Specifications
ARveo / Ref. 10 747 384 / Version 04 67
14.4 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,
hold the management system certificates for the international
standard ISO 13485 relating to quality management, quality
assurance and environmental management.
14.5 Limitations of use
The ARveo may be used only in closed rooms and must be placed on
a solid floor.
The ARveo is not suitable for crossing thresholds higher than
20 mm.
To move the surgical microscope 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 transport
position, pushing it by the handgrip.
Without auxiliary equipment, the ARveo can be moved across
thresholds up to a max. height of 5 mm.
