Trephine RAL - JOTA (229RF.RAL.080) - Delynov- Delynov - Quantity: 1

What is the RAL 229RF.RAL.080 trephine?

The RAL trephine, referenced under code 229RF.RAL.080 by the JOTA brand, is a rotary cutting instrument intended for bone surgery. This Class IIa medical device consists of a metallic structure designed for bone core harvesting or circular drilling. As a trephine bur, it is delivered non-sterile and requires a complete processing protocol before its first use. The manufacturer JOTA AG specifies that these instruments are reusable, subject to rigorous inspection by the practitioner. Its design allows for precise penetration into mineralized tissues for implantology or oral reconstructive surgery needs.

What are the clinical indications for this dental surgery trephine?

The intended use of this dental surgery trephine primarily concerns interventions requiring circular excision of bone. It is indicated for autogenous bone harvesting, the creation of specific implant sites, or the extraction of bone fragments. According to JOTA AG manufacturer guidelines, the instrument is classified as semi-critical. Its clinical application is strictly reserved for experts and physicians who must evaluate the instrument's condition before each procedure. The trephine is a key tool for dental surgeons performing bone grafts or explantations, ensuring a clean cut thanks to its geometry optimized for hard tissues.

What are the technical characteristics of the JOTA trephine?

The RAL trephine (229RF.RAL.080) from the JOTA brand meets the requirements of the CE0483 marking. It is manufactured from metallic materials resistant to repeated sterilization cycles. Technical specifications impose rigorous maintenance: cleaning can be performed by ultrasound with non-foaming agents, strictly respecting the concentrations and temperatures recommended by the detergent manufacturer. The use of demineralized or low-contamination sterile water (max. 10 germs/ml) is required for rinsing. Its durability depends directly on the absence of excessive stress and compliance with validated reprocessing parameters to maintain its initial cutting performance.

What are the contraindications for the use of this device?

The major contraindications lie in the use of an instrument showing signs of wear, corrosion, or potential breakage. The manufacturer JOTA AG emphasizes that the physician is solely responsible for the decision to reuse the product. In case of doubt regarding the integrity of the trephine bur, it is imperative to dispose of it prematurely to avoid any risk of failure. Furthermore, use is prohibited if validated sterilization and disinfection conditions cannot be guaranteed, or if the specific product labeling contains contradictory information regarding its reuse.

What are the precautions related to reuse and maintenance?

The JOTA brand trephine is reusable, but its longevity depends on the practitioner's expertise. Effective cleaning and disinfection are indispensable conditions for successful sterilization. It is crucial to use maintenance devices (washer-disinfector, sterilizer) that are regularly monitored. The manufacturer recommends avoiding any contamination and using only freshly prepared solutions. Material resistance must be checked against the detergents used. If the instrument shows signs of fatigue or if its cutting capacity is altered, it must be replaced immediately to ensure maximum patient safety during dental surgery procedures.

Who is the manufacturer and what standards are met?

The official manufacturer of this device is JOTA AG, located in Rüthi, Switzerland. This product is certified Class IIa and bears the CE0483 marking, guaranteeing its compliance with European regulatory requirements for medical devices. JOTA AG provides strict reprocessing instructions that apply to its entire distributed range. Responsibility for the sterility of the instruments lies with the user, who must implement validated procedures. Compliance with these international standards ensures that the trephine retains its mechanical properties and safety of use throughout its life cycle in a dental office or hospital environment.

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