Environmental Specifications - Bayer HealthCare MEDRAD 800 Module Operation & Installation Manual

Environmental
Specifications
Non-Operating: (Transportation and Storage)
o
Temperature: -25 C to 70
Humidity: 5% to 100% R.H., condensing
Air Pressure: 48 kPa to 110 kPa
Operating
(The system may not meet all performance specifications if operated outside
of the following conditions.)
o
Temperature: +10 C to + 40
Humidity: 20% to 90% R.H.
Air Pressure: 69 kPa to 110 kPa
Protection Against Electrical Shock
The ISI 800 Module is designed per IEC 60601-1.
EMI/RFI
NOTE: The injection system is classified as Group 1, Class A
equipment per the requirements of IEC 60601-1-2.
Accessories provided by Bayer will also comply with this
standard.
Electrical Leakage
Complies with UL, CSA and IEC requirements for safe Electrical Leakage
Current limits for Medical Equipment:
Earth Leakage Current:
Chassis (Touch) Leakage Current:
Ground Continuity
< 0.2 ohms from power cord ground pin to enclosure.
Protection Against the Ingress of Fluids
Per IEC 60529, the ISI 800 Module has been classified as drip proof. This is
indicated by the IPX1 designation on the ISI 800 Module.
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 or
contact Bayer for performing appropriate electrical safety and
operational checks prior to use.
Mode of Operation
Per IEC 60601-1 the mode of operation for the ISI 800 Module is continuous.
It is capable of operation under normal load for an unlimited period, without
excessive temperature being developed.
o o o
C (-13 F to +158 F)
o o o
C (+50 F to +104
< 300 microamps (NC)
< 100 microamps (NC)
20
F)