DRILL. INTERNAL DIAMETER 7.0 MM - Helmut Zepf (08.910.09) - Delynov
The TREPAN. DIAMETRE INTERNE 7.0 MM - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class IIa.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 08.910.09.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf TREPAN INTERNAL DIAMETER 7.0 MM?
The TREPAN INTERNAL DIAMETER 7.0 MM, referenced under code 08.910.09 by the manufacturer Helmut Zepf Medizintechnik GmbH, is a precision rotary instrument designed for bone surgery. This surgery trepan is characterized by a tubular structure allowing for clean bone core sampling. It is specifically dimensioned with an internal diameter of 7.0 mm, making it a tool suitable for the recovery of autogenous bone cylinders or for intervening on specific implant sites. As a Class IIa medical device, it meets safety and performance requirements for short-term invasive interventions in the oral cavity. Helmut Zepf manufacturing quality ensures optimal concentricity during rotation.
What are the clinical indications for this 7mm trepan?
Clinical indications for this 7mm trepan primarily include the creation of cylindrical bone blocks harvested from the jaw. These samples can be used as-is for onlay grafts or processed in a bone crusher for subsequent filling procedures. Another major indication is the explantation of implant devices. When implant removal is necessary, the trepan allows the bone-implant interface to be released with controlled peripheral bone loss. The choice of the 7.0 mm diameter must be rigorously validated by the surgeon based on the diameter of the implant to be removed or the size of the bone block desired for reconstruction.
What are the technical characteristics and usage protocols?
Technically, this Helmut Zepf trepan must be attached to a surgical contra-angle. The manufacturer recommends a motor setting with a rotation speed between 800 rpm and a maximum of 1000 rpm, depending on whether harvesting or explantation is being performed. The drilling and milling process must imperatively be accompanied by continuous insertion and withdrawal movements (pumping movement) to promote chip evacuation and prevent overheating. Abundant irrigation with sterile physiological saline solution is mandatory, either manually or via the contra-angle irrigation system. It is crucial not to stop the motor while the trepan is engaged in the surgical cavity to avoid any blockage or breakage of the instrument.
What are the contraindications for the use of this instrument?
Although the technical text does not list specific medical contraindications related to the patient, the use of this trepan is contraindicated in the event of non-compliance with speed parameters (never exceed 1000 rpm) or the absence of adequate irrigation, which could lead to thermal bone necrosis. Furthermore, applying excessive pressure during drilling is prohibited, as it can compromise the precision of the procedure and damage the structural integrity of the instrument or surrounding tissues. The practitioner must ensure that the trepan diameter is perfectly adapted to the implant to be explanted to avoid unnecessary collateral damage to the residual healthy bone.
What handling precautions should be taken to avoid breakage?
To guarantee the longevity of the Helmut Zepf instrument and patient safety, several handling precautions are necessary. During drilling, it is essential to maintain a constant back-and-forth movement. A critical error would be to stop the motor rotation while the trepan is still inserted in the surgical cavity; this can cause the instrument to jam and lead to its breakage. The surgeon must take care not to exert significant lateral force that could deform the trepan tube. After the procedure, the instrument must be cleaned and sterilized according to current protocols for reusable Class IIa rotary devices, ensuring total removal of bone residues inside the 7.0 mm internal diameter.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This manufacturer is recognized for its expertise in high-precision surgical instrumentation. The product is classified as a Class IIa medical device according to current European regulations (MDC0483). Compliance with these standards guarantees that the trepan has undergone strict quality controls regarding its mechanical properties and biocompatibility. As a Helmut Zepf product, this trepan benefits from a rigorous design intended to meet the requirements of the most demanding dental surgeons and implantologists in terms of reliability and clinical performance.
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Specifications
| Manufacturer | Helmut Zepf |
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