ACUSON Cypress™ Operator’s Manual
10-15
Patient Safety
a latex middle glove could be used. (Latex gloves labeled “hypoaller-
genic” may not always prevent adverse reactions.)
— Whenever latex-containing medical devices are used, especially
when the latex come in contact with mucous membranes, be alert to
the possibility of an allergic reaction.
— If an allergic reaction does occur and latex is suspected, advise the
patient of a possible latex sensitivity and consider an immunologic
evaluation.
Advise patients to tell health professionals and emergency personnel
about any known latex sensitivity before undergoing medical proce-
dures. Consider advising patients with severe latex sensitivity to wear
a medical identification bracelet.
FDA
is asking health professionals to report incidences of adverse
reactions to latex or other materials used in medical devices. (See the
October 1990 FDA Drug Bulletin). To report an incident, call the
FDA
Problem Reporting Program, operated through the U.S. Pharmacopeia
tool-free number 800-638-6725. (In Maryland call collect 301-881-
0256) For further information on the clinical aspects of latex sensitivity,
call Claudia Gaffey MD, FDA Office of Health Affairs, Center for
Devices and Radiological Health at 301-427-1060.
For a single copy of a reference list on latex sensitivity write to:
LATEX
,
FDA
HFZ
-220, Rockville, MD 20857.
Peripheral Device Connections
WARNING
Do not use a peripheral device, such as a monitor,
VCR
or printer
within 1.5 meters of a patient unless the device receives power
from an isolation transformer that meets medical safety stan-
dards.
WARNING
Accessory equipment connected to the analog and digital interfaces
must be certified according to the respective IEC standards (IEC 950 for
data processing equipment and IEC 601-1 for medical equipment). Fur-
thermore, all configurations shall comply with the system standard IEC
601-1-1. Any party who connects additional equipment to the signal
input part or signal output part is considered to be configuring a medical
system, and is therefore responsible for ensuring that the system com-
plies with the requirements of the system standard IEC 601-1-1. If you
have additional questions, contact your SIemens representative.
