Patienteninformation. Patient Information

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1 Patienteninformation Patient Information DE Druckdatum: Der Inhalt dieser Patienteninformation wird regelmäßig aktualisiert und ist beim Einsatz des Produktes unbedingt zu beachten. Weitere Informationen zu diesem Produkt finden Sie unter: Seite 2 GB Date printed: This patient information is regularly updated and should be strictly followed. You will find further information at: Page 7

2 GB Table of Contents 1. Declaration of Conformity 8 2. Warranty 8 3. Application 8 4. Safety Instructions Classification of the Safety Instructions Structure of the Safety Instructions Overview of all Safety Instructions for S1 Ankle Joint Orthosis 9 5. Shoe Recommendation Donning and Taking Off the S1 Ankle Joint Orthosis Cleaning 11 Page 7

3 Dear Patient, You have received from your orthopaedic technician a preproduced S1 ankle joint orthosis. 1. Declaration of Conformity We declare that our medical devices as well as our accessories for medical devices are in conformity with the requirements of the Medical Devices Directive 93/42/EEC. Regarding to these tests, FIOR & GENTZ products have the CE marking. 2. Warranty The warranty applies only if the product has been used under the described conditions and for the intended applications. Furthermore, we do not accept a multi-use of the product. 3. Application The S1 ankle joint orthosis is exclusively for use for orthotic fittings of the foot. 4. Safety Instructions In order that your orthosis works in the best way, you can handle it correctly and you can use it as long as possible, please note all information provided in this patient information, especially the safety instructions indicated by ATTENTION! WARNING! and DANGER! which are listed and explained in the following paragraph. Ignoring this information may lead to injuries and property damage. 4.1 Classification of the Safety Instructions DANGER! leads to death or irreversible injuries. WARNING! leads to reversible injuries that need medical treatment. leads to light injuries that do not need medical treatment. ATTENTION! leads to damage of the product. 8

4 4.2 Structure of the Safety Instructions The following example demonstrates the structure of the safety instructions: Attention symbol Signal word ATTENTION! Type of danger Possible consequences for components Possible consequences for you Measures Mechanical load is too high! Wear of the joint parts. Maintenance intervals shorten. Let your orthopaedic technician inform you about maintenance intervals and respect them. 4.3 Overview of all Safety Instructions for S1 Ankle Joint Orthosis Respect the following safety instructions to avoid injuries and property damage: WARNING! Orthosis is donned incorrectly! Pressure points and probable loss of fixing function. Don the orthosis as described in the manual. Orthosis is not cleaned after wearing it in salt water! Corrosion of rivet joints. Skin irritations and impairment of wound healing. After wearing the S1 in salt water, rinse it with clear water. Orthosis is worn directly on the skin! Skin irritations and impairment of wound healing. Do not wear the orthosis directly on your skin and never wear it on any injured skin. 9

5 5. Shoe Recommendation We recommend to wear the S1 with the FLENSBURG shoe. It enables a comfortable walking with the orthosis due to its rocker bottom sole (fig. 1) as well as an easy donning due to hook and loop fasteners (fig. 2). 6. Donning and Taking Off the S1 Ankle Joint Orthosis Fig. 1 Fig. 2 Check the orthosis for any defects before every donning. If you cannot use the orthosis properly, contact your orthopaedic technician. WARNING! Orthosis is donned incorrectly! Pressure points and probable loss of fixing function. Don the orthosis as described in the manual. Orthosis is worn directly on the skin! Skin irritations and impairment of wound healing. Do not wear the orthosis directly on your skin and never wear it on any injured skin. 1. Unless your foot is not protected by a bandage, always wear socks under the S1. 2. The S1 is donned when seated. When donning the orthosis, make sure that you pull in the heel to the very back: - Correct position of the heel (fig. 3) - Incorrect position of the heel (fig. 4) 3. Close the four hook and loop fasteners as follows: - upper front hook and loop fastener (fig. 5) - lower front hook and loop fastener (fig. 6) - upper back hook and loop fastener (fig. 7) - lower back hook and loop fastener (fig. 8) Fig. 3 Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig The hook and loop fasteners have to be tight fitted but they must not apply pressure to the muscles and soft parts. 5. To take off the S1 you simply have to open the front hook and loop fasteners. 10

6 7. Cleaning Orthosis is not cleaned after wearing it in salt water! Corrosion of rivet joints. Skin irritations and impairment of wound healing. After wearing the S1 in salt water, rinse it with clear water. The durability of the S1 ankle joint orthosis requires a proper handling. Clean the welt and the hook and loop fasteners regularly with a gentle detergent. After wearing the S1 in salt water, rinse it with clear water. 11

7 Ihre Orthopädie-Werkstatt (Stempel): Orthotic provider (stamp): Votre atelier d orthopédie (cachet) : Laboratorio ortopédico (sello): Der Qualitätsstandard der Firma FIOR & GENTZ ist durch eine unabhängige Zertifizierungsgesellschaft nach den internationalen Normen ISO 9001 und ISO geprüft und bescheinigt worden. The quality standard of the FIOR & GENTZ company has been controlled and certified by an independent certification organisation according to the international standards ISO 9001 and ISO FIOR & GENTZ Gesellschaft für Entwicklung und Vertrieb von orthopädietechnischen Systemen mbh Dorette-von-Stern-Straße 5 D Lüneburg +49(0) (0) info@fior-gentz.de PB1000-SO/1D-12/2013