Product Manual

Important safety considerations
Vscan – User Manual 7-9
GM092207 02
Figure 7-1. Patient environment
Allergic reactions to latex-containing medical devices
Due to reports of severe allergic reactions to medical devices
containing latex (natural rubber), the FDA advises health-care
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, incubation 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.
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 60601-1-2
(IEC 60601-1-2).
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.
1. Patient environment