Safescraper Twist Curve - Sterile Cortical Bone Scraper - Meta - Set of 3 - 3987
The Safescraper Twist Curve - Gratteur d'os cortical stérile - Meta - Lot de 3 - 3987 is a medical device manufactured by Meta Technologies S.R.L. — Class IIa, CE marking CE0123.
- Compliance: Medical device Class IIa, CE marking CE0123.
- Manufacturer: Meta Technologies S.R.L..
- Reserved for healthcare professionals. Read instructions carefully before use.
Fabricant : META TECHNOLOGIES S.R.L. Via E. Villa n.7, 42124 Reggio Emilia (RE) – Italy phone +39 0522 502311 - Usage prévu : Destination (usage prévu) : dispositif destiné au prélèvement, au prélèvement et à la libération d'os autologue dans des applications régénératives en chirurgie buccale. - Lire attentivement la notice. Avertissement et précautions : Dispositif médical STÉRILE pour la stérilisation à l'EtO.
L'appareil est JETABLE.
L'appareil ne peut pas être nettoyé, restérilisé et réutilisé.
La réutilisation du dispositif pourrait entraîner des risques de contamination croisée, d'infection pour le patient et compromettre le succès de la chirurgie de régénération osseuse, perte de capacité de coupe due à l'usure des lames.
Avant utilisation, assurez-vous que l'emballage est intact.
N'utilisez pas le produit si l'emballage est endommagé.
Si l'emballage stérile n'est pas intact ou est endommagé, ou s'il est involontairement ouvert avant utilisation, le produit doit être éliminé et remplacé par un nouveau dispositif conforme avec un emballage stérile intact et en bon état.
Présence d'une « invitation » sur le blister qui permet une ouverture en toute sécurité.
L'appareil ne peut être utilisé que par des chirurgiens spécialisés en dentisterie.
L'utilisation du dispositif dans des conditions d'hygiène inappropriées peut provoquer la transmission de maladies infectieuses au patient, des infections au niveau du site d'implantation et l'échec de la chirurgie de régénération osseuse.
Le chirurgien doit établir l’aptitude du patient aux opérations de régénération osseuse et la séquence chirurgicale appropriée.
Utilisez toujours des gants stériles et respectez des procédures strictes pour garantir la stérilité lors de la manipulation de l'appareil. Le chirurgien doit prendre toutes les précautions nécessaires pour prévenir les risques d’infection et de complications liés à la greffe osseuse.
Présence d'arêtes coupantes. Assurez-vous de ne pas couper les gants stériles avec l’extrémité pointue de l’outil.
Après utilisation, éliminer dans des conteneurs spéciaux pour déchets médicaux conformément aux décrets en vigueur qui réglementent la matière.
La date de péremption figure sur l'étiquette avec le symbole requis par la norme ISO 15223-1.
À la fin de ce manuel se trouve une légende avec une explication de la signification des symboles indiqués par le fabricant dans le manuel d'utilisation et sur l'étiquette.
Lors de l'utilisation de l'appareil, il est recommandé (précaution d'emploi) :
Porter des gants de protection stériles
Pour utiliser une protection oculaire
Pour utiliser un masque
Porter des vêtements de protection – Dispositif médical - Réservé aux professionnels de santé.
What is the Safescraper Twist Curve from Meta?
The Safescraper Twist Curve, designed by Meta Technologies S.R.L., is a sterile cortical bone scraper specifically developed for oral surgery. This medical device, offered in packs of 3 units under reference 3987, acts as a high-performance autologous bone collector. Its ergonomic and curved design facilitates access to difficult harvesting sites. As a precision bone harvester, it allows for the collection of high-quality bone chips while preserving cell viability. This device is essential for practitioners performing osteosynthesis and reconstruction procedures requiring an autogenous bone supply. It is delivered in sterile packaging ensuring optimal safety during its introduction into the surgical field.
What are the clinical indications for this bone collector?
The clinical indications for the Safescraper Twist Curve from the Meta brand primarily concern regenerative applications in oral surgery. This device is intended for the harvesting and release of autologous bone, considered the "gold standard" for bone regeneration. It is particularly recommended during implantology surgeries, sinus lifts, or the correction of periodontal defects. The surgeon uses this device to collect bone directly from the patient, thus avoiding systematic recourse to synthetic bone substitutes. It is the responsibility of the surgeon specialized in dentistry to establish the patient's suitability for such regeneration operations and to define the most appropriate surgical sequence to ensure the success of the graft.
What are the technical characteristics of the Safescraper Twist Curve 3987?
The Safescraper Twist Curve is distinguished by its curved shape which optimizes the surgical gesture during cortical harvesting. This device is a disposable instrument, delivered sterile (EtO sterilization). Its structure integrates precise cutting blades allowing for the efficient collection of autologous bone chips. The packaging in packs of 3 allows for stock management adapted to the needs of oral surgery practices. The product features an "invitation" on the blister pack, a technical feature facilitating a secure and aseptic opening. It is imperative to check the integrity of the packaging before use, as any damage compromises the sterility of the device. This equipment is strictly reserved for use by specialized surgeons, respecting rigorous hygiene protocols.
What are the contraindications for the use of this device?
Contraindications include the use of the device in inappropriate hygiene conditions, which could cause the transmission of infectious diseases or the failure of bone regeneration surgery. The Safescraper Twist from Meta must not be used if the sterile packaging is damaged, unintentionally opened, or not intact before the procedure. In such cases, the product must be discarded and replaced. Furthermore, use by unqualified personnel or those not specialized in dentistry is prohibited. The surgeon must evaluate systemic or local contraindications specific to the patient that could compromise bone healing or the success of the autologous graft before proceeding with harvesting with this bone collector.
What are the precautions for use and the risks related to reuse?
The Safescraper Twist Curve is a single-use (disposable) device. It is strictly forbidden to clean, resterilize, or reuse it. Reusing this Meta bone harvester would lead to major risks of cross-contamination and infection for the patient. On a technical level, a second use would compromise the success of the surgery due to the loss of cutting capacity related to blade wear. During handling, the practitioner must imperatively wear sterile gloves and respect strict aseptic procedures. Any breach in the sterile chain can lead to infections at the implantation site. In case of doubt regarding sterility after an accidental opening, the device must be replaced by a new, compliant one.
Who is the manufacturer and what standards are met by this product?
The Safescraper Twist Curve is manufactured by Meta Technologies S.R.L., located in Reggio Emilia, Italy. This medical device is classified as Class IIa according to current regulations. It bears the CE0123 marking, certifying its compliance with European safety and performance requirements. As the official manufacturer, Meta Technologies S.R.L. guarantees that each lot of 3987 respects ethylene oxide (EtO) sterilization standards. Healthcare professionals are invited to carefully read the instructions for use provided by the manufacturer before any intervention. Compliance with these standards and classifications ensures dental surgeons a reliable piece of equipment for their autologous bone harvesting procedures in complete safety.
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