InSight FD Mini C-arm User Guide
Regulations for X-ray Equipment
MAN-04858 Revision 006
3
2.3 X-ray Shielding
The scattered radiation from the InSight FD system is low compared to
many other radiological devices, and the requirement to wear protective
lead aprons and/or attenuating gloves is governed by applicable facility
policy. Also many states, provinces, countries, and individual institutions
may require persons in the same room with any operating fluoroscopic
device to wear lead aprons. The strict observation of safe operating
practices and the use of minimal fluoroscopic times is the key to reducing
user exposure.
3 Regulations for X-ray Equipment
3.1 United States Federal and State Regulations
InSight FD Mini C-arm Imaging Systems conform to the United States
Code of Federal Regulations, 21 CFR 1020.32 “Performance Standards for
Ionizing Radiation Emitting Products: Fluoroscopic Equipment.”
However, additional state regulations may apply to X-ray products. This
may require notifying your state regulatory agency about your installation
and/or operator training and certification.
It is the responsibility of the user to contact the applicable state radiation
control agency to verify that your installation is in compliance with
regulations in your state governing installation and use of X-ray
equipment.
The InSight FD Mini C-arm Imaging System complies with 21CFR
Subchapter J.
The InSight FD Mini C-arm Imaging System is intended for special
surgical applications that would be prohibited at the Source to Skin
Distances (SSD) specified in 21CFR 1020.32 (g) but are permitted under
21CFR 1020.32 (g) (2). The SSD is 10 cm minimum.
3.2 IEC Regulations
InSight FD Mini C-arm Imaging Systems comply with the requirements of
IEC 60601-1. The classification of the InSight FD Mini C
-
arm Imaging
Systems under this specification is Class 1, Type B.
The InSight FD Mini C-arm Imaging Systems comply with the following
IEC standards:
IEC/EN 60601-1
IEC/EN 60601-1-3
IEC/EN 60601-2-28
IEC/EN 60601-1-2
IEC/EN 60825-1
IEC/EN 60601-2-54
