FujiFilm VisualSonics Vevo MD, User Manual

Page: 341 / 463

Electromagnetic interference
WARNING: To avoid possible electrical shock or electromagnetic
interference, verify proper operation and compliance with relevant safety
standards for all equipment before clinical use. Connecting additional
equipment to the Vevo MD Imaging System constitutes configuring a
medical system. FUJIFILM SonoSite recommends verifying that the system,
all combinations of equipment, and accessories connected to the Vevo MD
Imaging System comply with JACHO installation requirements and/or
safety standards such as AAMI-ES 60601-1, NFPA 99 or EN/IEC Standard
60601-1-1 and electromagnetic compatibility standard IEC 60601-1-2
(Electromagnetic compatibility), and are certified according to IEC Standard
60950 Information Technology Equipment (ITE) or IEC 60601-1.
WARNING: The Vevo MD Imaging System system has been found to
temporarily lose touch screen functionality during 430kHz~2MHz common-
mode noise injection on the AC mains. FUJIFILM SonoSite recognizes
system's sensitivity to this kind of noise and assures users that such a loss
of the touch screen capability doesn't affect core ultrasound imaging
functionality of the system. This phenomenon is qualified as permissible
loss of performance for the Conducted Immunity test as per EC 61326-
1:2012, Table 1.
Caution: To avoid the risk of increased electromagnetic emissions or decreased
immunity, use only accessories and peripherals recommended by FUJIFILM
SonoSite. Connection of accessories and peripherals not recommended by
FUJIFILM SonoSite could cause your ultrasound system to malfunction or cause
other medical electrical devices in the area to malfunction.
Caution: The use of accessories, transducers and cables other than those
specified (with the exception of UHF transducers and Vevo MD Imaging System
cables sold by FUJIFILM SonoSite as replacement parts for internal components)
may result in increased emissions or decreased immunity of the Vevo MD Imaging
System.
Product safety 341