Universal PEEK Handpiece - Helmut Zepf (26.193.20) - Delynov
The Manche universel en PEEK - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.193.20.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf PEEK universal handle?
The PEEK universal handle, referenced under code 26.193.20 by Helmut Zepf, is a bionic instrument designed to serve as an extension for working ends in dental surgery. Manufactured in PEEK (Polyetheretherketone), this material offers a lightweight and resistant alternative to traditional metal handles. Its bionic structure (Zepf-Bionic handle) is designed to optimize grip during clinical acts. This specific model is a double extremity (2-ended) version in green color, compatible with M2.5 screw threads, allowing for the attachment of various working tips according to the needs of the intervention.
What are the clinical indications for this instrument?
According to data from the manufacturer Helmut Zepf Medizintechnik GmbH, this handle is indicated as an ergonomic handle intended to serve as an extension for various working ends. In clinical practice, it is used by dental surgeons and implantologists to manipulate instruments during various operative phases. Its primary role is to provide stable and comfortable support for diagnostic or treatment tools, thereby facilitating technical maneuvers in the mouth. It adapts to configurations requiring a double extremity to quickly alternate between two instruments on a single handle.
What are the technical characteristics of this handle?
The Helmut Zepf 26.193.20 handle is distinguished by its composition of PEEK, a high-performance polymer. It features a Zepf-Bionic type universal design, characterized by advanced ergonomics for a secure grip. Technically, it is a double extremity (2-ended) handle with a standard M2.5 connection for inserts. The product is delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before its first use and between each patient. Its durability is not limited by a defined number of cycles but depends on the absence of visible damage such as cracks or breaks.
What are the contraindications for the use of this device?
The main contraindication mentioned by the manufacturer concerns hypersensitivity to materials. Although the body of the handle is made of PEEK, contact with the medical stainless steel parts of the instrument may cause metal intolerance in certain patients. If a hypersensitivity reaction or an allergic reaction is triggered during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. It is also contraindicated to use the product if it shows visible signs of wear, such as cracks, breaks, or defects on the attachment areas.
What are the maintenance and reprocessing precautions?
The Helmut Zepf PEEK universal handle is a reusable device that requires a rigorous reprocessing protocol. Before the first use and after each subsequent use, the instrument must be cleaned, disinfected, and sterilized. The manufacturer specifies that due to the design and materials used, there is no defined maximum limit of processing cycles, as long as the physical integrity of the product is preserved. The practitioner must systematically check for the absence of damage or wear before each use. Any product that is damaged or presents defects on the cutting edges or threads must be discarded to ensure patient safety.
Who is the manufacturer and what standards are respected?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Germany. The product belongs to Class I according to current medical device regulations. As a Class I device, it meets the safety and performance requirements defined for this category of non-invasive or short-term invasive surgical instruments. The use of this equipment is strictly reserved for qualified healthcare professionals. Compliance with the cleaning and sterilization instructions recommended by Helmut Zepf is essential to maintain the conformity of the device throughout its useful life in the office or hospital environment.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |