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6.2
Function checks
►
Prior to each use, check that all products to be used are in good work-
ing order.
►
Check the secure connection of all products to be used.
►
Check that the tool holder 1 is securely locked in place. Turn tool
holder.
►
Check that the saw blade is coupled properly. Pull at the saw blade.
►
Check that the cutting edges of the saw blades are not showing any
mechanical damage.
►
Briefly run the applied part at maximum speed.
►
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!
►
WARNING
Cool the tool during operation.
►
Put down the applied part/tool beyond reach of
the patient.
►
Allow the applied part/tool to cool down.
►
Use a cloth to protect against burns when
changing the tool.
Risk of injury if the tool comes loose accidentally!
►
Do not press the piece on saw blade for tool
release during operation.
WARNING
►
Check for secure fixation of the tool after any
tool change.
Risk of infection from aerosol formation!
Risk of injuries caused by particles coming loose
from the tool!
WARNING
►
Take appropriate protective measures, e.g.
watertight protective clothing, face mask and
protective goggles, suction extraction.
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using
WARNING
the product.
Note
A speed in excess of the recommended 16 000 min
to heat up more quickly and adversely affect the lifetime of 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 at the same time and
■
the applied part type 4 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.
7.1
Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it
gives better and more reliable results.
Note
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility,
see also the Aesculap Extranet at https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap
sterile container system.
7.2
Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between appli-
cation and processing should not exceed 6 h; also, neither fixating pre-
cleaning temperatures >45 °C nor fixating disinfecting agents (active
ingredient: aldehydes/alcohols) should be used.
-1
can cause the product
Excessive neutralizing agents or basic cleaners may result in a chemical
attack and/or fading and the laser marking becoming unreadable either
visually or by machine.
Residues containing chlorine or chlorides, e.g., in surgical residues, medi-
cines, saline solutions, and in the service water used for cleaning, disin-
fection, and sterilization, will cause corrosion damage (pitting, stress cor-
rosion) and result damage to metallic products. These must be removed by
rinsing thoroughly with demineralized water and then drying.
Validated reprocessing procedure
General safety notes
General information
7
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