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Idiomas disponibles
Idiomas disponibles
Aesculap
ELAN 4 electro micro sagittal saw GA836
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!
►
Use the product only in accordance with the
WARNING
intended purpose.
Risk of injury and damage to property due to
improper handling of the product!
This product is an accessory of the ELAN 4 electro
WARNING
control unit GA800.
►
Follow the instructions for use of the
ELAN 4 electro control unit GA800
(TA014401).
►
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.
►
Observe "Notes on Electromagnetic Compatibility (EMC)", see
TA022130.
►
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.
4
®
►
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
3.1
Sterile ELAN 4 tools
The product is gamma-sterilized and supplied in sterile packaging.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►
read, follow, and keep the instructions for use.
►
Use the product only in accordance with its intended use, see Intended
use.
►
Do not use products from open or damaged sterile packaging.
►
Prior to each use, inspect the product for: Loose, bent, broken, cracked,
worn, or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►
Do not use the product after its use-by date.
3.2
ELAN 4 single-use spray nozzle for sawing
GA258SU
Risk of infection for patients and/or users and
impairment of product functionality due to reuse.
Risk of injury, illness or death due to contamination
DANGER
and/or impaired functionality of the product!
►
Do not reprocess the product.
The product is gamma-sterilized and supplied in sterile packaging.
The product must not be reused.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
►
read, follow, and keep the instructions for use.
►
Use the product only in accordance with its intended use, see Intended
use.
►
Do not use products from open or damaged sterile packaging.
►
Prior to each use, inspect the product for loose, bent, broken, cracked
or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
►
Do not use the product after its use-by date.
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