Indications; Contraindications; Safe Handling - B.Braun Aesculap GB866R Mode D'emploi

2.3

Indications

Modes of application Separating, removing and shaping hard tis-
sue, cartilage and similar, as well as for drill-
ing holes in bone and bone substitute mate-
rials.
Surgical discipline/areas Neurosurgery, ENT surgery, OMF surgery,
of application orthopedics and trauma surgery
Note
The type and area of application depend on the tools selected.
2.4

Contraindications

The ELAN 4 electro motor system is not authorized for use in the central
nervous system or central circulatory system.
Note
The safe and effective use of electrically driven applied parts depends heav-
ily on influences that only the user can control him or herself. Therefore the
specifications provided represent framework conditions only.
Note
The clinical success of the use of the ELAN 4 electro motor system is depen-
dent on the knowledge and experience of the surgeon. The surgeon must
decide which structures it is sensible to treat and take into account the
safety and warning information contained in these instructions for use.
3.

Safe handling

CAUTION
Federal law restricts this device to sale by or on order of a physician!
Risk of injury and material damage due to inappro-
priate use of the product!
►
WARNING Use the product only in accordance with the
intended purpose.
Risk of injury and damage to property due to
improper handling of the product!
WARNING This product is an accessory of the following prod-
ucts:
■
ELAN 4 electro handpieces Standard (1-ring)
GA861 - GA864
■
ELAN 4 air handpieces Standard (1-ring)
GA761 - GA764
■
ELAN 4 electro handpieces HD (2-ring) GA865
- GA869
■
ELAN 4 air handpieces HD (2-ring) GA765 -
GA769
►
Follow the instructions for use for ELAN 4
handpieces air/electro.
►
Follow the instructions for use of all products
used.
■
General risk factors associated with surgical procedures are not
described in this documentation.
■
It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
■
The operating surgeon must have a thorough understanding of both
the hands-on and conceptual aspects of the established operating
techniques.
►
Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
►
Prior to use, check that the product is in good working order.
►
To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturer liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►
Keep the instructions for use accessible for the user.
►
Always adhere to applicable standards.
►
Ensure that the electrical installations at the premises where the
device is to be used meet all requirements acc. to IEC/DIN EN.
►
Do not use the control unit and applied part in potentially explosive
areas.
►
Carry out sterile processing in any reusable applied parts, motor cables
and tools prior to use.
►
When handling, observe instructions for use that are relevant to
Aesculap holder systems TA009721, see Aesculap Extranet at
https://extranet.bbraun.com
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