Zeiss OPMI PROergo S7, Instructions For Use Manual, Page: 141 / 268

Version 11.0
G-30-1435-en
Page 141
S7 / OPMI PROergo Preparations for use
System kit
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 requirements set out in the standards for medical electrical
systems (see IEC 60601-1, chapter 16).
Anyone connecting additional equipment to medical electrical devices is
a system configurer and, as such, is responsible for compliance of the system
with the standard 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 Carl Zeiss Service.
WARNING Risk of serious injury due to unauthorized modification!
You must not modify this device without the permission of the manufacturer.
The manufacturer is
not liable for damages caused by an unauthorized use
of the device.
Unauthorized modifications of the device may result in severe, irreversible
injuries to users and/or patients.
• If you modify the device after consultation with the manufacturer,
you must carry out the appropriate inspections and tests to ensure that
it can still be used safely.
NOTE This equipment must not be modified without the manufacturer’s
approval!
Your devices may not be modified without the manufacturer’s approval.
If the system is modified after consultation with the manufacturer, suitable
inspections and testing must be completed to ensure subsequent safe use.
The manufacturer is not liable for damages caused by an unauthorized use
of the device. Furthermore, such unauthorized modifications will render the
warranty and any claims under warranty invalid.
R017