RS-3400 Blood Irradiator FAQ’s

Can I use Rad-Sure™ indicators?

Yes, Rad-Sure™ blood irradiation indicators work well in the RS 3400 Revolution

Can anyone operate the RS 3400 Revolution (security requirements)?

Yes, but check with your local regulations to ensure compliance

Does the RS 3400 Revolution require external cooling?

No, the RS 3400 uses a self contained water to air exchange system

Will the RS 3400 Revolution alert me if there are any problems with the unit?

Yes, there are multiple fault detectors that continuously monitor the irradiation cycle parameters

Is the RS 3400 Revolution easy to operate?

Yes, there is an integrated shelf for preparing and loading the canisters for easy placement into the carousel and the operator’s panel has a simple START button to initiate the cycle

How reliable is the RS 3400 Revolution?

• The RS 3400 has only ONE patented 4 pi X-ray tube and ONE power supply • The unit operates at less than 50% of it’s capability • The power supply is designed to military specifications and has proven very reliable in the RS 2400V irradiators

What is the dose uniformity?

The overall dose uniformity ratio is 1.6

Can you irradiate aliquots?

Yes, up to a 50ml loaded syringe

What is the capacity (number of bags) processed at one time?

From 1 to 6 units per cycle

What is the cycle time?

The cycle time for 1 to 6 units (whole blood bags, platelets, aliquots etc.) is about 300 seconds (5 minutes) depending upon centerline dose requested

Is the RS 3400 Revolution blood irradiator cleared by the FDA for GVHD?

Yes, the RS 3400 was cleared by the US-FDA for marketing for the irradiation of blood for the treatment of graft verses host disease (GVHD) in January 2009

How does the RS 3400 Revolution differ from other X-ray irradiators?

• The RS 3400 is designed to have the blood bags rotate around the 4 pi X-ray tube using our patented carousel and therefore delivers superior uniformity • Unlike other x-ray blood irradiators, the RS 3400 Revolution is completely self-contained and requires no external water supply for tube cooling • The RS 3400 Revolution is engineered for extreme reliability as it uses the proven 4 pi X-ray tube and Mil-Spec power supply • The RS 3400 has only ONE X-ray tube and ONE power supply

How does the RS 3400 Revolution differ from a Cs-137 gamma irradiator?

The RS 3400 uses a Rad Source patented 4 pi X-ray tube and therefore contains NO radioactive isotopes. It can be turned on and off, similar to a light bulb. As a result, there is no Nuclear Site License, Homeland Security issues, or room shielding requirements

What does CDRH stands for?

CDRH stands for the FDA’s Center for Devices and Radiological Health (CDRH). Performance Standards for Ionizing Radiation Emitting Products can be found at CDRH 21CFR1020.40