Cheek Retractor Helmut Zepf (37.445.01) - Delynov
The Écarteur des joues Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 37.445.01.
- 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 cheek retractor (37.445.01)?
The Helmut Zepf cheek retractor, reference number 37.445.01, is a high-precision manual dental instrument designed to facilitate access to the surgical field during oral procedures. Manufactured from premium quality medical stainless steel, this device guarantees optimal robustness and durability for repeated use in dental practices or hospital environments. As a Class I instrument, it meets the regulatory requirements for non-invasive medical devices. Its ergonomic design allows for effective retraction of soft tissues, thereby providing increased visibility to the practitioner while ensuring the relative comfort of the patient during the surgical procedure or clinical examination.
What are the clinical indications for this Helmut Zepf instrument?
This manual dental instrument is specifically indicated for oral surgery, implantology, and general dentistry procedures requiring clear exposure of the dental arches. The intended use by the manufacturer Helmut Zepf Medizintechnik GmbH is the retraction of cheeks and lips to clear the working area. Its use is reserved exclusively for qualified healthcare professionals. It is particularly useful during implant placement, periodontal surgeries, or complex extractions where maintaining soft tissue retraction is crucial for the safety of the surgical act. The practitioner must ensure the compatibility of this retractor with other products used during the intervention.
What are the technical characteristics of the 37.445.01 retractor?
The Helmut Zepf retractor (37.445.01) is distinguished by its medical stainless steel construction, a material chosen for its corrosion resistance and biocompatibility. This device is delivered non-sterile by Helmut Zepf Medizintechnik GmbH, which requires a strict processing protocol before the first use. Due to its robust design and the materials used, there is no defined maximum limit for processing cycles (cleaning, disinfection, and sterilization), subject to a prior visual inspection. The instrument must be free of visible damage such as cracks, breaks, or defects on the edges before any clinical handling.
What are the contraindications for the use of this dental retractor?
The main contraindication for the use of this instrument is known hypersensitivity or intolerance to metals in the patient. Since the retractor is designed in medical stainless steel, prolonged contact may trigger an allergic reaction in sensitive subjects. The manufacturer specifies that if such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken accordingly. Furthermore, it is strictly forbidden to use the instrument if it shows visible signs of wear, cracks, or structural defects that could compromise patient safety or soft tissue integrity.
What are the maintenance and sterilization precautions?
Like any reusable Class I instrument, the Helmut Zepf retractor must follow a complete reprocessing cycle. It is imperative to clean, disinfect, and sterilize the instrument before its first use, as well as before each subsequent use. Cleaning is a critical step to remove any biological residue. The practitioner must carefully inspect the tool for any wear or damage before use. The use of damaged or worn products is prohibited. Although the number of cycles is not limited by a fixed value, the end of the product's life is determined by the appearance of physical degradation. Compliance with these safety instructions guarantees the longevity of the instrument and aseptic safety.
Who is the manufacturer and what standards are respected?
The retractor is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer emphasizes that its products are intended exclusively for healthcare professionals. Each instrument is designed according to rigorous standards to meet the needs of manual dental instrumentation. Although specific CE marking is not detailed in the provided source data, compliance with safety and performance requirements for medical stainless steel instruments is ensured by Helmut Zepf's manufacturing protocols. Traceability is maintained via the product reference 37.445.01.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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