B.Braun Aesculap Acculan 4 Mode D'emploi page 6

Aesculap
Dermatome GA340 / Dermatome 0.1 mm GA341
2. General information
2.1 Intended use
Task/Function
The Dermatome GA340 / Dermatome 0.1 mm GA341, combined with der-
matome blade, is used for split skin removal in adjustable depth.
Application Environment
The product fulfills the requirements for type BF pursuant to
IEC/DIN EN 60601-1 and is used in operating rooms in sterile environ-
ments of explosion risk areas (such as areas with pure oxygen or anesthe-
sia gases).
2.2 Main functions and design characteristics
Oscillation frequency
min. 0 min
Operating mode Operation with non-periodic load and speed
changes (type S9 pursuant to IEC EN 60034-
1)
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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 the sys-
tem 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 Indications
The type and area of application depend on the tool selected.
2.4 Absolute contraindications
The product is not licensed for use on the central nervous system or cen-
tral circulatory system.
4
Acculan 4
®
-1 to max. 6 500 min
60 second application, 60 second pause
10 repetitions
30 min cooling time
Max. Temperature 48 °C
2.5 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 infor-
mation contained in these instructions for use.
3. Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
-1
WARNING
WARNING
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General risk factors associated with surgical procedures are not
described in this documentation.
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It is the operating surgeon's responsibility to ensure that the surgical
procedure is performed correctly.
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The operating surgeon must have a thorough understanding of both
the hands-on and conceptual aspects of the established operating
techniques.
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Remove the transport packaging and clean the new product, either
manually or mechanically, prior to its initial sterilization.
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Prior to use, check that the product is in good working order.
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Follow TA022450 "Notes on electromagnetic compatibility (EMC) for
Acculan
https://extranet.bbraun.com
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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.
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Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge, or experience.
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Keep the instructions for use accessible for the user.
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Always adhere to applicable standards.
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Ensure that the electrical installation of the room is consistent with
the requirements of IEC/DIN EN.
Risk of injury and material damage if this product
is not used as intended!
►
Use the product only for its intended purpose.
Risk of injury and damage to property due to
improper handling of the product!
►
Follow the instructions for use of all products
used.
components", see Aesculap Extranet at