User Risk Information

M1128

The RAMPART ic M1128 is a protective radiation shield intended to safeguard users from radiation exposure during fluoroscopic medical procedures. An optional arm board is available to support a patient’s arm during procedures requiring radial access. Sterile disposable drapes are placed over each individual panel and attached curtain assembly to maintain a sterile environment.

RAMPART ic M1128 offers radiation attenuation only to users positioned behind the M1128 shielding with correct use per the User Guides (Version 1 and Version 2). Full body radiation protection (including head and arms protection) is only achieved with the appropriate and combined use of the M1128, its Rampart Radial and Lower Extremity Curtains and under-table lead equivalent curtains, as per the User Guides (Version 1 and Version 2). Users should wear additional lead shielding aprons if the under-table and M1128 extremity curtains are not installed.

Sterile drapes are available for all M1128 panels and accessories that may come into contact with sterile field. Sterile drapes and appropriate aseptic technique must be used to prevent cross-contamination.

All users of RAMPART ic products should ensure that they are in compliance with any applicable laws and regulations governing the use and operation of radiation-producing equipment before removing lead aprons or protective clothing.

• What are the risks associated with the RampartIC M1128?

As with the use of any medical device, individual results may vary. See the RAMPART ic M1128 User Guide for all risks, warnings and contraindications. Potential risks include, but are not limited to:

Radiation exposure:

Failure to set M1128 panels and curtains at proper height and/or failure to use under-table lead equivalent curtains with M1128 may cause unwanted radiation exposure.  Users should wear additional lead shielding aprons if the under-table and M1128 extremity curtains are not installed.

Cross contamination or infection:

Failure to use sterile drapes or use of aseptic technique may lead to cross contamination and potential infection.

Incorrect use during transit:

Failure to lock legs and maintain control when moving the system can result in personal injury or property damage.

• RampartIC M1128 should not be used in the following environments:

M1128 is MR-unsafe: MR-unsafe items should not be brought into MRI scanner rooms.

• References:

M1128 User Guides (Version 1 and Version 2)

For product experience feedback, please email info@rampartic.com.

L148

RAMPART ic L148-TMS can only offer radiation protection when used properly, according to the guidelines found in the User Guide.