Specifications And Electrical Ratings; Electromagnetic Emissions; Electromagnetic Immunity - Keeler Cryomatic MKII Gebrauchsanleitung

11. SPECIFICATIONS AND ELECTRICAL RATINGS

The Keeler Cryomatic MKII Console and Reusable Probes are medical electrical instruments.
These instruments require special care concerning electromagnetic compatibility (EMC). This
section describes the suitability in terms of electromagnetic compatibility of these instruments.
When installing or using these instruments, please read carefully and observe what is described
here.
Portable or mobile-type radio frequency communication units may have an adverse effect on
these instruments, resulting in malfunctioning.

11.1 ELECTROMAGNETIC EMISSIONS

Guidance and manufacturer's declaration – electromagnetic emissions
The Cryomatic System is intended for use in the electromagnetic environment specified
below. The customer or user of the Cryomatic System should assure that it is used in such an
environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3

11.2 ELECTROMAGNETIC IMMUNITY

Guidance and manufacturer's declaration – electromagnetic immunity
The Cryomatic System is intended for use in the electromagnetic environment specified below.
The customer or the user should assure that it is used in such an environment.
Immunity test IEC 60601
Test level
Electrostatic ± 8 kV contact
discharge (ESD).
± 15 kV air
IEC 61000-4-2
Cryomatic MKII Cryosurgical console by KEELER
Compliance Electromagnetic environment – guidance
Group 1 The Cryomatic System uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
Class A The Cryomatic System is suitable for use in all
establishments, including domestic establishments and
those directly connected to the public low- voltage
Class A
power supply network that supplies buildings used for
domestic purposes.
Complies
Compliance
level
± 8 kV contact
± 15 kV air
23
Electromagnetic
environment – guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
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