Electromagnetic Compatibility - INTERSON ViewBladder 10 User Manual

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Electromagnetic Compatibility

Like other medical equipment, Interson USB Ultrasound Probes require special precautions to
ensure electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC), Interson USB Ultrasound Probes must be installed and
operated according to the EMC information provided in this manual.
The Interson USB Ultrasound Probes have been designed and tested to comply with IEC 60601-
1-2: 2002 requirements for EMC with other devices.
Y
CAUTION
Portable and mobile RF communications equipment may affect the normal function of the
Interson USB Ultrasound Probes.
Y
CAUTION
Do not use cables or accessories other than those provided with the Interson USB Ultrasound
Probe, as this may result in increased electromagnetic emissions or decrease immunity to such
emissions.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions & Immunity
Interson USB Ultrasound Probes are intended for use in the electromagnetic environment specified below. The customer or
the user of the Interson USB Ultrasound Probe should ensure that it is used in such an environment.
Environmental
Phenomena
Radiated Emissions
Electrostatic Discharge
Radiated Immunity
EFT
I/O Only
Conducted Immunity
I/O Only
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
Interson's USB Ultrasound Probes are intended for use in the electromagnetic environment specified below. The
customer or the user of the Interson USB Ultrasound Probe should ensure that it is used in such an environment.
Field strength form fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, armature radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Interson USB Ultrasound Probe is used exceeds
the applicable RF compliance level, the Interson USB Ultrasound Probe should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Interson
USB Ultrasound Probe system.
01-9932-00 ViewBladder 10 User Guide Revision 2
Test In
Accordance to
EN60601-1-2 Group 1
Class a
EN60601-1-2 ±2kV ±4kV ±8kV
contact discharge
±2kV ±4kV ±8kV
air discharge
EN60601-1-2 80MHz-2.5GHz
3V/m 80%@1kHz
EN60601-1-2 ±2kV
5/50 5kHz
EN60601-1-2 0.15 – 80MHz
3Vrms
80%@1kHz
Level Criteria
Under Limit
36.202.1 (j)
36.202.1 (j)
36.202.1 (j)
36.202.1 (j)
Basic Notes
Standard
CISPR 11 Measure at 5
meters
EN61000-4-2 Apply to all
accessible
components
EN61000-4-3 Expose all parts
of EUT to field
EN61000-4-4 None
EN61000-4-6 None
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