Ultra clean triton 72 does not pass efficacy tests when sanizyme enzymatic detergent is used and dosed at 1 ounce per gallon.Efficacy test and active enzyme test not passing with steris prolystica hp enzymatic detergent and check valve on detergent lines were plugged with debris.Once check valves were replaced, efficacy tests were still not passing in all levels, however active enzyme test strip passed.Sonochecks do not pass in all levels consistently.Based on the efficacy tests and sonocheck device, this sonic machines design doesn't have enough sonication power to reach every level when all lumen baskets are tested together.Fda safety report id # (b)(4).
|