Safe Operation; Normal Operation; Oscillating Operation Or Thread Cutting Operation; Validated Reprocessing Procedure - Braun Aesculap ELAN 4 Instructions For Use/Technical Description

USA
►
Ensure that the tool blades are not mechanically damaged.
►
Release product for use (ON position).
►
Run the product shortly at maximum speed in right and left rotation.
►
Make certain that the rotational direction is correct in each case.
►
Check the product for damage, abnormal operation noises, heavy vibra-
tion and excessive heat.
►
Do not use the product if it is damaged or defective.
►
Set aside the product if it is damaged.
6.3

Safe operation

WARNING
Coagulation of patient tissue or risk of burns for patients and user
through hot product!
►
Do not use products for acetabulum milling.
►
Cool the tool during operation.
►
Keep product/tool out of the reach of patients.
►
Let the product/tool cool down.
►
Use a cloth to protect against burns when changing the tool.
WARNING
Risk of infection from aerosol formation!
Risk of injuries caused by particles coming loose from the tool!
►
Use suitable protection (such as waterproof protective clothing,
face mask, safety gases, suction).
WARNING
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
►
Apply the product only under visual control.
WARNING
Risk of injury and damage to the tool/system!
The rotating tool may get caught in drapes (such as textiles).
►
Do not let the tool come into contact with drapes (such as textiles)
during operation.
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
Document No.: TA014436 - Version: 1.0 - Document ID: SOP-AIC-5002244 Date/Time Printed/Viewed: 2022-04-13 16:01 (CET)
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.
Effective