Mindray BeneFusion VP5 - A Product Specifications; Safety Specifications; Product Classification

A-1
A Product Specifications
A.1 Safety Specifications
A.1.1 Product Classification
Classified according to the China SFDA, this infusion pump is a Type II device.
Classifications of this infusion pump according to the IEC60601-1 standard are as
follows:
Safety
Components Host
Type of protection
against electrical shock
Class I
Degree of protection
against electrical shock
Type CF defibrillation proof
Ingress Protection IP23
Degree of safety of
application in the
presence of flammable
anesthetic mixture with
air or with oxygen or
nitrous oxide
The equipment is not suitable for use in the
presence of a flammable anesthetic mixture with air
or with oxygen or nitrous oxide
Mode of operation Continuous
Mobile level Portable
NOTE:
 CF: Type CF applied parts, can be directly used in the heart.
 IP23: Protected against solid foreign objects with a diameter no less than
12.5mm and protected against spraying water.
 Portable devices: Can be moved from one place to another by one or more
persons or by other means when the devices are in use or being used.