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3
Safety notes
The MyVeo is state-of-the-art technology. Nevertheless, hazards
can arise during operation.
Always follow the instructions in this user manual, and in
X
particular the safety notes.
3.1
Indications for use
MyVeo is an all-in-one surgical visualization headset used with
compatible surgical microscopes and other medical imaging
systems in the area of neurosurgery, ENT, spine, plastic and
reconstructive surgery.
3.2
Intended use
MyVeo is intended to be used to display the digital data and
images received from the surgical microscope and other compatible
medical imaging systems. It allows user to visualize these digital
data and images on an all-in-one surgical visualization headset.
MyVeo is an accessory to the surgical microscope and other
compatible medical imaging systems.
3.3
Contraindications for use
None.
3.4
Directions for the person
responsible for the instrument
Ensure that the MyVeo is used only by persons qualified to do
X
so.
Ensure that this user manual is always available at the place
X
where the MyVeo is in use.
Carry out regular inspections to make certain that the
X
authorized users are adhering to safety requirements.
When instructing new users, do so thoroughly and explain
X
the meanings of the warning signs and messages.
Only use the MyVeo all-in-one surgical visualization headset
X
when it is free of defects.
Inform your Leica representative or Leica Microsystems
X
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland,
immediately about any product defect that could potentially
cause injury or harm.
Ensure that the hub is properly fixed to the Leica operating
X
microscope.
• Handle medical devices with care.
• Modifications to or service on the MyVeo may be carried out
only by technicians who are explicitly authorized by Leica to do
so.
• Only original Leica replacement parts may be used in servicing
the product.
• If the instrument is modified or serviced by unauthorized
persons, is improperly maintained (as long as maintenance
was not carried out by Leica), or is handled improperly,
Leica Microsystems will not accept any liability.
• Like any other instrument in the operating theater, this
system may fail. Leica Microsystem (Schweiz) AG therefore
recommends that a backup system is kept available during
the operation and the binocular tube always assembled.
• Store the MyVeo adequately when not in use.
• Ensure that the viewing unit is folded up while storing MyVeo in
the dedicated case, see chapter 6.6.
3.5
Follow the instructions described here.
X
Follow the instructions given by your employer regarding the
X
organization of work and safety at work.
Do not touch unsterile interfaces.
X
Handle medical devices with care.
X
Remember that the viewing unit is unsterile when tilted
X
upwards while using binocular tube.
In the right and the left side visualization modes the surgeons
X
have a 2D view with a reduced field of view compared to the
main and the back visualization modes where the surgeons
have a 3D stereo view.
Additional external connected video sources will always be
X
displayed for all headsets in 2D.
The essential performance of the MyVeo is low latency, showing
X
correct information and having good image quality displayed to
the user.
3.6
When performing surgery with the all-in-one surgical visualization
headset always keep the binocular tubes for the main surgeon
mounted on the microscope and ready for use. In case of image loss
on the all-in-one surgical visualization headset the surgery can
always be completed by using the binocular tubes.
3.7
The intended target population are patients undergoing a surgical
procedure as defined within the intended purpose and indications
for use.
3.8
The MyVeo is intended for professional use only. The user must have
corresponding technical qualification and have been trained in the
use of the instrument.
MyVeo / Ref. 10 748 740 / Version 04
Directions for the operator of the
instrument
Directions for the use of the
system combination
Intended target population
Intended user
Safety notes
3
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