Zeiss opmi lumera 700, Instructions For Use Manual

Page: 213 / 236

Instructions for Use 11 Technical specifications
OPMI LUMERA 700 11.9 Guidance and manufacturer´s declaration – electromagnetic immunity
G-30-1673-en - 14.0 - 2018-07-12 213 / 236
11.9.1 EMC - electromagnetic compatibility IEC 60601-1-2
11.9.1.1 Electromagnetic disturbance emissions
The OPMI LUMERA 700 is intended for operation in an electromagnetic environment as specified below. The
customer or the user of the OPMI LUMERA 700 is responsible for ensuring that the device is operated in such
an environment.
Interference measurements Compliance
HF emissions as per CISPR 11 Group 1
HF emissions as per CISPR 11 Class B*
Harmonic emissions as per IEC
61000-3-2 Class A*
Emission of voltage fluctuations/
flicker as per IEC 61000-3-3 Compliant*
Note*
* The OPMI LUMERA 700 as a system combination with CALLISTO eye Panel PC (model I with SN 690912xxx
and 690914xxx) is suitable for use in facilities other than locations in residential environments and those
directly connected to the public power supply network which also supplies buildings used for residential
purposes, provided that the following warning note is observed:
WARNING: This system is only intended for use by trained medical personnel. This is a class A system as
specified in CISPR 11. In residential areas, this device may cause radio interferences necessitating appropriate
corrective measures to be taken, such as reorientation, repositioning or shielding of the OPMI LUMERA 700,
or filtering of the connection to the site of use.
11.9.1.2 Electromagnetic immunity for all ME equipment and ME
systems
The OPMI LUMERA 700 is intended for operation in an electromagnetic environment as specified below. The
customer or the user of the OPMI LUMERA 700 is responsible for ensuring that the device is operated in such
an environment.
Electromagnetic immunity tests IEC 60601 test level Compliance level
Electrostatic discharge (ESD) as per
IEC 61000-4-2 ± 8 kV
contact discharge ± 8 kV
contact discharge
±15 kV
air discharge ±15 kV
air discharge
Electrical fast transient/burst
immunity as per IEC 61000-4-4 ± 2 kV for
power supply lines ± 2 kV for
power supply lines
±1 kV for
input/output lines ±1 kV for
input/output lines
Surges as per IEC 61000-4-5 ± 1 kV
phase-to-neutral voltage ± 1 kV
phase-to-neutral voltage
± 2 kV
phase/neutral to ground voltage ± 2 kV
phase/neutral to ground voltage