Surgical wedge 3 to 3.5 mm, blue marking - Helmut Zepf (47.099.34) - Delynov

What is the Helmut Zepf 3 to 3.5 mm surgical wedge?

The 3 to 3.5 mm surgical wedge, referenced under code 47.099.34 by Helmut Zepf, is a specialized surgical measuring instrument for oral and implant surgery. This device is a precision tool designed to help the practitioner accurately assess bone distances and volumes. Its structure is optimized for easy handling in a clinical setting, offering direct reading of critical dimensions. The distinctive blue marking allows for rapid recognition of its specific size among other instruments on the surgical tray, facilitating workflow during complex reconstruction or site preparation procedures.

What are the clinical indications for this instrument?

This instrument is primarily indicated in bone surgery protocols where dimensional precision is crucial. It is used as a bone expansion wedge to verify the spacing obtained after using condensers or osteotomes. In implantology, this dental surgery wedge allows for the validation of inter-dental space or alveolar ridge thickness before implant insertion. Its use also extends to intraoperative planning to ensure that biological safety distances are respected. It assists in clinical decision-making by providing a stable physical reference of 3 to 3.5 mm directly at the operative site.

What are the technical characteristics of the 47.099.34 wedge?

The Helmut Zepf surgical wedge (47.099.34) is characterized by its double graduation of 3 mm and 3.5 mm. This technical specificity allows for fine measurement of the bone or prosthetic space. The instrument features blue color-coding, a characteristic specific to the identification system of the manufacturer Helmut Zepf Medizintechnik GmbH, ensuring efficient operating room organization. The design of the working part is engineered to insert precisely into expansion zones without damaging the bone walls. Its manufacturing meets the quality requirements for metallic surgical instruments intended to be sterilized and reused, ensuring longevity and corrosion resistance during cleaning cycles.

What are the contraindications for the use of this instrument?

There are no specific absolute medical contraindications for the use of a measuring wedge, other than the general contraindications related to oral surgery itself. However, the use of this instrument is prohibited in patients with known allergies to the metals constituting the instrument's alloy, although it is designed from medical-grade stainless steel. It must not be used if the operative site presents an uncontrolled acute infection or if the bone density is insufficient to support mechanical pressure, at the risk of causing a ridge fracture. The practitioner must always refer to the manufacturer's technical instructions for specific guidance.

What are the maintenance and durability precautions?

As a non-resorbable and reusable instrument, the Helmut Zepf wedge requires a rigorous decontamination and sterilization protocol after each use. Precautions include manual cleaning or ultrasonic bath followed by autoclave sterilization according to the parameters recommended by Helmut Zepf Medizintechnik GmbH. It is essential to avoid overly corrosive cleaning agents that could alter the blue marking or the surface finish. Before each intervention, the integrity of the instrument and the legibility of its graduations must be checked to guarantee measurement accuracy. Proper maintenance preserves the mechanical properties of the steel and ensures patient safety.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer in the field of high-precision surgical instrumentation. Although the specific regulatory class and CE marking are not detailed in the current technical sheet, Helmut Zepf products are developed according to rigorous industrial quality standards specific to European medical devices. As a reusable surgical instrument, it is designed to meet clinical performance requirements in dental and maxillofacial surgery. For any further information on certifications or compliance with the Medical Device Regulation (MDR), it is advisable to consult the official documentation provided by Delynov or directly from the manufacturer.

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Surgical medical consumables play a decisive role in operative safety.