Normal Operation; Oscillating Operation Or Thread Cutting Operation; Validated Reprocessing Procedure; General Safety Notes - Aesculap ELAN 4 Instrucciones De Uso

The application part can only be used and the setting parameters at the
control unit can only be altered if:
■
the application part is connected to the control unit,
■
there is no second application part activated (position "On") at the
same time and
■
the application part type 16 is shown in the display for the control unit.
Note
When two ELAN 4 electro drill tools GA844 are connected to the
ELAN 4 electro control unit GA800, the drill tool whose speed control safety
catch is actuated first is active.
Note
For additional information, see the operating instructions for the
ELAN 4 electro control unit GA800 (TA014401).
Note
The product drive motor is operated using a magnetic sensor system. In
order to prevent inadvertent activation of the motor, the product may not
be exposed to any magnetic fields (such as magnetic instrument pads).
6.3.1

Normal Operation

Product operating in right rotation mode:
►
Activate the knob for speed control 2.
The speed of the product 1 is continuously regulated pursuant to the
attachment utilized.
Product operating in left rotation mode:
►
Press the knob for left rotation 7 completely in and keep it depressed.
►
Activate the knob for speed control 2.
The speed of the product 1 is continuously regulated pursuant to the
attachment utilized.
6.3.2

Oscillating operation or thread cutting operation

Note
Check that the oscillation mode is set to "ON" at the control panel on the
ELAN 4 control unit (GA800).
Enable oscillating operation or thread cutting operation:
►
Keep the knob for left rotation 7 pressed for 3 seconds.
There will be multiple signal tones.
Oscillating operation:
►
Press the knob for speed control 2 in all the way.
Product 1 will rotate clockwise and counterclockwise in alternation.
Tapping operation:
►
Depress the speed control knob 2 up to a maximum of half-way.
Product 1 will gradually turn counterclockwise and clockwise, whereby
the rotational angle in the clockwise direction is greater than that of
the counterclockwise direction.
To activate left rotation:
►
Press the speed control knob 2 in addition to the knob for left
rotation 7.
The product 1 will rotate counterclockwise.
Disable oscillating operation or thread cutting operation:
►
Keep the knob for left rotation 7 pressed for 3 seconds.
There will be multiple signal tones.
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.
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

General information

Dried or affixed surgical residues can make cleaning more difficult or inef-
fective and lead to corrosion. Therefore the time interval between applica-
tion 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.
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.
On stainless steel, residues containing chlorine or chloride (such as surgi-
cal residues, drugs, saline solutions in water for cleaning, disinfection and
sterilization) may lead to corrosion (pitting corrosion, tensile corrosion)
and thus to the destruction of the product. These must be removed by rins-
ing thoroughly with demineralized water and then drying.
Perform additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or
FDA approval or CE mark) and which are compatible with the product's
materials according to the chemical manufacturers' recommendations
may be used for processing the product. All the chemical manufacturer's
application specifications must be strictly observed. Failure to do so can
result in the following problems:
■
Visual material changes (such as fading or color changes in titanium or
aluminum). For aluminum, the application/process solution only needs
to be pH >8 to cause visible surface changes.
■
Material damage (such as corrosion, cracks, breaks, premature aging or
swelling).
►
Do not use metal cleaning brushes or other abrasives that would dam-
age the product surface and could cause corrosion
►
For further detailed information on hygienically safe and material-pre-
serving/value-preserving reprocessing, see www.a-k-i.org, link to Pub-
lications, Red Brochure – Proper maintenance of instruments.
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