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Indications for Use/Intended Use
The LCD Monitor is intended to provide 4K 2D color
video displays of surgical and other medical
images.
Regulatory Information relevant under
the European Medical Device Regulation
2017/745 as amended (MDR)
The LCD Monitor is intended to provide displays of
surgical and other medical images for review and
treatment of disease or an injury.
Notes
• This equipment is not intended for diagnostic
use.
• This equipment is for medical professionals.
• This equipment is intended for use in medical
environments, such as clinics, examination
rooms, and operating rooms.
Contraindications
There are no known specific situations that
contraindicate the use of this device.
Patient population
Patient population is not subject to any
restrictions.
Warning
To reduce the risk of fire or electric shock, do not
expose this equipment to rain or moisture.
To avoid electrical shock, do not open the
cabinet. Refer servicing to qualified personnel
only.
No modification of this equipment is allowed.
Warning
To avoid the risk of electric shock, this
equipment must only be connected to a supply
mains with protective earth.
Warning
This unit has no power switch.
To disconnect the main power, unplug the power
plug.
When installing the unit, incorporate a readily
accessible disconnect device in the fixed wiring, or
connect the power plug to an easily accessible
socket-outlet near the unit.
Do not position the ME equipment where it is
difficult to unplug the power plug.
If a fault should occur during operation of the unit,
operate the disconnect device to switch the power
supply off, or disconnect the power plug.
Symbols on the product
Consult the instructions for use
Follow the directions in the instructions
for use for parts of the unit on which this
symbol appears.
This symbol indicates the manufacturer,
and appears next to the manufacturer’s
name and address.
This symbol indicates the Importer, and
appears next to the Importer’s name and
registered office address.
This symbol indicates the European
Community representative, and appears
next to the European Community
representative’s name and address.
This symbol indicates the UK
Responsible Person, and appears next to
the UK Responsible Person’s name and
address.
This symbol indicates the Swiss
authorized representative, and appears
next to the Swiss authorized
representative’s name and address.
This symbol indicates the medical device
in the European Community.
This symbol indicates the date of
manufacture.
This symbol indicates the serial number.
This symbol indicates the Unique Device
Identifier (UDI), and appears next to the
bar code representation of the Unique
Device Identification.
This symbol indicates the equipotential
terminal which brings the various parts
of a system to the same potential.
Storage and transport temperature
This symbol indicates the acceptable
temperature range for storage and
transport environments.
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