1 Safety and Certifications
Instructions for Use
2660021169042 Rev. A 2018-03
1.6 RoHS Compliance
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2660021169042 Rev. A 2018-03
ð
Test of protective ground conductor
ð
Function and wear test of brakes, if applicable
ð
Function test of all switches, buttons, sockets and indicator
lamps of the system
WARNING!
Making changes to equipment without first consulting your
ZEISS Field Representative
could result in the equipment being Out of Compliance.
u
Any additional equipment connected to medical electrical
devices must demonstrably comply with the applicable IEC or
ISO standards (e.g. IEC 60950 for data processing equipment).
u
All configurations must meet the normative requirements for
medical systems (see IEC 60601-1-1 or Clause 16 of the 3rd
edition of IEC 60601-1, respectively).
u
Anyone connecting additional equipment to medical electrical
devices is a system configurer and as such is responsible for
compliance of the system with the standards for systems.
u
Local legislation has priority over the above normative require-
ments.
1.5.3 Notification of Serious Incident
Any serious incident, affecting any person, that occurs in
connection with the use of this medical device, must immediately
be reported to the manufacturer or to the medical product
distributor. In the European Union, the operator must report this
serious incident to the responsible authorities in the applicable
country.
1.6 RoHS Compliance
The product is RoHS-compliant according to Directive 2011/65/EU.
Summary of Contents for PLEX Elite 9000
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