X1 Mega Stainless Mirror Fig.4 - Helmut Zepf (24.071.22.) - Delynov
Product features
The X1 Miroir Méga Inoxydable Fig.4 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Intended use: Surgical instrument intended for oral, dental, periodontal, and implant surgery, used by trained practitioners in sterile environments.
- Reference: 24.071.22..
- Reserved for healthcare professionals. Read instructions carefully before use.
fabricant : HELMUT ZEPF Medizintechnik Gmbh , Obere Hauptstraße 16-22, D- 78606 Seitingen-Oberflacht BUT PRÉVU / INDICATION Les instruments sont utilisés en médecine/dentisterie pour l'inspection intra-orale
visuelle de zones qui ne peuvent pas être vues directement. Ici, ils sont utilisés pour le diagnostic. Les effets secondaires indésirables l'intolérance aux métaux chez le patient peut résulter d'un contact avec l'instrument, qui est en acier inoxydable médical une réaction d'hypersensibilité était toujours déclenchée devenir. la procédure doit être arrêtée si une telle réaction se produit et les mesures nécessaires sont prises en conséquence. consignes d'utilisation et de sécurité tous les instruments doivent être nettoyés avant d'être utilisés pour la première fois et compléter avant toute utilisation ultérieure nettoyé, désinfecté et stérilisé ! il est très important de nettoyer chaque produit avant utilisation dommages et usures visibles, par ex. b. fissures, cassures ou des défauts sur les arêtes de coupe. n'utilisez jamais de produits endommagés ou usés. les produits de helmut zepf medizintechnik gmbh sont livrés non stériles. les produits doivent être à l'avance nettoyé et stérilisé. la compatibilité aussi les autres produits doivent être vérifiés au préalable. retraitement en raison de la conception du produit, des matériaux utilisés et il ne peut y avoir de limite maximale définie pour l'utilisation prévue des cycles de traitement réalisables peuvent être déterminés.réservé aux professionnels de santé.
What is the X1 Mega Stainless Steel Mirror Fig.4 from Helmut Zepf?
The X1 Mega Stainless Steel Mirror Fig.4, referenced under code 24.071.22., is a diagnostic instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This medical device is manufactured from medical-grade stainless steel, ensuring robustness adapted to the requirements of dental instrumentation. Its structure is specifically designed to offer optimal visibility during clinical examinations. As a diagnostic instrument, it allows practitioners to visually access areas of the oral cavity that are difficult to reach. This mirror is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use, as well as between each patient, in accordance with the manufacturer's recommendations to ensure the safety of care.
What are the clinical indications for this diagnostic mirror?
Instruments such as the X1 Mega Stainless Steel mirror from Helmut Zepf are primarily indicated in dentistry for visual intra-oral inspection. Their intended purpose is to allow the examination of areas that cannot be seen directly by the healthcare professional. They constitute fundamental tools for clinical diagnosis, allowing the detection of pathologies, evaluation of tissue condition, or monitoring of surgical sites in oral surgery and implantology. The use of this instrument is strictly reserved for qualified healthcare professionals. Its use occurs in all phases where indirect vision is necessary to guarantee the precision of the medical gesture or the reliability of the diagnosis made during routine consultations or specialized interventions.
What are the technical characteristics of this instrument?
The X1 Mega Stainless Steel Mirror Fig.4 (reference 24.071.22.) is characterized by the use of high-quality medical stainless steel. Its design allows for repeated reprocessing without a defined maximum limit of cycles, provided that the integrity of the instrument is preserved. The manufacturer states that the service life depends on the product design and the materials used, but it is the practitioner's responsibility to check for the absence of visible damage before each use. This includes checking for cracks, breaks, or defects on the edges. Any product showing signs of wear or damage must be immediately discarded. Compatibility with other products and accessories must also be verified beforehand by the user to ensure safe operation during intra-oral inspection.
What are the contraindications for the use of this stainless steel instrument?
The main contraindication related to the use of the Helmut Zepf mirror concerns metal intolerance in the patient. Contact with the instrument, manufactured from medical stainless steel, can trigger a hypersensitivity reaction in sensitive subjects. The manufacturer warns that if such an adverse reaction occurs during the examination or procedure, the intervention must be stopped immediately. Necessary medical measures must then be taken accordingly to manage the patient's hypersensitivity. It is therefore recommended that practitioners question patients about their history of metal allergies before any use. Apart from this specific sensitivity, use is contraindicated if the instrument shows structural defects or if sterilization protocols have not been rigorously followed.
What are the maintenance and sterilization precautions?
The X1 Mega Stainless Steel mirror is a non-sterile device that requires a rigorous processing cycle before any use. Safety instructions stipulate that all instruments must be cleaned, disinfected, and sterilized before the first commissioning and after each subsequent use. It is crucial to perform a complete cleaning to remove all residue before sterilization. The practitioner must visually inspect the instrument for any cracks or breaks. Due to its stainless steel composition, there is no fixed limit of processing cycles, but the use of damaged or worn products is formally prohibited. Compliance with these reprocessing protocols is essential to maintain the diagnostic performance of the instrument and prevent the risks of cross-contamination in the dental office.
Who is the manufacturer and what standards are met by this device?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. In accordance with medical device regulations, this mirror is classified as Class I. The manufacturer ensures the instrument's compliance with safety and performance requirements for its intended use in dental diagnosis. Although specific CE marking is not detailed in the source data, belonging to Class I indicates compliance with European regulatory standards for non-invasive or temporary-use instruments. As a Helmut Zepf product, this instrument benefits from the expertise of a recognized manufacturer in the field of surgical and dental instrumentation, guaranteeing traceability and manufacturing quality consistent with medical profession standards.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs that minimize tissue trauma. Precision and reliability are top priorities.
Specifications
| Manufacturer | Helmut Zepf |
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