Zeiss PLEX Elite 9000, Instructions For Use Manual

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1 Safety and Certifications Instructions for Use
2660021169042 Rev. A 2018-03 1.3 Safety
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CAUTION!
(United States) Federal law restricts this device for sale by, or
on the order of, a licensed healthcare practitioner.
u
Purchasing from an unlicensed healthcare practitioner is against
(United States) Federal law.
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Purchasing from an unlicensed healthcare could result in a non-
standard, incorrectly installed, and faulty instrument that could
risk result accuracy and patient or operator safety.
NOTE
The PLEX® Elite 9000 Power Table is safe to use within the
patient environment when the instrument is powered
through it, as instructed herein.
1.3.2 Product Safety
WARNING!
An ungrounded Device
could lead to electric shock.
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Do not remove or disable the ground pin.
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Only an authorized ZEISS service representative may service the
instrument.
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Only an authorized ZEISS representative may install the
instrument.
WARNING!
Installation of devices and systems by persons not autho-
rized by ZEISS
can lead to the injury of patients and operators, as well as to
property damage. Installation requires special knowledge and skills.
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Have the installation performed only by persons authorized by
ZEISS.
WARNING!
Non-compliance with system requirements laid out in
standard IEC 60601–1
could result in compromised patient safety.
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The person or the responsible organization connecting
additional devices or reconfiguring the system must evaluate
the complete system to ensure compliance to the applicable
IEC 60601–1 requirements.