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2.6
Application
2.6.1
System set-up
WARNING
Risk of infection due to unsterile parts!
►
Unsterile components must not enter the sterile area.
►
Process products and accessories that are delivered unsterile before
use and only use them with sterile accessories.
CAUTION
Risk to patient due to addition of leakage currents!
►
If the product is used with medical electrical equipment and/or
power-driven endoscope accessories the leakage currents can mul-
tiply.
WARNING
Risk to patient and user from burns, sparks or explosion!
►
When using a high frequency surgical device during an endoscopic
procedure, observe the safety instructions of the corresponding
instructions for use.
WARNING
Risk of injury due to improper use!
►
Observe the intended use of the camera control unit.
CAUTION
Interference of electromagnetic emissions with the image quality (e.g.,
minor banding, minor color changes on the monitor image)!
►
Check the image quality if used in combination with additional
peripheral devices (e.g., monitor, documentation system).
Note
Before application of endoscopic high frequency surgery prepare the
patient accordingly.
Take measures to remove or avoid formation of combustible gases (e.g.,
gastro-intestinal tract/colonoscopy, urinary bladder/transuretheral resec-
tion).
Note
In combination with the Full HD CMOS camera control unit, the endoscope
is classed as a type CF defibrillation-proof applied part.
Connecting the accessories
DANGER
Risk of injury due to unapproved configuration using additional com-
ponents!
►
For all applied components, ensure that their classification matches
that of the application component (e.g., type CF defibrillation-
proof) of the respective device.
Combinations of accessories that are not mentioned in the present
instructions for use may only be employed if they are specifically intended
for the respective application, and if they do not compromise the perfor-
mance and safety characteristics of the products.
All devices connected to the interfaces must also be proven to fulfill the
relevant IEC standards (IEC 60950 for data processing devices and
IEC/EN/DIN 60601-1 for medical electrical devices).
All
configurations
must
IEC/EN/DIN 60601-1. The person connecting the devices with each other
is responsible for the configuration and must ensure that the fundamental
standard IEC/EN/DIN 60601-1 or relevant national standards.
►
Please contact your B. Braun/Aesculap partner or the Aesculap Techni-
cal Service, address: see Technical service.
fulfill
the
fundamental
Connecting the power supply
DANGER
Risk of death by electric shock!
►
Connect the product only to a grounded power supply.
►
Ensure that the mains voltage at the site of operation corresponds to
that specified on the device nameplate.
►
Connect the power cord to the mains connection socket on the rear of
the device.
►
Connect the power cord to the power supply.
►
Lay the cable so that no-one can trip over it or get caught in it.
Visual inspection
Carry out a visual inspection prior to every procedure:
►
Ensure that the device has been properly set up. Ensure that the equi-
potential bonding has been properly connected.
►
Ensure that the housing is free from external damage.
►
Ensure that the power cord and all other cables are not damaged.
►
Ensure that the contacts in the connection sockets for the camera head
are free from moisture and contamination.
2.6.2
Function checks
WARNING
Risk of electric shock from defective cables or devices!
►
Inspect the electrical equipment regularly.
►
Replace loose, worn or defective cables/connections.
WARNING
Risk to patient and user from functional failure or electric shock!
►
Use only dry components (e.g., plug connector for camera control
unit, optical lens).
WARNING
Risk to patient due to incorrectly displayed image!
►
Prior to application and after every change of settings (e.g., acti-
vation of algorithms) check the correct display of the live image. If
necessary, perform white balance.
Note
Only perform the surgical procedure if all of the components being used are
in a flawless condition.
Note
Before each use, after a power failure or any interruption, the functionality
of all connected devices must be checked and all connections must be
checked to see they are correct.
Note
The endoscope image must be focused, bright and clean at an appropriate
working distance.
Note
Do not continue to use damaged products.
standard
en
11
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