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124/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2
Appendix COSMED srl
F-Type Applied Part Applied part in which the patient connections are isolated from other parts of the
medical electrical equipment to such a degree that no current higher than the
allowable patient leakage current flows if an unintended voltage originating from an
external source is connected to the patient, and thereby applied between the patient
connection and earth.
Type B Applied Part Applied part complying with the specified requirements of this standard to provide
protection against electric shock, particularly regarding allowable patient leakage
current and patient auxiliary current.
Type BF Applied Part F-type applied part complying with the specified requirements of this standard to
provide a higher degree of protection against electric shock than that provided by type
B applied parts.
Medical Electrical Equipment Electrical equipment having an applied part or transferring energy to or from the
patient or detecting such energy transfer to or from the patient and which is:
• provided with not more than one connection to a particular supply mains;
and
• intended by its manufacturer to be used:
– in the diagnosis, treatment, or monitoring of a patient; or
– for compensation or alleviation of disease, injury or disability
Medical Electrical System Combination, as specified by its manufacturer, of items of equipment, at least one of
which is medical electrical equipment to be inter-connected by functional connection
or by use of a multiple socket-outlet.
Class I Term referring to electrical equipment in which protection against electric shock does
not rely on basic insulation only, but which includes an additional safety precaution in
that means are provided for accessible parts of metal or internal parts of metal to be
protectively earthed.
Class II
Term referring to electrical equipment in which protection against electric shock does
not rely on basic insulation only, but in which additional safety precautions such as
double insulation or reinforced insulation are provided, there being no provision for
protective earthing or reliance upon installation conditions.
Visual inspection
Special attention shall be paid to the following:
• Safety related marking, labels and labelling are legible and complete.
• The integrity of mechanical parts.
• Any damage or contamination.
•
Assess the relevant accessories together with the device.
• The required documentation is available and reflects the current revision and/or configuration.
After testing, repair or adjustment, check that the device is restored to the conditions necessary for intended use
before being returned into service.