Bayer HealthCare Certegra, Operation Manual

Page: 94 / 104

MEDRAD
®
Stellant CT Injection System with Certegra
®
Workstation
17 - 86
17.5.2 Operating
NOTE:
The system may not meet all performance specifications if operated outside of the following
conditions.
17.5.3 Protection Against Electrical Shock
Per IEC 60601-1, the system is designed as a Class 1 or 2 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.
17.5.3.1 Electrical Leakage
Complies with UL, CSA and IEC requirements for safe Electrical Leakage Current limits for Medical
Equipment:
17.5.3.2 Ground Continuity
< 0.2 ohms from power cord ground pin to base, workstation, or head enclosure.
17.5.4 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.
17.5.5 Protection Against the Ingress of Fluids
Per IEC 60601-1, the injector head has been classified as drip proof equipment. This component of the
system is 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. This is indicated by the IPX1 designation on the
injector head.
NOTE:
In the event of fluid ingress or spillage on the injection system ensure all equipment and
accessory connections are removed, dried, and inspected. Follow hospital policies and
procedures, or contact Bayer Service personnel for performing appropriate electrical safety
and operational checks prior to use.
17.5.6 Mode of Operation
Per IEC 60601-1 the mode of operation for the base and the display is continuous operation. They are
capable of operation under normal load for an unlimited period, without excessive temperature being
developed.
The mode of operation for the injector head is continuous operation with intermittent loading. Although
power is applied to the head continuously, the intermittent use of loading and injecting will result in an
Temperature:
+10
o
C to + 40
o
C (+50
o
F to +104
o
F)
Humidity: 20% to 90% R.H.
Air Pressure: 70 kPa to 105 kPa
Earth Leakage Current: < 300 microamps (NC)
Chassis (Touch) Leakage Current: < 100 microamps (NC)
Patient Connection Leakage Current: < 100 microamps (NC)