User's Manual

Safety
2-8
Vscan Air
–
User Manual
Direction GP092020-1EN
Rev 08
Allergic reactions to latex-containing medical devices
Due to reports of severe allergic reactions to medical devices
containing latex (natural rubber), the FDA advises healthcare
professionals to identify latex-sensitive patients, and be
prepared to treat allergic reactions promptly. Latex is a
component of many medical devices, including surgical and
examination gloves, catheters, intubation tubes, anesthesia
masks, and dental dams. Patient reaction to latex has ranged
from contact urticaria, to systemic anaphylaxis.
For more details regarding allergic reaction to latex, refer to FDA
Medical Alert MDA91-1, March 29 1991.
The Vscan Air CL probe does not contain latex.
Electromagnetic Compatibility (EMC)
NOTE: This unit carries the CE mark. It complies with regulatory
requirements of the European Directive 93/42/EEC concerning
medical devices. It also complies with emission limits for a
Group 1, Class B Medical Device as stated in EN/IEC
60601-1-2. It complies with emission limits in RTCA DO-160G,
Section 21, Category M and ETSI EN 301489-1 and ETSI EN
301489-17.
NOTE: The ultrasound unit is suitable for use in all establishments,
including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Electrical medical equipment needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
AII types of electronic equipment may characteristically cause
electromagnetic interference with other equipment, transmitted
either through air or connecting cables. The term
Electromagnetic Compatibility (EMC), indicates the capability of
the equipment to curb electromagnetic influence from other
equipment, while at the same time not affecting other equipment
with similar electromagnetic radiation.
CAUTION
Contact with natural rubber latex may cause a severe
anaphylactic reaction in persons sensitive to the natural latex
protein. Sensitive users and patients must avoid contact with
these items. Refer to package labeling to determine latex
content.