Medrad Mark 7 Arterion, Operation Manual

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MEDRAD
®
Mark 7 Arterion Injection System
17 - 136
17.4 Environmental Specifications
17.4.1 Operating
The system may not meet all performance specifications if operated outside the following conditions.
17.4.2 Non-Operating: (Transportation and Storage)
17.4.3 EMI/RFI
The injector system is classified as Group 1, Class A equipment per the RF emission requirements of
EN 60601-1-2. Accessories provided by Bayer will also comply with this standard.
17.4.4 Equipment Classification
Type of protection against electrical shock: Class 1.
Degree of protection against electrical shock: Type CF Defibrillation-proof applied part.
Degree of protection against ingress of water: IPX1.
Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide: Equipment is not suitable for use in the presence of a flammable anaesthetic
mixture with air or with oxygen or with nitrous oxide.
Mode of operation: Continuous.
17.4.5 Class I Product
A product that is provided with a reliable protective earth (PE) such that all accessible metal parts
cannot become live in the event of a failure of basic insulation and therefore will provide protection
against electric shock in the case of failure of basic insulation.
17.4.6 Type CF Defibrillation-proof Applied Part
The Injection System is Type CF Defibrillation-proof as the System may be utilized in a situation when
the applied part is connected to the patient while defibrillation is applied. During the discharge of a
cardiac defibrillator to a patient connected to the Defibrillation-proof applied part, hazardous energies
do not appear on the enclosures, signal input and output parts.
17.4.7 IPX1
IEC 60529 classification of degree of protection (IP Code) provided by enclosures of electrical
equipment against ingress of vertically dripping water with harmful effects.
Temperature: +15ºC to +30º C (+59ºF to +104ºF)
Humidity: 20% to 75% R.H.
Air Pressure: 70 kPa to 106 kPa after it has stabilized to within the operating pressure ranges.
Temperature: -20ºC to 60ºC (-4ºF to +140ºF)
Humidity: 5% to 100% R.H.
Air Pressure: 57 kPa to 106 kPa after it has stabilized to ambient conditions.