Safety Notes
Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01 5
• The effect of the Leica M525 F20/CT20 surgical microscope on
other instruments has been tested as specified in EN 60601-1-2.
The system passed the emission and immunity test. Comply
with the usual precautionary and safety measures relating to
electromagnetic and other forms of radiation.
• The building's electrical wiring must comply with the relevant
national standards.
We recommend using a current-operated ELCB system (RCB).
• Like any other instrument in the operating theater, this system
may fail. Leica Microsystems (Schweiz) AG, Medical Division,
therefore recommends that a backup system be kept available
during the operation.
• Only the supplied power cord may be used.
• The power cord must have a protective conductor and must be
undamaged.
• The mains cable must be mechanically secured with the "Power
Input" socket to prevent accidental disconnection.
• The Leica Microsystems surgical microscope 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.
• Connecting electrical equipment to the Auxiliary Power outlet
will result in the establishment of a “ME System” and may result
in a reduced level of safety. The corresponding standard
requirements for “ME Systems” must be observed.
• All parts of the Leica M525 F20/CT20 shall not be serviced or
maintained while in use with a patient.
• Lamps shall not be changed while in use with a patient.
• Use of this equipment adjacent to other equipment should be
avoided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment
should be observed to verify that they are operating normally.
• Use of accessories and cables other than those specified or
provided by the manufacturer of his equipment could result in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.
• 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 Leica
Leica M525 F20/CT20, including cables specified by the
manufacturer. Otherwise, degradation of the performance of
this equipment could result.
Note:
The EMISSIONS characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is used in
a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting the
equipment.
3.5 Instructions for the user
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Follow the instructions described here.
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Follow the instructions given by your employer regarding the
organization of work and safety at work.
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Check the illumination intensity before and during surgery.
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Don't move system without released brakes.
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Operate the system only with all equipment in its proper
position (all covers fitted, doors closed).
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Make sure that the ventilation openings are not covered.
Otherwise, the instrument may overheat.
Stability (floor stands only)
When moved in the operating room, the swing arm must be folded
up and locked and the brakes must be applied, otherwise the swing
arm could drift out of control and the stand could topple.
Hazards due to movable parts
This section describes uses that, inadvertently, could lead to
hazardous situations.
• Add accessories and balance the stand before the operation, and
never over the field of operation.
• Never put your hand between the gas spring and the swing arm;
it could become trapped when the swing arm is moved.
• Do not put your fingers between the microscope and the
focusing drive; They could get crushed.
Floor stand
• Always push the instrument to move it; never pull it. Feet in
lightweight shoes could become trapped beneath the casing of
the base.
• The footbrakes must remain engaged throughout the operation.
Electrical connections
The control unit may be opened only by a Leica-approved service
technician.
Accessories
Only the following accessories may be used with the Leica
Leica M525 F20/CT20 surgical microscopes:
• The Leica Microsystems accessories described in this User
Manual.
• Other accessories, provided that these have been expressly
approved by Leica as being technically safe in this context.
