Main Functions And Design Characteristics; Application Environment; Indications; Absolute Contraindications - Aesculap ELAN 4 Instrucciones De Uso

en
2.2

Main functions and design characteristics

Speed
-1
min. 0 min to max. 1 250 min
Rotational direction
Right and left rotation, oscillation
Short-time interval operation
Drilling (clockwise/counterclockwise rotation):
■
60 second application, 60 second pause
■
6 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Medullary reaming (clockwise/anti-clockwise rotation):
■
30 second application, 30 second pause
■
8 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Drilling (oscillation):
■
15 s application, 15 s pause
■
3 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Saw operation with GB891R:
■
30 second application, 60 second pause
■
4 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Saw operation with GB892R:
■
30 second application, 60 second pause
■
5 repetitions
■
30 min cooling time
■
Max. temperature 48 °C
Screws with GB896R and GB897R:
■
10 s machine application, 10 s manual application, 30 s pause
■
30 repetitions
■
30 min cooling time
■
Max. Temperature 48 °C
Electrical systems generally heat up during continual operation. It is
advised to give the system a break after use to cool down, as listed in the
table on operating mode.
Heating depends on the tool used and the load. After a certain number of
repetitions, the system should cool down. This procedure prevents system
overheating as well as possible injury to the patient or user.
The user is responsible for the use and adherence to the pause sequence
described.
2.3

Application environment

Use in sterile and non-sterile areas
Sterile separation at the control unit.
2.4

Indications

The type and area of application depend on the attachment and tool
selected.
4
-1
2.5

Absolute contraindications

The product is not licensed for use on the central nervous system or central
circulatory system.
2.6

Relative contraindications

The safe and effective use of the product greatly depends on influences
which can only be controlled by the user. Therefore the specifications pro-
vided represent framework conditions only.
Clinically successful use of the product is dependent 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

WARNING
Risk of injury and material damage if this product is not used as
intended!
►
Use the product only for its intended purpose.
WARNING
Risk of injury and damage to property due to improper handling of the
product!
►
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.
►
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 installation of the room is consistent with the
requirements of IEC/DIN EN.
►
Do not operate the product in explosion-hazard areas.
►
Sterilize product before use.
►
When using the ECCOS holder system, observe the pertinent instruc-
tions for use for TA009721,
https://extranet.bbraun.com
Note
The user is obligated 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.
see Aesculap Extranet at