Ziehm Imaging, Inc. QUANTUM, User Manual, Page: 33 / 220

Section 3.0
MAN 06–0017H
ZIEHM QUANTUM
User’s Manual Page 33 of 220
WARNING
This x-ray unit may be dangerous to patient and operator unless safe exposure
factors, operating instructions and maintenance schedules are observed.
3.4.1 GETTERING
If the system is stored for more than 6 uninterrupted months, we recommend that you turn it on
for at least one hour
before using it. Doing so will significantly prolong the useful life of the
image intensifier.
We also recommend that you keep a logbook of operating hours, gettering times, and
maintenance details.
3.4.2 BONDING
If the equipment is used in combination with other equipment for the examination of the heart or
brain, or their proximity, a potential bonding conductor is required for the safety of patients and
operators (IEC and VDE regulations).
You must ensure that the x-ray system meets the requirements of IEC 601 part 1 through a
program of regular maintenance and periodic inspection. You can find a schedule for periodic
inspection in the Technical Manual.
Mobile Stands, and its integrated components (such as monitor, touch screen, USB image storage
devices) are not AP-version. They may not be used in the presence of flammable gasses.
WARNING
Any Supplementary, third-party devices, and or components used in combination
with the
ZIEHM QUANTUM must comply with the safety requirements
according to IEC 60601-1 and/or IEC 60601-1-1 or furnish proof of an equivalent
degree of safety. Combining the
ZIEHM QUANTUM with equipment that does
not comply with IEC 60601-1 and/or IEC 60601-1-1, will lower the safety
classification, compromising the safety of the whole system, which may result in
death or serious injury!
Non-compliance with IEC 60601-1 and or IEC 60601-1-1 may also result with
invalidation of warranty!
3.5 PROTECTION OF THE PATIENT
To minimize the radiation burden of the patient, you must keep the focus-skin distance as large as
possible. The generator design guarantees a minimum focus-skin distance of 20 cm.
WARNING
Make sure that no additional material (e.g. an operating table not suitable for X-
raying) is located in the beam path.
Additional material located in the beam path may result in a dose increase when
using a fluoroscopy mode with automatic exposure rate control.