pilote drill - JOTA (A2001) - Delynov

What is the x1 pilot drill - (A2001) - Delynov?

The x1 pilot drill - (A2001) - Delynov is a precision rotary instrument intended for oral surgery. Manufactured by JOTA AG under the brand JOTA, this metallic or plastic device is designed to initiate bone drilling. As a surgical guidance drill, it establishes the initial trajectory necessary for implant placement. This product belongs to the CONSO category and is delivered non-sterile, requiring a complete reprocessing protocol before its first use. Its design meets the requirements of modern implant practice, offering a reliable solution for practitioners seeking a guidance instrument compliant with Swiss manufacturing standards.

What are the clinical indications?

The implant pilot drill is indicated for the preparation of the implant site in oral surgery. Its primary role is to define the axis and initial depth of the osteotomy. JOTA brand products are reusable unless otherwise indicated on the labeling. It is the responsibility of the physician or expert user to decide on the frequency of reuse based on observed wear or the risk of breakage. This implant surgery drill is essential to ensure the precision of subsequent drilling steps. It is classified as a semi-critical instrument, which requires rigorous sterilization between each patient to prevent any risk of cross-contamination during invasive procedures.

What are the technical characteristics?

This medical device, referenced under code A2001 by Delynov, is manufactured by JOTA AG in Switzerland. It is designed from metallic or plastic materials resistant to sterilization cycles. For cleaning, it is imperative to use agents compatible with ultrasonic cleaners that do not form foam. The material resistance of the product must be verified by referring to the manufacturer's instructions regarding detergent concentration, temperature, and soaking time. The use of sterile demineralized or low-contamination water (max. 10 germs/ml) is required for the final rinse to maintain the integrity of the instrument and ensure maximum safety during its clinical application.

What are the contraindications for use?

The major contraindications concern the state of wear of the instrument. The manufacturer JOTA AG specifies that it cannot guarantee the failing operation and performance of products if they are worn or show signs of structural fatigue. In case of doubt regarding the integrity of the drill, it is strongly recommended to dispose of the product earlier than planned and replace it with a new one. Furthermore, the use of non-validated cleaning solutions or water heavily contaminated by endotoxins constitutes a contraindication to safe reprocessing. The practitioner must be the sole judge of the instrument's capacity to be reused according to the specific case encountered in the practice.

What are the maintenance and reuse precautions?

The reuse of JOTA brand instruments is subject to the exclusive responsibility of the expert using the device. Effective cleaning and disinfection are indispensable conditions for successful sterilization. It is imperative to follow the procedures validated specifically for the A2001 device, ensuring that washer-disinfectors and sterilizers are maintained and checked regularly. The practitioner must ensure to avoid any contamination during the process. If the labeling contains contradictory information, it prevails over the general rule of reuse. Vigilance regarding the wear of the cutting edges is crucial to maintain cutting performance and patient safety.

Who is the manufacturer and what standards are respected?

The x1 pilot drill - (A2001) is manufactured by JOTA AG, located in Rüthi, Switzerland. This medical device is certified Class IIa and bears the CE0483 marking, guaranteeing its compliance with current European regulatory requirements. The brand JOTA ensures that these instruments meet safety standards for semi-critical medical devices. The manufacturer insists on strict compliance with the approved parameters at each sterilization cycle. As a distributor, Delynov ensures that these products respect standardized reprocessing protocols, thus offering dental surgeons reliable, traceable equipment that complies with MDR directives for implant surgery.

State of the art

Surgical medical consumables play a decisive role in operative safety.