Segment Right-angled Plate - Helmut Zepf (12.300.16) - Delynov

What is the Helmut Zepf straight segment plate?

The straight segment plate, referenced under code 12.300.16 by the manufacturer Helmut Zepf Medizintechnik GmbH, is a specific manual instrument intended for oral surgery. Manufactured from medical stainless steel, this straight segment plate is designed to meet handling requirements in a sterile environment during dental interventions. This device belongs to the category of consumables and manual instruments, offering a structure adapted to the needs of implantologists and dental surgeons. As a Helmut Zepf product, it benefits from the expertise of a recognized manufacturer in the field of precision instrumentation, guaranteeing a tool that complies with quality standards for use in clinics or operating rooms.

What are the clinical indications for this instrument?

According to data from the manufacturer Helmut Zepf Medizintechnik GmbH, this instrument is classified as a manual dental instrument. Its use is indicated in oral surgery and implantology procedures where a straight segment plate is required to assist the practitioner. Although specific detailed indications are not exhaustive in the provided MDR documentation, this type of instrument is classically used for the management of segments during reconstructive or corrective surgeries in the oral cavity. It is imperative that use be exclusively reserved for qualified healthcare professionals mastering the surgical protocols associated with this type of manual equipment.

What are the technical characteristics of the 12.300.16 plate?

The Helmut Zepf straight segment plate (reference 12.300.16) is a Class I medical device. Its main characteristic is its medical stainless steel composition, a standard material for surgical instrumentation guaranteeing the necessary resistance to reprocessing cycles. The device is delivered non-sterile, which requires a strict protocol of cleaning, disinfection, and sterilization before the first use and between each patient. The design of the instrument does not allow for a defined maximum limit of treatment cycles, as this depends on visible wear and the physical integrity of the steel (absence of cracks or defects on the edges).

What are the contraindications for the use of this device?

The main medical contraindication mentioned by Helmut Zepf concerns hypersensitivity to metals. Contact with the medical stainless steel instrument can cause an allergic reaction or intolerance in certain sensitive patients. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore recommended to question the patient about their history of metal allergies before any intervention. Additionally, use is strictly contraindicated if the instrument shows visible damage such as cracks, breaks, or defects on the cutting edges, as this could compromise patient safety.

What are the maintenance and reprocessing precautions?

Like any Class I instrument from Helmut Zepf, this straight segment plate must undergo a complete cycle of cleaning, disinfection, and sterilization before each use. Before any use, the practitioner must perform a meticulous visual inspection to detect any signs of wear or damage. It is crucial to clean each product before using it. As Helmut Zepf Medizintechnik GmbH products are delivered non-sterile, the responsibility for sterilization lies with the healthcare professional. Compatibility with other products used simultaneously must also be verified beforehand to avoid any undesirable interaction or premature degradation of the material during reprocessing.

Who is the manufacturer and what standards are respected?

The official manufacturer of this device is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This product is a Class I medical device, compliant with the regulatory requirements applicable to manual dental instruments. The manufacturer specifies that the device is identified under reference 12.300.16. Although specific CE marking is not detailed in the sources, compliance with manufacturing standards for medical stainless steel and reprocessing processes is emphasized. As a Class I device, it meets safety standards for professional use in dental surgery, subject to compliance with the safety and maintenance instructions issued by Helmut Zepf.

State of the art

Surgical medical consumables play a decisive role in operative safety.