RA Punch - JOTA (225RF.RA.050) - Delynov
The Punch 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: 225RF.RA.050.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Punch RA - JOTA (225RF.RA.050)?
The Punch RA from the JOTA brand, bearing technical reference 225RF.RA.050, is a rotary instrument of the circular gingival scalpel type used in oral surgery. This medical device is manufactured by JOTA AG, a recognized manufacturer based in Switzerland. It is designed from high-quality metallic or plastic materials, compliant with medical sector requirements. This dental mucosal punch is specifically developed to provide an efficient solution during interventions requiring precise circular cutting of soft tissues. As a JOTA brand product, it benefits from a rigorous design to meet the needs of implantologists and periodontologists during their daily surgical procedures.
What are the clinical indications for this dental surgery punch?
The JOTA dental surgery punch is indicated for all procedures requiring a clean and circular excision of the mucosa. In implantology, it is frequently used for exposing submerged implants or for creating precise access to the alveolar ridge without full flap reflection. This gingival punch also allows for soft tissue core sampling during gingival grafts. According to the recommendations of the manufacturer JOTA AG, the intended use of these instruments falls within a professional framework where the practitioner must evaluate the condition of the instrument before each intervention. Its use is essential to minimize the extent of tissue trauma when accessing underlying structures.
What are the technical and maintenance characteristics?
The Punch RA (reference 225RF.RA.050) is a Class IIa device, certified according to the CE0483 marking. Technically, it is designed to be mounted on a contra-angle (RA). Regarding maintenance, the manufacturer JOTA AG specifies that these instruments are reusable, unless otherwise indicated on the labeling. The reprocessing process is strict: cleaning, disinfection, and sterilization are mandatory before the first use and after each use. It is imperative to use non-foaming cleaning agents compatible with ultrasound and to scrupulously respect the concentrations, temperatures, and soaking times recommended by the detergent manufacturer. The use of demineralized or low-contamination sterile water is required for the final rinse.
What are the contraindications for the use of this device?
There are no specific medical contraindications listed by the manufacturer JOTA AG in the provided documentation, beyond general rules of clinical caution. However, the decision to reuse the product belongs exclusively to the physician or the expert user. The latter is solely responsible for evaluating any wear or potential breakage of the products. In case of doubt regarding the structural integrity of the gingival punch or if the instrument shows signs of material fatigue, it is strongly recommended to dispose of the product earlier than planned and replace it immediately. The manufacturer emphasizes that it cannot guarantee maximum performance and safety if the products are used beyond their wear threshold.
What are the precautions related to reuse and wear?
The reuse of the Punch RA from the JOTA brand is possible under the direct responsibility of the practitioner. The fundamental rule states that the expert must judge the frequency of reuse based on the specific case and the condition of the instrument. Effective cleaning and disinfection are sine qua non conditions for successful sterilization. The practitioner must ensure that the procedures used (washer-disinfector, sterilizer) are validated and regularly monitored. Particular attention must be paid to material resistance against chemical agents. If the labeling contains specific contradictory information, it prevails over the general rule of reuse. Patient safety depends directly on maintaining the instrument in an optimal operational state.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is JOTA AG, located at Hirschensprungstrasse 2, 9464 Rüthi, Switzerland. This medical device belongs to Class IIa and bears the CE0483 marking, guaranteeing its compliance with current European regulatory requirements. All specific characteristics and reprocessing instructions apply to the entire range distributed by JOTA AG. The manufacturer insists that the instruments are delivered non-sterile and must undergo a complete preparation cycle (cleaning and disinfection after removal from protective packaging, then sterilization after packaging). Compliance with these standards and the validated parameters for each sterilization cycle is the responsibility of the healthcare facility or the practitioner.
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Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
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