Instructions for Use
1 Safety and Certifications
CLARUS 500
1.4 Report Serious Accidents
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NOTE
Connecting the device to a network that includes other
equipment
may result in previously unidentified risks.
u
You are responsible for analyzing and controlling these risks.
u
You must reassess these risks when you make any changes to
the network, including connecting, disconnecting, or upgrading
equipment.
NOTE
Unprotected devices
may be at risk from unauthorized individuals.
u
Select and set the Password strength setting in the User man-
agement screen.
1.4 Report Serious Accidents
Report any serious incident related to this instrument, the operator,
patient, or anyone else:
• To the instrument manufacturer or distributor.
• (European Union only) To the compentent authority in the state
where the instrument operator is established.
1.5 Essential Performance
The main clinical performance of the CLARUS 500 is to capture, dis-
play and store images to aid in the diagnosis and monitoring of dis-
eases and disorders occurring in the retina, ocular surface and visi-
ble adnexa. Since there is are no surgical or treatment decisions
made solely on data obtained by the instrument, it was determined
that the CLARUS 500 has no “essential performance” as defined in
IEC 60601-1 standard.
1.6 Electromagnetic Compatibility (EMC)
WARNING!
Installing or putting the device into service without regard to
EMC information provided
may void your Device warranty, result in damage to the instrument
and/or compromise safety for patients and operators.
u
CLARUS 500 has special EMC precaution requirements and
needs to be installed and put into service according to the EMC
information provided herein.
Содержание CLARUS 500
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