Leica M320 - Safety Notes; Intended Use; Indications for Use; Directions for Responsible Personnel

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Leica M320 / Ref. 10 718 878 / Version 02
3.1 INTENDED USE
• The Leica M320 surgical microscope is an optical instrument for improving the visibility of
objects through magnication and illumination. It can be applied for observation and doc-
umentation and for human and veterinary medical treatment.
• The Leica M320 surgical microscope is subject to special precautionary measures for elec-
tromagnetic compatibility.
• Portable and mobile as well as stationary RF communications equipment can have a nega-
tive eect on the reliability of the Leica M320 surgical microscope's functionality.
• The Leica M320 is intended for professional use only.
3.2 INDICATIONS FOR USE
• The Leica M320 surgical microscope is suitable for surgical applications such as ENT and
dental sugeries in hospitals, clinics or other human medical institutions.
• The Leica M320 surgical microscope may only be used in closed rooms and must be placed
on a solid oor or mounted to the ceiling.
• This User Manual is intended for physicians, nurses and other medical and technical sta
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
- The surgical microscope may be used by qualied and trained users only, with all covers t-
ted.
- Only use the surgical microscope if it is free of defects.
- Operate the system only with all equipment in its proper position (e.g. all covers tted, doors
closed).
- Regularly check to make sure the users are complying with safety requirements.
- Provide comprehensive instructions and explain the warning messages.
- Assign and monitor responsibilities for commissioning, operating and maintenance.
- Use the surgical microscope in proper condition only.
- Do not place the drape to close to the instrument, as otherwise it can overheat and shut o.
- Inform your Leica representative or Leica Microsystems (Schweiz) AG immediately if you
detect a product defect that could potentially cause injury or harm.
- Only the following accessories may be used with the surgical microscope.
• Leica Microsystems accessories described in this user manual
• Other accessories, provided that these have been expressly approved by Leica as being
technically safe in the context.
- Use original accessories or approved Leica accessories only.
- Use only high-quality HDMI cables with a maximum length of 15 m.
- Use only monitors approved for medical purposes or equipped with an isolating transformer.
- Modications or repairs may be carried out by authorized trained personnel only.
- Use only original Leica parts in maintenance work.
- After maintenance or technical modications, readjust the instrument in accordance with
our technical specications.
- If the instrument is modied by or maintenance has been performed by unauthorized per-
sonnel, if the equipment is improperly maintained or if the instrument has been operated
improperly, Leica disclaims all liability.
- The owner or operator shall be held liable for the function of the system if the system has
been assembled incorrectly by individuals who do not belong to Leica Microsystems
(Schweiz) AG.
- The inuence on other devices by the Leica M320 surgical microscope has been tested in
accordance with EN 60601-1-2. 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.
- Only the supplied power cord may be used.
- The power cord must have a protective conductor and must be undamaged.
- Use of accessories and cables other than those specied or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electro-
magnetic immunity of this equipment and result in improper operation.
- The Leica M320 surgical microscope may be used only in closed rooms and must be placed
on a solid oor.
- 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M320, including cables specied by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
- 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.
- 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 congurations 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 congures 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 SAFETY NOTES