Burins for oral surgery and implantology - Helmut Zepf (24.493.03) - Delynov
The Burins pour chirurgie orale et implantologie - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.493.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Helmut Zepf |
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What is the Helmut Zepf (24.493.03) oral surgery chisel?
The Helmut Zepf oral surgery chisel, referenced under code 24.493.03, is a specialized manual instrument for hard tissue work. Manufactured from medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device is designed to withstand mechanical stress during bone cutting phases. Its rigid structure and specific design allow for efficient force transmission during clinical use. This equipment is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use in the office or operating room.
What are the clinical indications for this chisel in implantology?
In clinical practice, this implantology chisel is indicated for various bone surgery maneuvers. It is primarily used for the resection of exostoses, harvesting autogenous bone chips, or remodeling the alveolar ridge before implant placement. In oral surgery, it also facilitates root separation or the removal of obstructing bone walls during complex tooth extractions. Its use is strictly reserved for qualified healthcare professionals mastering manual bone surgery techniques.
What are the technical characteristics of model 24.493.03?
The Helmut Zepf model 24.493.03 is characterized by its high-quality medical stainless steel composition, ensuring compatibility with repeated sterilization cycles. As a Class I instrument, it meets the safety requirements for non-invasive or temporary-use invasive medical devices. Although no maximum processing cycle limit is defined by the manufacturer due to its robust design, the instrument must be inspected before each use for visible damage such as cracks, breaks, or wear of the cutting edges.
What are the contraindications for the use of this instrument?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity or intolerance to metals, specifically stainless steel. If an allergic reaction or intolerance occurs in the patient upon contact with the instrument, the surgical procedure must be immediately interrupted and appropriate medical measures must be taken. It is therefore recommended to check the patient's allergic history before any intervention involving this device.
What are the maintenance and reprocessing precautions?
Before the first use and after each intervention, the chisel must undergo a complete cleaning, disinfection, and sterilization cycle. Since it is delivered non-sterile, compliance with these steps is crucial for patient safety. The practitioner must verify the integrity of the instrument, particularly the absence of defects on the sharp edges. The use of damaged products or those showing marked signs of wear is prohibited. Compatibility with other cleaning and disinfection products must also be validated beforehand by the user.
Who is the manufacturer and what standards are met?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This chisel is classified as a Class I medical device according to current regulations. The manufacturer emphasizes that the use of this manual dental instrument is strictly reserved for healthcare professionals. Compliance with reprocessing protocols and visual inspection ensures the instrument's conformity with the safety requirements for oral surgery and implantology.
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