Safety
HD11 XE Getting Started
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ARNINGS
• Use only acoustic standoffs that have been approved by Philips Ultrasound.
• Transducer covers may contain natural rubber latex. Those covers may cause
allergic reactions in some individuals. Refer to the FDA Medical Alert on Latex
Products, dated March 29, 1991.
• In contrast studies using a high-MI acoustic field, capillary rupture, due to
microbubble expansion within a capillary in an acoustic field, can cause
extravasation.
• Preventricular contractions can be caused by the oscillations of microbubbles
when a high-MI acoustic field is triggered in the heart at the end of systole. In
a very sick patient with certain risk factors, theoretically, this could lead to
ventricular fibrillation. References: 1. Skyba DM, Price RJ, Linka AZ, Skalak
TC, Kaul S. Direct in vivo visualization of intravascular destruction of microbubbles
by ultrasound and its local effects on tissue. Circulation 1998;98:290-293. 2. van
Der Wouw PA, Brauns AC, Bailey SE, Powers JE, Wilde AA. Premature ventric-
ular contractions during triggered imaging with ultrasound contrast. J Am Soc
Echocardiogr 2000;13(4):288-94.
• If the sterile transducer cover becomes compromised during an intraopera-
tive application involving a patient with Creutzfeldt-Jakob disease, follow the
recommendations described in “Transmissible Spongiform Encephalopathy”
on page 54.
• If the system becomes contaminated internally with bodily fluids carrying
pathogens, you must immediately notify your Philips Ultrasound service repre-
sentative. The system’s internal components cannot be disinfected. In this
case, the system must be disposed of as biohazardous material in accordance
with local or federal laws.
• The backlight lamps in the system displays contain mercury and must be recy-
cled or disposed of according to local, state, or federal laws.
ALARA Education Program
The guiding principle for the use of diagnostic ultrasound is defined by the “as low
as reasonably achievable” (ALARA) principle. The decision as to what is reason-
able has been left to the judgement and insight of qualified personnel. No set of
rules can be formulated that would be sufficiently complete to dictate the correct
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