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14.9 Electromagnetic compatibility
(EMC)
Environment for which the instrument is suitable
Hospitals except for near active HF Surgical Equipment and the RF
shielded room of an ME System for magnetic resonance imaging,
where the intensity of EM Disturbances is high.
Compliance IEC 60601-1-2
Emissions • CISPR 11, Class A, Group 1
• Harmonic Distortion per IEC 61000-3-2 Class A
• Voltage Fluctuation and Flicker per IEC 61000-3-3
Class A, Figures 3-7
Immunity • Electrostatic discharge IEC 61000-4-2:
CD +/- 8 kV, AD +/- 15 kV
• Radiated RF EM Fields IEC 61000-4-3:
80 – 2700 MHz: 10 V/m
• Proximity Wireless fields IEC 61000-4-3:
380 – 5785 MHz: 9 V/m; 28 V/m
• Electrical Fast Transients and
bursts IEC 61000-4-4:
± 2 kV: Power supply lines
• Surges IEC 61000-4-5:
± 1 kV Line-to-line
± 2 kV Line-to-ground
• Conducted disturbances, induced by RF fields
IEC 61000-4-6:
10 V rms
• Rated Power-frequency Magnetic Field IEC 61000-
4-8:
30 A/m
• Voltage dips and interruptions IEC 61000-4-11:
according to IEC 60601-1-2:2014
• Acceptable operating conditions/responses:
• flickering/noise on the HD monitor
• interruption on the HD monitor
• Specific compliance criteria for the voltage dips and
interruptions test:
• The equipment is allowed a deviation at the
immunity levels (0% of nominal voltage for 5 s),
provided the equipment remains safe,
experiences no component failures and is
restorable to the pre-test state with operator
intervention.
14.10 Standards fulfilled
CE conformity
• 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, 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.
14.11 Configurations and Weights
WARNING
Risk of injury from downward movement of surgical
microscope!
X
X
The stands have the following maximum load from the interfaces of
the microscope:
Stand
Max. load
M844 / Ref. 10 713 294 / Version 01
Do not exceed the max. load when equipping
components and accessories.
Check the total weight using the "List of weights of
balanceable configurations", chapter 14.13.
F40
12.2 kg
Specifications
F20
CT40
11.5 kg
12.2 kg
73
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