Specifications
60
PROVIDO Ref. 10732418 / Version 03
PROVIDO Ref. 10732418 / Version 03 61
14.6 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. 60601-1:14 (2014).
• 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,
EN60825-1, IEC 62471, EN62471.
• 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.
14.7 Limitations of use
The PROVIDO may be used only in closed rooms and must be placed
on a solid floor.
The PROVIDO 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.
1
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.
CAUTION
Damage to the PROVIDO during transportation.
X
Never move the stand in the extended condition.
X
Always change to transport position before move
PROVIDO stand.
X
Never roll over cables lying on the floor.
X
Never transport or move the system at an inclination of
more than 10°.
X
Do not tilt the system to more than 10° as it might tip
over.
X
Only move the PROVIDO in transport position.