Zeiss OPMI Lumera i, Instructions For Use Manual

Page: 161 / 184

Version 8.0
G-30-1720-en
Page 161
OPMI Lumera i Device data
System enhancements
The device OPMI Lumera i can be extended with the accessories offered by
ZEISS (see ordering data/accessories) to form an already tested system. This
device combination has been approved by ZEISS.
As per IEC 60601-1, this system’s power outlet is a multiple electrical outlet
intended for use with an ME system.
Connecting electrical devices not approved by ZEISS can lead to a reduced
level of safety on the ME system.
• When configuring your ME system (using the power outlet), you must
comply with the requirements of IEC 60601-1, section 16, as well as the
following measures:
– Do not place multiple electrical outlets on the floor.
– Do not connect any additional multiple electrical outlets.
– Only connect compatible components to the system.
– Do not exceed the max permissible electrical load of multiple electrical
outlets.
– Use multiple electrical outlets only for components of the system.
Medical electrical
systems
Any additional equipment you connect to medical electrical devices must
demonstrably comply with the applicable standards and directives (e.g.,
IEC 60950-1 for data processing equipment).
In addition, all configurations must meet the standard requirements for
medical electrical systems (see IEC 60601-1).
Anyone connecting additional equipment to medical electrical devices is
a system configurer and as such is responsible for compliance of the system
with the normative requirements for medical electrical systems.
Please note that local legislation takes priority over the requirements of the
above-mentioned standards. If you have any questions, contact your local
dealer or ZEISS Service.