SIZING:
Begin by measuring the patient's circumference approximately 2.5 cm above the widest part of the hips. For patients whose circumference falls between two sizes, choose the orthosis which is larger. NOTE:It is not uncommon for the patient to experience post-surgical swelling followed by a weight loss of 10 to 20 pounds. The 631/637 brace is designed with two (2) removable belt wings that can be easily repositioned for optimal fit. (Figure G).
CONTRAINDICATIONS:
- Pregnancy and circulatory, pulmonary, cardiovascular or bones at risk of worsening due to displaced, unstable or compression and/or pressure fractures.
- Do not use if you are allergic to any of the materials contained in this product.
WARNINGS AND PRECAUTIONS:This product must be prescribed and adjusted by a healthcare professional. The medical professional must determine the frequency and duration of its use. If you experience pain, swelling, sensation changes, excessive color change, skin irritation, or any unusual reaction while using this product, consult your physician immediately. Discontinue use if you notice any distortion of the support panels, fraying, or deterioration of the snap cords. The artesis is designed to be worn over clothing. DO NOT expose to temperatures above 49°C during routine use. Panels can be heated, as directed, to change the shape of the panel. Do not heat the orthosis once it is on the body. Make sure the orthosis is not too hot before application. The orthosis should be sized appropriately for the patient to ensure adequate support and function. If the orthosis does not fit properly, it may be fitted by a healthcare professional, a person working under the supervision of a healthcare professional, or another person with specialized training in orthotic provision. Do not modify the device without the presence of a healthcare professional. Care should be taken with patients, especially the elderly, not to apply the brace too tightly as this COULD cause excessive pressure. Patients should be explained how proper voltage is applied during continued use of the device. The patient should consult a healthcare professional for replacement if a product quality problem occurs within the warranty period. The orthosis should not be exposed to moisturizing products, chemicals or solvents, as these may affect durability. Do not use a device other than those listed in these instructions for use. Keep the product out of the reach of children under three years of age to avoid accidental ingestion of small parts. It should not be applied to open wounds. Do not use the device if it is damaged and/or if the packaging is open NOTE: Contact the manufacturer and the competent authority in case of a serious incident arising due to the use of this device.
INSTRUCTIONS FOR USE
