Biological Safety Safety
Lumify Ultrasound System 35
Philips Healthcare 4535 618 58571_A/795 * MAY 2016
WARNING
If the system becomes contaminated internally with bodily fluids carrying pathogens, you
must immediately notify your Philips service representative. Components inside the system
cannot be disinfected. In that case, the system must be disposed of as biohazardous
material in accordance with local or federal laws.
WARNING
Select the correct application when starting an exam, and remain in that application
throughout the exam. Some applications are for parts of the body that require lower limits
for acoustic output.
FDA Medical Alert on Latex
March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices
Because of reports of severe allergic reactions to medical devices containing latex (natural
rubber), the FDA is advising health care professionals to identify their latex sensitive patients
and be prepared to treat allergic reactions promptly. Patient reactions to latex have ranged
from contact urticaria to systemic anaphylaxis. Latex is a component of many medical devices,
including surgical and examination gloves, catheters, intubation tubes, anesthesia masks, and
dental dams.
Reports to the FDA of allergic reactions to latex-containing medical devices have increased
lately. One brand of latex cuffed enema tips was recently recalled after several patients died as
a result of anaphylactoid reactions during barium enema procedures. More reports of latex
sensitivity have also been found in the medical literature. Repeated exposure to latex both in
medical devices and in other consumer products may be part of the reason that the prevalence
of latex sensitivity appears to be increasing. For example, it has been reported that 6% to 7% of
surgical personnel and 18% to 40% of spina bifida patients are latex sensitive.
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