General Information; Intended Use; Application Environment; Indications - B.Braun Aesculap GA800 Manual De Instrucciones

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2.

General information

2.1

Intended use

The ELAN 4 electro control unit GA800 together with the accessory forms
an electrically operated motor system.
The ELAN 4 electro control unit GA800 supplies the energy and monitors
the motors in the ELAN 4 electro applied parts. The control unit receives
the speed request via the hand or foot control. The direction of rotation is
preselected by means of the foot control buttons, by means of the display
when using a hand control and by means of the pushers for the drill tool.
The purpose of the integrated coolant and irrigation pump is to deliver
coolant or irrigation fluid to the operating field for cooling the tool and
tissue or irrigating the operating field. It is activated via the buttons on the
foot control or via the display.
Maximum delivery rate of the pump
2.2

Application Environment

The motor system fulfills the requirements of Type BF in accordance with
IEC/DIN EN 60601-1.
For use in operating rooms, outside of the explosive hazard zone (e.g. areas
with highly pure oxygen or anesthetic gases).
Control unit
Application Environment
Set-up location
2.3

Indications

Modes of application Separation, removal and modeling of hard
tissue, cartilage, related matter and bone
substitutes
Surgical discipline/areas Neurosurgery, ENT surgery, OMF surgery,
of application orthopedics and trauma surgery
Note
Mode and area of application depend on the applied parts and tools
selected.
2.4

Absolute contraindications

The product is not approved for use in the central nervous system or cen-
tral circulatory system.
2.5

Relative contraindications

The safe and effective use of the product strongly depends on influences
only the user can assess. For that reason, the above information only out-
lines general conditions.
The clinically successful use of the product depends on the knowledge and
experience of the surgeon. The surgeon has to decide which structures can
be properly treated taking into account the safety and warning notices
listed in these instructions for use.
6
65 ml/min
In the unsterile area
Table, ceiling supply unit, equipment cart,
or similar
3.

Safe handling

DANGER
Risk of death by electric shock!
►
Do not open the product.
►
Connect the product only to a grounded power supply
WARNING
Risk of injury and material damage due to inappropriate use of the
product!
►
Use the product only in accordance with the intended use.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
The ELAN 4 electro control unit GA800 together with the accessory
forms an electronically operated motor system.
►
Follow the instructions for use of ELAN 4 electro accessories.
►
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 tech-
niques.
■
The ELAN 4 electro control unit GA800 fulfills the requirements of
CISPR11, Class A.
►
Inspect the new product after removing its transport packaging and
prior to first use to ensure it is in good working order.
►
Observe "Notes on Electromagnetic Compatibility (EMC) for
ELAN 4 electro control unit GA800" TA022452 , see B. Braun eIFU at
eifu.bbraun.com
►
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.
►
Do not pull any of the cables by the actual cable but only by the con-
nector.
Note
The user agrees to report all serious incidents occurring in connection with
the product to the manufacturer and to the competent authority of the
country in which the user is registered.