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Note
For the safety of patients and users it is essential that the mains power cord
and, especially, the protective earth connection are intact. In many cases
defective or missing protective earth connections are not registered imme-
diately.
Note
The equipotential plugs for all devices used must be connected with the
equipotential tape (see IEC/EN/DIN 60601 or consistent with national
standards).
Note
Unauthorized access to data or loss of data: Only use the Full HD CMOS
camera control unit on secure networks.
Note
Ensure that the corresponding Interconnection Conditions are kept. Also,
the relevant standards and the respective national deviations must be fol-
lowed.
Personnel responsible for setting up or installing medical electrical equip-
ment must possess the necessary qualifications and be familiar with the
safety regulations in place at the installation location and the applicable
official regulations.
2.4.2
Electromagnetic tolerance
Medical electrical equipment is subject to stringent electromagnetic com-
patibility (EMC) requirements.
Despite the device's high interference immunity and low emitted interfer-
ence, compliance with EMC-related requirements is necessary with regard
to installation, installation location, and ambient conditions.
It is therefore important that you observe and follow the related warning
notices in this document and the EMC brochure TA022467.
2.4.3
Combination with medical electrical equipment
The product can be used with components from other manufacturers if
they fulfill the requirements of IEC/EN/DIN 60601-1 for the safety of med-
ical devices.
It is the operator's responsibility to check and make sure that the system
is and remains fully operational.
When using devices from different manufacturers and when operating an
endoscope and/or endoscopic accessories together with medical electrical
equipment, it must be ensured that the applied part is properly isolated:
Type CF, defibrillation-proof.
2.4.4
Setup
►
Set up the device.
►
When setting up the device, ensure that:
– It is positioned on an even, non-slip surface that is able to support
its weight
– It is installed outside of the patient environment and the sterile area
on a sufficiently stable support
– It is protected from water drips and splashes
– It will not be subject to vibration during operation
– The ventilation slots are not obstructed
►
Connect the equipotential bonding connection on the rear of the
device to the equipotential bonding connection at the installation site.
10
Stacking of units
►
Do not exceed the maximum stack height of 450 mm.
►
Place the units in a stable position.
►
Aesculap devices must be stacked on top of each other facing identi-
cally.
►
Never stack in an offset arrangement.
Connecting 2D monitors
►
Follow the instructions for use of the monitors used.
►
Connect a DVI connector to a monitor or connect a 3G-SDI connector
to a 2D monitor.
Connecting a documentation system
In connection with an external documentation system (such as EDDY 3D),
the Full HD CMOS camera control unit can record images and videos.
►
Follow the instructions for use of the documentation system.
►
Connect a remote connection (Remote 1 or Remote 2) of the camera
control unit with the corresponding connection on the documentation
system.
Connecting the light source OP950
The connected light source can be controlled using the buttons on the
camera head.
►
Connect the MIS-Bus connectors of the camera control and light
source with each other.
►
Ensure that the connectors engage in place when inserting them.
2.5
First use
WARNING
Risk of injury and/or product malfunction due to incorrect operation
of the medical electrical system!
►
Adhere to the instructions for use of any medical device.
Requirement: Installation must have been completed.
►
Connect the camera head.
►
Switch on the device and all devices being used.
►
Use the focusing ring to focus the image.
►
Use the zoom ring to set the desired image size.
►
Set the white balance.
►
Check that a good image is displayed on the monitor at working dis-
tance without vertical lines, color variations, or flickering.
►
Ensure that the buttons on the camera head and camera control unit
can be operated properly.
►
If applicable, ensure that the light source can be switched on and off
via the buttons on the camera head and camera control unit.
Voltage
The mains voltage must correspond to the voltage indicated on the type
plate at the back of the unit.
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