Bayer HealthCare MEDRAD MRXperion, Operation Manual, Page: 113 / 126

Operation Manual 18 - 103
18.4.3 Protection Against Electrical Shock
Per IEC 60601-1, the system is designed as a Class 1 Medical Device with a type BF applied part.
Type BF corresponds to the degree of protection against electrical shock by the applied part of the Medical Device. Class 1
equipment requires a protective earth connection (electrical grounding) to ensure protection against electrical shock in the
event of a failure of the basic insulation system. The following are requirements for a Class 1 Type BF Medical Device:
18.4.3.1 Electrical Leakage
Complies with EN, UL, CSA, and IEC requirements for safe Electrical Leakage Current limits for Medical Equipment:
18.4.4 EMI/RFI
The injection system is classified as Group 1, Class A equipment per the requirements of IEC 60601-1-2. Accessories provided
by Bayer comply with this standard.
18.4.5 Protection Against the Ingress of Fluids
Per IEC 60601-1, the scan room unit has been classified as drip-proof equipment. The components of the system scan room
unit are provided with an enclosure that prevents the entry of such an amount of falling liquid as might interfere with the
safe operation of the injector, indicated by the IPX1 designation on the injector head. The scan room unit power supply, Pod
power supply, and display power supply, along with the display, and all other control room equipment are classified IPX0.
Care must be taken to prevent spilling fluids on these power supplies, displays, and control room equipment.
18.4.6 Mode of Operation
Per IEC 60601-1, the mode of operation for the control room unit is continuous operation. It will operate under normal load
for an unlimited period, without excessive temperature being developed.
The mode of operation for the scan room unit is continuous operation. Under normal operating conditions with a minimum
of 10 minutes between injections, the internal temperature of the scan room unit will not rise enough to degrade system
performance, reliability, or safety.
Earth Leakage Current: < 500 microamps (Normal Condition)
Chassis (Touch) Leakage Current: < 100 microamps (Normal Condition)
Patient Connection Leakage Current: < 100 microamps, a.c. (Normal Condition)