Zeiss PLEX Elite 9000 - 1.3.5 Electrical Safety

Instructions for Use 1 Safety and Certifications
2660021169042 Rev. A 2018-03 1.3 Safety
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1.3.4 Laser Safety and Compliance
Figure1: Laser Classification Label
Figure2: Laser Compliance Label
Complies with 21 CFR Subchapter J and with FDA performance
standards for laser products except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007.
1.3.5 Electrical Safety
Class I Equipment - Protection against electrical shock.
1.3.6 Printer and Peripherals Safety
WARNING!
Non-compliance with system requirements laid out in
standard IEC 60601–1 for instruments externally connected
to non-medical peripheral devices (i.e. printers, non-system
storage devices, etc.)
compromises patient safety.
u If a non-medical peripheral device is located within 1.5 m from
the patient, the usage of an isolation transformer is required.
u If the peripheral device is located outside the patient
environment (beyond 1.5 m) and is connected to the
instrument, a separation device must be used or there shall be
no electrical connection between the non-medical peripheral
device and the instrument.
WARNING!
Powering peripherals directly through a wall socket
could result in electrical shock to the patient and/or examiner.
u When using a printer in the USB configuration, always power
the printer through an isolation transformer. Some ZEISS
equipment comes with an isolation transformer that may be