Osteotomic disc RA-JOTA (231DEF.RA.070) - Delynov
The Disque ostéotomique RA-JOTA is a medical device manufactured by le fabricant — Class IIa, CE marking CE0483.
- Compliance: Medical device Class IIa, CE marking CE0483.
- Manufacturer: le fabricant.
- Reference: 231DEF.RA.070.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the RA-JOTA osteotomy disc (231DEF.RA.070)?
The RA-JOTA osteotomy disc, referenced under code 231DEF.RA.070 at Delynov, is a rotary medical device from the brand JOTA. Manufactured by JOTA AG, this instrument is designed for oral surgery interventions requiring precise cutting of hard tissues. This dental surgery disc is composed of metallic or plastic materials according to the manufacturer's specifications, ensuring compatibility with ultrasonic cleaning and thermal disinfection protocols. As a Class IIa device, it meets European safety requirements for invasive instruments for temporary surgical use.
What are the clinical indications for this osteotomy disc?
This surgical osteotomy disc is indicated for bone cutting and remodeling procedures. It is primarily used by dental surgeons and implantologists to perform segmental osteotomies, root separations, or alveolar ridge adjustments. According to JOTA AG manufacturer guidelines, these instruments are considered semi-critical. They must undergo a complete reprocessing cycle (cleaning, disinfection, and sterilization) before the first use and after each clinical use to ensure patient safety and cutting efficiency during dental surgery procedures.
What are the technical characteristics of this instrument?
The RA-JOTA osteotomy disc (231DEF.RA.070) is characterized by its compatibility with contra-angles (RA). Its design allows for material resistance adapted to enzymatic cleaning solutions and steam sterilization cycles. The manufacturer specifies that the performance and safety of the device depend directly on its wear status. It is crucial to respect the concentration, temperature, and soaking time parameters recommended by detergent manufacturers. The use of demineralized or low-contamination sterile water is required for the final rinse to avoid any deposits on the surgical diamond disc.
What are the contraindications for the use of this device?
There are no specific medical contraindications listed in the provided technical documentation, other than the fundamental principles of surgical prudence. However, use is contraindicated if the instrument shows visible signs of wear, breakage, or deformation. The practitioner is solely responsible for the decision to reuse the product based on its condition. In case of doubt regarding the structural integrity of the disc, the manufacturer recommends immediate disposal. Failure to comply with validated reprocessing protocols also constitutes a major contraindication to its use in a clinical setting.
What are the precautions related to reprocessing and reuse?
The disc from the brand JOTA is reusable, unless otherwise stated on the labeling. The expert physician is responsible for determining the frequency of reuse according to observed wear. For cleaning, non-foaming agents compatible with ultrasound must be used. Rinsing must be performed with water low in germs and endotoxins. The manufacturer JOTA AG emphasizes that failure in operation can occur if products are worn, compromising safety. It is therefore recommended to replace instruments earlier than planned if there is doubt about their cutting performance or mechanical resistance.
Who is the manufacturer and what standards are respected?
The RA-JOTA osteotomy disc 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 standards. The management of sterility and reprocessing is the responsibility of the user, who must implement validated procedures for cleaning, disinfection, and sterilization (autoclave). Maintenance devices, such as washer-disinfectors and sterilizers, must be checked regularly to ensure that approved parameters are applied to each treatment cycle for instruments of the brand JOTA.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
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