and circulatory disorders of the forearm and hand.
• Lymphatic drainage disorders – also unclear soft tissue swellings distant from the applied aid.
• Entrapment syndromes (pressure irritation of nerves in the arm).

Instructions for use:
Putting on the EpiPoint:
Open the strap and position the EpiPoint brace on your forearm so that the five-point pad rests directly on the muscle belly (laterally for tennis elbow) or on the inside (medially) for golfer's elbow. The firmer part of the brace should always be on the outside. Position the pad approximately 4-6 cm below the elbow. To secure the brace, place your forearm on a firm surface (table, etc.) and tighten the Velcro fastener. Please avoid overtightening! A red indicator will illuminate if the pressure is too high; the brace must then be loosened immediately.

Cleaning instructions:
Please refer to the care instructions on the sewn-in label in your EpiPoint. We recommend hand-washing your EpiPoint separately at 30°C with a mild detergent. To ensure the longevity of the hook-and-loop fasteners and prevent damage, we recommend closing them before washing. Do not expose to direct heat (e.g., radiators, sunlight, etc.) while drying. We have tested this product as part of our integrated quality management system. However, should you have any concerns, please contact your local sales representative.

Location:
According to the indications (elbow). See intended use.

Maintenance instructions:
With proper handling and care, the product is virtually maintenance-free.

Instructions for reuse:
The EpiPoint is solely for your care.

Warranty:
The legal regulations of the country in which the product was purchased apply. Where applicable, country-specific warranty rules apply between the retailer and the purchaser. If you suspect a warranty claim, please contact the person from whom you purchased the product directly first. Please do not make any modifications to the product yourself. This applies in particular to individual adjustments made by qualified personnel. Please follow our instructions for use and care. These are based on our many years of experience and ensure the long-term functionality of our medically effective products. Only optimally functioning aids can provide you with the best possible support. Furthermore, failure to follow these instructions may limit the warranty.

Reporting obligation:
Due to regional legal regulations, you are obliged to report any serious incident occurring during the use of this medical device immediately to both the manufacturer and the BfArM (Federal Institute for Drugs and Medical Devices).

Disposal:
You can dispose of the product in accordance with national legal regulations.

This patient information leaflet was last revised in August 2019.

Source: Information from the package insert
As of November 2021