CFI Medical awarded CE mark for Zero-Gravity radiation protection system
14 October 2014
CFI Medical has received the CE mark for its Zero-Gravity Suspended Radiation Protection System Floor Unit for protecting clinicians when using X-rays in operating theatres.
The flexible floor unit acts as a single, continuous lead barrier that covers critical parts of the body without exerting pressure. A body shield with 1 mm Pb equivalence and a clear acrylic head shield with 0.5 mm Pb equivalence are suspended from a rail attached to a wheeled base that is parked during use. This allows the clinician to move freely within the cath lab while being fully protected by the "floating" Zero-Gravity system.
There is growing evidence that conventional radiation protective apparel can cause great physical stress, leading to occupational injuries from orthopaedic problems to cumulative radiation doses. Zero-Gravity, designed to address these concerns, was first launched in the US in 2010 and now comprises an installed base of over 250 systems worldwide. Zero-Gravity technology eliminates painful body strain and shields a larger percentage of the body with greater lead equivalency, protecting the health of clinicians working with fluoroscopy and allowing physicians to perform more procedures with less fatigue.
"We are pleased to add the CE mark for personal protection equipment to Zero-Gravity. Combined with our relationship with Biotronik, CFI Medical is looking forward to improving the occupational health and safety of cath labs around the world," said Mike Czop, President, CFI Medical.
Berlin-based Biotronik will continue to act as the exclusive distributor of the system outside North America. "We fully expect Zero-Gravity to become a new standard in European and worldwide interventional labs," added Udo Tegtmeyer, Managing Director, Biotronik. "This personal protective equipment shows that we care about the needs of both patients and physicians. The technology will revolutionize the cath lab setup, dramatically reducing the occupational risks of radiation."
Following initial certification of the Zero-Gravity Floor Unit, three ceiling-mounted configurations will be sequentially submitted for evaluation and certification in the next few months.
Source: Biotronik press release