Aesculap Acculan 4 Mode D'emploi page 6

en
Drilling (oscillation)
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15 second application, 15 second pause
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3 repetitions
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30 min cooling time
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Max. Temperature 48 °C
Saw mode with GB891R
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30 second application, 60 second pause
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4 repetitions
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30 min cooling time
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Max. Temperature 48 °C
Saw mode with GB892R
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30 second application, 60 second pause
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5 repetitions
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30 min cooling time
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Max. Temperature 48 °C
Screwing with GB896R/GB897R
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10 second mechanical application, 10 second manual application,
30 second pause
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30 repetitions
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30 min cooling time
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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 Indications
Type and area of application depend on the selected tool.
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 depends greatly on factors that
only operators themselves can control. The information provided therefore
only represents general conditions.
The clinically successful use of the product depends on the knowledge and
experience of the surgeon. They must decide which structures can be sen-
sibly treated and must take the safety information and warnings in the
instruction for use into account.
4
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.
►
Check the functionality and proper condition before using the product.
►
Observe "Guidance on Electromagnetic Compatibility (EMC) for
Acculan Components" TA022450, 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.
►
Comply with valid 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 ECCOS holder systems, observe relevant instructions for
use TA009721, see B. Braun eIFU at eifu.bbraun.com
Note
The user must 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.