Section 1.0
MAN 06–0017H ZIEHM QUANTUM User’s Manual Page 13 of 220
1.0 SAFETY & RESPONSIBILITIES
This manual does not constitute a complete catalog of all safety and responsibility measures
necessary for the operation of the respective medical equipment, since special operating
conditions may require further measures. However, it does contain an overview of
responsibilities and instructions that must be observed in order to ensure the personal safety of
operating staff and patients as well as avoiding damage to property when operating the ZIEHM
QUANTUM Mobile C-Arm. These are highlighted as follows:
WARNING
This is the highest level of risk. Personal injury or damage to property may
occur if the operator does not observe the instructions provided here.
CAUTION
This means that a situation exists which may require a decision or action on
the part of the user for optimum equipment performance or to avoid a minor
hazard.
NOTE
Notes are informative. Additional useful information and hints are provided
for the operator here.
1.1 INTENDED USE
The ZIEHM QUANTUM Mobile C-arm, is a medical device intended for fluoroscopic imaging
in the field of surgical procedures, e.g. trauma, orthopedics, neurology, urology, pain
management, gastroenterology, ERCP, simple peripheral vascular and limited interventional
procedures such as pacemakers.
Third-party devices and components used in combination with the system must comply with the
safety requirements according to IEC 60601-1 and/or IEC60601-1-1 or furnish proof of an
equivalent degree of safety before use.
Proper and safe operation of the system requires adequate transportation, storage, assembly and
installation as well as appropriate use and maintenance. The limiting values indicated in this user
manual must not be exceeded; this applies also when putting the system into service.
1.2 OPERATION (U.S.A.)
In the U.S.A., Federal law restricts use of this device to trained personnel on the order of a
physician.
1.3 AUTHORIZED PERSONNEL
Only authorized personnel are allowed to assemble and/or repair the medical equipment described
in this manual. Authorized personnel are persons who have attended an appropriate training
course provided by the manufacturer.
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