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General| Category | Medical Equipment |
|---|---|
| Manufacturer | B. Braun |
| Brand | Aesculap |
| Product Line | Surgical Instruments |
| Material | Stainless Steel, Titanium |
| Sterilization | Autoclavable |
| Regulatory Compliance | CE marked, FDA approved (depending on specific product and market) |
Defines the handpiece's role, connection to the motor system, and tool driving capability.
Specifies the sterile area required for the device's application.
Lists surgical disciplines and areas where the system is suitable for use.
Identifies specific body areas where the system must not be used.
Guidelines for inspecting and using sterile ELAN 4 handpieces and tools.
Critical warnings and instructions regarding the reuse of single-use spray nozzles.
Lists various handpiece models and their corresponding shaft lengths.
Details the specific components included in the product packaging.
Lists essential system components needed for the handpiece to function.
Explains the mechanism of tool coupling and rotation with the handpiece.
Instructions for connecting accessories and configuring the system components.
Procedures to verify the correct functionality of the device before use.
Essential guidelines and warnings for operating the handpiece during surgical procedures.
Overarching safety guidelines applicable to all reprocessing steps.
Provides general details on cleaning, disinfection, and material compatibility for reprocessing.
Steps for preparing the product immediately after use before reprocessing.
Details on preparing the applied part and tools for the initial cleaning phase.
Safety guidelines for selecting and using cleaning/disinfection agents and temperatures.
Step-by-step manual cleaning and immersion disinfection process for the applied part.
Procedure for mechanical cleaning and disinfection using manual pre-cleaning for the applied part.
Method for mechanical cleaning and disinfection of tools with manual pre-cleaning.
Procedures for inspecting, maintaining, and checking the product's condition.
Guidelines for packaging and storage devices to ensure sterility.
Details on validated steam sterilization processes and recommended parameters.
Specific sterilization recommendations and parameters for the US market.
Instructions for storing sterile products to maintain their sterility.
Device classification according to the European medical device directive.
Technical performance specifications and relevant industry standards.
Information on adjustable motor direction and maximum speed settings.
Details concerning short interval application cycles and operational pauses.
Specifies operating and storage conditions for temperature and humidity.
