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with humidity 30/50% without deforming. With temperature higher then 33°C and with humidity ar 80%, the filament can be deformed and make the diagnosis less accurate. The filament was tested to determine the accuracy of bending to 10 grams and the deformation force has been recognized at +/- 10%. Substitute definitely the filament after 150/200 bendings. Hold the filament by exercising a moderate pressure perpendicular to the skin an use a smooth motion when testing. Hold the filament perpendicular to the skin and use a smooth motion when testing. Use a 3-step sequence that includes (1) touch the skin, (2) bend the filament, and (3) lift from the skin (See Figures 1- 3). Do not use rapid movement. The approach, skin contact, and departure of the filament should be approximately 1.5 seconds in duration. Ask the patient to respond “yes” when the filament is felt. If the patient does not respond when you touch a given point on the foot, continue on to another site. When you have completed the sequence, REPEAT on the area(s) where the patient did not indicate feeling the filament. Use the filament in a random sequence. MONOFILAMENTO MONOFILAMENT MONOFILAMENT EINZELFADEN MONOFILAMENTO MONO-FILAMENTO ΜΟΝΟΜΗΜΑΤΙΟ ‫ﺪﻴﺣﻮﻟﺍ ﻂﻴﺨﻟﺍ‬ È necessario segnalare qualsiasi incidente grave verificatosi in relazione al dispositivo medico da noi fornito al fabbricante e all’autorità competente dello Stato membro in cui si ha sede. All serious accidents concerning the medical device supplied by us must be reported to the manufacturer and competent authority of the member state where you registered office is located. Il est nécessaire de signaler tout accident grave survenu en relation avec le dispositif médical que nous fournissons au fabricant et à l’autorité compétente de l’État membre dans lequel il est basé. Es necesario notificar cualquier accidente grave que se produzca en relación con el producto sanitario suministrado por nosotros al fabricante y a la autoridad competente del Estado miembro en el que se encuentre. É necessário comunicar qualquer acidente grave que ocorra em relação ao dispositivo médico fornecido por nós ao fabricante e à autoridade competente do Estado-Membro em que está sediado. Jeder schwerwiegende Unfall im Zusammenhang mit dem von uns gelieferten Medizinprodukt ist dem Hersteller und der zuständigen Behörde des Mitgliedstaats, in dem es seinen Sitz hat, zu melden. Είναι απαραίτητο να αναφερθεί οποιοδήποτε σοβαρό ατύχημα που συνέβη σε σχέση με το ιατροτεχνολογικό προϊόν που παρέχεται από εμάς στον κατασκευαστή και στην αρμόδια αρχή του κράτους μέλους στο οποίο βασίζεται. ‫نم مدقملا يبطلا زاهجلاب قلعتي اميف عقي ريطخ ثداح يأ نع غالبإلا يرورضلا نم‬ ‫اهب دجوي يتلا وضعلا ةلودلا يف ةصتخملا ةطلسلاو ةعنصملا ةكرشلا ىلإ انلبق‬. Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy [email protected] - [email protected] www.gimaitaly.com Made in China LOSS OF PROTECTIVE SENSATION AT ANY ONE OF THE EIGHT SITES (shown on the diagram above) INDICATES A FOOT AT HIGH RISK. It is recommended to disinfect the product after each use on a patient by using a non-alcoholic antibacterial disinfectant. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies. ENGLISH MONOFILAMENT Show the filament to the patient and touch it to his/her hand or arm so that he/she knows it does not hurt. Use the 10 gram filament to test sensation at the indicated sites on each foot as shown. Apply the filament along the perimeter of, and NOT directly on, an ulcer, callus, scar or necrotic tissue. The monofilament is an instrument for a preliminary diagnosis of sensory neuropathy which can be caused, for example, by diabetes. The foot is one of the parts of the body which are affected by the damage caused by neuropathy as the peripheral sensory perception is compromised; the monofilament can detect a patient’s ability to perceive moderate pressures. The MONOFILAMENT bends at a pressure of 10 grams for at least 50/60 times before bending to a lower force; it is recommended to change the wire after the use on 6/15 patients and allowed to rest for at least 24 hours before being reused. It can work optimally at a temperature of 20/26°C M31282-M-Rev.6-05/21