Function Checks; Safe Operation; Validated Reprocessing Procedure; General Safety Instructions - Braun Aesculap GN200 Gebrauchsanweisung/Technische Beschreibung

Aesculap
Lektrafuse HF Generator GN200
Decommissioning
►
Switch off the device with the power OFF/ON switch 12.
All the poles of the device are disconnected from the power supply.
►
Disconnect power cord
The device is completely disconnected from the power supply.
4.2

Function checks

Prior to each use, carry out a functional test of the device:
►
Check that the accessories have no visible damage.
►
Prepare and set up the unit, see Preparation and setup.
►
Check the functionality of the following elements, one after the other,
in the following sequence:
– Switch on the power OFF/ON switch 12; the power on signal lamp 9
lights up
– Automatic self-test after each time the device is switched on: brief
acoustic signal, all display elements light up briefly
– Foot control, see Connecting the foot control
– Instrument, see Connecting the instrument
– Activation with RF on/off 2 on the front of the device, button on
the instrument and foot switch
– Switch off the the power OFF/ON switch 12
4.3

Safe operation

Risk of injury and/or malfunction!
►
Always carry out a function check prior to using
WARNING the product.
Risk of injury when using the product beyond the
field of view!
►
WARNING Apply the product only under visual control.
►
Start the sealing process (HF discharge) by pressing the button on the
instrument, the foot switch or the HF activation button (RF on/off) 2
on the front of the device once.
After completing the sealing process, the HF discharge is automatically
stopped.
During HF sealing, the message "Sealing in Progress" is shown on the
display 5.
Fig. 10
10
®
To activate/deactivate device
►
Switch on/switch off the device with the power OFF/ON switch 12.
Operating mode
The Lektrafuse HF generator GN200 automatically recognizes the con-
nected instrument. The internal device settings are loaded. It is not nec-
essary/possible for the user to set the operating mode or the parameters.
Activating the HF current
►
Be sure that the patient is prepared in such a way that the HF unit can
be applied without any risk to the patient.
►
Ensure that the instrument and foot switch, if used, are correctly con-
nected.
►
Activate the HF device via the hand switch, foot switch or HF activa-
tion button (RF on/off) 2 on the front of the device.
Note
Do not activate the foot switch or button continually during HF discharge.
The vessel sealing process is started and ended by pressing the foot switch
or the HF activation button (RF on/off) 2 on the front of the device or but-
ton on the instrument once. After completing the sealing process, the
device stops the HF discharge automatically. The sealing process can be
interrupted by repeatedly pressing the button.
5.

Validated reprocessing procedure

5.1

General safety instructions

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for sterile pro-
cessing.
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
Successful processing of this medical device can only be ensured if the pro-
cessing method is first validated. The operator/sterile processing techni-
cian is responsible for this.
The recommended chemistry was used for validation.