Safety Conformance - GE Voluson Swift Instructions For Use Manual

Technical Data/ Information

13.1 Safety conformance

Conformance details
Emission:
Immunity:
Electrical safety:
Mechanical safety:
Thermal safety:
Duty cycle:
Safety classification:
Safety classification with ECG
Ambient temperature:
Barometric pressure:
Humidity:
Humidity protection:
Maximum operating altitude:
Pollution degree:
Overvoltage category:
Material group:
Light conditions
Type and model
13-2
The Voluson™ SWIFT / Voluson SWIFT+ conforms to the following standards and
regulations :
CISPR11, EN 55011
IEC/EN61000-3-2
IEC/EN61000-3-3
IEC/EN61000-4-2
IEC/EN61000-4-3
IEC/EN61000-4-4
IEC/EN61000-4-5
IEC/EN61000-4-6
IEC/EN61000-4-8
IEC/EN61000-4-11
IEC/EN60601-1
IEC/EN60601-1
IEC/EN60601-1
100% on
Class I & INTERNALLY POWERED ME EQUIPMENT, applied parts type BF acc. to
IEC/EN60601 incl. national deviations
Class I, applied parts type CF acc. to IEC/EN60601 incl. national deviations
•
18ºC to 30ºC resp. 64ºF to 86ºF (operation temp. of instrument)
•
-10ºC to 50ºC resp. 14ºF to 122ºF (storage and transport temp.)
•
700 to 1060 hPa (operation condition)
•
700 to 1060 hPa (storage and transport condition)
•
30 to. 80% RH no condensation (operation condition)
•
10 to 90% RH no condensation ( Voluson™ SWIFT / Voluson SWIFT+ storage and
transport condition)
IPX0 no humidity protection
3000m; depending on the properties of the connected electronic devices the maximum
operating altitude is limited to the altitude stated in the corresponding user manual of
the connected electronic device
2
II
IIIb
Natural & artificial light source (Bright light could impact readability of screen)
Type: Voluson™
Model: Voluson™ SWIFT / Voluson SWIFT+
Group 1 Class A
Harmonic current emissions
Voltage Change, Fluctuations and Flicker
Electrostatic Discharge
Radiated RF EM Fields
Electrical Fast Transients and bursts
Surges
Conducted RF Fields
Rated Power-frequency Magnetic Field
Voltage Dips and Interruptions
Voluson™ SWIFT / Voluson SWIFT+ Instructions For Use
5831612-100 Revision 4