Additional Manufacturer Narrative · 1
CONCLUSIONS - THIS SEEMS TO BE A TRAINING ISSUE. THERE MUST BE A DIRECTED FORCE APPLIED ONTO THE EXPOSURE/FLUOROSCOPY FOOT PEDALS TO GENERATE X-RAYS. THIS MEANS THAT THE FLOOR ON WHICH THE MOBILE UNIT STANDS MUST BE UNEVEN OR SOME OTHER OBJECT COULD IMPACT WITH THE CORRECT FORCE TO ACTIVATE THE EXPOSURE/FLUOROSCOPY FOOT PEDALS. THIS IS OUTSIDE OF THE INTENDED USE. REPOSITIONING OF THE MOBILE UNIT IS OFTEN REQUIRED, BUT IT SHOULD NOT BE THE CASE THAT IT CAN COME INTO CONTACT WITH ANY CIRCUMSTANCE THAT CAN CAUSE ACTIVATION OF THE EXPOSURE/FLUOROSCOPY FOOT PEDALS INTENTIONALLY OR OTHERWISE. ALSO BEFORE STOW AWAY, ALL X-RAY PROCEDURES HAVE ENDED AND THE SYSTEM SHOULD BE PUT IN THE "DISABLED X-RAY FUNCTION", INDICATED BY A LED LIGHT AS STATED IN THE INSTRUCTION FOR USE (IFU). FINALLY, SECTION 2 IN THE IFU DISCUSSES THE NEED FOR ADEQUATE TRAINING BEFORE USING THE MULTIDIAGNOST ELEVA FOR ANY APPLICATIONS. THE FOOT SWITCH IS OPERATING TO SPECS.