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AUTOMATIC SELF-TEST SYSTEM---------------------------------------------------------------------------
The device is provided with a self-test system that checks its operation, its failures and wrong usages by users. It operates as follows:
At the switching ON. It performs a complete self-check that ends, if the device has properly passed it, with a short sound (on displays, the
code of the software release appears for a brief moment).
During use. It goes on checking the device operation, any wrong usages and output powers.
In both cases in the system detects both wrong usages and failures, it bloks the power delivery by informing users with acoustic and/or
visual signals named ERROR CODES.
Short list of ERROR CODES with possible countermeasures by users.
Error code Err OtA with intermittent sound.
It does not signal problems or failures, but it is only an information for users about the continuous power activation for a time < 40 sec.
Applicable countermeasures: Stop the power activation for a brief moment and start it again immediately.
Error code Err ACt with intermittent sound.
It signals that users are pushing either two activation switches simultaneously or an activation switch not usable with that use mode.
Applicable countermeasures: Stop the wrong use.
Error codes 12, 13 and 14 with intermittent sound.
It signals during the starting self-check a failure or an inadvertent pressure of the following:
12 = Pedals of the foot-switch, 13 = Buttons of the hand-switch pencil , 14 = Keys of the front panel.
Applicable countermeasures: Switch the device OFF and ON again to verify the signaling (If confirmed, ask for the technical assistance).
Error code t
o
2 + the detected temperature with intermittent sound
It signals that the device internal temperature is too high and could signal a failure.
Applicable countermeasures: Switch the device OFF and ON again to verify the signaling (eventually after 20/30 seconds).
Other Error Codes
They signal failures or technical problems
Applicable countermeasures: Switch the device OFF and ON again to verify the signaling (If confirmed, ask for the technical assistance).
Problems not detectable by the self-test system.
The unit is ON and it does not signal problems, but by pushing foot-switches it either does not deliver
the power (None acoustic and visual signal) or it operates in a not constant way.
Verify if the foot-switch (related tubing) is broken by inserting and pushing into the central hole of the socket a rounded tip .
The unit is ON, it does not signal problems and emits all activation signals, but it does not deliver the power or the normal power
appears less efficacious.
Verify accessories, cables and the proper connection of the monopolar neutral electrode as detailed in the paragraph
IMPORTANT WARNINGS (Mainly points: Use of currents and powers and Specific problems (Minor surgery, Veterinary)
HANDLING, STORAGE, CLEANING AND STERILIZATION --------------------------------------------
When not used, kept the device in a dry and not dusty place. Be careful that no liquid is poured on it.
Always store with care the device and all accessories in order to avoid damages. To ship it, use the original packaging.
Clean the unit with a simple soap solution, by taking care that no liquid goes inside and then wipe it with a dry cloth.
Clean the foot-switches in the same way or by using a cold disinfecting solution. Not use flammable products!
At the moment of the sale accessories are not sterile.
Sterilize monopolar and bipolar active accessories with related cables by steam autoclave at 121 °C
or with suitable cold solutions, the neutral ones by suitable cold solutions.
The packaging of each accessory includes a label with the instructions for use and the sterilization
mode (allowable number of cycles and time of each cycle).
DO NOT STERILIZE BY DRY HOT AIR DEVICES, THEY BREAK PLASTICS AND INSULATIONS!
During the sterilization, do not bend connection cables too much and wipe, before use, all the parts of the accessories very well in order
to eliminate all the humidity. The best thing to do is to centrifuge them.
CONSUMABLES, TECHNICAL CHECKS AND FINAL DISPOSAL ---------------------------------------
The device does not include consumables or materials with limited service life.
IEC standards require the performing by qualified personnel, even better by the Manufacturer, of a regular check of
these devices (Theoretically once per year) including the following:
In accordance with general standards IEC 60601-1.
The check of the electrical safety (Low Frequency Leakage currents, Resistance of the protective earth conductor and so on).
The check of the general operation, of the mains fuses, of the supply cord and so on.
In accordance with specific standards IEC 60601-2-2 for HF surgical equipment.
The check of electrical safety (High Frequency Leakage currents and so on).
The check of the operation of the control circuit of the neutral electrode.
The check of powers by considering the values specified in the diagrams included in this manual (the tolerance is 20% about the
powers higher than 10% of the maximum power of each current,
Perform the final disposal according to the specific National Laws, but remember that the unit does not include
dangerous substances or materials.
Sterilize before the disposal all accessories used on patients.
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