Safety notes
4 M320 Ref. 10734261 / Version 03 M320 Ref. 10734261 / Version 03 5
X
The power cord must have a protective conductor and must be
undamaged.
X
Use of accessories and cables other than those specified or
provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.
X
The Leica M320 surgical microscope may be used only in closed
rooms and must be placed on a solid floor.
X
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the LeicaM320,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
X
Like any other instrument in the operating theater, this system
may fail. Leica Microsystems (Schweiz) AG therefore
recommends that a backup system be kept available during the
operation.
X
Additional equipment connected to medical electrical
equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950 or IEC 62368 for data processing
equipment). Furthermore all configurations shall comply with
the requirements for medical electrical systems (see clause 16
of the latest valid version of IEC 60601-1). Anybody connecting
additional equipment to medical electrical equipment
configures a medical system and is therefore responsible that
the system complies with the requirements for medical
electrical systems. If in doubt, consult your local representative
or the technical service department.
3.5 User qualifications
The Leica M320 surgical microscrope may be used only by
physicians and medical assistance personnel with appropriate
qualifications who have been instructed in the use of the
instrument. Specific training is not required.
3.6 Directions for the user of the
instrument
X
Follow the user Manual.
X
Follow the instructions given by your employer regarding the
organization of work and safety at work.
X
Do not modify the surgical microscope.
X
Danger of tilting of the floor stand! When moving the floor
stand, fold up the swing arm as described above and tighten
the articulation brakes.
X
Risk of injury from moving parts! Assemble and balance the
accessories before the operation. Do not install it above the
field of operation.
X
Risk of injury from rolling of the floor stand! Always push the
microscope to move it; never pull it. Do not roll it over anyone’s
feet. Do not roll over cables lying on the floor. Lock the foot
brakes during the operation, and never move the device during
operation.
X
Do not shine lights in anyone’s eyes.
X
Do not switch off/on the surgical microscope during surgery.
X
Do not unplug the system during surgery.
X
Do not cover up the ventilation slot of the optics carrier.
X
Before an extended period of non-use, remove the battery from
the remote control.
X
To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
X
All parts of the M320 shall not be serviced or maintained while
in use with a patient.
X
Lamps shall not be changed while in use with a patient.
X
Only use the surgery microscope if it is free of defects.
NOTE
Using accessories or cables other than those specified here or as
approved by the manufacturer of the Leica M320 surgical
microscope can lead to elevated electromagnetic emissions or
reduced interference resistance.
The Leica M320 surgical microscope may not be used in direct
proximity of other devices. If it is necessary to operate it in the
vicinity of other instruments, the instrument should be monitored
to ensure that it functions properly in this arrangement.