en
►
Inspect the accessories regularly: Electrode cables and endoscopic
accessories, in particular, must be checked for possible damage to the
insulation.
►
Keep the instructions for use accessible for the user.
►
Always adhere to applicable standards.
1.1
Safe for use in conformance with IEC regulations
The operating environment
Risk of death by electric shock!
►
Do not open the product.
DANGER
►
Only ever connect the product to power mains
with equipment grounding conductor.
Risk of injury from ignition or explosion of flamma-
ble gases! Sparks may occur when using the HF
generator as directed.
WARNING
►
Do not use the device in explosion-hazard zones.
►
When operating in the head or thoracic region,
avoid using combustible anesthetics and accel-
erating gases (e.g. nitrous oxide or oxygen) or,
when using such substances, ensure they are
extracted from the region of operation.
►
If possible, use incombustible cleaning and dis-
infecting agents.
►
If combustible cleaning and disinfecting agents
or solvents have to be used: Verify that such
agents have evaporated prior to commencing HF
surgery.
►
Be sure that no inflammable liquids accumulate
under the patient's body or in body cavities (e.g.
the vagina). Before using the HF generator, wipe
up all fluids.
►
Ensure the absence of any endogenous, combus-
tible gases.
►
Check that oxygen-soaked materials (e.g. absor-
bent cotton or mull) are kept at a safe distance
from the HF field, so that they cannot ignite.
Risk of interference with other devices!
HF generators create potentially harmful magnetic
fields during normal use.
CAUTION
►
Be sure that no electronic devices that could be
damaged by an electromagnetic field are set up
in the vicinity of the HF generator.
Restriction to view and/or side-effects due to the
development of steam/smoke during HF surgery!
►
If necessary, use smoke suction.
CAUTION
►
Ensure that the device does not come in direct contact with the patient
or in the sterile area respectively.
►
Ensure that the user does not come into direct contact with the patient
and HF generator at the same time.
4
Patient safety
Danger to life from inadequate preparation or
operational errors in the HF generator!
►
Be sure that the HF generator is in perfect work-
DANGER
ing order.
►
Ensure that neither the foot switch nor the hand
switch has been penetrated by conductive fluids
(e.g. blood, amniotic fluid).
►
Ensure there is no short circuit in the foot or
hand switch cables.
Risk of burns suffered by the patient due to inad-
vertent activation of the HF generator!
►
Switch off the HF generator immediately using
DANGER
the power OFF/ON switch in the event that it is
activated accidentally.
►
Always exercise particular care when operating
the foot switch.
Risk of injury to the patient due to an unintended
rise of the HF output voltage due to a fault in the
HF generator!
DANGER
►
Stop using the HF surgical device as soon as it
shows even the slightest anomaly.
Risk of injury to patients/users due to defective
power cord or missing protective ground connec-
tions!
WARNING
►
Check the mains power cord/protective ground
connections.
Danger of injuries due to muscle contraction,
caused by stimulation of the nerves and muscles!
►
Work with particular care on sensitive struc-
WARNING
tures.
Always be sure to do the following:
►
Position the patient in such a way that s/he is not in contact with any
metal parts that are grounded or have a significant electric capacity
against ground (e.g. operating table, fixtures). If necessary, interpose
antistatic drape.
►
Ensure that the patient will not be in contact with any damp cloths,
drapes or bedding.
►
Safeguard areas prone to strong perspiration against skin contact with
the trunk of the patient's body by inserting antistatic tissue between
such areas and the trunk.
►
Siphon off urine with a catheter.
►
For heart surgery, ground the HF generator via the potential equaliza-
tion connection.
►
For patients with cardiac pacemaker or other active implants, consult
with the relevant medical specialist prior to applying HF surgery, so
that irreparable damage to the pacemaker or implant can be avoided.
►
If possible, remove from the vicinity of HF electrodes any electrodes
from physiological monitoring devices that are not equipped with pro-
tective resistors or HF dampers.