48 Leica M844 – Leica M820 / Ref. 10 713 294 / Version I
Safety notes
Intended use
• The Leica surgical microscope is an optical instrument for
improving the visibility of objects through magnification and
illumination. It can be applied for observation and documen tation and for human and veterinary medical treatment.
• The Leica surgical microscope may be used only in closed
rooms and must be placed on a solid floor or attached to a
strong ceiling.
• The Leica M820 and Leica M844 surgical microscopes are subject to special precautionary measures for electromagnetic
compatibility. They must be installed and put into operation in
accordance with the guidelines, manufacturer's declarations
and recommended safety distances (Tables 201, 202, 204, and
206 from EN 60601-1-2:2001).
• Portable and mobile as well as stationary HF communications
equipment can have a negative effect on the reliability of the
Leica M820 and Leica M844 surgical microscopes.
Directions for the person responsible for
the instrument
➩Ensure that the surgical microscope is used only by persons
qualified to do so.
➩Ensure that this user manual is always available at the place
where the surgical microscope is in use.
➩Carry out regular inspections to make certain that the
authorized users are adhering to safety requirements.
➩When instructing new users, do so thoroughly and explain
the meanings of the warning signs and messages.
➩Assign individual responsibilities for starting, operating and
servicing the Leica surgical microscope and monitor the
observance of these responsibilities.
➩Only use the surgical microscope if it is free of defects.
➩Inform your Leica representative or Leica Microsystems
(Schweiz) AG, Surgical Division, 9435 Heerbrugg, Switzerland,
immediately if you detect a product defect that could
potentially cause injury or harm.
➩If you use accessories made by third-party manufacturers
with the Leica surgical microscope, be sure that each such
manufacturer confirms the safety-engineering, harmless
usability of the product and observe the product's user
manual.
➩Modifications to or service on the 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 unit must
be reconfigured with observance to our technical
requirements.
➩If the unit 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 will not
accept any liability.
➩The influence on other devices by the Leica surgical
microscope has been tested in accordance with
EN 60 601-1-2. The system passed the emissions and
immunity test. The standard preventive measures and safety
regulations pertaining to electromagnetic and other radiation
have to be observed
User qualifications
The Leica surgical microscope may only be used by physicians
and medical assistance personnel with appropriate qualifi cations who have been instructed in the use of the instrument.
Specific training is not required.
Directions for the operator of the
instrument
➩Follow the instructions described here.
➩Follow the directions provided by your employer regarding
work organization and safety.
Stability (floor stands only)
When moved in OP, the swing arm must be folded up and
locked and the brakes must be applied, otherwise the swing
arm may drift out of control and the stand could topple.
Hazards due to moveable 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:
• When displacing the stand, push it. Do not 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
M820 and Leica M844 surgical microscopes:
• The Leica accessories described in this user manual.
• Other accessories, provided that these have been expressly
approved by Leica as being technically safe in this context.