Amoena Custom 300 Instrucciones De Uso página 7

DE
Gefahrenhinweis
Bitte von Kindern fernhalten. Das Produkt kann Kleinteile wie Adapter oder Ventile
enthalten. Beim Verschlucken dieser Teile besteht Erstickungsgefahr.
Besondere Hinweise
Seite 46
Entsorgungshinweis
Entsorgen Sie die Produkte in den haushaltsüblichen Müll.
Meldepflicht
Im Falle von Reklamationen im Zusammenhang mit dem Produkt, wenden Sie sich bitte direkt an
Ihren medizinischen Fachhändler. Nur schwerwiegende Vorkommnisse, die zu einer wesentlichen
Verschlechterung des Gesundheitszustandes oder zum Tod führen können, sind dem Hersteller und
der zuständigen Behörde des Mitgliedsstaates zu melden.
Schwerwiegende Vorkommnisse sind im Artikel 2 Nr. 65 der Verordnung (EU) 2017/745
(MDR) definiert.
Gewährleistung
Es gilt die gesetzliche Gewährleistungspflicht.
Servicehinweis
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Thank you for choosing a quality product from Amoena Medizin-Orthopädie-Technik GmbH . For
more than 45 years, Amoena has been synonymous with innovative and high-quality products that
support the needs of women following breast surgery .
Intended Purpose/Indication
Target group: Women after various breast surgeries.
Breast forms are required after partial or complete removal of the breast after breast cancer or other
diseases and in the case of breast malformation or degeneration. As well as providing a balanced look,
the breast form is designed to maintain the symmetry of the body (preventing shoulder misalign-
ment) by ensuring the breast form is the appropriate weight, and to simulate the movement of the
natural breast. Breast forms and shapers should only be worn after the scars have healed completely.
Custom breast forms are required for the definitive restoration due to anatomically or structurally
necessary individual adaptation and with the need to relieve the skin or scar area against pressure
and tensile forces. The Amoena Custom is individually designed and manufactured according the
individual needs of each patient. Breast forms and breast shapers should only be worn once the scar
area has fully healed. Medical indications for the custom breast form are:
• Structural damage with loss of substance of the mammary gland after surgery or radiation in case
of tumor diseases (e.g. after breast removal, partial removal or radiation fibrosis)
• Structural damage with loss of substance of the mammary gland after surgery for other diseases
such as phlegmon, abscesses (e.g. after partial or complete removal of the breast)
• Congenital structural damage with asymmetry of the breasts such as the Poland syndrome
Asymmetric breast prostheses are indicated if anatomical or structural conditions require
asymmetrical care.
Contraindications/risks/side effects
No contraindications or risks are known or expected when using the above mentioned products. In
rare cases allergic reactions may occur. A contraindication exists if there is a known allergy to one of
the components that may come into contact with the skin.
Material composition
Custom: Polyurethane film, polydimethylsiloxane, silicone oil
Also, depending on the product feature: lightweight microspheres, temperature regulating material
(PCM Phase Change Material), additives and color pigments
General instructions for use
• We recommend wearing the breast forms in the pocket of a well-fitting specialist bra. Shapers
can also be worn directly against the skin in a well-fitting non-pocketed bra. Custom Contact +++
ENG
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