Class 1 Equipment:
Equipment in which protection against electric shock does not
rely on basic insulation only, but includes a grounding pin on the power cord. For
ground reliability always plug the power cord into an AC grounded outlet.
Type BF Equipment:
Type B piece of equipment with an F-Type applied part.
A Type B piece of equipment is one that provides a particular degree of protection
against electric shock, particularly regarding allowable leakage current and reliability
of the protective earth connection (grounding).
F-Type applied part is one that extends from the patient into the equipment and is
isolated from all other parts of the equipment.
Water Ingress:
This device does not have protection against ingress of water.
Disinfection:
With the exception of the patient circuit, this device can be disinfec-
ted using 70% isopropyl alcohol or equivalent. (See Section 6: Cleaning and
Disinfection.)
Flammable Anesthetics:
This device is not suitable for use in the presence of a
flammable anesthetic mixture with air, or in the presence of a flammable anesthetic
mixture with oxygen or nitrous oxide.
Intermittent Operation:
This device is designed for
Intermittent Operation Only
and not for continuous use. The device should not be cycled continuously for more
than 5 minutes. After such time, the unit should either be turned off or left idling with
the blower on for at least 5 minutes.
E Q U I P M E N T C L A S S I F I C AT I O N
Per IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety, the
CoughAssist MI-E is classified as follows:
SECTION 2
W
A R N I N G S
A N D
C
A U T I O N S
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