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27.2.3 High-Level Disinfection
Follow a high-level disinfection protocol between the use of the device on different patients. Use
a high-level disinfectant, such as Steris Corporation’s Resert XL-HLD, and follow the
manufactures guidelines. See also “FDA-Cleared Sterilants and High Level Disinfectants with
General Claims for Processing Reusable Medical and Dental Devices” available at:
https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices-information-
manufacturers/fda-cleared-sterilants-and-high-level-disinfectants-general-claims-processing-
reusable-medical-and.
27.3 Resetting Your Lamp Hours
Whenever the lamps are changed in your device, it is important to reset the lamp age to zero.
Test unit only radiates RF energy for internal use in
powering lamps, and it seems unlikely that nearby medical
devices would be affected.