Allergic Reaction; Electromagnetic Compatibility (Emc); Information On Electromagnetic Compatibility - Whale PE-12-025 User Manual

Allergic Reaction

External Connection Of Other Peripheral Devices
Other external devices, such as laser cameras, printers, VCRs and external
monitors, usually exceed allowable leakage limits and, when plugged into
separate AC outlets that are then connected to the unit, are in violation of
patient safety standards, Suitable electrical isolation of such external AC out-
lets may be required in order to meet IEC 60601-1 (2005) standards for elec-
trical leakage.
2.12 Allergic Reaction
Due to reports of severe allergic reaction to medical devices containing la-
tex, the FDA advises health-care professionals to identify latex-sensitive pa-
tients, and to be prepared to treat allergic reactions promptly. Latex is a
component of many medical devices, including surgical and examination
gloves, catheters, incubation tubes, anesthesia masks, and dental dams. Pa-
tients' reaction to latex ranged from contact urticaria, to systemic anaphy-
laxis.
For more details regarding allergic reaction to latex, refer to FDA Medical
Alert MDA91-1, March 29.
2.13

Electromagnetic Compatibility (EMC)

2.13.1

Information on electromagnetic compatibility

Portable and mobile RF communications equipment can affect the Portable
Ultrasound Diagnostic Scanner.
The use of ACCESSORIES, transducers and cables other than those specified,
with the exception of transducers and cables sold by the manufacturer of
the Portable Ultrasound Diagnostic Scanner as replacement parts for inter-
nal components, may result in increased EMISSIONS or decreased IMMUNI-
TY of the Portable Ultrasound Diagnostic Scanner.
The Portable Ultrasound Diagnostic Scanner should not be used adjacent to
or stacked with other equipment. If adjacent or stacked use is necessary, the
Rev 1.00
External devices can be used only if Whale marked them to be in com-
CAUTION
pliance with related standards (IEC 60601-1: 2005).
External devices meeting IEC 60601-1: 2005 should be kept outside of
CAUTION
the patient environment.
Chapter 2 - Safety
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