Instructions for Use
1 Safety and Certifications
2660021169042 Rev. A 2018-03
1.3 Safety
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CAUTION!
Reconfiguring system components on the table, or adding
non-system devices or components to the table, or replacing
original system components with substitutes not approved
by ZEISS
could result in failure of the table height adjustment mechanism,
instability of the table, tipping and damage to the instrument, and
injury to operator and patient.
u
Do not reconfigure system components on the table, nor add
non–system devices or components to the table, nor replace
original system components with substitutes not approved by
ZEISS.
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.
u
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.
1.3.3 Optical Safety
• IEC 60825-1
•
ANSI Z80.36-2016
• Classification: Group 1 Instrument – Per
ANSI Z80.36-2016
.
Group 1 instruments are ophthalmic instruments for which no
potential light hazard exists
WARNING!
Device produces visual stimuli, including flickering light and
flashing patterns, between 5 and 65 Hz
may adversely affect certain patients, although this effect is yet
unproven.
u
Medical professionals need to determine whether this device
should be used for patients who may be photosensitive,
including those with epilepsy.
Содержание PLEX Elite 9000
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