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2.1.3
Components required for use
CAUTION
If the recommended components are not used, the following
errors/complications may occur, among others:
■
Incorrect color display
■
No/incorrect display of the camera menu
■
Restricted operating function of the camera head
Note
If the product is used with third party devices, unrestricted responsibility is
passed to the system configurator or medical institution.
The Full HD CMOS camera control unit PV480 is intended for use with the
following components:
■
PV481 Full HD CMOS camera head with pendulum coupler
■
PV482 Full HD CMOS camera head with zoom coupler
■
PV485 Full HD 3CMOS camera head with zoom coupler
Additionally, the following components are recommended to guarantee
full functionality:
■
OP950 LED light source
■
PV638 27" Full HD 2D monitor or PV628 31" 4K UHD 2D monitor
2.2
Areas of use and limitations of use
2.2.1
Intended use
The Full HD CMOS camera control unit (PV480) serves the 2D HD visual-
ization of the interior of the body during minimally invasive surgical pro-
cedures and endoscopic examinations.
The application in combination with a camera head serves 2D visualization
of the intracorporal surgical area during endoscopic diagnostic and surgi-
cal procedures.
The Full HD CMOS camera control unit is only used for visualizing and not
for diagnosis.
2.2.2
Indications
■
Minimally invasive procedures
■
General surgery
■
General endoscopy
2.2.3
Contraindications
The use of the Full HD CMOS camera components and its accessory is con-
traindicated if endoscopic procedures are contraindicated for any reason.
As is appropriate with any surgical procedure, consideration must be given
to patient size and workspace volume when using the Full HD CMOS cam-
era components.
Depending on the patient´s disease, there may exist contraindications that
rely on the general condition of the patient or the specific disease pattern.
The decision to perform an endoscopic procedure rests with the responsi-
ble surgeon and should be made on the basis of an individual risk-benefit
analysis.
2.3
Safety information
2.3.1
Clinical user
General safety information
To prevent damage caused by improper setup or operation, and to not
compromise the manufacturer warranty and liability:
►
Use the product only according to these instructions for use.
►
Follow the safety and maintenance instructions.
►
Ensure that the product and its accessories are operated and used only
by persons with the requisite training, knowledge and experience.
►
Store any new or unused products in a dry, clean, and safe place.
►
Prior to use, check that the product is in good working order.
►
Keep the instructions for use accessible for the user.
Note
The user is obligated to report all severe events in connection with the prod-
uct to the manufacturer and the responsible authorities of the state in
which the user is located.
Notes on surgical procedures
It is the user's responsibility to ensure that the surgical procedure is per-
formed correctly.
Appropriate clinical training as well as a theoretical and practical profi-
ciency of all the required operating techniques, including the use of this
product, are prerequisites for the successful use of this product.
The user is required to obtain information from the manufacturer if there
is an unclear preoperative situation regarding the use of the product.
2.3.2
Product
Product-specific safety information
Risk to user and patient from non-observance of instructions, warnings
and precautions!
►
Use the product only according to these instructions for use.
►
Check the product is in good working order before use.
►
Carry out function checks before using the equipment.
►
Do not use the product if irregularities are observed during inspections
and checks.
Risk of injury due to electric shock!
►
Ensure that the rear of the device and access to the mains plug is freely
accessible at all times.
►
When installing a medical electrical system, there is a risk of fire, short-
circuit or electric shock. Installation must be performed by qualified
personnel only.
►
For the combination of electrical devices, follow annex 1 of
IEC/EN/DIN 60601-1. Non-medical devices which adhere to the appli-
cable IEC safety standards may only be connected via a medical isola-
tion transformer. Do not connect any additional non-medical devices
to a medical electrical system.
►
Signal lines from devices with a functional connection, which are con-
nected to different branches of the mains power supply, must be gal-
vanically isolated at both ends.
►
Connect the devices only to a power supply with a protective earth
conductor.
►
After installation of a medical electrical system, perform a test pursu-
ant to IEC/EN/DIN 62353.
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