Safety notes
2
PROVIDO Ref. 10732418 / Version 03
PROVIDO Ref. 10732418 / Version 03 3
3 Safety notes
The PROVIDO surgical microscope is state-of-the-art technology.
Nevertheless, hazards can arise during operation.
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Always follow the instructions in this user manual, and in
particular the safety notes.
3.1 Intended use
• The PROVIDO surgical microscope is an optical instrument for
improving the visibility of objects through magnification and
illumination. It can be applied for observation and
documentation and for medical treatment.
• The PROVIDO surgical microscope is subject to special
precautionary measures for electromagnetic compatibility.
• Portable and mobile as well as stationary RF communications
equipment can have a negative effect on the reliability of the
PROVIDO surgical microscope's functionality.
• The PROVIDO is intended for professional use only.
3.2 Indication for use
• The PROVIDO surgical microscope is primarily used for
Neurosurgery/ Ear Nose and Throat surgery (ENT)/Spine
Surgery/Dental surgery and PRS surgery in hospitals, clinics or
other human medical institutions.
• The PROVIDO surgical microscope may be used only in closed
rooms and must be placed on a solid floor.
• These Instructions for Use are intended for professional
physicians, nurses and other medical and technical staff who
prepare, operate or maintain the device. It is the duty of the
device owner/operator to train and brief all the operating
personnel.
WARNING
Danger of injury to the eyes.
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Do not use the PROVIDO in ophthalmology.
3.3 Contraindications
Do not use the PROVIDO in Ophthalmology.
3.4 Directions for the person
responsible for the instrument
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Ensure that the PROVIDO surgical microscope is used only by
persons qualified to do so.
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Ensure that this user manual is always available at the place
where the PROVIDO surgical microscope is in use.
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Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
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When instructing new users, do so thoroughly and explain the
meanings of the warning signs and messages.
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Allocate responsibilities for commissioning, operation and
maintenance. Monitor compliance with this.
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Only use the PROVIDO surgical microscope if it is free of defects.
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Inform your Leica representative or Leica Microsystems
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland,
immediately about any product defect that could potentially
cause injury or harm.
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If you use accessories from other manufacturers with the
PROVIDO surgical microscope, make sure that these
manufacturers confirm that the combination is safe to use.
Follow the instructions in the user manual for those accessories.
• Modifications to or service on the PROVIDO surgical microscope
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.
• After service work or technical modifications, the device must
be readjusted in accordance with our technical specifications.
• If the instrument is modified or serviced by unauthorized
persons, is improperly maintained (as long as maintenance was
not carried out by us), or is handled improperly,
Leica Microsystems will not accept any liability.
• The effect of the 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 pre-
cautionary and safety measures relating to electromagnetic and
other forms of radiation
• The electric installation in the building must conform to the
national standard, e.g., current-operated ground leakage
protection (fault-current protection) is suggested.
• 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.
• 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.
• 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
PROVIDO, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.