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N
U
OTICE TO
SERS
Z-WORLD PRODUCTS ARE NOT AUTHORIZED FOR USE AS CRITICAL COMPONENTS IN LIFE-
SUPPORT DEVICES OR SYSTEMS UNLESS A SPECIFIC WRITTEN AGREEMENT REGARDING
SUCH INTENDED USE IS ENTERED INTO BETWEEN THE CUSTOMER AND Z-WORLD PRIOR
TO USE. Life-support devices or systems are devices or systems intended for surgical implantation into the
body or to sustain life, and whose failure to perform, when properly used in accordance with instructions for
use provided in the labeling and user's manual, can be reasonably expected to result in significant injury.
No complex software or hardware system is perfect. Bugs are always present in a system of any size. In
order to prevent danger to life or property, it is the responsibility of the system designer to incorporate
redundant protective mechanisms appropriate to the risk involved.
All Z-World products are 100 percent functionally tested. Additional testing may include visual quality con-
trol inspections or mechanical defects analyzer inspections. Specifications are based on characterization of
tested sample units rather than testing over temperature and voltage of each unit. Z-World products may
qualify components to operate within a range of parameters that is different from the manufacturer's recom-
mended range. This strategy is believed to be more economical and effective. Additional testing or burn-in
of an individual unit is available by special arrangement.
User's Manual
95
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