Rubber Dam Frame - Helmut Zepf (19.125.00) - Delynov
The cadre de digue - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 19.125.00.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf dam frame?
The Helmut Zepf dam frame, referenced under code 19.125.00, is a Class I dental instrument designed by Helmut Zepf Medizintechnik GmbH. This device is presented as a rigid external support made of high-quality medical stainless steel. Its structure is specifically designed to serve as a dam holder, allowing the rubber dam to be fixed and maintained under tension during clinical interventions. As an essential dental dam accessory, it ensures the stability of the surgical field outside the patient's mouth, thus guaranteeing a dry working environment isolated from oral fluids for the practitioner.
What are the clinical indications?
This dental dam frame is indicated for all procedures requiring absolute isolation of the surgical field, such as endodontic treatments, composite placement, or prosthetic bonding. Its intended purpose is to be used outside the mouth to fix the rubber dam on the gums. By keeping the latex or silicone sheet well tensioned, it allows the dental surgeon to operate with increased visibility while protecting the mucous membranes and preventing the accidental ingestion of instruments or chemical products by the patient.
What are the technical characteristics?
The Helmut Zepf dam frame (reference 19.125.00) is manufactured from a medical stainless steel selected for its resistance to reprocessing cycles. Although delivered non-sterile, this device is designed to withstand the mandatory cleaning, disinfection, and sterilization protocols before each use. Its ergonomic design allows for easy handling by the healthcare professional, ensuring uniform tension of the dam across its entire periphery. It is imperative to check for the absence of visible damage, such as cracks or defects on the edges, before any clinical implementation.
What are the contraindications for use?
The main contraindication for the use of this dam frame lies in metal intolerance. A hypersensitivity reaction or an allergy to the components of medical stainless steel may occur in some patients upon contact with the instrument. If such a reaction is triggered, the procedure must be stopped immediately and the necessary medical measures must be taken. Furthermore, the use of damaged or worn products showing cracks or breaks is strictly prohibited to guarantee patient safety and treatment effectiveness.
What are the maintenance and reprocessing precautions?
As Helmut Zepf Medizintechnik GmbH products are delivered non-sterile, they must undergo a complete cleaning, disinfection, and sterilization cycle before the first use and after each subsequent use. Due to the robust design of the stainless steel, there is no defined maximum limit of treatment cycles, provided the instrument shows no visible wear. The practitioner must carefully inspect the dam frame to detect any alterations to the edges or structure before integrating it into their operating protocol.
Who is the manufacturer and what standards are respected?
The dam frame is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. Compliance with safety and use protocols is essential, as the use of this instrument is exclusively reserved for qualified healthcare professionals. Compatibility with other dam accessories must be verified beforehand by the practitioner to ensure the smooth progress of the surgical or restorative procedure.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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