Gima RIGID CERVICAL COLLAR 41-46 cm User guide

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PROFESSIONAL MEDICAL PRODUCTS
COLLARI COLLARS COLLIERS COLLARES COLARES
ΠΕΡΙΛΑΙΜΙΑ
ZERVIKALSTÜTZEN KRAGEN KRAGAR
È necessario segnalare qualsiasi incidente grave vericatosi 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 your registered ofce is located.
Il est nécessaire de signaler tout accident grave survenu et lié au dispositif médical que nous avons livré au fabricant et à l’autorité compétente de l’état membre où on a le siège social.
Es necesario informar al fabricante y a la autoridad competente del Estado miembro en el que se encuentra la sede sobre cualquier incidente grave que haya ocurrido en relación con el producto sanitario que le hemos suministrado.
É necessário noticar ao fabricante e às autoridades competentes do Estado-membro onde ele está sediado qualquer acidente grave vericado em relação ao dispositivo médico fornecido por nós.
Σε περίπτωση που διαπιστώσετε οποιοδήποτε σοβαρό περιστατικό σε σχέση με την ιατρική συσκευή που σας παρέχουμε θα πρέπει να το αναφέρετε στον κατασκευαστή και στην αρμόδια αρχή του κράτους μέλους στο οποίο βρίσκεστε.
Jeder schwere Unfall im Zusammenhang mit dem von uns gelieferten medizinischen Gerät muss unbedingt dem Her­steller und der zuständigen Behörde des Mitgliedsstaats, in dem das Gerät verwendet wird, gemeldet werden.
Alle ernstige ongelukken die zich in verband met het door ons geleverde medische hulpmiddel voordoen, moeten gemeld worden aan de fabrikant en aan de bevoegde instantie van de lidstaat waar u gevestigd bent.
Det är nödvändigt att meddela tillverkaren och de behöriga myndigheterna i den berörda medlemsstaten, om alla al­lvarliga olyckor som inträffat i samband med den medicintekniska utrustning som levererats av oss.
M34600-M-Rev.5-06.21
34600 - 34601 - 34602 - 34610 - 34612 - 34614
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Made in Italy
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FEATURES
First-aid collars GIMA are conceived to guarantee the utmost efciency, comfort and safety as far as support and correc­tion in rst-aid conditions concerns. They are also equipped with an anatomical chin rest and a Velcro fastener, which makes the patient be more comfortable with the correct regulation. The product or its components cannot be used for purposes different from the one specied in the present manual.
PRESCRIPTIONS
The collar GIMA can be used only upon medical prescription. Before starting the therapy, it is advisable to identify the most suitable collar to meet each individual requirement and in case of necessity to customise it by means of adjustments in compliance with the doctor’s instructions.
In presence of plagues and infectious states, apply to a doctor for a suitable treatment and ask for indications on
the product cleaning!
Do not use the product if it is damaged. Apply to your retailer.
Since the product is made of corrosion-proof materials suitable for the environmental conditions foreseen for its normal use, does not require special care, however it is necessary to store it in a closed place making sure that is protected from dust and dirt to assure its hygenic conditions. Moreover, it is recommended to store the product in a place which can be reached easily by the personnel in case of necessity.
USE
The device must be correctly positioned on both sides and the patient must feel completely comfortable; furthermore it must not be subject to modications of its external appearance as long as it is used. The device must be installed by the patient itself, no assistance is needed. In case the patient is not able to position the product by himself or herself, it is
necessary to train the person assisting him or her on the correct and safe use of the collar.
In case the patient shows signs of hyperpressure or discomfort due to the device stiffness, immediately remove it until the situation has been completely normalised. In case the subject himself or herself is not able to show such discomfort or undesirable effects deriving from the presence
of the collar, carry out periodical inspections to check the situation.
In case of allergic reactions due to the contact of the collar with the skin (reddening, swelling, oedema, skin irritation, itch­ing) or bacterial infections due to lack of hygiene, apply to the family doctor. In case the patient’s weight changes, it is necessary to change the collar size, apply to your doctor. The doctor must inform the patient about the device usage times based on the type of pathology. The success of the appli­cation depends upon the patient’s care to follow the doctor’s instructions and the continuous contacts with him.
MAINTENANCE
The product can be washed with cold or warm running water and neutral soap. Do not use aggressive chemical products (bleach, ammonia, solvents...), which could alter the functionality of the product.
Do not expose the product to excessive mechanical stresses to avoid altering its functionality.
Carry out periodical controls to make sure that the device has not suffered from modications, which could jeopardize its
functionality. The product life can vary according to the therapeutic application; to guarantee a longer life of the product it is recommend­ed to correctly use, maintain and periodically check it.
GIMA WARRANTY TERMS
The Gima 12-month standard B2B warranty applies.
ENGLISH
Product code Keep away from sunlight Consult instructions for use
Lot number Keep in a cool, dry place
Manufacturer
Medical Device compliant
with Regulation (EU) 2017/745
Caution: read instructions
(warnings) carefully
Medical Device
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