Aesculap ELAN 4 Gebrauchsanweisung Seite 7

All configurations must comply with basic standard IEC/DIN EN 60601-1.
Any individual connecting devices with one another is responsible for such
configuration and must ensure compliance with basic standard IEC/DIN
EN 60601-1 or applicable national standards.
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Follow the instructions for use of individual accessories.
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Please address your B. Braun/Aesculap partner or Aesculap Technical
Service with any inquiries in this respect; for a contact address, see
Technical Service.
Coupling the tool to the applied part
Risk of injury when coupling/uncoupling tools in
the "On" position due to accidental activation of
the applied part!
WARNING
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Only couple/uncouple tools in the "Off" posi-
tion.
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Lock applied part ("Off" position), see instructions for use of
ELAN 4 electro control unit GA800 (TA014401).
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Pull back unlocking sleeve 2 on the applied part and push tool shaft 4
in the correct position as far as it will go into the tool coupling 1.
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Release unlocking sleeve 2.
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Pull at tool shaft 4 to check that it is securely coupled.
Uncoupling the tool from the applied part
Risk of injury when coupling/uncoupling tools in
the "On" position due to accidental activation of
the applied part!
WARNING
►
Only couple/uncouple tools in the "Off" posi-
tion.
►
Lock applied part ("Off" position), see instructions for use of
ELAN 4 electro control unit GA800 (TA014401).
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Pull back unlocking sleeve 2 on the applied part and remove tool by the
tool shaft 4 from the tool coupling 1.
6.2 Function checks
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Prior to each use, check that all products to be used are in good work-
ing order.
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Check the secure connection of all products to be used.
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Check that the tool is coupled properly. To do this, pull on the tool.
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Check that the cutting edges of the tools are not showing any mechan-
ical damage.
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Briefly run the applied parts at maximum speed.
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Do not use the product if it is damaged or defective. Set aside the prod-
uct if it is damaged.
6.3 Safe operation
Coagulation of patient tissue or risk of burns for
patients and users from hot applied part/tool!
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Cool the tool during operation.
WARNING
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Put down the applied part/tool beyond reach of
the patient.
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Allow the applied part/tool to cool down.
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Use a cloth to protect against burns when
changing the tool.
Improper use can result in injury to the dura mater
and brain tissues!
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DANGER Apply special care when using perforator driv-
ers.
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Make certain that the user is familiar with the
skull trepan and its mode of operation.
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Only use sharp tools.
Risk of infection from aerosol formation!
Risk of injuries caused by particles coming loose
from the tool!
WARNING
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Take appropriate protective measures, e.g.
watertight protective clothing, face mask and
protective goggles, suction extraction.
Risk of injury and/or malfunction!
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Always carry out a function check prior to using
WARNING the product.
It is only possible to operate the applied part and change the setting
parameters on the control unit if:
■
the applied part is connected to the control unit,
■
there is no second applied part released ("On" position) at the same
time and
■
the applied part type 5 is shown in the display of the control unit.
Note
For further information, see instructions for use of ELAN 4 electro control
unit GA800 (TA014401).
7. Validated reprocessing procedure
7.1 General safety notes
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
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