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Mounting the spray nozzle and tube set
►
Connect tube set GA395SU to pump of ELAN 4 electro control unit
GA800, see TA014401.
►
Push application-side tube end onto tube connection of the ELAN 4
single-use spray nozzle for 1 ring or 2 ring handpieces 7.
►
Push single-use spray nozzle for ELAN 4 1 ring or 2 ring
handpieces 7 onto the shaft of the applied part and push/turn into the
desired position, see Fig. A.
Note
The spray tube of the ELAN 4 single-use spray nozzle for 1 ring or 2 ring
handpiece is bendable by hand and can be adapted to the requirements of
application (e.g. aligned to tool head).
6.2
Function check
►
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 is coupled properly. To do this, pull on the tool.
►
Check that the cutting edges of the tools are not showing any mechan-
ical damage.
►
Briefly run the applied parts 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
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 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 test prior to each
WARNING
use of the product.
Risk of injury due to application of the product
outside the field of view!
►
WARNING
Only use the product under vision.
Risk of injury and damage to the tool/system!
The rotating tool may catch cover drapes (textile or
WARNING
other).
►
Never allow the tool to touch cover drapes (tex-
tile or other) during operation.
Danger of injury from foreign body reactions (e.g.
inflammation, encapsulation) if particles remain in
the body!
WARNING
When using diamond tools, it is always possible for
diamond grains/nickel particles to break away/off.
►
Carefully rinse and vacuum while and after
working with diamond tools.
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.
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 chemical was used for validation.
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