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Safety
G-30-1607-en
OPMI® VARIO on S8, S81 & S88 Suspension Systems
Issue 5.0
Printed on 30. 01. 2009
Connection of navigation systems (option)
The Carl Zeiss components "Surgical microscope on suspension system"
can be integrated into an external navigation system. An optional naviga-
tion interface is available.
•
The manufacturer of the external navigation system (system supplier)
is responsible for the following:
– Confirmation that his navigation systems have been tested and
certified for operation with the respective Carl Zeiss surgical micro-
scope on a suspension system in accordance with the require-
ments specified in the Carl Zeiss interface description "Navigation
Interface for Carl Zeiss Surgical Microscopes".
– Meeting all requirements (approval, qualifications, etc.) for the
medical system created through coupling via the navigation inter-
face.
– Provision of all accompanying documents required.
– Ensuring that the navigation system is only connected by person-
nel who have undergone appropriate training and instruction.
– Contacting the local Carl Zeiss representative for any inquiries that
may arise.
– Implementation of a procedure that guarantees the calibration of
the surgical microscope which is absolutely vital for the use of the
Carl Zeiss components "Surgical microscope on suspension sys-
tem" in combination with a connected navigation system.
This allows the calibrated surgical microscope combined with the
navigation system to be used like an optical pointer with a variable
length (corresponds to the working distance).
– Conducting complete functional testing, alignment and calibration
(landmark test) of the navigation system after every subsequent in-
stallation or exchange of navigation system components
– Incorporation of a regularly changing icon in the data injection dis-
play of surgical microscopes equipped with a data injection sys-
tem, i.e. the "heartbeat" of the navigation system must be
constantly visible for the user to permit data transmission errors to
be immediately detected.
•
To check the accuracy of the overall system, perform the test specified
by the navigation system manufacturer, e.g. the landmark test, also
using the surgical microscope. This allows you to ensure that the ster-
eotactic data has been correctly generated and transmitted to the nav-
igation system without errors.
