Braun Aesculap GN060, Instructions For Use/Technical Description

Page: 6 / 240

4
Aesculap
®
High frequency surgical device GN060
1. Safe handling
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
Note
These instructions for use only describe the setup, function and operation
of the high-frequency surgical device GN060 and is not suitable for intro-
ducing a beginner to high-frequency surgery. A general description of the
application of high-frequency electrosurgery can be found in the respec-
tive O.R. manuals and other relevant literature.
►
Transport the product only in its original box.
►
Prior to use, check that the product is in good working order.
►
Observe “Notes on Electromagnetic Compatibility (EMC)“, see
TA022130.
►
To prevent damage caused by improper setup or operation, and in order
not to compromise warranty and manufacturers liability:
– Use the product only in accordance with these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
– Adhere to application instructions according to relevant norms, see
Safe for use in conformance with IEC regulations.
►
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
►
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 the HF device at the same time.
DANGER
Risk of injury to patients due to inappropriate
application!
►
The product and accessories should only be
operated by qualified or trained and experi-
enced personnel.
DANGER
Risk of death by electric shock!
►
Do not open the product.
►
Only ever connect the product to power mains
with equipment grounding conductor.
WARNING
Danger of injury from burns and/or explosion from
flammable gases! Sparks can occur even if the HF
surgical device is used properly and according to its
intended use.
►
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.
►
Ensure that no combustible fluids accumulate
under the patient or in body cavities (e.g. the
vagina). Wipe off all fluids before using the HF
surgical device.
►
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.
WARNING
Risk of interference with other devices!
Even during normal use, the HF surgical device cre-
ates electromagnetic fields that can interfere with
other devices.
►
Check that no electronic devices that could be
subject to interference by electromagnetic fields
are set up in the vicinity of the HF surgical
device.
WARNING
Restriction to view and/or side-effects due to the
development of steam/smoke during HF surgery!
►
Select the lowest possible power output.
►
If necessary, use smoke suction.