Technical data
Leica M220 F12 / Ref. 10 716 922 / Version 03 41
13.9 Standards fulfilled
CE conformity
• Medical Devices Directive 93/42/EEC including amendments.
• Classification: Class I, in compliance with Annex IX, Rule 1 and
Rule 12 of the Medical Devices Directive.
• Medical electrical equipment, Part 1: Generally defined for the
security in IEC 60601-1; EN 60601-1; UL 60601-1;
CAN/CSA-C22.2 NO. 601.1-M90.
• Electromagnetic compatibility
IEC 60601-1-2; EN 60601-1-2; EN 61000-3-2; IEC 61000-3-2.
• Further applied harmonized standards: IEC 62366, IEC60825-1,
EN60825, IEC 62471, EN62471, EN 980.
• The Medical Division, within Leica Microsystems (Schweiz) AG,
holds the management system certificates for the international
standard ISO 13485 relating to quality management and quality
assurance.
13.10 Limitations of use
The Leica M220 F12 surgical microscope may be used only in
enclosed rooms and on solid, level floors and ceilings.
For the Leica M220 F12 drift effects must be taken into
account on floors which slant >0.3°.
The Leica M220 F12 is not suitable for crossing thresholds higher
than 20 mm.
Without auxiliary equipment, the Leica M220 F12 can only be
moved across thresholds up to a max. height of 5 mm.
To move the Leica M220 F12 over thresholds of 20 mm, the wedge
(1) included in the packaging can be used.
X
Place the wedge (1) in front of the threshold.
X
Move the surgical microscope across the threshold in the
transport position, pushing it by the handgrip.