Hologic Fluoroscan Insight FD - X-Ray Shielding; Regulations for X-Ray Equipment; United States Federal and State Regulations; IEC Regulations

Insight FD Mini C-Arm Imaging System User Guide
Regulations for X-Ray Equipment
3 MAN-09971 Revision 001
X-ray Shielding
The scattered radiation from the Insight 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.
Regulations for X-Ray Equipment
United States Federal and State Regulations
Fluoroscan 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.
IEC Regulations
Fluoroscan 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 60601-2-7
IEC/EN 60601-1-1 IEC/EN 60601-1-4 IEC/EN 60601-2-28
IEC/EN 60601-1-2 IEC/EN 60825-1 IEC/EN 60601-2-32