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Safety notes
3
Safety notes
The M844 surgical microscope 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
Intended use
• The M844 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 human and veterinary medical
treatment.
• The M844 surgical microscope may be used only in closed
rooms and must be placed on a solid floor.
• The M844 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
M844 surgical microscope's functionality.
• The M844 is intended for professional use only.
3.2
Indication for Use
• The M844 surgical microscope is suitable for ophthalmic
application such as Retina, Cornea and Cataract surgery in
hospitals, clinics or other human medical instituations.
• The M844 surgical microscope may only be used in closed
rooms and must be placed on a solid floor or mounted to the
ceiling.
• These Instructions for Use are intended for physicians, nurses
and other medical and technical staff who prepare, operate or
maintain the device after appropriate training. It is the duty of
the device owner/operator to train and brief all the operating
personnel.
3.3
Contraindications
No known contraindications for Use.
3.4
Directions for the person
responsible for the instrument
Ensure that the M844 surgical microscope is used only by
X
persons qualified to do so.
The M844 surgical microscope may only be operated by trained
X
personnel.
Ensure that this user manual is always available at the place
X
where the M844 surgical microscope is in use.
Carry out regular inspections to make certain that the
X
authorized users are adhering to safety requirements.
4
When instructing new users, do so thoroughly and explain the
X
meanings of the warning signs and messages.
Allocate responsibilities for commissioning, operation and
X
maintenance. Monitor compliance with this.
Only use the M844 surgical microscope when it is free of
X
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.
If you use accessories from other manufacturers with the M844
X
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.
• Only the following accessories may be used with the Leica M844
surgical microscope:
• The Leica Microsystems accessories described in chapter 10
this User Manual.
• Other accessories, provided that these have been expressly
approved by Leica as being technically safe in this context.
• Modifications to or service on the M844 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 Microsystem (Schweiz) AG therefore
recommends that a backup system is 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
M844 / Ref. 10 713 294 / Version 01
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