United States Federal Law restricts this medical device for sale by or on order of a licensed physician.
The Renew® NCP-5 should only be operated under the direct supervision of a licensed physician or by personnel who have completed the requisite training in the use of the NCP-5 system.
Technicians must be thoroughly familiar with the system’s controls, safety features and functions as detailed in the manual.
The Renew® NCP-5 must be connected to a properly grounded 110 Volt 15 amp electrical outlet for safe operation.
With the exception of a few specified minor routine maintenance procedures contained in the manual, the Renew® NCP-5 is not user-serviceable. To avoid electrical hazard, damage to the system and/or danger to the technician or patient, refer all service maintenance to LifeLine Sciences, LLC service personnel.
Renew® NCP-5 should not be used in the presence of flammable anesthetics or in an oxygen rich environment such as the ICU, CCU, ER or surgical operating suite, or in close proximity to strong magnetic fields such as found near an MRI.
Do not connect any other signal source to the electrocardiogram cable or the patient’s plethysmograph sensor without first consulting LifeLine Sciences, LLC.
No part of this medical device requires sterilization. Do not autoclave or immerse any component of this system in fluids.
Operation of the ECP treatment should not be performed if the system fails to initialize properly.