100 mm Rule - Helmut Zepf (48.286.08)
The Règle de 100 mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 48.286.08.
- 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 Instrument dentaire manuel 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 Helmut Zepf 100 mm ruler (48.286.08)?
The Helmut Zepf 100 mm ruler, referenced under code 48.286.08, is a high-precision manual dental instrument designed for intra-oral or instrumental measurements. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this CONSO category ruler is part of the range of essential measuring devices in dental surgery and implantology. Its robust structure guarantees excellent durability, although the manufacturer specifies that no maximum limit for processing cycles can be defined due to the quality of the materials used. This device is classified as a Class I instrument, meeting regulatory requirements for non-invasive medical devices used by healthcare professionals.
What are the clinical indications for this dental instrument?
The main indication for this Helmut Zepf instrument is its use as a manual dental instrument for precise measurement during clinical procedures. Its use is strictly reserved for qualified healthcare professionals. It is particularly useful for verifying dimensions, depths, or spacings during oral surgeries or implant planning phases. The manufacturer emphasizes the importance of verifying the compatibility of this instrument with other products used during the intervention. Before any clinical application, it is imperative to ensure that the instrument has undergone a full cycle of cleaning, disinfection, and sterilization, in accordance with the protocols in force in dental offices and surgical centers.
What are the technical characteristics of the 48.286.08 ruler?
The Helmut Zepf ruler (reference 48.286.08) is characterized by a total length of 100 mm, offering a measurement range adapted to the constraints of the oral environment. Its medical stainless steel composition provides optimal resistance to corrosion and thermal reprocessing cycles. As a Class I device, it is delivered non-sterile by Helmut Zepf Medizintechnik GmbH. The instrument must undergo a rigorous visual inspection before each use to detect potential damage, such as cracks, breaks, or defects on the edges. The use of damaged products or those showing visible wear is strictly prohibited to guarantee patient safety and measurement precision.
What are the contraindications for the use of this stainless steel instrument?
The main contraindication related to the use of this Helmut Zepf instrument concerns metal intolerance. Contact with medical stainless steel can cause undesirable side effects in patients with a known hypersensitivity to this material. If a hypersensitivity reaction is triggered during the surgical procedure, the procedure must be immediately interrupted and the necessary medical measures must be taken. It is therefore recommended to question the patient about their history of metal allergies before any intervention. Furthermore, use is contraindicated if the instrument shows signs of wear, cracks, or structural damage compromising its integrity or measurement precision.
What are the maintenance and sterilization precautions?
The Helmut Zepf 100 mm ruler requires a strict maintenance protocol. All instruments must be cleaned, disinfected, and sterilized before the very first use, as well as before each subsequent use. The manufacturer, Helmut Zepf Medizintechnik GmbH, insists that thorough cleaning is a critical step before sterilization. Given the design and materials used, there is no defined maximum limit for the number of achievable processing cycles, but the user must systematically check for the absence of defects on the cutting edges or the metal surface. Any worn or damaged product must be immediately removed from the use circuit to prevent any clinical risk.
Who is the manufacturer and what standards are respected by this device?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. It is a Class I instrument compliant with medical device regulations (MDR). Products are delivered non-sterile and their reprocessing is the responsibility of the healthcare professional. The manufacturer guarantees the use of high-quality medical stainless steel for the design of its manual instruments. Compliance with safety and performance requirements is ensured by following the instructions for use provided by Helmut Zepf, including the mandatory cleaning and sterilization steps before each surgical procedure. This device is exclusively intended for professional use in a dental environment.
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Specifications
| Manufacturer | Helmut Zepf |
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