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2.4
Preparation
Non-compliance with these rules will result in complete exclusion of lia-
bility on the part of Aesculap.
WARNING
Risk of injury and/or product malfunction due to incorrect operation
of the electromedical system!
►
Adhere to the instructions for use of any medical device.
►
When setting up and operating the product, adhere to:
– national regulations for installation and operation,
– national regulations on fire and explosion protection.
Note
For the safety of patients and users it is essential that the mains power cord
and, especially, the protective ground connection are intact. In many cases
defective or missing protective ground connections are not recognized
immediately.
►
Using the potential equalization lead mounted to the rear panel of the
device, connect the device to the potential equalization system of the
room used for medical purposes.
Note
The potential equalization lead can be ordered from the manufacturer as
art. no. GK535 (4 m long) or TA008205 (0.8 m long).
2.4.1
Set-up environment/set-up location
DANGER
Fire and explosion hazard!
►
Use the product outside of explosion hazard zones (e.g. areas with
highly pure oxygen or anesthetic gases).
The device is authorized for use in the operating room.
Note
After being installed and put into operation, the device must not be trans-
ported or moved to a different set-up location.
►
Make certain that the ventilation slots in the bottom of the housing
and in the rear panel of the device are not covered, e.g. by an OR cloth.
►
Make certain that the control elements, mains power switch and power
sockets are freely accessible for the user.
►
Make sure that the outlet is accessible to the user.
►
Make certain the system is set up on a sufficiently stable support (e.g.
a table, ceiling support, equipment cart, etc.).
►
Follow the instructions for use of the support.
CAUTION
Risk of electric shock from incorrect installation of the device!
►
First installation without power connection.
CAUTION
Risk to persons and risk of damage to equipment due to improper cable
routing!
►
Lay all cables and leads so that they do not present a tripping haz-
ard.
►
Do not place objects on the cables.
WARNING
Risk to patient from misdirected leakage current due to incorrect or
defective earthing!
►
Do not touch the device and patient at the same time.
WARNING
Risk to patient due to failure of a device!
►
Keep an operationally ready replacement device on hand. If neces-
sary, change to conventional surgical methods.
WARNING
Danger of explosion from a device that is improperly set up!
►
Make certain that the power plug is connected to the power supply
outside of any areas where there is a risk of explosion.
►
Do not use the product in potentially explosive areas or close to
highly flammable or explosive gases (e.g., oxygen, anesthetic
gases).
CAUTION
Risk to patient due to poor/lack of vision!
►
Adjust the monitors and display elements so that they are highly
visible to the user.
WARNING
Risk of fire or electric shock if moisture penetrates the device!
►
Ensure that the device is set up protected from water drips and
splashes.
►
Do not immerse the housing in any fluid.
►
Do not expose the device to rain or any moisture.
►
Do not place objects filled with fluid on the device.
CAUTION
Risk to patient and user due to condensation and short-circuit!
►
Before putting into operation make sure that all components used
have enough time to adjust to the changed environmental condi-
tions.
CAUTION
Malfunction of the device!
►
For sufficient ventilation, set up the Full HD CMOS camera control
unit so that the ventilation slots are always clear.
►
Set up and operate the Full HD CMOS camera control unit horizon-
tally.
WARNING
Interference of high frequency energy with the device!
►
Do not use any mobile or portable equipment that emit high-fre-
quency energy (e.g., mobile phones, cell phones, GSM phones) in
the vicinity of the product.
►
Portable HF communication devices (radio devices), including their
accessories such as antenna cables and external antennas should
not be used in a distance lesser than 30 cm from all parts of the
visualization system, including the cables specified by the manu-
facturer. Non-observance may lead to a reduction of the device
performance features.
WARNING
Interference of other devices by the camera control unit PV480!
►
When operating the camera control unit PV480 device immediately
next to other devices or with other devices stacked up, watch the
PV480 camera control unit and the other devices to make sure they
are working properly.
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